Terao E, Daas A
European Directorate for the Quality of Medicines & HealthCare (EDQM), Department of Biological Standardisation, OMCL Network & HealthCare (DBO), Council of Europe, Strasbourg, France,
European Directorate for the Quality of Medicines & HealthCare (EDQM), Department of Biological Standardisation, OMCL Network & HealthCare (DBO), Council of Europe, Strasbourg, France.
Pharmeur Bio Sci Notes. 2016;2015:35-47.
The European Pharmacopoeia (Ph. Eur.) prescribes the control of the activity of low molecular mass heparins by assays for anti-Xa and anti-IIa activities (monograph 0828), using a reference standard calibrated in International Units (IU). An international collaborative study coded BSP133 was launched in the framework of the Biological Standardisation Programme (BSP) run under the aegis of the Council of Europe and the European Commission to calibrate replacement batches for the dwindling stocks of the Heparin low-molecular-mass for assay Biological Reference Preparation (BRP) batch 8. Thirteen official medicines control and manufacturers laboratories from European and non-European countries took part in this study to calibrate two freeze-dried candidate batches against the 3rd International Standard (IS) for heparin, low molecular weight (11/176; 3rd IS). The Heparin low-molecular-mass for assay BRP (batch 8) was also included in the test panel to check the continuity between subsequent BRP batches. Taking into account the stability data, the results of this collaborative study and on the basis of the central statistical analysis performed at the European Directorate for the Quality of Medicines & HealthCare (EDQM), the 2 candidate batches were officially adopted by the Commission of the European Pharmacopoeia as Heparin low-molecular-mass for assay BRP batches 9 and 10 with assigned anti-Xa activities of 102 and 100 IU/vial and anti-IIa activities of 34 and 33 IU/vial respectively.
欧洲药典（Ph. Eur.）规定通过抗Xa和抗IIa活性测定法（专论0828）来控制低分子质量肝素的活性，使用以国际单位（IU）校准的参考标准品。在欧洲委员会和欧盟委员会支持下开展的生物标准化计划（BSP）框架内，发起了一项编号为BSP133的国际协作研究，以校准用于肝素低分子质量测定生物参考制剂（BRP）第8批库存日益减少的替代批次。来自欧洲和非欧洲国家的13个官方药品控制和生产厂家实验室参与了该研究，以针对肝素低分子质量第3国际标准品（11/176；第3 IS）校准两个冻干候选批次。肝素低分子质量测定BRP（第8批）也包含在测试组中，以检查后续BRP批次之间的连续性。考虑到稳定性数据、该协作研究的结果以及在欧洲药品质量管理局（EDQM）进行的中心统计分析，欧洲药典委员会正式采用这两个候选批次作为肝素低分子质量测定BRP第9批和第10批，其指定的抗Xa活性分别为每瓶102和100 IU，抗IIa活性分别为每瓶34和33 IU。
