FITOFARMAKA

Prof Dr dr M.T. Kamaluddin, MSc, SpFK

Department of Pharmacology
Medical Faculty Sriwijaya University
2012

Objectives
1.
2.
3.
4.

Terminology
Understand key issues in Fitofarmaka
Understand prospect of Fitofarmaka
Understand the principles of using
Fitofarmaka in medicine

Menurut Permenkes RI
No. 949/Menkes/Per/VI/2000
Penandaan
1. Obat bebas
2. Obat bebas terbatas
3. Obat keras
4. Obat wajib apotek
5. Obat narkotika
6. Obat psikotropika

Permenkes RI No.
949/Menkes/Per/VI/2000
Obat Bebas

Obat yang dapat

dijual bebas kepada
umum tanpa resep
dokter

Minyak kayu putih,

OBH, OBP,
Paracetamol, Vit. C,
B Komplex, dll.

Obat Bebas
Terbatas (W :
waarschuwing)

Obat bebas yang

pada penjualannya
disertai tanda
peringatan.

Antihistamin,
klorokuin, kalii
kloras, suppositoria,
dll.

Obat Keras
(G : Gevaarlijk)

Obat berbahaya jika

pemakaiannya tidak
berdasarkan resep
dokter.

Adrenalin,
antibiotika,
antihistamin, dll.

OWA

Obat keras yang

dapat diserahkan
oleh apoteker tanpa
resep dokter.

Linestrenol, antasid,
salbutamol,
basitrasin krim,
ranitidin, dll.

Permenkes RI No.
949/Menkes/Per/VI/2000
Narkotika

Zat atau obat yang berasal dari

tanaman atau bukan, sintetis atau
semisintetis yang dapat
menyebabkan penurunan atau
perubahan kesadaran, hilangnya
rasa, mengurangi sampai
menghilangkan rasa nyeri.

Tanm. Papaver
somniferum,
kokain, ganja,
heroin, morfin,
opium, kodein, dll.

Psikotropika

Zat atau obat baik alamiah

maupun sintetis bukan narkotika
yang berkhasiat psikoaktif melalui
pengaruh selektif pada SSP yang
menyebabkan perubahan khas
pada aktifitas mental dan perilaku.

Lisergida,
psilosibina,
amfetamin,
diazepam,
fenobarbital,
klordiazepoksida,
dll.

Tujuan terapi adalah

1. Memperpanjang harapan hidup dengan
harapan mencegah kematian lebih dini.
2. Memperpanjang kualitas hidup (quality of
life ) sehingga kecacatan akibat suatu
penyakit dapat dihindari atau diminimalisir.
3. Mengatasi keluan atau gejala yang menjadi
masalah penderita.
Adapun cara mencapai tujuan tersebut
melalui penanganan penderita secara
komprehensip yang meliputi upaya promotif,
preventif, kuratif dan rehabilitatif.

Peraturan Kepala Badan POM No. HK.00.05.4.1384 Tahun 2005 tentang

Kriteria dan Tata Laksana Pendaftaran Obat Tradisional, Obat Herbal
Terstandar dan Fitofarmaka, ditetapkan bahwa :
-Obat tradisionaladalah bahan atau ramuan bahan yang berupa
bahan tumbuhan, bahan hewan, bahan mineral, sediaan sarian
(galenik) atau campuran dari bahan tersebut, yang secara turun
temurun telah digunakan untuk pengobatan berdasarkan pengalaman

-Jamuadalah Obat Tradisional Indonesia.

-Obat Herbalterstandar adalah sediaan obat bahan alam yang
telah dibuktikan keamanan dan khasiatnya secara ilmiah dengan uji
praklinik dan bahan bakunya telah distandardisasi.
-Fitofarmakaadalah sediaan obat bahan alam yang telah
dibuktikan keamanan dan khasiatnya secara ilmiah dengan uji
praklinik dan klinik, bahan baku dan produk jadinya telah
distandardisasi.
-Sediaan galenikadalah hasil ekstraksi simplisia yang berasal dari
tumbuh-tumbuhan atau hewan.

Obat Fitofarmaka yg beredar saat ini

1. Nodiar (POM FF 031 500 361)

Komposisi:
Attapulgite (bahan kimia, obat untuk diare), 300 mg
Psidii folium ekstrak (daun jambu biji), 50 mg
Curcumae domesticae rhizoma ekstrak (kunyit), 7.5 mg

Khasiat: untuk pengobatan diare non

spesifik
Produksi: PT. Kimia Farma

2. Stimuno (POM FF 041 300 411, POM FF 041 600 421)

Komposisi: Phyllanthi herba ekstrak (meniran), 50 mg
Khasiat: Membantu memperbaiki dan meningkatkan daya
tahan tubuh (sebagai imunomodulator)
Produksi: PT. Dexa Medica

PT Phapros
3.

