四妙丸溶出度测定方法的建立及溶出曲线相似性评价*

作者：史文娟，杨玉畅，朱 倩，刘 娟，易丽莎，王子恒，倪 健，曲昌海

单位：北京中医药大学中药学院，北京 102488

引用：引用：史文娟，杨玉畅，朱倩，刘娟，易丽莎，王子恒，倪健，曲昌海.四妙丸溶出度测定方法的建立及溶出曲线相似性评价[J].中医药导报,2025,31(5):80-84.

DOI：10.13862/j.cn43-1446/r.2025.05.013

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摘要：目的：建立四妙丸体外溶出实验方法及相关的高效液相色谱（HPLC）检测方法。方法：溶出条件为桨法，转速为100 r/min，溶出介质为pH值为1.2的盐酸溶液，检测方法为HPLC法。采用建立的溶出方法对不同批次的四妙丸中盐酸小檗碱、盐酸黄柏碱、木兰花碱、绿原酸的溶出情况进行考察，采用不同的数据模型对溶出数据进行模型拟合，确定其最佳溶出模型。结果：通过相似因子法评价比较，发现不同批次间的相似因子（f2）和差异因子（f1）有明显差异，表明其不同时间生产的样品存在一定的差异性；4种指标成分溶出曲线拟合最符合Weibull方程，多种成分的溶出行为具有同步性且有相似的释药特点。结论：采用建立的体外溶出实验方法对不同批次的样品进行溶出曲线相似性评价，可为四妙丸的质量研究提供参考。

关键词：四妙丸；溶出度；批次一致性评价；Weibull方程；非模型依赖法

Abstract：

Objective: To establish an in vitro dissolution test method and an HPLC detection method for Simiao Pill. Methods: The dissolution conditions included the paddle method at 100 r/min with hydrochloric acid solution (pH 1.2) as the dissolution medium. The established dissolution method was applied to investigate the dissolution profiles of berberine hydrochloride, phellodendrine hydrochloride, magnoflorine, and chlorogenic acid in different batches of Simiao Pill. Dissolution data were fitted using various mathematical models to determine the optimal dissolution model. Results: Similarity factor (f2) and difference factor (f1) analyses revealed significant variations between batches, indicating differences in samples produced at different time points. The dissolution curves of the four marker components were best fitted by the Weibull equation, demonstrating synchronized dissolution behavior and similar drug release characteristics. Conclusion: The established in vitro dissolution method enables batch-to-batch similarity evaluation of dissolution profiles, providing a reference for quality control studies of Simiao Pill.

Key words：Simiao Pill; dissolution; batch consistency evaluation; Weibull equation; model-independent method

发布时间：2025-12-31

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