Post on 12-Nov-2014
transcript
Balan, Lim, J., Lim, V., Macasaet, Madulara, Maulion, Medina, Nallas, Ong, Ongoco, Palma
HERBAL MEDICINE
University of Santo TomasFaculty of Medicine and Surgery
Department of Pharmacology
Seminar on
HERBAL MEDICINE
Lim, Maria Joane Faye C. Class No. 22
HERBAL MEDICINE Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Definition of Terms
Traditional and Alternative Health Care
The sum total of knowledge, skills and practices on health care, other than those embodied in biomedicine, used in the prevention, diagnosis and elimination of physical or mental disorder
Lim, Maria Joane Faye C. Class No. 22
HERBAL MEDICINE
Definition of Terms
Traditional Medicine
The sum total of knowledge, skills and practice on health care, not necessarily explicable in the context of modern, scientific philosophical framework, but recognized by the people to help maintain and improve their health.
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Lim, Maria Joane Faye C. Class No. 22
HERBAL MEDICINE
Definition of Terms
BIOMEDICINE
A discipline of medical care advocating therapy with remedies that produce effects differing from those of the diseases treated.
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Lim, Maria Joane Faye C. Class No. 22
HERBAL MEDICINE
Definition of Terms
BIOMEDICINE
Practiced by holders of M.D. (medical doctor) or D.O. (doctor of osteopathy) degrees and by their allied health professionals, such as physical therapists, psychologists, and registered nurses
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Lim, Maria Joane Faye C. Class No. 22
HERBAL MEDICINE
Definition of Terms
BIOMEDICINE
Also called allopathy, western medicine, regular medicine, conventional medicine, mainstream medicine, orthodox medicine, or cosmopolitan medicine.
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Lim, Maria Joane Faye C. Class No. 22
HERBAL MEDICINE
Definition of Terms
Alternative Health Care Modalities
Other forms of non-allopathic, occasionally non-indigenous or imported healing methods, though not necessarily practiced for centuries nor handed down from one generation to another.
Some of the modalities are reflexology, acupuncture, chiropractic care, acupressure, massage, applied kinesiology, homeopathy, diet, and herbal medicine.
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Lim, Maria Joane Faye C. Class No. 22
HERBAL MEDICINE
Definition of Terms
HERBAL MEDICINE
Finished, labeled medicinal products that contain as active ingredient/s aerial or underground part/s of plant or other materials or combination thereof, whether in the crude state or as plant preparations.
However, it may contain excepients in addition to the active ingredient(s).
Medicines containing plant material(s) combined with chemically-defined active substances, including chemically-defined, isolated constituents of plants, are NOT considered to be herbal medicines.
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Lim, Maria Joane Faye C. Class No. 22
HERBAL MEDICINE
Definition of Terms
Natural Product
Foods that grow spontaneously in nature whether or not they are tended by man.
Foods that have been prepared from grains, vegetables, fruits, nuts, meats, fish, eggs, honey, raw milk, and the like, without the use or addition of additives, preservatives, artificial colors and flavors, or manufactured chemicals of any sort after harvest or slaughter
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Lim, Maria Joane Faye C. Class No. 22
HERBAL MEDICINE
Definition of Terms
Manufacture
Any and all operations involved in the production:
including preparation, propagation, processing, formulating, filling, packing, repacking, altering, ornamenting, finishing, or otherwise changing the container, wrapper, or labeling of a consumer product in the furtherance of the distribution of the same from the original place of manufacture to the person who makes the final delivery or sale to the ultimate consumer.
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Lim, Maria Joane Faye C. Class No. 22
HERBAL MEDICINE
Definition of Terms
Traditional Healers
Relatively old, “highly” respected people with a profound knowledge of traditional remedies
They have strong ethical principles that they extend to all life.
They believe it is their duty to foster life in all its forms and to alleviate suffering.
They also believe that Nature's laws must be obeyed in order to avoid decline and ultimate disaster.
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Lim, Maria Joane Faye C. Class No. 22
HERBAL MEDICINE
Definition of Terms
Intellectual Property Rights
Legal basis by which the indigenous communities exercise their rights 'to have access to protect, control over their cultural knowledge and product, including but not limited to, traditional medicines, and includes the right to receive compensation for it.
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
HERBAL MEDICINE
National Integrated Research Program on Medicinal Plants (NIRPROMP)
is a multi disciplinary, multi-agency effort iniated by National Science and Development Authority (NSDA), now the Department of Science and Technology (DOST) in 1974 which aims to:
provide the scientific ground work for the further development of Herbal medicine in the Philippines
systematize the study of medicinal plants in the Philippines with an end goal of providing safe, effective, and affordable pharmaceutical products derived from commonly available plants
Ongoco, Renncee A. Class No. 113
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
HERBAL MEDICINE
National Integrated Research Program on Medicinal Plants (NIRPROMP)
Two IMMEDIATE DRUG NEEDS identified by NIRPROMP
1. Need to distribute medicines within the reach of most Filipinos (safe, effective but affordable to Filipinos)
2. Need to discover new or better drugs for common diseases in the Philippines.
Ongoco, Renncee A. Class No. 113
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
HERBAL MEDICINE
National Integrated Research Program on Medicinal Plants (NIRPROMP)
Ongoco, Renncee A. Class No. 113
Done researches in developing herbal plants in dosage forms with consistent potency. 2 preliminary steps:
They plan and develop the fastest way to get the raw materials needed ( in terms of cultivation, growing, maintenance and harvest of plants)
Harvested leaves are then brought to U.P. College of Pharmacy to be processed, but first tested –
Harvested plant shouldn’t contain: MUTAGENIC and TERATOGENIC COMPOUNDSPESTICIDE RESIDUESAFLATOXINHEAVY METALS(shouldn’t exceed WHO approved levels)Microbial counts not exceeding 100,000 colony forming units
HERBAL MEDICINE
National Integrated Research Program on Medicinal Plants (NIRPROMP)
Ongoco, Renncee A. Class No. 113
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
To date, NIRPROMP has transferred the technology to pharmaceutical manufacturers for the production of 7 herbs in commercial form:
LAGUNDI SAMBONG TSAANG GUBAT
HIERBA BUENA ATIS ACAPULCO
AMPALAYA
HERBAL MEDICINE
National Integrated Research Program on Medicinal Plants (NIRPROMP)
Ongoco, Renncee A. Class No. 113
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Latest Achievements of NIRPROMP
Recent reclassification of ampalaya back to its previous status as a scientifically validated herbal medicinal plant by using a phase 3 clinical trials.