X-Gra (POM FF 031 300 011, POM FF 031 300 021)

Komposisi:
Ganoderma lucidum (jamur ganoderma), 150 mg
Eurycomae radix (akar pasak bumi), 50 mg
Panacis ginseng radix (akar ginseng), 30 mg
Retrofracti fructus (buah cabe jawa), 2.5 mg
Royal jelly 5 mg
Khasiat: Meningkatkan stamina dan kesegaran tubuh, membantu
meningkatkan stamina pria, membantu mengatasi disfungsi ereksi dan
ejakulasi dini.

4. Tensigard Agromed

(POM FF 031 300 031, POM FF 031 300 041)

Komposisi:
Apii Herba ekstrak (seledri), 95 mg
Orthosiphon folium ekstrak (daun kumis kucing), 28mg
Khasiat: Membantu menurunkan tekanan darah sistolik dan
diastolik pada penderita hipertensi ringan hingga sedang
Produksi: PT. Phapros

Jamu

Jamu sebagai obat tradisional :

- disediakan secara tradisional,
- tersedia dalam bentuk seduhan, pil maupun larutan.
- dibuat berdasarkan resep turun temurun.
-Jamu harus memenuhi beberapa kriteria, yaitu:
Aman
Klaim khasiat berdasarkan data empiris (pengalaman)
Memenuhi persyaratan mutu yang berlaku
Sebuah ramuan disebut jamu jika telah digunakan masyarakat melewati 3 generasi.
Artinya bila umur satu generasi rata-rata 60 tahun, sebuah ramuan disebut jamu jika
bertahan minimal 180 tahun.
Bedakan dengan fitofarmaka, dimana pembuktian khasiat tersebut baru sebatas
pengalaman, selama belum ada penelitian ilmiah. Jamu dapat dinaikkan kelasnya menjadi
herbal terstandar atau fitofarmaka dengan syarat bentuk sediaannya berupa ekstrak
dengan bahan dan proses pembuatan yang terstandarisasi

Obat Herbal Terstandar (OHT)

- obat tradisional yang berasal dari ekstrak bahan tumbuhan, hewan maupun mineral.
- Perlu dilakukan uji pra-klinik untuk pembuktian ilmiah :
- mengenai standar kandungan bahan yang berkhasiat,
- standar pembuatan ekstrak tanaman obat,
- standar pembuatan obat yang higienis
- uji toksisitas akut maupun kronis
- proses pembuatannya, OHT memerlukan peralatan yang lebih kompleks dan berharga
mahal serta memerlukan tenaga kerja dengan pengetahuan dan keterampilan pembuatan
ekstrak, yang hal tersebut juga diberlakukan sama pada fitofarmaka.
Kriteria OHT :
Aman
Klaim khasiat secara ilmiah, melalui uji pra-klinik
Memenuhi persyaratan mutu yang berlaku
Telah dilakukan standardisasi terhadap bahanbakuyang digunakan dalam produk jadi.
Di Indonesia sendiri, telah beredar 17 produk OHT, seperti : diapet, lelap, kiranti, dll.
Sebuah herbal terstandar dapat dinaikkan kelasnya menjadi fitofarmaka setelah melalui
uji klinis pada manusia.

Fitofarmaka
- obat tradisional setara dengan obat modern ;
- proses pembuatannya yang telah terstandar
- khasiatnya telah dibuktikan melalui uji klinis.
Karena fitofarmaka perlu proses penelitia yang panjang serta uji klinis yang detail, sehingga
fitofarmaka termasuk dalam jenis golongan obat herbal yang telah memiliki kesetaraan
dengan obat, karena telah memiliki clinical evidence.
Kriteria fitofarmaka :
Aman
Klaim khasiat secara ilmiah, melalui uji pra-klinik dan klinik
Memenuhi persyaratan mutu yang berlaku
Telah dilakukan standardisasi bahan baku yang digunakan dalam produk jadi
Indonesia saat ini baru terdapat 5 fitofarmaka, contoh produk fitofarmaka yang sudah
beredar adalah: Nodiar (PT Kimia Farma), Stimuno (PT Dexa Medica), Rheumaneer PT.
Nyonya Meneer), Tensigard dan X-Gra (PT Phapros).
Setelah lolos uji fitofarmaka, produsen dapat mengklaim produknya sebagai obat. Namun
demikian, klaim tidak boleh menyimpang dari materi uji klinis sebelumnya. Misalnya, ketika uji
klinis hanya sebagai antikanker, produsen dilarang mengklaim produknya sebagai antikanker
dan antidiabetes.

What, Why and How...

