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貴州百靈(002424.SZ):“中藥6.1.2類新藥黃連解毒丸”現已完成II期臨牀試驗
格隆匯 11-24 19:00

格隆匯11月24日丨貴州百靈(002424.SZ)披露黃連解毒丸研發項目的進展,“中藥6.1.2類新藥黃連解毒丸”已完成II期臨牀試驗。

黃連解毒丸是公司申辦的我國第一個獲得批准開展臨牀研究的證候類“全科中藥”新藥,是體現中醫藥“異病同治”思想和最具代表性的中醫清熱解毒方劑學中的經典名方。原方黃連解毒湯始載於東晉葛洪的《肘後備急方》,具有瀉火解毒功效,主治一切實熱火,歷經1600多年臨牀使用,廣泛用於由於實熱火毒證引起的各系統的疾病,是典型的“證候類”藥物。

黃連解毒丸由中國中醫科學院中藥研究所開展的臨牀前研究;天津中醫藥大學第二附屬醫院王保和教授為主要研究者,聯合遼寧中醫藥大學附屬醫院、黑龍江中醫藥大學附屬醫院、成都中醫藥大學附屬醫院、湖南中醫藥大學第一附屬醫院等全國著名三甲中醫院開展II期臨牀研究;天津中醫藥大學校長、中國工程院張伯禮院士親自參與指導了黃連解毒丸臨牀證候診斷和評價標準工作。同時,中國中醫科學院中藥研究所邊寶林研究員團隊對實熱火毒證患者證候轉歸前後Biomarkers(生物標誌物)進行了系統研究,從最初的兩萬多個生物標誌物中,篩選出近十個與實熱火毒證候和臨牀療效相關的 Biomarkers,並在II期臨牀研究中得到驗證;黃連解毒丸採用的這種獨特的“中醫證候+Biomarkers”評價方式,將傳統中醫藥與現代醫藥學完美結合,對我國中藥新藥評價方式具有開創性作用,具有里程碑意義。

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