胶塞硅油在输液制剂中的迁移研究

Migration of Silicone Oil from Rubber Plug to Infusion Preparation

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。

The migration of silicone oil from rubber plug to the infusion preparation was carried out by using simulated water-based infusion preparation(WIP)sealed with different silicification level rubber plugs and different types of dimethyl silicone oil.The bottles were placed upside down and under the temperature of 60℃to accelerate the migration of silicone oil.The results showed that the amount of silicone oil in WIP was affected by the silicification level of rubber plug and silicone oil type.When the silicification level of rubber plug was higher,the residual amount of silicone oil was higher,more insoluble particles in WIP was detected,and more silicone oil deposition on the bottle wall was observed.The silicone oil with low viscosity migrated more severely.Pharmaceutical companies should pay attention to the residual silicone oil on the surface of rubber plug and its migration in infusion preparations,and select appropriate rubber plug according to drug properties.