A Seminar on Development of an Antidiabetic formulation from the leaves extract of Costus Pictus D.DON Submited to Savitribai Phule , University of Pune In Partial fulifillment of Requirements for the Award of Degree of MASTER OF PHARMACY IN QUALITY ASSURANCE TECHNIQUES Presented by- Guided by- Miss.Veena.S.Katoriya Dr.Gitanjali S.Deokar M.Pharm(QAT)Sem III (M.Pharm,Ph.D) Bhujbal Knowledge City, MET’S Institute of Pharmacy, Adgaon,Nashik. 2015-2016 1
Transcript
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A Seminar on
Development of an Antidiabetic formulation from the leaves extract of Costus Pictus D.DON
Submited to Savitribai Phule , University of Pune
In Partial fulifillment of Requirements for the Award ofDegree of
of Costus Pictus.D.Don• Geographical source: South &Central America, In India it is
cultivated in South India.
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LITERATURE SURVEY
• C.T Shiny,Anuj Saxena et al.2013 has discussed about the Phytochemical investigation of the insulin plant "Costus Pictus”D.Don.The Hypoglycemic activity of the Costus pictus is mainly because of secondary metabolites.Different solvent extract of leaves were subjected to Phytochemical studies.Further analysis such as Column chromatography,HPLC& GC-MS of Methanolic leaf extract has been revealed the presence of glycoside compound similar to a reference compound,ᵦ-L-Arabinopyranose methyl glycoside & That might be the inducer molecule of its Anti-Diabetic property.
• C.T Shiny, et al.2013 has discussed about the Phytochemical & Hypoglycemic activity investigation of Costus Pictus plants from Kerala & Tamilnadu.Different solvent extract of leaves were subjected to Phytochemical screening studies & checked the hypoglycemic activity in glucose fed albino mice.The study suggests the large scale of cultivation of C.Pictus at varied geographical locations as the phytochemical profile were quit stable with environmental variables.
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• R.Remya et al.2012 has discussed about the Phytochemical & Pharmacognostic investigation of Antidiabetic Costus Pictus.D.Don.The study carried out to evaluate the antidiabetic activity of Costus pictus.D.Don,on alloxan induced diabetic rats.Oral administration of fresh leaf extract(200 & 400mg/kg body weight)for 60 days treatment resulted in significant decrease in blood glucose level & lipid profile.The studies clearly showed that the effect of the drug(400mg/kg body weight) was equally effective with standard drug glibenclamide.The studies were carried out to find out the biomarkers.The leaf of C.Pictus is characterized by simple unicellular,pointed non-glandular trichomes,absence of palisade layer & hypodermal layers containing shattered crystals.
• Ajithadas Aruna et al.2014 has discussed about the Insulin Plant(Costus Pictus)Leaves:Pharmacognostical Standardization & Phytochemical Evaluation.The study explored the micro morphology & physiocochemical parameters of the leaves of C.Pictus D.Don.Macroscopy,Microscopy,Physicochemical analysis,preliminary phytochemical screening & other WHO recommended parameters for standardizations were performed.The studies provided the valuable information regarding the morphology of crude drugs.
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NEED & OBJECTIVE
• Need: The need of the present work is to standardized formula, Chemical
constituents which is responsible for Anti-diabetic activity.
• Objective:1. At present condition the Powder & Extract of leaves of Costus
Pictus is consumed by Diabetic Patients as oral dosage form.
2. Formulation & Development of advanced dosage forms like Nano suspension ,Microsphere & Nanosphere.
3. Exploration of Anti diabetic formulation using advanced dosage form approaches.
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PLAN OF WORK
Literature review Selection of drug, polymers and excipients Characterization of drug • Phytochemical Screening of Plant drug• Infra-red spectrophotometer (FT-IR) • High Pressure Liquid Chromatography(HPLC)• Column Chromatography• Gas Chromatography Mass Spectrophometer(GC-MS)• UV-Visible spectrophotometer Calibration curve of Diosgenin Characterization of Polymers • Organoleptic properties of Polymers• Infra-red spectrophotometer (FT-IR)
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• STANDARDIZATION: Standardization of drug means confirmation of its identity&
determination of its quality, purity& detection of nature of adulterant by various parameters like morphological, microscopical, physical, chemical &biological observations.
