人血白蛋白中不溶性微粒的检测及制品质量考察趋势分析

目的: 考察目前市售国内外人血白蛋白制品中不溶性微粒的含量情况并与自检结果进行对比。 方法: 随机抽取来自国内外企业的规格为200 g·L^-1,每瓶50 mL的人血白蛋白共53批,以GWF-8JA型微粒检测仪按2010年版中国药典三部附录第一法光阻法对抽检样品进行不溶性微粒质量考察。每批供试品取1瓶,分别检测供试品中≥10 μm和≥25 μm 2个通道的微粒总数,将所得结果与自检数据进行趋势比对,并将2个粒径通道所测得的结果按微粒数的多少分成A、B、C、D、E 5个级别并计算符合各个级别的人血白蛋白的批次数。 结果: 53批人血白蛋白全部符合2010年版中国药典三部的相关规定,抽验的人血白蛋白样品中有80%以上的制品的不溶性微粒结果能够达到A级水平,各批次的检验结果与企业自检结果具有一致性。 结论: 随机抽样结果表明80%以上的人血白蛋白不溶性微粒结果远低于国家相关标准规定,制品质量控制良好,实验室间结果趋势一致。

Objective: To determine the insoluble particles in human albumin from domestic and overseas manufacturers and the results were compared between NIFDC and the manufacturers. Methods: 53 batches of human albumin from domestic and foreign enterprises were tested by random sampling and all the sample specification were 200 g·L^-1,50 mL per bottle.All the batches were tested with light obscuration particle count test method published on appendix of 2010 edition CHP by GWF-8JA laser particle size analyzers.One bottle from each batch of human albumin sample was tested and insoluble particles that were greater than 10 μm and greater than 25 μm were counted.Trend analysis and comparison of the results from NIFDC and enterprises and were done.Batches of human albumin conform to A,B,C,D,E grade were counted according to the insoluble particles quantity greater than 10 μm and greater than 25 μm. Results: Insoluble particles results of all the 53 batches of human albumin comply with requirements in 2010 ChP and the results are in agreement between NIFDC and enterprises.Greater than 80% of human albumin samples match A rank. Conclusion: Results indicates similar trend between laboratories and over 80% of human albumin samples can match A rank which is far lower than relevant national standard and the quality control of human albumin shows fine.

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[5] USP.NF32.2009.310
[6] BP.2010.A338
[7] EP.6.0.2008.300
[8] ChP(中国药典).2010.Vol Ⅲ(三部).Appendix(附录) ⅤⅠ
[9] ChP(中国药典).2010.Vol Ⅲ(三部):212