目的 考察市售不同厂家阿司匹林肠溶片的质量和工艺稳定性.方法 按2015年版《中国药典(二部)》方法对14个厂家49批次阿司匹林肠溶片的性状、鉴别、游离水杨酸、释放度、重量差异、含量测定等进行检测,并对同一生产厂家不同批号产品及不同厂家之间产品逐项进行比较和分析.结果 3个厂家各1批游离水杨酸不合格;1个厂家2批释放度不合格;所有样品性状、鉴别、含量测定合格;1个厂家1批样品为肠溶糖衣片,不需要检查重量差异,其余样品重量差异均合格.结论 14个厂家中阿司匹林肠溶片工艺可靠,质量稳定,但4个厂家质量不稳定,应改进工艺.%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.
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