4:i"dMeeting of National Working Group on Indonesia Medicinal INTERNATIONAL CONFERENCE ON MEDICINAL PLANTS Scientification of Jamu (Evidence-based Jamu Development):A Breakthrough

This

is

to certify

that

Teguh

Widodo

has

participated in

4:i"dMeeting

of

National

Working

Group on

Indonesia

Medicinal

INTERNATIONAL

CONFERENCE

ON MEDICINAL

PLANTS

Scientification of

Jamu

(Evidence-based Jamu Development):

A

Breakthrough

Program

from

Plant

to

Medicine

for

Health

Care

Purwokerto,

Indonesia

october

ll -

13,2012

as

Presenter

The

National

Working

Group

on

Indonesia

Medicinal Plant

Secretary General,

gf,RT[FlgAT'f,

,q

Plant

a

fenderal

Soedirman

University

Organizing

Comrnittee

Chairperson,

t

/11,..--rl>

l.,

l

ii i

i',:'

tl

\r/li

/l

Scientification

of

f

am u

(Evidence-based

f

amu

Development):

A

Breakthrough

Program

from

Plant

to

Medicine

for

Health

Care

lt f 'l

1.1

t )\

,tn

f

The 43'dMeeting

of

National

Working

Group

on

Indonesia

Medicinal

Plant

"Exploration, Conservation, Development,

rnd

Utilization of

lndonesian

Medicinal

Plant"

Penerbit

:

UNIVERSITAS

IENDERAL

SOEDIRMAN

PURWOKERTO

/-"\

b?s)

\

e.:-7l

\

\"--.-'l

I

I

PROCEEDINGS OF

INTERNATIONAL

CONFERENCE ON

MEDICINAL

PLANTS

Scientification of

Jamu (EVidence.based Jamu

DeVeIopment):

A

Breakthrough

Program

lrom

Plant

to

Medicine

for

Health care

ln occasion

of

The

43th

National Meeting

of

National Working Group on Indonesia

'

Medicinal Plant

'il'"'-fi:::::3:::'"

Editors:

dr.

Agung

saprasetya Dwi

Laksana,

M'5c',

PH' HenY

Ekowati,

M.Sc',

APt'

Dr. Agus

Nuryanto,

M'Si'

Dr. Puli

Widodo, M'Sc'

Rehana,

M.5i., APt'

Lay-out: Sarmoko Prima Andika Citra

Revo Almando Harris

Published

bY.

Ed

itor

Pera nca ng

Sampul

Penata Letak

Pracetak

dan Produksi

Perpustakaan Nasional Rl: Katalog Dalam

Terbitan

PROCEEDINGS OF

INTERNATIONAL

CONFERENCE

ON MEDICINAL PtANTS

Scientification

ofJamu

(Evidence-based Jamu

Development):A Breakthrough Program from

Plant

to

Medicine

for

Health

Care

O

U

niversitas

Jenderal Soedirman

cetaka n

Pertama,

2012

llak

Cipta dilind

ungi Undang-undang

All Right

Reserved

Penerbit

@

UNIVERSITAS JENDERAL SOEDIRMAN

Jalan

Prof. Dr.

H.R.

Boenyamin

708

Purwokerto

Kode

Pos

53122 Kotak

Pos 115

lelepon 635292 (Hunting) 638337, 638795

Faksimile

631802

www.u nsoed.ac.id

ISBN:

978-979'9204-80-6

vii

+27L

hal,29.7

cmx21

cm

Dilarang

keras

memfotokopi atau memperbanyak

sebagian

atau seluruh buku ini tanpa

seizin

tertulis dari penefbit

dr.

Agung Saprasetya

Dwi

Laksana, M.Sc.,

PH.

Heny

Ekowati,

M.Sc.,

Apt.

Dr. Agus

Nu

ryanto, M.5i.

Dr. Puji

Widodo,

M.Sc.

Rehana, M.Si.,

Apt.

