Pengembangan dan Pengujian obat.pptx

8/16/2019 Pengembangan dan Pengujian obat.pptx

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engujian dan pengembangan Obat

Oleh:

Moch.Saiful Bachri, M.Si, Ph.D, Apt


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PENGUJIAN DAN PENGEMBANGAN OBAT

Rangkaian penelitian penemuan obat:

1. Meneliti dan menapis (skrining !a"an #!at

$. Mensintesis dan meneliti %at (sen&a'aanal#g dari #!at &g sda" ada dan diketa"ie)ek )armak#l#gin&a

*. Meneliti dan mensintesis dan mem!at+ariasi strktr

,. Dikem!angkan #!at alami denganserangkaian peng-ian &g dilaksanakanseara sistematis/ terenana dan terara" tkmendapatkan data )armak#l#gik &g pn&ainilai terapetik


8/3215/10/2010 Ngatidjan, DRUGSCREENING-1 8

STUDIES IN DRUG SCREENING

Drug candidate

Prelinial std&

pharmacological, pharmaceutical and toxicological study

0linial std&phase 1, 2 and 3

Mass pr#dti#n and marketed

P#st marketing sr+eillane

(phase 4 clinical study)


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$ ta"ap -i Peneman #!at !ar

1. UJI Praklinik: pada "e'an -iMelipti:armak#l#gi/ t#ksik#l#gi

(akt/ s! kr#nis/ kr#nis dll dan

)armasetika

$. UJI 23INI2: Pada mansia

Ada , )ase: U-i klinik )ase 1/ $/ *dan,


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UJI 23INI2

Uji klinik fase 1

• Pada mansia se"at

• Mengeta"i asepta!ilitas dant#lera!ilitas pr#!ands ter"adap al#n#!at

• Mengeta"i e)ek terapi/ e)ek samping/

"!ngan d#sis e)ek• Drug safety


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UI klinik fase !

• Pada mansia sakit dalam -mla" ter!atas/tanpa kel#mp#k k#ntr#l

• Mengeta"i e4kasi dan keman-ran #!at padakeadaan pat#l#gis tertent

• 2esimplan masi" !ersi)at sementara

Uji "linik fase #

• Pada mansia sakit/ ada kel#mp#k k#ntr#l dankel#mp#k pem!anding• 0akpan le!i" las !aik -mla" pasien

mapn keragaman (mlti ras/ internasi#nal• 5etela" ter!kti e)ekti) dan aman #!at dapat

dipasarkan


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UI klinik fase $

• U-i ter"adap #!at &g tela" dipasarkan( post marketing surveilance)

• Memanta e)ek samping &g !lmnampak pada -i se!elmn&a

• Drug safety: drug mortality atau drugmorbidity

• ME5O: m#nit#ring E)ek samping O!at


13/32Drg De+el#pment


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Data badan POM

Jumlah jamu di Indoneia e!itar "#

ribu, herbal $%

fitofarma!a han&a lima

'tempo intera!tif, % Juli $#"#(.

Negara dengan keka%aaanbiodi&ersit% terbesar ke'! di duniasetela( )ra*ilia+

IND,NESI-


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Jinten )itam

'*igella

ati+a(

at a!tif: -h&mo.uinone


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/eladi -i!u '-&phonium flagelliforme(


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at a!tif : 0urcumin,

demeto!i !ur!umin ,

bidemeto!i !ur!umin

"un%it .Curcuma domestica/a(l


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TE0U-2-" .Curcuma3ant(orr(i*a4

Efek 5armakologi6 anti in7amasi8antioksidan8 imunomodulator8 anti bakteri8

anti kanker+

9at aktif6Curcumin3ant(orri*

ol


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Sambiloto .Andrographipaniculata(

Sen&a1a a!tif: andrographolide


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Andrographi paniculata

Mempun&ai efe! anti2o3idant, anti2inflamai,

antidiabetic ,anti angiogenic, anti hepatoto3icit&,

anti +iral and antithrombotic.

laporan penelitian tera!hir andrographolide

menghambat i!atan *42!B dg D*A dan mengurangi

e!prei dari proinflammator& protein uch a

c&clo3&genae2$ '0O52$( .


