CN110013525B - 一种治疗慢性睾丸***的药物及制备方法 - Google Patents
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Abstract
本发明公开了一种治疗慢性睾丸***的药物及制备方法,该药物有效成分的原料组成为:防己、滇车前、三白草、土牛膝、小茴香、少花龙葵、水豆瓣、牛蒡、玉米须、半枝莲、叶下珠、头花蓼、响铃草和石蝉草;将上述中药材根据各自的特性制得稠膏、汁液以及细粉后混合,再制成胶囊、片剂或丸剂,即得所述的治疗慢性睾丸***的药物。本发明药物具有清热解毒利湿,理气止痛,能有效缓解慢性***导致的阴囊坠胀和疼痛不适,回缩肿胀的附睾。此外,本药物还能活血化瘀促进患处血液微循环,有效地消除附睾可见的小结节,帮助炎症的减轻吸收和消散,具有疗程短,见效快,成本低,无毒副作用,标本兼治的优点,可推广应用于慢性***的临床治疗。
Description
技术领域
本发明属于中药领域,具体涉及一种治疗慢性睾丸***的药物及制备方法。
背景技术
男性生育能力下降已成为全球关注的问题。临床上仍存在着许多不明病因的无精、少精、畸形及低活力***病例,尽管睾丸具有一定的免疫力,但其仍然容易发生炎症性病变。研究表明,***症与男性少弱***症密切相关,***对生育能力的影响长期以来被低估了,炎症因子对***发生的影响应该受到关注。慢性***患者大部分是急性***未得到有效治疗或治疗不彻底而转为慢性,是一种以睾丸内炎症细胞浸润,生精小管损伤为特征的炎性病变,可由细菌病毒和寄生虫等引起,也由一些病因不明的病原微生物引起,从婴儿到90岁均可发病,对***的深入研究定能解释更多的男性生育能力低下的病因。
慢性***分为三类,第一类,慢性炎症性***,指伴有异常肿胀、硬结及其他炎症表现的疼痛或不适。第二类,阻塞性慢性***,指伴有先天性、获得性或医源性的附睾或输精管梗阻所致的疼痛或不适(如先天性梗阻或输精管结扎术后瘢痕形成)。第三类,慢性附睾痛,指触诊附睾形态质地正常,无明确病因的附睾痛或不适。一般认为慢性炎症性***的致病菌是通过输精管腔逆行进入,通过淋巴***入侵。由于附睾的解剖特点,附睾受感染后易发生肿胀、组织机化甚至结节形成,显微镜下瘢痕非常显著,常可看到***闭塞,组织被淋巴细胞和浆细胞浸润。
目前,慢性或急性睾丸和***的治疗包括内科保守治疗和外科手术治疗,抗生素是最常用的治疗药物,慢性***单纯应用抗菌药物效果不一定理想,有些药物见效慢,疗程长,使用后还有副作用,内科治疗患者症状缓解后易复发。外科治疗创伤大、费用贵,可影响患者生育功能,部分年轻未生育患者无法接受。因此,寻找一个既可以保留患者生育功能,又可以解决睾丸***症反复发作,创伤小的治疗方法,成为临床泌尿外科医生亟待解决的问题。
有研究结果显示,中医中药治疗***更注重机体的整体性,通过调整人体内在环境,纠正各种不利状态,提高患者抗病能力,云南拥有丰富的中草药资源,为从中草药中提取化合物治疗该疾病创造了良好的条件。因此研制一种简单、高效、无副作用的中药配方来治疗慢性睾丸***是客观需要的。
发明内容
本发明的目的在于提供一种治疗慢性睾丸***的药物及制备方法,本发明药物具有清热解毒利湿,理气止痛,以达到消炎止痛,提升元气,增强抗病能力,加速疾病痊愈。对于***引起的阴囊坠胀、腹股沟疼痛、高热、生殖器***,辗转不安等症状具有显著的治疗效果,并且能够提高机体免疫功能,缓解病人痛苦,疗程短,见效快,成本低,无毒副作用,标本兼治,治愈后不复发,可推广应用于慢性***的临床治疗。
