黄地安消胶囊的质量控制方法研究

Study on Quality Control of Huangdi Anxiao Capsules

目的：建立黄地安消胶囊质量控制的方法。方法：采用薄层色谱法（TLC）对黄地安消胶囊中的黄连、麦冬、葛根、枇杷叶进行定性鉴别研究;采用高效液相色谱法（HPLC）对黄地安消胶囊中君药黄连的活性成分盐酸小檗碱进行含量测定,色谱条件：Agilent Eclipse Plus C18色谱柱（4.6 mm×250 mm,5μm）,流动相：乙腈-0.05 mol·L^-1磷酸二氢钾（30∶70）,流速：1 m L·min^-1,柱温：30℃,检测波长：345 nm。结果：薄层色谱鉴别斑点清晰,易于鉴别;采用HPLC法对黄地安消胶囊中的盐酸小檗碱进行含量测定,盐酸小檗碱在0.235-3.760μg范围内呈良好的线性关系,r=0.9999;平均加样回收率为99.84%,RSD=0.27%。结论：定性鉴别和含量测定方法操作简单,重现性、精密度及稳定性均良好,可用作黄地安消胶囊的质量控制研究方法。

Objective： To establish the qualitative and quantitative analytic methods for quality control of Huangdi Anxiao capsules. Methods： The Berberine, Radix, Arrowroot, and Eriobotrya Japonica leaves in Huangdi Anxiao capsules were identified by TLC, and the content of the active ingredient berberine hydrochloride in the principle drug Rhizoma Coptidis was determined by HPLC. The samples were separated at 30 ℃ on a Agilent Eclipse Plus C18 column （4.6 mm×250 mm,5μm） and the mobile phase was acetonitrile -0.05 mol·L^-1 potassium dihydrogen phosphate （30 ： 70, pH 4.0）. The flow rate was 1.0 m L·min^-1 and the detection wavelength was at 345 nm. Results： The TLC spots were clear. A good linear correlation was observed within the range of 0.235-3.760 μg （r=0.9999） for berberine hydrochloride, and the average recovery rate was 99.84% with RSD of 0.27% （n=6）. Conclusion： The qualitative and quantitative analytic methods are stable, simple and accurate, which can be used for quality control of berberine hydrochloride of Huangdi Anxiao capsules.