抗妇炎胶囊质量标准研究

Research on the Quality Standard of Kangfuyan Capsule

目的完善抗妇炎胶囊的质量控制标准。方法建立鉴别苦参、黄柏的显微鉴别方法,建立鉴别连翘、黄柏的薄层色谱鉴别(TLC)方法,采用高效液相色谱法(HPLC)测定盐酸小檗碱的含量,色谱柱以十八烷基硅烷键合硅胶为填充剂,流动相为乙腈-0.05 mol/L磷酸二氢钾溶液(50∶50)(每100 mL中加十二烷基硫酸钠0.4 g,再以磷酸调节pH值为4.0),流速为1.0 mL/min,检测波长为265 nm。结果显微鉴别特征明显;TLC法专属性强;HPLC方法学考察结果表明,盐酸小檗碱在0.0975~1.9508μg范围内与峰面积呈良好线性关系,回归方程为Y=4853194.24 X-82272.75(R=0.9999),平均回收率为101.72%,RSD=0.8%(n=6)。结论建立的质量控制方法,专属性强,重复性好,可作为抗妇炎胶囊的质量控制方法。

Objective To improve the quality control standard of Kangfuyan capsule.Methods The micro identification method of sophorae flavescentis radix and phellodendri chinensis cortex was established,the TLC identification method of phellodendri chinensis cortex and forsythiae fructus was established.The content of Berberine Hydrochloride was determined by HPLC.The column was C18,and the mobile phase was acetonitrile-0.05mol/l potassium dihydrogen phosphate solution(50:50)(add dodecyl sulfur per 100ml).The detection wavelength was 265 nm and the flow rate was 1.0 ml/min.Results The characteristic of microscopic identification was obvious.TLC method was specific and feasible.HPLC method showed that berberine hydrochloride had a good linear relationship with peak area in the range of 0.0975μg-1.9508μg,the regression equation was y=4853194.24 x-82272.75(r=0.9999),the average recovery was 101.72%,RSD=0.8%(n=6).Conclusion The established quality control method has strong specificity and good repeatability,can be used as the quality control method of Kangfuyan capsule.