高效分子排阻色谱-多角度激光光散射法测定人凝血因子Ⅷ产品分子量及其分布  

Determination of Molecular Weight and Distribution of Human Coagulation FactorⅧby High Performance Molecular Exclusion Chromatography-Multi Angle Laser Light Scatter

作　　者：王皓南 王文晞 郭江红 姜红 WANG Haonan;WANG Wenxi;GUO Jianghong;JIANG Hong(Hubei University of Chinese Medicine,Wuhan 430065,China;Hubei Institute for Drug Control,Wuhan 430075,China)

机构地区：[1]湖北中医药大学药学院,武汉430065 [2]湖北省药品监督检验研究院,武汉430075

出　　处：《医药导报》2022年第5期703-707,共5页Herald of Medicine

摘　　要：目的建立高效分子排阻色谱-多角度激光光散射法(HPSEC-MALLS)测定人凝血因子Ⅷ产品分子量及其分布的方法,并对不同企业产品的测定结果进行比较。方法采用HPSEC-MALLS法,以磷酸盐缓冲液为流动相,流速0.5 mL·min^(-1),采用TSK gel G3000SWXL(7.8 mm×300 mm,5μm)色谱柱,柱温为30℃。结果不同企业的人凝血因子Ⅷ产品均由4个组分组成,分子量分别为7.8×10^(6),5.3×10^(5),2.5×10^(5),2.0×10^(5),不同企业各组分含量存在差异。结论该文所建立的方法可用于人凝血因子Ⅷ分子量及其分布的测定,并能对不同企业的产品进行区分,为产品质量控制提供参考。Objective To estabish a method for the determination of molecular weight and distribution of human coagulation factorⅧproducts by high performance molecular exclusion chromatography-muti angle laser light scatter(HPSEC-MALLS),and compare the measurement results of products from different enterprises.Methods HPSEC-MALLS was used and mobile phase was selected as phosphate buffer.The flow rate was 0.5 mL·min^(-1);chromatographic column was TSK gel G3000 SWXL(7.8 mm×300 mm,5μm);and column temperature was 30℃.Results Human coagulation factorⅧproducts from different enterprises are composed of four components with molecular weights of 7.8×10^(6),5.2×10^(5),2.5×10^(5) and 2.0×10^(5),respectively.Moreover,there are differences in the content of each component in different enterprises.Conclusion The method established in this paper can be used to determine the molecular weight and distribution of human coagulation factorⅧ.Besides,it can distinguish the products from different enterprises and provide reference for product quality control.

关 键 词：人凝血因子Ⅷ 分子量 多角度激光光散射 高效分子排阻色谱法 

分 类 号：R977.8[医药卫生—药品] R927.1[医药卫生—药学]