片仔癀(600436.SH):養巢顆粒收到藥物臨牀試驗批准通知書
格隆匯3月24日丨片仔癀(600436.SH)公佈,公司於近日收到國家藥品監督管理局核准簽發的關於養巢顆粒的《藥物臨牀試驗批准通知書》,養巢顆粒(公司內部研發項目代號:PZH1219)是基於杭州市中醫院院內製劑(浙藥製備字:Z20220005000)研製的中藥1.1類新藥,其處方組成、工藝路線、臨牀定位、用法用量等均與院內製劑臨牀應用一致。該處方是從“始於晚清、傳承五代”的何氏經驗育麟方優化而來,已在臨牀使用多年,臨牀觀察顯示養巢顆粒對於防治卵巢功能衰退、改善伴隨症狀具有較好的療效及安全性。養巢顆粒的擬定功能主治為:益腎填精,調和陰陽。用於腎虛型卵巢儲備功能下降,症見月經先期或後期或量少、腰膝痠軟、性慾減退、畏寒肢冷、神疲乏力、夜尿頻多、口乾咽燥、頭暈耳鳴、潮熱盜汗、失眠多夢,舌淡或紅,脈沉或細數。
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