穿黄消炎胶囊的制备及质量标准研究

目的建立穿黄消炎胶囊的定性定量分析方法。方法采用薄层色谱法定性鉴别制剂中的穿心莲和一枝黄花,采用高效液相色谱法测定制剂中脱水穿心莲内酯的含量。结果薄层色谱法可定性检出穿心莲内酯与脱水穿心莲内酯;脱水穿心莲内酯质量浓度在0.03～0.15g/L范围内与峰面积线性关系良好,r=0.9999,平均回收率为98.44%,RSD为0.72%（n=5）。结论所用定性定量方法可用于穿黄消炎胶囊的质量控制。

Study on Quality Standards of Chuanhuang Xiaoyan Capsules

Objective To establish the qualitative and quantitative analysis methods of Chuanhuang Xiaoyan Capsules.Methods Thin layer chromatography（TLC） method was adopted to the qualitative identification of Andrographis paniculata and Solidago decurrens in Chuanhuang Xiaoyan Capsules,and high performance liquid chromatography（HPLC） was used to determine the dehydroandrographolide content.Results The TLC method could qualitatively detect andrographolide and dehydroandrographolide.In the determination by HPLC,dehydroandrographolide showed the linear relationship within the range of 0.03-0.15 g /L,r = 0.999 9;the average recovery rate was 98.44%,RSD was 0.72%.Conclusion The used qualitative and quantitative methods can be used for the quality control of Chuanhuang Xiaoyan Capsules.