CN103432270B - 一种治疗慢性前列腺炎的中药组合物 - Google Patents
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Abstract
一种治疗慢性前列腺炎的中药组合物，是将熟地黄、白芍、蛇床子、车前子、没药、丹皮、夏枯草、菟丝子混合加水煎煮，将煎液浓缩成清膏，粉碎后装入胶囊中制得。本发明药物中各组分可以相互协同，有效治疗湿热症、淤血症、中虚症或肾虚症型慢性前列腺炎，尤其适用于治疗肾虚症型慢性前列腺炎。经临床观察，总有效率达到90％以上，治疗效果较理想，且价格低廉，制备方法简便易行。
Description
技术领域
本发明涉及一种治疗前列腺炎的药物，特别是涉及一种以中药为原料药制备的治疗前列腺炎的中药组合物及其制备方法。
背景技术
中医学并无前列腺炎的记载，根据临床症状及体征，一般将其归入“淋证”、“精浊”、“白淫”等范畴。中医认为其病因一为嗜食烟、酒、辛辣、肥甘厚味，损伤脾胃，酿生湿热，流注下焦；二为房事不节，直接染毒，湿热毒邪逆行，留驻下焦；三为社会和环境因素，传媒刺激等影响，性欲得不到正常疏泄，频繁手淫，房事不节，忍精不泄，致前列腺反复充血，败精瘀阻精室，蕴久酿霉，阻于经络；或情志不畅，郁怒伤肝，肝气失于疏泄，久则血行不畅而致气血凝滞，气血凝滞又可加重湿热毒邪形成，两者互为因果。慢性前列腺炎的症状因人而异，主要分为以下两种：一种为疼痛症状，含下腹部、腰骶部、肛门周围、会阴部及睾丸、阴茎等部位疼痛；另一种为排尿不适，如尿不尽、尿频、尿急、尿无力、尿滴白等。全身症状主要为焦虑、精力不集中、精神不振，还会伴随有性功能异常，如射精过快、阴茎勃起不坚、性欲低下等。
前列腺炎分急性细菌性、慢性细菌性和非细菌性等不同类型。其发病机理是细菌感染；表皮葡萄球菌免疫反应；关节炎、虹膜炎，尿道器械检查、导尿管放置，上呼吸道、泌尿系感染、性机能变化或饮食不节，喜怒不时引起湿热内蕴、败精浊腐，导致腺体发炎，脓肿，急性期的典型症状是发冷发热、体温升高、恶心呕吐、尿频尿急、尿痛尿浊、便秘、会阴部及下背部胀痛、前列腺肿痛。慢性期的临床表现是头昏头晕、腰部酸痛、尿频尿急、排尿不尽、尿后排出粘液、性欲减退、阳痿早泄、睾丸肿痛前列腺炎病有症状复杂，病程迁延、顽固难愈、容易复发等特点。传统医学应用清利湿热、热毒通淋法多能奏效。
慢性前列腺炎是男性青壮年的常见病，多发病，在36岁以上的男性中慢性前列腺炎患病率可高达35％～37％。临床上以发病缓慢，病因病理复杂，症状表现多样，体征不典型，病情迁延反复发作，经久难愈为特点。
目前西医治疗前列腺炎基本上没有很好的药物，除了服用一些前列康，前列通等药物起一些缓解症状作用外，再就是静脉输注消炎药，但都存在消炎不消肿的现象，并且西药毒副作用较大，如对肝肾功能损伤。也有采用局部注射、手术进行治疗的，但疗效不很显著，易复发。中药在治疗慢性前列腺炎方面已取得了较好的疗效，尤其是在改善患者症状、提高患者生活质量方面具有较明显的优势，且费用较低廉，近年来，有关中药治疗前列腺炎的药物与研究越来越受到本领域研究人员的关注。
发明内容
本发明所要解决的技术问题在于，提供一种疗程短、见效快、组方精简，适合口服的治疗慢性前列腺炎的中药物组合物及其制备方法。
本发明的目的之一是在祖方的基础上经过多年研究提供了一种治疗慢性前列腺炎的中药物组合物，其特征在于，由含有以下中药材的原料制备而成：熟地黄、白芍、蛇床子、车前子、没药、丹皮、夏枯草、菟丝子。
