注射液中不溶性微粒国家标准变革和微粒防控技术

摘要

本文综述了中国药典关于注射液不溶性微粒的标准变革,并与国外药典进行了比较,针对国家标准越来越严格的趋势,论述了注射液生产过程中有关空气净化、洁净压缩空气制备及物料密闭输送等微粒防控技术;深入探讨论述了聚丙烯新型塑料包装注射液有关输液瓶环一体化、一步法制瓶(袋)、洗灌封三合一和高温灭菌新技术以及全密闭吹灌封(BFS)三合一聚丙烯塑料安瓿高新技术产品.%The article reviews the national standard reformation for insoluble microparticle in injections in Chinese Pharmacopoeia,and compare it with foreign Pharmacopoeia. In view of the increasingly strict trend of the national standards, the article expounds the preventive and control technique about microparticles including airpurification, clean compressed air preparation and material airtight transportation,moreover,which investigates deeply the new high temperature sterilization techniques in new type polypropylene plastic package injections preparation including infusion bottle and ring integration, one-step making bottle or bag,triad for washing,filling and encapsulating,high temperature sterilization and all airtight blow molding,filling and sealing (BFS) triad polypropylene plastic ampoule preparation.