Compared the efficacy and safety of Momordica Charantia, L (ampalaya Makiling variety) leaf tablet and glibenclamide among patients with Type 2 DM
Pascual Laboratories Inc. has secured the license to manufacture, distribute and market a new Ampalaya (bitter gourd) tablet as an anti-diabetic medicine developed by NIRPROMP.
HERBAL MEDICINE
National Integrated Research Program on Medicinal Plants (NIRPROMP)
NIRPROMP Today:
Ongoco, Renncee A. Class No. 113
Screens more plants for possible inclusion in pharmacologic studies.
More plants are being screened for possibly effectiveness in treating malaria, dengue fever, and tuberculosis
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
HERBAL MEDICINE
National Integrated Research Program on Medicinal Plants (NIRPROMP)
What is the PITAHC?
A government owned and controlled corporation (GOCC) in association with the DOH
Answers the present needs of the people on health care provision and delivery of traditional and alternative health care (TAHC) products, services and technologies that have been proven safe, effective and affordable
Philippine Institute of Traditional and Alternative Health Care (PITAHC)
Lim, Vanessa Class No. 25
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
HERBAL MEDICINE
Philippine Institute of Traditional and Alternative Health Care (PITAHC)
VISION-MISSION of PITAHC
Lim, Vanessa Class No. 25
VISION: "Traditional and alternative health care
in the hands of the people"
MISSION: "PITAHC upholds the right of every Filipino
for better health through the provision of safe, effective and affordable traditional and alternative health care products, services and technologies."
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
HERBAL MEDICINE Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
President GMA's 2007 SONA
quest for cheaper medicines through parallel importations without complementary support for developing our own drugs, including alternative
or herbal medicines
Palma, Sharlene Mae S. Class No. 132
HERBAL MEDICINE
DR. JAIME GALVEZ-TAN- former director of the National Institutes of Health (NIH)- president of Health Futures Foundation Inc.
Health research and development over the past 30 years has focused on only 10 medicinal plants.
about P20 million to complete necessary chemical and clinical tests on one plant
at least P200 million for the research and development of a new batch of herbal medicines
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
10 Medicinal Plants (Feria. 2007)
Palma, Sharlene Mae S. Class No. 132
HERBAL MEDICINE
Philippine Council for Health Research and Development (Jaime Montoya, executive director)• coordinates and helps fund studies in alternative medicine
Eight new ongoing research projects• four involve plants on the old-10 list but for new uses
SambongUlasimang batoTsaang gubatBayabas
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
10 Medicinal Plants (Feria. 2007)
Palma, Sharlene Mae S. Class No. 132
HERBAL MEDICINE
This is the list of the 10 medicinal plants that the DOH endorsed through its "Traditional Health Program"
All 10 herbs have been thoroughly tested and clinically proven to have medicinal value in the
relief and treatment of various ailments.
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Palma, Sharlene Mae S. Class No. 132
HERBAL MEDICINE
THE LIST
1. Akapulko (Cassia alata) 2. Ampalaya (Momordica charantia) 3. Bawang (Allium sativum) 4. Bayabas (Psidium guajava)5. Lagundi (Vitex negundo)6. Niyog-niyogan (Quisqualis indica L.)7. Sambong (Blumea balsamifera)8. Tsaang Gubat (Ehretia microphylla Lam.)9. Ulasimang Bato /Pansit-pansitan (Peperomia pellucida)10. Yerba Buena (Clinopodium douglasii)
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Palma, Sharlene Mae S. Class No. 132
HERBAL MEDICINE
AKAPULKO (Cassia alata)
abundant throughout the Philippines
“Bayabas-bayabasan" and “Ringworm bush“
The plant is six feet in height belonging to the legume family.
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Palma, Sharlene Mae S. Class No. 132
HERBAL MEDICINE
AKAPULKO (Cassia alata)
Active substance: Chrysophanic acidtoxic to cattles
Saponin content of leaf extractlaxative useful in expelling intestinal parasitestoxic in rats
Toxic effectschronic diarrhea, loss of appetite, weight loss (in rats)
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Palma, Sharlene Mae S. Class No. 132
HERBAL MEDICINE
AKAPULKO (Cassia alata)
In-vitro studies : high anti-fungal activity on dermatophytic fungi
low activity on non-dermatophytic fungi
plant water extract was also reported to have anti-fungal activity against Candida albicans, and even anti-bacterial activity against E. coli
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Palma, Sharlene Mae S. Class No. 132
HERBAL MEDICINE
AKAPULKO (Cassia alata)
Bioactivity studies on Cassia alata Linn. leaf extracts (Villaseñor, et. al. 2002)
5 mg/20 g mouse the hexane extract was analgesic
5 mg/20 g mouse hexane and EtOAc (Ethyl Acetate)extracts exhibited anti-inflammatory activity with a 65.5% and 68.2% decrease in carrageenan-induced inflammation, respectively
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Palma, Sharlene Mae S. Class No. 132
HERBAL MEDICINE
AKAPULKO (Cassia alata)
2 mg/20 g mouse extract was antimutagenic with a 65.8% inhibition in the mutagenicity of tetracycline
50 mg/mL hexane most active against Trichophyton mentagrophytes, at a concentration of but it had no activity against Candida albicans.
