低分子量肝素产品生物样本分析关注点讨论  

Discussions on considerations for low molecular weight heparin products bioanalysis

作　　者：陈一飞 王莹 张琼光 刘晓翠 李刚 CHEN Yi-fei;WANG Ying;ZHANG Qiong-guang;LIU Xiao-cui;LI Gang(Shanghai Center forDrug Evaluation and Inspection,Shanghai 201203,China;Center for Food and Drug Inspection of National Medical Products Administration,Beijing 100044,China)

机构地区：[1]上海药品审评核查中心,上海201203 [2]国家药品监督管理局食品药品审核查验中心,北京100044

出　　处：《中国临床药理学杂志》2022年第24期3045-3048,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：低分子量肝素产品因较普通肝素药物表现出更好的临床使用优势,其仿制产品的开发与评价受到较多关注。目前在低分子量肝素产品的生物等效性评价中,一般进行以抗Xa因子活性和抗Ⅱa因子活性为终点指标的药效学评价。因此,低分子量肝素产品的生物样本分析对于此类产品的评价具有重要作用,而与常规生物样本定量分析方法相比,以检测抗Xa/Ⅱa因子活性进行的药效学指标测定具有方法的特殊性,方法开发与样本分析中需要关注的重点较多。本文简介了低分子量肝素产品的特征,综述了该类产品一致性评价的技术要求,讨论了现有生物样本分析方法,基于其分析方法特殊性,讨论了生物样本分析的方法学验证及样本检测中的关注考量。Low molecular weight heparin products(LMWH) show more advantages in clinical application than unfraction heparins, and the development and evaluation for LMWH attract increasing attentions. At present, the pharmacodynamic endpoint bioequivalence study is required to support the consistence evaluation of LMWH products. The bioanalytical method validation and study sample analysis play an important role in the evaluation of such products. Compared with the chromatographic assays and ligand binding assays, LMWH pharmacodynamic quantitative analysis based on the measurement of anti-FXa and anti-FIIa activity, and more attentions need to be paid to the method validation and analysis performance. In this work, the characteristics of LMWH are introduced, the technical requirements for consistency evaluation of such products are reviewed, the existing biological sample analysis methods are discussed, and the considerations for bioanalytical method validation and study sample analysis are discussed based on the particularity of their analysis methods.

关 键 词：低分子量肝素 生物等效性评价 生物样本分析 

分 类 号：R97[医药卫生—药品]