Universitas Indonesia Conferences, Asian Federation for Pharmaceutical Sciences (AFPS) 2019

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Acute and Subchronic Toxicity Study of Ethyl Acetate Fraction Tablet of Andrographis paniculata (AS201-01) by Oral Administration in Wistar Rats
Hilkatul Ilmi, Alvin Laila Najiha, Yesinta Kurniawati, Lidya Tumewu, Indah Setyawati Tantular, Endang Widiastuti, Achmad Fuad Hafid, Aty Widyawaruyanti

Last modified: 2019-07-14


Background: Andrographis paniculata was known as potential antimalarial. Extract, fractions and isolates from A.paniculata had proven as antimalarial in vitro and in vivo as well. In order to develop fraction as antimalarial drug, formulation study of ethyl acetate fraction from this plant was conducted. Ethyl acetate fraction was formulated as a tablet dosage form, namely AS201-01. Objective: This study aims to evaluate the safety, toxicity signs, and tablet’s  influence to liver and kidney of Wistar rats. Materials and Methods: To assess the acute toxicity profile, AS201-01 was administered orally at a dose of 5, 50, 200 and 2,000 mg/kg BW. The toxicity sign and mortality were observed after 4 hours and 24 hours of tablet administration. Observation continued 24 hours periodically for 14 days. Meanwhile, AS201-01 was administered at a dose of 50, 327 and 1,000 mg/kg BW per day for 28 days to assess subchronic toxicity. Biochemical, hematological and histopathological were assessed and compared to control group. Results: AS201-01 at a single dose 2,000 mg/kg BW was not produce treatment related signs of toxicity or mortality in tested rats during 14 days observation period. Therefore, LD50 was estimated to be more than 2,000 mg/kg BW. In the subchronic study, the results were not shown treatment related abnormalities in terms of biochemical parameters in liver. In terms of kidney biochemical parameters, creatinine was significantly different (p>0.05) between treatment and control group.  However, creatinine of treatment group was still at a normal range. Meanwhile, there was a significantly different (p>0.05) in haematological parameter, especially in haematocrit between treatment and control group. But treatment group was still at a normal range as well. Mild to moderate histopathological changes were observed in liver and kidney in all groups including control group. The changes observed at a dose of 50 mg/kg BB which was five fold higher than equivalent therapeutics dose. Conclusion: The results suggest that AS201-01 was relatively safe when administered orally at equivalent therapeutics dose in rats.