具体地，治疗慢性前列腺炎的中药制剂，其特征在于，各种原料药的重量份数比为：
熟地黄12～22份，白芍6-12份，蛇床子6～8份，车前子3-6份，没药8～12份，丹皮4-6份，夏枯草12～22份，菟丝子16～22份。
优选地，本发明治疗慢性前列腺炎的中药制剂中各种原料药的重量份数比为：熟地黄18份，白芍8份，蛇床子6份，车前子4份，没药10份，丹皮6份，夏枯草12份，菟丝子18份。
本发明还提供了一种治疗慢性前列腺炎的中药物组合物的制备方法。本发明的上述中药组合物加入制备不同剂型时所需的各种常规辅料，例如崩解剂、润滑剂、黏合剂等以常规的中药制剂方法制备成任何一种常用的口服制剂，例如可以是，片剂、糖衣片剂、薄膜衣片剂、肠溶衣片剂、胶囊剂、硬胶囊剂、软胶囊剂、口服液、口含剂、颗粒剂、冲剂、蜜丸剂、散剂、丹剂、溶液剂或硬膏剂等。
本发明中药组合物优选为胶囊剂，具体的制备方法如下：
a.将所述原料药混合，切碎，浸泡；
b.将浸泡的原料药加3-5倍量水加热回流提取2次，每次1～2小时；
c.再取上述水提取后的药渣，加5～8倍重量份的50～75％乙醇加热回流提取2次，每次1～2小时；
d.将上述两种提取液合并，减压浓缩为，浓缩成50℃相对密度1.0～1.2的清膏，于50～60℃干燥后，粉碎成80～120目的药粉，装入胶囊中，灭菌消毒制得胶囊剂产品。
具体地，上述治疗慢性前列腺炎的中药组合物的制备方法，其特征在于，制备方法包括：
a.将所述原料药混合，切碎，浸泡；
b.将浸泡的原料药加3倍量水加热回流提取2次，每次2小时；
c.再取上述水提取后的药渣，加5倍重量份的60％乙醇加热回流提取2次，每次2小时；
d.将上述两种提取液合并，减压浓缩为，浓缩成50℃相对密度1.0～1.2的清膏，于60℃干燥后，粉碎成80目的药粉，装入胶囊中，灭菌消毒制得胶囊剂产品。
中医认为，慢性前列腺炎发病原因主要为湿热下行，瘀热阻于下焦，以致精道不利而病，其中医证型以多种多样，临床所见，本病主要病变部位在肾，与膀胱、心脾、肝等也有关，而“精窍”应该是前列腺、精囊腺、尿道球腺等分泌组成精液的组织器官。本病病因错综复杂，总的来说是败精淤浊，湿热下注，精关不固。概括而言，急慢性前列腺炎在内因上以湿热症，淤血症、中虚症、肾虚症为主要原因和进行症型分类。
方解：
熟地黄滋阴补血，益精填髓。用于肝肾阴虚，腰膝酸软，骨蒸潮热，盗汗遗精，内热消渴，血虚萎黄，心悸怔忡，月经不调，崩漏下血，眩晕，耳鸣，须发早白。
白芍入肝、脾经，养血柔肝，缓中止痛，敛阴收汗。治胸腹胁肋疼痛，泻痢腹痛，自汗盗汗，阴虚发热，月经不调，崩漏，带下，妇人血闭不通，消瘀血，能蚀脓，益女子血。《日华子本草》：治风、补劳，主女人一切病，并产前后诸疾，通月水，退热，除烦，益气，天行热疾，瘟瘴，惊狂，妇人血运，及肠风，泻血，痔瘘。发背，疮疥，头痛，明目，目赤努肉。赤色者多补气，白者治血。
蛇床子性辛、苦，温；有小毒。归肾经。主治温肾壮阳，燥湿，祛风，杀虫。用于阳痿，宫冷，寒湿带下，湿痹腰痛；外治外阴湿疹，妇人阴痒；滴虫性阴道炎，是妇科外用良药。《本草缢疏》载：蛇床子，味苦平；《别录》辛甘无毒；今详其气味，当必兼温燥，阳也。故主妇人阴中肿痛，男子阴痿湿痒，除痹气，利关节，恶疮。《别录》温中下气，令妇人子服热，男子阴强，令人有子。盖以舌能除湿，温能散寒，辛能润肾，甘能益脾，故能除妇人男子一切虚寒湿所生病。寒湿既除，则病去，性能益阳，故能己疾，而又有补益也。
