健脑胶囊质量控制研究

目的修订提高健脑胶囊的质量标准。方法采用高效液相色谱法对健脑胶囊中五味子醇甲进行含量测定;采用薄层色谱法对复方中的3味主要药物进行定性鉴别。结果五味子醇甲在0.02054～0.57512μg范围内的线性关系良好(r=0.9999),平均回收率为98.68%,RSD=1.13%;薄层色谱可明显鉴别复方中的枸杞子、肉苁蓉、酸枣仁。结论建立的HPLC方法简单准确、专属性强、重现性好,所建立的质量标准能更有效地控制该复方的质量。

Study on the quality control of Jiannao Capsule

OBJECTIVE To revise and enhance the quality standard and study the quality of Jiannao Capsule in the market at present. METHODS HPLC was adopted to determine the content of schisandrin and three main medicinal materials were identified by TLC. RESULTS The calibration curve was linear over the concentration range of 0. 02054 ～0. 57512/,g （ r = 0. 9999）, the average recovery of schisandrin was 98.68% RSD = 1.15 % （ n = 5） ;The Fructus Lycii Herba Cistanches and Semen Ziziphi Spinosae were significantly identified by TLC. CONCLUSION The method was simple,rapid,sensitive and accurate for the determination of Fufangqingdai pills,and can control the quality of it more effectively.