溶菌酶口服制剂质量分析及关键质控技术研究  

Quality Analysis and Key Quality Control Techniques of Lysozyme Oral Preparations

作　　者：刘莉莎[1] 何东妹 李京[1] 张斗胜[1] 贺兰英 董欣 邓利娟[1] 王悦[1] 刘博[1] 范慧红[1] LIU Lisha;HE Dongmei;LI Jing;ZHANG Dousheng;HE Lanying;DONG Xin;DENG Lijuan;WANG Yue;LIU Bo;FAN Huihong(NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs,National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,国家药品监督管理局化学药品质量研究与评价重点实验室,北京102629

出　　处：《中国药学杂志》2024年第19期1853-1860,共8页Chinese Pharmaceutical Journal

摘　　要：目的对溶菌酶口服制剂的质量现状进行检验分析,并针对现行标准中的共性问题开展关键质控技术研究,为药品监管提供技术支持。方法通过国家药品抽检的方式获取的28批溶菌酶含片和47批溶菌酶肠溶片采用现行法定标准进行检验,并针对质量现状建立了多项分析方法进行探索性研究。结果按照法定标准检验,75批溶菌酶口服制剂合格率为100%,但发现法定标准存在效价测定方法误差较大,缺少溶出度、含量均匀度等关键质控项目的问题。通过开展相关方法的研究,发现效价测定结果与法定检验结果差异较大;溶出度研究结果部分肠溶片不易溶出;含量均匀度研究结果部分大规格肠溶片不符合规定。结论作为传统生物提取类生化药品种,上市时间较早,部分质量标准已不能控制产品现状,随着药品监管日趋严格,企业应优化生产工艺,完善并提高质量标准。OBJECTIVE To investigate and analyze the quality status of lysozyme oral preparations,and study the key quality control technologies for common problems in current standards,so as to provide technical support for drug supervision.METHODS The 28 batches of lysozyme lozenges and 47 batches of lysozyme enteric-coated tablets obtained by medicine post market quality surveillance were tested according to the current legal standards,and several analytical methods were established for exploratory research.RESULTS According to the legal standard test,although the qualified rate of 75 batches of lysozyme oral preparations was 100%,it was still found that there were problems in the legal standard such as the potency determination has significant errors and lacks key quality control items such as dissolution and content uniformity.The results of exploratory study on potency differed greatly from those of statutory test,the results of dissolution study showed that some enteric-coated tablets were not easy to dissolve,and the results of content uniformity study showed that some large size enteric-coated tablets did not meet the requirements.CONCLUSION As a traditional biological extraction type of biochemical drugs,lysozyme oral preparations are marketed early,so some quality standards can no longer reflect the current situation of the products.The enterprises should optimize the production processes and improve current standards.

关 键 词：溶菌酶 国家药品抽检 探索性研究 质量标准 

分 类 号：R917[医药卫生—药物分析学]