国家药包材标准2015年版卤化丁基橡胶密封件红外鉴别修订建议

Revision proposals for the infrared identification method of pharmaceutical halogenated butyl rubber seals in National Standards for Drug Packaging Materials 2015

目的:对《国家药包材标准》2015年版中卤化丁基橡胶密封件标准红外光谱鉴别提出修订建议,为科学完善药包材标准提供参考。方法:研究《国家药包材标准》2015年版中卤化丁基橡胶密封件标准红外光谱鉴别试验采用衰减全反射法在实际检验部分样品中存在的问题,参照热裂解法及改进方法提出修订建议。结果:对《国家药包材标准》2015年版中卤化丁基橡胶密封件红外光谱鉴别项目提出修订意见和建议。结论:修订后卤化丁基橡胶密封件标准红外鉴别项目叙述更加全面、合理。

Objective:Revision for the infrared identification method of pharmaceutical halogenated butyl rubber seals in National Standards for Drug Packaging Materials 2015 was proposed to provide a reference for the scientific improvement of the method in the future.Methods:The problems occurred in the examination of the infrared identification method of pharmaceutical halogenated butyl rubber seals using attenuated total reflection method in National Standards for Drug Packaging Materials 2015 was investigated,and revision was proposed with reference to the pyrolysis transmission method and its improved method.Results:The revision suggestions on the infrared identification method of pharmaceutical halogenated butyl rubber seals were proposed.Conclusion:The description of the infrared identification method of pharmaceutical halogenated butyl rubber seals is more comprehensive and reasonable.