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目的:筛选盐酸二甲双胍缓释微丸薄膜衣处方。方法:以体外释放度为主要考察指标,采用单因素筛选法,初步确定薄膜衣的处方,再利用正交试验对其进行优化;测定所制备的缓释胶囊的体外释放度,并与微丸进行比较。结果:优化处方为薄膜材料Eudragit NE30D∶Eudragit L30D55=10∶1,加入聚合物量40%的滑石粉及0.25%的十二烷基硫酸钠。缓释胶囊缓释性优于微丸。结论:所制备的缓释胶囊可持续24h释放药物,达到缓释要求。
Objective: To screen the prescription of metformin hydrochloride sustained-release pellets. Methods: The in vitro release was the main index. The single-factor screening method was used to preliminarily determine the prescription of film coat and then optimize it by orthogonal test. The in vitro release of the prepared sustained-release capsules was measured and compared with pellets Compare. Results: The optimal formulation was Eudragit NE30D: Eudragit L30D55 = 10: 1. The amount of polymer was 40% talc and 0.25% sodium dodecyl sulfate. Slow release capsules are better than pellets. Conclusion: The prepared sustained release capsules can release the drug for 24 hours and reach the sustained release requirement.