液体制剂生产过程中药物含量控制的常见问题分析  

Analysis on Common Problems of Drug Concentration Control in Production of Liquid Preparation

作　　者：殷雪芹 张真庆[1] 

机构地区：[1]苏州大学药学院,江苏苏州215000

出　　处：《抗感染药学》2015年第6期807-809,共3页Anti-infection Pharmacy

摘　　要：液体制剂如大输液、针剂、液体喷剂和口服液等,被广泛用于治疗多种疾病。其成分含量的准确性对于治疗有效与否甚至对患者的生命安全至关重要。在药品生产实践过程中,由于液体制剂的成分含量单位和工艺过程控制单位的不同,以及工艺过程中温度的变化,溶液混合过程中各组分的量总是困扰着工程师和操作人员。以某一实际工艺生产为例,运用溶液混合的基本原理,对不同的产品浓度要求下,溶液配制工艺中的组份在不同单位与温度下进行了计算。此计算与讨论理清了一些易混淆的概念,为制定配制工艺中各组份的质量控制标准提供参考。Liquid dosages such as large and small parenteral injections, liquid spray and oral liquids are widely used for treating various diseases. One of liquid dosages＇ key parameters, the components＇ concentrations, is essential for their effectiveness, even crucial for patients＇ health and lives, The differences between the labeling concentrations and processing control quantities, and the effect of temperature on liquid volumes, usually cause confusions among process engineers and operators. To obtain accurate components＇ concentrations of medical dosages, the present work applies fundamentals of mixing process, computing the quantities of components by different control methods. The calculation can provide reference for clarifying the contusions for medical process engineers and operators when determining the components＇ quantities of medical products.

关 键 词：液体制剂 溶液配制工艺 溶液温度 

分 类 号：R927.2[医药卫生—药学]