Objective This study evaluated the current quality status and existing problems with domestic ampicillin capsules.Methods According to the overall requirements of the national drug sampling plan,the sample of ampicillin capsules was tested using statutory methods combined with exploratory research.The quality status of this product was analyzed by examining impurity profiles,dissolution,dissolution curve,the impact of raw materials on the quality of the products and the impact of packaging materials on the quality of the preparation.Results A total of 103 batches of samples were tested according to the specifications,and all of them complied with regulations.Compared with the results obtained in 2016,the product quality of ampicillin capsules was generally stable.Exploratory research had confirmed the sources and structures of various impurities in the products.There was no significant difference between the results of the HPLC test and those of the standard test after excluding the interference of the capsule shell.The dissolution curves of samples from different manufacturers were significantly different.The quality of the raw materials affected the quality of the products.The impurity changes of ampicillin capsules with different packages varied significantly under the same storage conditions.Conclusion The quality of ampicillin capsules was generally good,and the current specifications needed to be further improved.It was recommended to revise the dissolution determination method to the HPLC method to eliminate the interference from the capsule shell.It was also recommended that enterprises carry out a consistent evaluation of the quality and efficacy of generic drugs,choose better-quality raw materials,choose aluminum foil-plastic-aluminum foil packaging with a better moisture-proof effect,or add a moisture-proof bag to the aluminum-plastic blister.
万方数据
维普
