HISTORY OF HERBAL MEDICINES:
Ø In t he last few decades t her e has been an exponent ial g rowt h in the fi el d of her bal me dici ne.
Ø It is gett ing popular ized in de vel opi ng as w el l as in de veloped count ri es owi ng to its n atu ral or igin and lesser si de effect.
Ø In ol den tim es, vai dy as used to t rea t pa ti ent s o n indi vi dual b asis, and pr epar e dr ug accor di ng t o the r equirement of t he pa tient.
Ø But the scenari o has changed no w; herbal medi ci nes ar e bei ng manufact ur ed on the lar ge scal e in Phar maceut ical uni ts, wher e manuf actu rer s come acr oss many p roble ms suc h as availabi lit y of good qual ity raw ma ter ial, aut hentica tion of raw ma ter ial and other quality contr ol par am eter s.
Ø T he use of her bal medi ci ne i s due to toxi cit y and s ide ef fects of al lopa thi c medi ci nes, has led to sud den incr ease in the number of her bal dr ug
WHAT ARE HERBAL DRUGS? Ø 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.
Ø Herbal medicines are in great demand in the developed world for primary health care because of their efficacy, safety and lesser side effects.
Ø HERBAL medicine is still the mainstay of about 75–80% of the world population.
AD VANTAGES OF HERB AL MEDI CI NE. 1. Herbal me dici ne ha ve long hi st or y of use and b etter pa tient tol er ance as well as accept ance.
2. Medici nal pl ants ha ve a renew abl e s our ce, w hic h is our onl y hope for s ustai na bl e suppl ies of chea per medi ci nes for the w orld g rowing p opulati on.
3. Availabi lit y of medici nal plant s is not a pr obl em especi al l y in de vel opi ng countr ies lik e India ha vi ng ri ch a g ro-c lim atic, cul tur al a nd et hni c biodi ver si ty.
4. T he cul tiv ation and pr ocess ing of m edi cinal her bs and her bal pr oducts i s en vi ronment al fri endl y.
5. Prol ong and a pparentl y une vent ful use of her bal medic ines may of fer test im ony of their saf et y and ef ficac y.
STANDARDIZATION OF HERBAL DRUGS.
NEED FOR STANDARDIZATION. Ø In al most a ll the t radi tional sys tem of medi ci ne, the quali ty control aspect h as been consi der ed.
Ø T hus today qual ity a ssur ance is thr us t ar ea for t he evalua ti on of tr adit ional use d medi cinal pl ants and her bal for mul ati on.
Ø In moder n concept it requi re necessa r y changes i n their a ppr oach by tha t way concr et e meth od of quality contr ol in ter ms de velopm ent of m oder n methodol ogi es.
Ø In or der t o obtai n qual ity or iented herb al pr oduct s car e shoul d be tak en rig ht from the pr oper identi fication of pl ant s, season and a rea o f coll ect ion, e xt racti on, isola ti on and ver ifi ca tion pr ocess.
Ø A st andar di zed extr act means tha t the manuf act ur er has ver ifi ed th at the acti ve ing redi ent bel ieved to be pr es ent in t he herb is pr esent i n the prepar ation.
ØAn d t ha t the pot enc y and th e am ount of t he a ctive ing redi ent
CHEMICAL AND INSTRUMENTAL ANALYSIS. Ø Ch emi cal and inst r ument al anal yses ar e rout inel y used for a nal yzi ng synt heti c dr ugs to c onfi r m its aut henti ci ty.
Ø In the c ase o f herbal dr ugs, ho wever the scene is di f fer ent especia ll y for pol yherbal for mula tion, as there i s no chemical or anal yt ical methods availabl e.
Ø In the c ase o f herbal dr ugs, the qual ity of r aw mate ri al s and p roducts can be fur ni shed by re gular phar macognost ic ident if ica tions and phy toc hemical anal ys is.
Ø T he her bal for mul ations in gener al can be sta ndardiz ed sc hem atic ally as to for mul ate t he medi cam ent usi ng raw materi al s col le cted from di f fer ent locali ties and a com par ative chemi cal effi cac y of dif fer ent ba tc hes of for mul ation ar e t o be o bser ved.
Ø T he pr epar ati ons wit h bet ter c linic al ef ficac y ar e to be sel ected.
