人血白蛋白批签发留样铝离子含量检验结果讨论与监管思考  

Information Statistics and Discussion on the Results of Aluminumion Content Determination of Retention Samples of Human Albumin

作　　者：王敏力[1] 肖林[1] 梁蔚阳[2] 邵泓[3] 周长明[4] 郭江红 田洪斌 王叔桥 谢楠 侯继锋[1] 

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 [2]广东省药品检验所,广州510180 [3]上海市食品药品检验所,上海201203 [4]北京市药品检验所,北京102206 [5]湖北省食品药品监督检验研究院,武汉430075 [6]吉林省药品检验所,长春130033 [7]四川省食品药品检验检测院,成都611731 [8]甘肃省药品检验研究院,兰州730000

出　　处：《中国药学杂志》2018年第2期145-153,共9页Chinese Pharmaceutical Journal

摘　　要：目的抽样测定国产及进口人血白蛋白批签发留样的铝离子含量,评价其有效期末的含量水平。方法统计调查2017年国产及进口人血白蛋白批准文号及进口注册情况、批准储藏条件、批签发铝含量检测值等信息,由中国食品药品检定研究院联合全国7个血液制品批签发授权药检机构,对药检机构留样或企业临近效期留样抽查,按2015年版《中国药典》四部原子吸收法或经验证的电感耦合等离子体质谱(以下简称ICP-MS)法测定留样铝离子含量。结果国内共28家血液制品生产企业,共有158个人血白蛋白批准文号(日常在生产的文号40个,2017),批准保存条件为"常温"的共21家企业,"冷藏"的共7家;本次共抽检到国内25家企业的185批次人血白蛋白留样,其批签发放行时铝离子含量总体均值为61μg·L^(-1)(Min 8μg·L^(-1),Max 134μg·L^(-1)),此次留样检测铝离子含量总体均值为137μg·L^(-1)(Min 20μg·L^(-1),Max 487μg·L^(-1)),整体均值升高约1倍。留样抽检中铝离子含量超过200μg·L^(-1)的共33批次,占比17.8%(33/185)。进口人血白蛋白企业共13家(常规进口规格共17个,2017),批准的保存条件均为"常温",本次共抽查到11家进口企业的78批次人血白蛋白留样,其批签发放行时铝离子含量总体均值为27μg·L^(-1)(Min 7μg·L^(-1),Max 60μg·L^(-1)),留样的铝离子含量总体均值为50μg·L^(-1)(Min 1μg·L^(-1),Max 175μg·L^(-1)),总体均值升高约1倍,与国产人血白蛋白情况一致,但这两项指标均低于国产人血白蛋白。进口人血白蛋白留样中铝离子含量超过200μg·L^(-1)批次数为0%(0/78)。结论部分批次的国产人血白蛋白有效期末的铝离子含量超过200μg·L^(-1),进口人血白蛋白铝离子含量初始值及有效期末值低于国产人血白蛋白。OBJECTIVE To evaluate the quality of human albumin products, and determine the content of aluminumion in the upcoming expired human albumin samples of both domestic and imported products for batch release. METHODS Statistics was car- tied out for domestic and imported human albumin products in 2017 about the approved registration, import approval number, storage conditions, aluminumion content of batch release and other information. Aluminumion contents of the samples were detected by Nation- al Institutes for Food and Drug Control which banded with 7 authorized agencies for batch release of blood products according to the a- tomic absorption spectrometry or verified inductively coupled plasma mass spectrometry （ICP-MS）method for the determination of alu- minumion content in China Pharmacopoeia 2015. RESULTS There were a total of 28 domestic manufacturers of blood products and 158 human albumin drug approval numbers （ totally 40 for daily production, 2017）, among which 21 were approved for the storage con- dition of ＂room temperature＂ and 7 for ＂refrigerate＂. A total of 185 batches of human albumin samples from 25 domestic manufacturers were sampled. The mean aluminumion content in the batch release reports was 61 μg · L-1 （8 - 134 μg · L-1 ） ,while that in the sam- ples of the upcoming expired products was 137μg · L-1 （20 -487 μg · L-1 ）. The mean aluminumion content increased by about 1time after the storage period. There were about 17, 8% （33/185）samples having aluminumion content over 200 μg ·L-1. There were a total of 13 manufacturers of imported human albumin with a total of 17 import specifications in 2017. The approved storage condition was all ＂room temperature＂. A total of 78 batches of human albumin products for batch release from 11 import enterprises were sam- pled. The mean aluminumion content in the batch release reports was 27μg · L- 1 （7 - 60 μg · L- 1 ） , while that in the samples of the upcoming expired products was 50 μg ·L-1 （ 1 - 175 μg

关 键 词：人血白蛋白 质量控制 铝离子含量 血液制品 

分 类 号：R917[医药卫生—药物分析学]