马来酸氨氯地平分散片处方及制备工艺研究分析

Amlodipine Maleate Dispersible Tablets Formulation and Preparation Technology Research and Analysis

目的探讨马来酸氨氯地平分散片的处方以及制备工艺。方法通过实验对马来酸氨氯地平分散片的处方以及制备工艺进行研究。结果使用交联聚维酮和低取代羟并纤维素为崩解剂,预胶化淀粉和微晶纤维素作为填充剂,使用聚维酮-K30作为粘合剂以及二氧化硅和硬脂酸镁为润滑剂制成的马来酸氨氯地平分散片,可以在3min内崩解,并且能够通过2号筛,硬度适中,成型性好,外观光洁,可以迅速的分散,符合《中国药典》对分散片的要求。结论马来酸氨氯地平分散片符合分散片的制剂要求,溶出度比较高,崩解迅速,制备工艺简单,符合大规模生产要求。

Objective To investigate the amlodipine maleate dispersible tablets formulation and preparation process. Methods through the experiment of amlodipine maleate dispersible tablets f^maulation and preparation process of. Results using PVPP and low substituted hydroxyl and cellulose as disintegrating agent, pregelatinized starch and microcrystalline cellulose as fillers, the use of povidone - K30 as binder and silica and magnesium stearate as lubricant which amlodipine maleate dispersible tablets, can be disintegrated within 3 minutes, and can through 2 sieve, moderate hardness, forming a good, smooth appearance, can be rapidly dispersed, with＂ Chinese Pharmacopoeia＂ on the dispersible tablet requirements. Conclusion Amlodipine maleate dispersible tablet with dispersing tablet preparation requirements, dissolution rate is relatively high, rapid disintegration, simple preparation process, meets the requirement of mass production.