Acute toxicity of the galactagogue phytomedicine containing Sauropus androgynous, Trigonella foenumgraecum, and Moringa oleifera

Q4 Pharmacology, Toxicology and Pharmaceutics Pharmaceutical Sciences Asia Pub Date : 2022-01-01 DOI:10.29090/psa.2022.04.21.217
Zulkhah Noor, D. L. Kusindarta, A. Sadewa, D. S. Heriyanto, D. R. Hadiati, Mustofa
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Abstract

This study aims to evaluate acute toxicity of the herbal preparation on rats as an early step to evaluate its safety. This study used 25 females Rattus norvegicus strain Sprague Dawley rats aged 8 weeks with a body weight of at least 120 g divided into 5 groups of doses of herbal preparation (0/aquadest, 50, 300, 2,000, 5,000) mg/kg BW. After administration of the herbal preparation, rats were observed using a camera continuously for 14 days and manual observation intensively for the first 24 hours and then once a day for up to 14 days. The toxic effects including death, behavioral changes, neural symptoms, and other abnormalities were recorded. The weight of the rats was monitored every three days. On the 15 th day, the rats were sacrificed to collect vital organs for macroscopic and histopathological examinations. The LD 50 was estimated based on OECD Guideline. No mortality and significant toxicity signs in any of the rats after receiving the herbal formula at highest dose of 5000 mg/kg was reported during the 14-day observation period. Body weight and organ weight did not show significant variation between controls and treatment groups. In addition, no abnormalities of liver, heart and lungs were also observed in macroscopic and histopathological examinations. In conclusion, the herbal preparation shows the LD 50 of greater than 5,000 mg/kg can be classified as category 5 or unclassified. Further sub chronic toxicity study will be conducted to evaluate its safety after repeated exposure.
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含有雌雄同体龙、三角Trigonella foenumgraecum和辣木的催乳植物药的急性毒性研究
本研究旨在评价中药制剂对大鼠的急性毒性,作为评价其安全性的早期步骤。本实验选用25只8周龄、体重≥120 g的雌性褐家鼠Sprague Dawley大鼠,分为5组,分别给药0/aquadest、50、300、2000、5000 mg/kg BW。给药后,用相机连续观察14天,前24小时进行人工密集观察,然后每天1次,持续观察14天。毒性作用包括死亡、行为改变、神经症状和其他异常记录。每三天监测一次大鼠的体重。第15天处死大鼠,采集重要脏器进行肉眼和组织病理学检查。ld50是根据经合组织指南估算的。在14 d的观察期内,最高剂量5000mg /kg给药后,未见大鼠死亡和明显毒性反应。体重和器官重量在对照组和治疗组之间无显著差异。此外,肉眼及组织病理学检查均未见肝、心、肺异常。综上所述,该中草药制剂的ld50大于5000 mg/kg可归类为第5类或未分类。将进一步开展亚慢性毒性研究,评估其反复接触后的安全性。
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来源期刊
Pharmaceutical Sciences Asia
Pharmaceutical Sciences Asia Pharmacology, Toxicology and Pharmaceutics-Pharmacology, Toxicology and Pharmaceutics (all)
CiteScore
0.90
自引率
0.00%
发文量
59
期刊介绍: The Pharmaceutical Sciences Asia (PSA) journal is a double-blinded peer-reviewed journal in English published quarterly, by the Faculty of Pharmacy, Mahidol University, Thailand. The PSA journal is formerly known as Mahidol University Journal of Pharmaceutical Sciences and committed to the timely publication of innovative articles and reviews. This journal is available in both printed and electronic formats. The PSA journal aims at establishing a publishing house that is open to all. It aims to disseminate knowledge; provide a learned reference in the field; and establish channels of communication between academic and research expert, policy makers and executives in industry and investment institutions. The journal publishes research articles, review articles, and scientific commentaries on all aspects of the pharmaceutical sciences and multidisciplinary field in health professions and medicine. More specifically, the journal publishes research on all areas of pharmaceutical sciences and related disciplines: Clinical Pharmacy Drug Synthesis and Discovery Targeted-Drug Delivery Pharmaceutics Biopharmaceutical Sciences Phytopharmaceutical Sciences Pharmacology and Toxicology Pharmaceutical Chemistry Nutraceuticals and Functional Foods Natural Products Social, Economic, and Administrative Pharmacy Clinical Drug Evaluation and Drug Policy Making Antimicrobials, Resistance and Infection Control Pharmacokinetics and Pharmacodynamics.
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