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康緣藥業(600557.SH):棗柏安神顆粒獲批臨牀試驗
格隆匯 04-14 15:58

格隆匯4月14日丨康緣藥業(600557.SH)公佈,公司近日收到國家藥品監督管理局簽發的棗柏安神顆粒藥物臨牀試驗批准通知書》

棗柏安神顆粒審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,2022年2月8日受理的棗柏安神顆粒符合藥品註冊的有關要求,同意開展用於肝血不足、虛熱內擾所致的慢性失眠症的臨牀試驗。

棗柏安神顆粒處方源於臨牀經驗方,功能主治為養血安魂,清熱除煩,用於肝血不足,虛熱內擾證之失眠。症見虛煩不眠,或入睡困難,或夜寐不安,甚則徹夜難眠;常伴有手足心熱,盜汗,口乾少津,健忘耳鳴,心悸不安等症,舌質紅少苔,脈細數;適用於慢性失眠見上述證候者

目前該產品已完成製備工藝、質量標準、穩定性及藥效、安評等臨牀前研究。臨牀前藥效學研究顯示,棗柏安神顆粒具有中樞鎮靜、調節神經遞質、延長慢波睡眠時間等藥理活性,治療失眠障礙藥效較好,且對中樞神經系統未見不良影響。毒理學研究顯示,藥物安全性好,安全劑量範圍較寬

公司擁有該新藥獨立完整自主的知識產權。截止目前,該新藥公司累計研發投入1184.25萬元

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