提高八味痛经胶囊质量标准的研究

Study on quality standard for Baweitongjing Capsules

目的 建立八味痛经胶囊的质量控制标准。方法 采用TLC法对八味痛经胶囊中当归、桂枝、牡丹皮、延胡索进行鉴别,用HPLC法测定八味痛经胶囊中的牡丹皮和白芍共同有效成分芍药苷的含量。结果 薄层色谱可鉴别出当归、桂枝、牡丹皮、延胡索的特征斑点,且阴性对照无干扰;HPLC法测定芍药苷0.2575~2.5750μg线性关系良好,平均加样回收率为98.98%,RSD=1.0%（n=6）。结论 该方法简便可靠,专属性强,重现性好,可用于八味痛经胶囊的质量控制。

Objective To establish quality standard for Baweitongjing Capsules. Methods Angelicae sinensis Radix, Cinnamomi Ramulus, Moutan Cortex, Corydalis Rhizoma were identified by TLC, and the content of Paeoniflorin in Moutan Cortex and Paeoniae Alba Radix was determined by HPLC. Results TLC could identify Angelicae sinensis Radix, Cinnamomi Ramulus, Moutan Cortex, Corydalis Rhizoma. Paeoniflorin showed a good linear relationship at a range of 0.2575-2.5750 p. g. The average recovery was 98.98 % （n=6） and RSD was 1.0 % . Conclusion The method is simple, accurate, high specificity, and with good repeatability. The method can be used for Baweitongjing Capsules quality control.