炎可宁片的质量标准研究

Research of quality standard of Yankening Tablets

目的:建立炎可宁片中大黄的薄层色谱鉴别及盐酸小檗碱含量的HPLC测定方法。方法:采用TLC法对大黄进行鉴别,采用HPLC法对炎可宁片中盐酸小檗碱含量进行测定。色谱柱:Shim-pack C18(4.6mm×150mm,5μm);乙腈-0.1%磷酸(50∶50)(每100毫升加十二烷基磺酸钠0.1g)为流动相,流速:1.0ml/min,检测波长:265nm;柱温:30℃。结果:TLC色谱中在与大黄素、大黄酚对照药材相应位置显相同颜色的斑点。HPLC色谱中,盐酸小檗碱进样量在1.59～15.94μg范围内线性良好,平均回收率为99.94%,RSD=1.00%(n=6)。结论:本文建立的方法方便、准确,可用于该制剂的质量控制。

Objective： To establish a method for determining berberine hydrochloride and identification method for rhubarb in Yankening Tablets. Methods： TLC method was used for the identification of rhubarb. HPLC method was taken for the determination of berberine hydrochloride. Shim-pack Cls（4.6 mm×150mm, 5 μm）column was used. The mobile phases consisted of acctonitrile-0.1% of phosphate （50：50）（added sodium dodecyl sulfonate 0.1 g/100 ml）. The flow rate was 1.0 ml/min, and the detection wavelength was at 265 nm. The column temperature was 30℃. Results： It presented the dots with the same color and position in TLC. In the HPLC determination research, the linear range of berberine hydrochloride was in the range of 1.59-15.94μg, the average recovery was 99.94% with a RSD of 1.00%（n=6）. Conclusion： The method is fast, reliable, accurate and can be used in the quality control of Yankening Tablets.