Herbal medicine is....
Medicinal Plants
Phytomedicines

Global Use of Alternative or Traditional

Medicines
15% 33%
40%
25%

25-50%
50-75%
60%
40%
55%

>90%

75%
~60%

>80%

>80%

>80%

60-70%
40-70%

60-80%
~50%

70%

www.WHO.org

CAM
Pelengkap
-- pilihan
lain
--diversifikas
i

CAM and Traditional Medicine Use

in the USA
Herbal medicines Shiatsu Homeopathy Qi
gong Osteopathy Tai ji Unani Tuina
Acupuncture/acupressure Chinese medicine
Ayruveda
Chiropractic
Naturopathy
Siddha
Native American Yoga
Curanderismo Folk practices Laying on of
hands Kampo

www.CDC.gov: 2002 NHIS survey

Prevalence and
demographics
Use 75%
p year 62%

Female > male

Higher education level
Ethnicity determines
type of CAM used
Hospitalized p year

CAM becomes popular

1995

NIH Office of Dietary Supplements

FDA declassifies Acupuncture
needles as experimental product

1996

NIH Consensus Conference on Acupuncture

1997

First large trial of CAM therapy, St. Johns

Wort for depression

1998

National Center for Complementary &

Alternative Medicine (NCCAM) established
http://nccam.nih.gov/
First full scale article in JAMA on herbal
medicine
Office of Cancer Complementary and
Alternative Medicine (OCCAM) established
http://www.cancer.gov/cam/

2001

CAM on PubMed (NCCAM and NLM)

2009 - $296 million in NIH CAM research

Impact of CAM
CDC Report (2007)

38% of adults used some form of CAM

Children whose parent used CAM were 2x as
likely to have used CAM
CAM use more prevalent for: women, adults aged
30-69, higher levels of education, adults who were
not poor, adults living in the West, and former
smokers

Full report:
http://nccam.nih.gov/news/camstats/

Diseases and Conditions

Top CAM Therapies

Top 10 Supplements

Herbal Medicine in the UK

1 in 5 regularly use CAM - Herb no 1
European market 2001 3.2 billion Euros
Registered herbalists: ~ 650 Western,
550 Chinese, 150 Ayurvedic & 56 other
Unregistered ~ Approximately 1000
6 BSc NIMH accredited courses
EHPA - Statutory Self Regulation

Why Use Medicinal Plants?

Whole plant medicines usually have a
more gentle and balanced effect
Synergy within a plant & between plants
Low cost
Promote homeostatic mechanisms not
suppress the bodys efforts heal
Safe and effective treatment option when
pharmaceuticals inappropriate

Scope of Herbal Medicine

Nutrition: food & nutrients
e.g.
Coriander, Garlic, Nettle & Oats
Maintenance of Health: systems
e.g.Dandelion, Garlic & Slippery Elm
Treatment of Disease: acute & chronic
e.g. self-medication, over-thecounter-products, medical herbalist &
other practitioners

Herbal Medicines
Herbal medicines prescribed according to
the needs of the individual patient
Traceable products from unpolluted and
sustainable sources
Versatility of herbal preparations
e.g.
fresh, juice, tisane, tincture, syrup,
aromatic water, powder, capsule, tablet,
pessary, lotion, cream, ointment & oil

Sources of Herbal Medicines

Cultivated and wild plants where appropriate
A Medical Herbalist
Herbal shop or other retail outlet e.g. Napiers 0131 553
7999 www.napierstheherbalists.com
Avicenna 01570 471 000 avicenna@clara.co.uk
Herbal Apothecary 0116 2602690 www.herbalapothecary.net
The Organic Herb Trading Co. 01823 401205
www.organicherbtrading.com
Phyto Products 01623 644334 www.phyto.co.uk
Rutland Biodynamics Tel 01572 757440
www.rutlandbio.com

Materia Medica
Antiviral Effects
of Herbs
Lomatium
dissectum

Constituents:
Flavonoids;
Coumarins;
Tetronic acids.
Root of L.dissectum may
be valuable for the
treatment of the Chronic
fatigue syndrome, for
which there is no accepted
orthodox treatment.

Anti viral Effects and Phyllanthus

Amarus
Phyllanthus Amarus.
*Constituents:
Lignans such as:
Phyllanthin and
hypophyllanthin;
Flavonoids;
Alkaloids.
Leaves of Phyllanthus
are an important remedy
in south of India for
jaundice.

HIV and Hypericum

Perforatum Herb
The most significant
development in herbal
treatment of viral
infections is the recent
discovery of the antiviral
properties of hypercin
and pseudohypericin
the major components
of St Johns wort
(hypericum).

Drugs Sources

B Biological; usually a large

(>45 residues) peptide or
protein either isolated from
an organism/cell line or
produced by biotechnological
means in a surrogate host.
N Natural product.
ND Derived from a natural
product and is usually a
semisynthetic modification.
S Totally synthetic drug,
often found by random
screening/ modification of an
existing agent.
S* Made by total synthesis,
but the pharmacophore
is/was from a natural
product.
V Vaccine.
Subcategory. NM Natural
product mimic

New Chemical Entities (Total 1010 NCEs )

by Source of Compound 01/1981-06/2006

S*
5%

S*/NM
11%

V
4%

S/NM
11%

B
12%
N
4%

ND
23%

S
30%

J. Nat. Prod. 2007, 70, 461-4

Medicinal Herbs
The Whole better than part.

