关键词: font-size:medium, ">复方α-酮酸片；评价性抽验；质量研究；药品标准

Abstract: 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.

Key words: font-size:medium, ">Compound α-ketoacid tablets； Evaluation sampling； Quality research； Specification