三种口服固体制剂粉体学性质研究

Powder Property of Three Oral Solid Preparations

目的:考察3种口服固体制剂药物粉体性质差异。方法:选择化学药-阿司匹林肠溶片、中药片剂-黄连上清片、中药胶囊剂-复方牛黄消炎胶囊3个品种,比较药物颗粒制粒方式、干燥方式及处方组分复杂性引起的粉体学差异。结果:阿司匹林肠溶片颗粒、黄连上清片浸膏粉(热风循环干燥)粒度均匀,休止角与卡氏指数均较小;复方牛黄消炎胶囊颗粒和黄连上清片浸膏粉(带式真空干燥)粒度分布分散,休止角与卡氏指数均较大。黄连上清片浸膏粉(带式真空干燥)经二次制粒后粉体学特征得到显著改善。结论:单一成分的阿司匹林粉体学性质较优,中药制剂干燥方式、制粒工艺和物料组成不同,所得粉体性质差异显著。

Objective： To investigate the differences of powder property in three oral solid preparations. Methods： Aspirin enteric-coated tablets, Huanglianshangqing tablets and compound Niuhuang Xiaoyan capsules were compares to figure out the differences of powder properties in granulation process, drying methods and complex components. Results： It was epigranular in the granule of Aspirin enteric-coated tablets and the extract of Huanglianshangqing tablets（hot-air circulate drying）, angle of repose and Carr＇s index of both were small, which was opposite to the granule of compound Niuhuang Xiaoyan capsules and the extract of Huanglianshangqing tablets（band-type vacuum drying）. The powder property of the extract of Huanglianshangqing tablets（band-type vacuum drying） was improved after secondary granulation. Conclusion： The powder property of aspirin entericcoated tablets was better than that of the others. The powder property was greatly influenced by drying method, technology and materials.