EtOAc extract more active against C. albicans. hypoglycemic at a dosage of 5 mg/20 g mouse,decreased the blood sugar level by 58.3%
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Palma, Sharlene Mae S. Class No. 132
HERBAL MEDICINE
AMPALAYA (Momordica charantia)
“Bitter gourd” or “Bitter melon”
Treatment ofDiabetes Mellitus(non insulin dependent)
Fruit is used
Contraindications: Individuals with liver disease, pregnant women
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Palma, Sharlene Mae S. Class No. 132
HERBAL MEDICINE
AMPALAYA (Momordica charantia)
Active constituents: - sterols (charantin)- triterpenes (momorcharaside A and
momorcharaside B)- proteins (momorcharin A and B, MAP-30)
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Palma, Sharlene Mae S. Class No. 132
HERBAL MEDICINE
AMPALAYA (Momordica charantia)
Contains flavanoids and alkaloids make the Pancreas produce more insulin
Good source of vitamins A, B and C, iron, folic acid, phosphorus and calcium
Hypoglycemic effect: insulin secretagogue effect; insulin like activity found in seeds
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Palma, Sharlene Mae S. Class No. 132
HERBAL MEDICINE
AMPALAYA (Momordica charantia)
Reduces hepatic cholesterol and triglyceride in a dose dependent manner
MAP30 (anti-HIV plant protein) – acts on some stages in viral cycles in acute and chronic infections
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Palma, Sharlene Mae S. Class No. 132
HERBAL MEDICINE
AMPALAYA (Momordica charantia)
Anti-diabetic potentials of Momordica charantia and Andrographis paniculata and their effects on estrous cyclicity of alloxan-induced diabetic rats (Reyes, et. al. 2005)
The blood glucose levels in the groups used in the study were significantly reduced
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Palma, Sharlene Mae S. Class No. 132
HERBAL MEDICINE
AMPALAYA (Momordica charantia)
An Inquiry to the Hypoglycemic Action of Momordica charantia Among Type 2 Diabetes Patients (Rosales and Fernando. 2001)
Ampalaya fruit prepared as a tea can be a useful dietary adjunct in the treatment of diabetes. It is well tolerated and safe with minor gastrointestinal side effects particularly increased bowel movement
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Palma, Sharlene Mae S. Class No. 132
HERBAL MEDICINE
AMPALAYA (Momordica charantia)
The effect of Momordica charantia capsule preparation on glycemic control in Type 2 Diabetes Mellitus needs further studies (Dans, et. al 2006)
More RCT’s with a bigger sample size should be made because results are inconclusive
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Palma, Sharlene Mae S. Class No. 132
HERBAL MEDICINE
BAWANG (Allium sativum)
Hypertension - reduces cholesterol in the blood and hence, helps control blood pressure
Fresh bulbs are the main part utilized for its therapeutic effect
primary active compound in garlic is Allicin (derived from cysteine)
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Palma, Sharlene Mae S. Class No. 132
HERBAL MEDICINE Evaluation of Safety and Efficacy The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
BAWANG (Allium sativum)
Therapeutic effects:Antihypertensive,
Anticholesterolemic, Antilipidemic, Reduces platelet aggregation, Vasodilator, Expectorant, Antihistaminic, Antimicrobial
Palma, Sharlene Mae S. Class No. 132
HERBAL MEDICINE Evaluation of Safety and Efficacy The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
BAWANG (Allium sativum)
Medicinal plants for toothache relief (Marasigan, et. al 2000)
The efficacy of crude ethanolic and aqueous extracts of guava, yerba-buena, avocado, bawang and calachuchi in inhibiting the growth of Lactobacillus acidophilus
Antibacterial activity was determined by paper disc-agar plate method of assay
Palma, Sharlene Mae S. Class No. 132
HERBAL MEDICINE Evaluation of Safety and Efficacy The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
BAYABAS (Psidium guajava)
Used as an antiseptic, to disinfect wounds
mouth wash: tooth decay and gum infection
Rich in tannins, phenols, triterpenes, flavonoids, essential oils, saponins, carotenoids, lectins, vitamins, fiber and fatty acids
Palma, Sharlene Mae S. Class No. 132
HERBAL MEDICINE
BAYABAS (Psidium guajava)
Other flavonoids and triterpenes in guava leaves show antispasmodic activity
Polyphenols (leaves) – antioxidant; Bark and leaf extracts - antibacterial propertiesantifungal, anti-yeast (candida), anti-amebic, and anti-malarial actions
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Palma, Sharlene Mae S. Class No. 132
HERBAL MEDICINE
BAYABAS (Psidium guajava)
A Comparative Study on the Drying Effects of Guava Decoction, 70% Isopropyl Alcohol and Water on Umbilical Cords of Newborns, An In Vitro Experimental study (Dacumos. 2008) Guava decoction double strength has better drying properties (percentage decrease in weight cord) compared to distilled water and 70% Green Cross Isopropyl Alcohol
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Palma, Sharlene Mae S. Class No. 132
HERBAL MEDICINE
LAGUNDI (Vitex negundo)
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
relief of coughs and asthma
endorsed by the DOH as effective in the treatment of colds, flu, and pharyngitisprevent the body's production of leukotrienes
Palma, Sharlene Mae S. Class No. 132
HERBAL MEDICINE
LAGUNDI (Vitex negundo)
Chrysoplenol D: smooth muscle relaxant with anti-histamine properties
Isoorientin
Casticin
Luteolin-7-0-glucoside – anti-histamine effect
Inhibit leukotriene release
National Integrated Research Program on Medicinal Plants, DOST
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Palma, Sharlene Mae S. Class No. 132
HERBAL MEDICINE
LAGUNDI (Vitex negundo)
Main constituents are volatile oil, resin, alkaloid, lichen acids and glucoside
May be used as a leaf decoction for
fever, headache, toothacheanalgesic and antitussive (prepared as a pleasant tasting cough syrup)
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Palma, Sharlene Mae S. Class No. 132
HERBAL MEDICINE
LAGUNDI (Vitex negundo)
Replacement for Dextromethorphan in public health systems
Reduces coughing and relaxes bronchial smooth muscles
Lagundi is one of the few herbs recently registered with the Bureau of Foods and Drugs (BFAD) as medicines
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Palma, Sharlene Mae S. Class No. 132
HERBAL MEDICINE
NIYOG-NIYOGAN (Quisqualis indica L.)
“Chinese honey suckle”
seeds are utilized for its therapeutic effect; dried seeds are preferred
Chemical components of seeds include quisqualic acid (active ingredient), fatty oils, gum and resin
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Balan, Ralph Class No. 03
HERBAL MEDICINE
NIYOG-NIYOGAN (Quisqualis indica L.)
Uses
Antihelminthics (ascariasis) alleviation of nephritis remedy for boils and ulcers relief from ache caused by fever treatment of rheumatism
Adverse Effects
diarrhea, abdominal pain, distention and hiccups, especially if the seeds are eaten fresh or continuously for consecutive days
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Balan, Ralph Class No. 03
HERBAL MEDICINE
SAMBONG (Blumea balsamifera)
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Balan, Ralph Class No. 03
also known as “Camphor”
high in essential oils, and contains significant amounts of camphor oil
commonly used in capsule form or as teas
HERBAL MEDICINE
SAMBONG (Blumea balsamifera)
Diuretic that helps in the excretion of urinary stones
Anti-urolithiasis
Hypertension Mild to moderate congestive heart failure
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Balan, Ralph Class No. 03
HERBAL MEDICINE
SAMBONG (Blumea balsamifera)
THE PHILIPPINE CLINICAL PRACTICE GUIDELINES ON THE DETECTION AND MANAGEMENT OF HYPERTENSION
Report of the Multisectoral Task Force on the Detection and Management of Hypertension Convened by the Philippine Society
of Hypertension (Phil. J. Internal Medicine, 35:67-85, March-April, 1997)
No indigenous herbal preparations have been adequately tested for its antihypertensive effect
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Balan, Ralph Class No. 03
HERBAL MEDICINE
SAMBONG (Blumea balsamifera)
Among the many herbal preparations being speculated as having anti-hypertensive properties, only “sambong” is undergoing a rigorous evaluation.
