CN114099520A - 格列喹酮用于制备治疗溃疡性结肠炎的药物的用途 - Google Patents
格列喹酮用于制备治疗溃疡性结肠炎的药物的用途 Download PDFInfo
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Abstract
本发明公开了格列喹酮用于制备治疗溃疡性结肠炎的药物的用途。本发明发现,格列喹酮可以有效缓解溃疡性结肠炎模型大鼠的疾病症状,有效改善肠道损伤。因此,格列喹酮具有开发成治疗溃疡性结肠炎的药物的前景。
Description
技术领域
本发明属于医药领域,涉及已知化合物的新用途,具体涉及格列喹酮用于制备治疗溃疡性结肠炎的药物的用途。
背景技术
溃疡性结肠炎(Ulcerative colitis,UC)是一种慢性非特异性炎性疾病,其临床表现复杂,内镜和病理表现均没有特异性,因而诊断较为困难。患者多出现腹痛、腹泻和便血等症状,如不及时治疗,可能会引起贫血、穿孔以及癌变等并发症,常累及结直肠的黏膜层及黏膜下层,并呈连续弥漫性分布,且病程较长,迁延难愈,已被列为现代难治疾病之一。近年来,全球炎性肠病的发病率逐年上升,已然成为一个亟待解决的社会健康问题。
然而现代医学对该疾病的病因和发病机制尚未完全阐明,可能涉及环境、遗传、微生物、免疫等多方面因素。在治疗上也未有长期疗效肯定的方案,目前临床中常用的氨基水杨酸类、皮质类固醇激素、免疫调节剂类药物,往往会带来较为严重的副作用,因此,制备疗效好、耐受性高的抗UC新药尤为重要。
全新药物的研发往往周期长、成本高,而现有药物的安全性普遍较好,研究资料和临床数据也更为丰富。“老药新用”是药物研发的有效策略,可大大缩短研发周期,降低成本,减少风险。格列喹酮作为第二代口服磺脲类降糖药,通过促进胰岛素的释放发挥较强的降糖作用。单次口服30mg格列喹酮后2~3h血药浓度可达最高水平,且大部分代谢产物经胆道系统从粪便中排出,肾脏排泄极少,被广泛用于肾受损Ⅱ型糖尿病的治疗。
目前,未见格列喹酮用于治疗溃疡性结肠炎的报道。
发明内容
本发明的目的在于提供格列喹酮用于制备治疗溃疡性结肠炎的药物的用途。
本发明上述目的通过如下技术方案实现:
格列喹酮或其药学上可以接受的盐用于制备治疗溃疡性结肠炎的药物的用途。动物实验结果显示:模型组大鼠给予5%DSS后诱发溃疡性结肠炎的发生,连续灌胃给予2.5mg/kg格列喹酮能够有效延缓疾病进程,减少体重降低,缓解结肠损伤症状、降低疾病活动指数、血清尿素氮/肌酐水平。
进一步地,所述药物包括活性成分格列喹酮或其药学上可以接受的盐和药学上可以接受的载体或辅料,制成药学上可以接受的剂型。
更进一步地,所述载体或辅料为液体、固体或半固体。
更进一步地,所述剂型包括片剂、胶囊和注射剂。
有益效果:
本发明发现,格列喹酮可以有效缓解溃疡性结肠炎模型大鼠的疾病症状,有效改善肠道损伤。因此,格列喹酮具有开发成治疗溃疡性结肠炎的药物的前景。
附图说明
图1为格列喹酮干预对DSS导致大鼠体重降低的影响,其中(A)为在药物处理期间各组大鼠每天的体重变化趋势,(B)为各组大鼠处死前体重相比于第0天的变化情况;
图2为格列喹酮干预期间对DSS导致大鼠疾病活动指数的影响;
图3为格列喹酮干预对DSS导致大鼠胃肠道出血情况的影响;
图4为格列喹酮干预对DSS导致大鼠结肠组织损伤的影响;
图1~图4中,C代表对照组,DSS代表模型组,Glq代表格列喹酮给药组。
具体实施方式
下面结合实施例具体介绍本发明实质性内容,但并不以此限定本发明的保护范围。
实施例1:
一、实验动物和试剂
