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蛋白及多肽类药物长效化制剂学技术研究进展
引用本文:丁源, 陈新, 涂家生, 孙春萌. 蛋白及多肽类药物长效化制剂学技术研究进展[J]. 中国药科大学学报, 2020, 51(4): 433-440. DOI: 10.11665/j.issn.1000-5048.20200407
作者姓名:丁源  陈新  涂家生  孙春萌
作者单位:1.中国药科大学药用辅料及仿创药物研发评价中心,南京 210009;2.国家药品监督管理局药品审评中心,北京 100022
基金项目:国家自然科学基金资助项目(No.81972894, 81673364);国家药典委员会“药品医疗器械审评审批制度改革专项课题”(No.ZG2017-5-03);国家科技“重大新药创制”专项课题(No.2017ZX09101001006)
摘    要:
蛋白及多肽类药物近年来越来越多地应用到疾病的预防、诊断和治疗之中,然而,蛋白及多肽类药物通常需要注射给药且缺乏长效剂型,给需要长期用药的慢性病患者带来困扰。本文综述了通过制剂学手段对蛋白及多肽类药物进行长效化改造的策略,包括缓释注射剂、植入剂、口服制剂以及经皮给药系统,并总结其缓释机制、研究进展和优缺点,以期为此类药物的剂型改良提供研究思路及理论参考。

关 键 词:蛋白及多肽类药物  长效化  缓控释  剂型改良  进展
收稿时间:2019-11-09
修稿时间:2020-08-04

Progress in technology of long-acting preparations of protein and peptide drugs
DING Yuan, CHEN Xin, TU Jiasheng, SUN Chunmeng. Progress in technology of long-acting preparations of protein and peptide drugs[J]. Journal of China Pharmaceutical University, 2020, 51(4): 433-440. DOI: 10.11665/j.issn.1000-5048.20200407
Authors:DING Yuan  CHEN Xin  TU Jiasheng  SUN Chunmeng
Affiliation:1.Center for Research, Development and Evaluation for Pharmaceutical Excipients and Generic Drugs, China Pharmaceutical University, Nanjing 210009;2.Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
Abstract:
As one of the most important biological drugs, protein and peptide drugs have been increasingly used in the prevention, diagnosis and treatment of diseases in recent years. However, most of them need to be injected and lack of long-acting formulations, which brings many troubles to patients suffering from chronic diseases. In this review, we summarized the strategies for engineering long-acting formulations for proteins and peptides via preparation means, including extended-release injection, implant, oral preparations and transdermal drug delivery systems, and analyzed their release mechanisms, research advances, advantages and shortcomings, thereby providing potential approaches for promoting the formulation improvement of these drugs.
Keywords:protein and peptide drugs  long-acting performance  extended-release and controlled-release  formulation improvement  advances
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