羅欣藥業(002793.SZ):鹽酸左沙丁胺醇霧化吸入溶液獲得藥品註冊證書
格隆匯3月14日丨羅欣藥業(002793.SZ)公佈,近日,羅欣藥業集團股份有限公司下屬子公司羅欣安若維他藥業(成都)有限公司收到國家藥品監督管理局覈準簽發的鹽酸左沙丁胺醇霧化吸入溶液《藥品註冊證書》。
左沙丁胺醇爲β2-腎上腺素受體激動劑,主要激動呼吸道平滑肌上的β2-腎上腺素受體,導致腺苷酸環化酶激活,增加細胞內的3',5'-環磷酸腺苷(cAMP)的濃度。cAMP的增加激活蛋白激酶A,蛋白激酶A抑制肌球蛋白磷酸化並降低細胞內鈣離子濃度,舒張平滑肌。左沙丁胺醇可舒張從氣管到終末細支氣管的所有氣道平滑肌。鹽酸左沙丁胺醇霧化吸入溶液適用於治療或預防成人及6歲以上兒童可逆性氣道阻塞性疾病引起的支氣管痙攣。
鹽酸左沙丁胺醇霧化吸入溶液原研爲美國SepracorInc.公司,於1999年在美國上市,商品名:XOPENEX®,該原研製劑尚未進口中國。公司鹽酸左沙丁胺醇霧化吸入溶液按化學藥品新註冊分類3類獲得藥品註冊證書,視同通過一致性評價。
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