Panitia

Sarmoko

Prima

Andika

Citra

Revo

Almando

Ha

rris

Committee

sterring

committee:

Dr. Hj. Retno

Widiastuti,

M5

Indah

Yuning

Prapti,

SKM., M.Kes.

Prof. lr. Totok Agung

DH,

M.P.,

Ph.D.

Prof.

Suwijiyo Pramono,

DEA.,

Apt.

Prof.

Dr. lr. Suwarto,

MS.

lr.

Agus

Margiwiyatno,

MS.,

Ph.D

Dr. Bambang

Heru Budianto,

MS.

Dr.

lr. Akhmad Sodiq,

M.Sc., Agr.

Sugiyono,

Ph.D

Tuti

Sri

Suehesti,

M.5c.

Dr. Lesley Braun

Assoc.

Prof. Wandee

G ritsa

napan

Chariperson:

Dra.

Warsinah,

M.Si.,

Apt.

iza), Turmeric (Curcuma domestica) and

n.J

Cing".

(Zingiber

fficinale

cv. Rubrum) As Preventive of Nephrotoxicity Due to the Use

of

Doxorubicin

Soroyi

iiliwironi,

Ulya Rahn awati, Ayu Mayangtari,-Retna Pancaw.ati, Dina Arumi,

Sarmoko

- .

CombinationExtractCiandCurcumaxanthorrhizal01

As Anticardiotoxicity of Doxorubicin

Yohan Budi

Alint,

Wulan P. Rahayu, Agustin Damayanti, Ning Uswiyatun, Rika Triyanaputri, Heny

97

Ekowati

a domestica, and Zingiber officinale Combination 106

Against Doxorubicin: A Hematological Study

Revo Almando Harris, Sornroko,

Itn! ilro.o!

(Psidiunlguajava)onAcuteToxicityRatLiverTissue

that Induced Glrrcose

Kristianto, A

S.f.

y

Er.t".tt""

"f

Slimming Herbal X In Liver Function of Fernale Wistar Rat

Giva Oliviana Yudhista, Honrf Natiotul

Bororoh,Vitit

118

ffiicityStudyofExtractSecang(CaesalpiniasappanL)

127

T. _Sari

eSemenUsingGlucoseToleranceTestinAlbinoMaleRats Monica IVidyawati Irwan Set

i.

Yohanes Herntawan

eleontidae Species (Myrmeleon sp') As an Oral Hypoglycemic Agent

Rahajeng P. Aryani, Sherliyana Novi.ta,

-N94i!t Ayunjtu'

llarwqEo

.

.

.

--N"pht"qrt""*

D*trativesas Potential Inhibitors of o-Glucosidase

Activity

142

138

Mutia Hardhiyuna, Rilianawati,

Firdqtani,

Susi Kusununi Siska Andrina K.

Eff""t

Of

Hyd-.y

G.oup Addition on 1,4 Naphtoquinon to Inhibit Alpha Glycoside Enzyme 147 Siska Andrina Kttsuntttstuti, Rilianawati, Mutia

Hu1!!yng'

Sus!

@eenEthanolicLeafExtractofCaricaPapayaL.with

l)J

Hydroclorotiazid to Male White Rat

Ratih Febrina Puspi' Printananda

Zilni,

E".lr"ti""

"f

F"r-ulation

of Antidiabetic Herbal TableI of Andrographis panicr.r/a/a Ness

15'7

Darntawan, Sri

F"r-"t"ti""

""d

Evaluation Metfomrin Hydrochloride Beads Using Matrix of Chitosan-Sodium

162 Alginate Crosslinkage

Wahvu Kurniawan, Vitis Vini Fera, Prisci Perntanasari

F"r-rl.ti"r

"rd

Evaluation of Preparations Lotion Antioxidant Ethanolic Extract of Soursop Leaves

(Annona nruricata L.)

