CN100348241C - 治疗慢性前列腺炎的药物及其制备方法 - Google Patents
治疗慢性前列腺炎的药物及其制备方法 Download PDFInfo
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Abstract
本发明涉及治疗慢性前列腺炎的药物及制备方法，其重量份数组成如下：泽泻10～25、丹参8～20、青皮5～12、黄柏8～18、车前子10～25、萆薢10～25、金钱草20～45、猪苓5～15、牵牛子5～12、小茴香5～12、滑石10～25、甘草5～12。本发明还涉及所述药物的各种制剂的制备方法。本发明药物治疗慢性前列腺炎效果显著，尤其对临床症状改善更为突出。服用量小，无毒副作用。
Description
技术领域
本发明涉及一种中药药物，具体是涉及治疗慢性前列腺炎的药物及其制备方法。
背景技术
发病情况：前列腺炎，尤其是慢性前列腺炎，是男性常见病。在泌尿外科门诊患者中，约有25％是因前列腺炎就医。分类：一般分为三类：由明显的病原菌感染引起的慢性细菌性前列腺炎，约占患者总数的5-10％；慢性非细菌性前列腺炎的患者约占30-50％；第三种就是前列腺痛，约占30-40％。其临床表现有症状表现多样化、且症状与炎症轻重不成正比的特点。表现为：1、排尿不适：可出现尿频、尿道灼痛等。晨起可见尿道口有粘液、粘丝及脓液分泌，尿液混浊或大便后流白。2、局部症状：后尿道、会阴和肛门部不适、重压或饱胀感等。3、放射痛：腰酸腰痛等，疼痛可放射到阴茎、睾丸、阴囊、小腹、大腿等处。4、性功能紊乱：主要表现为性欲减退、早泄，青年未婚者多表现遗精等。5、其它症状：记忆力减退，注意力分散，失眠、精神不振、神疲乏力等。6、常见并发症：慢性精囊炎、尿道炎、膀胱炎、附睾炎等。西医认为，本病的发生可能与下列因素有关：1、前列腺充血①性生活不正常②直接压迫会阴部③饮酒：饮酒能使生殖器官充血及引起性兴奋。④按摩过重⑤感冒受凉2、微生物感染3、自体免疫性因素4、对某种病毒的过敏反应5、心身医学方面的因素。中医认为，本病属于“淋证”、“精浊”、“劳淋”““白淫”等病的范畴，其病因病机为：1、过度饮酒或过食辛辣，损伤脾胃，运化失司，水湿潴留，郁而化热，湿热内生，湿热之邪下注或湿热循经上行，侵犯精室，蕴结于下焦，而致膀胱气化不利。湿热长期不清，相火久遏不泄，病久入络，则精道精室气血瘀滞，败精瘀浊伴湿热阻于精室。2、禀赋不足或素体虚弱，性交过频或手淫过度，肾阴耗损，阴虚火旺，相火亢盛，或所愿不遂，精未外泄，或同房手淫忍精不泄或性交中止，肾火郁而不散，内蕴精室，而致本症。总之，久病入络，精室脉络瘀阻，败精瘀浊与湿热之邪互结，贯穿于整个病变过程，形成本虚标实，虚实挟杂的病理特点。故治宜清热利湿、化瘀行气、滋肾养阴，益气升清，标本兼顾，虚实兼治，方能取效。
发明内容
本发明的目的就是为了解决上述问题，按照中医药理论提供一种治疗慢性前列腺炎的药物，该药物是根据中医理论认为慢性前列腺炎有湿热瘀血交结、虚实夹杂的特点，总结数十年临床治疗慢性前列腺炎经验的基础上科学提取，弃粗留精，配伍而成具有清热利湿、化瘀行气、滋肾养阴，益气升清等作用的医中药产品。该产品在临床300例病人中经长期观察，证明其疗效显著、无任何毒副作用。
本发明的目的还在于提供所述药物各种制剂的制备方法。
本发明的治疗慢性前列腺炎药物的重量份数组成如下：泽泻10～25、丹参8～20、青皮5～12、黄柏8～18、车前子10～25、萆薢10～25、金钱草20～45、猪苓5～15、牵牛子5～12、小茴香5～12、滑石10～25、甘草5～12、
最佳组成如下：泽泻20～23、丹参14～18、青皮6～9、黄柏10～14、车前子18～24、萆薢20～24、金钱草40～45、猪苓6～10、牵牛子8～10、小茴香6～9、滑石18～23、甘草6～9
