重组人血白蛋白蛋白质含量RS20国家标准品的研制

Development of national protein content standard RS20 for recombinant human albumin

目的制备重组人血白蛋白蛋白质含量RS20国家标准品,用于重组人血白蛋白产品的质量控制。方法以重组人血白蛋白为原料,经灭菌注射用水稀释、除菌过滤后,进行分装、冻干,制备重组人血白蛋白蛋白质含量RS20国家标准品。8家实验室采用凯氏定氮法进行协作标定,并检测标准品的分装误差、水分含量、均匀性及稳定性。结果8家实验室测定本批标准品蛋白质含量实验室间均值为19.05 mg/mL,95%置信区间为18.80~19.31 mg/mL,均值标准差为0.3087 mg/mL,标准误为0.1091 mg/mL,相对标准偏差(RSD)为1.62%。标准品分装过程前、中、后段随机抽取6支样品,分装误差为-0.07%~0.08%,均在±0.1%以内;3支标准品样品的水分含量分别为1.44%、2.43%、2.25%,均<3.0%;5支标准品样品的装量差异为-0.5%~0.5%,均在±1%以内;标准品于-20℃保存2~14个月时蛋白质含量为18.09~18.88 mg/mL,于-20、4、23、32℃保存6个月时蛋白质含量为18.35~18.82 mg/mL,两者变化均较小。结论制备的重组人血白蛋白蛋白质含量RS20国家标准品符合相关规定,规定代码为:280030-201901,可用于重组人血白蛋白产品的相关质量控制。

Objective To develop a national protein content standard RS20 for quality control of recombinant human albumin.Methods The recombinant human albumin product selected as raw material was diluted with sterilized water for injection,sterilized by filtration,filled and lyophilized.The prepared national protein content standard RS20 for recombinant human albumin was collaboratively calibrated by Kjeldahl method in eight laboratories,determined for filling error and moisture content,and evaluated for homogeneity and stability.Results The mean protein content of the standard determined in eight laboratories was 19.05 mg/mL,with a 95%CI of 18.80~19.31 mg/mL,a mean standard deviation of 0.3087 mg/mL,a standard error of 0.1091 mg/mL,and a relative standard deviation(RSD)of 1.62%.The filling errors of six containers of standards taken at early,moderate and late stage of filling process separately were-0.07%~0.08%,all of which were within±0.1%.The moisture contents in three containers of standard were 1.44%,2.43%and 2.25%respectively,all of which were less than 3.0%.The filling deviations of five containers of standard were-0.5%~0.5%,all of which were within±1%.The protein contents of the standard after storage at-20℃for 2~14 months were 18.09~18.88 mg/mL,while those at-20,4,23 and 32℃for 6 months were 18.35~18.82 mg/mL,both of which showed no significant change.Conclusion The national protein content standard RS20 for recombinant human albumin,with a specified code of 280030-201901,met the relevant requirements,which might be used for the quality control of recombinant human albumin.