CN116570696A - 一种用于治疗前列腺炎的中药组合物及其制备方法和应用 - Google Patents
一种用于治疗前列腺炎的中药组合物及其制备方法和应用 Download PDFInfo
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Abstract
本发明公开了一种用于治疗前列腺炎的中药组合物及其制备方法和应用,属于药物技术领域。本发明的中药组合物由包括以下原料制成:黄芪、三七、黄柏、紫花地丁、蜜制高乌头、败酱草、白芷、龙胆草、茜草、薏苡仁、猪苓、赤小豆、桂枝、酒白芍、柴胡、莪术、香附、牛膝、荔枝核、覆盆子、淫羊藿、甘草。本发明中药组合物在制备预防或/和治疗前列腺炎、或/和提高免疫力的药物中的应用;在制备减缓前列腺炎引发的疼痛或/和排尿问题或/和改善长期患病造成的心理或/和生理障碍药物中的应用。本发明中药组合物具有扶正祛邪,清热解毒、消炎止痛、活血化瘀、疏肝理气、补肾壮阳、提高免疫力的功效,能有效治疗炎症所致的各类不适症状及心理、生理障碍。
Description
技术领域
本发明属于药物技术领域,具体涉及一种用于治疗前列腺炎的中药组合物及其制备方法和应用。
背景技术
前列腺炎,相当于中医学的精浊病,是一种好发于中年及青年男性的男科及泌尿外科疾病,此类患者可占男科及泌尿外科门诊患者总数的三分之一,具有发病率及复发率均较高的特征。目前,指南推荐使用药物治疗为主的综合治疗方案,但临床常用的几种药物,包括α-受体阻滞剂、抗生素等,均仅能起到短暂的作用,难以持续有效的根治炎症。这就导致患者用药后症状有所好转,一旦停药症状又再次出现。或在患者认为已经治愈后,症状又出现反复,且长期使用易产生耐药性。久而久之,各种不适症状成为了患者难以甩去的阴影。而中医治疗则可达到清热解毒,化瘀止痛,增强机体免疫力,标本兼治的全面效果。
发明内容
本发明的目的之一在于,提供一种用于治疗前列腺炎的中药组合物,组合物中的诸药配伍,共同作用,不仅能够缓解炎症引发的疼痛症状,还能改善前列腺炎导致的排尿问题,减轻病情所引发的心理、生理障碍。
本发明的目的之二在于,提供该中药组合物的制备方法。
本发明的目的之三在于,提供该中药组合物在制备预防或/和治疗前列腺炎的药物中的应用。
为实现上述目的,本发明采用的技术方案如下:
本发明提供的一种用于治疗前列腺炎的中药组合物,由包括以下重量份的原料制成:黄芪20-55份、三七15-45份、黄柏10-35份、紫花地丁15-45份、蜜制高乌头10-25份、败酱草10-25份、白芷10-25份、龙胆草10-25份、茜草15-35份、薏苡仁15-35份、猪苓15-35份、赤小豆15-35份、桂枝10-25份、酒白芍10-25份、柴胡15-35份、莪术10-25份、香附15-35份、牛膝10-25份、荔枝核10-25份、覆盆子15-35份、淫羊藿15-35份、甘草10-25份。
本发明的部分实施方案中,该中药组合物由包括以下重量份的原料制成:黄芪20-50份、三七15-40份、黄柏10-30份、紫花地丁15-40份、蜜制高乌头10-20份、败酱草10-20份、白芷10-20份、龙胆草10-20份、茜草15-30份、薏苡仁15-30份、猪苓15-30份、赤小豆15-30份、桂枝10-20份、酒白芍10-20份、柴胡15-30份、莪术10-20份、香附15-30份、牛膝10-20份、荔枝核10-20份、覆盆子15-30份、淫羊藿15-30份、甘草10-20份。
本发明的部分实施方案中,由包括以下重量份的原料制成:黄芪50份、三七40份、黄柏30份、紫花地丁40份、蜜制高乌头20份、败酱草20份、白芷20份、龙胆草20份、茜草30份、薏苡仁30份、猪苓30份、赤小豆30份、桂枝20份、酒白芍20份、柴胡30份、莪术20份、香附30份、牛膝20份、荔枝核20份、覆盆子30份、淫羊藿30份、甘草20份。
本发明提供的一种用于治疗前列腺炎的中药组合物,由以下重量份的原料制成:黄芪20-55份、三七15-45份、黄柏10-35份、紫花地丁15-45份、蜜制高乌头10-25份、败酱草10-25份、白芷10-25份、龙胆草10-25份、茜草15-35份、薏苡仁15-35份、猪苓15-35份、赤小豆15-35份、桂枝10-25份、酒白芍10-25份、柴胡15-35份、莪术10-25份、香附15-35份、牛膝10-25份、荔枝核10-25份、覆盆子15-35份、淫羊藿15-35份、甘草10-25份。
本发明的部分实施方案中,所述中药组合物还包括有药学上可接受的载体。
本发明的部分实施方案中,所述中药组合物是以黄芪、三七、黄柏、紫花地丁、蜜制高乌头、败酱草、白芷、龙胆草、茜草、薏苡仁、猪苓、赤小豆、桂枝、酒白芍、柴胡、莪术、香附、牛膝、荔枝核、覆盆子、淫羊藿、甘草为原料药,加入药学上可接受的载体按照常规方法制备而成的制剂。
本发明的部分实施方案中,所述制剂为口服制剂;
优选地,所述制剂为固体制剂;
更优选为口服固体制剂。
本发明提供的上述中药组合物的制备方法,包括以下步骤:
步骤1.将黄芪、三七、黄柏、蜜制高乌头、白芷、龙胆草、茜草、薏苡仁、猪苓、赤小豆、荔枝核、酒白芍、桂枝、柴胡、莪术、香附、牛膝、甘草粉碎后,用乙醇回流提取,提取液冷却至室温,过滤,得滤液I,备用;
步骤2.将紫花地丁、败酱草、淫羊藿、覆盆子用水提法进行提取,过滤,得滤液II,备用;
步骤3.将滤液I和滤液II合并,混匀,浓缩成浸膏,经干燥,制得浸膏粉。
步骤4.将浸膏粉加入药学上可接受的载体制备成制剂。
本发明的部分实施方案中,所述步骤1中,将黄芪、三七、黄柏、蜜制高乌头、白芷、龙胆草、茜草、薏苡仁、猪苓、赤小豆、荔枝核、酒白芍、桂枝、柴胡、莪术、香附、牛膝、甘草混合粉碎后,过筛,加乙醇在恒温水浴锅中回流提取,提取液冷却至室温后进行过滤;
优选地,粉碎后过5号筛;
优选地,用70-85%的乙醇回流提取;更优选为75%的乙醇;
优选地,乙醇用量为粉碎药材总量的8-10倍量;
优选地,在70-90℃恒温水浴锅中回流1-3h。