动物:SPF级雄性Sprague-Dawley大鼠24只,6-8周龄,购自北京维通利华实验动物技术有限公司(许可证号:SCXK(浙)2019-0001),所有实验大鼠按照实验室标准饲养条件饲养,温度24±2℃,湿度50±5%,12h/12h昼夜循环条件下饲养一周,使其充分适应环境。
药品与试剂:葡聚糖硫酸钠(DSS,MW:40KD)购自上海阿拉丁生化科技股份有限公司;格列喹酮(Gliquidone,Glq,CAS No.:33342-05-1)购于美国MedChem Express公司;肌酐(CRE)和尿素氮(BUN)测定试剂盒购自南京建成生物工程研究所。
仪器与设备:多功能酶标仪(Tecan Infinite 200Pro,Switzerland),微孔板恒温振荡器(杭州奥盛仪器有限公司,中国),电子天平(TD50002A)购自邦西仪器科技(上海)有限公司。
二、实验方法
1、分组、造模、给药和样本采集
所有动物实验及章程均按照《美国国立卫生研究院实验室护理和使用指南》执行,并被中国药科大学动物伦理委员会批准,实验动物使用许可证号:SYXK(苏)2021-0011。
依据实验室标准方法将24只SD大鼠随机分为3组,分别为对照组(C,n=8)、模型组(DSS,n=8)、给药组(Glq,n=8)。模型组、给药组大鼠给予含5%DSS(w/v)饮水,连续7天,对照组大鼠给予正常饮水。给药组在给予含5%DSS(w/v)饮水同时,每日灌胃给予2.5mg/kg格列喹酮溶液,对照组和模型组同法给予等量相应溶媒,连续7天。
实验期间每天监测大鼠体重变化,观察大鼠腹泻、便血情况并进行打分。大鼠于第8日处死前禁食12h,获取静脉血,静置1h后,8000rpm离心15分钟,取血清储存于-80℃。取相同部位的结肠组织样本,生理盐水洗净后每个样本分为两份,分别置于10%中性福尔马林溶液中和储存于-80℃备用。
2、指标测定
(1)体重自实验开始当日起,每日上午九点称量并记录体重1次。
(2)疾病活动指数(Disease activity score,DAI)用以评价实验过程中大鼠溃疡性结肠炎严重程度。根据Hyo-JinAn疾病活动指数评分方法,自给予大鼠DSS饮水之日起,每日观察大鼠大便及肛周出血情况,结合体重、粪便、便血情况进行综合评分。
(3)血清尿素氮/肌酐(BUN/CRE)水平评价消化道出血情况常用指标,多用于反映胃肠道毒性水平,该指标严格按照试剂盒说明书步骤进行测定。
(4)肠组织形态评价实验结束后大鼠处死解剖获得肠组织,测量并记录结肠长度,观察肠内粪便状态、结肠组织红肿、出血等情况。
3、数据处理
所有数据以Mean±SD表示,GraphPad Prism 5.0软件(GraphPad Software,USA)对数据进行处理,用双侧非配对t检验统计显著性差异,P<0.05为差异显著。
三、实验结果
对照组大鼠在实验期间生活状态、摄食、饮水均正常,模型组大鼠造模前3天的精神、反应及运动状态与正常对照组大鼠相比没有明显不同,从第4天开始模型组大鼠行为出现疾病状态,主要表现为精神倦怠、运动迟缓、毛色黯淡无光、被毛杂乱,摄食、饮水显著减少,随实验的进行以上情况逐日加重;格列喹酮给药组大鼠上述疾病状态发展较模型组缓慢,指标检测显示该组大鼠肠道组织损伤显著缓解,具体指标评估结果如下:
1、大鼠体重
从图1A可以明显看出,在造模给药的1-3天,三组大鼠间体重无明显区别;从第4天开始,与对照组相比,模型组大鼠体重持续显著下降;格列喹酮给药组大鼠体重于第6天开始下降,且变化幅度显著小于模型组。对实验第7天大鼠处死前的体重进行统计分析,结果表明格列喹酮能够显著缓解DSS导致的大鼠体重降低(图1B)。