对于人均用量，上述组成的单位为克。
本发明药物各组份的主要成份包括：
泽泻：含氨基酸、脂肪酸、糖类、四环三萜类如泽泻醇(alisol)等。
丹参：含丹参酮(tanshinone)类、丹参醇(tanshinol)、原儿茶醛(protocatechualdehyde)、原儿茶酸(protocatechuic acid)、丹参素等成分。
青皮：含挥发油类、黄酮类等成分。
黄柏：含小檗碱(berberine)、巴马汀(palmatine)、药根碱(jatrorrhizine)、黄柏碱(phellodendrine)等。
车前子：苯丙苷、环烯醚萜苷、挥发油、黄酮及其糖苷、维生素(vitamin)及甾醇类。
萆薢：含甾体类化合物。
金钱草：含黄酮类、酚性成分、甾醇、氨基酸、鞣质、挥发油及胆碱(chol ine)。
猪苓：含多糖类成分。
牵牛子：含树脂苷类、生物碱及酸性成分。
小茴香：含挥发油、氨基酸、甾醇及其糖苷、脂肪酸及香豆素、齐墩果酸(oleanolic acid)。
滑石：主要含含水硅酸镁。
甘草：含三萜类、黄酮类、多糖类、生物碱类成分。
发明人针对慢性前列腺炎的病因病机，经过探索性试验，摸索出特定组成、特定用量的药物，其临床疗效非常显著。方中泽泻利水渗湿、泄热，猪苓利水渗湿；萆薢利湿除浊，车前子利水通淋，滑石利水通淋，金钱草除湿清热、利水通淋，牵牛子祛积逐水以清热利湿、利水通淋；丹参活血祛瘀、小茴香理气和胃，青皮疏干破气、消积化滞以活血祛瘀、行气化滞；黄柏滋阴降火；甘草益气补中。全方合用共奏清热利湿、化瘀行气、滋肾养阴、益气升清之功效。
本发明的药物可以粉碎制成散剂、丸剂、片剂、胶囊剂等固体制剂，或用水煎煮或用醇提取后制成各种口服制剂。
本发明药物的口服液的具体制备方法是：药物中加入相当药物总重量5～13倍的水或乙醇进行提取；提取的时间1～3小时，提取1～3次；提取后的药液经过滤后进行真空浓缩，放置，沉淀，取上液制备成合剂、口服液等液体制剂；
本发明药物的固体制剂的具体制备方法是：药物中加入相当药物总重量5～13倍量的水或乙醇进行提取；提取的时间1～3小时，提取1～3次；提取后的药液经过滤后进行真空浓缩，60℃下浓缩液的相对密度为1.01～1.30，喷雾干燥，得到干浸膏粉，干法制粒，混合均匀，制备成颗粒剂、片剂、胶囊剂等固体制剂。
本发明与现有技术相比，具有如下优点：
(1)本药物临床效果明显：对轻、中度慢性前列腺炎，单独使用该药可达到抗菌消炎效果；对重度慢性前列腺炎患者，也能明显减轻症状；改善性功能紊乱；改善情志抑郁症状。使用方便、疗效可靠，安全无毒，可长期服用。
(2)本发明的口服制剂其组方精当，为常用中药所组成，药源清楚，来源广泛，价廉易得；
(3)制备工艺简单易行，采用了喷雾干燥、干法制粒等先进技术，服用方便，剂量准确，经济实惠。
具体实施方式
实施例1、生产丸剂药物
组成(单位克)：泽泻22、丹参15、青皮8、黄柏11、车前子18、萆薢24、金钱草40、猪苓6、牵牛子8、小茴香6、滑石20、甘草7
先将上述十二味中药，按处方量称量配齐，干燥(80℃以下)、粉碎成粉末，过筛(80目筛以上)、混匀、每100g粉末加炼蜜90～110g制成蜜丸，即得。本方法制备工艺简便，作用缓和持久，服用、携带方便。
实施例2、生产合剂
组成(单位克)：泽泻22、丹参17、青皮6、黄柏13、车前子20、萆薢20、金钱草45、猪苓9、牵牛子9、小茴香7、滑石23、甘草6
先将上述十二味中药，按处方量称量配齐，放入提取罐中，加5～13量水提取，提取1～3次，每次1～3小时，滤过，合并滤液，提取液经真空浓缩至清膏状，加矫味剂、防腐剂适量，静置，滤过，搅匀，分装、即得。本方法制备工艺简便，口服后吸收快，生物利用度高。
实施例3、生产胶囊剂
组成(单位克)：泽泻20、丹参15、青皮8、黄柏12、车前子22、萆薢22、金钱草42、猪苓7、牵牛子10、小茴香6、滑石18、甘草9