本发明的部分实施方案中,所述步骤2中,将紫花地丁、败酱草、淫羊藿、覆盆子混合后,再加蒸馏水用水提法进行提取,过滤;
优选地,先加入2-3倍量蒸馏水浸泡30-60min后再加热提取;
优选地,再加入6-8倍量水提取1-3次,每次1-2h;
优选地,将浸膏喷雾干燥,制得浸膏粉。
本发明还提供了上述中药组合物在制备预防或/和治疗前列腺炎、或/和提高免疫力的药物中的应用;
优选地,在制备减缓前列腺炎引发的疼痛或/和排尿问题或/和改善长期患病造成的心理或/和生理障碍药物中的应用。
病理病机分析:从中医学角度分析,精浊病病位在下焦,总体属于虚实夹杂,本虚标实,病机以脾肾亏虚为本,痰、湿、热、瘀为标。中医学认为“湿、热、瘀、滞、虚”贯穿在前列腺炎的不同阶段。“湿热蕴结,气滞血瘀”是本病的发病关键,发病初期以湿热为主,出现尿频、尿急、尿痛等症状;中期以湿毒内蕴为主,出现尿道口有乳白色分泌物等症状;后期瘀浊互结,阻滞下焦,致使前列腺脉络阻滞不通,出现会阴部、后尿道疼痛等症状,随着病情进展,或因病情反复,迁延不愈,必然损伤人体正气,亏虚日盛。肝主筋,而患者常存在心理问题,肝气不舒,肝失疏泄,气机郁滞,血行受阻,阻滞精室,气血不能灌注宗筋,阴器局部不能充盈而致阳痿、早泄等。肝与血瘀关系密切,肝不疏泄,气血郁遏于内,所滞之处皆可成瘀。前列腺属阴器,为肝经所过,由肝经所主,肝之经气不舒,疏泄不利,则瘀浊阻滞精窍。肾藏精而主生殖,男子以肾为先天,肾阳是人体全身阳气的根本,有温煦、蒸腾、气化、推动、激发和固摄等作用,男子生殖器官发育和生殖功能的维持都离不开肾阳的作用。故治疗此病应优先治其标然后补其根本,治当以清热止痛、解毒消炎,消肿排脓为主,活血散瘀,利尿除湿为辅,佐以疏肝益肾之品以固本,形成先于解除症状,再者治其心理,最后增强性功能的治疗原则。
黄芪:为豆科植物蒙古黄芪Astragalus membranaceus(Fisch.)Bge.var.monghlicus(Bge.)Hsiao或膜荚黄芪Astragalus membranaceus(Fisch.)Bge.的干燥根。具有补气固表,利尿托毒,排脓,敛疮生肌之功。常用于气虚乏力,食少便溏,中气下陷,久泻脱肛,气虚水肿,痈疽难溃,久溃不敛,血虚痿黄,内热消渴。与猪苓、赤小豆、薏苡仁等配伍应用可加强组方利尿除湿之功。与三七配伍主要作用是活血、祛瘀、补气。黄芪与紫花地丁药联用具有解毒消肿,生肌排脓的作用。现代药理研究发现,黄芪可通过抗氧化应激和炎性因子、抑制内脏的纤维化和抗细胞凋亡对脏器形成保护作用。实验发现,黄芪提取物可以通过抑制炎症反应,改善能量代谢。
三七:为五加科植物三七Panax notoginseng(Burk.)F.H.Chen的干燥根和根茎。具有化瘀止血、活血止痛的功能,主治吐血、咳血、外伤出血、胸腹剌痛,跌扑肿痛等。与高乌头、茜草、酒白芍配伍应用具有活血化瘀止痛之功。现代药理研究表明,三七总皂苷可以促进造血细胞增殖,促进红细胞、血红蛋白和网织红细胞的恢复,对急性炎症引起的毛细血管通透性升高、炎症渗出和组织水肿等炎症均有抑制作用。三七皂苷Rg1和原人参皂苷可提高血小板内GAMP的含量,可以对熔接纤维蛋白原起到一定的促进作用,从而使血液的黏度降低,抑制血小板聚集,血栓的形成,改善微循环的作用。
黄柏:为芸香科植物黄皮树Phellodendron chinense Schneid.的干燥树皮。具有清热燥湿、泻火除蒸、解毒疗疮之功效。配合白芷、龙胆草用于带下阴肿,治湿热疮疡、湿疹之症。现代药理研究表明,黄柏通过调调节蛋白的表达水平,改善肾功能炎症症状,增强免疫系统能力。实验发现,从黄柏中分离出的二氢小檗碱可通过对NF-κB和丝裂原活化蛋白激酶信号通路的双重调控发挥抗炎作用。
紫花地丁:为堇菜科植物紫花地丁Viola yedoensis Makino的干燥全草。具有清热解毒、凉血消肿、消痛散结的功效。常与蒲公英、金银花、野菜花等同用。紫花地丁与败酱草配伍使用具有清热解毒,凉血消痈,祛瘀散痛之力。现代药理学研究发现,紫花地丁对于多种病菌均有比较强的抑菌作用,其提取物能够很好地降低由于炎症引起的血清白细胞介素水平、肿瘤细胞坏死因子水平、炎性组织中前列腺素E2的水平。
蜜制高乌头:为高乌头的炮制品,为蜜煮生高乌头而得。高乌头为毛茛科乌头属植物高乌头Aconitum sinomontanum Nakai的干燥根茎,具有祛风除湿,散瘀止痛的功效。用于风湿腰腿痛,胃气痛,跌打损伤。现代药理学研究表明,高乌头可以抑制由单核巨噬细胞产生的TNF-α的产生,促进IL-4、IL-10等抑炎因子的生成,提高抗炎细胞因子的活性,抑制炎症因子,从而达到抗炎的作用,高乌甲素还可以通过抑制相关神经的传导并阻碍Na+运输,从而使去甲肾上腺素的含量增加,抑制产热因子的释放发挥清热作用。
败酱草:为败酱科植物黄花败酱Patrinia scabiosaefolia Fisch.ex Link、白花败酱P.villose Juss.的干燥全草。具有清热解毒、消痈排脓、祛瘀止痛之功效。用于肠痈、肺痈及疮痈肿毒,实热瘀滞所致的胸腹疼痛,产后瘀滞腹痛等症,凡热毒、瘀血或热毒兼血瘀者皆可选之。配伍薏苡仁既清解热毒、消痈排脓,又祛瘀止痛,兼健脾。现代研究表明,败酱草能增强网状细胞和白细胞的吞噬能力,促进抗体形成,提高血清溶菌酶的水平,从而达到抗菌消炎的目的。白芷:为伞形科植物白芷Angelica dahurica(Fisch.ex Hoffm.)Benth.et Hook.f.或杭白芷Angelica dahurica(Fisch.ex Hoffm.)Benth.etHook.f.var.formosana(Boiss.)Shan et Yuan的干燥根。具有祛风除湿、通窃止痛、消肿排脓的作用。主治感冒头痛,眉棱骨痛,牙痛,鼻塞,鼻渊,湿胜久泻,妇女白带,痈疽疮疡,毒蛇咬伤。现代药理研究表明,白芷提取物在治疗炎症方面,与抗生素治疗相比,治疗具有较短的治疗过程,并且可使致病因子产生耐药性的可能性较低。
