HPLC法同时测定健腰密骨片浸膏粉中5种指标成分  

Simultaneous determination of five constituents in Jianyao Migu tablets by HPLC

作　　者：商晓慧 赵晓玲 詹常森 SHANG Xiaohui;ZHAO Xiaoling;ZHAN Changsen(Shanghai Hutchison Pharmaceuticals/Shanghai Engineering Research Center for Innovation of Solid Preparation of TCM,Shanghai 201401,China)

机构地区：[1]上海和黄药业有限公司/上海中药固体制剂创新工程技术研究中心,上海201401

出　　处：《上海医药》2024年第3期71-75,共5页Shanghai Medical & Pharmaceutical Journal

基　　金：上海市2021年度“科技创新行动计划”生物医药科技支撑专项项目(21S21903100)。

摘　　要：目的:建立健腰密骨片浸膏粉的多成分定量分析方法,为评价浸膏粉中间体的质量提供依据。方法:采用HPLC法,以乙腈-磷酸盐缓冲液为流动相,梯度洗脱,测定健腰密骨片浸膏粉中5种成分的含量。结果:木兰花碱、丹酚酸B、朝藿定C、淫羊藿苷和宝藿苷Ⅰ5种成分在各自质量浓度范围内呈良好线性关系,r≥0.9997;5种化合物的平均回收率分别为100.47%、104.37%、95.38%、95.93%、96.66%。该方法的专属性、重复性均良好。结论:该分析方法准确、重复性好,可作为健腰密骨片浸膏粉的质量控制方法。Objective:To establish a multi-component quantitative analysis method for the extract powder of Jianyao Migu tablets and provide a basis for comprehensive evaluation of the quality of extract powder.Methods:The contents of five components in the extract powder of Jianyao Migu tablets were determined by HPLC method with acetonitrile-phosphate buffer as mobile phase and gradient elution.Results:The five components including magnoflorine,salvianolic acid B,epimedin C,icariin and baohuosideⅠshowed a good linear relationship in their respective concentration ranges(r≥0.9997).The average recovery rates of 5 compounds were 100.47%,104.37%,95.38%,95.93%and 96.66%,respectively.The specificity and reproducibility of this method were good.Conclusion:The established analytical method is accurate and reproducible,and can be used for the quality control of extract powder in Jianyao Migu tablets.

关 键 词：健腰密骨片浸膏粉 HPLC 多成分定量分析 

分 类 号：O657.72[理学—分析化学] R286[理学—化学]