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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≥10μm和≥25μm 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 investigate the content of insoluble particles in human serum albumin products at home and abroad at present and to compare with the results of self-test. Methods: A total of 53 batches of human serum albumin with a volume of 200 gL-1 and a volume of 50 mL were randomly selected from domestic and foreign enterprises. The first method of the Chinese Pharmacopoeia (2010 Edition) was adopted by GWF-8JA particle detector Law sample sampling for insoluble particle quality inspection. Each batch of test samples taken 1 bottle, respectively, for the test sample ≥ 10μm and ≥ 25μm 2 channels the total number of particles, the results obtained with the self-test data trend comparison, and the two particle size channels measured The results were divided into five levels A, B, C, D and E according to the number of particles and the number of batches of human serum albumin corresponding to each level was calculated. Results: All the 53 batches of human albumin were in accordance with the relevant provisions of the 2010 edition of the Chinese Pharmacopoeia. The results of insoluble batches of more than 80% of the samples of human serum albumin tested can reach Grade A level. The test results of batches Self-test results with the enterprise consistency. Conclusion: Random sampling results show that the results of 80% or more human serum albumin insoluble particles are much lower than the national standards, product quality control is good, the inter-laboratory results tend to be the same.