Shinta Angresti, Iskandar Sobri, Tuti Sri $ulgst[

fo.-"tution

of Enteric Coated Tablets Containing Pineapple (Ananas Comosus Merr.) Fruit Juice 1'77 Teguh l(idodo, A , Ferry lrau,an

I"ftu."..

of

Va.io*

Concentrations of PVP K-30 As a _{Binder on The Physical Quality} of Cerme (Phyllantus acidus) Leaves Extract Tablet

Kuncoro Foe, Teguh Widodo, Juleiry Selfiuni

184

Standirdization and Fonnulation of Antipyretic Tablet of Holy Basil Leaves Extract (Ocintum sanctLtm

L.)

Farida Lanawati Darsono, Yuliani, Sri

Harti

Effectiueness of Antifungi Galanga Essential Orl (Alpinia galunga) Preparations in Ointment 197

Tri Ayu Apriyani, Banu

Aii

lhijayanto, Ardhea Fredyantara, Testy Dwi Septiandini, Sarmoko

P"t."tt.t

""d

A*ty*

L.r"*ide

Fraction of Interest on Rumput Laut (Eryngium foetidunt)

Against

202 Mosquito Larva Aedes aegtpti

Budi Untari, Herlina

epptl*ti*

of High Performance Liquid Chromatography in the Determination of Antifungal Drug in

2t0

Samples

Dadan Hermawan, Nur Atiqah binti Abu Bakar, Wan

Aini

Wan lbrahim, Mohd Marsin Sanagi

@iiofTriterpenoidandFlavonoidfromCentellaasiaticaLeafExtracts219

Harwoko, Esy Nansy, Suwijiyo Prantono

184

|

K. Foe et ol.

Influence of Various Concentrations

of

Pvp K-30

As

A Binder on The Physical Quality

of

Cerme (Phyllanthus acidusl

Leaves

Extract Tablet

Kuncoro Foe*, Teguh Widodo, Juleiny Selfiani

Faculty of Pharmacy,

llidya

Mandala Catholic IJnirersity.

Jl

Dinoyo 12-44 Surabaya

* _{C o rre sp o ndin g a u t hor : ku n c orofo e@ya h o o. c o m}

Abstract

A study on the inlluence o1'tablet lbrmulae containing cernre leaves extract using PVP K-30 as a binder in the concentrations

of 27o (lbrmula

A),3%

(tbrmula B),4% (lbrmula C) on the physical quality ol'tablet has been conducted. (lernte leaves

extract was obtained by percolation method employing ethanol 960/o as a solvent. Tablets rvere prepared by wet granulation

nrethod arrd the physical quality ofresulting granules was evaluated including moisture content, repose angle, tlow rate, and

compressibility. Granules were then compressed to yield tablets of 650 nrg. in which each tablet contains 449 mg of dry extract of cerme leaves. The physical quality of resulting tablets was evaluated including rveiglrt unifonnities, hardness.

fiiability. disintegration time. dissolution. and a comparative qualitative determination of chernical contents of certne leaves

extract by TLC (Thin Layer Chronratography) in various samples conrnrencirtg frolrr viscous extract until tablet dosage fornr.

The hardness. friability. disintegration tinre. and dissolution data werc evaluated using contpletely randorlized design

ANOVA rvith a level of confidence of 95o/". and subsequentll' tbllorved b1 LSD (Least Signilicant Difl-erence) test. lt can be

concftrded Ihat cernte leaves extract could be formulated as a tablet arrd rrret the physical quality requirernents oftablet. There

\\€re no significant dill'erences orr the hardness and dissolution of three fbrntulae tablets (F""t.< l-'061"). On tlre otlter hand. the

liiabilit-r and disintegration tinre ofthree fornrulae tablets diflered significantll'(I"."r.) Frnr,r"). Fotrrtttla A rvas the selected one

osing ttt its shortest disintegration tirne and highest econonric value (least binder corrcerltlal.iorr).

Kcl

rvords: Cemte (Phvllanthus crcidus) leaves extract: Tablet tbrnrulation: Physical qualitl ol'tablet: Bindcr: PVP K-30.