龙胆草:为龙胆科植物条叶龙胆Gentiana manshurica Kitag.、龙胆Gentianascabra Bge.、三花龙胆Gentianatriflora Pall.或坚龙胆Gentiana rigescens Franch.的干燥根和根茎。具有清热燥湿,泻肝胆火的作用。用于湿热黄疸,阴肿阴痒,带下,强中,湿疹瘙痒,目赤,耳聋,胁痛,口苦,惊风抽搐。龙胆草配以薏苡仁、猪苓、赤小豆,则清利湿热,配以柴胡,则清肝泻火。现代药理研究表明,龙胆草中的龙胆苦苷对急、慢性炎症反应有抑制作用,对热和化学刺激引起的疼痛反应有明显的镇痛作用,对炎症早期渗出具有一定的抑制作用。
茜草:为茜草科植物茜草Rubia cordifolia L.的干燥根和根茎。味苦性寒,具凉血止血,活血化瘀,通经之力,用于吐血、衄血、崩漏下血、外伤出血、经闭瘀阻、关节痹痛、跌扑肿痛。现代药理研究表明,茜草可使全血黏度及血浆黏度有所降低,血浆纤维蛋白原的含量升高,而且茜草能够显著延长凝血酶原时间,缩短凝血酶时间和活化部分凝血活酶时间,对由ADP诱导的血小板聚集表现出更加明显的促进作用。
薏苡仁:为禾本科植物薏米Coix lacryma-jobi L.var.ma-yuen(Roman.)Stapf的干燥成熟种仁。具有健脾渗湿,除痹止泻,清热排浓之效。用于水肿,脚气,小便不利,湿痹拘挛,脾虚泄泻,肺痈,肠痈;扁平疣。实验发现,薏苡仁可以通过降低血管通透性减少炎性渗出以及干预IKK/NF-κB信号通路,降低多种炎症因子分泌水平等作用。
猪苓:为多孔菌科真菌猪苓Polyporus umbellatus(Pers.)Fries的干燥菌核。具有利水渗湿的作用,主治小便不利,水肿,泄泻,淋浊,带下。现代药理研究表明,猪苓可抑制尿Ca2+排泄,抑制尿草酸钙结晶的生长与聚集,显著降低血清尿素氮和肌酐的浓度,对机体肾功能有明显的保护作用,从而改善肾功能,减少腺嘌呤代谢产物对肾脏的病理性损害。猪苓多糖具有抗肿瘤和提高机体免疫力的作用,且有明显的肝脏保护作用,可抑制肝损伤。
赤小豆:本品为豆科植物赤小豆Vigna umbellata Ohwi et Ohashi或赤豆Vignaangularis Ohwi et Ohashi的干燥成熟种子。具有利水消肿、解毒排脓的功能,主治水肿胀满,脚气肢肿,黄疸尿赤,风湿热痹,痈肿疮毒,肠痈腹痛等。现代药理研究表明,具有补益、抗氧化、增强免疫、抗菌、雌激素样作用等药理作用。临床上常用于肝硬化腹水、急性肾炎、泌尿系统感染等疾病的辅助治疗。
桂枝:樟科植物肉桂Cinnamomum cassia Presl的干燥嫩枝。具有发汗解肌,温通经脉,助阳化气,平冲降气之功效,可温助一身之阳气,流畅一身之血脉。上以宣通心胸之阳,下以温化中下二焦之阴气,既通阳又降逆,故方中以桂枝温阳化气以助利水,解表散邪以祛表邪。与赤小豆、猪苓等同用,以助阳化气利水。现代药理研究表明,桂枝具有缓和肠胃刺激、强心、改善微循环、抗炎、抗血小板凝集等多种生理活性。实验发现,肉桂醛能以细菌Fts Z蛋白为作用靶点抑制细菌的分裂,从而达到抑菌杀菌效果。
酒白芍:白芍为毛茛科植物芍药Paeonia lactiflora Pall.的干燥根。酒白芍是以白芍为原料酒制而成。增强其活血通络、和里缓急止痛的功效,用于血瘀腹痛、脘腹挛痛、经行腹痛诸症。现代药理研究表明,白芍对醋酸扭体法致小鼠疼痛模型有镇痛作用,其提取物能够明显增加具有血流的节间血管数量,抑制血栓生成、促进血液流动的活性。白芍对肝炎、肝损伤和肝纤维化有保护作用。
柴胡:为伞形科植物柴胡Bupleurum chinense DC.或狭叶柴胡Bupleurumscorzonerifolium Willd.的干燥根。具有和解表里,疏肝,升阳的作用。主要用于感冒发热,寒热往来,胸胁胀痛,月经不调,子官脱垂,脱肛诸症。具轻清升散,又能疏泄的特点,既能透表退热、疏肝解郁,又可用于升举阳气。现代药理研究表明,柴胡皂苷通过调节胆碱能神经系统达到抗抑郁和抗焦虑的功效。柴胡皂苷a和d具有一定的抗炎作用,通过抑制脂多糖(LPS)活性,减少与炎症相关的前列腺素E2(PGE2)和一氧化氮(No)的分泌。
莪术:为姜科植物蓬莪术Curcuma phaeocaulis VaL.、广西莪术Curcumakwangsiensis S.G.Lee et C.F.Liang或温郁金Curcuma wenyujin Y.H.ChenetC.Ling的干燥根茎。具有行气破血,消积止痛的作用。荔枝核对对腺体增生结节、息肉有软坚散结之功,且能行气止痛。莪术可行气活血,使气行血行,络脉畅通,通则不痛。二者配伍具有行气散结,止痛的功效。现代研究表明,莪术有效成分姜黄素可以通过直接抑制NF-κB信号传导通路,进而影响促炎因子发挥抗炎作用。
香附:为莎草科植物莎草Cyperus rotundus L.的干燥根茎。具有疏肝解郁、理气宽中、宽胸化痰之功。现代药理研究表明,香附可参与促性腺激素释放信号通路、神经营养因子信号通路以及黏着斑信号通路,进而抑制因抑郁而导致的神经元的损伤,其次其还能调节相应的信号转导通路以产生抗抑郁效应。
荔枝核:为无患子科植物荔枝Litchi chinensis Sonn.的干燥成熟种子。行气散结,祛寒止痛。用于寒疝腹痛,睾丸肿痛。宣散寒湿甘涩而温。入肝肾。散滞气,辟寒邪。现代药理研究发现,荔枝核提取物通过抑制花生四烯酸环氧酶代谢途径发挥显著的消炎、镇痛的效果。还可以抑制小鼠血浆电胶原蛋白和ADP诱导的血小板凝聚,延长凝血时间并提高纤溶活性,具有良好的抗血小板凝聚、抗凝血及促进纤维蛋白水解的活性。
覆盆子:蔷薇科植物华东覆盆子Rubus chingii Hu的干燥果实。具有益肾、固精、缩尿,养肝明目的功效。用于治疗遗精滑精,遗尿尿频,阳痿早泄,目暗昏花等症。现代药理研究发现,覆盆子的活性成分可直接作用于下丘脑—垂体—性腺轴系统,具有调节血清中性激素的水平的特性,通过抗氧化、抗衰老保持机体活力、调节免疫、抗炎、调节微量元素改善男性生殖功能。
