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科倫藥業(002422.SZ):羥乙基澱粉130/0.4電解質注射液獲藥品註冊批件
格隆匯 01-02 16:24

格隆匯1月2日丨科倫藥業(002422.SZ)公佈,公司子公司湖南科倫製藥有限公司於近日獲得國家藥品監督管理局核准簽發的化學藥品“羥乙基澱粉130/0.4電解質注射液”的《藥品註冊批件》。

羥乙基澱粉130/0.4電解質注射液為膠體類血容量擴充劑2013年費森尤斯卡比在中國批准上市,用於治療和預防血容量不足。

血容量擴充劑臨牀主要用於手術和創傷等的液體治療,分為晶體與膠體兩類。臨牀常用的膠體類血容量擴充劑主要包括人血白蛋白、右旋糖酐類和羥乙基澱粉。羥乙基澱粉根據分子量與取代度目前已歷經三代產品發展。

本品為第三代羥乙基澱粉類產品,在保持第二代產品平穩擴容效力的同時因分子量更小更集中使得降解更快、腎臟安全性更好。此外,本品處方中同時含有膠體與晶體,與同屬第三代的羥乙基澱粉130/0.4氯化鈉注射液相比,可有效降低高氯酸中毒風險、更好地維持電解質和酸鹼平衡目前已被《外科病人圍手術期液體治療專家共識(2015)》、《麻醉手術期間液體治療專家共識(2014修訂稿)》等指南或專家共識推薦使用。羥乙基澱粉130/0.4電解質注射液2019年經談判進入國家醫保目錄,公司為國內首仿獲批

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