| Migration of Silicone Oil from Rubber Plug to Infusion Preparation |
| Received:July 20, 2019 Revised:July 20, 2019 |
| DOI：10.12136/j.issn.1000-890X.2020.8.0632 |
| Key Words: rubber plug；silicification；silicone oil；infusion preparation；migration |
| Author Name | Affiliation | E-mail | | YUAN Yi* | Hubei Institute for Drug Control/Hubei Engineering Research Center for Drug Quality Control | 49368474@qq.com | | CHEN Xiaoli | Hubei Institute for Drug Control/Hubei Engineering Research Center for Drug Quality Control | | | FU Meng | Hubei Institute for Drug Control/Hubei Engineering Research Center for Drug Quality Control | | | ZHOU Shu | Hubei Institute for Drug Control/Hubei Engineering Research Center for Drug Quality Control | |
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| Abstract: |
| 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. |
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