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目的:建立穿黄消炎胶囊的质量标准。方法:采用薄层色谱法对穿黄消炎胶囊中穿心莲和一枝黄花进行定性鉴别;采用高效液相色谱法测定穿心莲内酯和脱水穿心莲内酯的含量。结果:薄层鉴别色谱特征明显,专属性强;穿心莲内酯在0.2164~1.9476μg内线性关系良好(r=0.9999),加样回收率为97.90%~99.76%,RSD=0.76%;脱水穿心莲内酯在0.1872~1.6848μg内线性关系良好(r=0.9999),加样回收率为97.65%~99.78%,RSD=0.82%。结论:该方法灵敏、准确,可作为穿黄消炎胶囊的质量控制方法。
Objective: To establish the quality standard of Tonghuang Xiaoyan Capsule. Methods: The qualitative identification of Andrographis paniculata and S. purpurea in Chuanhuang Xiaoyan capsule was performed by TLC. The contents of andrographolide and dehydroandrographolide were determined by high performance liquid chromatography. RESULTS: The characteristics of the TLC were obvious and the specificity was strong. The linearity of the andrographolide was good in the range of 0.2164~1.9476μg (r=0.9999). The recovery rate of the sample was 97.90%~99.76%, and the RSD was 0.76%. The linearity of esters was good from 0.1872 to 1.6848 μg (r=0.9999). The recovery of the sample was 97.65%-99.78% with RSD=0.82%. Conclusion: This method is sensitive and accurate and can be used as a quality control method for Chuanhuang Xiaoyan capsule.