Powerful ingredients.
Only 15% of estimated plant
species on earth have been
investigated for possible
Medicinal uses.
The world Health
organization estimates that
80% of the earth population
today depends on plants to
treat common ailments.
Traditional Healers are good
resources for scientific
based research.
39

POISONOUS PLANT AND SAFE

MEDICINE
*Straightforward definition
of a poisonous plant.
*The major poisonous
principles found among
plants are organic
compound.
*Herbal medicines are to
be prescribed with
greatest care.

Makna/pengembangan TOI

Diduga Obat
Herbal
Manfaat
empiris
Skrining obat Plasebo

Makanan

Teruji

Potensi
Obat/baru DOC/mekanisme
kerja setara

Alur Perkembangan Obat

Biomaterial / Mineral
Etnofarmaka
Senyawa Bioaktif

Biomimik

Natural

Derivatik

Sintetik

Obat Herbal

Semisintetik

Paradigma Pemanfaatan Obat

one drug, one target and
one disease

Multidrug Therapy

Multitarget Therapy
which is directed primarily toward the activation of
defence, protective and repair mechanisms of the body
rather than toward the direct destruction of the
damaging agents
(ARKIVOC 2004 (vii) 277-284)

Paradigma Obat Herbal Sinergi

Multi-targeted Therapy

Herbal Medicine

Synergistic effects
It is one main aim of the herbal
research to find a scientific rational for
the therapeutic superiority of many
herbal drug extracts derived from
traditional medicine as compared with
single constituents thereof

Isobol curve for 50% inhibition of a

Ginkgolide AB-combination In PAF-induced in
vitro thrombocyte aggregation assay
Pure Appl. Chem., Vol. 71, No. 9, pp. 1649-1654, 1999.

Produk-Produk Herbal
Jamu

Herbal
Terstandar

Fitofarma
ka

Multi components-Multi ingredients

Uji Keamanan
Toksisitas

Uji

46

TAHAP PENELITIAN
WHO 1993

BAHAN UJI OBAT

HERBAL
(TELAH TERSTANDAR)

Aktivitas
Biologik

UJI
PRAKLINIK

Aktivitas
Terapi

UJI
KLINIK

-Toks Akut
-Toks Jangka Panjang
-Toks khusus
-Uji Khasiat

Fase
Fase
Fase
Fase

I
II
III
IV

UJI KHASIAT
KEAMANAN

ASY 2010

Contaminants Repeatedly Found in

Herbal Remedies
Aluminum
Aminopyrine
Arsenic
Aspirin
Betamethasone
Bromhexine
Cadmium
Caffeine
Chlordiazepoxide
Chlorpheniramine
Corticosteroids
Diazepam
Diclofenac

Ephedrine
Indomethacin
Lead
Mefanamic acid
Mercury
Paracetamol
Phenacetin
Phenylbutazone
Thallium
Theophylline
Thiazide diuretics
Tin
Zinc

Batas Keamanan
Kisaran antara dosis toksik dan dosis yg
memberikan manfaat atau yg memberikan
efek terapi.
Disebut juga sebagai Indeks Terapi
Makin besar indeks terapinya makin aman
TD 1
ED
99

LD 50
ED 50

UJI PREKLINIK OBAT

SUBJEK : 3 jenis binatang mengerat

Apakah 2 jenis tidak cukup; Bagaimana bila h
TOKSISITAS AKUT : toksisitas yang terjadi pada
pemberian dosis tunggal atau berulang, tapi tidak lebih
dari 24 jam.
LD50 : dosis yg membunuh 50 % hewan coba.
LD 50/ED50 : batas keamanan , makin besar rasionya
TOKSISITAS
SUBKRONIS : 3 bulan + KEL.
makin
aman.
SATELIT
,,
SATELIT

KRONIS

,,

KHUSUS

: 6 bulan + KEL.
:-

Masa penggunaan klinis dan Masa uji toksisitas

Masa Penggunaan Klinis *

- Dosis tunggal atau < 1 minggu

- Dosis berulang 1- 4 minggu

- Dosis berulang 1 -6 bulan
- Dosis berulang > 6 bulan

Masa Uji toksisitas **

2 minggu 1 bulan
4 minggu 3 bulan
3 - 9 bulan
9 12 bulan

Pedoman Uji Klinik OT Depkes 2000 / WHO 1993

*oleh manusia
** pada tikus/mencit

PERRKIRAAN KESETARAAN DOSIS

antara berbagai spesies berdasarkan luas permukaan tubuh.

