CN116747229A - 环二肽在制备治疗生殖类疾病的药物中的应用 - Google Patents
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Abstract
本发明公开了环二肽在制备治疗前列腺系统类疾病的药物中的应用。本发明在环二肽原有功效的基础上进行新的用途开发,试验证明:赖氨酸‑酪氨酸环二肽可以富集于前列腺、膀胱组织;能够降低前列腺增生模型大鼠的湿重比;改善前列腺增生模型大鼠的导管上皮细胞增生及炎症。并且实验发现赖氨酸‑酪氨酸环二肽可以通过调节雄激素影响生殖系统,具有很好的治疗前列腺增生或性激素相关疾病的功效。本发明提供的环二肽具有疗效确切,安全性好、无毒副作用等优点。
Description
技术领域
本发明涉及环二肽的新用途,特别涉及环二肽在制备治疗生殖类疾病的药物中的应用。
背景技术
前列腺系统疾病是老年男性最常见的疾病之一,随着年龄增长其患病率逐渐增高。这类疾病虽然不致命,但治愈率低、复发率高、病程长,严重影响身体及生殖健康,是影响中老年男性健康的重要公共卫生问题。
由于前列腺、膀胱组织内部存在血-前列腺屏障,药物难以通过此屏障达到治疗生殖系统疾病的有效浓度,成为生殖系统药物治疗过程中存在的最大障碍。血-前列腺屏障是由血管内皮细胞和紧密连接蛋白共同构成的一种位于血管与前列腺组织之间的天然生物屏障,提高药物对生殖系统生物屏障的渗透性,是前列腺系统治疗药物功效的关键。
发明内容
发明目的:本发明的目的是为了克服现有技术的不足,开发环二肽(包括赖氨酸-酪氨酸环二肽等)新的临床用途,提供其在制备治疗生殖系统疾病的药物中的应用,实验结果表明环二肽具有良好治疗前列腺增生或性激素相关疾病的作用。
技术方案:为了实现以上目的,本发明采取的技术方案为:
环二肽在制备治疗生殖类疾病的药物中的应用。
作为优选,所述的生殖类疾病包括前列腺增生、前列腺炎或前列腺肥大及性激素相关疾病。
作为优选,所述的环二肽包括赖氨酸-酪氨酸环二肽或它的衍生物及其药学上可接受的盐类。
所述的赖氨酸-酪氨酸环二肽分子式为C15H21N3O3,分子量为291。结构式如下:
作为优选方案,将环二肽和药学上可接受的载体制成片剂、注射剂、胶囊剂、颗粒剂、丸剂、微丸、散剂、滴丸剂、汤剂、糖浆剂、合剂、煎膏剂或浸膏剂剂型的药物。制成眼用制剂包括滴眼剂、眼用凝胶剂等。
作为优选,所述的环二肽是通过人工合成或者自然物中获得。
有益效果:本发明相比现有技术具有以下优点
本发明在环二肽进行新的用途开发,试验证明:赖氨酸-酪氨酸环二肽可以富集于前列腺、膀胱组织;能够降低前列腺增生模型大鼠的湿重比;改善前列腺增生模型大鼠的导管上皮细胞增生。并且实验发现赖氨酸-酪氨酸环二肽可以通过调节雄激素受体影响生殖系统。具有很好的治疗前列腺增生、前列腺炎或前列腺肥大和调节性激素的功效。本发明提供的环二肽具有疗效确切,安全性好、无毒副作用等优点。
附图说明
图1是赖氨酸-酪氨酸环二肽组织分布图。
图2是赖氨酸-酪氨酸环二肽改善前列腺增生的前列腺指数图。
图3是赖氨酸-酪氨酸环二肽改善前列腺增生的组织切片图。
具体实施方式
下面结合具体实施例进一步阐明本发明,应理解这些实施例仅用于说明本发明而不用于限制本发明的范围,在阅读了本发明之后,本领域技术人员对本发明的各种等价形式的修改均落于本申请所附权利要求所限定的范围。
实施例1
1实验材料.
