青霉胺片的质量评价  

Quality evaluation of penicillamine tablets

作　　者：李倚天 李茜[1] 王立萍[1] 杨博涵[1] 王晨[2] 刘英[1] Li Yi-tian;Li Qian;Wang Li-ping;Yang Bo-han;Wang Chen;Liu Ying(Henan Food and Drug Inspection Institute,Zhengzhou 450018;State Food and drug administration,Beijing 102629)

机构地区：[1]河南省食品药品检验所,郑州450018 [2]中国食品药品检定研究院,北京102629

出　　处：《中国抗生素杂志》2021年第3期244-250,共7页Chinese Journal of Antibiotics

摘　　要：目的对国产青霉胺片的质量现状进行评价。方法对从调研企业收集到的样品和国家计划抽查的31批的样品进行法定标准检验与探究性研究,分析制剂的质量状况及质量标准合理性。结果所有批次的青霉胺片经过法定验检测显示全部合格,有4个批次的样品经过探究性实验显示有关物质较高,分析原因为企业工艺所致;溶出度批间和批内产品溶出行为差异较大,分析原因为包衣不均匀。针对标准中缺少有关物质和溶出度检查项,建立了青霉胺有关物质及溶出度测定方法,进一步控制药品的质量。结论青霉胺片质量总体一般。建议改进处方生产技术,提高药物的溶出度。建议将有关物质和溶出度的检查项目增订入质量保准,以确保标准的可控性和用药的安全性和有效性。Objective To evaluate the quality status of domestic penicillamine tablets.Methods 31 batches of samples from national drug plan and scientific research institutions were tested and investigated by combining statutory standard test with exploratory research.The quality status of preparations and the rationality of quality standard were analyzed.Results The qualified rate of all batches of tablets was 100%.The exploratory research showed that the related substances of the 4 batches were too high,the results may be caused by the production process;the dissolving behaviors of productions showed significantly differences in and between batches,analysis of the causes showed that the coating of domestic penicillamine tablets were uneven.In view of the lack of related substances and dissolution methods in the legal standard,methods for measuring penicillamine tablets related substances and dissolution were established to further control the quality of drugs.Conclusion According to the current research and conclusion,the quality of the tablets was moderate.Suggestions for interested companies should investigate and optimize prescription manufacturing process to improve the drug dissolution.It is suggested that the relevant substances and dissolution test should be added in the current standard to ensure the controllability of the standard and the safety and effectiveness of drug use.

关 键 词：青霉胺片 质量评估 相关物质 溶出行为 

分 类 号：R917[医药卫生—药物分析学]