不同厂家小剂量阿司匹林肠溶片释放度研究

Study on the Release Rate of Low-dose Aspirin Enteric-coated Tablets from Different Manufacturers

采用转篮法于303 nm波长处测定水杨酸吸光值,计算阿司匹林肠溶片释放度,通过对3个厂家25 mg阿司匹林肠溶片的释放度研究,以评价其内在质量。结果表明:阿司匹林肠溶片在酸中释放量较小,随着时间延长释放量变化不大,在90 min左右,1号和2号药品的释放度反而有所降低。阿司匹林肠溶片在缓冲液中的释放度均明显增大,1号药品的释放度达到80.92%,2号和3号的释放度均在60%左右,2号和3号属于不合格产品。不同厂家的阿司匹林肠溶片释放度存在一定差异,生产企业应筛选合理的处方和制备工艺,经营企业应控制好运输及经营环节的温湿度,以保证药物的质量及稳定性。

The absorbance value of salicylic acid at 303 nm wavelength was measured by rotating basket method.The release rate of aspirin enteric-coated tablets was calculated.The release rate of 25 mg aspirin enteric-coated tablets from 3 manufacturers was studied to evaluate the intrinsic quality.The result shows that aspirin enteric-coated tablets release less in the acid,the amount of release does not change much over time,and at about 90 min,the release rate of No.1 and No.2 drugs has decreased.The release rate of aspirin enteric-coated tablets in the buffer solution is significantly increased,the release rate of No.1 drug reaches 80.92%,and the release rate of No.2 and No.3 is about 60%.No.2 and No.3 are unqualified products.There are some differences in the release rate of aspirin enteric-coated tablets from different manufacturers.In order to ensure the quality and stability of the drug,manufacturers should select reasonable prescription and preparation technology,and control the temperature and humidity in transportation and management.