Study on a non-pharmacopeial formulation for its hepatoprotective activity against drug induced hepatotoxicity in animal model
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Syeda Asma Firdose
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Abdul Wadud
Abstract
Objectives
This study assessed the hepatoprotective efficacy of a non-pharmacopeial formulation (NPF) against rifampicin-induced hepatotoxicity, aiming to expand the repertoire of hepatoprotective agents in Unani medicine.
Methods
An acute toxicity study and HPTLC analysis were performed. The experiment utilized 42 Wistar rats, each weighing between 150 and 200 g. The rats were systematically allocated into seven distinct groups, each containing six animals, identified as negative, positive, standard, and test groups A, B, C, and D. Liver damage was induced by oral administration of rifampicin at a dose of 500 mg/kg daily for 30 days, following a 2-hour interval after the administration of standard and test drugs. The standard and test groups received Silymarin (100 mg/kg), NPF, Afsanteen, Kasni, and Asaroon at doses of 167, 117, 167, and 217 mg/kg, respectively, orally once daily for 30 days. Serum levels of marker enzymes (SGOT, SGPT, and ALP), total protein (TP), and albumin (S. Alb) were evaluated. All groups underwent biochemical and histopathological analysis.
Results
The formulation was deemed safe at a dose of up to 2000 mg/kg. Compared to the standard drug, test groups A and D demonstrated potential protective effects on the liver enzymes. Test groups B and C exhibited normal liver architecture.
Conclusions
Asaroon (test group D) demonstrated greater efficacy than NPF. Histopathologically, Afsanteen and Kasni were found to be effective. The study indicated that formulations by Unani scholars were more effective than non-pharmacopeial formulations, although the tested NPF remained effective and safe in this study.
Acknowledgments
Sincere gratitude is due to the HOD, Prof Ghulamuddin Sofi, Dept. of Ilmul Advia, NIUM for his guidance, and providing necessary infrastructure and support to conduct this research. I extend my heartfelt gratitude to my co-guide, Khaleequr Rahman, Associate Professor from the Department of Ilmul Saidla (Pharmacy) at NIUM, for his invaluable guidance and support throughout this study.
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Research ethics: IAEC Approval taken before the commencement of the study. IAEC/06/21/IA/01 dated 27/08/2022.
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Informed consent: Not applicable (Preclinical study).
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Use of Large Language Models, AI and Machine Learning Tools: Grammarly, Paperpal, and Quillbot were used for language, consistency, and paraphrasing.
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Conflict of interest: The authors state no conflict of interest.
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Research funding: National Institute of Unani Medicine.
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Data availability: All the data has been shared. For the HPTLC, supplementary data has been shared.
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Supplementary Material
This article contains supplementary material (https://doi.org/10.1515/jcim-2025-0160).
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