At present, a randomized, double-blind crossover study is ongoing to test the efficacy of this herbal medicine among mild hypertensiveness [reference unpublished].
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Balan, Ralph Class No. 03
HERBAL MEDICINE
TSAANG GUBAT (Ehretia microphylla Lam.)
“Wild Tea”, “Forest Tea”, “Alibungog” (Visayas Region), “Putputai” (Bicol Region) and Maragued (Ilocos Region)
available commercially in capsules, tablets and tea bags
BFAD registered as an herbal medicine
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Balan, Ralph Class No. 03
HERBAL MEDICINE
TSAANG GUBAT (Ehretia microphylla Lam.)
antispasmodic for abdominal (stomach) pains
high fluoride content – mouthwash; effective in treating intestinal motility
Active compounds are triterpenes
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Balan, Ralph Class No. 03
HERBAL MEDICINE
TSAANG GUBAT (Ehretia microphylla Lam.)
UsesGastroenteritisDysenteryDiarrhea or Loose Bowel Movement (LBM)Body cleanser/wash
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Balan, Ralph Class No. 03
HERBAL MEDICINE
TSAANG GUBAT (Ehretia microphylla Lam.)
Dr. Gerard Penecilla- pharmaceutical scientist of the National Council of the Philippines (DOST)
Yeast Bioassay- to determine pharmacologic activities (anticancer) of medicinal plants
Tsaang Gubat-high potential in fighting growth and multiplication activities of cancer cells
Philippine Star , 18 July 2008
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Balan, Ralph Class No. 03
HERBAL MEDICINE
Ulasimang Bato /Pansit-pansitan (Peperomia pellucida)
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Balan, Ralph Class No. 03
“Olasiman-ihalas” & “Tangon-tangon” in the Philippines
English name: Peperomia
Small herb that grows from 1 to 1 1/2 feet, leaves and stalk are edible
HERBAL MEDICINE
Ulasimang Bato /Pansit-pansitan (Peperomia pellucida)
main components are Dillapiole (39.7%) and Trans-caryophyllene (10.7%)
Apiole, a phenolic ester, may stimulate uterine contractions and also hepatotoxic
as a salad, helps relieve rheumatic pains and gout
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Balan, Ralph Class No. 03
HERBAL MEDICINE
Ulasimang Bato /Pansit-pansitan (Peperomia pellucida)
Uses
skin disorders (abscesses, pimples and boils)leaves and/or stalks boiled and pounded then applied directly to the afflicted area
Infusion or Decoction:
boil 1 cup of leaves/stem in 2 cups of water and taken twice a day
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Balan, Ralph Class No. 03
HERBAL MEDICINE
YERBA BUENA (Clinopodium douglasii)
Herb of the mint family & commonly known as Peppermint
Primary active component is menthol responsible for antispasmodic, antiseptic, carminative, anesthetic, and choleretic properties
Main parts used are flowers and leaves
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Balan, Ralph Class No. 03
HERBAL MEDICINE
YERBA BUENA (Clinopodium douglasii)
Main components
volatile peppermint oil, composed of 50-78% menthol and 5-20% menthol esterfied with various organic acids, such as acetic and bovaleric
Other important components include
flavonoids (luteolin, menthoside), phenolic acids, and triterpenes
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Balan, Ralph Class No. 03
HERBAL MEDICINE
HERBAL PLANT CLINICAL USEAkapulko Antifungal
Ampalaya NIDDM
Bawang Antihyperlipidemic
Bayabas Antiseptic
Lagundi Asthma/Cough
Niyog-niyogan Antihelminthic
Sambong Diuretic
Tsaang gubat Antispasmodic
Ulasimang-Bato Rheumatism/Gout
Yerba Buena Antiseptic/Antispasmodic
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Balan, Ralph Class No. 03
HERBAL MEDICINE
Other Commonly Used Herbal Medicines in the Philippines
Not approved by regulatory agencies such as the Philippine BFAD or the US FDA
In general, due to lack of pharmacologic and toxicologic data, avoid use in pregnancy
Evidence of effects sometimes anecdotal
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Balan, Ralph Class No. 03
HERBAL MEDICINE
Other Commonly Used Herbal Medicines in the Philippines
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Plant Uses
Banaba Non-insulin dependent diabetes
Luya/Ginger (Zingiber officinale)
cold, cough, fever, sore throat, lowering cholesterol levels, nausea and vomiting; anti-fungal, anti-viral, and anti-inflammatory properties
Sabila (Aloe barbardensis)
moisturizing and hydrating the skin; supposed anti-oxidant effect when ingested (anti-hypertensive effects as well as for arthritis and diabetes)
Ginseng (Panax ginseng) improved physical and cognitive performance, mood, and metabolism, Additive anti-coagulant effect if used with warfarin
Balan, Ralph Class No. 03
HERBAL MEDICINE Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Usual Formulations Available for Herbal Preparations
For External Applications
• Oils
• Lotion
• Expressed from leaves, flowers of plants/herbs and peels of fruits, mostly citrus fruits
• Diluted before applied topically
• For massage, aromatherapy, mild astringent, carminative, stimulant, anti-septic
• Liniments
• Ointments• Semi-solid preparation with
one or more herbal medicaments dissolved or dispersed in suitable base
• Applied on skin and mucous• Base + Essential/Herbal
Oils
• Liquid or semi-liquid preparation
• Applied on skin without friction
• Mixtures of Oils, Creams and Glycerin
• Liquid or Semi-liquid preparation
• Applied on intact skin with friction
• Mixtures of Oils
• Pastes
• Semi-solid mixture of paraffin or mucilages as the base and finely powdered herbal medicaments
• External use only• More of powdered herbs than
base
Maulion, Marienelle R. Class No. 66
HERBAL MEDICINE Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Usual Formulations Available for Herbal Preparations
For Oral Intake
Maulion, Marienelle R. Class No. 66
• Elixirs
• Infusions
• Capsules
• Juices
• Syrups
• Aromatic liquid preparation with high proportion of alcohol, glycerin and propylene glycol
• For potent or nauseous herbal medicaments
• Ground-powdered fresh or dried herbs contained in hard or soft gel capsules
• Easily swallowed, tasteless
• Very popular to consumers
• Expression from fruits, flowering tops, leaves
• Taken immediately after extraction
• Can be stored and refrigerated in tightly sealed bottle
• Dilute solutions of water-soluble herbal extracts
• Maceration for varying short periods of time (5 mins to 2 hours)
• Herbs enclosed in cloth and suspended like a tea bag
• Concentrated solutions of sucrose
• Sweet vehicle for nauseous herbal medicines
• Higher sucrose concentration for preservation of herbal extracts
HERBAL MEDICINE
Herbal Therapies +
Prescription and Non-prescription
Medications
HERB-DRUG INTERACTIONS Herbal therapies and drugs can interact in the body, causing changes in the way the herbs and/or drugs work. Interactions can be beneficial or harmful.
