桂枝解郁胶囊的质量标准研究

Studies on Quality Standard for Guizhi Jieyu Capsule

目的建立桂枝解郁胶囊的鉴别方法;建立制剂中芍药苷的含量测定方法。方法采用TLC法对制剂中桂枝、巴戟天进行鉴别;采用HPLC法对制剂中的芍药苷进行定量分析。结果鉴别项下的阴性对照品无干扰,专属性强;芍药苷在0.0283-1.7μg范围内有良好的线性关系,r=0.9998,平均回收率为97.5%(n=6),RSD为2.36%。结论本研究建立的鉴别与含量测定方法,专属性、重现性好,可有效控制桂枝解郁胶囊的质量。

Objective To establish the methods of identify and the content determined of Paeoniflorin for Guizhi Jieyu Capsule. Meth- ods Cinnamomi Ramulus , Morinda officinalis How were identified by TLC. The content of Paeoniflorin was determined by HPLC. Results TLC spots developed were fairly clear and the blank test showed no interference. The linear rangers was 0. 0283 - 1.7 ~g（ r = 0. 9998 ）for Paeonifiorin. The average recovery of sample was 97.5% with RSD of 2.36% （ n = 6）, respectively. Conclusion The methods are effective for the quality control of the capsules.