橡胶密封件水分测定方法制订与解析  

Formulation and Interpretation of Determination Method of Water in Rubber Closures

作　　者：江燕 王晓兰 冯霞兰 张小春 兰婉玲 陈蕾[2] JIANG Yan;WANG Xiaolan;FENG Xialan;ZHANG Xiaochun;LAN Wanling;CHEN Lei(Sichuan Institute for Drug Control(Sichuan Testing Center for Medical Devices),Chengdu 611731,China;Chinese Pharmacopoeia Commission,Beijing 100061,China)

机构地区：[1]四川省药品检验研究院(四川省医疗器械检测中心),成都611731 [2]国家药典委员会,北京100061

出　　处：《医药导报》2024年第11期1765-1768,共4页Herald of Medicine

摘　　要：目的制订解析《中华人民共和国药典》系列药包材标准之橡胶密封件水分测定方法。方法阐述橡胶密封件水分测定方法的制订过程,分析该标准的重点内容,对烘干法、卡氏干燥炉-库仑滴定法水分含量测定结果进行比较。结果多批胶塞样品水分含量测定结果,烘干法普遍高于卡氏干燥炉-库仑滴定法。后者专属性强,准确度高,更能反映橡胶密封件真实的水分含量。结论企业可根据其产品预期用途及日常检测需求等,从橡胶密封件水分含量测定两种方法中选择适用方法。Objective To establish methods for detection of water in rubber closures as one of the Chinese Pharmacopoeia series of standards for pharmaceutical packaging material.Methods The formulation process of determination of water in rubber closures was explained,the key contents of the standard were analyzed,and the determination results of water content by oven-drying method and Karl Fischer drying furnace-coulometric titration method were compared.Results The determination results of water content in multiple batches of rubber stopper samples by over-drying method were generally higher than that by Karl Fischer drying oven-Coulometric titration method.The latter method is highly specific and accurate,and can better reflect the true water content of rubber closures.Conclusion Two methods for determining water content in rubber closures have been developed.Enterprises can choose the appropriate method based on the intended use of their products and daily testing needs.

关 键 词：橡胶密封件 水分 烘干法 卡氏干燥炉-库仑滴定法 

分 类 号：R95[医药卫生—药学] R921