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0innamon

!a&u mani memili!i efe! biomole!uler di pan!rea.6/a&u mani mengandung en&a1a !imia &ang diebut

P-P"B &ang be!erja menga!tif!an en&a1a di

pan!rea dengan cara menga!tif!an el beta &ang

berfungi menghail!an inulin


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Protective Effect of White-Skinned Sweet Potato (Ipomoea batatas L.) from Indonesia on Streptozotocin-Induced OxidativeStress in Rats

Moch. Saiful Bachri, Hye won Jang1, Jongwon Choi2 and Jong-Ok Park3*Faculty of Pharmacy, Ahmad Dahlan University, Yogjakarta 55164, Indonesia1Division of Endocrinology & Metabolism, Samsung Medical Center, Sungkyunkwan University

School of Medicine, Seoul 135-710, Korea

2College of Pharmacy , Kyungsung University, Busan 608-736, Korea

3Department of Chemistry, Kyungsung University, Busan 608-736, Korea

Received February 16, 2010 /Accepted November 12, 2010

Sweet potato (Ipomoea batatas L.) is widely used in Indonesia and other countries as a traditional medicinefor thetreatment of diabetes mellitus (DM). The MeOH extract of white skinned sweet potatoes (WSSP) was administeredorally in doses of 100 and 200 mg/kg body weight in streptozotocin (STZ)-induced diabetic rats. Experimentaldiabetes was induced by a single dose of STZ (45 mg/kg, i.p.) injection. Oxidative stress was measured by tissuelipid peroxide (LPO) levels, serum aspartate transaminase (AST), alanine transaminase (ALT), total triglyceride(TG), total cholesterol (TC) and by antioxidative enzymatic activities of superoxide dismutase (SOD), catalase(CAT), glutathione peroxidase (GPx) and glutathione S-transferase in the liver. An increase in blood glucose, LPOlevel, AST, ALT, TG and TC levels was observed in the STZ-induced diabetic rats. Administration of MeOH extractof WSSP at a dose of 200 mg/kg for two weeks caused a significant reduction in blood glucose, LPO levels, AST,

ALT, TG and TC levels in the STZ-induced diabetic rats. Furthermore, oral administration of MeOH extract showedsignificant improvement in the activities of antioxidant enzymes (SOD, GPx, and CAT) compared to STZ-induceddiabetic rats. In conclusion, the obtained resultsclearly indicate the role of oxidative stress in the induction of diabetes, and that the protective effects of MeOHextracts of WSSP could be used to benefit diabetic patients.Key words : Oxidative stress, white-skinned sweet potato, diabetes mellitus, streptozotocin

ISSN : 1225-9918

Journal of Life Science 2010 Vol. 20. No. 11. 1569~1576 DOI : 10.5352/JLS.2010.20.11.1569


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7bi jalar Ipomoea batata

Penderita !encing mani dapat mengonumi 8## gr

pucu! daun ubi jalar etiap hari ebagai lalapan. A!an

tetapi, untu! penderita !encing mani &ang memili!i

juga a!it mag, ebai!n&a jangan memilih reep daun

ubi jalar ini.


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Momordica charantia

9 pare

at !arantin pada pare ber!aiat hipogli!emi!

' menurun!an !adar glu!oa darah( ia terdiri atacampuran en&a1a2en&a1a ponin teroid &ang

!haiatn&a lebih !uat daripada tolbutamida. at ini

mentimulai 'mengarang( el2el B pulau langerhan

ehingga mening!at!an produ!i hormon inulin,

pening!atan jumlah el2el B !elenjar pan!rea

memper!uat hipogliemi! buah pare.

Dibi!in ju


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ingiber Officinale rocoe

/haiat: Analgeti!, anti2inflamai, remati!,

antio!idan, gingi+iti, tro!e dan amaat a!tif: ingerol, hogaol, ;ingerone dan

Paradol

Jahe Merah


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Stelecocharpu

burahol

/


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:egagan . Centellaasiatica4

9at aktif6-siaticoside

Efek farmakologi6 -nti in7amasi8antitumor8 anti kanker8 anti kejang8 antiproliferatif8 immuno modulator8 asamurat8 (epatoto;icit%8 anti oksidan


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Sirsak .-nnonamuricata4

-kti


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6 * 7 16 1,6.66

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k#ntr#l ;

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166 mg=2gBB

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>ari

kombinasi daun sirsak, meniran dan pegagan terhadap

penurunan kadar asam urat ayam kampung jantan yang

diinduksi jus hati ayam


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6 * 7 16 1,6.66

1.66

$.66

*.66

,.66

8.66

9.66

7.66

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k#ntr#l ;k#ntr#l <

166 mg=2gBB

$66 mg=2gBB

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Efek kombinasi daun sirsak, meniran dan pegagan terhadap

penurunan kadar asam urat ayam kampung jantan yang

diinduksi jus hati ayam 30 menit pasca pemberian sampel

Pengembangan dan Pengujian obat.pptx

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