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In t he last few decades t her e has been an exponent ial g rowth in the fi eld ofher bal medicine.

It is gett ing popular ized in developi ng as well as indeveloped count ries owing to its n atural or igin and lesser side effect.

In ol den times, vai dyas used to t reat patient s o n indi vidual b asis,and prepar e dr ug accor ding t o the r equirement of the patient.

But the scenari o has changed now; herbal medi cines are bei ngmanufact ured on the large scal e in Phar maceut ical uni ts,

wher e manuf actu rers come acr ossmany p roble ms suc h as availabi lity ofgood qual ity raw mater ial, aut hentication of

raw material and other qual ity contr ol par ameter s.

The use of her bal medi cine is due to toxicit y ands ide ef fects of al lopa thic medi cines, has led tosud den incr ease in the number of her bal dr ug

HISTORY OF HERBALHISTORY OF HERBAL

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World Health Organization (WHO) has defined herbal

medicines as finished labeled medicinal product that contain

active ingredients, aerial or underground parts of the plant or

other plant material or combinations.

Herbal medicines are in great demand in the developed

world for primary health care because of their efficacy, safety

and lesser side effects.

HERBAL medicine is still the mainstay of about 7580% of

the world population.

WHAT ARE HERBAL DRUGS?

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ADVANTAGES OF HERB ALMEDI CI NE.

1. Herbal medicine have long hi story of use and b etter patient tolerance as well asaccept ance.

2. Medici nal plants have a renew able s our ce, w hic h is our onl y hope for sustai nablesuppl ies of cheaper medi cines for the w orld growing p opulation.

3. Availability of medici nal plant s is not a pr obl em especi ally in developi ng countr ies likeIndia ha ving rich agro-climatic, cul tur al a nd et hni c biodi ver si ty.

4. The cul tivation and process ing of medi cinal her bs and her bal products i s envi ronment alfriendl y.

5. Prolong and apparentl y une vent ful use of her bal medic ines may of fer test imony of theirsaf ety and ef ficac y.

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STANDARDIZATION OFHERBAL DRUGS.

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NEED FOR STANDARDIZATION.NEED FOR STANDARDIZATION.

In almost a ll the t radi tional sys tem of medi cine, the quali tycontrol aspect has been consi der ed.

Thus today qual ity a ssur ance is thr ust ar ea for t he evaluationof tr adit ional used medi cinal plants and her bal formul ation.

In moder n concept it requi re necessa ry changes in theirappr oach by tha t way concr ete meth od of quali ty contr ol inter ms developm ent of moder n methodol ogi es.

In or der to obtai n qual ity or iented herb al pr oduct s car eshoul d be taken right from the pr oper identi fication of pl ant s,season and a rea o f coll ect ion, extracti on, isola tion andverifi cation process.

A standar dized extr act means that the manuf act urer hasverifi ed that the acti ve ingredi ent bel ieved to be pres ent in t heherb is present in the prepar ation.

And that the pot enc y and the amount of the active ing redi ent

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CHEMICAL AND INSTRUMENTALCHEMICAL AND INSTRUMENTAL

ANALYSIS.ANALYSIS. Chemical and inst rument al anal yses are rout inel y used for analyzi ngsynt heti c dr ugs to c onfir m its authenti city.

In the c ase o f herbal drugs, however the scene is di fferent especia lly forpol yherbal formula tion, as there i s no chemical or anal ytical methodsavailable.

In the c ase o f herbal drugs, the qual ity of r aw materials and p roducts canbe fur nished by regular phar macognost ic ident ifications and phy tochemicalanal ysis.

The her bal formul ations in gener al can be sta ndardized schematicall y as toformul ate t he medi cam ent usi ng raw materi als col lected from di fferentlocali ties and a com par ative chemi cal efficac y of dif fer ent batches offor mul ation ar e to be o bserved.

The pr epar ations with bet ter clinical eff icac yare to be sel ected.

