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目的:测定不同厂家生产的辛伐他汀片的溶出曲线,并对其进行一致性评价。方法:采用光纤药物溶出度实时测定仪在测定波长238nm处,测定光程为10mm,分别测定5个不同厂家辛伐他汀片的溶出曲线,通过相似因子f2法评价溶出曲线的相似性。结果:不同厂家生产的药品溶出曲线差异较大。结论:本实验选用的方法简便、数据真实可靠,可用于区分体外溶出曲线的相似性,为制剂生物等效性实验提供参考数据。
OBJECTIVE: To determine the dissolution profile of simvastatin tablets produced by different manufacturers and to evaluate their consistency. Methods: The optical fiber drug dissolution real-time detector was used to measure the optical path length of 10 mm at a wavelength of 238 nm. The dissolution profiles of simvastatin tablets from 5 different manufacturers were determined. The similarities of the dissolution profiles were evaluated by similarity factor f2 method. Results: Drug dissolution curves produced by different manufacturers varied greatly. Conclusion: The method used in this study is simple and the data is reliable. It can be used to distinguish the similarity of in vitro dissolution curves and provide reference data for bioequivalence experiment.