CN101804181B - 治疗前列腺炎的中药制剂及其制备方法 - Google Patents
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Abstract
本发明是一种治疗前列腺炎的中药制剂及其制备方法,处方为:菝葜10~30份,苦参10~30份,苍术10~20份,黄柏10~20份,牛膝5~15份,茯苓10~30份,泽泻10~20份,丹参10~30份,土茯苓10~30份,车前子10~25份,败酱草10~30份,山萸肉10~25份,枸杞10~20份,石苇10~30份,三棱5~15份,莪术5~16份,三七3~6份。所制得的胶囊剂命名为“前列欣安胶囊”。本发明的中药制剂用于治疗急慢性前列腺炎,治愈率达62.50%,总有效率高达97.12%。
Description
(一)、技术领域 本发明涉及一种治疗前列腺炎的中药制剂,并涉及该中药制剂的制备方法。
(二)、背景技术 前列腺疾病属于中医的“精浊”“劳淋”范围,是男性中青年常见的生殖系疾病。《类证治裁·淋浊篇》载‘浊在精者,相火妄动或逆精使然,至精溺并出”。由于饮食、劳累等原因,湿热侵扰精室,致精室不能闭藏,精离其位,与尿并出,湿热长期不清,则精道气血瘀阻。病理基础为湿瘀互阻,病性以实证居多,有时虚实夹杂。本方所治浊淋,多由下焦湿热、湿浊下注兼有气滞血瘀所致,治疗以清利湿热、活血化瘀、行气活血或行气止痛为原则。方中菝葜、苦参、败酱草、石苇、土茯苓清热利湿,为治热淋之主药;车前子、泽泻、茯苓、牛膝,利水渗湿,泄下焦湿热;黄柏苦寒燥湿,止遗浊尿频;丹参、三棱、莪术、三七活血、散瘀、止痛;山萸肉、枸杞温肾阳、缩小便。
慢性前列腺炎是成年男性常见的疾病,其症状复杂多样,统称为前列腺炎综合征,尽管这些症状不会威胁到生命,但其对生活质量的影响程度甚至超过良性前列腺增生或前列腺癌。在慢性前列腺炎的诊断中,患者的症状和EPS检查及病原学检查是重要的依据,但对于各种微生物的致病性、致病机制,一直存在着争议。有研究显示,在症状程度分度各组之间微生物检出阳性率差异无统计学意义(P>0.05)。所以对于慢性前列腺炎的治疗不能拘于一种模式,尽管治疗慢性前列腺炎的药物多种多样,但用中药治疗往往会取得较好疗效。
美国国家健康统计中心研究资料表明,前列腺炎占泌尿生殖系统患病率的25%以上,是一种常见的男性疾病。其中,慢性非细菌性前列腺炎占前列腺炎患者总数的64%以上,因此,采用单纯西医抗菌疗法治疗前列腺炎效果较差。
调查发现,目前市场上还缺乏针对性强、疗效高、复发率低的治疗慢性前列腺炎的中药制剂。
(三)、发明内容 本发明所要解决的技术问题是,提供一种治疗前列腺炎的中药制剂及其制备方法,主要对于前列腺炎针对性强、疗效好、复发率低。以克服现有治疗该类疾病药品的缺陷。
本发明解决上述技术问题所采用的技术方案如下:
一种治疗前列腺炎的中药制剂,其特征在于其处方为:菝葜10~30份,苦参10~30份,苍术10~20份,黄柏10~20份,牛膝5~15份,茯苓10~30份,泽泻10~20份,丹参10~30份,土茯苓10~30份,车前子10~25份,败酱草10~30份,山萸肉10~25份,枸杞10~20份,石苇10~30份,三棱5~15份,莪术5~16份,三七3~6份;所述的份均指重量份。
所述的治疗前列腺炎的中药制剂的制备方法,其特征在于按照以下步骤制备而成:
1)、将所述的三七粉碎成细粉,过筛,备用;
2)、将其余十六味中药混合,加入以重量计九至十一倍的水;第一次煎煮1~2小时,第一次过滤,取滤液备用;
3)、将第一次滤过的药渣加入所述十六味中药重量七至九倍的水,第二次煎煮1~2小时,第二次滤过,取滤液备用;