淫羊藿:为小檗科植物淫羊藿Epimedium brevicornu Maxim.、箭叶淫羊藿Epimedium sagittatum(Sieb.et Zucc.)Maxim.、柔毛淫羊藿Epimedium pubescensMaxim.或朝鲜淫羊藿Epimedium koreanum Nakai的干燥叶。补肾阳,强筋骨,祛风湿。用于阳痿遗精,筋骨痿软,风湿痹痛,麻木拘挛。现代中药药理学研究表明,淫羊藿中生物碱能显著提升睾丸系数、附睾系数,提升睾酮水平等作用。淫羊藿苷可以明显增加生精小管管壁厚度,同时精子数量增多,血清睾酮含量增加。淫羊藿总黄酮直接刺激雄性生殖系统中睾酮、雌二醇的分泌,从而促进黄体生成素的分泌来增强雄性生殖器功能,通过对细胞激素和生殖器官的增益起到作用。
牛膝:为苋科植物牛膝Achyranthes bidentata Bl.的干燥根。补肝肾,强筋骨,逐瘀通经,引血下行。用于腰膝酸痛,筋骨无力,经闭症瘕,肝阳眩晕,能引诸药下行。现代药理研究表明,牛膝多糖具有显著的增强人体免疫功能的作用,能升高血清溶血素和脾脏内抗体形成细胞数,激活网状内皮系统的吞噬功能,促进淋巴细胞增殖,增强NK细胞和CTL细胞的活性。牛膝提取物对蛋清引起的大鼠足肿胀和棉球引起的肉芽肿胀有明显抑制作用,从而表明牛膝提取物具一定的抗炎镇痛作用。
甘草:甘草为豆科植物甘草Glycyrrhiza uralensis Fisch.、胀果甘草Glycyrrhiza inflata Bat.或光果甘草Glycyrrhiza glabra L.的干燥根和根茎。具有益气补中、清热解毒、润肺止咳的功效,还具有缓急止痛、调和药性的效果。现代药理学研究证实,甘草素能激活雌激素受体减少神经炎症,甘草查尔酮A可显著抑制环氧合酶2的活性和表达,使得甘草具备了抗炎作用。
《灵枢·口问》有言“中气不足,溲便为之变”,认为脾气虚弱,中气下陷可引发此病。黄芪甘温补升,善补中气,升举清阳,补气行滞,治脾肺气虚,中气下陷。气有推动、温煦、固摄作用,气虚后推动功能不足,会造成血瘀。三七微苦泄散,甘补温通,走守兼备,泄中兼补,具有活血化瘀兼补虚的功效,活血不留瘀的特点。黄芪与三七配伍补脾气分以统摄血液在脉中的正常运行,以三七开通之,则补而不滞,具有补气活血祛瘀之功。血瘀会造成血脉流通不畅,血行郁阻不通则痛,高乌头辛温有毒,善散瘀止痛,三七配伍高乌头主攻血液瘀滞的疼痛,具有活血散瘀止痛之功。《素问·至真要大论篇》又言“诸转反戾,水液浑浊,皆属于热”,认为下焦有热可引发此病。黄柏苦泄寒清,燥而沉降,既清泻实热而解热毒,又燥湿、除湿毒而解湿热毒,作用偏于肾及下焦膀胱,最善清相火,除下焦湿热。紫花地丁寒清,苦泄辛散,善清解血分热毒而凉血消肿。二者合用,重在清热解毒。同时,本组方用药以寒温之性并用,苦甘之味并存,以蜜制高乌头和黄柏配伍,高乌头性温能祛风除湿,散瘀止痛,黄柏苦寒泻火坚阴、清下焦湿热,一温一寒,相辅相成。紫花丁地苦寒具清热解毒,凉血消肿之效,黄芪甘温具补气固表,利尿托毒,排脓,敛疮生肌之功,两者一温一寒,一苦一甘,协同作用。两组药对共为君药,寒热同调,配以三七从而散瘀止痛,清热解毒,消肿排脓,又以黄芪善补气行滞,使气旺血行瘀散,共为君药。三七、黄柏、紫花地丁、高乌头皆具苦泄之力,因此重用黄芪以其补气升阳之功使君药攻补兼施,升降相伍。
败酱草辛散苦泄,微寒能清,走气入血,既清热解毒,排脓消痈,又祛瘀止痛,与紫花丁地相使为用,增强紫花地丁清热解毒之功;白芷辛散温通,芳香走窜,既走气分又走血分,茜草苦泄散,寒清凉,入肝经,善活血凉血而化瘀通经,白芷、茜草、三七合用,可助三七活血行气止痛通经;又有龙胆草大苦大寒,清泄而燥沉降下行,入肝经、胆经,兼入膀胱经,既泻胆肝实火而解热毒,善除肝胆及膀胱湿热而解湿热毒,与黄柏、白芷相须,增强组方清解湿热之功;薏苡仁、猪苓皆甘淡渗利兼补,善于渗利水湿,薏苡仁又兼健脾之功,赤小豆清中而又活血,桂枝善温通助阳、温化水湿,四药合用与黄芪相须为用,使湿热从小便而出,又能健脾和胃,以复脾胃之运化,从而固其脾虚之病机根本。以上八药相合共为臣药,使组方具清热毒,化瘀血,祛湿邪,利小便之功,从而协助君药主攻湿毒热邪所致尿频、尿急、尿痛,分泌物增多等症状。
酒白芍具有增强活血通络的功效,与桂枝、甘草同用,可增强和里缓急止痛的作用,牛膝苦泄降,酸入肝,甘补渗,善补益肝肾,逐瘀通经,引血下行,酒白芍与牛膝二者合用可助三七、茜芷、高乌头等活血散瘀诸药行于下焦,攻以瘀浊互结,阻滞下焦,所致的前列腺脉络阻滞不通。柴胡辛散苦泄微寒,善疏肝解郁,且引药直达病所,使肝气升发条达,香附辛香行散,微苦略降,善疏肝理气止痛,二药相须为用,从而增强组方疏肝理气之功。莪术辛散苦泄温通,入血走气,善于破血破气而止痛消癥,荔枝核微苦泄散,甘温能通,能行气散结止痛,二药相须为用,可助君药行气散结。覆盆子酸敛甘补,微温质润,既收敛固涩,又滋养肝肾,且略兼助阳。淫羊藿能补肾阳而强筋骨,二药相使为用,增强淫羊藿补肾阳之功。以上诸药合为佐药,辅以君臣药治标的同,佐以行气通络,疏肝益肾之品以固本。甘草甘补和缓,平而偏凉,既清热,缓急止痛,又调和诸药,以牛膝引血下行之功,二者同为使药。
前列腺炎以“痰、湿、热、瘀”为标,本发明组合物以先于治标,再者固本,为治疗原则。以上诸药合用以中医的“君臣佐使”理论为依据,合理配置,相互配伍。本组方以黄芪、三七、黄柏、紫花地丁、蜜制高乌头为君药,补气行滞,活血散瘀,清热解毒;以败酱草、白芷、龙胆草、茜草、薏苡仁、猪苓、赤小豆、桂枝为臣药,清热除湿,活血化瘀,利小便;以酒白芍、莪术、柴胡、香附、牛膝、荔枝核、覆盆子、淫羊藿为佐药,通经活络,疏肝理气,补肾助阳;甘草、牛膝清热解毒,调和诸药,引药下行,是为使药。本发明诸药合而为用,共奏清热解毒、消炎止痛、活血化瘀、疏肝理气、补肾助阳之效,形成先于解除症状,再调畅心理,后助其恢复肾脏功能的治疗方式。本发明配方诸药行于下焦发挥其调节气血,扶正祛邪的作用,通过药效持续不断的作用于患者的病灶,从而达到治疗疾病的目的。
