消栓肠溶胶囊质量标准研究  

Research on Quality Standard of Xiaoshuan Enteric Capsule

作　　者：王海波[1] 赵佳丽 王晓伟 WANG Hai-bo;ZHAO Jia-li;WANG Xiao-wei(Henan Institute for Food and Drug Control,Henan Zhengzhou 450018,China;Xinxiang Institutes for Food and Drug Control,Henan Xinxiang 453000,China)

机构地区：[1]河南省食品药品检验所,河南郑州450018 [2]新乡市食品药品检验所,河南新乡453000

出　　处：《中国药物评价》2021年第1期48-51,共4页Chinese Journal of Drug Evaluation

基　　金：国家药品监督管理局国家药品标准提高行动计划(编号582)。

摘　　要：目的:提高消栓肠溶胶囊的质量标准。方法:修订消栓肠溶胶囊中赤芍的薄层色谱鉴别方法;建立HPLC-ELSD法测定消栓肠溶胶囊中黄芪甲苷的含量。结果:薄层色谱中特征斑点明显,分离度好,阴性无干扰;黄芪甲苷在0.1038~1.5570μg范围内线性关系良好,回归方程Y=1.4302 X+4.9968,γ=0.9992;平均回收率为100.6%,RSD为1.5%。结论:该方法专属性高,重复性良好,可作为消栓肠溶胶囊质量控制的方法。Objective:To improve the quality standard of Xiaoshuan Enteric Capsule.Methods:The TLC method for the identification of Paeoniae Radix Rubra in Xiaoshuan Enteric Capsule was revised.HPLC-ELSD was adopted to determine the content of astragalosideⅣin Xiaoshuan Enteric Capsule.Results:The TLC showed that the spots were clear and the separation was good,and free from negative intervention.The calibration curve was linear in the range of 0.1038-1.5570μg for astragalosideⅣ,the regression equation was Y=1.4302 X+4.9968(γ=0.9992).The average recovery of astragalosideⅣwas 100.6%with RSDs of 1.5%.Conclusion:The simple and accurate methods for qualitative and quantitative detection of Xiaoshuan Enteric Capsules can be used in the evaluation and control of the quality of Xiaoshuan Enteric Capsules.

关 键 词：消栓肠溶胶囊 黄芪甲苷 质量标准 高效液相色谱-蒸发光散射检测(HPLC-ELSD)法 

分 类 号：R926[医药卫生—药学]