长效注射剂体外释药检查方法研究进展  

Current approaches for in vitro drug release study of long-acting injectable formulations

作　　者：王静文[1] 文强 彭玉帅 赵文[1] 尹利辉[1] WANG Jing-wen;WEN Qiang;PENG Yu-shuai;ZHAO Wen;YIN Li-hui(National Institutes for Food and Drug Control,National Medical Products Administration Key Laboratory for Quality Research and Evaluation of Chemical Drugs,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院国家食品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：《药物分析杂志》2024年第11期1842-1851,共10页Chinese Journal of Pharmaceutical Analysis

基　　金：中国食品药品检定研究院中青年发展研究基金项目(2023A3)。

摘　　要：目的:长效注射剂在治疗慢性疾病方面具有优势,由于长效注射剂的多样性,现有药典方法和监管指南尚未提供针对长效注射剂的体外释药检查方法,这增加了这些制剂的研发和审批时间。本文回顾了用于研究长效注射剂体外释放度的检查方法,包括药典方法和非药典方法,如流通池法、取样分离法、透析法等,并讨论了这些方法的优缺点,以期为开发长效注射剂体外释药检查方法提供参考,缩短长效注射剂的研发周期。Long-acting injectable formulations are preferred over conventional formulations for the treatment of chronic diseases.The regulatory guidelines and pharmacopoeia have remained silent on dissolution methods for long-acting injectable formulations due to their diverse nature.The lack of compendial method for dissolution testing increases the duration of approval process for long-acting injectable formulations.This article reviews various dissolution methods used to study in vitro drug release profile of long-acting injectable formulations.Compendial as well as noncompendial methods,such as-flow-through cell method,sample and separate method,the dialysis method are used by researchers for drug release profile of long-acting injectable formulations.This review article also highlights the advantages and disadvantages of reported dissolution methods.The compiled work will help the researchers in designing the bio-relevant dissolution method and expedite the development of long-acting injectable formulations.

关 键 词：长效注射剂 释放度检查方法 流通池法 取样分离法 透析法 体外释放模型 

分 类 号：R917[医药卫生—药物分析学]