CN114869870B - Epi-001用于预防和/或治疗非酒精性脂肪肝病的用途 - Google Patents
Epi-001用于预防和/或治疗非酒精性脂肪肝病的用途 Download PDFInfo
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Abstract
本发明公开了一种雄激素受体抑制剂EPI‑001在制备用于预防和/或治疗非酒精性脂肪肝的药物中的用途。
Description
发明领域
本发明属于生物医药领域,具体地说,涉及一种雄激素受体抑制剂EPI-001在制备用于预防和/或治疗由高脂高糖饮食诱导的非酒精性脂肪肝的药物中的用途。
背景技术
非酒精性脂肪肝(non-alcoholic fatty liver disease,NAFLD)是一种无酒精摄入史,而脂肪组织却在肝脏内异常聚集,造成肝脂肪变性,以及肝功能受损的疾病,包括单纯性脂肪肝、脂肪型肝炎、肝纤维化和肝硬化四个阶段。在我国,NAFLD发病率逐年上升,已成为仅次于病毒性肝炎的第二大肝脏疾病。在一般人群中,非酒精性脂肪肝患病率>10%,在肥胖人群中,非酒精性脂肪肝患病率>60%,这严重威胁着人民的生命健康。若不加以防治,非酒精性脂肪肝发展成肝纤维化、肝硬化、甚至肝癌的比例就会提高。另一方面,由于非酒精性脂肪肝病情复杂,发病机制尚未完全解析清除,目前还没有FDA批准的特效药物,因而针对非酒精性脂肪肝的药物发现是目前的研究热点。
肥胖、肝脏肿涨、颜色苍白是非酒精性脂肪肝疾病的常见体征,该疾病是肝脏生物化学指标异常的直接原因,如血清谷丙转氨酶(ALT)和谷草转氨酶(AST)升高。而该疾病的实质是肝脏脂质代谢异常或脂质摄入超标而导致的脂肪成分在肝脏过度积累形成脂肪肝,而血脂异常是脂肪肝的重要血清学基础。因此,改善肝脏脂肪沉积和血脂异常、降低肝功酶是防止非酒精性脂肪肝的主要措施。
现阶段可用于非酒精性脂肪肝治疗的药物大多为减肥药、胰岛素增敏剂、降脂药和保护肝细胞药。其中减肥药,如西布曲明和奥司利他的毒副作用明显;胰岛素增敏剂,如二甲双胍治疗非酒精性脂肪肝的短期疗效较好,但中长期疗效经常反复,且存在毒副作用;而保肝类药物通常是作为配合基础治疗的辅助药物来应用的。只有降脂类药物,如非诺贝特等目前被广泛应用。由此可见,开发一种安全有效的预防和治疗非酒精性脂肪肝的产品具有重要意义。
EPI-001是一种雄激素受体(AR)抑制剂,化学结构式如下式I所示。靶向AR的反式激活单元5(Tau-5),可以抑制AR氨基末端结构域(NTD)的反式激活。此外,EPI-001也是一种选择性的PPAR-γ调节剂,目前文献表明EPI-001仅对去势抵抗性前列腺癌具有治疗作用和疗效。
发明内容
本发明的目的在提供一种雄激素受体抑制剂EPI-001在制备用于预防和/或治疗非酒精性脂肪肝的药物中的用途。
为实现本发明的目的,提供如下实施方案。
在一实施方案中,本发明的一种式I所示化合物在制造预防和/或治疗非酒精性脂肪肝病的药物中的用途。
在上述实施方案中,所述的用途,任选的,包括与其它药物联合使用或组成复方制剂使用。
在上述实施方案中,所述的用途,式I所示化合物的给药剂形式为口服制剂、注射剂或外用制剂。
在上述实施方案中,所述的用途,式I所示化合物的给药剂形式为注射剂。
在上述实施方案中,所述的用途,所述注射剂为1-5mg/ml,优选为4mg/ml。
在上述实施方案中,所述的用途,所述注射剂为每1天、每2天或每3天给药一次。
在上述实施方案中,所述的用途,日剂量为1-100mg。
附图说明
图1是本发明正常饮食、高脂饮食和干扰组小鼠的体重随时间增长的趋势图;
图2是本发明正常饮食、高脂饮食和干扰组小鼠的肝重比较;
图3是本发明正常饮食、高脂饮食和干扰组小鼠的肝脏视觉检查照片;
图4是本发明正常饮食、高脂饮食和干扰组小鼠附睾脂肪组织重量比较和外观大小比较;
图5是本明正常饮食、高脂饮食和干扰组小鼠肝脏油红O染色显微镜下观察结果。
具体实施方式
