在健康的志愿者中对Withania somnifera (L.) Dunal根提取物进行临床药理动力学评估:使用UHPLC-MS/MS分析进行的一次剂量非随机化研究
Vidyadhar G Vaidya1, Ninad N Naik1, Gayatri Ganu2
1Lokmanya Medical Research Centre and Hospital, Pune, 411033, Maharashtra, India.
Journal of ethnopharmacology
|December 20, 2023
概括
阿什瓦甘达根提取物 (WSE) 的成分被快速吸收,在人类中显示出高口服生物可用性. 这项研究开发了一种经过验证的方法来量化这些化合物,证实了WSE.
科学领域:
- 药理动力学和生物分析
- 植物化学 植物化学
- 传统印度医学 传统印度医学
背景情况:
- 阿什瓦甘达 (Withania somnifera) 是一种重要的阿育韦德草药,具有悠久的传统使用历史.
- 尽管有广泛的民族药理学应用,但阿什瓦甘达根提取物 (WSE) 的临床药动力学数据有限.
- 这项研究解决了对药理动力学参数的需求,以指导未来的临床WSE评估.
研究的目的:
- 开发和验证一种敏感的生物分析方法,用于量化人体血中的维他诺化物和维他诺化物.
- 在健康志愿者中评估标准化阿什瓦甘达根提取物 (WSE) 的生物可访问性和药理动力学.
- 建立一个可靠的方法,用于未来对WSE的临床研究.
主要方法:
- 开发并验证了一种UHPLC-MS/MS方法,用于同时量化五种关键的维他诺化物和维他诺化物.
- 在18名健康的男性志愿者中进行了一项药理动力学研究,在禁食条件下接受一次500毫克的WSE (AgeVel®/Witholytin®) 剂量.
- 通过分析生物活性成分的血度随时间推移来评估药物动力学概况.
主要成果:
- 该UHPLC-MS/MS方法显示出高选择性,特异性,线性,没有矩阵效应或转移.
- 在WSE给药后,维他诺化物IV,维他诺化物A,维他费林A和12-脱氧-维他拉莫诺化物的量化Cmax和Tmax.
- 检测到维他诺酸V,但低于定量化的下限 (LLOQ).
结论:
- 一种新的生物分析方法已成功开发并应用于量化人类血中的WSE生物活性成分.
- 来自WSE的维他诺化物和维他诺化物被快速吸收,呈现出高口服生物可用性,并且具有药理活性的最佳半衰期.
- 发现WSE配方 (AgeVel®/Witholytin®) 在500毫克剂量时是安全的,并且耐受良好.
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