Antimalarial and toxicological assessment of the tablet (AS201-01) ethyl acetate fraction of Andrographis paniculata Nees in animal models

Autor: Aty Widyawaruyanti, Hilkatul Ilmi, Lidya Tumewu, Dwi Ayu Fitrianingtyas, Yesinta Kurniawati, Alfin Laila Najiha, Hanifah Khairun Nisa, Che Puteh Osman, Nor Hadiani Ismail, Achmad Fuad Hafid
Jazyk: English<br />Spanish; Castilian
Rok vydání: 2023
Předmět:
Zdroj: Journal of Pharmacy & Pharmacognosy Research, Vol 11, Iss 5, Pp 863-873 (2023)
Druh dokumentu: article
ISSN: 0719-4250
DOI: 10.56499/jppres23.1679_11.5.863
Popis: Context: Andrographis paniculata has been used as a traditional medicine to treat malaria. The ethyl acetate fraction of A. paniculata containing diterpene lactone compounds was developed into a tablet dosage form, AS201-01. Aims: To determine the antimalarial activity and toxicity of AS201-01 to guarantee its efficacy and safety. Methods: Antimalarial assay in male Balb/c mice based on Peter’s four-day suppressive test at a dose of 6.25, 12.5, 25, and 50 mg/kg BW and 10 mg/kg BW of chloroquine as a positive control. In acute toxicity, AS201-01 was administered orally at a dose of 5, 50, 200, and 2,000 mg/kg BW in male rats (Wistar rats) and observed for 14 days to identify signs of toxicity and mortality. Meanwhile, AS201-01 was administered at 50, 327, and 1,000 mg/kg BW per day for 28 days in male and female rats to assess subchronic toxicity. Results: AS201-01 has antimalarial activity and exhibited the highest suppressive effect at 50 mg/kg BW dose with inhibition of 73.48%. Meanwhile, chloroquine at 10 mg/kg BW has an inhibition of 97.94%. AS201-01 was highly active as an antimalarial with an ED50 value of 5.95 mg/kg BW and increased survival time. Administration of AS201-01 is relatively safe in acute and subchronic toxicity studies. No clinical signs and mortality were observed in either study. The 50% lethal dose (LD50) was above 2,000 mg/kg BW. Conclusions: AS201-01 is effective as an antimalarial and non-toxic when administered orally at an equivalent therapeutic dose in an animal model.
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