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目的:建立蒲公英阴道栓的制备方法及质量控制标准。方法:筛选基质,确定栓剂中的主要成分和基质的组成与比例,并采用高效液相色谱法测定栓剂中绿原酸、咖啡酸的含量。结果:制备得到水溶性基质的蒲公英栓剂;主要成分绿原酸2～50mg.L-1质量浓度范围内线性关系良好(r=0.994 3),平均回收率为(100.6±3.4)%;咖啡酸在2～50mg.L-1质量浓度范围内线性关系良好(r=0.994 4),平均回收率为(101.0±3.0)%。结论:该制剂制备工艺简单,质量稳定,质量控制方法简便、准确、精密度好。
Objective: To establish the preparation method and quality control standard of dandelion vaginal suppository. METHODS: The matrix was selected to determine the composition and proportion of the main components and matrix in suppositories, and the contents of chlorogenic acid and caffeic acid in suppositories were determined by HPLC. RESULTS: A dandelion suppository with a water-soluble base was prepared. The linear range of chlorogenic acid concentration in the range of 2 to 50 mg.L-1 was good (r=0.994 3). The average recovery was (100.6±3.4)%; caffeic acid. The linear relationship was good in the range of 2～50mg.L-1 (r=0.994 4), and the average recovery was (101.0±3.0)%. Conclusion: The preparation process is simple, the quality is stable, and the quality control method is simple, accurate, and accurate.