车前子性味甘；淡；性微寒。归肺经；肝经；肾经；膀胱经。清热利尿；渗湿止泻；明目；祛痰。主治：主小便不利；淋浊带下；水肿胀满；暑湿泻痢；目赤障翳；痰热咳喘。
没药散血去瘀，消肿定痛。主治跌打损伤、金疮、筋骨、心腹诸痛、症瘕、经闭、痈疽肿痛、痔漏、目障。味苦，辛，平。入肝、脾、心、肾经。《本草经疏》载其：“凡骨节痛与夫胸腹胁肋痛，非瘀血停留而因于血虚者不宜用。产后恶露去多，腹中虚痛者不宜用。痈疽己溃不宜用。目赤肤翳非血热甚者不宜用。”
丹皮味苦，微寒，能清营分、血分实热，有凉血止血之功。治温病热入营血，迫血妄行。归肝经。功能主治清热凉血，散瘀止痛。用于温毒发斑，吐血衄血，目赤肿痛，肝郁胁痛，经闭痛经，症瘕腹痛，跌扑损伤，痈肿疮疡。丹皮清热凉血的作用较佳，既能清血分实热，又能治阴虚发热。《本经》载其：“主寒热，中风契从、痉、惊痫邪气，除坚症瘀血留舍肠胃，安五脏，疗痈疮。
夏枯草微苦，清肝、散结、利尿；治瘟病、乳痈、目痛、黄疸、淋病、高血压等症；治淋巴结核、甲状腺肿大、瘰疬、瘿瘤、乳痈、乳癌、目珠夜痛、羞明流泪、头目眩晕、口眼歪斜、筋骨疼痛、肺结核、急性黄疸型传染性肝炎、血崩、带下。夏枯草为清肝火、散郁结的要药，它所主治的大多是肝经的病症。本品配以菊花、决明子，可清肝明目，治目赤肿痛、配以石决明、钩藤，可平降肝阳，治头痛、头晕；配以玄参、贝母、牡蛎等品，可软坚散结，治瘰历结核。《滇南本草》：祛肝风，行经络，治口眼歪斜。行肝气，开肝郁，止筋骨疼痛、日珠痛，散瘰窃、周身结核。
菟丝子甘辛平，入肝、肾经。补肾益精，养肝明目，安胎。用于肝肾亏虚，腰膝酸痛，阳痿遗精，尿频遗尿，两目昏暗，胎动不安等症。功能滋补肝肾，固精缩尿，安胎，明目，止泻。用于阳痿遗精、尿有余沥、遗尿尿频、腰膝酸软、目昏耳鸣、肾虚胎漏、胎动不安、脾肾虚泻。
经临床实验验证，本发明中药制剂中各组分可以相互协同，有效治疗湿热症、淤血症、中虚症或肾虚症型慢性前列腺炎，尤其适用于治疗肾虚症型慢性前列腺炎。
此外，与现有的中药组合物相比还具有以下优点：
1)组方精简，与现有治疗中药药物相比大大缩减了处方。
2)原材料易得，制备工艺简单，适合工业化大规模生产。
3)治疗有效率高，经临床实验证实，总有效率高达90％以上，远高于前列康片。
为了证明本发明药物具有治疗慢性前列腺炎的功效，本发明作了大量的临床观察，现将临床实验公开如下：
1.选择病例
1.1诊断及纳入标准
诊断参照卫生部颁布的《中药新药临床研究指导原则》及美国国立卫生研究院慢性前列腺炎症状积分指数(N IH2CPSI)评分标准。基本诊断标准为前列腺按摩液(EPS)常规镜检白细胞(WBC)＞10个/HP、细菌培养阴性，另外有下列3项中的2项：①尿路刺激症状：尿频、尿急、尿痛、尿不尽、尿道滴白；②疼痛症状：腰骶、会阴、小腹、睾丸等部位疼痛或不适；⑧性功能异常：早泄、阴茎勃起功能障碍、性欲减退。
1.2排除标准
①神经原性膀胱炎、膀胱肿瘤、膀胱结石、前列腺癌等患者及有前列腺手术史者；②肝肾功能异常者；⑧两周内采用其他治疗前列腺疾病的药物，包括抗生素、受体阻滞剂、中药制剂等。
1.3一般资料
所有病例来源于自2009年3月～2013年7月来本院生殖医学科的就诊患者。随机分为两组，治疗组80例(其肾虚型慢性前列腺炎患者16例)，年龄20～52岁，病程8个月～10年；对照组60例(其肾虚型慢性前列腺炎患者12例)，年龄19～50岁，病程8个月～10年。两组患者年龄、病程经比较差异均无统计学意义(经x2检验，P＞0.05)，具有可比性。