= possible dangerous side effects and/or reduced benefits from the medications
Medina, Kristianne Rachel P. Class No. 69
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
HERBAL MEDICINE
Research on herbal therapies is not nearly as advanced as research on drugs
Herbal studies are not studied or monitored for safety and potential interactions
Herbal products have not been regulated for purity and potency
Very little is known about herb-drug interactions
– anecdotal information– clinical experience– case reports
Sources of information
– in vitro studies– observational studies– pharmacokinetic studies
Medina, Kristianne Rachel P. Class No. 69
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
HERBAL MEDICINE
DIETARY SUPPLEMENT-a product (other than tobacco) that is intended to
supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients
- not subject to premarket safety evaluations - must meet the requirements of other safety provisions
Dietary Supplement Health and Education Act of 1994 (DSHEA)
Medina, Kristianne Rachel P. Class No. 69
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
HERBAL MEDICINE
Claims to prevent, treat, or cure a specific disease are expressly prohibited.
Statements describing the supplement's effects on the "structure and function" or general "well-being" of the body are allowed, as long as they are truthful and should bear the statement "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.“
The product label must identify the product as a dietary supplement.- Dietary Supplement Health and
Education Act of 1994
Labeling of Dietary Supplements
Medina, Kristianne Rachel P. Class No. 69
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
HERBAL MEDICINE
Populations most susceptible to interactionsPatients with Cardiac or CVD disease
Take drugs with narrow therapeutics windowsAnticoagulants, cardiac glycosides
ElderlyChronic drugs
DiabeticsEffects on glucose controlSecondary problems warranting drug therapy
Who is at risk of herb-drug interactions?
Medina, Kristianne Rachel P. Class No. 69
HERBAL MEDICINE Evaluation of Safety and Efficacy The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Significant risk for patientsImmunosuppressives
cyclosporine
AnticoagulantsWarfarin
Protease inhibitors (AIDS)
Who is at risk of herb-drug interactions?
Medina, Kristianne Rachel P. Class No. 69
HERBAL MEDICINE Evaluation of Safety and Efficacy The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Absorption a herb/drug that alters the stomach pH (anti-acids) or intestinal motility (laxatives)
Metabolism duration of an herb or drug in the body depends on whether the liver’s metabolism is induced or inhibited
Elimination affected by the individual’s kidneys function or by drugs’ toxic side effects
Health condition, age, body weight, metabolic rate and dosage
Pharmacokinetic Interactions
Medina, Kristianne Rachel P. Class No. 69
HERBAL MEDICINE Evaluation of Safety and Efficacy The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Substances may interact by direct chemical action with each other, either before ingestion, or while mixed together in the stomach and intestines.
Herb and drugs may work together (synergistically) or in opposition (antagonistically).
Difficult to predict or prevent
Pharmacodynamic Interactions
Medina, Kristianne Rachel P. Class No. 69
HERBAL MEDICINE Evaluation of Safety and Efficacy The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Herb-Drug and Herb-Herb Interactions
Medina, Kristianne Rachel P. Class No. 69
Decreased bioavailability of drug
↓ Absorption fibersmucilage herbs↑ p-glycoprotein
↑ Metabolism ↑ CYP 450
↑ Eliminationlaxative herbsdiuretic herbs
Increased bioavailability of drug
↑ AbsorptionGingerCayenneBlack Pepper
↓ Metabolsim ↓ CYP 450 Grapefruit Juice
↓ EliminationLicorice- anti-
diuretic
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
HERBAL MEDICINE
Herb-Drug and Herb-Herb Interactions
Medina, Kristianne Rachel P. Class No. 69
Potentiation of drug via similar activityDrug diuretic and herb diuretic
Potentiation of drug via complementary activity↓ P-glycoprotein system (Eluthero and antibiotics)Bitter melon, gymnema, fenugreek and insulin or oral
hypoglycemicsDecreased effectiveness of drug via antagonistic activity
CNS stimulant with CNS depressantReduced side effects of drug
Milk Thistle and hepatotoxic drugsLicorice and corticosteroidsAstragalus and chemotherapeutics
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
HERBAL MEDICINE
Herb-Drug and Herb-Herb Interactions
Medina, Kristianne Rachel P. Class No. 69
May ↑ bleeding with anticoagulants
May ↑ effects of antibiotics
↑ efficacy of vincristine and 5-fluoroiuracil
Bromelain
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
HERBAL MEDICINE
Herb-Drug and Herb-Herb Interactions
Medina, Kristianne Rachel P. Class No. 69
↑ metabolism of drugs by enhancing absorption (↑ bioavailability)
↓ gastric mucosal damage when taken 30 minutes before ASA
Aggravates ACE inhibitor cough and reduces drug action
Cayenne
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
HERBAL MEDICINE
Herb-Drug and Herb-Herb Interactions
Medina, Kristianne Rachel P. Class No. 69
Additive effect on neurotransmitter levels with MAO inhibitors
↓ drug performance of beta blockers, may cause arrythmias or BP elevation
↑ steroid drug clearance thus, reducing therapy effectiveness
Ephedra
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
HERBAL MEDICINE
Herb-Drug and Herb-Herb Interactions
Medina, Kristianne Rachel P. Class No. 69
May ↑ bleeding times with anticoagulants risk of spontaneous and post-op bleeding
↓ blood levels of protease inhibitors
↑ indomethacin, insulin, statins
Preparations containing allicin may increase the activity of 3A4
Garlic
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
HERBAL MEDICINE
Herb-Drug and Herb-Herb Interactions
Medina, Kristianne Rachel P. Class No. 69
May ↑ absorption of drugs
↑ bioavailability
Synergistic with anticoagulants, possible ↑ coagulation
May ↑ cholesterol lowering effects of statins
Reduces after-effects of general anesthesia (↓ N & V)
Case reports of ↓ effect of antacids (heartburn)
Ginger
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
HERBAL MEDICINE
Herb-Drug and Herb-Herb Interactions
Medina, Kristianne Rachel P. Class No. 69
May ↑ spontaneous and post-op bleeding with anticoagulants, ASA and general anesthetics
May ↑ activity and side effects of MAO inhibitors
May ↑ efficacy (potency) of haloperidol in schizophrenia (study)
↑ nifedipine plasma levels
Gingko
HERBAL MEDICINE
Herb-Drug and Herb-Herb Interactions
Medina, Kristianne Rachel P. Class No. 69
Potentiation when taken with anticoagulants
↑ alcohol metabolism leading to ↑ clearance
Synergistic with insulin, improves diabetic symptoms
Synergistic with influenza vaccine, reduces flu symptoms, frequency and severity
Ginseng
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
HERBAL MEDICINE
Herb-Drug and Herb-Herb Interactions
Medina, Kristianne Rachel P. Class No. 69
Inhibits absorption of codeine or theophylline
May ↓ effect of coronary vasodilator drugsSynergistic with sulindac and/or tomaxifen, ↓ adverse effects
Contains vitamin K, thus, can render warfarin ineffective
Should not be mixed with aspirin because they both prevent platelets from clotting
Green Tea
Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
HERBAL MEDICINE
Herb-Drug and Herb-Herb Interactions
Medina, Kristianne Rachel P. Class No. 69
Take the herbs and the drugs at different times of day, or at least separated by many hours.
