Faktor-faktor yang mempengaruhi

Keaman Obat Bahan Alam

Safety

Medical opinion : it is impossible any medicine to have effects without side effects

If herbs are claimed to be free from side effects they are probably no effective either

Patients believe that herbs are safe Many herbalists emphasize the same

point They refer to the most established

remedies by millions of people since prehistory

Faktor Keamanan

Endogenus Eksogenous

Sumber

EndogenousIndex terapi sempit; Digitalis Datura stramonium (50 mg), Atropa belladona ( herba 50 mg,

radix 30 mg)

CURCUMIN

Curcumin is a major component of food flavouring turmeric and has been used as a herbal medicine.

Curcumin shows a variety of physiological and pharmacological effects, and several studies indicate curcumin to be anticarcinogenic and antiinflammatory

Acceptable daily intake (ADI) for curcumin is

1–3 mg/kg body weight, based on the no observed effect (NOE) level of 250–320 mg/kg body weight per day in the multi generation study in rats and the application of a safety factor of 100

LICORICEGlycyrrhiza glabra

penggunaan

Perasa dalam produk rokok Perasa dalam permen Farmakologi:

Antivirus Pengobatan kanker Obat gangguan GI Anti inflamasi Obat diabetes

Dosis: 2-15 gr untuk ulcer dan gastritisdosis yang lebih tinggi dapat menyebabkan hiperkalemia

NOAEL : 2 mg/ kg hariADI : o,2 mg/ kg BB

STEVIAStevia rebaudiana

Kegunaan : Pemanis (Stevio glikosida) pengganti gula pada

penderita diabetes

ADI : 4 mg/ kgBB

Safe

EUROPEAN HERBAL INFUSIONS ASSOCIATION

Inventory list of Herbals considered as Food

Endogenous

Alkaloid : pirrolizidine hepatotoxic Glikosida sianida Asam aristolosat

Cyanide

Many common plants contain the natural form of cyanide, cyanic glucoside. Its presence may be the product of evolution, as it deters animals and insects from consuming the entire plant.

Pyrrolizidine Alkaloids Pyrrolizidine alkaloids (PAs) are of special

interest currently because several of them have been shown to cause toxic reactions in humans, primarily veno-occlusive liver disease, when ingested with foods or herbal medicines. Comfrey, a well-known medicinal herb characterized by U.S. FDA researchers as having been "one of the most popular herb teas in the world," contains PAs that are capable of causing liver damage

Aristolochic acid

Aristolochic acids are a family of carcinogenic, mutagenic and nephrotoxic

compounds commonly found in the Aristolochiaceae family, including Aristolochia and Asarum, which are commonly used in Chinese herbal medicine Aristolochic acid I is the most abundant of the aristolochic acids and is found in almost

all Aristolochia species Aristolochic acids are often accompanied by aristolactam

NO2

OHO

O

O

OCH3

Exogenous

Cemaran Saat kultivasi ; kimia, biologi Proses produksi, transportasi,

penyimpanan

Interaksi

Herbal-herbalHerbal-modernHerbal-makanan

Tugas KHI

Pembuatan makalah ilmiah Tema tentang efikasi dan keamanan

obat herbal Tugas terlampir

Terima kasih