Background

Obesitl tna)

cause a serious problem since

it

can lower someone's self'-esteem and result itr various diseases

including: cardiovascular.

gall

bladder. and diabetes. The causes

ol'obcsity.

anrong others. are excessive tbod collsunlption. exercise patterns. psychological and genetic I'actors. as rvcll as metabolic abnormalities. Various techniques

to

handle obesity include diet. exercise. psychothel'apy and nredication intervention using appetite suppressants (Gu1,ton. I 997).

One

tlpe of

plant that can lorver the body weight and leduce the appetite is cerme (Phyllanthus acidtrs).

ltis

knorvn that the viscous extract of ce,'nre leaves at a dose

of

I

g/kg brr ma) reduce

bodl

rveight and epididimus

lipid ot'albino Wistar rats. The administration ot'cerme leaves inlusion can also reduce the

bodl'weight

lvithout

clecreasing the appetite and this infusion is not toxic in rnice (Altlah. 2000). -fhe

leaves. bark and stem parts of cernte contain saponins. flavonoids. tannins and polyphenols (Hutapea. 1994:

Sastloamid.joyo.200l).

lt

rvas hypothesized that tannins ma1'clenronstrate slimnring efl'ect

by

precipitating

r.nucosal proteins

in

the intestine and hence. reducing the absorption

of

ibod (Robinson. 1995). The content clf'

tarrnins in cernte leaves extract can be detelrnined b1 pernranganonretr) titfation rnethod (Anonymous. l9tl9).

l:requent problerns arising

lionr

the adnrinistration

of

tladitional nrcdicine are unpleasant tastc and odor. less

practical use and less precise dose (YapLrtra. 1989). Developn.rent ol'scicnce in plralmaceutical technologl, lield

lras rcsulted

in

a rapid developnrent

of

the dosage

lblnr.

Extract can

bc

tblmulated into various dosage lblrns

suclr irs granules. tablets. capsules and

slrup.

Tablet is selected becausc

it

can mask the unpleasant

odor

and

tastc..fablet

phlsico-chemicalll is

Inore stable than s1'rup.

it

has a solid shapc and srnall volunre so that

it

is

casily packaged. stored and transported. and is not easily contar.ninated

bl

rricrobes (Allen el a|..2011).

(

errrs

leaves extlact is hl,groscopic. sticky. pool corlpressibilitl'. has a chalactelistic taste and odor. Theretbre aerosil should be incorporated as a desiccant in the preparation ol'cerme

drl

extract. Wet granulation method is

selected

in

the

preparation

of

tablet

!ince

the

chemical contents

in

cernrc leaves

are relatively

stable to tempcrature and humidity. Binders play a signilicant role

in

'uvet granulation method. by binding

all

particles in

Proceedings International Conference on Medicinal plants I

20t2

|

tablet tbrmulation, PVP K-30 can be employed in the solution lbrm or dry powder subsequently tbllowed by the addition

of

wetting liquid. The amount

of

binder in the fbrmula can afi'ect the stredgth of granules and hence.

influencing

the

physical

quality

of

the

resulting tablets. Cholit'ah (2003) reported that

PVP K-30

at

high concentrations increase the hardness and prolong the disintegration time

of

tablet. This

will

in turn reduce the amount of dissolved drug. Thus the determination of optimum concentrltion of PVP in the lbrmula is necessary.

In this study. PVP K-30 at various concentrations

of

2, 3 and4Yo were employed as a binder in tablet lbrmula

containing cerme leaves extract.

The

physical

quality

of

resulting

tablets including

hardness- triability. disintegration

time

and dissolution lvas observed.

lt

is

expected

that

cernre leaves extract

tablet

tblmula

contbrming the physical qualitl, requirements of tablet could be obtained.

Material

and Methods

M ate ri al s and A ppara ! us

Cerme leaves were obtained liom'Nongkojajar region East.lava grown in a land

of

approximately 300 m above

sea levef with rainlhll of approximately 2271 mL/year. Priol to the study. cernte leaves r.vere characterized by the UPT Materia Medica Batu-galang East.lava Provincial Health Council.