4)、合并两次过滤的滤液,将合并的滤液浓缩至相对密度50℃下1.25~1.30g/cm3,制成稠膏;
5)、将所述的稠膏与所述的三七细粉混匀,经干燥,粉碎,过筛,制得颗粒剂。
经第5)步过筛后制粒,装入胶囊,可以制成胶囊剂。
还可以经常规工艺制成中药煎剂或者丸剂。
药物作用:
菝葜;味甘,平温,无毒。归经《纲目》:足厥阴、少阴。祛风湿,利小便,消肿毒。治关节疼痛,肌肉麻木,泄泻,痢疾,水肿,淋病,疔疮,肿毒,瘰疬,痔疮。
苦参:味苦;性寒归经:肝;肾;大肠;小肠经;膀胱;心经;膀胱经。清热燥湿;祛风杀虫。主湿热泻痢;肠风便血;黄疸;小便不利;水肿;带下;阴痒;疥癣;麻风;皮肤瘙痒;湿毒疮疡。
茯苓:甘、淡、平,归心、脾、肺、肾经;具有利水渗湿、健脾宁心的功效;有于小便不利,水肿,痰饮,脾虚倦怠,食少便溏,心神不宁,惊悸失眠。
莪术:苦、辛、温,归肝经;具有行气破血、消积止痛的功效;用于经闭瘀阴,食积腹痛。
丹参:苦、微寒,归心、心包、肝经;具有活血祛痰、凉血消肿、清心安神的功效;用于月经不调,心腹刺痛,胁痛胸痹,风湿热痹,痈肿疮毒,热入营血,心烦不寐,心悸失眠。
苍术,味辛主散,性温而燥,燥可去湿,专入脾胃,主治风寒湿痹,山岚瘴气,皮肤水肿。统治三部之湿,若湿在上焦,易生湿痰,以此燥湿行痰;湿在中焦,滞气作泻,以此宽中健脾;湿在下部,足膝痿软,以此同黄柏治痿,能令足膝有力;取其辛散气雄,用之散邪发汗,极其畅快。
黄柏,性味归经:苦,寒。归肾、膀胱经。功能与主治:用于湿热泻痢,黄疸,带下,热淋,脚气,痿辟,骨蒸劳热,盗汗,遗精,疮疡肿毒,湿疹瘙痒。盐黄柏滋阴降火。用于阴虚火旺,盗汗骨蒸。味苦入骨,是以降火能自顶至踵,沦肤彻髓,无不周到,专泻肾与膀胱之火。
牛膝:性味:苦;酸;性平。归经:肝;肾经。功效:补肝肾;强筋骨;活血通经;引敌国(火)下行;利尿通淋。
主治:腰膝酸痛;下肢痿软;血滞经闭;痛经;产后血瘀腹痛;徵瘕;胞衣不下;热淋;血淋;跌打损伤;痈肿恶疮;咽喉肿痛。
泽泻:性味:甘;淡;性寒。:归经:归肾;膀胱经。
功能主治:利水渗湿;泄热通淋。主小便不利;热淋涩痛;水肿胀满;泄泻;痰饮眩晕;遗精。
土茯苓:性味归经:甘、淡,平。归肝、胃经。功能主治:除湿,解毒,通利关节。用于湿热淋浊,带下,痈肿,瘰疬,疥癣,梅毒及汞中毒所致的肢体拘挛,筋骨拘挛疼痛、瘰疬、疮疡。
车前子:性味与归经:甘,微寒。归肝、肾、肺、小肠经。功能与主治:清热利尿,渗湿通淋,明目,祛痰。用于水肿胀满,热淋涩痛,暑湿泄泻,目赤肿痛,痰热咳嗽。
败酱草:性味归经:辛、苦,凉。入胃、大肠、肝经。功能主治:清热解毒,消痈排脓,活血行瘀。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。
山萸肉:性味归经:酸、涩,微温。归肝、肾经。功能主治:补益肝肾,涩精固脱。用于眩晕耳鸣,腰膝酸痛,阳痿遗精,遗尿尿频,崩漏带下,大汗虚脱。内热消渴。
枸杞:性味与归经:甘,平。归肝、肾经。功能与主治:滋补肝肾,益精明目。用于虚劳精亏,腰膝酸痛,眩晕耳鸣,内热消渴,血虚萎黄,目昏不明。
石苇:性味:苦甘,凉。归经:入肺、膀胱经。
功用主治-石韦的功效:利水通淋,清肺泄热。治淋痛,尿血,尿路结石,肾炎,崩漏,痢疾,肺热咳嗽,慢性气管炎,金疮,痈疽。
三棱:性味归经:辛、苦,平。归肝、脾经。功能主治:破血行气,消积止痛。用于症瘕痞块,瘀血经闭,食积胀痛。
汉三七:性味归经:味甘微苦,性温,归肝、胃经。功能主治:生用可止血化瘀、消肿止痛,是云南白药主要成分,内服:(1)具有良好的止血功效、显著的造血功能;(2)能加强和改善冠脉微循环。
本发明的积极效果在于:十七味中药协同作用,通过清热利湿、活血化瘀、行气止痛,彻底改善症状,缓解痛苦。其中滋补中药培肾固元,使药效持久,达到标本兼治的目的。
