摘要:
目的 研制非洛地平缓释片,评价其与原研制剂的体外释放度相似性。 方法 采用骨架片技术,通过研究骨架材料种类、粘度、用量,稀释剂及制备工艺对释放的影响,研制非洛地平缓释片,通过相似因子法研究其与原研制剂在体外4种不同pH条件下的释放度的差异。 结果 以HPMC为骨架材料,工艺采用湿法制粒法,乙醇溶液浓度为80%,制粒时间为40s,压片硬度在50~70N时,所得的非洛地平缓释片的释放度与原研制剂最接近。4种不同pH条件下的释放度的相似因子均大于50。 结论 研制的非洛地平缓释片,其体外释放与原研制剂相似。
Abstract:
Objective To prepare felodipine sustained release tablet and evaluate the similitude of release rate with original preparation. Methods Matrix technology was used. felodipine sustained release tablet was prepared through studying the influence of matrix material sorts, viscosity, quantity, fillers and process. The similitude of release rateof SR tablet were evaluated in 4 kinds of pH media with original preparation. Results The release rate of felodipine sustained release tablet which was prepared by HPMC as matrix material ,applied by wet granulation with alcohol content of 80% and granulation time of 40 sec, was similar to original preparation with the hardness between 50~70 N. F2 functions of release rate in 4 kinds of pH media were all exceed 50. Conclusions Release rate of felodipine sustained release tablet prepared was similar to original preparation.
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