Li Wenzhu, Yang Jiayu, Zhao Fang, Xie Xinyuan, Pan Jianyang, Qu Haibin
Pharmaceutical Informatics Institute, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, China.
State Key Laboratory of Component-Based Chinese Medicine, Innovation Center, Zhejiang University, Hangzhou 310058, China.
Pharmaceuticals (Basel). 2023 Jun 29;16(7):947. doi: 10.3390/ph16070947.
Dammarane-type saponins (DTSs) exist in various medicinal plants, which are a class of active ingredients with effects on improving myocardial ischemia and immunomodulation. In this study, a quantitative H NMR method of total DTSs in herbal medicines was developed based on the analytical procedure lifecycle. In the first stage (analytical procedure design), the Ishikawa diagram and failure mode effects and criticality analysis were used to conduct risk identification and risk ranking. Plackett-Burman design and central composite design were used to screen and optimize critical analytical procedure parameter. Then, the method operable design region was obtained through modeling. In the second stage (analytical procedure performance qualification), the performance of methodological indexes was investigated based on analytical quality by design. As examples of continued procedure performance verification, the method was successfully applied to determine the total DTSs in herbal pharmaceutical preparations and botanical extracts. As a general analytical method to quantify total DTSs in medicinal plants or pharmaceutical preparations, the developed method provides a new quality control strategy for various products containing dammarane-type saponin.
达玛烷型皂苷（DTSs）存在于多种药用植物中，是一类具有改善心肌缺血和免疫调节作用的活性成分。在本研究中，基于分析程序生命周期，开发了一种测定草药中总DTSs的定量核磁共振方法。在第一阶段（分析程序设计），利用石川图和失效模式影响及危害性分析进行风险识别和风险排序。采用Plackett-Burman设计和中心复合设计筛选并优化关键分析程序参数。然后，通过建模获得方法可操作设计区域。在第二阶段（分析程序性能确认），基于设计的分析质量研究方法学指标的性能。作为持续程序性能验证的实例，该方法成功应用于测定草药制剂和植物提取物中的总DTSs。作为一种测定药用植物或药物制剂中总DTSs的通用分析方法，所开发的方法为各种含达玛烷型皂苷的产品提供了一种新的质量控制策略。
