卤化丁基胶塞对注射用西咪替丁与注射用多索茶碱澄清度的影响研究  

Effect of halogenated butyl rubber stoppers on the clarity in cimetidine for injection and doxofylline for injection

作　　者：付蒙 周姝 袁怡 陈晓莉 朱胜节 胡敏 FU Meng;ZHOU Shu;YUAN Yi;CHEN Xiao-li;ZHU Sheng-jie;HU Min(Hubei Institute for Drug Control,Hubei Engineering Research Center for Drug Quality Control,Wuhan 430075,China;Hubei Renmin Pharmaceutical Co.Ltd.,Wuhan 430030,China)

机构地区：[1]湖北省药品监督检验研究院,湖北省药品质量检测与控制工程技术研究中心,武汉430075 [2]湖北人民制药有限公司,武汉430030

出　　处：《药物分析杂志》2020年第8期1459-1466,共8页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:研究卤化丁基胶塞对注射用西咪替丁与注射用多索茶碱澄清度的影响。方法:采用气质联用技术,对药品及所用胶塞的可挥发性物质进行测定,并分析胶塞与软化剂的二氯甲烷提取物信息。结果:饱和烷烃类化合物是影响澄清度的主要因素,其来源于胶塞配方中的软化剂。结论:此次研究可为这2种药物选择合适的胶塞以及相容性实验提供有效的实验数据。Objective:To investigate the effect of halogenated butyl rubber stoppers on the clarity in cimetidine for injection and doxofylline for injection. Methods:By using GC-MS,the volatile substances in the drug and halogenated butyl rubber stoppers were determined,and the dichloromethane extracts of the stoppers and softener were also analyzed. Results:Saturated alkanes were the main factor affecting the clarity,which come from the softener in the stopper formula. Conclusion:This study could provide effective experimental data for the selection of appropriate stoppers and compatibility test.

关 键 词：卤化丁基胶塞 注射用西咪替丁 注射用多索茶碱 澄清度 饱和烷烃 

分 类 号：R917[医药卫生—药物分析学]