基于国家药品抽检的对乙酰氨基酚片质量评价OA

Objective To evaluate the quality of paracetamol tablets based on national drug sampling tests,to analyze existing quality problems,and to provide references and suggestions for the production,quality control,and supervision of this pro-duction.Methods Two hundred and eighty-nine batches of paracetamol tablet samples were spot checked.Through statutory specifications and exploratory research,the causes of unqualified samples,in vitro dissolution profiles,antioxygen thiourea,scored-tablets,and related substances were studied and evaluated.Results The qualification rate of samples according to the statutory specification was 99.7%,which was higher than that in previous national drug sampling tests.One batch product that passed the consistency evaluation was found to be abnormal in dissolution.The exploratory study results indicated that 5 manufacturers pro-ducts suspected of failing the consistency evaluation.of unauthorized thiourea addition and not producing according to the approved prescription process.The results of the in vitro dissolution profiles indicated that the quality of the products have passed the consis-tency evaluation is superior to that of the products have not passed the consistency evaluation.Conclusions The overall quality status of the products have passed the consistency evaluation is superior to that of the products have not passed the consistency evaluation,the consistency evaluation of generic drugs could promote the quality improvement of paracetamol tablets.The manufac-turers should strictly adhere to the approved prescription and production processes,strengthen precisely control over key manufac-turing parameters,and enhance their emphasis on the consistency evaluation of generic drugs.