人血白蛋白中枸橼酸离子测定与铝离子含量影响因素分析  

Determination of Citrate ion Content and Analysis of Related Factors of Aluminum Content in Human Albumin Products

作　　者：王敏力[1] 肖林[1] 赵卉[1] 侯继锋[1] WANG Min-li;XIAO Lin;ZHAO Hui;HOU Ji-feng(Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing 100050, China)

机构地区：[1]中国食品药品检定研究院,卫生部生物技术产品检定方法及标准化重点实验室,北京100050

出　　处：《中国药学杂志》2018年第5期379-382,共4页Chinese Pharmaceutical Journal

摘　　要：目的对目前进口及国产人血白蛋白中的枸橼酸离子含量进行测定,考察其残留情况并分析铝离子含量相关影响因素。方法选择65批人血白蛋白产品(围货架期末),其中国产人血白蛋白54批,进口人血白蛋白11批,按照酶反应法测定枸橼酸离子含量,按照原子吸收法测定铝离子含量;统计人血白蛋白生产制备信息,例如透析时间、玻璃瓶来源、样品保存条件、铝含量初始值等,并分析其与围货架期末铝离子含量的相关性。结果 65批人血白蛋白枸橼酸离子残留量整体均值为24μmol·L^(-1)(ρMin0μmol·L^(-1),ρMax144μmol·L^(-1)),54批国产人血白蛋白枸橼酸离子残留量均值为24μmol·L^(-1),11批进口人血白蛋白枸橼酸离子残留量均值为23μmol·L^(-1)。枸橼酸离子残留量与围货架期末铝离子含量值总体相关系数r为0.315 5(国产样品两者r为0.331 8,进口样品r为0.746 6);储存时间与围货架期末的铝离子含量值总体相关系数r为0.102 6(国产样品两者r为0.059 3,进口样品r为-0.037 4)。54批国产样品的铝含量初始值与围货架期末铝含量值相关系数r为0.325 5;超滤工序时间与围货架期末铝含量值相关系数r为0.011 8;超滤工序时间与枸橼酸离子残留量相关系数r为-0.108 2。结论人血白蛋白枸橼酸离子残留量均低于150μmol·L^(-1),枸橼酸离子残留量与围货架期末铝离子含量呈低度相关,但进口人血白蛋白两者相关性高于国产样品;铝含量初始值与围货架期末铝含量值呈现低度相关;超滤时间、储存时间与围货架期末铝离子含量相关度微弱。OBJECTIVE To determine the citrate ion and aluminum contents in human albumin products and investigate the related factors of aluminum content. METHODS Sixty-five batches of human albumin products which were very close to the end of shelf life or would be expired within not more than 2 m, including 54 batches of imported ones and 11 batches of domestic ones, were analyzed. The content of citrate ion was determined using the enzyme reaction method, and aluminum content was determined using the atomic absorption method. Factors related to human albumin production, such as ultrafiltration time, glass bottles, sample storage conditions, and the ini- tial value of aluminum content were investigated and analyzed, especially the relationship with the aluminum content at the end of the shelf life. RESULTS The overall mean content of citrate ion in 65 batches of human albumin was 24 μmol· L^-1 （0 -144 μmol· L^-1 ）, the mean content of citrate ion in 54 batches of domestic human albumin was 24 μmol· L^-1 , and that in 11 batches of imported human albumin was 23 μmol· L^-1. The linear correlation coefficients between final aluminum content and citrate ion content of 65 bat- ches of human albumin, 54 batches of domestic human albumin and 11 imported human albumin were 0. 315 5, 0. 331 8 and 0. 746 6, re- spectively. The linear correlation coefficients between the final aluminum content and storage time of 65 batches of human albumin, 54 batches of domestic human albumin and 11 imported human albumin were 0. 102 6, 0. 059 3 and -0. 037 4, respectively. The linear cor- relation coefficient between the final and initial aluminum contents of 54 batches of domestic human albumin was 0. 325 5. The linear cor- relation coefficients between final aluminum content and uhrafihration process time, citrate ions and ultrafihration process time of 54 bat- ches of domestic human albumin were 0. 011 8 and -0. 108 2, respectively. CONCLUSION Citrate ion content in human albumin re- tention samples are lower than 150 p^mol ~ L-1.

关 键 词：人血白蛋白 枸橼酸离子含量 铝离子含量 质量控制 血液制品 

分 类 号：R917[医药卫生—药物分析学]