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目的:制备美乐托宁缓释片,以国外上市制剂美乐托宁缓释片为参比制剂,考察自研制剂和参比制剂在不同pH释放介质中体外释放行为的相似性及体外释药机制。方法:采用释放度测定法转篮法的装置进行体外释放实验,用HPLC法测定释放度,采用f2相似因子对2种制剂释放曲线的相似度进行评价,并进行释放行为模型的拟合。结果:在不同pH的释放介质中,自制制剂释放度曲线与参比制剂比较,f2相似因子均大于50;美乐托宁缓释片在4种释放介质中体外释药拟合模型更接近一级方程、Higuchi方程和Peppas方程。结论:参比制剂与自制制剂在不同pH释放介质中的体外释放一致,释放机制为扩散释药。
OBJECTIVE: To prepare Melatonin sustained-release tablets and compare the release behavior of self-made formulations and reference preparations in different pH-releasing media with the listed preparation Mellitidine sustained-release tablets as reference preparation and in vitro release Drug mechanism. Methods: The in vitro release experiment was performed by the device of releasing degree determination method and the release degree was determined by HPLC method. The similarities of release profiles of two preparations were evaluated by f2 similarity factor, and the release behavior model was fitted. Results: Compared with the reference preparation, the f2 release factor curve of the self-made formulation was greater than 50 in different pH releasing media. The in vitro release fitting model of melatonine sustained-release tablet in four release media was closer to one Equations, Higuchi Equations and Peppas Equations. CONCLUSION: The in vitro release of reference preparations and homemade preparations in different pH release media are identical, and the release mechanism is diffusion drug release.