中国药业2016，Vol.25Issue(17)：25-28,4.
聚醚砜滤芯对舒血宁注射液生产质量的影响
Influence of PES Filter Cartridge on the Production Quality of Shuxuening Injection
摘要
Abstract
Objective To study the influence of PES filter cartridge on the production quality of Shuxuening Injection. Methods The filter cartridge before and after filtration was conducted integrity test, SEM analysis, dissolution analysis, non volatile residue determination, and the content of total flavonoids and fingerprint of Shuxuening liquid were determined. Results and Conclusion The PES filter of bubble point and electron micrographs showed no significant difference before and after filtration, Soluble substances that may enter the Shuxuening Injection were polyvinylpyrrolidone, caprolactam and polyethylene glycol, but they can be ignored when the process was enlarged to industrial size, the NVR of 10 inch PES filter cartridge did not exceed 0. 161 0 g. There was no significant effect on total flavonoids and fingerprint of Shuxuening Injection in the filtering process. PES filter has no significant effect on the production quality of Shuxuening Injection.关键词
聚醚砜滤芯/舒血宁注射液/溶出物/影响Key words
PES filter cartridge/Shuxuening Injection/soluble substance/influence分类
化学化工引用本文复制引用
周晓雨,孙胜斌,陈翔宇,张岩岩,姜国志,陈钟..聚醚砜滤芯对舒血宁注射液生产质量的影响[J].中国药业,2016,25(17):25-28,4.基金项目
国家重大新药创制专项，项目编号2014ZX09201022-004。 （）