The experimental materials

of

pharmaceutical grade included magnesium stearate. talcum. aerosil. PVP K-:]0.

sodium starch

gllcolate.

dibasic calcium phosphate and kaolin.

The

fbllorving materials. including KMnOr.

H2SO4. oxalic acid. sodium hydloxide. iodine. FeClr. l-lCl and indigo carmine. \vefe

ot'plo

analytical grade.

Equipments used in this

studl

r.vere tabletting machine single punch. tablet haldness tester (Schleuniger 6D-30 type. German)'). tablet

tiiabilitl

tester (Elr.veka

TA-3

type. Celmany). disintegration appalatus

(Elneka

Z-l'3-l

t1 _{pe. (ierntan) ). Inoisture analyzer'(Sartorius}

MA

30 t;-pe. Cermanl). analytical balance (Toledo Metler

Al. 20i

t1pe. Cerrnanl,). glass appafatus and otlrer supporting equipments.

P re pat'cr I i o n of C t'ucle,l lat e r i a

I

'l-he leal'es nete nashed ancl rinsed. and then dried in a shady aerated place.'fhe dlied leaves n'ere glounded and

sieved thlough a no. 4/8-mesh siever. Ex|t'aclion ,l'lethod

l'he

extractiorl method enrployed in this study was percolation using 967o etharrol. u,ith a Uou, fate

of'I

mLintin.

-l-he

lesultins pelcolate \{as evaporated on a water bath at a controlled temperature ol'less than 50

"C.I'uentr-live _-eratns ol'aelosil rras added into the lesulting viscous extract. and dlied irr an oven a[ a ternperatLrre ol'50 "C. to obtain a clrv cxtt'itct subsecluentlr gloundcd and sier"ed thlough a-100 nresh siever'.

Dose Calcttltttion

('elzre lcaves

e\tlact

\\'as adnrinistered at a dose

of I

g/kg br.r'ma) reduce the body rl'eight and epididinrus lipid

as rvell as alter tligll.ceride level irr rats.

[)oseinhurnan= r'atdoscxconversionl'actor(=

l/1000x200x56)=

ll.2glT0kgdail;

'l'he body u,eight ol'Indonesian people is gener.alll, 60 kg

160/701

x

ll.2

g = 9.6 9/60 kg brvol'r,iscous extract daill

Dose :

[dly extract/viscous extfact] x dose ofviscous exrfacr (= 96.85/l

l5

x 9.6) = 8.08 g/da1

ln

this stud1. each tablet contained

drl

extract

of

cerme leaves

oi'

0.449,s and

six

tablets n,ere adnrinister.ed

thlee tinres

dailr.

Celnre leaves extract tablets u,as prepalcd into three dill'erent tbrmulae

bl

rvet _-eranulation method trsing PVP

K-i0

at

concentrations

of

2% (FA).

3%

(FB)

and 4Vo

(FC)

as

a

binder. Each tbrmula consisted

of

| 0t) tablets and prepared in triplicates.

Formula tablets are shown irr Table

l.

186

|

K. Foe et al.

Table

l.Tablet

fblrnula of cerme leaves extt'act

i*ul3

B

('*)

rotmu-ll-C (m*)

l.

Cernte leaves extract

2.

Dibasic calcium PhosPhate

3.

Sodium stafch glycolate

4.

PVP K-30 (2' 3 and 4o/o)

5.

Talcum (4%)

6.

Magnesiumstearate(lVo)

449

I z)

32.5

l3

26 6.5 650 449 I 16.5

32.5 19.5 26 6.5 650 449

lt0

32.5 26 26 6.5 650

I otal wel

Ta b I et tr4 a nufac tw' i ng P rocess

Dry

extfact was mixed

with

dibasic calciunr phosphate, sodium starch glycolate

(5%)

until

honrogeneous' A

solution

of

pVp

K-30 was added to tbrm a damp gr.anule mass.then was sieved thlough a-16 ffresh siever and dr.ied

in

an oven at a remperatu'e

of

50 oC. Dried !ro,',ules were re-sieved th'ough a-20 mesh siever and then

mixed,"vith 4%o of talcum and l%o of maguesium stearate. The physical quality

of

nrixed granules

r'vas evaluated

including: moisture content,

flowabilitl'.

r'epose angle and conrpressibility index' Gt'anules

of

good quality rvet'e compressed using a tabletting nrachine

u'ith

a-13 nrnr diatrleter

of

molds arrd a tablet rveight

of

650 mg'

The

quality

of

r.esulting tablets was evaluated includirrg:

u,eight a.d

size uniib'nrities-

liiabilit}'

disintegration time and dissolution fate of tablets.

