人血白蛋白注射剂与环烯烃聚合物包装材料的相容性及包装完整性研究

Compatibility and Packaging Integrity between Human Albumin Injection and Container of Cyclic Olefin Polymer

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。

OBJECTIVE To explore the feasibility of using cyclic olefin polymer(COP)as packaging material for human albumin 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,protein 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 cyclohexane that may be produced by COP bottles were all lower than the quality standard limits.Moreover,the human albumin packaging container assembled by COP bottle,halogenated butyl rubber plug and aluminum-plastic combination cap showed excellent package integrity.CONCLUSION COP can be used in the storage and transport of human albumin.