研究发现“自身免疫”在前列腺炎的发生发展中可能起到了比较重要的作用。另有研究发现前列腺导管常因炎症刺激使管腔狭窄,或结石阻塞,致使前列腺导管引流不畅。本发明组合物从药理角度以提高自身免疫,消除炎症为主要目的。实验发现,黄芪、三七、猪苓、荔枝核、淫羊藿、牛膝等中药的多糖成分皆对免疫功能有影响,能从多个层面调节免疫系统,增强人体的免疫力。紫花地丁与黄柏在增强机体免疫和细胞免疫方面也具有非常重要的作用。黄芪、紫花地丁、黄柏、三七、高乌头、败酱草、龙胆草、白芷、薏苡仁、香附、白芍、莪术、牛膝、甘草等中药提取物皆具有保护脏器、抑制炎症反应作用。其中,三七总皂苷通过抑制因炎症引起的毛细血管通透性升高、炎症渗出和组织水肿。黄柏通过调节蛋白表达水平,改善肾功能炎症症状。紫花地丁通过降低炎症引起的细胞水平起到抗炎作用。高乌头可减少致炎因子及相关炎症介质形成,抑制毛细血管通透性。败酱草能提高血清溶菌酶的水平,达到抗菌消炎的目的。龙胆草提取物可抑制炎症早期渗出,且有明显的镇痛作用。白芷总挥发油可抑制炎症因子的释放。薏苡仁降低多种炎症因子分泌水平等作用。莪术有效成分姜黄素可影响促炎因子或信号通路发挥抗炎作用。高乌甲素、三七总皂苷、龙胆苦苷具有极好的镇痛作用,且无成瘾性。白芷香豆素类成分可与受体结合,通过介导痉挛、炎症等相关的信号通路辅助三七、高乌头、龙胆草发挥镇痛作用。赤小豆对金黄色葡萄球菌等多种细菌都有抑制作用。桂枝中挥发油类成分具有显著的抗菌活性荔枝核具有消炎、镇痛,抗血小板凝聚、抗凝血的作用。三七可抑制血小板聚集,促进造血细胞增殖,茜草可使血液黏度降低,延长凝血酶原时间,联合三七共同抑制血小板聚集,血栓的形成。以上诸药联用,能够清晰明确的解决前列腺因炎症刺激导致的管腔狭窄,引流不畅等临床问题。
心理障碍程度与病程长短关系密切,病程越长,心理障碍越重,而心理负担愈重,病程愈迁延。香附、白芍提取物具有很强的抗抑郁作用。柴胡能加快新陈代谢,使得气血流通加快,同样具有抗抑郁和抗焦虑的功效。以上三药联用,可有效控制前列腺炎患者因病情反复带来的情绪低落、焦虑、抑郁、恐惧、悲观等心理症状。因病情导致的精神症状同时伴随着尿频、尿急、腰背部和会阴部肌肉紧张疼痛,严重影响生活质量。猪苓对肾功能具有很好的保护作用。覆盆子能显著提高肾虚的阴茎勃起时间,增强自主活动能力。淫羊藿具有增强雄性生殖器功能。三药合用,配合香附、白芍、柴胡等心理治疗,使其性生活时能够获得更好的表现,有利于解除症状-心理-性功能上的死循环,对前列腺炎的治疗会有很大帮助。
本发明中英文简写对应的中文名称为:
MCC:微晶纤维素;PVPP:交联聚乙烯吡咯烷酮;PEG-4000:聚乙二醇-4000;PEG-6000:聚乙二醇-6000。
与现有技术相比,本发明具有以下有益效果:
本发明设计科学,配方合理,诸药合用,具有扶正祛邪,清热解毒、消炎止痛、活血化瘀、疏肝理气、补肾壮阳、提高免疫力的功效,能有效治疗炎症所致的各类不适症状及心理、生理障碍。利用黄芪既能利尿托毒,补气固表,又能抑制炎症反应,改善能量代谢,提高免疫力的作用,巧妙的配合蜜制高乌头强化组方活血化瘀、止痛消炎的功效,使得组方功效明显优于常规消炎止痛组方。药理实验显示,本发明中药组合物可有效增加大鼠排尿量,减轻炎症引发的疼痛,显著提高大鼠前列腺中锌含量,有效降低白细胞数,对前列腺炎有明显抑制作用。临床实践充分证明,本组方可有效治疗前列腺炎所致的各类不适症状,具有改善病情,促进其预后,增强机体免疫力,加快病情恢复的作用。同时,兼有制备方法简单,能够更好的保留药物组分的有效成分,生产成本较低、服用方便等优势,市场前景广阔。
具体实施方式
下面结合具体的实施例和组合物药理效果的验证,对本发明做进一步的详细说明,所述是对本发明的解释而非限定。实施例中未注明具体条件者,按照常规条件或制造商建议的条件进行。所用试剂或仪器未注明生产厂商者,均为可以通过市售购买获得的常规产品。
本申请中所有涉及的份数如无特殊说明,均指重量份。
实施例1
本实施例公开了本发明的中药组合物的制备方法,其原料组成为:
黄芪50份、三七40份、黄柏30份、紫花地丁40份、蜜制高乌头20份、败酱草20份、白芷20份、龙胆草20份、茜草30份、薏苡仁30份、猪苓30份、赤小豆30份、桂枝20份、酒白芍20份、柴胡30份、莪术20份、香附30份、牛膝20份、荔枝核20份、覆盆子30份、淫羊藿30份、甘草20份。
本实施例的制备方法为:
步骤1.将黄芪、三七、黄柏、蜜制高乌头、白芷、龙胆草、茜草、薏苡仁、猪苓、赤小豆、荔枝核、酒白芍、桂枝、柴胡、莪术、香附、牛膝、甘草混合粉碎,过5号筛,用10倍量的75%乙醇在80℃恒温水浴锅中回流1h,提取液冷却至室温后进行过滤,制的滤液I,备用。
步骤2.将紫花地丁、败酱草、淫羊藿、覆盆子混合后,先加入3倍量蒸馏水浸泡30min,再加入6倍量水煎煮2次,每次1h,滤过,合并滤液,得滤液II,备用。
步骤3.将滤液I和滤液II合并,混匀,浓缩成浸膏,经喷雾干燥,制得浸膏粉。
步骤4.将步骤3所得浸膏粉,以浸膏粉:填充剂(异麦芽酮糖醇:MCC=1:3)=1:1.5的质量比混合均匀,加入80%的乙醇溶液进行湿法制粒,在60℃下干燥,加入1%的硬脂酸镁,与1%的PVPP,压制成片,每片0.6g,每次2片。
实施例2
本实施例公开了本发明的中药组合物的制备方法,其原料组成为:黄芪35份、三七28份、黄柏20份、紫花地丁28份、蜜制高乌头15份、败酱草15份、白芷15份、龙胆草15份、茜草23份、薏苡仁23份、猪苓23份、赤小豆23份、桂枝15份、酒白芍15份、柴胡23份、莪术15份、香附23份、牛膝15份、荔枝核15份、覆盆子23份、淫羊藿23份、甘草15份。
制备方法如下:
步骤1.将黄芪、三七、黄柏、蜜制高乌头、白芷、龙胆草、茜草、薏苡仁、猪苓、赤小豆、荔枝核、酒白芍、桂枝、柴胡、莪术、香附、牛膝、甘草混合粉碎,过5号筛,用药材9倍量的75%乙醇在75℃恒温水浴锅中回流2h,提取液冷却至室温后进行过滤,制的滤液I,备用。
步骤2.将紫花地丁、败酱草、淫羊藿、覆盆子混合后,先加入2.5倍量蒸馏水浸泡45min,再加入7倍量水煎煮3次,每次1.5h。滤过,合并滤液,得滤液II,备用。
步骤3.将滤液I和滤液II合并,混匀,浓缩成浸膏,经喷雾干燥,制得浸膏粉。
