五味香连丸质量标准研究

Studies on the quality standards on Wuwei Xianglian Wan

目的：建立五味香连丸的质量标准。方法：采用薄层鉴别方法进行定性鉴别,运用高效液相色谱法测定盐酸小檗碱的含量。结果：确立了制剂中延胡索的鉴别方法。通过方法学系统考察,建立了盐酸小檗碱的含量测定方法,其盐酸小檗碱的线性范围为0.224~1.120μg,回归方程Y=11.78552＋7316.313X（r=0.9999）,平均加样回收率为98.10%,RSD为1.89%（n=6）。结论：建立的鉴别和含量测定方法简便、准确、重复性好,适用于质量控制。

Objective： To establish the quality standards on Wuwei Xianglian Wan. Methods： The thin layer chromatography （TLC） was adopted for qualitative identification; the content of berberine hydrochloride was detected by HPLC. Results： The identifying methods of Yanhusuo were established. The determination method for the content of berberine hydrochloride was established. The calibration curve ofberberine hydrochloride was liner in the range of 0.224-1.120μg.The regression equation was Y=11.78552 ＋ 7316.313 X（r=0.9999）. The average recovery was 98.10%, and RSD was 1.89% （n=6）, Conclusion： The method is simple, accurate and reproducible, It can be used for the quality control.