人血白蛋白内包装材料相容性研究

Material compatibility of human albumin

目的考察国药集团兰州生物制药有限公司人血白蛋白与其内包装材料的相容性。方法采用4种提取溶剂对1批内包装材料(中硼硅玻璃模制注射剂瓶和注射液用卤化丁基橡胶塞)进行提取试验,对内包装潜在的浸出物进行毒理学评估。通过模拟加速试验,对样品中的元素进行趋势分析以及玻璃瓶内表面观察;并测定长期稳定性试验过程药物常规检查项目。结果内包装材料浸出元素检出结果均≤50%的限值,有机物安全阈值(margin of safety,MOS)均>1.0,表明浸出元素及有机物在当前的暴露量下均不会对使用者有安全风险。模拟加速试验结果表明药品在长期稳定性条件放置一段时间后不会有脱片风险,长期稳定性试验药物常规检查项目均符合药典要求。结论内包材对药品质量无明显影响,总体相容性良好,可用于人血白蛋白的包装。

Objective To investigate the compatibility of human albumin and its internal packaging materials of Sinopharm Lanzhou Biopharmaceutical Co.,Ltd.Methods One batch of inner packaging materials(medium borosilicate glassmolded injection bottle and halogenated butyl rubber plug for injection)was extracted with 4 extraction solvents to conduct the toxicological evaluation of potential inner packaging extracts.Through the simulated acceleration test,the trend analysis of the elements in the sample and the inner surface of the glass bottle were observed,and the routine drug inspection items during the long-term stability test process were determined.Results The detection results of the leaching elements of the internal packaging materials did not exceed the limit of 50%,and the organic matter safety threshold(margin of safety,MOS)was greater than 1.0,indicating that both the leaching elements and the organic matter had no safety risk to the user under the current exposure.The results of the simulated acceleration test show that the drug will not have the risk of peeling tablets after the long-term stability condition was placed for a period of time,and the routine inspection items of the long-term stability test drugs all meet the requirements of the pharmacopoeia.Conclusion The inner packaging material has no significant impact on the quality of drugs and has good overall compatibility,making it suitable for packaging human albumin.