Just because it’s natural does not mean it is harmless.
Knowledge is the best defense againstdrug-herb and herb-herb interactions.
Remember that no drug or herb has “no known side effects”.
HERBAL MEDICINE Introduction History The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb InteractionsLaws Collection, Processing and Manufacturing WHO Guidelines on Good Agricultural Collection Practices
Proclamation No. 698
IntrinsicGenetic factors
Growth Characteristics
On August 19, 2004, Pres. Gloria Macapagal-Arroyo declared the month of November as
“TRADITIONAL & ALTERNATIVE HEALTH MONTH”
to promote and be able to provide an array of adorable, accessible and effective traditional and complementary / alternative health care
options for our people to choose from
to accelerate the development of traditional and alternative medicine for the good of our people
HERBAL MEDICINELaws Collection, Processing and Manufacturing WHO Guidelines on Good Agricultural Collection Practices
BA 2008-002
BFAD Health Advisory on January 16, 2008Immediate Recall of Penrex Herbal Supplement For Men
It was found to contain Sildenafil Citrate, a component dangerous to persons with heart ailments
Classified as herbal supplement, so it should not contain any active ingredient for drug products
Lim, Vanessa Class No. 25
HERBAL MEDICINE
BA 2001-001
BFAD Health Advisory on March 26, 2001Warning on the use of Glo-herbal drink/products
It is NOT REGISTERED with the Bureau NOR ALLOWED TO BE ADVERTISED OR PROMOTED
FOR ANY THERAPEUTIC INDICATION.
manufacturer of said products have not submitted scientifically valid proofs to show and substantiate the therapeutic effects that are being claimed for the products
Laws Collection, Processing and Manufacturing WHO Guidelines on Good Agricultural Collection Practices
Lim, Vanessa Class No. 25
HERBAL MEDICINELaws Collection, Processing and Manufacturing WHO Guidelines on Good Agricultural Collection Practices
BA 2000-006
BFAD Health Advisory on September 1, 2000
Warning on the use of “CURE-ALL” products
Adverse events being associated with the use of some “cure all” products such as the "PDA Water" from Tarlac City, Mahogany seeds and other herbal preparations have been reported.
Products that are being promoted as "cure-all" do not have any scientific basis of safety and efficacy
Lim, Vanessa Class No. 25
HERBAL MEDICINELaws Collection, Processing and Manufacturing WHO Guidelines on Good Agricultural Collection Practices
Important Guidelines in Taking Herbal Medicine
Factors Affecting Safety and Quality Control of Raw Materials
IntrinsicGenetic factors
Growth Characteristics
ExtrinsicEnvironment
Collection methods
Cultivation
Harvest
Post-harvest
Processing
Transport
Storage practices
Macasaet, Aelleen P. Class No. 44
HERBAL MEDICINE
WHO Guidelines on Good Agricultural Collection Practices
Reasons for Formulation of the Guidelines:
Macasaet, Aelleen P. Class No. 44
Increase in use of herbal medicines worldwide
Increase in reports of adverse effects
Insufficient attention paid to the quality assurance and control of herbal medicines
Laws Collection, Processing and Manufacturing WHO Guidelines on Good Agricultural Collection Practices
HERBAL MEDICINE
WHO Guidelines on Good Agricultural Collection Practices
STRUCTURE
Macasaet, Aelleen P. Class No. 44
Section 1: General Introduction
Section 2: Good agricultural practices for medicinal plants
Section 3: Good collection practices for medicinal plants
Section 4: Common technical aspects of good agricultural
practices for medicinal plants and good collection practices for
medicinal plants
Section 5: Other relevant issues
Laws Collection, Processing and Manufacturing WHO Guidelines on Good Agricultural Collection Practices
Laws Collection, Processing and Manufacturing WHO Guidelines on Good Agricultural Collection Practices
HERBAL MEDICINE
Section 2
Macasaet, Aelleen P. Class No. 44
• Selection of Medicinal PlantsConsult national pharmacopoeia or authoritative national documents of the end-user's country or that of other countries
Identification/authentication of cultivated medicinal plants
Laws Collection, Processing and Manufacturing WHO Guidelines on Good Agricultural Collection Practices
HERBAL MEDICINE
Section 2
Macasaet, Aelleen P. Class No. 44
• Selection of Medicinal Plants– Consult national pharmacopoeia or authoritative
national documents of the end-user's country or that of other countries
– Newly introduced plants• Species/botanical variety used in traditional medicine
of the original country
Identification/authentication of cultivated medicinal plants
Laws Collection, Processing and Manufacturing WHO Guidelines on Good Agricultural Collection Practices
HERBAL MEDICINE
Section 2
Macasaet, Aelleen P. Class No. 44
• Botanical Identity– Scientific name• Genus, Species, subspecies/variety, Author,
Family– Local and English common names if available– Others (e.g. Cultivar) as appropriate
Identification/authentication of cultivated medicinal plants
HERBAL MEDICINE
Section 2
Macasaet, Aelleen P. Class No. 44
• Specified• Provide information– Identity, Quality, Performance, Breeding
history• Of best quality
Seeds and other propagation materials
Laws Collection, Processing and Manufacturing WHO Guidelines on Good Agricultural Collection Practices
Laws Collection, Processing and Manufacturing WHO Guidelines on Good Agricultural Collection Practices
HERBAL MEDICINE
Section 2
Macasaet, Aelleen P. Class No. 44
• Intensive care and management• Different plant materials vary in conditions and
duration• Should have a basis– Scientifically published– Traditional methods– Research
• Apply Conservation Agriculture (CA) techniques– Prevent build-up of organic matter– Conserve soil humidity
Cultivation
Laws Collection, Processing and Manufacturing WHO Guidelines on Good Agricultural Collection Practices
HERBAL MEDICINE
Section 2
Macasaet, Aelleen P. Class No. 44
• Optimal season or time period• Depends on the plant part to be used• Should have a basis
N.B. Best time of harvest based on the quality and quantity of biologically active constituents not on the total vegetative yield.
