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目的:建立虫创愈胶囊的质量标准。方法:采用薄层色谱法对制剂中红参、续断、骨碎补进行定性鉴别;采用高效液相色谱法对续断中川续断皂苷Ⅵ进行含量测定;色谱条件:C18柱(150 mm×4.6 mm,5μm),流动相:乙腈-水(30∶70)。检测波长:212 nm。结果:在薄层色谱中可检出红参、续断、骨碎补的特征斑点,阴性对照无干扰;川续断皂苷Ⅵ在4.16~41.6 mg(r=0.999 9)的范围内呈良好的线性关系,平均回收率为97.4%。结论:建立的虫创愈胶囊中主要活性成分的定性定量方法准确、专属性及重现性好,且快速简便,可作为该制剂质量的控制方法。
Objective: To establish the quality standard of Eupolyphage Capsule. Methods: TLC and HPLC were used to qualitatively identify red ginseng, Dipsacus and Rhizoma Drynariae. The content of Daphniphyllum saponins Ⅵ was determined by high performance liquid chromatography (HPLC). The chromatographic conditions were as follows: C18 column (150 mm × 4.6 mm, 5 μm), mobile phase: acetonitrile-water (30:70). Detection wavelength: 212 nm. Results: The characteristic spots of red ginseng, Dipsacus and Rhizoma Drynariae could be detected in the thin layer chromatogram without any interference with the negative control. The Dictyosaponin Ⅵ was good in the range of 4.16-41.6 mg (r = 0.999 9) The linear relationship, the average recovery was 97.4%. Conclusion: The established qualitative and quantitative methods for the determination of the main active components in Chongyu Chuyu Capsules are accurate, specific and reproducible, and can be quickly and conveniently used as a control method for the quality of the preparation.