以嶺藥業(002603.SZ):益腎養心安神片獲得藥品註冊證書
格隆匯9月6日丨以嶺藥業(002603.SZ)公佈,近日,公司收到國家藥品監督管理局核准簽發的《藥品註冊證書》,為益腎養心安神片。
益腎養心安神片(曾用名:益智安神片、百靈安神片)是公司根據中華通絡養生八字經理論指導失眠症病機治法、並在臨牀經驗方基礎上研製的中藥新藥復方製劑。公司擁有該藥獨立完整的知識產權。截至目前,公司對益腎養心安神片項目累計研發投入約2600萬元。
益腎養心安神片的功能為益腎、養心、安神。用於失眠症中醫辨證屬心血虧虛、腎精不足證,症見失眠、多夢、心悸、神疲乏力、健忘、頭暈、腰膝痠軟等。
藥效學研究證實該藥可發揮系統調控改善睡眠作用特點,即保護海馬區腦神經元細胞,抑制下丘腦-垂體-腎上腺軸(HPA 軸)激活,改善應激狀態,發揮鎮靜、催眠藥效作用,同時增進記憶、抗疲勞,顯示出不同於西醫鎮靜催眠藥的作用優勢。針對該藥開展的隨機、雙盲、安慰劑平行對照、多中心臨牀試驗結果顯示,該藥可明顯減輕患者入睡困難、睡而易醒、早醒、睡眠時間短等失眠相關症狀的同時,還能夠改善多夢、心悸不安、健忘、頭暈、神疲乏力、腰膝痠軟等症狀,且臨牀應用安全,未發現不良反應發生。該中藥新藥的上市,為失眠症患者提供了一種新的治療選擇。
益腎養心安神片新獲得《藥品註冊證書》,預計不會對公司近期經營業績產生重大影響。公司將盡快啟動該產品的相關生產和銷售工作。
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