摘要
目的:元胡止痛片的质量控制研究。方法:收集10批不同厂家、批号的元胡止痛片,经过全面、规范的方法学验证,建立HPLC法控制元胡止痛片中延胡索乙素的含量。结果:延胡索乙素在5.09～71.23μg·mL-1时,质量浓度与峰面积积分值呈良好的线性关系(r=0.99997),平均回收率为97.94%(RSD=2.10%);含量限度定为每片含延胡索乙素(C21H25NO4)不得少于75μg。结论:该方法简便、快速、准确,能有效控制元胡止痛片的内在质量。
Objective： To study on quality control of Yuanhuzhitong Tablets. Methods： 10 batches of Yuanhuzhitong Tablets from different companies were collected, and the HPLC concentration determination method of tetrahydropalmatine in Yuanhuzhitong Tablets was established after comprehensive and standardized methodology validation. Results： The linear detection ranges of tetrahydropalmatine were 5. 09 - 71.23 μg· mL^ -1 （ r = 0. 999 97 ）, and the average recovery was 97.94% （ RSD 2. 10% ） ; The content of tetrabydropalmatine shall not be less than 75μg per tablet. Conclusion： This method is convenient, rapid and accurate, which could be used for quality control of Yuanhuzhitong Tablets.
出处
《中国药品标准》
CAS
2010年第5期343-346,共4页
Drug Standards of China
关键词
元胡止痛片
延胡索乙素
HPLC
含量测定
Yuanhuzhitong Tablets
Tetrahydropalmatine
HPLC
Determination of Concentrations