TLC C hromatogram Prof les

Toe'aluatethestabilityofchenrical

conteuts itrcet'me leavesdurin-e.tabletnranulhcturingprocess'aTLCstudy

u,as perfbrmed in the Stages of ext|action process. drl,ing pI.ocess. and tabletting.

Preparalion of Test SamPles

Extract pouders. granules and tablets

of

each tblrnula rlere lveighed (650 mg)' dissolved in96Yo ethanol up to

l0

mL. fllter.ed. and the tlrst frltrate rvas discarded r,r,hereas the subsequent tlltrate r'vas collected' Ten microlitel's

offiltrate

rras applied onto a-GF:5a silica plate and eluated using a nrixture

ofn-hexane:

ethyl acetate

(4:l'

v/v)

u,ith a development dlstance

of

8 cm. The spot rvas obserYed using visible

light'

uv

254

and

366 nm' Follou,ing the above obser.r,ation. the spot uas sprayed using

vanillin

sulphate as a spra;-ing reagent' dried

and

obser.ved using visible light.

UV

254 and366 nrn. -fhe Rf value r'vas 0'2-0'5 cnr (Kirchner' 1978)'

Results and Discussion

Thepartsofplantusedinthisstudywerelieshatrdgreencernte|eayes.Toensurethetypeofplantemployingin

this stud1. the cet.nre leaves were characterized by the UPT Materia Medica Batu-Malang East Java Provincial Health Council'

pr.ior

to

extr.action.

cernte

leaves por'r'der rvas sub.lect

to

several

crude

standardization

tests

including: organoleptic. ash content. loss on dr-ying. and chernical identillcation^as shorvn in Table 2' The lesults indicated that the ct'ude rnatel'ial met all the requirements (Anonylnous' 1989)'

Table 2. The results of crude material of cerne leaves porvder

Remarks Reference Result

No.

l.

OrganolePtic:

-

Color

-

Odor'

-

Taste

2.

Ash content

3.

Loss on dlving

4.

ldentiflcation

Brortnish green

T1'pical at'omatic Chelate/tasteless l.ess tlran 77o

l,ess than l0olo

Brorvn Green

Yellow

Blownish green

Typical aromatic Chelate/tasteless 5.44% 8.60% Brou'n Green Yellorr' Confblmed Contbrmed Contbrmed Confbrrned Conlbrmed Contbnned Corrfbrmed Contblmed

+

i

drops t/-concentrated I-lrSO1

Proceedings International Conference on Medicinal plants

20t2

The extraction process employed

in

this study was pelcolation _{using 96% ethanol.}

to

_{maintain the stability ol.}

active compounds in the crude material orving to the absence

of

heating process.

Tht

testing result ol'viscous

extfact is presented in Table 3.

lrcr

t"

Table 3, Examination results of viscous extract No. Observation _{Reference Remarks}

l

2.

3.

Color' Odor

Brownish green

Typical aromatic Viscous

Contbrmed Confbrmecl Confbrnred

Aerosil was added into _{the resulting viscous extracts and subsequently dried in an}

o'en

_{r.r,ith a temper.ature}

of

50 "C until dry. This resulting dry extract was used as an active ingledient in the tablet manuf'acturing process.

Each tablet contained 449 mg of dry extract.

wet

granulation method using PVP K-30 as a binder at concentratior-rsof

2yo(FA).3%

(FB). and 4% (FC) rras selected' To identily the compessibilit.v- and flou,ability charactelistics of gmnules. seyeral tests \\,ere pertbrnrecl.

as shosn in Table 4.

