CN116327851A - 一种中药组合物在改善良性前列腺增生和其所致下尿路症状中的应用 - Google Patents
一种中药组合物在改善良性前列腺增生和其所致下尿路症状中的应用 Download PDFInfo
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Abstract
本发明公开了一种中药组合物在改善良性前列腺增生和其所致下尿路症状中的应用，所述中药组合物，是以经典名方程氏萆薢分清饮为基础，原料药经煎煮浓缩，得到的提取物进行冷冻干燥后，获得粉剂。通过良性前列腺增生模型动物研究发现，程氏萆薢分清饮能显著改善前列腺体积、增生水平，降低良性前列腺增生标志物前列腺特异性抗原、双氢睾酮和睾酮含量，并能改善前列腺增生导致的下尿路症状。
Description
技术领域
本发明涉及一种组合物的应用，具体涉及一种中药组合物在改善良性前列腺增生和其所致下尿路症状中的应用。
背景技术
人口老龄化是世界、特别是中国存在的一个突出性社会问题，提高老年人的身体健康和生活质量已成为全球关注的焦点。良性前列腺增生在60岁以上的老年男性中发病率占到了50％以上，由于前列腺体积增大而造成的下尿路症状，使患者表现出尿频、尿急、尿不净等一系列临床症状。
目前，良性前列腺增生存在发病机制不明、缺乏有效治疗药物的问题。中医中药治疗为解决临床疑难杂症提供了新的机遇。程氏萆薢分清饮出自清代程钟龄的《医学心悟》，共8味药材组成，配伍严谨，具有清利湿热、化瘀泄浊的功用，已广泛用于多种疾病尤其是慢性前列腺炎的治疗。
然而，程氏萆薢分清饮虽对前列腺炎安全有效，但尚无研究将其用于良性前列腺增生的治疗。前列腺炎和良性前列腺增生是两种不同的疾病，具有发病人群不同、发病机制不同、症状不同、治疗原则不同、病情归转不同的差异。而目前涉及到的研究内容均不能说明程氏萆薢分清饮对良性前列腺增生有治疗作用。列举如下。
潘志强等(程氏萆薢分清饮对经尿道前列腺电切术后膀胱痉挛的临床效果，甘肃医药，2021年，40卷，第9期)所述程氏萆薢分清饮的治疗作用是针对膀胱痉挛，而非治疗前列腺增生，属于药物作用的疾病类型不同。而文中参考文献[11]的引用则是错误的，参考文献[11]即卢恒等(程氏萆薢分清饮联合八正散加减治疗湿热蕴结型慢性前列腺炎的临床观察，光明中医，2016年，12月，第31卷，第23期，3388页)的研究，其在排除标注1.4中明确排除了前列腺增生，未述程氏萆薢分清饮能够治疗良性前列腺增生。
卢恒等(程氏萆薢分清饮联合八正散加减治疗湿热蕴结型慢性前列腺炎的临床观察，光明中医，2016年，12月，第31卷，第23期，3388页)在排除标注1.4中明确排除了前列腺增生，未述程氏萆薢分清饮能够治疗良性前列腺增生。
朱政衡等(程氏萆薢分清饮治疗前列腺痛74例临床观察，云南中医中药杂志，2017年，第38卷，第9期，95页)在排除标注⑥中明确排除了前列腺增生，未述程氏萆薢分清饮能够治疗良性前列腺增生。
发明内容
发明目的：本发明的目的在于提供一种能够用于治疗良性前列腺增生的中药组合物。
技术方案：中药组合物在制备改善良性前列腺增生和其所致下尿路症状的药物中的应用，该中药组合物包括以下重量份比例的原料药：萆薢6～12份，盐炙车前子6～12份，丹参6～12份，炒黄柏2～4份，石菖蒲2～4份，茯苓4～8份，炒白术4～8份，莲子心3～5份。
所述改善良性前列腺增生的表现包括抑制前列腺体积、前列腺器官指数、前列腺病理增生和良性前列腺增生标志物的表达。