先将上述十二味中药，按处方量称量配齐，放入提取罐中，加药量5～13倍量50～80％乙醇提取一次，滤过，滤液真空浓缩，回收乙醇，得醇提取液液备用。药渣加5～10倍量水提取1～2小时，滤过，滤液经真空浓缩，与醇提取浓缩液合并，混匀，浓缩液喷雾干燥，得干浸膏粉，干浸膏粉混匀，经干法制成颗粒，装入胶囊，即得。
本方法制备工艺先进，采用了喷雾干燥和干法制粒技术，工艺合理可行，药物稳定性高，服用后吸收快，生物利用率高。
实施例4、生产颗粒剂
组成(单位克)：泽泻21、丹参16、青皮9、黄柏10、车前子21、萆薢23、金钱草43、猪苓10、牵牛子8、小茴香9、滑石23、甘草6
先将上述十二味中药，按处方量称量配齐，放入提取罐中，加药量5～13倍量水提取，提取液经真空浓缩，得到浓缩液，浓缩液喷雾干燥，得干浸膏粉，干浸膏粉混匀，制粒、分装，即得。
实施例5、生产片剂
组成(单位克)：泽泻23、丹参17、青皮6、黄柏14、车前子19、萆薢21、金钱草41、猪苓9、牵牛子10、小茴香8、滑石22、甘草8
先将上述十四味中药，按处方量称量配齐，放入提取罐中，加药量5～43倍量30～80％乙醇提取，提取液经真空浓缩，得到浓缩液，浓缩液喷雾干燥，得干浸膏粉，干浸膏粉混匀，制粒、压片、即得。
实验及临床疗效评价
(一)、实验资料
我们根据药理特性，造成大鼠前列腺体炎症及纤维增生性改变，再现察该药物对其影响，发现给药组大鼠前列腺间质炎症细胞浸润及成纤维细胞增生程度均明显轻于给水组，该药物有减轻消痔灵注射液引起的大鼠前列腺炎细胞浸润及纤维组织增生作用，并可使病理模型的前列腺上皮细胞的分泌功能恢复，增加Zn含量，增强前列腺的抗炎及损伤组织的修复能力。为了观察该药物用药的安全性，我们在动物体内对该药物进行了急慢性毒性实验，均无毒性反应。由此说明该药物是安全的，长期服用，无任何毒副作用。
(二)、临床疗效评价
经多家医院用该药物治疗228例慢性前列腺炎患者，临床症状明显改善，证实总有效率达92.8％。总结临床结果，该药物治疗慢性前列腺炎呈现以下特点：
1、对轻、中度慢性前列腺炎，单独使用该药可达到抗菌消炎效果。避免了应用抗生素等类西药及其它疗法的副作用。
2、对重度慢性前列腺炎患者，也能明显减轻症状。如配合抗生素应用，则效果更加明显，同时能减少抗生素用量，减轻副作用，增加疗效，缩短疗程。
3、改善性功能紊乱。对因慢性前列腺炎引起的性欲减退，举而不坚，坚而不久，或早泄、阳萎、遗精等症，有明显治疗作用。对伴有精液改变，精子活动力差、精液液化时间延长、畸形精子增加等导致男性不育症的患者也能起到一定治疗作用。
4、改善情志抑郁症状。服用该药物可使许多患者情志抑郁症状得到明显改善。
5、使用方便、疗效可靠，安全无毒，可长期服用。
Claims (3)
1、一种治疗慢性前列腺炎的药物，其特征在于该药物是由下述中药原料制成：泽泻10～25、丹参8～20、青皮5～12、黄柏8～18、车前子10～25、萆薢10～25、金钱草20～45、猪苓5～15、牵牛子5～12、小茴香5～12、滑石10～25、甘草5～12。
2、权利要求1所述治疗慢性前列腺炎的药物口服液的制备方法，其特征在于在药物中加入相当药物总重量5～13倍的水或乙醇进行提取；提取的时间1～3小时，提取1～3次；提取后的药液经过滤后进行真空浓缩，放置，沉淀，取上液。
3、权利要求1所述治疗慢性前列腺炎的药物固体制剂的制备方法，其特征在于在药物中加入相当药物总重量5～13倍量的水或乙醇进行提取；提取的时间1～3小时，提取1～3次；提取后的药液经过滤后进行真空浓缩，60℃下浓缩液的相对密度为1.01～1.30，喷雾干燥，得到干浸膏粉，干法制粒，混合均匀。
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