2、大鼠疾病活动指数(Disease activity score,DAI)
实验期间各组DAI情况如图2所示,对照组大鼠生长状况、排便情况及粪便状态均正常,模型组大鼠给予5%DSS饮水后1-3天排便情况正常,于第4天开始出现轻微的疾病状态,表现为粪便湿软、水样,至第7天模型组大鼠均出现严重便血,疾病活动指数升至最高,而给格列喹酮药组大鼠疾病进程发展较缓慢,部分出现稀便、不成形,表现为DAI显著低于模型组。以上结果表明DSS造成了大鼠慢性肠道损伤,且格列喹酮能够显著缓解DSS导致的大鼠腹泻、便血情况。
3、血清尿素氮/肌酐(BUN/CRE)水平
与模型组相比,给药组大鼠BUN/CRE显著下降(图3),说明格列喹酮能够缓解DSS引起的肠道出血情况。
4、大鼠结肠形态评估
实验第7天处死大鼠并解剖获得结直肠组织(图4),观察发现对照组大鼠结肠无红肿或出血,总长度大于15cm且肠内粪便呈颗粒状,模型组大鼠结肠组织呈现明显的红肿、溃疡、出血及肠内容物水样等病态情况,而格列喹酮给药组大鼠结肠长度较模型组增加,红肿、出血情况显著减少,表明格列喹酮能够改善肠道的损伤症状。
综上,格列喹酮能够显著缓解溃疡性结肠炎模型大鼠的疾病症状,有效改善肠道损伤。因此,格列喹酮具有开发成治疗溃疡性结肠炎的药物的前景。
实施例2:
一种用于治疗溃疡性结肠炎的片剂,活性成分为格列喹酮,辅料为片剂常规辅料。
一种用于治疗溃疡性结肠炎的胶囊,活性成分为格列喹酮,辅料为胶囊常规辅料。
一种用于治疗溃疡性结肠炎的注射剂,活性成分为格列喹酮,辅料为注射剂常规辅料。
上述实施例的作用在于具体介绍本发明的实质性内容,但本领域技术人员应当知道,不应将本发明的保护范围局限于该具体实施例。
Claims (4)
1.格列喹酮或其药学上可以接受的盐用于制备治疗溃疡性结肠炎的药物的用途。
2.根据权利要求1所述的用途,所述药物包括活性成分格列喹酮或其药学上可以接受的盐和药学上可以接受的载体或辅料,制成药学上可以接受的剂型。
3.根据权利要求2所述的用途,所述载体或辅料为液体、固体或半固体。
4.根据权利要求2所述的用途,所述剂型包括片剂、胶囊和注射剂。
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WO2001021159A2 (en) * | 1999-09-17 | 2001-03-29 | Novartis Ag | Pharmaceutical composition of nateglinide and another antidiabetcagent |
CN101537182A (zh) * | 2002-03-22 | 2009-09-23 | 诺瓦提斯公司 | 含有HMG CoA还原酶抑制剂和胰岛素分泌促进剂或胰岛素增敏剂的组合 |
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WO2001021159A2 (en) * | 1999-09-17 | 2001-03-29 | Novartis Ag | Pharmaceutical composition of nateglinide and another antidiabetcagent |
CN101537182A (zh) * | 2002-03-22 | 2009-09-23 | 诺瓦提斯公司 | 含有HMG CoA还原酶抑制剂和胰岛素分泌促进剂或胰岛素增敏剂的组合 |
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