1.1组织分布
利用MS对赖氨酸-酪氨酸环二肽的组织分布进行测定;
①给药方案
组织分布研究:取雄性SD大鼠18只,体重约200g,分为3组,每组6只,试验前禁食12-24h,自由饮水。试验时,3组给药剂量均为10mg/kg。
②血浆、组织的采集与匀浆液的制备
经给药后不同时间点(15min、30min、120min),异氟烷麻醉后眼眶静脉丛取血,然后处死一组大鼠,立即取心、肝、脾、肺、肾、胃肠、脑、生殖腺等组织,表面用生理盐水将血液清洗干净后,用滤纸吸干水分,称重,至于玻璃匀浆管中,加入3倍生理盐水进行研磨匀浆,即得各组织匀浆液,置-80℃保存。
分别置于干净的EDTA·Na2抗凝EP管中,4℃条件下5000r·min-1离心10min,取血浆,-80℃冰箱中保存备用。
③血浆与组织样品的预处理
取血浆或组织匀浆液100μL于1.5mL EP管中,加入500μL乙腈涡旋5min,12 000r/min离心10min,精密吸取400μL上层乙腈提取液,至新的EP离心管中,室温下氮气吹干,残留物以500μL流动相复溶,12000r/min离心5min,上清液经0.22μm滤膜过滤,装进样小瓶,备用。
(2)样品分析
色谱条件:赛分Sepax Bio-C18色谱柱(4.6mm×250mm,5μm;流动相:0.1%TFA(三氟乙酸)乙腈-0.1%TFA水(10:90);柱温30℃;等度洗脱,流速:1.0mL/min,进样量10μL。
质谱条件:电喷雾离子源(ESI源);检测方式为负离子模式,扫描时间100ms,碰撞气模式:Medium,气帘气(CUR)压力36psi,离子化电压(IS voltage)-4500V,离子源温度(TEM)550℃,喷雾气(GS1,N2)压力55psi,辅助加热气(GS2,N2)压力55psi。进行组织分布浓度计算。
结果见图1赖氨酸-酪氨酸环二肽的组织分布,本发明提供的赖氨酸-酪氨酸环二肽可以富集于前列腺及膀胱。
1.2列腺增生指数及组织观察
取54只雄性,8周SD大鼠随机分为6组,健康对照组,模型组(丙酸睾酮肌肉注射50mg/kg,每两天注射一次,连续四周),赖氨酸-酪氨酸环二肽低剂量治疗组(每天灌胃给药3mg·kg-1,连续两周),赖氨酸-酪氨酸环二肽中剂量治疗组(每天灌胃给药10mg·kg-1,连续两周),赖氨酸-酪氨酸环二肽高剂量治疗组(每天灌胃给药30mg·kg-1,连续两周),非那雄胺(每天灌胃给药5mg·kg-1,连续两周)。最后一次给药前禁食12-24h,自由饮水。最后一次给药后,异氟烷麻醉后眼眶静脉丛取血,然后处死大鼠,立即取前列腺组织。并进行称重、观察。计算前列腺指数并形态观察。
前列腺指数=前列腺湿重(mg)/体重(g)×100%,结果见图2。前列腺组织用10%甲醛进行常规脱水、石蜡包埋,4μm连续切片,HE染色,光镜观察,结果见图3。A对照组B前列腺增生模型组、C非那雄胺组、D赖氨酸-酪氨酸环二肽低剂量组、E赖氨酸-酪氨酸环二肽中剂量组F赖氨酸-酪氨酸环二肽高剂量组(*与健康对照组比较,P<0.05)。
由以上图3的实验结果可知,非那雄胺组、赖氨酸-酪氨酸环二肽各剂量组较前列腺增生组前列腺指数均降低;前列腺增生模型组的前列腺增生显著,非那雄胺组、赖氨酸-酪氨酸环二肽各剂量组的前列腺上皮乳头增生情况组较增生模型组均得到改善;赖氨酸-酪氨酸环二肽能有效的抑制前列腺组织增生。
以上所述仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以做出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。
Claims (5)
1.环二肽在制备治疗生殖系统疾病的药物中的应用。
2.根据权利要求1所述的应用,其特征在于,所述的生殖系统疾病包括前列腺增生、前列腺炎、前列腺肥大或性激素相关疾病。
3.根据权利要求1所述的应用,其特征在于,所述的环二肽包括赖氨酸-酪氨酸环二肽或它的衍生物及其药学上可接受的盐类。
4.根据权利要求1所述的应用,其特征在于,将环二肽和药学上可接受的载体制成片剂、注射剂、胶囊剂、颗粒剂、丸剂、微丸、散剂、滴丸剂、汤剂、糖浆剂、合剂、煎膏剂或浸膏剂剂型的药物。
5.含有环二肽的组合物在制备治疗生殖系统疾病的药物中的应用。
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