为实现上述目的,本发明采用的技术方案是:一种治疗慢性睾丸***的药物及制备方法,制成所述药物有效成分的原料组成及重量份数为:
防己80~120份、半枝莲50~80份、三白草50~80份、滇车前30~60份、土牛膝30~60份、小茴香30~60份、少花龙葵20~50份、水豆瓣15~40份、牛蒡20~40份、玉米须10~30份、叶下珠10~35份、头花蓼10~30份、响铃草15~30份和石蝉草10~30份。
进一步地,一种治疗慢性睾丸***的药物,制成所述药物有效成分的原料组成及重量份数为:
防己85~115份、半枝莲55~75份、三白草55~75份、滇车前35~55份、土牛膝35~55份、小茴香35~55份、少花龙葵25~45份、水豆瓣20~35份、牛蒡25~35份、玉米须15~25份、叶下珠15~30份、头花蓼15~25份、响铃草20~25份和石蝉草15~25份。
进一步地,一种治疗慢性睾丸***的药物,制成所述药物有效成分的原料组成及重量份数为:
防己100份、半枝莲65份、三白草65份、滇车前45份、土牛膝45份、小茴香45份、少花龙葵35份、水豆瓣28份、牛蒡30份、玉米须20份、叶下珠22份、头花蓼20份、响铃草22份和石蝉草20份。
进一步地,本发明治疗慢性睾丸***的药物的制备方法,包括以下工艺步骤:
(1)将半枝莲、三白草、滇车前、小茴香、少花龙葵、水豆瓣、玉米须、头花蓼和响铃草洗净,放入容器内,加入8~10倍量的蒸馏水,浸泡7~8小时后,煮沸4~5小时,提取;再次加入6~8倍量蒸馏水,煮沸3~4小时,提取;最后,加入4~6倍量蒸馏水,加热煮沸1~2小时,提取;合并三次提取液,过滤,得滤液,浓缩成60℃下相对密度为1.10~1.16的稠膏,备用;
(2)将防己、牛蒡子和石蝉草洗净,浸入10倍量的85%的乙醇溶液浸泡5~6小时,加热回流提取3~4小时,回收乙醇,滤过,将滤液浓缩为60℃环境下相对密度1.20~1.25的稠膏,备用;
(3)将叶下珠带根全草,除去杂质,洗净,切段,放入容器内,煎汤,加糖、滤杂质,留汁液备用;
(4)将土牛膝洗净晒干,进行粉碎处理,研末,过180目细粉,备用;
(5)将上述步骤(1)~(4)所制得的稠膏、汁液以及细粉混合,制成胶囊、片剂或丸剂,即得所述的治疗慢性睾丸***的药物。
本发明所用中药的药性如下:
防己:性寒,味苦,清热利湿,解毒消肿。用于祛风湿,止痛,利水,风湿关节疼痛;湿热肢体疼痛;水肿;小便不利;脚气湿肿。
半枝莲:辛,平。用于疔疮肿毒,咽喉肿痛,跌扑伤痛,水肿,黄疸,蛇虫咬伤。
滇车前:甘,微寒。清热利尿,祛痰,凉血,解毒。用于水肿尿少,热淋涩痛,暑湿泻痢,痰热咳嗽,吐血衄血,痈肿疮毒。
三白草:苦辛,寒。清热解毒,利尿消肿。用于小便不利,淋沥涩痛,白带,***,肾炎水肿;外治疮疡肿毒,湿疹。
土牛膝:味甘、微苦、微酸,性寒。闭经,跌打损伤,风湿关节痛,痢疾,白喉,咽喉肿痛,疮痈,淋证,水肿。
小茴香:味辛,性温。主治胃寒痛、小腹冷痛、痛经、腹胁痛、疝痛、***积液、血吸虫病等1、《医学发明》天台乌药散:常于乌药、青皮、高良姜等配伍用治寒疝腹痛。2、《本草汇言》:与高良姜、香附、乌药等同用可治胃寒气滞之脘腹胀痛。
少花龙葵:味微苦、甘,性寒。内服清热利湿、凉血解毒。外用消炎退肿,入肝肺肾经。
水豆瓣:味甘、淡,性凉。功能主治清热利湿;消肿解毒。主痢疾;淋病;水臌;急性肝炎;痈肿疮毒;牙龈肿痛;痔肿;乳痈;急性脑膜炎;急性咽喉炎;***;痛经;烫火伤。
牛蒡:味苦、微甘,性凉。降血糖、降血脂、降血压;补肾壮阳;润肠通便;牛蒡叶煎药:牛蒡叶还有很好的药用效果,和桔梗、甘草、荆芥一起配用,效果更好。牛蒡子根洗净研烂,酒煎成膏,摊在纸上,贴肿处,仍以热酒调下,一服,肿止痛减。
