噬菌体药物开发及质控研究进展
Progress in Development and Quality Control of Bacteriophage Drugs
杨蓉 1赵晨 1李端华 1饶峻 1王辂1
作者信息
摘要
噬菌体治疗作为抗生素治疗细菌感染的替代方法之一,近年来受到越来越多科学家们的关注,该法主要用于针对由耐药菌及多重耐药菌(Multi-drug resistant,MDR)引起的公共卫生安全问题.如今,噬菌体在农业和兽医治疗方面及其在西方国家用于人类治疗方面越来越受到重视,过去几十年西方世界进行了许多临床试验和治疗探索,并且国外某些授权药店正在销售人用噬菌体药物.但噬菌体用于人类治疗时仍然存在一些问题,如噬菌体的高度特异性限制了其应用范围和噬菌体制剂管理法规不完善使得其不能进行规模化生产等.本文结合我国现行药典关于生物制品生产、制备及质量控制要求和欧洲药品管理局(The European Medicines Agency,EMA)近年来以噬菌体治疗药物批准途径的探索为参照,着重对噬菌体库构建与控制、噬菌体制备与质控和临床前测试等进行分析.
Abstract
As one of the alternative methods of antibiotic treatment for bacteria infection,bacteriophage therapy has gotten more and more attention in recent years.It mainly aims at the problems to public health caused by the emergence and spread of drug-resistant bacteria and multi-drug-resistant bacteria(MDR).In the West,bacterial phages are becoming more and more common in both human medicine and animal husbandry.In the past few decades,many clinical trials and treatments have been carried out in the Western world,and some authorized pharmacies abroad have been selling human phage drugs.However,the problem of using bacteriophages in human treatment still exists,such as the high specificity of bacteriophages limiting its application scope and the imperfect management regulations of bacteriophage preparations making it impossible to carry out large-scale production.Based on the specifications of China's existing pharmacopeia for biological product quality control,and the investigation into the EMA's recent approval of bacteriophage therapy medications,this review focuses on the analysis of phage library construction and control,phage preparation and quality control,and preclinical testing.
关键词
噬菌体库/细菌/抗生素/制剂/制备工艺Key words
bacteriophage bank/bacteria/antibiotic/preparation/preparation process引用本文复制引用
基金项目
四川省科技厅国际合作项目(2021YFH0016)
广东省重点领域研发计划项目(2022B1111050003)
出版年
2024
NETL
NSTL
万方数据