2治疗方法
治疗组服用本发明实施例1胶囊剂，一日两次，每次2粒。连续服用1个月。对照组口服前列康片(浙江康恩贝有限公司生产)，每次3片，每日3次，疗程为1个月。两组治疗前后均进行N IH2CPSI评估、前列腺液及肝、肾功能和血、尿常规检查。
3治疗结果
参照《中药新药临床研究指导原则》及美国国立卫生研究院慢性前列腺炎症状积分指数(N IH2CPSI)的评分及EPS中WBC计数作为疗效判定的标准。
治愈：N IH2CPSI评分减少95％以上，EPS镜检连续两次正常；
显效：NIH2CPSI评分减少60％～94％，EPS镜检WBC减少≥60％；
有效：NIH2CPSI评分减少30％～59％，EPS镜检WBC减少≥30％；
无效：IH2CPSI评分减少＜30％，EPS镜检WBC减少＜30％。
| 组别 | 例数(n) | 治愈 | 显效 | 有效 | 无效 |
| 治疗组 | 80 | 28(35.00％) | 25(31.25％) | 20(25.00％) | 7(8.75％) |
| 对照组 | 60 | 18(30.00％) | 14(23.33％) | 12(20.00％) | 16(26.67％) |
注：总有效率＝治愈率+显效率+有效率，两组总有效率比较，P＜0.05
两组治疗结果见表1，治疗组总有效率为91.25％，对照组总有效率为73.33％，两组总有效率比较，差异有显著性(P＜0.05)。其中治疗组中的16例肾虚型慢性前列腺炎患者治愈人数为14例，显效2例，总有效率为100％。而对照组中的12例肾虚型慢性前列腺炎患者治愈人数为4例，显效3例，有效2例，总有效率为75％，具有显著差异。
此外，实验还发现治疗组在改善患者会阴不适、小腹痛、阴茎痛、睾丸痛、阴茎勃起功能方面明显优于对照组。治疗前后血、尿常规及肝、肾功能无异常。
具体实施方式
以下通过具体实施实施例对本发明作进一步说明，但应该理解这并非是对本发明的限制，本领域技术人员根据本发明的基本思想，可以做出各种修改或改进，但是只要不脱离本发明的基本思想，均在本发明的范围之内。
实施例1
称取原料药材熟地黄1800g，白芍800g，蛇床子600g，车前子400g，没药1000g，丹皮600g，夏枯草1200g，菟丝子1800g混合，切碎，浸泡；将浸泡的原料药加3倍量水加热回流提取2次，每次2小时；取上述水提取后的药渣，加5倍重量份的60％乙醇加热回流提取2次，每次2小时；将上述两种提取液合并，减压浓缩为，浓缩成50℃相对密度1.0～1.2的清膏，于60℃干燥后，粉碎成80目的药粉，装入胶囊中，灭菌消毒制得胶囊剂产品。
实施例2
称取原料药材熟地黄1200g，白芍600g，蛇床子600g，车前子300g，没药800g，丹皮600g，夏枯草1200g，菟丝子2000g混合，切碎，浸泡；将浸泡的原料药加3倍量水加热回流提取2次，每次2小时；取上述水提取后的药渣，加5倍重量份的60％7醇加热回流提取2次，每次2小时；将上述两种提取液合并，减压浓缩为，浓缩成50℃相对密度1.0～1.2的清膏，于60℃干燥后，粉碎成80目的药粉，装入胶囊中，灭菌消毒制得胶囊剂产品。
实施例3
