CN114831984A - 一种吲哚丙酸在制备用于预防和/或治疗肾炎药物中的用途 - Google Patents
一种吲哚丙酸在制备用于预防和/或治疗肾炎药物中的用途 Download PDFInfo
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Abstract
本发明属于医药领域，涉及一种吲哚丙酸或其药学上可接受的盐、或其溶剂合物、或其前体药物、或其代谢产物在制备用于预防和/或治疗肾炎药物中的新用途。本发明经实验研究证实吲哚丙酸能显著改善肾炎的临床症状，显著降低尿蛋白定量、血肌酐和尿素氮水平，且无明显的毒副作用。所述吲哚丙酸可用于研发肾炎治疗药物，具有广阔的应用前景。
Description
技术领域
本发明涉及药物新用途技术领域，具体涉及一种吲哚丙酸或其药学上可接受的盐、或其溶剂合物、或其前体药物、或其代谢产物在制备用于预防和/或治疗肾炎药物中的用途。
背景技术
肾炎是一组由多种病因、多种病理类型组成的原发于肾小球的免疫性疾病，其发病隐匿，病程迁延，病情发展缓慢。大多数患者有不同程度蛋白尿或血尿，并伴有高血压病史，随着病情进展，可持续缓慢地破坏肾单位，发展为肾功能不全，最终进展为终末期肾病，并进一步导致肾部纤维化。目前临床尚未完全明确肾小球肾炎的发病机制，普遍认为免疫系统功能异常是肾炎发病的始发机制，免疫系统激活补体系统，引发肾脏的炎症反应，慢性炎性反应继而引起肾脏基底膜受损、蛋白质排泄增加。因此，尿蛋白指数升高是慢性肾小球肾炎临床的主要症状之一。现阶段肾小球肾炎的治疗药物主要为动物激素类和抗感染类药物，长期应用该类药物会导致免疫系统紊乱及强抗药性致病菌的产生。因此，研究安全性高、长期应用无显著不良反应的肾炎治疗药物具有重要意义。
吲哚丙酸是色氨酸由肠道菌群代谢产生的衍生物，研究表明，吲哚丙酸与人类多种疾病的发生发展相关。同时，吲哚丙酸也能调节肠道微生物多样性，缓解肠道菌群失调；具有抗炎、抗氧化等作用。已有吲哚丙酸用于治疗自闭症，治疗肿瘤放疗引起的副反应，治疗类风湿性关节炎，以及含吲哚丙酸的药物组合物用于治疗肝癌的相关专利。目前，未见吲哚丙酸用于治疗肾炎，能够降低尿蛋白定量和血清肌酐、尿素氮水平的报道。
发明内容
为了克服现阶段肾小球肾炎治疗药物长期应用会引起致免疫系统紊乱，以及强抗药性致病菌的产生等问题，本发明提供了一种吲哚丙酸在制备用于预防和/或治疗肾炎药物中的用途。
一方面，本发明所述的吲哚丙酸，其化学结构为吲哚-3-丙酸；
更进一步地，所述吲哚丙酸，包括吲哚丙酸原形药物或其药学上可接受的盐、或其溶剂合物、或其前体药物、或其代谢产物。
另一方面，所述肾炎是指原发于肾小球的急性或慢性肾炎；
进一步地，所述治疗用途包括(但不限于)肾炎有关的高尿素氮病症；
进一步地，所述治疗用途包括(但不限于)肾炎有关的高血清肌酐病症；
进一步地，所述治疗用途包括(但不限于)肾炎有关的高尿蛋白定量病症。
又一方面，本发明所述的药物，其使用方式为口服。
第四方面，本发明所述的药物，是指吲哚丙酸、或其药学上可接受的盐、或其溶剂合物、或其前体药物、或其代谢产物为药效成分，加上药学上可接受的辅料制备得到的制剂。
发明的效果：
吲哚丙酸是人体肠道内肠道菌群的代谢产物，大量研究已证实吲哚丙酸对人体的有益作用，也表明了吲哚丙酸的安全性高，无明显的不良反应。吲哚丙酸不仅不会引起免疫系统紊乱，还能通过对肠道菌群的分布和多样性的有益性调节作用，稳定肠道粘膜屏障，发挥抗炎作用；另外，吲哚丙酸无抑菌作用，不会引起肠道菌群紊乱和强抗药性致病菌的产生。本发明的实验研究结果表明吲哚丙酸能过够显著降低肾炎模型动物的尿蛋白定量和血清中肌酐、尿素氮水平，发挥显著的治疗作用，在肾炎治疗方面具有广阔的应用前景。
附图说明
图1吲哚丙酸对尿蛋白定量水平的影响，与对照组比较：##P<0.01；与模型组比较：**P<0.01
图2吲哚丙酸对血清尿素氮水平的影响，与对照组比较：##P<0.01；与模型组比较：**P<0.01
图3吲哚丙酸对血清肌酐水平的影响，与对照组比较：##P<0.01；与模型组比较：**P<0.01
具体实施方式
