摘要
目的依托国家药品抽检工作,系统评估药用辅料丙交酯乙交酯共聚物(PLGA)的质量现状,明确影响其质量的关键因素,为完善质量标准和监管策略提供科学依据。方法采用法定标准对抽检的12批次样品进行检验,结合文献分析和企业生产工艺调研数据,开展质量特性与降解行为关联性研究。结果法定检验结果显示样品合格率为100.0%(除特性黏数和水分项外)。探索性研究揭示:PLGA分子链中乙交酯嵌段长度增加、乙醇酸/乳酸单体残留量升高,或暴露于热、高湿及偏酸/碱性环境时,可加速聚合物链断裂,导致重均分子量显著下降及药物突释现象。结论目前PLGA总体质量较好,质量标准有待提高,建议企业关注包装、贮存和运输的温湿度条件。
Objective Based on the sampling test of national drugs,the quality of Poly(lactide-co-glycolide)(PLGA)was systematically evaluated,and the crucial factors of its quality were clarified to provide scientific basis for improving quality standards and regulatory strategies.Methods Twelve batches of samples were tested by using ChP2020.The exploratory studies on the correlation between quality characteristics and degradation behavior were conducted based on the results of the legal tests,literature review,and research results.Results According to the statutory the inspection results,the sample qualification rate was 100%except for the intrinsic viscosity and water.The exploratory studies have shown that an increase in the length of ethyl ester block in the PLGA molecular chain,an increase in the residual amount of glycolic acid/lactic acid monomers,or exposure to heat,high humidity,and acidic/alkaline environments can accelerate polymer chain breakage,leading to a significant decrease in weight-average molecular weight and drug burst release.Conclusions The overall quality of the PLGA is good.The quality standards need to be improved.It is recommended that companies should pay attention to the temperature and humidity conditions for packaging,storage,and transportation.
作者
赵恂
张晓艳
周小华
朱林
赵浩东
芮美琪
陈蕾
袁耀佐
施海蔚
ZHAO Xun;ZHANG Xiaoyan;ZHOU Xiaohua;ZHU Lin;ZHAO Haodong;RUI Meiqi;CHEN Lei;YUAN Yaozuo;SHI Haiwei(Jiangsu Institute for Drug Control,Nanjing 210019,China;China Pharmaceutical University,Nanjing 210024,China;Chinese Pharmacopoeia Commission,State Key Laboratory of Drug Regulatory Science,Beijing 100061,China)
出处
《医药导报》
北大核心
2026年第2期230-237,共8页
Herald of Medicine
基金
2024年国家药品抽检计划项目
江苏省药品监督管理局科技计划项目(202320)
江苏省市场监督管理局科技计划项目(KJ2024050)。
关键词
丙交酯乙交酯共聚物
关键质量属性
特性黏数
玻璃化转变温度
降解规律
Poly(lactide-co-glycolide)
Crucial quality factors
Intrinsic viscosity
Glass transition temperature
Degradation rule
