第一次低分子量肝素效价测定用国家标准品协作标定

通过理化指标及活性等测定,筛选出适合的标准品原料,溶解、分装、冻干后制备成低分子量肝素(low molecular weight heparin,LMWH)国家标准物质待标品(140647-200801)。应用第二次国际标准品(01/608),采用生色底物法(chromogenic substrate method),组织国内8个实验室对其效价进行协作标定。效价标化结果经统计学分析,实验室内及实验室间的几何变异系数(geometric coefficient of var-iation,gcv)均小于10%。经药品标准物质专家委员会审定后批准,待标品(140647-200801)用作LM-WH效价测定用国家标准品,其抗Xa因子效价为1151 IU/安瓿,抗IIa因子效价为424 IU/安瓿。

A Collaborative Study to Establish the 1st National Standard of Low Molecular Weight Heparin for Assay

After lots of physical,chemical and biological tests,we selected one batch of low molecular weight heparin(LMWH) which is suitable to prepare the first national standard for assay.The bulk material were dissolved with distilled water.The solution was distributed into ampoules.The content of the ampoules were then freeze-dried.We co-calibrate the potency of the proposed preparation(140647-200801) against the 2nd international standard(01/608),using the chromogenic substrate method.8 laboratories took part in the collaborative study.Based on the statistical analysis,the candidate gave low intra and inter laboratories variations,geometric coefficient variations were all less than 10%.After the examination of the expert committee on pharmaceutical standardization,the candidate(140647-200801) was approved as the first national standard of LMWH for assay.The anti-FXa potency is 1151 IU/ampoule,and the anti-FIIa potency is 424 IU/ampoule.