预灌封注射器橡胶活塞表面硅油提取及向甲氨蝶呤注射液中迁移的研究  

Study on Extraction of Silicone Oil from Rubber Plunger Surface of Prefilled Syringe and Its Migration into Methotrexate Injection

作　　者：陈超 王丹丹 程磊 CHEN Chao;WANG Dandan;CHENG Lei(Zhejiang Institute for Food and Drug Control,Key Laboratory of Drug Contacting Materials Quality Control of Zhejiang Provincial,National Medical Products Administration Key Laboratory for Core Technology of Generic Drug Evaluation,Hangzhou 310051,China)

机构地区：[1]浙江省食品药品检验研究院,浙江省药品接触材料质量控制研究重点实验室,国家药品监督管理局仿制药评价关键技术重点实验室,杭州310051

出　　处：《中国现代应用药学》2022年第9期1187-1191,共5页Chinese Journal of Modern Applied Pharmacy

基　　金：浙江省药品监管系统科技计划项目(2022017)。

摘　　要：目的 研究预灌封注射器的橡胶活塞表面硅油的使用量,以及硅油在甲氨蝶呤注射液中的迁移量。方法 采用傅里叶变换红外光谱法测定预灌封注射器中溴化丁基橡胶活塞表面的硅油含量,并采用电感耦合等离子体质谱法测定甲氨蝶呤注射液中的硅油迁移量。结果 活塞表面的硅油含量为每个0.191 mg,0.5,0.2,0.15 mL规格甲氨蝶呤注射液的最大迁移量分别为2.65,1.26,1.04μg。结论 傅里叶变换红外光谱法和电感耦合等离子体质谱法能分别快速测定橡胶活塞表面的硅油量和硅油在制剂中的迁移量。OBJECTIVE To study the amount of silicone oil used on the surface of rubber plunger of prefilled syringe and the migration of silicone oil into methotrexate injection.METHODS The content of silicone oil on the surface of brominated butyl rubber plunger in pre potted syringe was determined by Fourier transform infrared spectroscopy,the migration amount of silicone oil in methotrexate injection was determined by inductively coupled plasma mass spectrometry.RESULTS The content of silicone oil on the surface of plunger was each 0.191 mg,the maximum migration amounts of 0.5,0.2,0.15 mL methotrexate injection were 2.65,1.26,1.04 μg,respectively.CONCLUSION Fourier transform infrared spectroscopy and inductively coupled plasma mass spectrometry can be used to determine the amount of silicone oil on the surface of rubber plunger and the migration of silicone oil into the preparation.

关 键 词：预灌封注射器 橡胶活塞 硅油 傅里叶变换红外光谱法 电感耦合等离子体质谱法 甲氨蝶呤注射液 

分 类 号：R927.11[医药卫生—药学]