精康宁胶囊质量标准研究

Quality control for Jingkangning capsules

目的制定精康宁胶囊的质量标准。方法采用薄层色谱法对制剂中的人工牛黄、白术、冰片进行定性鉴别;采用高效液相色谱法对制剂中的大黄素、大黄酚进行含量测定。结果薄层鉴别斑点清晰,阴性对照无干扰。精康宁胶囊中大黄素含量平均为0.627 mg/g,平均回收率为98.47%,RSD=0.93%;大黄酚平均含量为1.251 mg/g,平均回收率为98.58%,RSD=1.38%。结论方法实用,专属性强,重复性好,可作为该制剂的质量控制指标。

Objective o establish the quality standards for Jingkangning capsules. Methods Calculus bovis, bomeol and Rhizoma atuactylodis Macrocephalae were identified qualitatively by TLC. Contents of emodin and chrysophanol were determined by HPI,C. Results The content, average recovery and RSD of emodin in Jingkangning capsules were 0. 627 mg/g, 98.47% and 0.93%, respectively. The content, average recovery and RSD of chrysophanol in Jingkangning capsules were 1. 251 mg/g, 98.58% and 1.38%, respectively. Conclusion This method is reproducible and reliable for the quality control of Jingdangning capsule.