本发明的中药制剂用于治疗急慢性前列腺炎,治愈率达62.50%,总有效率高达97.12%,明显高于国内其它同类中药,比如《中国性科学》2009年,第六期和第九期的相关报道,其治愈率分别为47.82%和56%,总有效率分别为94%和97%。
(四)、具体实施方式 下面结合具体实例进一步说明本发明。
处方实例:
实例一
菝葜30g,苦参30g,苍术15g,黄柏15g,牛膝10g,茯苓20g,泽泻10g,丹参30g,土茯苓30g,车前子20g,败酱草30g,山萸肉15g,枸杞10g,石苇30g,三棱10g,莪术10g,三七3g。
实例二
菝葜10g,苦参20g,苍术20g,黄柏20g,牛膝5g,茯苓10g,泽泻15g,丹参10g,土茯苓20g,车前子10g,败酱草10g,山萸肉10g,枸杞15g,石苇10g,三棱15g,莪术16g,三七6g。
实例三
菝葜20g,苦参10g,苍术10g,黄柏10g,牛膝15g,茯苓30g,泽泻20g,丹参20g,土茯苓10g,车前子25g,败酱草20g,山萸肉25g,枸杞20g,石苇20g,三棱5g,莪术5g,三七4g。
颗粒剂制备例
1)、将处方实例一所述的三七粉碎成细粉,过120目筛,备用;
2)、将处方实例一所述的其余十六味中药混合,加入以重量计十倍的水;第一次煎煮1小时,第一次过滤,取滤液备用;
3)、将第一次滤过的药渣加入所述十六味中药重量八倍的水,第二次煎煮1小时,第二次滤过,取滤液备用;
4)、合并两次过滤的滤液,将合并的滤液浓缩至相对密度50℃下1.25~1.30g/cm3,制成稠膏;
5)、将所述的稠膏与所述的三七细粉混匀,经干燥,粉碎,过80目筛,制得颗粒剂。
胶囊剂制备例
在颗粒剂制备例基础上,将制得的颗粒装入胶囊,制成胶囊剂。
临床实验:
烟台新安男科医院从2003年3月开始关注此病种,通过长期观察,总结了有效的中药方剂,并进行了临床观察,逐步形成固定方(处方实例一)。于2005年将本发明的胶囊剂定名为前列欣胶囊,后更名为前列欣安胶囊。
该院先后使用该处方1200余张(约8400付药),治疗急慢性前列腺炎患者400余例,以下是其中104的临床数据。
1、临床资料
1.1、一般资料本组104例,均来源于烟台新安男科医院门诊及部分住院病例,所有病例病情均按表1进行分级。年龄分组:年龄<30岁43例,年龄≥31岁47例,年龄≥45岁14例;病程0.5~10年不等,2~3年的占65%以上;病情按表1症状积分表分为重度34例,中度55例,轻度15例。
表1 症状积分表
症状 | 3(重) | 2(中) | 1(轻) |
尿频 | 次数增加,夜尿≥5次 | 次数增加,夜尿3-4次 | 次数增加,夜尿≤2次 |
尿急 | 小便急迫,迫不及待 | 急迫感,仅可忍耐片刻 | 小便急迫,可忍耐 |
尿痛 | 小便时尿道刺痛难忍 | 尿道痛较重,排尿不爽 | 尿道隐痛,不影响排尿 |
会阴疼痛 | 持续出现,难以忍受 | 间断出现,时轻时重 | 偶尔出现疼痛 |
腰膝酸软 | 腰膝酸痛难忍 | 腰膝酸痛持续 | 晨起腰膝酸痛,捶打可止 |
尿后滴沥 | 持续,常湿裤 | 间断,较明显 | 偶有,轻微 |
尿道白浊 | 持续出现 | 间断出现 | 偶尔出现 |
阳痿 | 无勃起 | 勃起不满意 | 偶有勃起困难 |
Eps-WBC | ≥30个/Hp | 20~30个/Hp | 10~19个/Hp |
EPS-磷脂体 | 0~+ | ++ | +++ |
注:病情轻重分级,轻度≤11分,中度12~22分,重度≥23分。
