除烦安神胶囊的质量标准的研究

Study on the quality standard of Xiaofan Anshen capsule

目的为了提高除烦安神胶囊的检验方法。方法采用薄层色谱方法对药品中的五味子进行了定性鉴别;采用高效液相色谱方法对处方中君药丹参中丹酚酸B的含量进行了测定,色谱柱为Waters SPHERISORB-C18柱,流动相为甲醇-乙腈-0.5%甲酸溶液(27:8:65),流速为0.9 mL/min,柱温为30℃,检测波长为286 nm,进样量为10μl。结果在TLC色谱中检出了五味子成分;在含量测定中丹酚酸B的检测浓度在0.7931~25.38μg/mL范围内与其峰面积呈良好的线性关系(r=0.9998),平均加样回收率为98.6%,RSD=1.0(n=6)。结论该方法操作简便、专属性强、结果准确,能够有效控制除烦安神胶囊的药品质量。

Objective To improve the test method of Chufananshen capsule.Methods A TLC method was used to identify Schisandra in drugs.HPLC was used to determine the content of Salvia miltiorrhiza B in prescription Salvia miltiorrhiza.The chromatographic column was Waters SPHERISORB-C18 column and the mobile phase was methanol-acetonitrile-0.5%formic acid solution(27:8:65).The flow rate is 0.9 ml/min,the detection wavelength is 286 nm,and the sample feed is 10μl.Results The components of Schisandra and Acorus were detected in TLC chromatography.In the determination of the content,the detection concentration of Danphenolic acid B has a good linear relationship with its peak area(R=0.9998)in the range of 0.7931 to 25.38μg/ml,with an average sampling recovery rate of 98.6%and RSD=1.0(N=6).Conclusion The method is simple,specialized and accurate,and can effectively control the quality of Medicine in Anshen capsule.