复方茵陈合剂质量标准的建立

Quality Standard for Compound Yinchen Mixture

目的:建立复方茵陈合剂的质量标准。方法:采用薄层色谱法对复方茵陈合剂中茵陈、栀子、大黄进行定性鉴别;采用高效液相色谱法测定复方茵陈合剂绿原酸和栀子苷含量。结果:薄层色谱斑点清晰、分离效果较好、且阴性无干扰。绿原酸在浓度0.04~0.20 mg·ml^(-1)范围内呈良好的线性,栀子苷在浓度0.05~0.25 mg·ml^(-1)范围内呈良好的线性。两者的加样回收率分别为94.4%,102.2%,RSD分别为1.85%,1.15%(n=6)。结论:该方法准确可靠、专属性强、重复性好,可以作为控制复方茵陈合剂质量的有效方法。

Objective： To establish the quality standard for compound Yinchen mixture. Methods： A TLC method was used to identify Artemisiae scopariae Herba,Gardeniae Fructus,and Rhei Radix et Rhizoma in the mixture. An HPLC method was used to quantitatively analyze the concentration of chlorogenic acid and geniposide. Results： The TLC spots were clear without any interference the negative control. The linear range of chlorogenic acid was 0.04-0.20 mg·ml^（-1）,and that of geniposide was 0.05-0.25 mg·ml^（-1）. The average recovery of chlorogenic acid was 94.4% with RSD of 1.85%,and that of geniposide was 102.2% with RSD of 1.15%（ n = 6）.Conclusion： The method is accurate,reliable,specific and reproducible,which can be used for the quality control of compound Yinchen mixtures.