Monneret C
UMR 176, section de recherche, institut Curie, 26, rue d'Ulm, 75248 Paris cedex 05, France.
Ann Pharm Fr. 2008 Aug;66(4):212-5. doi: 10.1016/j.pharma.2008.07.004. Epub 2008 Sep 9.
In January 2008, following the detection of severe allergic reaction, several batches of heparins were removed from the United-States market. Although less dramatic, comparable side effects were also reported in Germany but not in France despite the fact that low-weight heparins, obtained from contaminated batches of unfractionated heparins, were used to limit shortage. So far, tainted injectable heparin has been linked to over 80 deaths in the USA. Analyses demonstrated that such tainted heparins were contaminated by high levels of chondroïtin persulfate (5-20%), a cheaper hemi-synthetic product. All batches were furnished by several Chinese chemical industries, China representing 50% of all heparins produced worldwide. Thus, contamination of the heparin supply is a worldwide problem. Following this event, the efficiency of the quality insurance, particularly analytical controls before proceeding, remains questionable. The strict respect of the pharmaceutical chain is urgently required to avoid any kind of quality problem in the future.
2008年1月,在检测到严重过敏反应后,几批肝素被撤出美国市场。德国也报告了类似的副作用,不过没那么严重,而法国却没有,尽管为缓解短缺使用了从受污染的未分级肝素批次中获取的低分子量肝素。到目前为止,受污染的注射用肝素在美国已导致80多人死亡。分析表明,此类受污染的肝素被高含量的过硫酸软骨素(5%-20%)污染,过硫酸软骨素是一种更便宜的半合成产品。所有批次均由几家中国化工企业提供,中国生产的肝素占全球总产量的50%。因此,肝素供应的污染是一个全球性问题。这一事件之后,质量保证的效率,尤其是生产前的分析控制,仍然存在疑问。迫切需要严格遵守药品供应链,以避免未来出现任何质量问题。