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The stabil ity p aramet ers for the herbal formulations inc lude p hysicalpar ameter s, chemical par amet ers, and microbio logi cal par amet er s. Physi cal paramet er s include col or, appear ance, odor , clari ty, vi scosity,moi sture cont ent, pH, disinte gration t ime, friabil ity, har dnes s, f lowabil ity,floccul ation, sedim enta tion, set tl ing rate and ash v alues.

Chemical par amete rs include limit tests,extracti ve val ues, chemi cal assays, etc.

Chroma tographi c anal ysi s of her bals can be done usi ngTLC, HPLC,

HPTLC and GC, UV, Fluorimet ry, GC- MS, etc.

Micr obi ologi cal par amete rs includetotal viable cont ent, total mol d count,

tot al enter obact erial and thei r count

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THE GUIDELINES SET BY WHOTHE GUIDELINES SET BY WHO

CAN BE SUMMERIZED AS FOLLOWS:CAN BE SUMMERIZED AS FOLLOWS: Reference to the identity o f the drug. Bo tani cal eval uation sensor y char act ers,for eign or gani c matter, micr oscopic al, histo logi cal , histoc hemical eval uation,quant itative measur ements, etc . Reference to the physi ochem ical character of the dr ug. Chr oma tog raphi c profi les,ash val ues, extract ive val ues, refract ive inde x, pol ari metric readings, mo istur e cont ent,volati le oil cont ent, etc. Reference to the phar macol ogical par ameters. Biolo gical acti vity prof iles, bi tter nessval ues, haemol ytic inde x, ast ringenc y, swelling factor, foami ng index, etc. Toxici ty detai ls hea vy metals li ke cadmi um, lead, ar senic, mer cur y, et c. Pest icideresi dues.Maximum resi due lim its =

Accept able dai ly index x body w eight x extr action factor----- ---- ------ ----- ----- ------ ---- ---- ------ ----- ----- ------ ---- ---- ------ ----- ----- ------ ---- -- x

Ther apeut ic d osesMean d aily intak e o f drug x safety fact or x 100

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Indi a is s itting on a gol d mine o f well-r ecor ded and wel l pract iced knowledge oftradi tional her bal medic ine.

But , unlike Chi na, Indi a has not been able t o capital ize on thi s her bal weal th bypromot ing i ts use in the developed wor ld desp ite thei r renew ed interest in herbalmedi cin es.

This can be achieved by jud icious pr oduct identifi cation based on diseases foundin the developed w orld for w hich no m edi cin e or onl y pal liative therapy isavai lable.

The basi c requi rement s for gai ning ent ry into developed count ries inc lude:(i) well -document ed tradit ional use,(ii ) s tandar diz ation based on chem ical and act ivi ty profi le, and(iii) safety and stability. Such sci enti fical ly gener ated data wi ll project her bal medic ine in a properper spect ive and hel p in su stai ned global market .

The subj ect of herbal drug standar diza tion i s massively wide and deep . Ther e i s somuch t o know and so m uch seem ingly contr adict ory theor ies on the subje ct of her bal

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Ind ia ca n e merge as themaj or co unt ry and p la y thelead role in pr od uc tion o fstand ar dized,therapeutically effectiveay ur vedi c for mu latio n.

In di a ne eds to expl or e themed ic ina lly imp ortantplants. This can be achievedonl y i f t he h er bal pr od uct sare evalu ated an d ana lyzedusing soph is ti cated moderntechn iq ues ofstand ardiz atio n such as UV-visib le , TL C, HPL C, HPTL C,GC-M S, spe ctr oflu ori met ric

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THANK YOUTHANK YOU

BYBY

D.M.SRUJANAD.M.SRUJANA

&&

N.PRAVEESHA.N.PRAVEESHA.

CMR COLLEGE OFCMR COLLEGE OFPHARMACY.PHARMACY.