药用卤化丁基胶塞相容性研究

Research on the Compatibility of Medical Grade Halogenated Butyl Rubber Stopper

目的采用不同浸提溶剂对两种类型的药用卤化丁基胶塞进行浸提,对其相容性进行研究,为卤化丁基胶塞使用安全性提供支持。方法参考YBB00042005《注射液用卤化丁基胶塞》、YBB00142002《药品包装材料与药物相容性试验指导原则》、EMEA:《GUIDELINE ON PLASTIC IMMEDIATE PACKAGING MATERIALS》、FDA:《Container Closure Systems for Packaging Human Drug and Biologics》、FDA:《Stability Testing of Drug Substances and Drug Products》、PDA:《Technical Report No.5,Sterile Pharmaceutical Packaging:Compatibility and Stability》、《中国药典》2010年版、《欧洲药典》第7版、USP〈381〉。结果与结论两种卤化丁基胶塞浸提试验结果较好,相容性结果可接受,为制药企业选择卤化丁基胶塞提供参考。

OBJECTIVE To provide safety guidance on the use of two kinds of medical grade Halogenated butyl rubber stopper through the extraction of two kinds of Halogenated butyl rubber stopper for medicine with various ex- traction solvent. METHODS Studies is based on YBB00042005《Halogenated butyl rubber stopper for injection》, YBB00142002《Guiding principles of drug packaging materials and drug compatibility test》, EMEA： 《GUIDELINE ON PLASTIC IMMEDIATE PACKAGING MATERIALS》, FDA： 《Container Closure Systems for Packaging Human Drug and Biologics》, FDA： 《 Stability Testing of Drug Substances and Drug Products》, PDA： 《 Technical Report No. 5, Sterile Pharmaceutical Packaging：Compatibility and Stability》, the Pharmacopoeia of the People＇s Republic of China （2010 ed. ）,the European Pharmacopoeia （7thed. section） and USP 〈 381 〉. RESULTS and CONCLU- SION The results showed that the Halogenated butyl rubber stopper for medicine had good compatibility, suggesting that the Halogenated butyl rubber stopper can be safely used by pharmaceutical enterprises.