以下通过具体实施例对本发明的上述内容作进一步的说明，以下实例是用于阐释本发明的技术内容，并不是对本发明内容的限定，所有基于本发明所作出的变化或等同替换，均应属于本发明的保护范围。
实施例1动物分组、肾炎模型构建与给药
健康SD大鼠24只，雄性，正常适应性喂养1周后，称体重，尿蛋白试纸检测均为阴性，24h尿蛋白定量均在10mg以下。
将大鼠随机分为空白对照组8只和造模组16只。
通过改良border法制备造模试剂：阳离子化牛血清白蛋白(C-BSA)，C-BSA与等体积生理盐水混合后，再加入等体积弗氏不完全佐剂，并将其充分乳化。
造模组大鼠在腹股沟皮下注射1mL乳化液，隔天注射1次，预免疫1周，共注射3次。
1周后，造模组腹腔注射C-BSA，每周3次，连续注射3周后，测24h尿蛋白定量>8mg则造模成功。造模成功后，将造模组随机分为模型组8只和给药组8只。
给药组大鼠给予吲哚-3-丙酸(IPA)灌胃20mg/kg/day，对照组和模型组给予同体积生理盐水灌胃，连续给药3周。
给药后每7天记录一次大鼠体重。
实施例2血清肌酐、尿素氮和尿蛋白定量检测
实验结束后，大鼠禁食不禁水，采集24h尿液，测尿蛋白定量(UTP)。
大鼠禁食12h后，麻醉，腹主动脉取血，用罗氏Cobas Integra 800全自动生化分析仪测尿素氮(BUN)和血清肌酐(CRE)。
用SPSS 28.0统计软件进行数据处理，结果以均数±标准差表示，所有定量数据均经过正态性和方差齐性检验，组间比较采用单因素方差分析(one-way ANOVA)，多重比较采用LSD检验，方差不齐时采用秩和检验。
表1大鼠体重变化
如表1和图1～3所示，体重记录数据显示，均呈线性增长趋势，各组增长趋势近似，这提示吲哚丙酸无明显毒副作用。与模型组相比，给予吲哚丙酸的大鼠表现出更好的精神状态、进食量和进水量。
表2吲哚丙酸对大鼠UTP和血清BUN、CRE水平的影响
与对照组比较：##P<0.01；与模型组比较：**P<0.01
血清肌酐(CRE)、尿素氮(BUN)和尿蛋白定量(UTP)水平数据如表2和图1～3所示，给予造模试剂后，大鼠出现明显的蛋白尿症状，UTP为10.92±1.29mg，显著高于空白组的7.37±0.77mg，同时伴随血液中CRE和BUN水平的显著提升，二者分别升高至138.46±28.73μmol/L和10.43±0.97mg/L，而空白对照组的这两个指标分别为74.46±24.46μmol/L和6.62±1.52mg/L。这表明肾炎模型构建成功，模型稳定，临床表现典型。在给予吲哚丙酸治疗后，大鼠的尿蛋白定量、血肌酐和尿素氮水平显著下降至5.07±1.09mg、104.01±21.40μmol/L和7.28±0.95mg/L。结果表明，吲哚丙酸能显著改善肾炎模型动物的临床症状，对肾炎具有显著的治疗作用，且无明显的毒副作用。所以吲哚丙酸在制备治疗肾炎药物中具有很好的开发前景，有望成为一种新型的肾炎治疗药物。
Claims (8)
1.吲哚丙酸在制备用于预防和/或治疗肾炎药物中的用途。
2.根据权利要求1所述的吲哚丙酸，为吲哚-3-丙酸、或其药学上可接受的盐、或其溶剂合物、或其前体药物、或其代谢产物。
3.根据权利要求1所述的应用，其特征在于，所述药物在制备用于预防和/或治疗原发于肾小球的炎性疾病药物中的用途。
4.根据权利要求3所述的应用，其特征在于，所述药物在制备用于预防和/或治疗降低血尿素氮水平的药物中的用途。
5.根据权利要求3所述的应用，其特征在于，所述药物在制备用于预防和/或治疗降低血肌酐水平的药物中的用途。
6.根据权利要求3所述的应用，其特征在于，所述药物在制备用于预防和/或治疗降低尿蛋白定量水平的药物中的用途。
7.根据权利要求1所述的应用，其特征在于，药物的使用方式为口服。
8.一种药物，其特征在于：它是以权力要求1～2任意一项所述的吲哚丙酸、或其药学上可接受的盐、或其溶剂合物、或其前体药物、或其代谢产物为药效成分，加上药学上可接受的辅料制备得到的制剂。
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