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目的:建立染料木素阴道片的质量控制方法。方法:采用《中国药典》pH测定法测定染料木素阴道片的pH,采用薄层色谱法对染料木素进行定性鉴别,采用高效液相色谱法测定染料木素阴道片中染料木素的含量。结果:薄层色谱斑点清晰,分离度良好,专属性强;染料木素在0.201 2~1.006 0μg(r=0.999 9)线性关系良好,平均回收率为97.72%,RSD1.65%(n=6),且不同批次染料木素阴道片的pH及其染料木素的含量无明显差异。结论:所建立方法简便准确,重复性好,适用于染料木素阴道片的质量控制。
Objective: To establish the quality control method of genistein vaginal tablets. Methods: The pH of genistein vaginal tablets was determined by “Chinese Pharmacopoeia” pH measurement. The genistein was qualitatively identified by TLC. The content of genistein in genistein vaginal tablets was determined by high performance liquid chromatography . Results: The TLC spots were clear, the resolution was good and the specificity was good. The linearity of genistein was good at 0.201 2 ~ 1.006 0 μg (r = 0.999 9) with an average recovery of 97.72% and RSD of 1.65% (n = 6 ), And different batches of genistein vaginal pH and its genistein content no significant difference. Conclusion: The established method is simple, accurate and reproducible. It is suitable for the quality control of genistein vaginal tablets.