咳立平胶囊质量标准研究

Study on Quality Standard for Keliping Capsule

目的:探讨咳立平胶囊的质量标准。方法:用沉淀反应鉴定麻黄总生物碱,用薄层色谱鉴别处方中的麻黄碱及原药材桑白皮,采用高效液相色谱法测定麻黄碱的含量。结果:盐酸麻黄碱在0.2462～1.231μg范围内呈良好的线性关系,r=0.9998;平均回收率为99.27%,RSD为0.65%。结论:所建立的方法可准确、快速地进行定性、定量检测,可用于该制剂的质量控制。

Objective:To establish the quality control standard for Keliping Capsule.Methods:The total alkaloid in Ephedra equisetina was identified by precipitation reaction.Ephedrine and Cortex Mori were identified by TLC. The content of Ephedrine in Keliping Capsule was determined by RP-HPLC.Results:Ephedrine Hydrochloride showed a good linear relationship at a range of 0.246 2～1.231 μg,r=0.999 8;the average recovery was 99.27%,and RSD was 0.65%.Conclusion:The method is accurate and quick, and can be used for the quality control of Keliping Capsule.