离子色谱法测定A型肉毒毒素及其胶塞中的氟  

Determination of Fluoride in Botulinum Toxin Type A and Its Rubber Stopper by Ion Chromatography

作　　者：叶婷 陈立宏 王璇 田向斌 赵成梅 冯靖喻 李小娟 YE Ting;CHEN Li-hong;WANG Xuan;TIAN Xiang-bin;ZHAO Cheng-mei;FENG Jing-yu;LI Xiao-juan(Lanzhou Biotechnology Development Co.,Ltd.,Gansu Lanzhou 730046;Gansu Institute for Drug Control,Gansu Lanzhou 730070,China)

机构地区：[1]兰州生物技术开发有限公司,甘肃兰州730046 [2]甘肃省药品检验研究院,甘肃兰州730070

出　　处：《广州化工》2023年第2期140-142,153,共4页GuangZhou Chemical Industry

摘　　要：建立了离子色谱法测定注射用A型肉毒毒素与其覆聚乙烯-四氟乙烯膜氯化丁基橡胶塞中的氟离子。此方法线性范围为25~400 ng·mL^(-1),r为0.9994,检测限为0.1 ng·mL^(-1),定量限>0.3 ng·mL^(-1),胶塞浸提液中氟离子回收率为83%~88%,RSD为2.4%,注射用A型肉毒毒素中氟离子回收率为88%~104%,RSD为5.9%。本文所建方法简单可行,且胶塞中迁移出的氟离子远小于注射用A型肉毒毒素中含有的氟离子,表明此胶塞有望作为注射用A型肉毒毒素的内包材。An ion chromatography method for detecting the fluoride ion in botulinum toxin type A for injection and its coated polyethylene-tetrafluoroethene chlorinated butyl rubber stopper was established.The method showed that there was a good linearity when the measured range from 25 to 400 ng·mL^(-1).The correlation coefficients r was 0.9994.The limit of detection was 0.1 ng·mL^(-1).The limit of quantitation was less than 0.3 ng·mL^(-1).The recoveries of fluoride ion in the extract of coated polyethylene-tetrafluoroethylene chlorinated butyl rubber stopper was 83%~88%.RSD value was 2.4%.The recoveries of fluoride ion in botulinum toxin type A for injection was 88%~104%.RSD value was 5.9%.The method was simple and feasible.The migration of fluoride ion from coated polyethylene-tetrafluoroethene chlorinated butyl rubber stopper was much less than the content of fluoride ion from botulinum toxin type A for injection,which indicated that the rubber stopper was expected to be used for botulinum toxin type A for injection as inboard material.

关 键 词：氟离子 覆聚乙烯-四氟乙烯膜氯化丁基橡胶塞 注射用A型肉毒毒素 

分 类 号：R927.11[医药卫生—药学]