摘要
目的 探索环烯烃聚合物(COP)包材应用于人血白蛋白制品包装的可行性.方法 使用COP瓶分装储存人血白蛋白制品,在长期稳定性(2～8℃,24个月)和加速稳定性[(25±2)℃,12个月]试验条件下,分析制品的关键质量指标和包材的浸出物指标,并检测COP包材的密封完整性.结果 在两种试验条件下,制品的外观、可见异物、不溶性微粒、pH、纯度、多聚体、铝残留量、蛋白含量、激肽释放酶原激活剂和毒性指标都在质量标准范围内,符合药典要求.制品中,COP包材可能产生的浸出物钼、镍、甲苯、环己烷的含量均低于质量标准限值.COP瓶与卤化丁基橡胶塞、铝塑组合盖组装的人血白蛋白包装容器具有良好的密封完整性.结论 初步试验表明COP可应用于人血白蛋白的储存和运输.
Abstract
OBJECTIVE To explore the feasibility of using cyclic olefin polymer(COP)as packaging material for human albu-min products.METHODS Human albumin products were stored in COP bottles.Under the conditions of long-term stability(2-8 ℃ for 24 months)and accelerated stability[(25±2)℃ for 12 months],the key quality indexes of albumin and the probable extracts of COP material were analyzed,and the seal integrity of COP packages was tested.RESULTS Under both test conditions,the appearance,visible foreign matter,numbers of insoluble particles,pH,purity,polymer content,residual aluminum content,pro-tein content,activity of prekallikrein activator and abnormal toxicity of the albumin products all conformed to the quality standards and met the requirements of Chinese Pharmacopoeia.In the products,the contents of molybdenum,nickel,methylbenzene,and cyclohex-ane that may be produced by COP bottles were all lower than the quality standard limits.Moreover,the human albumin packaging con-tainer assembled by COP bottle,halogenated butyl rubber plug and aluminum-plastic combination cap showed excellent package integri-ty.CONCLUSION COP can be used in the storage and transport of human albumin.
基金项目
甘肃省青年科技基金计划资助(21JR7RA322)
兰州交通大学大学生创新创业训练计划项目资助(DC2410732CX0326)
NETL
NSTL
万方数据