步骤4.将步骤3所得浸膏粉,按重量比为1:1.5加入辅料,辅料配方为乳糖、糊精与甜菊糖苷1:1:0.015(质量比),混匀,加入70%乙醇,过筛后,湿法挤压制粒,干燥,即得。所得颗粒剂的规格为每袋6g,每次服用一袋。
实施例3
本实施例公开了本发明的中药组合物的制备方法,其原料组成为:黄芪20份、三七15份、黄柏10份、紫花地丁15份、蜜制高乌头10份、败酱草10份、白芷10份、龙胆草10份、茜草15份、薏苡仁15份、猪苓15份、赤小豆15份、桂枝10份、酒白芍10份、柴胡15份、莪术10份、香附15份、牛膝10份、荔枝核10份、覆盆子15份、淫羊藿15份、甘草10份。
制备方法如下:
步骤1.步骤1.将黄芪、三七、黄柏、蜜制高乌头、白芷、龙胆草、茜草、薏苡仁、猪苓、赤小豆、荔枝核、酒白芍、桂枝、柴胡、莪术、香附、牛膝、甘草混合粉碎,过5号筛,用药材8倍量的75%乙醇在70℃恒温水浴锅中回流3h,提取液冷却至室温后进行过滤,制的滤液I,备用。
步骤2.将紫花地丁、败酱草、淫羊藿、覆盆子混合后,先加入2倍量蒸馏水浸泡60min,再加入8倍量水煎煮,提取时间2h。过滤提取液,得滤液II,备用。
步骤3.将滤液I和滤液II合并,混匀,浓缩成浸膏,经喷雾干燥,制得浸膏粉。
步骤4.将步骤3所得浸膏粉,以PEG-4000:PEG-6000=1:1(质量比)为基质,按照提取物浸膏粉∶基质=1:9、滴制温度90℃、冷却剂温度(0-5℃)、滴距8cm,制备成滴丸,每袋装0.5g,一次1袋。
实施例4
本实施例公开了本发明的中药组合物的制备方法,其原料组成为:黄芪45份、三七45份、黄柏10份、紫花地丁10份、蜜制高乌头15份、败酱草10份、白芷10份、龙胆草10份、茜草15份、薏苡仁35份、猪苓35份、赤小豆35份、桂枝10份、酒白芍15份、柴胡35份、莪术10份、香附15份、牛膝25份、荔枝核10份、覆盆子15份、淫羊藿15份、甘草15份。
制备方法如下:
步骤1.将黄芪、三七、黄柏、蜜制高乌头、白芷、龙胆草、茜草、薏苡仁、猪苓、赤小豆、荔枝核、酒白芍、桂枝、柴胡、莪术、香附、牛膝、甘草混合粉碎,过5号筛,用药材9倍量的85%乙醇在75℃恒温水浴锅中回流2h,提取液冷却至室温后进行过滤,制的滤液I,备用。
步骤2.将紫花地丁、败酱草、淫羊藿、覆盆子混合后,先加入3倍量蒸馏水浸泡30min,再加入5倍量水煎煮3次,每次1h。滤过,合并滤液,得滤液II,备用。
步骤3.将滤液I和滤液II合并,混匀,浓缩成浸膏,经喷雾干燥,制得浸膏粉。
步骤4.将步骤3所得浸膏粉,按重量比为1:1.5加入辅料,辅料配方为乳糖、糊精与甜菊糖苷1:1:0.015(质量比),混匀,加入70%乙醇,过筛后,湿法挤压制粒,干燥,即得。所得颗粒剂的规格为每袋6g,每次服用一袋。
实施例5
本实施例公开了本发明的中药组合物的制备方法,其原料组成为:
黄芪55份、三七15份、黄柏35份、紫花地丁45份、蜜制高乌头25份、败酱草25份、白芷25份、龙胆草10份、茜草35份、薏苡仁15份、猪苓30份、赤小豆35份、桂枝25份、酒白芍25份、柴胡15份、莪术25份、香附35份、牛膝10份、荔枝核25份、覆盆子35份、淫羊藿35份、甘草25份。
本实施例的制备方法为:
步骤1.将黄芪、三七、黄柏、蜜制高乌头、白芷、龙胆草、茜草、薏苡仁、猪苓、赤小豆、荔枝核、酒白芍、桂枝、柴胡、莪术、香附、牛膝、甘草混合粉碎,过5号筛,用10倍量的70%乙醇在80℃恒温水浴锅中回流1h,提取液冷却至室温后进行过滤,制的滤液I,备用。
步骤2.将紫花地丁、败酱草、淫羊藿、覆盆子混合后,先加入2倍量蒸馏水浸泡30min,再加入6倍量水煎煮3次,每次1h,滤过,合并滤液,得滤液II,备用。
步骤3.将滤液I和滤液II合并,混匀,浓缩成浸膏,经喷雾干燥,制得浸膏粉。
步骤4.将步骤3所得浸膏粉,以浸膏粉:填充剂(异麦芽酮糖醇:MCC=1:3)=1:1.5的质量比混合均匀,加入80%的乙醇溶液进行湿法制粒,在60℃下干燥,加入1%的硬脂酸镁,与1%的PVPP,压制成片,每片0.6g,每次2片。
试验例1-4
试验例1-试验例4公开了本发明中药组合物的药效学试验。试验例1-试验例4所述的组合物1组、组合物2组、组合物3组分别为实施例1、实施例2和实施例3制备得到的中药组合物。
试验例1
本试验例公开了本发明的中药组合物对前列腺炎小鼠的尿流量影响试验。
实验材料
1、动物:SD雄性大鼠,体重160~180g。
2、药物:前列泰治疗组、组合物1组、组合物2组、组合物3组四个处方组。药物在实验前用蒸馏水配置,灌胃给药。
实验方法
SD雄性大鼠50只,体重160~180g,随机分成5组,每组10只。实验前大鼠禁食不禁水16h,各组按20ml/kg体重剂量腹腔注射生理盐水,并轻压下腹部使膀胱排空,接着各组分别给药。对照组灌胃同体积的蒸馏水,前列泰治疗组、组合物1组、组合物2组、组合物3组均灌胃给药为0.8、0.2、0.4、0.8g/kg。给药后立即将大鼠放入代谢笼内,按大鼠代谢笼实验法收集药后6h内总尿液量。实验结果:见表1。
表1对大鼠排尿量的影响结果表
组别 | 动物数(只) | 剂量数(g/kg) | 尿量(ml) |
正常对照组 | 10 | - | 4.42±0.33Cc |
前列泰治疗组 | 10 | 0.8 | 4.92±0.05Bb |
组合物1组 | 10 | 0.2 | 5.75±0.07Aa |
组合物2组 | 10 | 0.4 | 5.84±0.12Aa |
组合物3组 | 10 | 0.8 | 5.69±0.04Aa |
注:表中数据为平均值±标准误,同一列数据后小写字母不同者表示差异显著(P<0.05);大写字母不同者表示差异极显著(P<0.01)
结果分析
疼痛和排尿症状是前列腺炎患者的最主要症状。本发明组合物的三个试验组较前列泰治疗组对大鼠在给药后6h内尿量明显增加,对水负荷大鼠有显著的利尿作用,与对照组相比有极显著性的差异。本发明组合物与前列泰治疗组相比较有极显著性差异。可见,本发明组合物具有利尿作用。