• HERBS: Herbs are crude plant material such as leaves, flowers, fruit, seed,
stems, barks, roots, rhizomes or other plant parts, which may be entire, fragmented or powdered.
• HERBAL DRUGS/HERBAL FORMUATION: These are the finished labelled products that contain active
ingredients such as aerial or underground parts of plant or other plant material or combinations thereof,whether in the crude state or as plant preparations.
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HERBAL DRUGS
Phytomedicines or phytopharmaceuticals sold as Over The Counter(OTC) products in modern dosage forms such as Tablets,Capsules & Liquids for oral use.
Dietary Suppliments containing Herbal products,also called Neutraceuticals available in modern dosage forms.
Herbal Medicines consisting of either Crude,Semi Processed or Processed Medicinal Plants.
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GUIDELINES FOR QUALITY CONTROL OF HERBAL FORMULATION
• Quality control of crude drugs material, plant preparations and finished products
• Stability assessment and shelf life
• Safety assessment; documentation of safety based on experience or toxicological studies
• Assessment of efficacy by pharmacological informations and biological activity evaluations
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MACROSCOPIC STUDY
• Visual inspection provides the simplest and quickest means by which to establish identity, purity and quality.
• Macroscopic identity of medicinal plant materials is based on shape, size, colour, surface characteristics, texture, fracture characteristics and appearance of the cut surface.
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MICROSCOPY STUDY
• Detail of cell structure and arrangement of the cells useful for differentiating similar species.• Select a representative sample of the material & If it is dried parts
of a plant than it may require softening before preparation for microscopy, preferably by being placed in a moist atmosphere, or by soaking in water.
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Histochemical detection:• Starch grains • Aleurone grains • Fats, fatty oils, volatile oils and resins • Calcium oxalate/carbonate crystals• Lignified cell wall• Cellulose cell wall• Mucilage• TanninLeaf constants:Quantitative analytical microscopy is useful in measuring the cell
contents of the crude drugs & help in their identification,characterization & standardization.
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• Stomatal Number: It is the average number of stomata per square mm of the
epidermis of the leaf.• Stomatal Index: Stomatal index is the percentage which the number of stomata
form to the total number of epidermal cells,each stomata being counted as one cell.
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SR. NO
PARAMETERS REPORTED VALUES
OBTAINED VALUES
1. Stomatal number(lower epidermis)
13±0.28 12
2. Stomatal index(lower epidermis)
10.38±0.23 10
3. Vein islet number 4.1±0.057 4
4. Vein termination number
3.9±0.088 4
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ASH VALUE
• It involves non-volatile inorganic components. • High ash value is the indicative of contamination, substitution,
adulteration or carelessness in preparing the crude drugs.
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TOTAL ASH VALUE• Total ash is designed to measure the total amount of material
produced after complete incineration of the drug material at as low temperature as possible (about 450°C) to remove all the carbons.
• Total ash usually consists of carbonates, phosphates, silicates and silica.
• Actually drug incinerated at 390°C.• Total Ash Value=12.5-20%
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ACID INSOLUBLE ASH VALUE
• Ash insoluble in HCl is the residue obtained after extracting the total ash with HCl. It gives idea about the earthy matter.
• Acid Insoluble Ash of drug=21.5%
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WATER SOLUBLE ASH
• Total ash content which is soluble in water. It’s good indicator of presence of previous extraction of water soluble salts in the drug or incorrect preparation or amount of inorganic matter.
• Amount of the active constituents present in crude drug material when extracted with specific solvent.
