消痔胶囊的质量标准研究

Studies on Quality Standard of Xiaozhi Capsules

目的研究消痔胶囊的质量控制标准。方法采用薄层色谱法对制剂中大黄、槐花进行定性鉴别,采用高效液相色谱法测定消痔胶囊中黄芩苷的含量。结果大黄、槐花的薄层色谱鉴别专属性强;黄芩苷进样量在0.1002-1.6032μg范围内呈良好线性关系,r=0.999 8;平均回收率为99.3%,RSD=0.98%。结论该方法简便、灵敏、准确、重复性好,可作为消痔胶囊的质量控制标准。

OBJECTIVE To establish a quality standard of Xiaozhi capsule.METHODS The identification of Radix et Rhizoma Rhei,Flos sophorae were carried out by TLC.The content of baicalin in Xiaozhi capsule was determined by HPLC. RESULTS Radix et Rhizoma Rhei,Flos Sophorae could be idetifid by TLC.A good linearity of baicalin was obtained in the range of 0.1002～1.6032 μg（r=0.999 8） and the average recovery of baicalin was 99.3%,RSD was 0.98%.CONCLUSION This method is simple,sensitive and accurate,and has good reproducibility.It can be used for the quality control fo Xiaozhi Capsule.