下面通过实施例来进一步理解和阐明本发明的实质,本领域的技术人员应当认识到,这些具体的实施例仅表明为了达到目的而选择的实施技术方案,并不是对技术方案的限制。根据本发明的教导,结合现有技术对本发明技术方案的改进是显然的,都属于本申请保护的范围。
EPI-001购自MCE公司(产品编号:HY-100348),溶剂二甲基亚砜购自默克生物公司(产品编号:D2650-100ML)。
实施例1注射剂的制备
EPI-001注射液制备方法为:
EPI-001→5%DMSO→30%PEG300→10%Tween80→55%生理盐水,获得4mg/ml(10.13mM)的澄清溶液。
首先加入体积百分比为5%的DMSO溶解EPI-001,待充分溶解后,依次加入体积百分比为30%的PEG300、10%的Tween80和55%的生理盐水组成的溶液中,得到澄清溶液,灭菌,制得EPI-001注射液,EPI含量为1-10mg/ml,优选配制成4mg/ml注射液。
实施例2 EPI-001对高脂饮食诱导的非酒精性脂肪肝的治疗作用
实验动物:SPF级C57BL/6J雄性小鼠24只,动物初始年龄为3-4周,体重为16-18g,正常或高脂饲料喂食,高脂喂食8周建立NAFLD模型。
实验分组:正常小鼠组8只(对照组)、NAFLD模型组8只、NAFLD模型EPI-001干预组8只(以下简称干预组),继续喂养8周,定期观察小鼠状况并及时更换饲料和饮水。
体重和肝重,处死前12h给小鼠禁食,次日清晨称重后处死小鼠,分离完整肝脏并立即称重。
于处死小鼠前,收集血清做生化分析,主要检测各项血脂和肝功指标。
附睾脂肪组织,处死小鼠后剥离其下腹部与睾丸相连的白色脂肪组织,称重并记录。
处死小鼠后分离肝脏,取新鲜肝脏组织制备冰冻切片,油红O染色;最后在显微镜下观察油红O切片中肝脏脂肪滴的变化。
统计学方法数据录入GraphPad Prism7.0软件进行统计分析,结果描述以均数±标准差表示,组间比较采用Mann-Whitney U test,P<0.05表示两者间的差异具有统计学意义。
结果分析
(1)体重:实验前8周,对照组小鼠体重明显轻于模型组小鼠,第8-16周,模型组小鼠体重增长速度较快,而干预组小鼠体重增长显著减慢,如图1所示。
(2)肝脏重量:处死小鼠后分别称各组小鼠肝重,发现对照组小鼠肝脏明显轻于模型组和干预组小鼠,而模型组小鼠肝重又显著高于干扰组小鼠,且具有统计学意义,如图2所示。
(3)肝脏大体标本检查:处死小鼠后,开腹行肉眼观察肝脏大体形态、大小及颜色,用指腹感受肝脏质地,分离肝脏后触摸肝脏切面。可见对照组小鼠肝脏呈红褐色,质地柔软,肝韧带附近无明显脂肪组织,模型组小鼠肝脏部分区域呈淡黄色,肝脏略有增大,肝包膜轻度紧张,切面轻微油腻感,EPI-001干预组小鼠肝脏体积小于模型组,表面呈红褐色,肝脏表面淡黄色区域较少,如图3所示。
(4)附睾脂肪组织:模型组小鼠附睾脂肪组织显著高于对照组小鼠,而干预组小鼠附睾脂肪组织则较模型组显著减少,如图4所示。
(5)油红O染色:肝脏组织冰冻切片并行油红染色,显微镜下观察发现模型小鼠肝脏细胞内聚集了大量的脂肪滴,而对照组和干预组小鼠肝脏细胞内的脂肪滴则较少,如图5所示。
以上结果表明,EPI-001可明显抑制脂肪的形成和增长,可以用于防止和治防非酒精性脂肪肝。
本申请包括但不限于以上实施例,凡是在本申请精神的原则下进行的任何等同替代或局部改进,都将视为在本申请的保护范围之内。
Claims (7)
1.式I所示化合物在制备预防和/或治疗非酒精性脂肪肝的药物中的用途,
2.如权利要求1所述的用途,任选的,包括与其它药物联合使用或组成复方制剂作用。
3.如权利要求1所述的用途,式I所示化合物的给药剂形式为口服制剂、注射剂或外用制剂。
4.如权利要求3所述的用途,所述给药形式为注射剂。
5.如权利要求4所述的用途,所述注射剂为1-10mg/ml。
6.如权利要求5所述的用途,所述注射剂为4mg/ml。
7.如权利要求4-6任一所述的用途,所述注射剂为每1天、每2天或每3天给药一次或二次。
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