国产静脉注射人免疫球蛋白制品中凝血激活物水平分析  

Analysis of procoagulants in domestic human immunoglobulin for intravenous injection

作　　者：孙盼[1] 马莉[1] 袁婧 林方昭[1] 刁戈[1] 李长清[1] 

机构地区：[1]中国医学科学院&北京协和医学院输血研究所,四川成都610052 [2]贵州泰邦生物制品有限公司,贵州贵阳550000

出　　处：《中国生物制品学杂志》2015年第9期934-937,共4页Chinese Journal of Biologicals

基　　金：国家卫生公益性行业科研专项(200902008)

摘　　要：目的分析11家中国血液制品企业共计64批次上市后的静脉注射人免疫球蛋白（immunoglobulin for intravenous injection,IVIG）（p H 4）制品中凝血激活物水平,对国内IVIG制品在促凝血方面的安全性作出评估,为提高制品质量标准提供参考。方法利用非活化的部分凝血活酶时间法（non-activated partial thromboplastin time,NAPTT）、凝固法（一期法）及本实验室建立的改良凝血酶生成试验（modified thrombin generation test,M-TGT）,分别测定64批次国产和7批次进口IVIG样品的NAPTT、系列凝血因子活性、活化凝血因子Ⅺ（FⅪa）的含量及凝血酶生成含量达到最高值时所需时间（time to peak,TTP）,分析IVIG的凝血激活物水平。结果除国内厂家F所生产的2批IVIG中FⅪ活性为0.030～0.036 IU/ml外,其余国产62批次产品中FⅪ活性均低于试剂最低检测限未检出;所有产品中TTP均大于40 min,FⅪa含量均小于0.37 nmol/L,NAPTT均大于203 s。结论所调查的11家共计64批次的国产IVIG制品的凝血激活物水平均较低。今后在我国是否推行IVIG制品的凝血激活物检测尚需进一步研究。Objective To analyze the procoagulants in 64 batches of human immunoglobulin（p H 4） for intravenous injection（IVIG） produced by 11 manufacturers in China, evaluate the safety of IVIG products in promoting coagulation,and provide a reference for improvement of product quality. Methods The non-axtivated partial thromboplastin time（NAPTT）, activities of a series of coagulation factors, activated coagulation factor Ⅺ content and the time when thrombinn content reaches peak value（TTP） of 64 batches of domestic IVIG and 7 batches of imported IVIG were determined by NAPTT method, coagulation method（one-stage method）and modified thrombin generation test（M-TGT）developed by our laboratory, respectively, based on which the procoagulant levels of IVIG were analyzed. Results The F Ⅺ a activities in62 batches of domestic IVIG were lower than the minimum detection limit, while those in the other two batches manufactured by manufacturer F were 0. 030 ～ 0. 036 IU / ml. However, all the TTPs in the products were more than40 min, while the FⅪa contents were less than 0. 37 nmol / L, and NAPTTs were more than 203 s. Conclusion All the procoagulant levels of 64 batches of domestic IVIG from 11 manufacturers were low. Further study is required to determine whether a program for procoagulant determination in IVIG products should be launched in China.

关 键 词：静脉注射人免疫球蛋白 凝血激活物 安全性 

分 类 号：R457.2[医药卫生—治疗学] R392-33[医药卫生—临床医学]