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

王敏力, 肖林, 梁蔚阳, 邵泓, 周长明, 郭江红, 田洪斌, 王叔桥, 谢楠, 侯继锋

中国药学杂志 ›› 2018, Vol. 53 ›› Issue (2) : 145-153.

PDF(1105 KB)
PDF(1105 KB)
中国药学杂志 ›› 2018, Vol. 53 ›› Issue (2) : 145-153. DOI: 10.11669/cpj.2018.02.014
资源与鉴定

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

  • 王敏力1, 肖林1, 梁蔚阳2, 邵泓3, 周长明4, 郭江红5, 田洪斌6, 王叔桥7, 谢楠8, 侯继锋1*
作者信息 +

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

  • WANG Min-li1,XIAO Lin1,LIANG Wei-yang2, SHAO Hong3, ZHOU Chang-ming4, GUO Jiang-hong5, TIAN Hong-bin6, WANG Shu-qiao7, XIE Nan8, HOU Ji-feng1*
Author information +
文章历史 +

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61 μg·L-1(Min 8 μg·L-1,Max 134 μg·L-1),此次留样检测铝离子含量总体均值为137 μg·L-1(Min 20 μg·L-1,Max 487 μg·L-1),整体均值升高约1倍。留样抽检中铝离子含量超过200 μg·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27 μg·L-1(Min 7 μg·L-1,Max 60 μg·L-1),留样的铝离子含量总体均值为50 μg·L-1(Min 1 μg·L-1,Max 175 μg·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200 μg·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200 μg·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。

Abstract

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 carried 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 National Institutes for Food and Drug Control which banded with 7 authorized agencies for batch release of blood products according to the atomic absorption spectrometry or verified inductively coupled plasma mass spectrometry (ICP-MS)method for the determination of aluminumion 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 condition 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 samples of the upcoming expired products was 137 μg·L-1(20-487 μg·L-1). The mean aluminumion content increased by about 1 time 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 sampled. The mean aluminumion content in the batch release reports was 27 μg·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·L-1). The overall mean increased about 1 time after the storage period, which was consistent with the domestic human albumin products. But the two parameters of the imported products were both lower than the domestic ones. None (0/78)of the samples having aluminumion content over 200 μg·L-1. CONCLUSION The aluminumion contents of some batches of upcoming expired domestic human albumin products are over 200 μg·L-1. The overall aluminumion contents in the initial batch release and the upcoming expired products in the import albumin products are lower than the domestic ones.

关键词

人血白蛋白 / 质量控制 / 铝离子含量 / 血液制品

Key words

human albumin / quality control / aluminumion content / blood product

引用本文

导出引用
王敏力, 肖林, 梁蔚阳, 邵泓, 周长明, 郭江红, 田洪斌, 王叔桥, 谢楠, 侯继锋. 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[J]. 中国药学杂志, 2018, 53(2): 145-153 https://doi.org/10.11669/cpj.2018.02.014
WANG Min-li,XIAO Lin,LIANG Wei-yang, SHAO Hong, ZHOU Chang-ming, GUO Jiang-hong, TIAN Hong-bin, WANG Shu-qiao, XIE Nan, HOU Ji-feng. Information Statistics and Discussion on the Results of Aluminumion Content Determination of Retention Samples of Human Albumin[J]. Chinese Pharmaceutical Journal, 2018, 53(2): 145-153 https://doi.org/10.11669/cpj.2018.02.014
中图分类号: R917   

参考文献

[1] Ch. P(2015)Vol Ⅳ(中国药典2015年版.四部)[S]. 2015: 240-241.
[2] Ch.P(2015) Vol Ⅲ(中国药典2015年版.三部)[S]. 2015: 244-246.
[3] MENDITTO A, SARDELLI R, LANZIERI G, et al. Time-dependent increase of aluminium in human albumin solutions: the role of initial citrate content[J]. Vox Sang, 2001,80(2):121-121.
PDF(1105 KB)

Accesses

Citation

Detail

段落导航
相关文章

/