20 g mencit
200 g tikus
400 g marmot
1,5 kg kelinci
2 kg kucing
4 kg monyet
12 kg anjing
70 kg manusia

20 g
mencit

200g
tikus

400 g 1,5
2 kg
marm kg
kucin
ot
kelinc
g
i

4 kg
mon
yet

12 kg
anjing

70 kg
manu
sia

1
0,14
0,08
0,04
0,03
0,016
0,008
0,0026

7
12,25 27,8 29,7 64,1
1
1,74
3,9
4,2
9,2
0,57
1
2,25
2,4
5,2
0,25
0,44
1
1,08 2,4
0,23
0,41 0,.92
1
2,2
0,11
0,19 0,42 0,45
1
0,06
0,10 0,22 0,24 0,52
0,018 0,031 0,07 0,076 0,16

124,2
17,8
10,2
4,5
4,1
1,9
1
0,32

387,9
56
31,5
14,2
13
6,1
3,1
1

Laurence D.R. dan Bacharach, 1964

53

54

55

Pharmacodynamics
Pharmacokinetics

56

Konsep Pengembangan
Current Drug Targets, 2009, 10, 202-211

Konsep Pengembangan

Products :
Jamu,
Standardized
extracts,
Phytopharmac
a
Public Health Nutrition: 3(4A), 515-522

Teknik uji bahan berkhasiat/zat

aktif

Studi Standardisasi Bahan Baku

Fingerprint

Information

Development of Quality Control Method

Proses dan Faktor Penentu Kualitas

dalam Pengolahan Produk Obat
Herbal:
Waktu Panen, Sortasi, dan
Tumbuhan
Pencucian
Segar
Perajanga Peralatan, ukuran, dan cara
n
Pengeringa Peralatan, temperatur, dan
metode
n
Penggilinga Peralatan, ukuran
n

Simplisia

Tingkat kekeringan, kandungan

senyawa bioaktif, aspek higienis,
dll

Proses dan Faktor Penentu Kualitas

dalam Pengolahan Produk Obat
Herbal:
Simplisia

Ekstraksi

Ukuran partikel, Metode, Pelarut

Pengentala
n

Teknik, Peralatan

Ekstrak

Tingkat kekeringan, kandungan

senyawa bioaktif, aspek higienis,
dll

Proses dan Faktor Penentu Kualitas

dalam Pengolahan Produk Obat
Herbal:
Ekstrak

Fraksinasi

Metode dan Peralatan

Purifikasi

Metode dan Peralatan

Pengeringa
n

Metode dan Peralatan

Senyawa
Obat

Kemurnian senyawa bioaktif,

stabilitas, aspek higienis, dll

Proses dan Faktor Penentu Kualitas

dalam Pengolahan Produk Obat
Herbal:
Ekstrak
Obat

dan/atau

Senyawa

Formulasi

pengujian

Produksi

Metode dan Peralatan

Sediaan
Obat

Formula, homogenitas,
stabilitas, aspek higienis, dll

Variasi kandungan zat aktif

Varietas bibit dan Lingkungan
Tumbuh

JAMINAN MUTU
GAP

GCP

GMP
Simplisia

GMP

Budidaya
Hutan
Tanaman/
satwa liar

Pengum- Pasca
pulan
panen
Industri
hulu

Pemeliharaan mutu harus

diupayakan dari hulu sampai

Serbuk
Ekstrak
Tingtur
Industri
bahan
baku

Industri
produk
jadi

Common Adulterants and Contaminants

steroids: prednisolone, hydrocortisone, triamcinolone,
methyltestosterone

benzodiazepines: diazepam, estazolam,

chlordiazepoxide

heavy metals: mercury, lead, arsenic, antimony,

cadmium

analgesics and NSIADs: acetaminophen, aspirin,

indomethacin, mefanamic acid

other drugs and chemicals: hydrochlorothiazide,

digitalis, caffeine, scopolamine, atropine, strychnine,
carbamazepine, phenytoin, valproic acid, dipyrone,
diacetyldiphenolisatin

Kelemahan riset CAM / Herbal

Medisin
1.
2.
3.
4.

Lemah ketrampilan riset

Lemah infrastruktur akademik
Jumlah subjek terlalu kecil
Kesulitan analisis dan interpretasi
data
5. Metodologi sulit dimengerti

Study Etnobotani ~ Etnofarmakologi

Study on Biota Medica at Bukit Tigapuluh
National Park and Bukit Duabelas Biosfer
Reserve Riau and Jambi Provinces
Ethnobotanical Study
Research on Akar Kuning (Arcangelesia Flava)

Study Etnobotani ~ Etnofarmakologi

There are three native
ethnics on location study i.e
Melayu Tradisional, Talang
Mamak, Anak Dalam
Melayu Tradisional ethnic use
182 species of medicinal
plant, Talang Mamak ethnic
use 110 species of medicinal
plant, and Anak Dalam
ethnic use 101 species of
medicinal plant

Study Etnobotani ~ Etnofarmakologi

Akar Kuning (Arcangelesia flava) use for Hepatitis

(Traditionally use for curing yellow disease, fever and sprue.)

