糖心平胶囊的4种药效成分定量方法研究

Research on quantitative method for four effective components of Tangxinping capsule

目的:建立糖心平胶囊多种药效成分的HPLC含量测定质量控制标准。方法:采用HPLC法建立处方中五味子(五味子醇甲、五味子甲素)、麸炒枳实(橙皮苷)、黄芪(毛蕊异黄酮葡萄糖苷)4种药效成分的含量测定方法。结果:4种药效成分的方法学考察均满足药品质量分析方法指导原则的要求,其中毛蕊异黄酮葡萄糖苷的线性范围1.6~161.2μg·mL^-1(r=0.999 8),平均回收率100.1%;五味子醇甲0.7~71μg·mL^-1(r=0.999 8),平均回收率99.3%;五味子甲素1.1~113μg·mL^-1(r=0.999 8)平均回收率99.0%;橙皮苷1.0~103.3μg·mL^-1(r=0.999 8),平均回收率99.1%。结论:该HPLC测定方法操作简便、专属性高,可作为糖心平胶囊质量控制的标准检测方法。

OBJECTIVE To establish the quality control standard of content determination based on HPLC for multiple effective components of Tangxinping capsule.METHODS Using HPLC to establish the method for content determination of four effective components of Schisandrae Chinensis Fructus(Schizandrol A and Schizandrin A), bran-processed Aurantii Fructus Immaturus(Hesperidin) and Astragali Radix(calycosin-7-glucoside) in the prescription.RESULTS The methodological investigation of four effective components met the requirements of the guiding principles of pharmaceutical quality analysis. The linearity range of calycosin-7-glucoside was 1.6-161.2 μg·mL^-1(r=0.999 8), and the average recovery rate was 100.1%. The linearity range of Schizandrol A was 0.7-71 μg·mL^-1(r=0.999 8), and the average recovery rate was 99.3%. The linearity range of Schizandrin A was 1.1-113 μg·mL^-1(r=0.999 8), and the average recovery rate was 99.0%. The linearity range of hesperidin was 1.0-103.3 μg·mL^-1(r=0.999 8), and the average recovery rate was 99.1%. CONCLUSION The established HPLC determination method was easy to operate and had high specificity, which could be used as the standard detection method for quality control of Tangxinping capsules.