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目的欧洲药品质量管理局(European Directorate on Quality of Medicines,EDQM)和英国国家生物制品检定所(National Institute for Biological Standards and Control,NIBSC)组织国际协作标定,建立第2批和第3批欧洲药典(European Pharmacopoeia,EP)低分子肝素(low molecular weight heparin,LMWH)相对分子质量对照品。方法标定分为2个阶段,中国食品药品检定研究院(National Institutes for Food and Drug Control,NIFDC)参加了第二阶段的标定工作,采用EP中收载的高效体积排阻色谱法,用首批相对分子质量对照品(CRS1)和换批对照品(cCRS2、cCRS3)对7个市场上销售的具有不同相对分子质量及分布的低分子肝素产品(A～G)进行测定。结果 cCRS2和cCRS3数均相对分子质量(number average molecular mass,Mn)的最初赋值为3 700,测定结果表明,该赋值使cCRS2和cCRS3的计算结果与CRS1存在较大的系统误差,于是调整Mn赋值为3 800,经重新计算,cCRS2与cCRS3和CRS1的计算结果十分接近。NIBSC还对相对分子质量测定方法进行了规范。结论待标品(cCRS2、cCRS3)可以作为EP的低分子肝素相对分子质量对照品使用,Mn=3 800。
Purpose The European Directorate for Quality of Medicines (EDQM) and the National Institute for Biological Standards and Control (NIBSC) organize international collaborative calibration to establish the second and third European Pharmacopoeia European Pharmacopoeia, EP) low molecular weight heparin (LMWH) relative molecular weight reference substance. The method calibration was divided into two stages. The National Institutes for Food and Drug Control (NIFDC) participated in the second stage of calibration work. High-performance size-exclusion chromatography Seven commercially available low molecular weight heparin products (A to G) with different relative molecular masses and distributions were tested on relative molecular mass reference (CRS1) and batch control (cCRS2, cCRS3). Results The initial assignment of number average molecular mass (Mn) to cCRS2 and cCRS3 was 3 700. The results showed that the assignment made the calculated results of cCRS2 and cCRS3 have greater systematic errors than CRS1, Is 3 800, recalculated, cCRS2 and cCRS3 and CRS1 calculations are very close. NIBSC also regulates the molecular weight determination method. Conclusions The target products (cCRS2, cCRS3) can be used as low molecular weight heparin relative molecular weight reference substance for EP, Mn = 3 800.