丁基胶塞在注射剂领域中的选用策略

Application and Selection Strategy of Butyl Rubber Stopper in Injections

目的:为制药企业选择合格的丁基胶塞提供指导。方法:简要介绍丁基胶塞的生产工艺、分类及特性,分析了普遍存在的丁基胶塞与药品的相容性问题,针对丁基胶塞的选择提出建议。结果与结论:丁基胶塞可能引起吸附、浸出物及微粒污染等相容性问题,制药企业应了解胶塞的工艺及特点,结合药物自身的特性,选择合适的胶塞。

Objective： To provide guidance for pharmaceutical enterprises to choose qualified butyl rubber stoppers. Methods： The production process, classification and characteristic of butyl rubber stoppers were briefly introduced. The main problems relevant to the compatibility between drugs and butyl rubber stoppers were analyzed and suggestions on the selection of butyl rubber stoppers were put forward. Results and Conclusion： Butyl rubber stoppers might cause problems including adsorption, extraction and particle contamination. Pharmaceutical enterprises should investigate the production process and characteristics of butyl rubber stoppers, and take into account the characteristics of drug, so as to choose the suitable butyl rubber stoppers.