文章摘要
陈宇堃,陈倩茹,邓锋,梁蔚阳.人血白蛋白中铝离子含量稳定性试验结果的探讨[J].中国药品标准,2019,(4):332-338
人血白蛋白中铝离子含量稳定性试验结果的探讨
Study on the Stability Test Results of Aluminum Content in Human Albumin
投稿时间:2019-01-02  修订日期:2019-06-27
DOI:
中文关键词: 人血白蛋白  质量控制  铝离子含量  原子吸收分光光度法  稳定性试验  
英文关键词: human albumin  quality control  aluminumcontent  atomic absorptionspectrometry  stability test  
基金项目:广东省医学科学技术研究基金项目(B2018130、B2018220)
作者单位E-mail
陈宇堃 广东省药品检验所广东省食品药品监督管理局血液制品质量控制与风险监测重点实验室 bettycyk@163.com 
陈倩茹 广东省药品检验所广东省食品药品监督管理局血液制品质量控制与风险监测重点实验室  
邓锋 广东省药品检验所广东省食品药品监督管理局血液制品质量控制与风险监测重点实验室  
梁蔚阳 广东省药品检验所广东省食品药品监督管理局血液制品质量控制与风险监测重点实验室 wl-1023@163.com 
摘要点击次数: 42
全文下载次数: 61
中文摘要:
      摘要:目的:考察人血白蛋白铝离子含量的稳定性。方法:根据抽样原则,选取生产时间在2013年至2017年之间的158批人血白蛋白样品(4家国内生产企业共90批次,6家进口企业共68批次),按《中国药典》2015年版通则3208人血白蛋白铝残留量测定法,分别测定样品在批签发发行时(储存时间<8个月)与有效期内(储存时间为9个月至有效期内)的铝离子含量。并对其中29批次样品(4家国内生产企业共17批次,6家进口企业共12批次)进行加速稳定性试验(温度为30℃)。结果:29批次的国产人血白蛋白有效期内的铝离子含量超过200μg?L-1。国产人血白蛋白铝离子含量与储存时间呈高度相关,进口人血白蛋白铝离子含量与储存时间呈低度相关;人血白蛋白铝离子含量与加速稳定性试验(温度为30℃)放置时间无相关性。结论:长期稳定性试验结果表明本品在有效期内铝离子含量均呈上升趋势;加速稳定性试验结果表明,在温度为30℃的保存条件下,本品铝离子含量无明显变化。
英文摘要:
      ABSTRACT: OBJECTIVE Study on the stability tests of aluminium content in human albumin. METHODS: According to the sampling principle, selected 158 batches of human albumin samples (90 batches from 4 domestic manufacturers and 68 batches from 6 imported manufacturers) produced from 2013 to 2017. The samples were determined the aluminum contents in the initial and validity period, according to the atomic absorption spectrophotometry method for the determination of aluminum content in general rule 3208 of Chinese Pharmacopoeia 2015. The accelerated stability tests were carried out on 29 batches of samples (17 batches from 4 domestic manufacturers and 12 batches from 6 imported manufacturers). Samples were placed in an artificial climate chamber with the temperature of 30℃ for 0、1、3 months, and then determined. RESULTS: There were 29 batchs of samples having aluminum content over 200μg?L-1 in validity period. Aluminum contents of domestic human albumin was highly correlated with storage time, and aluminum contents of imported human albumin was lowly correlated with storage time. There was no correlation between the content of aluminium in human albumin and the storage time of accelerated stability test with the temperature of 30℃. CONCLUSION: The results of long-term stability test show that the contents of aluminium in human albumin increased during validity period. There was no correlation between the aluminum content and the time of accelerated stability test with the temperature of 30℃.
  查看/发表评论  下载PDF阅读器
关闭