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目的:建立真元颗粒的质量标准。方法:采用薄层色谱法对制剂中当归、防风和青蒿进行定性鉴别,对毒性成分乌头碱进行限量检查;采用高效液相色谱法测定制剂中甘草酸的含量。结果:薄层鉴别斑点清晰、分离度好、专属性强、阴性对照溶液无干扰;含量测定中甘草酸在4.406~234.1μg/mL范围内线性关系良好(r=0.9994),平均回收率为100.3%,RSD=2.16%(n=9)。结论:所建立的定性、定量分析方法简便易行、重复性好、准确度高,能有效的控制真元颗粒的质量。
Objective: To establish the quality standard of Zhenyuan granule. Methods: The Angelica sinensis, windbreak and Artemisia annua were identified by TLC. The aconitine was tested for toxicity. The content of glycyrrhizic acid in the preparation was determined by HPLC. Results: The identification spots of the TLC were clear, the resolution was good, the specificity was strong, and the negative control solution had no interference. The content of glycyrrhizin had good linearity (r = 0.9994) in the range of 4.406 ~ 234.1μg / mL with the average recovery of 100.3 %, RSD = 2.16% (n = 9). Conclusion: The established qualitative and quantitative analysis method is simple, reproducible, accurate and can effectively control the quality of Zhenyuan granules.