楝栀口服液质量标准研究

Study on the Quality Standard of Lianzhi Oral Liquid(楝栀口服液)

目的:建立楝栀口服液的质量标准。方法:采用薄层色谱法对楝栀口服液中黄连、延胡索所含成分盐酸小檗碱、延胡索乙素进行定性鉴别,采用HPLC法同时测定楝栀口服液中栀子苷、芍药苷的含量,Waters SunFire C_(18)柱,以乙腈-0.2%磷酸溶液(15∶85)为流动相,流速为1.0 m L/min,检测波长为238 nm,进样量为10μL。结果:栀子苷进样量在0.004,1~0.400,0μg范围内、芍药苷进样量在0.004,1~0.406,4μg范围内与各自峰面积积分值均呈良好的线性关系;栀子苷、芍药苷的平均回收率分别为98.13%、97.27%,RSD%分别为1.11%、1.45%(n=6)。建立了楝栀口服液的鉴别及含量测定方法。结论:所建立的方法操作简单、准确、重复性好,为楝栀口服液的质量控制提供了科学可行的依据。

Objective： To establish a method for quality standard of Lianzhi oral solution. Method： The berberine hydrochloride of Coptis chinensis and the tetrahydropalmatine of corydalis tuber in this medicine were identified qualitatively by TLC and the contents of geniposide and paeoniflorin in Lianzhi oral solution were determined simultaneously by HPLC, the separation was performed on Waters SunFire C18 column with mobile phase consisted of acetonitrile-0.2% phosphoric acid solution （15：85） at the flow rate of 1.0 mL/min. The detection wavelength was set at 238 nm and injection volume was 10 μL. Results： The linear range was 0.0041- 0.4000μg for geniposide, 0.0041-0.4064μg for paeoniflorin, and the average recoveries of them were 98.13% （RSD%=1.11%, n=6）, 97.27%（RSD%=1.45%, n=6）, respectively. The author established the identification and content determination method of Lianzhi oral solution. Conclusion： The method is simple, accurate and repeatability, and offers scientific and feasible basis for control the quality of Lianzhi oral solution.