固本安神胶囊质量标准研究

Quality Standard of Guben Anshen Capsules

目的建立固本安神胶囊的质量标准。方法对固本安神胶囊中君药葛根及臣药五味子、黄芩进行薄层色谱鉴别;采用紫外分光光度计法测定君药葛根中活性成分葛根素的含量。结果固本安神胶囊的薄层色谱图与相应对照药材和对照品的色谱均显相同斑点,且阴性对照无干扰;葛根素的质量浓度在0.003 2~0.0112g/L范围内与峰面积线性关系良好(r=0.999 2),平均加样回收率为100.80%,RSD为2.46%(n=6)。结论该方法可用于固本安神胶囊的质量控制。

Objective To establish the quality control of Guben Anshen Capsules.Methods The principal drug(Radix Puerariae)and the ministerial drugs(Schisandra chinensis and Radix Scutellariae)in Guben Anshen Capsules were identified by TLC.The content of puerarin in the principal drug(Radix Puerariae)was determined by ultraviolet spectrophotometer.Results The TLC of Guben Anshen Capsules showed the same spots as those of the corresponding reference crude drugs and standard substances,the negative control had no interference.In the content determination,the puerarin showed good linear relationship with peak area in the range of 0.003 2-0.011 2 g/L(r=0.999 2),the average recovery was 100.80%and RSD was 2.46%(n=6).Conclusion The method can be used for the quality control of Guben Anshen Capsules.