玉米须:味甘、淡,性平。主水肿,小便淋沥,黄疸,胆囊炎,胆结石,高血压,糖尿病,乳汁不通。
叶下珠:微苦、甘,凉。清热解毒,利水消肿,明目,消积。用于痢疾,泄泻,黄疸,水肿,热淋,石淋,目赤,夜盲,疳积,痈肿,毒蛇咬伤。
头花蓼:酸,寒。用于***,痢疾,腹泻,血尿;外用治尿布疹,黄水疮。
响铃草:味苦、微酸,性平。用于耳鸣,耳聋,头目眩晕,遗精,月经过多,白带,久咳痰血,哮喘,肾炎,小便不利,扁桃体炎,腮腺炎,疔疮肿毒。
石蝉草:味辛,性凉。用于肺热咳喘,麻疹,疮毒,癌肿,烧烫伤,跌打损伤,肾炎水肿。
本发明的有益效果是:
本发明药物具有清热解毒利湿,理气止痛,以达到消炎止痛,提升元气,增强抗病能力,加速疾病痊愈。对于***引起的阴囊坠胀、腹股沟疼痛、高热、生殖器***,辗转不安等症状具有显著的治疗效果,并且能够提高机体免疫功能,缓解病人痛苦,疗程短,见效快,成本低,无毒副作用,标本兼治,治愈后不复发,可广泛推广应用于慢性***的临床治疗。
附图说明
图1为正常组睾丸附睾标本图;
图2为造模后睾丸附睾标本图;
图3为正常组雄兔附睾尾部组织细胞图;
图4为本发明中药组雄兔附睾尾部组织细胞图;
图5为西药组雄兔附睾尾部组织细胞图;
具体实施方式
下面结合实施例对本发明作进一步的说明,实施例包括但不限制本发明保护范围。
实施例1
一种治疗慢性睾丸***的药物,制成所述药物有效成分的原料组成及重量份数为:
防己120份、半枝莲80份、三白草80份、滇车前60份、土牛膝60份、小茴香60份、少花龙葵50份、水豆瓣40份、牛蒡40份、玉米须30份、叶下珠35份、头花蓼30份、响铃草30份和石蝉草30份。
本发明治疗慢性睾丸***的药物的制备方法,包括以下工艺步骤:
(1)将半枝莲、三白草、滇车前、小茴香、少花龙葵、水豆瓣、玉米须、头花蓼和响铃草洗净,放入容器内,加入8~10倍量的蒸馏水,浸泡7~8小时后,煮沸4~5小时,提取;再次加入6~8倍量蒸馏水,煮沸3~4小时,提取;最后,加入4~6倍量蒸馏水,加热煮沸1~2小时,提取;合并三次提取液,过滤,得滤液,浓缩成60℃下相对密度为1.10~1.16的稠膏,备用;
(2)将防己、牛蒡子和石蝉草洗净,浸入10倍量的85%的乙醇溶液浸泡5~6小时,加热回流提取3~4小时,回收乙醇,滤过,将滤液浓缩为60℃环境下相对密度1.20~1.25的稠膏,备用;
(3)将叶下珠带根全草,除去杂质,洗净,切段,放入容器内,煎汤,加糖、滤杂质,留汁液备用;
(4)将土牛膝洗净晒干,进行粉碎处理,研末,过180目细粉,备用;
(5)将上述步骤(1)~(4)所制得的稠膏、汁液以及细粉混合,制成胶囊、片剂或丸剂,即得所述的治疗慢性睾丸***的药物。
实施例2
本发明药物有效成分的原料组成及重量份数为:
防己106份、半枝莲70份、三白草70份、滇车前50份、土牛膝50份、小茴香50份、少花龙葵40份、水豆瓣32份、牛蒡33份、玉米须23份、叶下珠28份、头花蓼23份、响铃草25份和石蝉草23份。
本实施例的药物制备方法工艺步骤及用法用量与实施例1相同。
实施例3
本发明药物有效成分的原料组成及重量份数为:
防己100份、半枝莲65份、三白草65份、滇车前45份、土牛膝45份、小茴香45份、少花龙葵35份、水豆瓣28份、牛蒡30份、玉米须20份、叶下珠22份、头花蓼20份、响铃草22份和石蝉草20份。
本实施例的药物制备方法工艺步骤及用法用量与实施例1相同。
实施例4
防己93份、半枝莲60份、三白草60份、滇车前40份、土牛膝40份、小茴香40份、少花龙葵30份、水豆瓣25份、牛蒡26份、玉米须16份、叶下珠20份、头花蓼16份、响铃草20份和石蝉草16份。
