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華森製藥(002907.SZ):六味安神膠囊獲得新加坡註冊批文
格隆匯 02-06 16:17

格隆匯2月6日丨華森製藥(002907.SZ)公佈,公司於近日收到新加坡衞生科學局(Health Sciences Authority)(以下簡稱“HSA”)核准簽發的中成藥註冊批文,批准公司重點中成藥六味安神膠囊符合新加坡中成藥標準註冊,並批准其在新加坡上市銷售。

六味安神膠囊為公司重點中成藥,是中藥1.1類創新藥,國家發明專利品種(發明專利號:ZL200610038346.6),國家醫保品種。六味安神膠囊由地黃、酸棗仁、蓮子心、遠志、陳皮、甘草六味藥物組成,寒温並用,攻補兼施,藥性平和,共奏滋陰清心、化痰安神之功。《六味安神膠囊治療陰虛火旺夾痰失眠症312例》《六味安神膠囊治療失眠陰虛火旺挾痰證隨機雙盲安慰劑平行對照臨牀研究》等多項RCT研究顯示,六味安神膠囊可通過鎮靜催眠、抗抑鬱、抗焦慮、抗氧化、提高耐缺氧能力等作用,整體改善失眠患者睡眠質量和中醫證候。六味安神膠囊被列入中華中醫藥學會《神志病中西醫結合臨牀診療指南》、中國睡眠研究會《成人慢性失眠中醫診療專家共識》、世界中醫藥學聯合會急診專業委員會《新型冠狀病毒感染者成人居家中醫藥健康管理專家共識》等臨牀指南推薦用藥。

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