1.2、诊断标准:参照国家中医药管理局发布的《中医病证诊断疗效标准》制定。具体标准如下:①以男性中青年为多见,常呈慢性经过,且反复发作。②小腹、会阴、睾丸部有胀痛感,尿频、尿急,排尿时尿道可有白色分泌物溢出。③伴有神疲乏力,头晕,腰酸痛,性欲减退,遗精,早泄,阳痿,不育等症。④直肠指检,精室肿大有压痛,慢性者亦可缩小。⑤前列腺液镜检,WBC>10/HP或成堆出现,卵磷脂小体显著减少或消失。
中医辨证标准:
中医辨证为湿热下注、气滞血瘀之证,主症:后尿道、会阴、肛门处和少腹坠胀不适感。尿道和会阴疼痛,还会向其附近放射,以腰骶部疼痛最为多见,疼痛并放射到阴茎头部。次症:尿频、尿急、排尿时尿道灼热。清晨尿道口可有粘液等分泌物,还可出现排尿困难的感觉。舌质暗紫有瘀班、苔黄腻,脉弦数或涩。
1.3、排除标准:①前列腺增生症、前列腺癌、神经源性膀胱、尿道畸形或狭窄及严重神经官能症;②以局部疼痛为主要表现者,应注意排除下腹、会阴、腰骶等部位的其他病变;③合并有心、脑、肝和造血系统等严重原发性疾病者;④无法合作者,如精神病患者,未按规定用药,无法判定疗效或资料不全者。
1.4、观察指标:①治疗前后主要症状积分变化;②治疗前后主要体征积分变化包括前列腺触诊;③治疗前后前列腺液(EPS)常规、尿十项等指标的变化情况。
2、治疗方法
两组在治疗过程中均配合温水坐浴、提肛运动锻炼,治疗2周左右前列腺触诊、复查前列腺液(EPS)常规。生活起居均按同样原则指导进行。治疗期间大量饮水,禁酒精及辛辣刺激饮食。
治疗组:口服本发明的胶囊剂(药物处方:菝葜30g,苦参30g,苍术15g,黄柏15g,牛膝10g,茯苓20g,泽泻10g,丹参30g,土茯苓30g,车前子20g,败酱草30g,山萸肉15g,枸杞10g,石苇30g,三棱10g,莪术10g,三七3g。)每日3次,每次4~6粒。
3、疗效观察
3.1、疗效标准参照《中药新药临床研究指导原则(试行)》拟定。
①临床治愈:中医临床症状、体征消失或基本消失,症状积分减少≥90%。
②显效:中医临床症状、体征明显改善,症状积分减少≥60%。
③有效:中医临床症状、体征均有好转,症状积分减少≥30%。
④无效:中医临床症状、体征均无明显改善,甚或加重,症状积分减少不足30%。
3.2、治疗结果
病例数:104例。其中治愈62.50%,显效21.16%,有效13.46%,无效2.88%,总有效率97.12%。
3.3、安全性观察:治疗前后测定血常规、尿十项、肝肾功能,部分病人进行心电图检查。2组患者的白细胞、血红蛋白、红细胞、肝肾功能及心电图均未发现异常。治疗组有3例服药后出现腹泻,1例出现皮疹,无发热反应,停药后症状消失。
Claims (2)
1.一种治疗前列腺炎的中药制剂,其特征在于其处方为:菝葜10~30份,苦参10~30份,苍术10~20份,黄柏10~20份,牛膝5~15份,茯苓10~30份,泽泻10~20份,丹参10~30份,土茯苓10~30份,车前子10~25份,败酱草10~30份,山萸肉10~25份,枸杞10~20份,石苇10~30份,三棱5~15份,莪术5~16份,三七3~6份;所述的份均指重量份;
按照以下步骤制备而成:
1)、将所述的三七粉碎成细粉,过筛,备用;
2)、将其余十六味中药混合,加入以重量计九至十一倍的水;第一次煎煮1~2小时,第一次过滤,取滤液备用;
3)、将第一次滤过的药渣加入所述十六味中药重量七至九倍的水,第二次煎煮1~2小时,第二次滤过,取滤液备用;
4)、合并两次过滤的滤液,将合并的滤液浓缩至相对密度50℃下1.25~1.30g/cm3,制成稠膏;
5)、将所述的稠膏与所述的三七细粉混匀,经干燥,粉碎,过筛,制得颗粒剂。
2.如权利要求1所述的治疗前列腺炎的中药制剂,其特征在于:经第5)步过筛后制粒,装入胶囊,制成胶囊剂。
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