There are following Methods for determination of Extractive value.a) Cold methodb) Hot methodc) Soxhlet method
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CHEMICAL TESTSSR.NO
PLANT MATERIA
L
EXTRACTION
SOLVENTS
STEROIDS TRITERPENOIDS
ALKALOIDS PHENOL GLYCOSIDE QUINONES
COUMARINES
FLAVONOIDS
FURANOID
TANNIN
1. LEAVES METHANOL
Std. ++ ++ ++ ++++ ++++ ++ ++ ++++ -- --
control ++ ++ ++ ++++ ++++ ++ ++ ++++ -- --
2. LEAVES AQUEOUS + + + + + + + + - -
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CHROMATOGRAPHY OF HERBAL DRUG
• Seperation, identification, impurity detection and assay of herbal drug in the formulation or in the extract are carried out by following methods :-
a) TLCb) HPTLCc) HPLC/Densitometric chromatographyd) GLC• On trial error basis various solvents were used for drug solubility :a)Acetoneb)Ethyl actetatec)Chloroformd)Dichloromethanee)n-Hexanef)Iso propyl alcohole)Methanolf)DSMO
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• Mobile phase tried:Chloroform:Ethyl Acetate:Methanol:Benzene(70:4:8:24)
• Visualising agent: P-anisaldehyde• Comparison of Methanolic extract (Standard & Control)-TLC -Solvent System: Toluene:Ethyl acetate:Methanol(5:3:2) -Detection: Visual & UV light at 254 & 366nm The Rf value of the spots obtained by standard formula. Rf(standard)=1.052 Rf(control)=1.081
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BOTTLENECKS
• Use of multiple ingredients• Inconsistency of Finished formulations• Overlapping of Chemical & Chromatographic profiles• Stability of formulations• Difficulty in developing standards
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FORMULATION INCONSISTENCY
• Large variations in different samples of same formulation• Variations in ingredients• Variations in Quantity of Ingredients• No Uniform Manufacturing Protocols
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MARKERS
• Markers are chemically defined constituents which may or may not have therapeutic activity and are of high significance for control purpose.
• In this case markers : -Diosgenin -Quercetin
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CONCLUSION Herbs possess enormous healing power & only a part is known to
mankind Great market potential Superior quality of crude drugs &finished products needed It is essential to ensure quality Control at all levels for standardization,
efficacy, safety and consistency Marker compounds are highly useful for Quality Control Markers specific to formulations need to be isolated Identified various chromatographic & spectroscopic techniques By Performing chemical tests, its proved that the presence of Alkaloids &
Glycosides along with other chemical constituents in standard as well as in control drug powder as well its methanolic extract.
The other evaluations (standardization ) tests are performed & they proved that revealed the same results which is reported in literature.
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REFERENCES Ajithadas Aruna, et al. 2014, ‘Insulin Plant (Costus
pictus)Leaves: Pharmacognostical Standardization and Phytochemical Evaluation’ American journal of pharmacy and health research, volume 2, PP . 107-119
Ramya.R,etal. 2012 , ‘Phytochemical and pharmacognostic of antidiabetic Costus Pictus .D.Don’International journal of pharmaceutical and biomedical research ,volume 3 (1), PP. 30 -39
Shiny C.T. et al . 2013 , ‘ Phytochemical and hypoglycaemic activity investigation of Costus pictus plants from kerala and tamilnadu,Internation journal of pharmaceutical science invention, volume 2 ,PP . 11-18
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Shiny C.T et al . 2013,Phytochemical investigation of the insulin plant “Costus pictus”D.Don,International Journal Pharmaceutical & Biomedical Research,Volume 4(2) ,PP.97-104
Arun Rasheed et al . 2012,“ A review on standardisation of herbal formulation”,International journal of Phytotherapy, Volume 2, PP.74-88
Dr.K.R.Khandelwal,Edited by Dr.Vrunda Sethi, Practical Pharmacognosy Techniques & Experiments,21st edition, Nirali prakashan Pune, PP. 23.1-25.9
