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
TLC, HPLC,
HPTLC and GC , UV, Fluori met r y, GC- MS, et c.

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.

Ø 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
 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 V-
visib 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.