聚乳酸-羟基乙酸共聚物关键质量属性的分析技术研究进展  

Research Progress on Analytical Techniques for Critical Quality Attri⁃butes of Poly(lactic-co-glycolic acid)

作　　者：王保成 陈振 李月茹 高正松 WANG Baocheng;CHEN Zhen;LI Yueru;GAO Zhengsong(Nanjing Well Pharmaceutical Group Co.Ltd,Nanjing 210042,China)

机构地区：[1]南京威尔药业集团股份有限公司,南京210042

出　　处：《药学与临床研究》2025年第1期4-8,共5页Pharmaceutical and Clinical Research

基　　金：2023年度江苏省工业和信息产业转型升级专项资金项目。

摘　　要：聚乳酸-羟基乙酸共聚物(PLGA)是一种重要的生物可降解高分子材料,广泛应用于药物递送、组织工程和医疗器械等领域。PLGA独特的分子结构、降解行为和药物释放特性使其成为长期药物递送系统的理想选择。尽管PLGA已获美国食品药品监督管理局(FDA)批准用于创新药配方,但PLGA仿制药产品的研制仍面临巨大挑战,这主要源于对PLGA关键质量属性缺乏全面理解以及有效质量控制手段的缺失。为应对这些问题,FDA启动了专项研究,以推动PLGA结构表征技术的发展。本文综述了PLGA关键质量属性分析技术的进展,内容涵盖相对分子量及分布、分子结构、形态学特征、热性能与结晶行为等方面,旨在为PLGA的质量控制和仿制药一致性评价提供理论支持,推动PLGA在生物医学领域的精准设计与应用。Poly(lactic-co-glycolic acid)(PLGA)is an important biodegradable polymer widely used in drug delivery,tissue engineering and medical devices.Its unique molecular structure,degradation behavior and drug release characteristics make it an ideal choice for long-term drug delivery systems.While PLGA has been approved by the FDA for new drug formulations,the development of generic versions still faces significant challenges,primarily due to the lack of a comprehensive understanding of its critical quality attributes and effective quality control methods.To address these challenges,the FDA has initiated special-ized research projects to advance the development of PLGA structural characterization techniques.This article reviews recent technological advancements in the analysis of PLGA on its critical quality attributes,including relative molecular weight distribution,molecular structure,morphological characteristics,thermal properties and crystallization behavior.These advancements provide crucial theoretical support for the qual-ity control and consistency evaluation of PLGA generic drugs,facilitating precise design and application of PLGA in biomedical fields.

关 键 词：聚乳酸-羟基乙酸共聚物 药物递送系统 关键质量属性 生物医学 结构表征技术 

分 类 号：R917[医药卫生—药物分析学]