智通财经APP讯，康缘药业(600557.SH)发布公告，公司近日收到国家药品监督管理局签发的固本消疹颗粒《药物临床试验批准通知书》。
据悉，固本消疹颗粒处方源于临床经验方。功能主治为益气温阳，祛风固表。用于慢性自发性荨麻疹卫表不固证。临床前主要药效学研究显示，固本消疹颗粒能减少致敏后动物抓挠行为，降低皮肤局部毛细血管通透性、减轻耳肿胀，抑制致敏后小鼠腹腔肥大细胞脱颗粒现象、增加豚鼠致痒阈值，通过降低小鼠血清中炎症因子含量，有效缓解慢性荨麻疹症状。毒理学研究结果表明该药物安全剂量范围较宽，安全性良好。
公司在收到固本消疹颗粒临床试验通知书后，需根据通知书以及新药开发及药品注册法规要求，开展并完成Ⅱ期、Ⅲ期临床试验后，整合申报资料申报产品上市。
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