论文部分内容阅读
注射剂中渗透压摩尔浓度的控制是药品质量控制的重要指标。近年来,随着对疫苗类生物制品渗透压摩尔浓度研究的深入,《中国药典》三部(2015版)中增加渗透压摩尔浓度为疫苗的质控项目,其标准由各生产企业根据各自的生产工艺制定符合要求的限度范围,并经批准后执行~([1])。本文通过测定多批次腮腺炎减毒活疫苗渗透压摩尔浓度~([2]),确定其限度标准,为制定腮腺炎减毒活疫苗的质量标准提供依据。
The control of osmolality in injection is an important indicator of quality control of medicines. In recent years, along with the research on the osmotic pressure molar concentration of vaccine biological products, the osmolality is increased as the quality control item of vaccines in the three parts of “Chinese Pharmacopoeia” (2015 edition). The standards are controlled by each manufacturer according to their respective Production process to develop to meet the requirements of the scope and approval after the implementation of ~ ([1]). In this paper, by measuring the molar concentration of multi-dose mumps live attenuated vaccine osmolality ([2]), to determine the limits for the development of live attenuated mumps vaccine quality standards provide the basis.