称取原料药材熟地黄2200g，白芍1200g，蛇床子600g，车前子600g，没药800g，丹皮400g，夏枯草2000g，菟丝子2000g混合，切碎，浸泡；将浸泡的原料药加3倍量水加热回流提取2次，每次2小时；取上述水提取后的药渣，加5倍重量份的60％乙醇加热回流提取2次，每次2小时；将上述两种提取液合并，减压浓缩为，浓缩成50℃相对密度1.0～1.2的清膏，于60℃干燥后，粉碎成80目的药粉，装入胶囊中，灭菌消毒制得胶囊剂产品。
实施例4
称取原料药材熟地黄1800g，白芍1000g，蛇床子600g，车前子600g，没药800g，丹皮400g，夏枯草1600g，菟丝子1800g混合，切碎，浸泡；将浸泡的原料药加3倍量水加热回流提取2次，每次2小时；取上述水提取后的药渣，加5倍重量份的60％乙醇加热回流提取2次，每次2小时；将上述两种提取液合并，减压浓缩为，浓缩成50℃相对密度1.0～1.2的清膏，于60℃干燥后，粉碎成80目的药粉，装入胶囊中，灭菌消毒制得胶囊剂产品。
实施例5
称取原料药材熟地黄2000g，白芍700g，蛇床子700g，车前子500g，没药800g，丹皮600g，夏枯草1800g，菟丝子2000g混合，切碎，浸泡；将浸泡的原料药加5倍量水加热回流提取2次，每次2小时；取上述水提取后的药渣，加5倍重量份的70％乙醇加热回流提取2次，每次2小时；将上述两种提取液合并，减压浓缩为，浓缩成50℃相对密度1.0～1.2的清膏，于55℃干燥后，粉碎成100目的药粉，装入胶囊中，灭菌消毒制得胶囊剂产品。
Claims (6)
1. 一种治疗慢性前列腺炎的中药组合物，其特征在于，各种原料药的重量份数比为：
熟地黄12～22份 白芍6-12份 蛇床子6～8份 车前子3-6份
没药8～12份 丹皮4-6份 夏枯草12～22份 菟丝子16～22份。
2.根据权利要求1所述治疗慢性前列腺炎的中药组合物，其特征在于，所述中药制剂中各种原料药的重量份数比为：熟地黄18份，白芍8份，蛇床子6份，车前子4份，没药10份，丹皮6份，夏枯草12份，菟丝子18份。
3.一种根据权利要求l～2中任一项所述治疗慢性前列腺炎的中药组合物的制备方法，其特征在于，制备方法包括：
a．将所述原料药混合，切碎，浸泡；
b．将浸泡的原料药加水加热回流提取2次，每次l～2小时；
c．再取上述水提取后的药渣，加5～8倍重量份的50～75%乙醇加热回流提取2次，每次l～2小时；
d．将上述两种提取液合并，减压浓缩为，浓缩成50℃相对密度1.0～1.2的清膏，于50～60℃干燥后，粉碎成80～120目的药粉，装入胶囊中，灭菌消毒制得胶囊剂产品。
4.根据权利要求3所述治疗慢性前列腺炎的中药组合物的制备方法，其特征在于，制备方法包括：
a．将所述原料药混合，切碎，浸泡；
b．将浸泡的原料药加水加热回流提取2次，每次2小时；
c．再取上述水提取后的药渣，加5倍重量份的60%乙醇加热回流提取2次，每次2小时；
d．将上述两种提取液合并，减压浓缩为，浓缩成50℃相对密度1.0～1.2的清膏，于60℃干燥后，粉碎成80目的药粉，装入胶囊中，灭菌消毒制得胶囊剂产品。
5.一种根据权利要求l～2中任一项所述治疗慢性前列腺炎的中药组合物在制备治疗湿热症、淤血症、中虚症或肾虚症型慢性前列腺炎药物中的用途。
6.根据权利要求5所述治疗慢性前列腺炎的中药组合物在制备治疗肾虚症型慢性前列腺炎药物中的用途。
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