首批人血白蛋白国家参考品的研制

发布时间：2018-04-21 01:24

  本文选题：国家参考品 + 人血白蛋白　； 参考：《中国药学杂志》2017年06期

【摘要】：目的制备首批人血白蛋白国家参考品,用于人血白蛋白产品放行、批签发或注册检验等质量控制工作。方法选择经检验合格的人血白蛋白产品作为原料进行合并、除菌、分装。制备后按照2015年版《中国药典》三部人血白蛋白各论初步选定7个检验项目,包括:蛋白质含量(凯式定氮)、辛酸钠含量测定、多聚体含量、pH测定、吸光度测定、钠离子含量、铝离子含量,在11家实验室进行协作标定,同时进行稳定性监测。结果依据11家实验室协作标定结果确立该批国家参考品的参考值范围分别为:蛋白质含量(193.30±5.08)g·L~(-1);辛酸钠含量(0.162 4±0.009 2)mmol·g(Pro)~(-1);多聚体含量(2.72±0.29)%(HPLC-SEC);pH值(6.71±0.08)[测定温度(22±3)℃];吸光度(0.030±0.005);钠离子含量(134.9±23.6)mmol·L~(-1);铝离子含量协作标定范围为(88.4±30.5)μg·L~(-1),但铝离子含量项目在稳定性监测过程中出现明显上升趋势,因此该项目不纳入参考品最终发布的标定项目。结论该批人血白蛋白参考品符合相关要求,可以作为国家参考品发放。有利于人血白蛋白产品的质量控制。
[Abstract]:Objective to prepare the first batch of human serum albumin (HSA) reference material for quality control, such as release, batch issuance or registration inspection. Methods the qualified human serum albumin product was selected as raw material to be combined, sterilized and partitioned. After preparation, according to the 2015 edition of the Chinese Pharmacopoeia, seven tests were preliminarily selected for each of the three parts of human serum albumin, including: protein content, sodium octanoate content, pH determination, absorbance determination, sodium ion content, Aluminum ion content was calibrated in 11 laboratories and stability monitoring was carried out at the same time. Results according to the calibration results of 11 laboratories, the reference ranges of the national reference materials were determined as follows: protein content was 193.30 卤5.08g / L ~ (-1), sodium octanoate was 0.162 4 卤0.009 2)mmol / g ~ (-1) ~ (-1), pH value of HPLC-SECU was 6.71 卤0.08) [determination temperature was 22 卤3 鈩僝, sodium ion content was 0.030 卤5 ~ (-1) 鈩，

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