摘要
Abstract
Objective To investigate the quality and process stability of Aspirin Enteric-Coated Tablets from different manufacturers. Methods The properties, identification, free salicylic acid, degree of release, weight difference and content of 49 batches of Aspirin Enteric-Coated Tablets from 14 manufacturers were determined according to the method of Chinese Pharmacopoeia ( 2015 Edition, Volume Ⅱ) . The products of different batches in the same manufacturer and the products in the different manufacturers were compared and analyzed. Results There were 1 batch of unqualified free salicylic acid in 3 manufacturers, 2 batches of unqualified release in 1 manufacturer, the characters, identification and content determination of all samples were qualified, 1 batch of samples from 1 manufacturer were enteric coated tablets without checking the weight difference, the weight differences of the other samples were qualified. Conclusion In most of the 14 manufacturers, the process of Aspirin Enteric-Coated Tablets is reliable and the quality is stable. However, the quality of the 4 manufacturers is unstable, and the process should be improved.关键词
阿司匹林肠溶片/质量考察/游离水杨酸/释放度Key words
Aspirin Enteric-Coated Tablets/quality inspection/free salicylic acid/degree of release分类
医药卫生