所述下尿路症状指由良性前列腺增生导致的排尿异常。
所述改善良性前列腺增生所致下尿路症状为降低排尿次数，提升平均排尿量。
中药制剂在制备改善良性前列腺增生和其所致下尿路症状的药物中的应用，该中药制剂是由以下重量份比例的原料药提取制得：萆薢6～12份，盐炙车前子6～12份，丹参6～12份，炒黄柏2～4份，石菖蒲2～4份，茯苓4～8份，炒白术4～8份，莲子心3～5份。
所述中药制剂是原料药经煎煮浓缩，得到的提取物进行冷冻干燥后，获得粉剂。
本研究通过经典的去势手术结合丙酸睾酮注射构建了良性前列腺增生大鼠模型，用于验证所述的中药组合物改善良性前列腺增生和其所致下尿路症状。
有益效果：与现有技术相比，本发明具有如下优点：本发明提供所述的中药组合物在改善良性前列腺增生和其所致下尿路症状上的应用，为良性前列腺增生和其所致下尿路症状的防治提供一种新的药物选择，其可以显著改善良性前列腺增生和其所致下尿路症状。
附图说明
图1空白组、对照组、阳性药组和中药组合物治疗组对良性前列腺增生大鼠前列腺体积和前列腺器官指数的抑制作用；
图2空白组、对照组、阳性药组和中药组合物治疗组对良性前列腺增生大鼠排尿参数的改善作用；
图3空白组、对照组、阳性药组和中药组合物治疗组对良性前列腺增生大鼠良性前列腺增生标志物表达的抑制作用；
图4空白组、对照组、阳性药组和中药组合物治疗组对良性前列腺增生大鼠前列腺病理水平的改善作用。
具体实施方式
1、实验材料
1.1中药组合物：萆薢6～12份，车前子(盐炙)6～12份，丹参6～12份，黄柏(炒)2～4份，石菖蒲2～4份，茯苓4～8份，白术(炒4～8份，莲子心3～5份，加水没过药面(约9倍量)，浸泡30min后大火煮沸，改文火慢煎45min，取水煎液，100目尼龙纱布过滤；药渣再加水约7倍量，同法煎煮30min，过滤，合并二次滤液，低温(60℃)减压(-0.8Mpa)浓缩，冷冻干燥，得中药组合物冻干粉。
1.2动物：8周龄SPF级Wistar雄性大鼠(体重230±20g)购自南京市江宁区青龙山动物繁殖场。饲养条件：实验动物用颗粒饲料，置于清洁级实验动物房，自由饮食饮水。动物许可证号：SYXK(苏)2018-0049。
1.3试剂：丙酸睾酮(南京中医药大学动物实验中心提供)，苏木素伊红(H&E)染色试剂盒(碧云天生物技术有限公司)，大鼠PSA、DHT和T试剂盒(上海茁彩生物科技有限公司)。
2、实验方法
2.1良性前列腺增生大鼠模型的建立和给药分组：大鼠适应性饲养1周后，行假手术+玉米油的大鼠作为空白组(Sham)外；去势手术+丙酸睾酮造模为对照组(BPH)；BPH给药非那雄胺为阳性药组(Fin组)；BPH给药高、中、低中药组合物为高(High)、中(Middle)、低剂量(Low)组。
2.2排尿参数记录：造模给药后，采用代谢笼，大鼠灌胃30mL饮用水后，观察大鼠排尿频次、单次排尿量，并计算排尿总量和平均排尿量。
2.3前列腺大小记录：实验周期结束后，大鼠称重，处死取前列腺，前列腺按组拍照记录；前列腺器官指数为前列腺质量/大鼠体重。
