Interdisciplinary School of Health Sciences, University of Pune, Pune 411007, India.
Evid Based Complement Alternat Med. 2011;2011:915240. doi: 10.1093/ecam/nep237. Epub 2011 May 3.
Safety pharmacology studies help in identifying preclinical adverse drug reactions. We carried out routine safety pharmacology with focus on cardiovascular variables and pharmacokinetic herb-drug interaction studies on rats fed with standardized traditional hydro-alcoholic extract and technology-based supercritical extract of Cassia auriculata for 12 weeks. Our studies indicate that both these extracts are pharmacologically safe and did not show any significant adverse reactions at the tested doses. The traditional hydro-alcoholic extract did not show any significant effect on pharmacokinetics; however, the technology-based supercritical extract caused a significant reduction in absorption of metformin. Our results indicate the need to include pharmacokinetic herb-drug interaction studies as evidence for safety especially for technology-based extracts.
安全药理学研究有助于识别临床前药物不良反应。我们进行了常规的安全药理学研究,重点关注心血管变量,并对大鼠进行了药代动力学草药-药物相互作用研究,这些大鼠分别用标准化的传统水醇提取物和基于技术的番泻叶超临界提取物喂养 12 周。我们的研究表明,这两种提取物在药理学上都是安全的,在测试剂量下没有显示出任何明显的不良反应。传统水醇提取物对药代动力学没有显著影响;然而,基于技术的超临界提取物导致二甲双胍的吸收显著减少。我们的结果表明,需要包括药代动力学草药-药物相互作用研究作为安全性的证据,特别是对于基于技术的提取物。