The Herbal Treatment of

Diseases
Phytotherapy (Herbal
medicine), the natural
therapies, by contrast,
aims not to cure disease
by a technological fix.
The nature in totality, is the
expression of a universal
harmony and equilibrium
the rupture of which gives
rise to numerous ill effects.
Objectives

Kendala Pemanfaatan Herbal

Medisin
1. Regulasi belum standar dan berlaku umum
2. Belum diajarkan dalam kurikulum resmi
F.Kedokteran
3. Penggunaan secara alamiah
4. Garapan terlalu holistik, tidak spesifik
5. Fungsi alternatif bila konvensional gagal
6. Belum banyak terbukti dalam uji klinik berdskala
besar
7. Bersifat irrasional
8. Mungkin berbahaya

Concerned Developments

Pekerjaan rumah di masa

datang
1

OKU Selatan

Muaradua

Gedung Lepihan
Mehanggin
Batu Belang 2

Buay Rawan

Rantau Panjang

Mahkota Dewa

Reumatik, Asma

Kumis Kucing

Ginjal

Mahkota Dewa

Reumatik, Asma

Kumis Kucing

Ginjal, Sakit Pinggang

Mahkota Dewa

Reumatik, Asma, Darah tinggi

Kayu Kuman

Penyakit Kulit

Kumis Kucing

Sakit pinggang

Mahkota Dewa

Darah tinggi

Kaca Beling

Batu ginjal

Sirih

Sari rapet

Kunyit

Pelancar darah

Jahe

Bandrek

Mengkudu

Darah tinggi

Kencur

Parem

OBAT IDEAL
Efektif
Aman
Selektif
Mudah dalam pemberian
Bebas dari interaksi obat
Biaya murah
Stabil scr kimia
Memiliki nama generik yang simpel
81

Evidence-based medicines ?
U.S. National Library of Medicine
National Institutes of Health
Department of Health & Human Services
last updated: 26 August 2009

A: Strong scientific evidence for this use;

B: Good scientific evidence for this use;
C: Unclear scientific evidence for this use;
D: Fair scientific evidence against this use;
F: Strong scientific evidence against this use.

Alfalfa (Medicago sativa)

Atherosclerosis (cholesterol plaques in heart arteries)
Several studies in animals report reductions in cholesterol plaques of the
arteries after use of alfalfa. Well-designed research in humans is
necessary before a firm conclusion can be drawn.

Evidence-based medicines ?
Aloe (Aloe vera)

Constipation (laxative)

Genital herpes

Psoriasis vulgaris

Seborrheic dermatitis (seborrhea, dandruff)

Evidence-based medicines ?
Aloe (Aloe vera)
Lung Cancer prevention

Canker sores (aphthous stomatitis)

Diabetes (type 2)

Dry skin (moisturizer)

HIV infection

Lichen planus .

Skin burns

Skin ulcers

Ulcerative colitis (including inflammatory bowel disease)

Wound healing

Mucositis

Pressure ulcers

Radiation dermatitis

Evidence-based medicines ?
Beta-carotene

Dietary intake: Consuming 5 servings of fruit and

vegetables daily provides 6-8 milligrams of beta-carotene.
Beta-carotene requires some dietary fat for absorption,
but supplemental beta-carotene is similarly absorbed
when taken with high-fat or low-fat meals. 1,800
micrograms of beta-carotene has been reported to
maintain adequate vitamin A levels.

Carotenoid deficiency
Cataract prevention
Chemotherapy toxicity
Chronic obstructive pulmonary disease (COPD)
Cognitive performance
Cystic fibrosis
Exercise-induced asthma prevention
Immune system enhancement
Osteoarthritis
Polymorphous light eruption (PLE)
Abdominal aortic aneurysm (AAA) prevention
Alzheimer's disease
Stroke

C
C
C
C
C
C
C
C
C
C
D
D
D

Evidence-based medicines ?
Echinacea (Echinacea angustifolia DC, Echinacea pallida,
Echinacea purpurea)
Prevention of upper respiratory tract infections (adults and children)

Treatment of upper respiratory tract infections (adults)

Cancer

Immune system stimulation

Low white blood cell counts after X-ray treatment (leukopenia)

Uveitis (eye inflammation)

Vaginal yeast infections

Genital herpes

Treatment of upper respiratory tract infections (children)

Evidence-based medicines ?
Garlic (Allium sativum L.)
High cholesterol

Anti-fungal (applied to the skin) .

Anti-platelet effects (blood thinning)

Atherosclerosis ("hardening" of the arteries)

Cancer

Cryptococcal meningitis

Familial hypercholesterolemia

Heart attack prevention in patients with known heart disease .