2.4前列腺组织病变评估：实验周期结束后，进行脏器病理学分析(H&E染色)。大鼠处死取前列腺，用10％的福尔马林固定后，石蜡包埋，脱蜡后用苏木精-伊红染液进行染色，光学显微镜下观察脏器病理学变化。本实验使用的是组织的石蜡切片。样品切片先在60℃烘箱中放置1h左右，直至切片的石蜡呈水滴状。随后置入二甲苯中脱蜡10min，换新配二甲苯，再次脱蜡10min。将样品切片依次浸泡在无水乙醇中5min，90％乙醇中2min，70％乙醇中2min，蒸馏水中2min。随后将样品切片用苏木素染色液染色10min，PBS洗涤10min以洗去多余的染色液。蒸馏水再清洗10min，95％乙醇5s，伊红染色液染色30s。随后将样品切片置于95％乙醇中脱水2min，换新配95％乙醇，再次脱水2min。再将样品切片置于二甲苯中浸泡5min。换新配二甲苯，再次浸泡5min，封片剂封片，显微镜下观察。
2.5良性前列腺增生标志物检测：取大鼠静脉血，分离血清，利用Elisa试剂盒检测PSA、DHT和T的含量。经加样、酶标抗体孵育、底物显色和数据记录后，计算可得。
2.6统计分析：结果以均值±标准差表示，采用Graphpad 8.0进行t-test显著性差异分析，p值均标识在图中，以p＜0.05为统计学差异有显著性。
实施例1
中药组合物对良性前列腺增生的抑制作用
如图1所示，给药周期结束后，取大鼠前列腺，比较其体积和器官指数。结果显示，良性前列腺增生造模(BPH)显著增加了前列腺体积和器官指数，高、中、低剂量的中药组合物均能抑制前列腺器官指数。说明中药组合物对良性前列腺增生有抑制作用。
实施例2
中药组合物对良性前列腺增生所致下尿路症状的改善作用
如图2所示，中药组合物能缓解良性前列腺增生所致下尿路症状，在不影响总尿量前提下，降低排尿频次，提高平均尿量，高剂量中药组合物疗效显著。
实施例3
中药组合物对良性前列腺增生标志物的抑制作用
如图3所示，中药组合物抑制了良性前列腺增生标志物(PSA、DHT和T)的水平，说明中药组合物对良性前列腺增生有抑制作用。
实施例4
中药组合物对良性前列腺增生病理的改善作用
如图4所示，实验周期结束后，取大鼠前列腺，进行组织病理学检测分析。高剂量中药组合物显著抑制良性前列腺增生模型的前列腺腺腔中突出和腺上皮细胞厚度。
综上结果表明，中药组合物能抑制良性前列腺增生疾病的前列腺增大现象、抑制其所致下尿路症状、抑制良性前列腺增生标志物的表达并改善组织增生病理水平。以上结果均说明该中药组合物能治疗良性前列腺增生。
Claims (6)
1.一种中药组合物在制备改善良性前列腺增生和其所致下尿路症状的药物中的应用，其特征在于，该中药组合物包括以下重量份比例的原料药：萆薢6～12份，盐炙车前子6～12份，丹参6～12份，炒黄柏2～4份，石菖蒲2～4份，茯苓4～8份，炒白术4～8份，莲子心3～5份。
2.根据权利要求1所述的应用，其特征在于，所述改善良性前列腺增生的表现包括抑制前列腺体积、前列腺器官指数、前列腺病理增生和良性前列腺增生标志物的表达。
3.根据权利要求1所述的应用，其特征在于，所述下尿路症状指由良性前列腺增生导致的排尿异常。
4.根据权利要求3所述的应用，其特征在于，所述改善良性前列腺增生所致下尿路症状为降低排尿次数，提升平均排尿量。
5.一种中药制剂在制备改善良性前列腺增生和其所致下尿路症状的药物中的应用，其特征在于，该中药制剂是由以下重量份比例的原料药提取制得：萆薢6～12份，盐炙车前子6～12份，丹参6～12份，炒黄柏2～4份，石菖蒲2～4份，茯苓4～8份，炒白术4～8份，莲子心3～5份。
6.根据权利要求5所述的应用，其特征在于，所述中药制剂是原料药经煎煮浓缩，得到的提取物进行冷冻干燥后，获得粉剂。
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