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

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...

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Main Authors: 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
Format: Article
Language:English
Published: GarVal Editorial Ltda. 2023-09-01
Series:Journal of Pharmacy & Pharmacognosy Research
Subjects:
Online Access:https://jppres.com/jppres/pdf/vol11/jppres23.1679_11.5.863.pdf
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author 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
author_facet 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
author_sort Aty Widyawaruyanti
collection DOAJ
description 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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spelling doaj.art-82e9114432174ebbb19bcca88d5e4d232023-09-17T19:24:07ZengGarVal Editorial Ltda.Journal of Pharmacy & Pharmacognosy Research0719-42502023-09-0111586387310.56499/jppres23.1679_11.5.863Antimalarial and toxicological assessment of the tablet (AS201-01) ethyl acetate fraction of Andrographis paniculata Nees in animal modelsAty Widyawaruyanti0Hilkatul Ilmi1Lidya Tumewu2Dwi Ayu Fitrianingtyas3Yesinta Kurniawati4Alfin Laila Najiha5Hanifah Khairun Nisa6Che Puteh Osman7Nor Hadiani Ismail8Achmad Fuad Hafid9Department of Pharmaceutical Sciences, Faculty of Pharmacy, Universitas Airlangga, Surabaya, 60115, Indonesia. Center for Natural Product Medicine Research and Development, Institute of Tropical Disease, Universitas Airlangga, Surabaya, 60115, Indonesia.Center for Natural Product Medicine Research and Development, Institute of Tropical Disease, Universitas Airlangga, Surabaya, 60115, Indonesia.Center for Natural Product Medicine Research and Development, Institute of Tropical Disease, Universitas Airlangga, Surabaya, 60115, Indonesia.Undergraduate Program of Faculty of Pharmacy, Universitas Airlangga, Surabaya, 60115, East Java, Indonesia.Undergraduate Program of Faculty of Pharmacy, Universitas Airlangga, Surabaya, 60115, East Java, Indonesia.Undergraduate Program of Faculty of Pharmacy, Universitas Airlangga, Surabaya, 60115, East Java, Indonesia.Center for Natural Product Medicine Research and Development, Institute of Tropical Disease, Universitas Airlangga, Surabaya, 60115, Indonesia.Atta-ur-Rahman Institute for Natural Product Discovery, Universiti Teknologi MARA, Cawangan Selangor, Kampus Puncak Alam, 42300 Bandar Puncak Alam, Selangor Malaysia. Faculty of Applied Sciences, Universiti Teknologi MARA, 40450 Shah Alam, Selangor, Malaysia.Atta-ur-Rahman Institute for Natural Product Discovery, Universiti Teknologi MARA, Cawangan Selangor, Kampus Puncak Alam, 42300 Bandar Puncak Alam, Selangor Malaysia. Faculty of Applied Sciences, Universiti Teknologi MARA, 40450 Shah Alam, Selangor, Malaysia.Department of Pharmaceutical Sciences, Faculty of Pharmacy, Universitas Airlangga, Surabaya, 60115, Indonesia. Center for Natural Product Medicine Research and Development, Institute of Tropical Disease, Universitas Airlangga, Surabaya, 60115, Indonesia.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.https://jppres.com/jppres/pdf/vol11/jppres23.1679_11.5.863.pdfacute toxicityandrographis paniculateantimalarialsubchronic toxicitymedicine
spellingShingle 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
Antimalarial and toxicological assessment of the tablet (AS201-01) ethyl acetate fraction of Andrographis paniculata Nees in animal models
Journal of Pharmacy & Pharmacognosy Research
acute toxicity
andrographis paniculate
antimalarial
subchronic toxicity
medicine
title Antimalarial and toxicological assessment of the tablet (AS201-01) ethyl acetate fraction of Andrographis paniculata Nees in animal models
title_full Antimalarial and toxicological assessment of the tablet (AS201-01) ethyl acetate fraction of Andrographis paniculata Nees in animal models
title_fullStr Antimalarial and toxicological assessment of the tablet (AS201-01) ethyl acetate fraction of Andrographis paniculata Nees in animal models
title_full_unstemmed Antimalarial and toxicological assessment of the tablet (AS201-01) ethyl acetate fraction of Andrographis paniculata Nees in animal models
title_short Antimalarial and toxicological assessment of the tablet (AS201-01) ethyl acetate fraction of Andrographis paniculata Nees in animal models
title_sort antimalarial and toxicological assessment of the tablet as201 01 ethyl acetate fraction of andrographis paniculata nees in animal models
topic acute toxicity
andrographis paniculate
antimalarial
subchronic toxicity
medicine
url https://jppres.com/jppres/pdf/vol11/jppres23.1679_11.5.863.pdf
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