High blood pressure

Peripheral vascular disease (blocked arteries in the legs)

Tick repellant

Upper respiratory tract infection

Diabetes

Stomach ulcers caused by Helicobacter pylori bacteria

Evidence-based medicines ?
Ginger (Zingiber officinale Roscoe)
Nausea and vomiting of pregnancy (hyperemesis gravidarum)

Anti-platelet agent

Migraine

Motion sickness / seasickness

Nausea (due to chemotherapy)

Nausea and vomiting (after surgery)

Osteoarthritis

Rheumatoid arthritis

Urinary disorders (post-stroke)

Shortening labor

Weight loss

Evidence-based medicines ?
Ginkgo (Ginkgo biloba L.)
Claudication (painful legs from clogged arteries)

Dementia (multi-infarct and Alzheimer's type)

Cerebral insufficiency

Acute hemorrhoidal attacks

Age-associated memory impairment (AAMI)

Altitude (mountain) sickness

Asthma

Cardiovascular disease

Chemotherapy side effects reduction

Chronic venous insufficiency

Cocaine dependence

Deafness (cochlear)

Depression and seasonal affective disorder (SAD)

Diabetic neuropathy

Dyslexia

Gastric cancer

Evidence-based medicines ?
Glaucoma

Graves' disease

Macular degeneration

Memory enhancement (in healthy people)

Mood and cognition in post-menopausal women

Multiple sclerosis

Premenstrual syndrome (PMS)

Pulmonary interstitial fibrosis

Quality of life

Raynaud's disease

Retinopathy (diabetes mellitus type 2)

Ringing in the ears (tinnitus) .

Schizophrenia

Sexual dysfunction

Stroke .

Vertigo

Vitiligo

Mental performance (after eating) .

Evidence-based medicines ?
Ginseng (American ginseng, Asian ginseng, Chinese
ginseng, Korean red ginseng, Panax ginseng: Panax
spp., including P. ginseng C.C. Meyer and P.
quinquefolius L., excluding Eleutherococcus senticosus)
Heart conditions

High blood sugar/glucose intolerance

Immune system enhancement

Type 2 diabetes (adult-onset)

Aplastic anemia

Attention deficit hyperactivity disorder (ADHD)

Birth outcomes (anoxemic encephalopathy)

Bronchodilator

Evidence-based medicines ?
Glucosamine

Glucosamine is commonly taken in combination with chondroitin, a glycosaminoglycan

derived from articular cartilage. Use of complementary therapies, including
glucosamine, is common in patients with osteoarthritis, and may allow for reduced doses
of non-steroidal anti-inflammatory agents.

Knee osteoarthritis (mild-to-moderate)

(Rotta Research Laboratorium)

Osteoarthritis (general)

Chronic venous insufficiency

Diabetes (and related conditions)

Inflammatory bowel disease (Crohn's disease, ulcerative colitis)

Pain (leg pain)

Rehabilitation (after knee injury)

Rheumatoid arthritis

Evidence-based medicines ?
Kava (Piper methysticum G. Forst)
Kava beverages, made from dried roots of the shrub Piper methysticum, have been used
ceremonially and socially in the South Pacific for hundreds of years and in Europe since the
1700s.

Anxiety

Insomnia

Parkinson's disease

Stress

Evidence-based medicines ?
Saw palmetto (Serenoa repens [Bartram] Small)
Saw palmetto was listed in the United States Pharmacopeia from 1906 to 1917 and in the
National Formulary from 1926 to 1950. Saw palmetto extract is a licensed product in
several European countries. Possess 5--reductase inhibitory activity (thereby
preventing the conversion of testosterone to dihydrotestosterone).

Enlarged prostate (benign prostatic hypertrophy/BPH)

Male-pattern hair loss

Prostate cancer

Prostatitis/chronic pelvic pain syndrome (CP/CPPS)

Underactive bladder

Evidence-based medicines ?
Soy (Glycine max)
Soy contains protein, isoflavones, and fiber, all thought to provide health benefits. Soy is an excellent source of
dietary protein, including all essential amino acids. Soy is also a source of lecithin or phospholipid. Soy isoflavones
and lecithin have been studied scientifically for numerous health conditions. Isoflavones such as genistein are
believed to have estrogen-like effects in the body, and as a result are sometimes called "phytoestrogens."
Dietary source of protein

High cholesterol

Diarrhea (acute) in infants and young children

Allergies (prevention of food allergies)

Antioxidant

Bowel/intestinal disorders

Cancer (prevention and treatment)

Cardiovascular disease

Cognitive function

Crohn's disease

Cyclical breast pain

Diabetes

Exercise performance enhancement

Gallstones (cholelithiasis)

Gastrointestinal motility

Evidence-based medicines ?
Turmeric (Curcuma longa Linn.) and Curcumin
Blood clot prevention

Cancer

Cognitive function

Dyspepsia (heartburn)

Gallstone prevention/bile flow stimulant

High cholesterol

HIV/AIDS

Inflammation

Irritable bowel syndrome (IBS)

Liver protection

Oral leukoplakia

Osteoarthritis

Peptic ulcer disease (stomach ulcer)

Rheumatoid arthritis

Tabel 1. Tanaman obat fitofarmaka yang prospektif

No.