Table 4. The quality of granules No. Parameters utrements FA

t.

2.

3.

4.

Moisture content Flolv tinre

Repose angle

Conrplessibilit1,(%)

2-5%

<

| 0 seconds

20-40"

5-l8o/o

4.48 + 0.20

9. t5 + 0.03

3t.45+0.03

13.73

*

0.59

FB 4.44 + 0.22 7.77 + 0.10 31.78 +

0.0i

14.t0 + 0.72

FC 4.75

r

0.42 9.44

r

0.

ti

3 l. t5

r

0.06

I

i.80

+ 0.56

fhe results shoued that FA. FB and FC rnet the quality standar.d of good grat.lules" _{narrrelr the ntoisture content}

ol'2-5o/o (Bandelin

&

Shangrau- 1989:

Voigt,

1995), the

flou,time

of

less tlran

l0

seconds (Voi-er. 1995). the

repose angle

ot'20-40'(Marshall.

1996). compressibility of

5-lg%

(Fierse

&

FIagen. 1996).

Good quality o1'tablets should meet the quality requirements as desired. including uei_shr and dose unifbrmities. lack ot'incompatibilities. _{att|active appeafance. as well as possible and etllcient large scalc}

producti.,

(Bandelin

&

Shang|ar'r'. 1989). The examination results of the qualitv ot'c,er.rze lear,es exl.ract rabler ar.e shorin

in

l.able 5.

Based on data shown

in'fable

5- FA. FB and FC demonstrated good r.r,eight _{uniibrnrit-r since none of'the tablets}

shorted r'r'eight deviations

of

mot'e than 5o4 and

all of

thern passed the size

unilbrrnitl

test.'l-he diamelers.1. labfet \\'ere

of'

no mot'e than three times and of no less than 413 tinres of'tablet thickness (AnonVnrous. _1979).

Table 5. 'l'he clualitl testing ol'rablc-ts

No. P:rr:r meters en ts FA

xt50h

648 + 0.20

4.i3-9.73mrn

4.42 + 0.03

FB 654 + 0.22 4.43 L 0. t0

652 + 0.42 1.42 + 0.13

FC

l.

WeightLrnifbrmit-r,

2.

'l _hickness

3.

l lardness

1.

Friabilitr

5.

Disinteglationtinte

6.

'l'annin ler, el

4-8

kgf

5.99 + 0.48 6.03 +

0.50

6.17

r

0.35

<

l%o

l5

minr

0.58

r

0.03 0.38 .L 0.03 0.18

r

0.03

: |

/e

rr.Jd

i (r.Uj

_U.jE :L

0.0j

0.lg

t

_0.03

nrinutes

13.26

rr.zo:t

+

0.08

U.UU

14.20,r l4.2U,t

0.05

0.05

14.92 14.92 + + 0. 0. l(

l0

10.67 +

0.08

_t0.59 +

0.08

10.i6 r v.Jv

{

! 0.08w.vo08

7.

Dissolved

tannins

e45>75%

_{97.69 +}

0.0g

_{97.gj +}

0.08

97.96

*

0.0g

.l

ablet ha|clness is the lb|ce reqtrired to _{break or-crush tablets and expressed in a kilo_ur.anr lbrce r,rnit. Accor.ding}

to

Pat'rot (197 1)

a

good hardness

of

tablet should

vary

betneen

4-8

kgl.

'l'lre

r.esLrlts sho*,ed

an

increased concentration ol'PVP K--i0 may enhance the hardness oltablets although they <tid not

difler.signiticantll

188 I K. Foe et o,.

Tablet ti.iability test is used to deterrnine the exrerrt

ot

tablet lesistance to'uvard

iiiction

and shocks experienced

during manuf'acturing, packagirrg ancl transportation.l-he t'esults shorved that FA, FB and FC had good

{iiability

because its value was

of

less than

l%

(Banker

&

Anderson, 1996). Statistical analysis by orre way

ANoVA

showed no signiflcant dillerence in the tablet

tiiabilitl

anrong lbrmulae (p

<0'0'j)'

Disintegration tirne is an important parameter

tbl

arr oral tablet since

it

may atfectthe oral bioavailability' Tablet

is claimed

to

be completely crushed

if'the

renrairring preparatiorrs lel1 on the apprratus scleen is a soft mass

which does not have a clear.cor.e. Tablet disintegratiotl time should be of no mot'e than

l5

minutes (Anonynrous'

1979).