试验例2
本试验例公开了本发明的中药组合物对醋酸所致小鼠扭体反应的影响试验。
实验材料
1、动物:昆明种小鼠,雌性兼有,体重18~22g。
2、药物:前列泰治疗组、组合物1组、组合物2组、组合物3组四个处方组。药物在实验前用蒸馏水配置,灌胃给药。
实验方法
昆明种小鼠50只,雌雄各半,体重18~22g,随机分成5组,每组10只。对照组灌胃同体积的蒸馏水,前列泰治疗组、组合物1组、组合物2组、组合物3组均灌胃给药为1.6、0.4、0.8、1.6g/kg。连续给药7d,末次给药1h后,每鼠均腹腔注射0.6%醋酸0.25ml/只,记录20min内小鼠扭体次数,并计算各组镇痛百分率。实验结果:见表2。
表2对醋酸所致小鼠扭体反应的影响试验结果表
组别 | 动物数(只) | 剂量数(g/kg) | 扭体次数(次) | 镇痛百分率(%) |
正常对照组 | 10 | - | 64.45±4.02Aa | - |
前列泰治疗组 | 10 | 1.6 | 42.98±1.35Bb | 33.31 |
组合物1组 | 10 | 0.4 | 38.70±0.30Bc | 39.95 |
组合物2组 | 10 | 0.8 | 28.36±2.16Cd | 55.99 |
组合物3组 | 10 | 1.6 | 31.80±1.61Cd | 50.66 |
注:表中数据为平均值±标准误,同一列数据后小写字母不同者表示差异显著(P<0.05);大写字母不同者表示差异极显著(P<0.01)。
结果分析
本发明组合物和前列泰治疗组对醋酸所致小鼠扭体具有明显的抑制作用,与对照组相比有极显著性的差异;本发明组合物与前列泰治疗组相比较有显著性差异。可见,本发明组合物具有镇痛作用。
试验例3
本试验例公开了本发明的中药组合物对前列腺炎的作用及大鼠前列腺锌含量的影响试验。
实验材料
1、动物:SD大鼠雄性大鼠,体重180-220g。
2、药物:前列泰治疗组、组合物1组、组合物2组、组合物3组四个处方组。药物在实验前用蒸馏水配置,灌胃给药。
实验方法
SD雄性大鼠60只,体重180-220g,随机分为6组,每组10只,对照组灌胃同体积的蒸馏水,前列泰治疗组、组合物1组、组合物2组、组合物3组均灌胃给药为1.6、0.4、0.8、1.6g/kg。连续给药7d,于给药后第4d,腹腔注射戊巴比妥钠45mg/kg麻醉后,在无菌条件下腹正中切口,于前列腺腹部,以1.4×107CFU/ml大肠杆菌生理盐水悬液0.1ml,注射在于前列腺头叶相连的精囊内。对照组注射0.1ml生理盐水,缝合后放入笼中饲养,造模后动物继续给药,并于第7d给药后处死,迅速剖腹,取前列腺按摩液测定白细胞数。
用剪刀将前列腺剪碎按100mg前列腺重量加1mL生理盐水至小烧瓶中将小烧瓶放入冰水浴然后用匀浆器搅拌充分制成匀浆(注意搅拌时要间断暂停以防止匀浆过热变性)。将搅拌好的匀浆吸取入离心试管中用TGL离心机进行离(3000r·min-1)10min后取匀浆上清液用BH5100五通道原子吸收光谱仪检测锌含量。实验结果,见表3。
表3对前列腺炎的作用及大鼠前列腺锌含量的影响(±S,n=10,只)
注:表中数据为平均值±标准误,同一列数据后小写字母不同者表示差异显著(P<0.05);大写字母不同者表示差异极显著(P<0.01)。
结果分析
本发明组合物和前列泰治疗组对醋酸所致小鼠扭体具有明显的抑制作用,与对照组相比有极显著性的差异;本发明组合物与前列泰治疗组相比较有显著性差异。可见,本发明组合物具有镇痛作用。
试验例4
本试验例公开了本发明的中药组合物对大鼠交配及阴茎勃起的影响试验。
实验材料
1、动物:SD雄性大鼠,体重160~180g。
2、药物:前列泰治疗组、组合物1组、组合物2组、组合物3组四个处方组。药物在实验前用蒸馏水配置,灌胃给药。
实验方法
雄鼠的处理:50只大鼠随机分为正常对照组10只和造模组40只。造模组动物按45mg/kg腹腔注射戊巴比妥钠麻醉,摘除右侧睾丸、左侧不做处理。正常对照组大鼠做假手术处理。术后各组动物肌肉注射青霉素钠,每只80000U,每天1次,连续3d。术后3d,造模组动物按体重随机分为前列泰治疗组、组合物1组、组合物2组、组合物3组,每组10只,分别均灌胃给药0.8、0.2、0.4、0.8g/kg,正常组给予纯净水,灌胃体积为10mL/kg,1次1d,共40d。
雌鼠的处理:50只大鼠按45mg/kg腹腔注射戊巴比妥钠麻醉,摘除双侧卵巢。术后按上述方法肌注青霉素钠进行抗感染处理。
(1)大鼠交配实验
为使去势的雌鼠同时发情,进行交配实验前2d,皮下注射给予苯甲酸雌二醇,剂量为0.2mg/kg;交配实验前4h,皮下注射给予黄体酮,剂量为2mg/kg。雄鼠在灌胃第30天晚上按1只/笼放入饲养笼中,适应环境5min后,然后每笼投入1只发情雌鼠。记录投入雌鼠起40min内,雄鼠首次捕捉雌鼠的时间、首次射精的时间、捕捉及射精的次数,并计算每组雄鼠的捕捉率和射精率。实验结果,见表4。
表4对大鼠交配情况的影响(±S,n=10,只)
注:表中数据为平均值±标准误,同一列数据后小写字母不同者表示差异显著(P<0.05);大写字母不同者表示差异极显著(P<0.01)
(2)大鼠阴茎勃起实验
雄鼠在结束第35天灌胃的1h后,检测动物的阴茎勃起潜伏期。将生物机能仪的电极固定于阴茎根部,以35V、35Hz的电流进行刺激,记录刺激开始到阴茎充血勃起的时间,记为阴茎勃起潜伏期。雄性大鼠第40天末次灌胃1h后,动物腹腔注射戊巴比妥钠麻醉,腹主动脉采血,离心,取上清,根据睾酮检测试剂盒(南京建成生物工程研究所)说明书检测睾酮的含量。实验结果,见表5。
表5对大鼠阴茎勃起的影响(±S,n=10,只)
组别 | 剂量数(g/kg) | 勃起潜伏期(s) | 睾酮(nmol/L) |
正常对照组 | - | 5.26±0.27Dd | 24.13±0.25Aa |
前列泰治疗组 | 1.6 | 6.45±0.25Cc | 17.30±0.36Dd |
组合物1组 | 0.4 | 8.63±0.09Aa | 20.87±0.25Cc |
