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目的:建立乌梅透骨口服液的质量控制方法。方法:采用TLC法对组方中的川续断、当归、五味子进行鉴别:用柱层析方法处理样品,用HPLC法测定样品中川续断皂苷Ⅵ的含量。结果:在薄层色谱中能检出川续断、当归、五味子;川续断皂苷Ⅵ在0.05～1.5 mg·ml~(-1)范围内线性关系良好(r=0.999 9),平均回收率为96.99%,RSD为2.10%(n=9)。结论:所建立的定性方法专属性强,定量方法准确,重复性好,可有效控制该制剂质量。
Objective: To establish a quality control method of Wu Mei Huo Gu Oral Liquid. Methods: The TLC method was used to identify Chuan Xiu-Duan, Angelica and Schisandra chinensis in the prescription. The samples were treated by column chromatography and the content of Chuan Ssu-Duan saponin Ⅵ in the samples was determined by HPLC. Results: Chuanxuan broken, Angelica sinensis and Schisandra chinensis could be detected by TLC, the linear relationship was good (r = 0.999 9) in the range of 0.05-1.5 mg · ml -1, and the average recovery was Was 96.99% with a RSD of 2.10% (n = 9). Conclusion: The established qualitative method has the advantages of high specificity, accurate quantitative method and good repeatability, which can effectively control the quality of the preparation.