复方α-酮酸片质量研究

Quality Research of Repaglinide Tablets in National Assessment Programs

目的:评价国内上市的复方α-酮酸片的药品质量与质量标准现状。方法:采用法定检验方法和探索性研究进行样品检验,统计分析国内复方α-酮酸片上市产品的质量现状并进行评价。结果:按照法定检验方法检验140批样品,合格率为100%。探索性研究显示,复方α-酮酸片对高湿较敏感,酮苯丙氨酸钙易氧化降解成苯乙酸;高湿或光照条件下,氨基酸钙类与氨基酸类原料药混合放置后苯乙酸含量明显增长。抽取部分批次样品按拟定标准检验,均符合要求。结论:国内上市的复方α-酮酸片整体质量较好,现行标准需进一步完善。建议相关企业避免使用高吸湿性辅料,关注包材密封性与两大类原料药单独制粒的必要性。

Objective:To evaluate the current status and suitability of statutory standard of domestic listed compound α-ketoacid tablets. Methods:The current statutory testing methods combined with exploratory studies were used to test the samples, and the quality status of compound α-ketoacid tablets was evaluated by statistical analysis of the results. Results: According to the statutory tests, the qualified rate of 140 batches of samples was 100%. The exploratory research showed that compound α-ketoacid tablets were sensitive to humidity, as the calcium ketophenylalanine was easy to be oxidized and degrade into phenylacetic acid. Under the condition of high humidity or strong light, the content of phenylacetic acid increased significantly in the mixture of all ten APIs. All selected products met the requirement of the improved standard draft. Conclusion:At present, the overall quality of compound α-ketoacid tablets is good and the current statutory standard should be further improved. It is recommended that relevant manufactures avoid using high hygroscopic pharmaceutical excipients, and pay attention to the sealing of packing material and the necessity of separate granulation for two categories of APIs.