TERATOGENICITY TEST OF TEMPUYUNG (SONCHUS ARVENSIS L.) EXTRACT
Nowdays, traditional medicines are expected to evolve into a standardized herbal medicines or phytopharmaca (clinical based herbal medicines) class so they can be used in health care facilities. Drugs used in health care facilities must meet the requirements of a safe, beneficial and also have been standardized. Security affirmation efforts should be necessary to meet the requirements through some toxicity and efficacy tests, which will be followed by clinical trials if it meets the requirements.
Toxicity testing is divided into two categories. First, the general toxicity tests include acute toxicity test (conducted by giving animal a single or multiple doses of a test substance for 24-hours period), sub chronic toxicity test (conducted by giving animal repeated exposure of a test substance, usually for 3-months period), and chronic toxicity test (conducted to observe the toxic effects by giving animal long-term repeated administration of a test substance usually for 1-year period). Second, the special toxicity tests typically investigate the carcinogenic and mutagenic (cancer triggers effects), as well as teratogenic effects, because of a substance that interferes the fetal development and leads to the birth defects.
The aim of this study was to evaluate teratogenicity effect of ethanolic extract of tempuyung (Sonchus arvensis, L.) leaves in Wistar rats.
Methods used in this study were based on a standard procedure to test the teratogenic effect (Organization for Economic Cooperation and Development, 1987, 2001). Wistar rats were randomly divided into four groups: a control group that received 2% tragacanth, and three experimental groups, each was administrated with 100, 400 and 1000 mg/kg bw of ethanol leaf extracts of tempuyung (in a suspension form in 2% tragacanth). The lowest dose used was derived from the conversion of therapeutic dose in humans, while the highest dose was a limit dose on teratogenicity test, at which if the embryo toxicity or teratogenicity was not found, then it was not necessary to test at the other doses. The drug was administered orally once daily on day 6 to day 15 of gestation. The drug administration period was in the organogenesis phase of rat gestation.
Teratogenicity test results showed that there was no abnormality in all grown fetus but there were the ungrowth fetus observed in all groups of tempuyung extract. Average of ungrowth fetus of control, tempuyung extract at a dose of 100, 400 and 1000 mg/kg bw group were 0.0± 0 , 1.7± 5.3 , 8.4± 8.6, 1.8± 3.8 % while fetus body weigh were1.7 ±0.1 , 1.5± 0.3, 1.6 ±0.1,and 1.8± 0.1 g, respectively. Skeletal evaluation showed that there was no malformation of sacral vertebrae, convulated costal stucture, palate, head cavity, nasal cavity, eye cavity ,r and liver in all group.
Ethanolic extract of binahong at doses of 100, 400 and 1000 mg/kg bw in rat did not have teratogenic effect.
LIST OF RESEARCH OUTPUT
Prototype: Tempuyung extract capsules
HEAD OF RESEARCH TEAM : Prof. Dr. Elin Yulinah Sukandar
TEAM MEMBERS : Dr. Kusnandar Anggadiredja, Rini Hendriani, Msc
OFFICIAL ADDRESS : Sekolah Farmasi, Laboratorium Farmakologi, Institut Technologi Bandung, Jl. Ganesha 10 Bandung
EMAIL : elin[at]fa.itb.ac.id