粉针无菌分装过程中影响粉针剂质量的因素探究  

Exploration of factors affecting the quality of powder injections during aseptic packaging process

作　　者：朱琳 ZHU Lin(North Best Branch Factory of North China Pharmaceutical Co.,Ltd.,Shijiazhuang Hebei,050015,China)

机构地区：[1]华北制药股份有限公司北元分厂,河北石家庄050015

出　　处：《质量安全与检验检测》2025年第2期33-36,共4页QUALITY SAFETY INSPECTION AND TESTING

摘　　要：粉针剂是指将供注射用的无菌药物粉末分装至安瓿瓶或西林瓶中,临用前注入对应溶剂溶解或混悬后用于注射的针剂。此类药物的稳定性较差,一般是在无菌环境中制备,因此对无菌操作有极为苛刻的要求。避免药物污染不仅可以保证药物在施用过程中能够发挥最大药效,最重要的是能够避免对被施用患者的身体健康造成进一步的损害。在粉针无菌分装过程中存在诸多不稳定的因素能够对粉针剂质量造成影响,这些因素主要包括尘埃粒子、微生物、包装材料、压差、空气温度和相对湿度等。因此,本文针对上述因素进行了讨论,旨在能够引起业界的重视并为完善粉针的制备流程和操作规范提供参考。Powder injection refers to the injection of sterile drug powder which is filled into ampoules or penicillin bottles for injection.Before use,it should be dissolved or suspended in the corresponding solvent and then used for injection.The stability of such drugs is poor,and they are generally prepared in a sterile environment,so there are extremely strict requirements for sterile operations.Avoiding drug contamination not only ensures that drugs can exert their maximum efficacy during administration,but most importantly,it can prevent further damage to the health of the patients being administered.There are many unstable factors in the aseptic packaging process of powder injections that can affect the quality of powder injections,including dust particles,microorganisms,packaging materials,pressure difference,air temperature,relative humidity.Therefore,this article discusses the aforementioned instability factors,aiming to draw industry attention and provide reference for improving the preparation process and operating standards of powder injections.

关 键 词：粉针剂 无菌分装 影响因素 

分 类 号：TQ460.6[化学工程—制药化工]