国产肠溶片抽检不合格信息统计及质量风险浅析  

Statistics of non-conformance information and quality risk analysis of domestic enteric coated tablets in sampling inspection

作　　者：吴艳琳 王姗姗 乔戈 聂小春 WU Yanlin;WANG Shanshan;QIAO Ge;NIE Xiaochun(Wuhan Institute for Drug and Medical Device Control,Wuhan 430075,China)

机构地区：[1]武汉药品医疗器械检验所,武汉430075

出　　处：《药学前沿》2025年第4期582-587,共6页China Pharmacist

摘　　要：目的通过汇总武汉药品医疗器械检验所在日常监督抽检中发现的市售双氯芬酸钠肠溶片溶出度异常结果,分析我国肠溶片质量现状。方法通过系统收集和梳理肠溶片不合格记录中产品名称、不合格项目、生产企业、抽样所在地、批号及年份等信息,进行文献检索、归类与原因分析。结果本次统计的54个品种肠溶片中,有15个品种存在124批次不合格记录,其中的10个品种共78批次溶出度项目不合格。结论肠溶片溶出度项目不合格与肠溶衣材料、包衣工艺、产品贮藏条件等存在密切联系,可通过改进包衣材料、优化工艺参数、加强日常监督抽检等措施,提高肠溶片质量。Objective To summarize the abnormal results of dissolution degree of commercially available diclofenac sodium enteric-coated tablets found in the daily supervision and sampling test of Wuhan Institute for Drug and Medical Device Control,and analysis the quality status of enteric coated tablets in China.systematically analyze the reasons for its occurrence,assess its quality risks,provide risk warnings,and provide reference for improving the quality of such preparations and ensuring clinical drug safety.Methods The product name,unqualified items,manufacturer,sampling location,batch number and year in the unqualified records of enteric-coated tablets were systematically collected and sorted,and the literature search,classification and causal analysis were conducted.Results Among the 54 enteric-coated tablets,there were 124 batches of unqualified records for 15 varieties,of which 10 varieties had a total of 78 batches of unqualified dissolution projects.Conclusion The unqualified dissolution of enteric-coated tablets is closely related to the enteric-coating materials,coating process,product storage conditions,etc.The quality of enteric-coated tablets can be improved by improving the coating materials,optimizing the process parameters,and strengthening the daily supervision and sampling.

关 键 词：药品抽检 肠溶片 溶出度 监管 

分 类 号：TQ460.72[医药卫生—药物分析学]