Tanaman obat

Bagian tan. obat

Indikasi potensi

1.

Temulawak
(Curcuma xantorrhiza oxb)

Umbi

Hepatitis, artritis

2.

Kunyit
(Curcuma domestica Val)

Umbi

Hepatitis, artritis, antiseptik

3.

Bawang putih
(Allium sativum Lynn)

Umbi

Kandidiasis, hiperlipidemia

4.

Jati Blanda
(Guazuma ulmifolia Lamk)

Daun

Anti hiperlipidemia

5.

Handeuleum (Daun ungu)

(Gratophyllum pictum Griff)

Daun

Hemoroid

6.

Tempuyung
(Sonchus arvensis Linn)

Daun

Nefrolitiasis, diuretik

7.

Kejibeling
(Strobilanthes crispus Bl)

Daun

Nefrolitiasis, diuretik

8.

Labu merah
(Cucurbita moschata Duch)

Biji

Taeniasis

9.

Katuk
(Sauropus androgynus Merr)

Daun

Meningkatkan produksi ASI

10.

Kumis kucing
(Orthosiphon stamineus Benth)

Daun

Diuretik
98

11.

Seledri
(Apium graveolens Linn)

Daun

Hipertensi

12.

Pare
(Momordica charantia Linn)

Buah
Biji

Diabetes mellitus

13.

Jambu biji (klutuk)

(Psidium guajava Linn)

Daun

Diare

14.

Ceguk (wudani)
(Quisqualis indica Linn)

Biji

Askariasis, oksiuriasis

15.

Jambu Mede
(Anacardium occidentale)

Daun

Analgesik

16.

Sirih
(Piper betle Linn)

Daun

Antiseptik

17.

Saga telik
(Abrus precatorius Linn)

Daun

Stomatitis aftosa

18.

Sebung
(Blumea balsamifera D.C)

Daun

Analgesik, antipiretik

19.

Benalu the
(Loranthus spec. div.)

Batang

Anti kanker

20.

Pepaya
(Carica papaya Linn)

Getah
Daun
Biji

Sumber papain
Anti malaria
Kontrasepsi pria

21.

Butrawali
(Tinospora rumphii Boerl)

Batang

Anti
malaria,
melitus

diabetes
99

22.

Pegagan (kaki kuda)

(Centella asiatica Urban)

Daun

Diuretika,
antiseptik,
antikeloid, hipertensi

23.

Legundi
(Vitex trifolia Linn)

Daun

Antiseptik

24.

Inggu
(Ruta graveolens Linn)

Daun

Analgesik, antipiretik

25.

Sidowajah
(Woodfordia floribunda Salibs)

Daun

Antiseptik, diuretik

26.

Pala
(Myristica fragrans Houtt)

Buah

Sedatif

27.

Sambilata
(Adrographis paniculata Nees)

Seluruh
daun

28.

Jahe (Halia)
(Zingibers officinale Rosc)

Umbi

Analgesik.
antiinflamasi

29.

Delima putih
(Punica granatum Linn)

Kulit buah

Antiseptik, antidiare

30.

Dringo
(Acorus calamus Linn)

Umbi

Sedatif

31.

Jeruk nipis
(Citrus aurantifolia Swiqk)

Buah

Antibatuk

tanaman

Antiseptik, diabetes melitus

Antipiretik,

100

Drugs Sources

B Biological; usually a large

(>45 residues) peptide or
protein either isolated from
an organism/cell line or
produced by biotechnological
means in a surrogate host.
N Natural product.
ND Derived from a natural
product and is usually a
semisynthetic modification.
S Totally synthetic drug,
often found by random
screening/ modification of an
existing agent.
S* Made by total synthesis,
but the pharmacophore
is/was from a natural
product.
V Vaccine.
Subcategory. NM Natural
product mimic

New Chemical Entities (Total 1010 NCEs )

by Source of Compound 01/1981-06/2006

S*
5%

S*/NM
11%

V
4%

S/NM
11%

B
12%
N
4%

ND
23%

S
30%

J. Nat. Prod. 2007, 70, 461-4

103

KESIMPULAN
Obat herbal makin populer di seluruh dunia,
tetapi upaya mewujudkan EBM menyeluruh
butuh waktu, perencanaan dan semangat
tinggi agar pemanfaatannya dapat
dipertanggung-jawabkan.
Tidak semua obat herbal berkhasiat seperti
yang diduga secara empiris benar, perlu
pembuktian lanjut agar manfaatnya dpat
dijadikan sumber obat konvensional.
104