%0 Journal Article
%T 胶塞硅油在输液制剂中的迁移研究
%A 付蒙
%A 周姝
%A 袁怡
%A 陈晓莉
%J -
%D 2020
%R 10.12136/j.issn.1000-890X.2020.8.0632
%X 通过不同硅化级别胶塞包装的注射用水制剂和不同型号硅油（二甲基硅油）的模拟注射液，进行注射剂瓶倒置的60 ℃高温加速试验，研究胶塞硅油在输液制剂中的迁移情况。结果表明：注射用水制剂中的硅油量受胶塞硅化级别和硅油型号的影响；胶塞硅化级别越高，硅油残留量越大，注射用水制剂中不溶性微粒越多，硅油挂壁现象越明显；粘度低的硅油更容易迁移。药企应关注胶塞表面的硅油残留量及其在输液制剂中的迁移性，根据药性选择合适的胶塞。;Objective To investigate the influence factors of silicone gel plug oil in infusion preparation. Methods Water for injection preparations with different silicification grades were prepared and accelerated at high temperature to investigate the wall hanging phenomenon, insoluble particles, residues and migration of silicone oil in different silicification grades, and the migration of silicone oil in simulated injection preparations with different types of silicone oil. Results The silicone oil in infusion preparation was affected by the silicification grade and the type of silicone oil. The higher the grade of silica gel plug, the higher the residual amount of silica oil, the more the number of particles in the solution, and the more obvious the wall hanging phenomenon. Migration is more likely with low Through the water for injection preparations（WIP） packed with different silicified rubber plugs and simulated injection with different types of silicone oil（dimethylsilicone oil），the work that the injection bottles were inverted and tests were accelerated at 60 ℃ high temperature to study the migration of silicone oil in the injection preparation was carried out.The results showed that the amount of silicone oil in WIP was affected by the silicification level and silicone oil type of rubber plug.The higher the silicification level of rubber plug was，the greater the residual amount of silicone oil was，the more insoluble particles in WIP was，the more obvious the wall hanging phenomenon of silicone oil was，and the silicone oil with low viscosity was easier to migrate.Pharmaceutical companies should pay attention to the residual silicone oil on the surface of rubber plug and its migration in infusion preparations，and select the appropriate rubber plug according to the drug properties
%K [胶塞
%K 硅化
%K 硅油
%K 输液制剂
%K 迁移
%K 胶塞
%K 硅化
%K 硅油
%K 输液制剂
%K 迁移
%K infusion preparation
%K rubber stopper
%K silicone oil
%K influencing factors]
%U http://www.rubbertire.cn/gy/xjgy/ch/reader/view_abstract.aspx?file_no=XJ2019-0229&flag=1