组合物2组 | 0.8 | 9.04±0.52Aa | 22.23±0.45Bb |
组合物3组 | 1.6 | 7.45±0.45B | 21.20±0.50Cc |
注:表中数据为平均值±标准误,同一列数据后小写字母不同者表示差异显著(P<0.05);大写字母不同者表示差异极显著(P<0.01)。
结果分析
前列腺是人体锌含量最高的组织,高浓度的锌能抑制前列腺组织中致病菌生长,使炎症消退并维持前列腺的正常生理功能等。锌含量降低时前列腺对炎症的防御机制下降,抗菌能力也下降。白细胞是一种无色有核细胞,在机体防御系统中发挥重要功能。本实验结果显示,经过中药组合物治疗后,减轻了病变前列腺间质炎症反应及促进病损修复,同时Zn水平有了显著的提高,白细胞指标极显著低于模型对照组。表4与表5显示,本发明组合物可提高半去势雄性大鼠交配过程中的捕捉率、射精率和射精次数,同时改善睾酮的分泌,可以有效改善大鼠性功能表现。可见,本发明组合物对大鼠前列腺炎具有明显抑制作用,能有效改善病情,促进其预后,同时增强机体免疫力,明显提高大鼠性功能,加快病情恢复。
以上所述仅为本发明的较佳实施例而已,并不用以限制本发明,凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等,均应包含在本发明的保护范围之内。
Claims (10)
1.一种用于治疗前列腺炎的中药组合物,其特征在于,由包括以下重量份的原料制成:黄芪20-55份、三七15-45份、黄柏10-35份、紫花地丁15-45份、蜜制高乌头10-25份、败酱草10-25份、白芷10-25份、龙胆草10-25份、茜草15-35份、薏苡仁15-35份、猪苓15-35份、赤小豆15-35份、桂枝10-25份、酒白芍10-25份、柴胡15-35份、莪术10-25份、香附15-35份、牛膝10-25份、荔枝核10-25份、覆盆子15-35份、淫羊藿15-35份、甘草10-25份。
2.根据权利要求1所述的一种用于治疗前列腺炎的中药组合物,其特征在于,由包括以下重量份的原料制成:黄芪20-50份、三七15-40份、黄柏10-30份、紫花地丁15-40份、蜜制高乌头10-20份、败酱草10-20份、白芷10-20份、龙胆草10-20份、茜草15-30份、薏苡仁15-30份、猪苓15-30份、赤小豆15-30份、桂枝10-20份、酒白芍10-20份、柴胡15-30份、莪术10-20份、香附15-30份、牛膝10-20份、荔枝核10-20份、覆盆子15-30份、淫羊藿15-30份、甘草10-20份;所述中药组合物由包括以下重量份的原料制成:黄芪50份、三七40份、黄柏30份、紫花地丁40份、蜜制高乌头20份、败酱草20份、白芷20份、龙胆草20份、茜草30份、薏苡仁30份、猪苓30份、赤小豆30份、桂枝20份、酒白芍20份、柴胡30份、莪术20份、香附30份、牛膝20份、荔枝核20份、覆盆子30份、淫羊藿30份、甘草20份。
3.一种用于用于治疗前列腺炎的的中药组合物,其特征在于,由以下重量份的原料制成:黄芪20-55份、三七15-45份、黄柏10-35份、紫花地丁15-45份、蜜制高乌头10-25份、败酱草10-25份、白芷10-25份、龙胆草10-25份、茜草15-35份、薏苡仁15-35份、猪苓15-35份、赤小豆15-35份、桂枝10-25份、酒白芍10-25份、柴胡15-35份、莪术10-25份、香附15-35份、牛膝10-25份、荔枝核10-25份、覆盆子15-35份、淫羊藿15-35份、甘草10-25份。
4.根据权利要求1-3任意一项所述的中药组合物,其特征在于,还包括有药学上可接受的载体。
5.根据权利要求4所述的中药组合物,其特征在于,所述中药组合物是以黄芪、三七、黄柏、紫花地丁、蜜制高乌头、败酱草、白芷、龙胆草、茜草、薏苡仁、猪苓、赤小豆、桂枝、酒白芍、柴胡、莪术、香附、牛膝、荔枝核、覆盆子、淫羊藿、甘草为原料药,加入药学上可接受的载体按照常规方法制备而成的制剂。
6.根据权利要求5所述的中药组合物,其特征在于,所述制剂为口服制剂;
优选地,所述制剂为固体制剂;
更优选为口服固体制剂。
7.根据权利要求1-6任意一项所述的中药组合物的制备方法,其特征在于,包括以下步骤:
步骤1.将黄芪、三七、黄柏、蜜制高乌头、白芷、龙胆草、茜草、薏苡仁、猪苓、赤小豆、荔枝核、酒白芍、桂枝、柴胡、莪术、香附、牛膝、甘草粉碎后,用乙醇回流提取,提取液冷却至室温,过滤,得滤液I,备用;
步骤2.将紫花地丁、败酱草、淫羊藿、覆盆子用水提法进行提取,过滤,得滤液II,备用;
步骤3.将滤液I和滤液II合并,混匀,浓缩成浸膏,干燥,制得浸膏粉;
步骤4.将浸膏粉加入药学上可接受的载体制备成制剂。
8.根据权利要求7所述的中药组合物的制备方法,其特征在于,所述步骤1中,将黄芪、三七、黄柏、蜜制高乌头、白芷、龙胆草、茜草、薏苡仁、猪苓、赤小豆、荔枝核、酒白芍、桂枝、柴胡、莪术、香附、牛膝、甘草混合粉碎后,过筛,加乙醇在恒温水浴锅中回流提取,提取液冷却至室温后进行过滤;
优选地,粉碎后过5号筛;
优选地,用70-85%的乙醇回流提取;更优选为75%的乙醇;
优选地,乙醇用量为粉碎药材总量的8-10倍量;
优选地,在70-90℃恒温水浴锅中回流1-3h。
9.根据权利要求7所述的中药组合物的制备方法,其特征在于,所述步骤2中,将紫花地丁、败酱草、淫羊藿、覆盆子混合后,再加蒸馏水用水提法进行提取,过滤;
优选地,先加入2-3倍量蒸馏水浸泡30-60min后再加热提取;
优选地,再加入6-8倍量水提取1-3次,每次1-2h;
优选地,将浸膏喷雾干燥,制得浸膏粉。
10.根据权利要求1-6任意一项所述的中药组合物在制备预防或/和治疗前列腺炎、或/和提高免疫力的药物中的应用;
优选地,在制备减缓前列腺炎引发的疼痛或/和排尿问题或/和改善长期患病造成的心理或/和生理障碍药物中的应用。
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