The

expefimental results demonstrated

that

FA- FB

and

FC

nret

the

requirenrents'

An

increased

concentrationofpVpK-30prolongedthedisinteg|atiorrtime

ot'cerme leavesextractsandtherewasasignificant

dift-erence in the disinteglation time among tablet forrnulae by one r'vay

ANOVA

(p <0'05)'

Dissolution test results showed that FA. FB and FC met the requi|empnts acoording to Shargel

&

Yrr (1999)' that

is the

per.centage

of

released drug

is

75%o rvithin

45

minutes. Thet'e was

no

signiticant dill'erence

in

tablet

dissolution among lbrmulae

by

one $,ay

ANOVA

(p<0.05) and

this

may be due

to

a small ditl'e|ence

in

the concentrations of PVP K-30 as a binder among FA' FB and FC'

Figure

l.

chromatogram

of

constitutents ttt cernrc leaves extract, from crude materials

until

tablets lbllorving observation under

UV

366.Notes:

l.

crude materials;2. viscous

extract;

3'

Dry extract:4'

FA

granu|es: 5. FB granules: 6. FC granules:7. FA tab|etl 8. FB tab.let; 9. FC tab|et.

The

chromatogranr protiles

of

tablets

during

nranut'acturing plocess: crude materials, extracts, g|anules and tablets using a-GF25a silica plate as a stationarl phase and a mixture

of

n-hexane : ethyl acetate

(4:l'

r'/r') as a

mobile phase u'ith vanillin as a spraying feagent catr be seen in Figure

l'

The

results

of

the

chromatogram dernonstrated that

tlre

chemical constituents

in

cernre leaves'

tiom

crude materials until tablets. u,ere relatively unchangcd.'l'annins spot of purple color w'hich was used as a rnarker (RI' 0.20 and 0.50) rvas identitled in-the.extracts. e\tract porvder. granules and tablets'

The tannins contents

in

crude matelials. dry e)itracls. granules, and tablets were2'97Yo,

l5'33%'

l0'63%'

and 10.63% respectively. The cgntent ol'tannins

in

the extlact rvas lbund to be higher than that

in

crude mate|ials due to a relatively long extr.action process ol'actir,e constitutents

in

the preparation o1'extfacts' The addition ot' tablet excipients resulted in a decrease in tannins content. Tannins contents in granules and tablets did not dil'f'er

signilicantly

since tannins were resistant to heat and rrroistut'e. T rus wet granulation process did not leduce thc content of tannins in the samPles.

All

tbrnrulae

of A. B.

and

c

showed good ph1'sical quality

of

tablets. Horvever, tbrmula

A

demonstrated :r

slrorter. disintegration time than those

of

lbr.nrulac

Il

and C. Thtrs

it

is expected that tbrrrrula

A rvill

disintegt'irtc

I

l'aster and be readily absorbed

in

the body so that

it

will

exhibit a

lbrmulae B and C.

Proceedings International Conlerence on Medicjnal Aants

J

1g9

more rapid pharmacological _{effect than}

Conclusion

cefme _{leaves extract courd be lbrmurated into}

a tabre{ dosage

tbrrr

\ihich

eets the requir.cments

ofphlsical

quality

oftablet

_{The addition}

ofPVP

_K-30

as a binder at co-ncentrations

ol

_2.

i

_{and 4yo may resurt in} a tabrel

wh _{ich meets the fequ irements. The}

serected rbrmu ra \vas _{FA with}

pvp

K-i'

_{at a concentration of}

270.

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