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                                                                                                                                                                                                                                                            美國藥典公布新的肝素質量標準

                                                                                                                                                                                                                                                            2011.06.15 6432 字號 A - A A +

                                                                                                                                                                                                                                                              為了確保肝素產品的質量和防止潛在污染,美國藥典委員會決定對肝素采用新的生產控制方法。修訂后的美國藥典標準已于10月1日起公布生效。
                                                                                                                                                                                                                                                              
                                                                                                                                                                                                                                                              據了解,修訂后的美國藥典肝素鈉參考標準和肝素鈉單位定義比修訂前的效價降低了10%。美國生產商必須依據美國藥典標準對其產品包含的肝素劑量粘貼標簽。此次肝素產品藥典標準修訂的內容還包括新的鑒別方法、新的效價測定方法的實施和附加雜質測試,以及肝素效價單位與國際單位的一致性。此外,肝素抗凝溶液、人抗凝血酶III,肝素鈣、肝素鈣注射液、肝素沖洗液和硫酸魚精蛋白等幾項內容也進行了修訂。美國藥典采用了新的肝素效價評定方法,使用生色抗IIa因子測定法代替此前藥典中的羊血漿法測定肝素效價。這種測定方法的高度專一性能夠為肝素的純度提供進一步安全保證,識別出此前藥典中羊血漿法不能識別的肝素相似性潛在假藥。這些修訂也將提高肝素的純度,改善效價測定和鑒別試驗的結果。美國市場上的處方藥和OTC也必須滿足美國藥典的公開標準。
                                                                                                                                                                                                                                                              
                                                                                                                                                                                                                                                              根據FDA的公布,美國主要的肝素及其鹽生產企業有四家,規模最大的是APP制藥公司,銷售管形瓶裝肝素及其鹽;Hospira公司銷售的肝素及其鹽以靜脈袋、管形瓶和注射器包裝;百特國際有限公司和貝朗醫療銷售靜脈袋裝肝素及其鹽。FDA要求所有的制藥商能夠識別并區分其新產品,以幫助藥房和醫療保健專業人員區分新標準產品與舊標準產品。

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