雙鷺藥業(002038.SZ):獲得硝酸甘油噴霧劑藥品註冊證書
格隆匯4月8日丨雙鷺藥業(002038.SZ)公佈,公司於近日收到國家藥品監督管理局核准簽發的硝酸甘油噴霧劑(商品名:立生樂®)《藥品註冊證書》。
硝酸甘油噴霧劑為溶液型噴霧劑,通過口腔黏膜直接吸收,無需溶解步驟,通常30秒至1分鐘即可起效,適合緊急情況(如心絞痛急性發作)使用。臨牀研究顯示,患者用藥後立即起效者為23.5%,1分鐘之內起效者為62%,2分鐘內起效者可高達85.75%。本品與氣霧劑相比,其不含拋射劑,通過手動泵的壓力將藥液轉化為霧狀形態;同時藥物不氣化,系霧滴給藥,因而其沒有致冷效應,不會使皮膚引起不適和刺激感,安全性更高,起效更快。臨牀上主要用於快速緩解或緊急預防冠心病引起的心絞痛發作。
本次公司獲批系國內首家獲批硝酸甘油噴霧劑新劑型,目前為國內獨家。本次獲批視同通過一致性評價。
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