消疝合剂质量标准研究

Studies on Quality Standard of Xiaoshan Mixture

目的建立中药制剂消疝合剂的质量标准。方法采用薄层色谱法对消疝合剂中苦参、当归、延胡索、野菊花等进行定性鉴别;采用高效液相色谱法测定苦参碱的含量。色谱柱:NUCLEOSIL-NH2柱;流动相:乙腈-无水乙醇-3%磷酸溶液(82:10:8);检测波长为220nm;流速:1.0ml/min;柱温:30℃。结果定性鉴别薄层色谱斑点清晰,阴性对照均无干扰;苦参碱在0.0804～0.8040μg范围内呈良好的线性关系,r=0.9992,平均加样回收率为97.76%,RSD为1.45%(n=6)。结论该方法简便、准确、可靠,可作为消疝合剂的质量控制方法。

Objective To establish the quality standard of Xiaoshan mixture. Methods TLC were used to distinguish Kushen, Danggui, Yanhusuo, and Yejuhua in Xiaoshan mixture. HPLC method was used for the content determination of matrine. The NUCLEOSIL-NH2 was used as column; the mobile phase were acetonitrile-absolute alcohol- 3% phosphoric acid solution （82： 10： 8）; the detection wavelength was 220 nm; flow rate was 1.0 ml/min, and the column temperature was 30~C. Results The thin-layer chromatography spots were clear, and the negative samples have no interferences. Matrine showed a good linear relationship in the range of 0. 080 4 - 0. 804 0 μg, r = 0. 999 2, and the average recovery was 97.76%, with RSD = 1.45% （n = 6）. Conclusion This method is simple, accurate, reliable, and can be used for the quality control of Xiaoshan mixture.