Ø T he st a bil ity p aramet er s for the herbal for mul atio ns inc lude p hysi cal par am eter s, chemi cal par amet ers, and microbio logi cal par amet er s. Ø Physi cal paramet er s inc lude col or, a ppear ance, odor , c lari ty, vi scosi ty, moi st ur e cont ent, pH , di si nte g ration t ime, fri abil ity, har dnes s, f lowabil ity, fl occul ati on, s edim enta tion, set tl ing rate and ash v al ues.
Ø Ch emi cal par amete rs include li mit te sts, e xt racti ve val ues, chemi cal assays, et c.
Ø Ch roma tog raphi c anal ysi s of her bals can be done usi ng HPTLC and GC , UV, Fluori met r y, GC- MS, et c.
TLC, HPLC,
Ø Mi cr obi ol ogi cal par amete rs include to tal vi a ble cont ent, to tal mol d count, tot al enter obact er ial and thei r c ount
THE GUIDELINES SET BY ‘WHO’ CAN BE SUMMERIZED AS FOLLOWS: Ø Ref er ence to the id enti ty o f the dr ug. Bo tani cal e val ua ti on – sensor y char act er s, for ei gn or gani c ma tte r, micr oscopic al, hi sto logi cal , h is toc hemical e val ua tion, quant it ative m easur em ents, et c. Ø Ref er ence to the physi oc hem ical character of th e dr ug. Chr oma tog raphi c profi les, ash val ues, ext ract iv e val ues, ref ract iv e inde x, pol ari metric r eadings, mo is tur e cont ent, vol ati le oi l cont ent, et c. Ø Ref er ence to the phar macol ogical par am eter s. Bi olo gical acti vit y pr of il es , bi tter ness val ues, haemol yti c inde x, ast ri ngenc y, swelling factor, foami ng index, etc. Toxici ty detai ls – hea vy met al s li ke cadmi um, lead, ar senic, mer cur y, et c. P est ici de resi dues. Ma ximum resi due lim its = Accept a ble dai l y inde x x body w ei ght x extr acti on factor ----- ---- ------ ----- ----- ------ ---- ---- ------ ----- ----- ------ ---- ---- ------ ----- ----- ------ ---- -- x T her apeut ic d oses Mean d aily in tak e o f dr ug x safety fact or x 100 Ø
CONCLUSION:
Ø Indi a is s it ting on a gol d mi ne o f well -recor ded and wel l pr act iced knowledge of tr adi tional her bal m edic ine. Ø But , u nlike Chi na, Indi a has not been abl e t o ca pi tal ize on thi s her bal weal th by promot ing i ts use in the de vel oped wor ld desp it e thei r renew ed i nt er est in her bal medi cin es. Ø T hi s can be ac hi eved by ju dici ous pr oduct id enti fi ca ti on based on di seases found in the devel oped w orld for w hi ch no m edi cin e or onl y pal lia ti ve therapy is avai la ble.
Ø T he basi c requi rement s for gai ni ng ent r y into de vel oped count ri es inc lude: (i) well -document ed tr adit ional us e, (ii ) s tandar diz ati on based on chem ic al and act ivi ty pr of ile, and (ii i) safety and st a bil ity. Ø Suc h sci enti fical l y gener ated da ta wi ll proj ect her bal medic ine in a pr oper per spect ive and hel p in su stai ned global ma r ket .
Ø T he subj ect of h erbal dr ug standar diza tion i s massiv el y wi de and deep . T her e i s so muc h t o kno w and so m uc h seem ingly contr adict or y theor ies on the subje ct of her bal
ØInd ia ca n e me r ge as the maj or co unt r y an d p la y t he lea d r ole in pr od uc tion o f stand ar diz ed, ther apeut ica ll y ef fec tive ay ur vedi c for mu latio n. ØIn di a ne eds to e xpl or e the med ic ina ll y i mp or tant pla nts . T hi s ca n be ac hie ved onl y i f t he h er bal pr od uct s ar e e valu ated an d a na l yzed usin g soph is ti cated m ode r n techn iq ues of stand ar diz atio n such as U Vvisib le , TL C , HPL C , H PTL C , GC-M S, spe ctr oflu ori met ric
THANK YOU BY D.M.SRUJANA & N.PRAVEESHA. CMR COLLEGE OF PHARMACY.