Harvest
Laws Collection, Processing and Manufacturing WHO Guidelines on Good Agricultural Collection Practices
HERBAL MEDICINE
Section 2
Macasaet, Aelleen P. Class No. 44
• Adequate knowledge• Maintain appropriate personal hygiene• Apply agrochemicals: wear appropriate
protective clothing• Receive instruction on proper agricultural
stewardship
Personnel
HERBAL MEDICINEWHO General Strategies and Methods for Collection of Fresh Medicinal Plants WHO Post Harvesting Processing
Permission to Collect
Nallas, Anna Pauline R. Class No. 91
Need to procure permission prior to collectCollection permits and related documents (government and landowners)National “red” listsExport from country of origin – permits also
WHO General Strategies and Methods for Collection of Fresh Medicinal Plants
Laws Collection, Processing and Manufacturing WHO Guidelines on Good Agricultural Collection Practices
HERBAL MEDICINEWHO General Strategies and Methods for Collection of Fresh Medicinal Plants WHO Post Harvesting Processing
WHO General Strategies and Methods for Collection of Fresh Medicinal Plants
Technical Planning
Nallas, Anna Pauline R. Class No. 91
“Geographical distribution and population density” of any medicinal plant
Location of the collection area from the home base and the quality of the plant after being transported
Research and the Team: Personnel and Transportation
Social and Ecological Impact
Sustainability and Management
HERBAL MEDICINEWHO General Strategies and Methods for Collection of Fresh Medicinal Plants WHO Post Harvesting Processing
WHO General Strategies and Methods for Collection of Fresh Medicinal Plants
Selection of Medicinal Plants for Collection
Nallas, Anna Pauline R. Class No. 91
“National Pharmacopoeia” or those recommended by other “authoritative national documents” for the target country
Sufficient identification, documentation and description of the plant (traditional medicine)
Prepare and submit botanical specimens to the “regional or national herbaria” for authentication
“Recorded and maintained” for identification
HERBAL MEDICINEWHO General Strategies and Methods for Collection of Fresh Medicinal Plants WHO Post Harvesting Processing
WHO General Strategies and Methods for Collection of Fresh Medicinal Plants
Collection
Nallas, Anna Pauline R. Class No. 91
“Long-terms survival of wild populations and their associated habitats” Demographic structures Government and environmental authorities ensure the continuous cultivation Best possible quality, Best time of collectionEcologically non-destructive systemsLocation cautionProper collected and packed, Preliminary processing
HERBAL MEDICINEWHO General Strategies and Methods for Collection of Fresh Medicinal Plants WHO Post Harvesting Processing
WHO General Strategies and Methods for Collection of Fresh Medicinal Plants
Personnel
Nallas, Anna Pauline R. Class No. 91
ExpertsFull documentationBotanical trainingInstructions protection, sustainability, maintenanceKnowledgeable linksWelfare and safetyProtect personnel clothing and health
HERBAL MEDICINEWHO General Strategies and Methods for Collection of Fresh Medicinal Plants WHO Post Harvesting Processing
Post Harvesting
Ong, Maynard Ivan F. Class No. 110
Inspection and sortingvisual inspection for cross-contamination visual inspection for foreign matter
EvaluationAppearancefree from contamination and decomposition
Storage and Transportationensure their integrity
HERBAL MEDICINE
Processing
Ong, Maynard Ivan F. Class No. 110
Dryingmoisture content kept as low as possible reduce damage from mould and other microbial infestationtemperature and humidity should be controlled
MethodsIn the open air (shaded from direct sunlight)Direct sunlight, if appropriate
WHO General Strategies and Methods for Collection of Fresh Medicinal Plants WHO Post Harvesting Processing
HERBAL MEDICINE
Processing
Ong, Maynard Ivan F. Class No. 110
Indirect fireDrying ovens/rooms and solar dryersBakingLyophilizationMicrowave or infrared devices
WHO General Strategies and Methods for Collection of Fresh Medicinal Plants WHO Post Harvesting Processing
HERBAL MEDICINE
Specific Processing
Ong, Maynard Ivan F. Class No. 110
To improve the purityEnhance efficacyReduce time of processingReduce damage due to environment exposureMethods
pre-selection peeling the skins of roots and rhizomes
WHO General Strategies and Methods for Collection of Fresh Medicinal Plants WHO Post Harvesting Processing
HERBAL MEDICINE
Specific Processing
Ong, Maynard Ivan F. Class No. 110
boiling in water steaming soaking pickling distillationfumigationroasting natural fermentationtreatment with lime and chopping
WHO General Strategies and Methods for Collection of Fresh Medicinal Plants WHO Post Harvesting Processing
HERBAL MEDICINE
Processing Facilities
Ong, Maynard Ivan F. Class No. 110
Location– Accessibility– Drainage– Odors ,smoke, dust
Building– Design and layout of station areas– Construction materials– Environment control
WHO General Strategies and Methods for Collection of Fresh Medicinal Plants WHO Post Harvesting Processing
HERBAL MEDICINEWHO General Strategies and Methods for Collection of Fresh Medicinal Plants WHO Post Harvesting Processing
Handling Areas
Ong, Maynard Ivan F. Class No. 110
Construction considerations Preventing accumulation of dirt, moulds, and general cleanliness
Objective Preventing contamination Preserving their therapeutic integrity Provide minimal alterations to their physical
or chemical properties
HERBAL MEDICINEWHO General Strategies and Methods for Collection of Fresh Medicinal Plants WHO Post Harvesting Processing
Other Considerations
Ong, Maynard Ivan F. Class No. 110
Water SupplyEffluent and Waste DisposalChanging facilities and ToiletsHand-washing and disinfection facilitiesLightingVentilationBulk packaging and Labeling
HERBAL MEDICINE
Ong, Maynard Ivan F. Class No. 110
Storage and TransportationMaterialsIdentificationQuality AssuranceDocumentationPersonnel
WHO General Strategies and Methods for Collection of Fresh Medicinal Plants WHO Post Harvesting Processing
HERBAL MEDICINEWHO General Strategies and Methods for Collection of Fresh Medicinal Plants WHO Post Harvesting Processing Evaluation of Safety and Efficacy
Classification of Herbal Medicines
Madulara, Glaiza M. Class No. 47
