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苑东生物「格隆溴铵注射液」即将第2家获批

2020-10-15 医药魔方 医药魔方

10月14日,苑东生物3类仿制药格隆溴铵注射液上市申请进入「在审批」阶段,有望于近期正式获批,成为国内继恒瑞医药之后第2家该药品获批厂家。

10月14日,苑东生物3类仿制药格隆溴铵注射液上市申请进入「在审批」阶段,有望于近期正式获批,成为国内继恒瑞医药之后第2家该药品获批厂家。

格隆溴铵注射液是一种抗胆碱能药物,主要为麻醉前和术中用药,用于对抗肌松拮抗剂,如新斯的明药物等出现的肠蠕动增强、分泌物增多、支气管痉挛和心率减慢等毒蕈碱样副作用。

国内临床术前使用的抗胆碱药有阿托品、东莨菪碱和盐酸戊已奎醚,阿托品作为临床经典药物用药至今,临床应用广泛,但常用剂量的阿托品可引起心率增快,而东莨菪碱对呼吸道腺体分泌的抑制作用较阿托品稍弱,并且阿托品、东莨菪碱和盐酸戊已奎醚均可透过血脑屏障。与阿托品比较,格隆溴铵抑制唾液分泌作用强而持久,心血管不良反应较低;并且该药物类脂膜通过性较差,不易透过血脑屏障,因而对中枢神经系统影响较小。格隆溴铵是理想的阿托品的替代产品。

格隆溴铵注射液弥补了临床现有疗法的不足,能更好的满足临床需求。2017年全球销售额约为1.8 亿美元(数据来源:IQVIA 数据库)。目前,国内洞庭药业的格隆溴铵片和恒瑞医药的格隆溴铵注射液已经获批上市。

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