激肽释放酶原激活剂在人血白蛋白制品中的评价分析  

Evaluation and Analysis of Prekallikrein Activator in Human Serum Albumin Products

作　　者：白亦昊 赵璇 周长明 Bai Yihao;Zhao Xuan;Zhou Changming(Beijing Institute for Drug Control,NMPA Key Laboratory for Safety Research and Evaluation of Innovative Drugs,Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,Beijing 102206,China)

机构地区：[1]北京市药品检验研究院,国家药品监督管理局创新药物安全研究与评价重点实验室,中药成分分析与生物评价北京市重点实验室,北京102206

出　　处：《中国药事》2025年第2期175-181,共7页Chinese Pharmaceutical Affairs

摘　　要：目的:考察国内外8家企业人血白蛋白制品中激肽释放酶原激活剂(PKA)含量并进行评价分析,为提高该品种的国家标准,从而改进人血白蛋白制品质量提供参考依据。方法:按照《中华人民共和国药典》(简称《中国药典》)2020年版三部通则3409测定市售8家企业生产的70批人血白蛋白制品中PKA含量。采用单因素方差分析考察各企业间PKA含量的差异性,并采用离散度分析企业的批间一致性情况。结果:所考察的PKA含量为0.33~16.90 IU·mL^(-1),中位数结果为3.48 IU·mL^(-1),平均结果为5.45 IU·mL^(-1)。各厂家的人血白蛋白制品中PKA含量均在药典规定(35 IU·mL^(-1))的范围内,但各企业间PKA含量存在显著差异(P<0.01),部分企业批间一致性较差。结论:PKA是考察人血白蛋白制品安全性的一项重要指标,根据有效优化及控制生产工艺有望降低产品中PKA的含量,建议在《中国药典》质量标准中应严格控制PKA含量限度。Objective:To investigate the content of prekallikrein activator(PKA)in human serum albumin products from eight domestic and international companies and conduct evaluation analysis,so as to provide a reference for improving the national standards for this product,thereby enhancing the quality of human serum albumin(HSA)products.Methods:The PKA content in 70 batches of HSA products from eight companies was measured according to the general rule 3409 in 2020 edition of the Chinese Pharmacopoeia.One-way analysis of variance(ANOVA)was used to examine the variability of PKA content among enterprises,and dispersion was used to analyze and harmonize the batch-to-batch consistency of the enterprises.Results:The PKA content ranged from 0.33 to 16.90 IU·mL^(-1).The median result was 3.48 IU·mL^(-1) and the mean result was 5.45 IU·mL^(-1).Although the PKA content in HSA products from different domestic and international manufacturers was within the range specified by the pharmacopoeia(35 IU·mL^(-1)),there were significant differences in PKA content between companies(P<0.01),and lot-to-lot consistency for some companies was poor.Conclusion:PKA is an important indicator for assessing the safety of HSA products.According to the effective optimization and control of the production process,it is expected to reduce the content of PKA in the products.The limit of PKA content should be strictly controlled in the quality standard of the Chinese Pharmacopoeia.

关 键 词：激肽释放酶原激活剂 血液制品 人血白蛋白 酶反应法 质量控制 评价分析 

分 类 号：R917[医药卫生—药物分析学]