World Health Organization (WHO)• Guidelines for the regulation of herbal medicines in the South-East Asia Region • based on origin, evolution and the forms of current usage
assessment of the ways in which quality, safety and efficacy of these medicinal plants can be determined and further improved
HERBAL MEDICINE Evaluation of Safety and Efficacy
Classification of Herbal Medicines
Madulara, Glaiza M. Class No. 47
Category 1 --- Indigenous herbal medicines• historically used medicinal plants in a local community or region
Category 2 --- Herbal medicines in systems• used for a long time and officially documented with their special theories and concepts
Category 3 --- Modified herbal medicines• modified medicinal plants• shape, form, dose, dosage form, mode of administration, herbal medicinal ingredients, methods of preparation and medical indications
Category 4 --- Imported products with a herbal medicine base• all imported herbal medicines
HERBAL MEDICINE Evaluation of Safety and Efficacy
Requirements for Assessment of Safety of Herbal Medicines
Madulara, Glaiza M. Class No. 47
SAFEcauses no known or potential harm to user
Categories of Safety WHO
To determine the nature of the safety requirements that would have to be ensured
Three categories
HERBAL MEDICINE Evaluation of Safety and Efficacy
Requirements for Assessment of Safety of Herbal Medicines
Madulara, Glaiza M. Class No. 47
Three Categories of Safety:
Safety Category 1 • safety is well-established due to use over long time
Safety Category 2 • safe under specific conditions of use
Safety Category 3 • uncertain safety • the safety data required for this class of drugs will be identical to that of any new substance
HERBAL MEDICINE Evaluation of Safety and Efficacy The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Madulara, Glaiza M. Class No. 47
Guidelines for Toxicity Investigation of Herbal Medicines General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine by the WHO
Specify the standard methods of toxicological studies assessing the safety and efficacy of herbal medicines
Two Main Toxicity Tests used in the study of herbal medicine Acute toxicity studies
necessary for any pharmaceutical intended for human use
Long term toxicity test observe symptoms, herbal actions and toxicity after prolonged treatment
Data Gathering
HERBAL MEDICINE Evaluation of Safety and Efficacy The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Madulara, Glaiza M. Class No. 47
Data Gathering
Acute-Toxicity Testing
Animal species At least two species: rodents AND non-rodents
Sex In at least one of the species, males and females should be used.
Number of animals Rodents
at least five animals per genderNon-rodents
at least two animals per gender.
Route of administration oral route - normal route of clinical administrationparenteral route of administration
Long-term Toxicity Testing
Animal species At least two species: rodents AND non-rodents
Sex Same number of male and female animals should be used
Number of animals Rodents
at least 10 males and 10 femalesNon-rodents
at least 3 males and 3 females
Route of administration oral route parenteral route of administration
HERBAL MEDICINE Evaluation of Safety and Efficacy The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Madulara, Glaiza M. Class No. 47
Data Gathering
Acute-Toxicity Testing
Dose levels Rodents
Verify the approximate lethal dosenon-rodents
Observation of overt toxic signs.
Frequency of administration Test substance should be administered in one/more doses during a 24-hr period.
Observation Observed and recorded in relation to dose & time
Toxic signs Severity, onset, progression and Reversibility of the signs
Observed for at least 7 - 14 days
Dead and surviving animalsshould be autopsied, histopathological examination
HERBAL MEDICINE Evaluation of Safety and Efficacy The 10 DOH Herbal Medicines Potential Harmful Herb-Drug and Herb-herb Interactions
Madulara, Glaiza M. Class No. 47
Data Gathering
Long-term Toxicity TestingExpected Period of
Clinical UseAdministration period for the Toxicity Study
Single Administration or Repeated
Administration for < 1 week
2 weeks – 1 month
Repeated Administration,
between 1 – 4 weeks
4 weeks – 3 months
Repeated Administration,
between 1 – 6 months
3 – 6 months
Long-term repeated administration for > 6
months
9 – 12 months
Administration period • test substance should be administered 7 days a week.
• the commonly used ranges of administration periods
HERBAL MEDICINE Evaluation of Safety and Efficacy
Madulara, Glaiza M. Class No. 47
Establishment of Safety and Efficacy
Guiding principle in the assessment of safety when the product has been traditionally used without demonstrated harm
Lack of any reported or documented side-effects not an absolute assurance of safety for herbal medicines
Additional toxicity studies must be performed only whendoubts about its safetyno documentation of long historical use in-vitro studies -- preferredin-vivo study -- conducted humanely
Safety
HERBAL MEDICINE Evaluation of Safety and Efficacy
Madulara, Glaiza M. Class No. 47
Establishment of Safety and Efficacy
Requirements for proof of efficacy -- supporting documentation Well-established, randomized controlled clinical trials
provide the highest level of evidence for efficacy designed to determine the efficacy and safety of the product under normal conditions of use
Efficacy
HERBAL MEDICINE Evaluation of Safety and Efficacy
Traditional/Herbal Medication Quality Assurance and Promotion in the Philippine Setting
Madulara, Glaiza M. Class No. 47
Quality assurance and control measuresNational quality specification and standards for herbal materials, good manufacturing practices (GMP) for herbal medicines, labeling, and licensing schemes for manufacturing, imports and marketingvital for ensuring the safety and efficacy of herbal medicines
Weak regulation and quality control may result in a high incidence of adverse reactions attributable to poor quality of herbal medicines
Regulation and control of herbal products Under the authority of the Bureau of Food and Drugs (BFAD) of the DOH
Quality Assurance BFADOnce achieved High promotion of the BFAD seal of good quality to
physicians and pharmacists
Balan, Lim, J., Lim, V., Macasaet, Madulara, Maulion, Medina, Nallas, Ong, Ongoco, Palma
HERBAL MEDICINE
THANK YOU.
University of Santo TomasFaculty of Medicine and Surgery
Department of Pharmacology
Seminar on
HERBAL MEDICINE