本实施例的药物制备方法工艺步骤及用法用量与实施例1相同。
实施例5
本发明药物有效成分的原料组成及重量份数为:
防己80份、半枝莲50份、三白草50份、滇车前30份、土牛膝30份、小茴香30份、少花龙葵20份、水豆瓣15份、牛蒡20份、玉米须10份、叶下珠10份、头花蓼10份、响铃草15份和石蝉草10份。
本实施例的药物制备方法工艺步骤及用法用量与实施例1相同。
实验动物材料与方法:
1实验
1.1材料
健康雄性新西兰大白兔30只,体质量2.3~3.9kg。
1.2方法
1.2.1***模型建立新西兰雄性白兔30只,随机分为3组,每组10只。分别为正常组、本发明中药组、西药组。西药组和本发明中药组用同样方法实施造模。造模方法:20只实验兔术前禁食8h以上,称重后,3%戊巴比妥钠lml/kg,耳缘静脉注射,麻醉成功后,仰卧位固定于兔鼠解剖台上,手术野常规剪毛,8%硫化钠褪毛,碘伏消毒皮肤,充分暴露雄兔两侧睾丸,术者用手触摸双侧睾丸,沿着睾丸上极依次寻找附睾头、体、尾部。下极确定附睾尾后,左手固定附睾尾部,右手持注射器,将注射器针头朝与***约45°方向,斜向刺入***壁,直至针尖有落空感后,边向外抽拉针尖,用注射器注入冰乙酸0.5ml,注射完毕后,按压注射部位片刻。在保证饮水条件下,普通块状饲料喂养。按照原分组情况分别放回笼中。麻醉失效后按常规饲养,观察雄兔阴囊部伤口3天。于造模后第4天分别从每组中随机抽取2只雄兔,将6只雄兔断颈处死,做好标记后快速解剖其附睾尾部,观察其附睾尾部组织的色泽、与周围组织粘连情况,取出附睾尾部组织称重后光镜下观察,并做病理切片,鉴定慢性***雄兔模型造模是否成功。本试验中4只雄兔均附睾尾部组织明显增大,颜色相对较暗,与周围组织有轻度粘连,附睾腔内组织充血水肿明显,腔内分泌物增多,部分组织纤维化明显,***腔狭窄甚至闭塞,出现明显的炎症反应,病理切片中可见较多炎症细胞,说明造模已成功;未造模正常组2只雄兔附睾尾部组织呈淡红色,与周围组织无粘连,且未见明显炎症反应,病理切片中未见明显炎症细胞。
1.2.2给药方法
于造模后第5天开始,3组按以下方法剂量分别给予灌药:正常组:蒸馏水30ml/kg,连续灌胃4周;本发明中药组:每天备本发明药物溶液30ml/kg,每ml中含有1mg本发明药物有效成分,连续灌胃4周;西药抗生素类组:每天予头孢拉啶粉碎调和溶液30ml/kg,连续灌胃4周。
1.2.3标本采集与制备方法
末次给药后24h,称雄兔体重,然后将所有雄兔行空气栓塞处死,常规切开阴囊,分别取出每只雄兔附睾尾部组织,按原来分组称重后标记,并观察记录3组附睾尾部的体积、颜色、重量后,附睾尾部组织放入10%中性***液,送病理科固定48h,逐级乙醇脱水,二甲苯透明、浸蜡、石蜡包埋,常规切片4um,HE染色,用普通光镜观察雄兔附睾尾部组织间质充血、水肿、炎细胞浸润、组织纤维化及上皮组织增生等形态学方面的病理学改变,待病理结果回报后综合分析各种治疗方法的疗效。
1.2.4观察指标与检测方法
肉眼下观察附睾尾部组织表面色泽,附睾尾部体积大小,查看有无灰白色结节及周围组织粘连情况。使用电子称称取各雄兔附睾尾部组织湿重并记录,光学显微镜下观察附睾尾部腔内分泌物多少、炎细胞浸润、纤维及上皮组织增生情况。附睾尾部组织病理学观察标准为:淋巴细胞、浆细胞浸润:无(-),轻度(-)(+),较明显(+),显著(++)或者(+++);纤维、上皮组织增生:无(-),少许(-)(+),少量(+),大量(++)或者(+++)。
2结果
2.1.4组雄兔体重、活动、饮食的比较
在饲养过程中,30只雄兔动物在造模前后及用药前后,体毛、体重未见明显变化。期间,动物活动、饮食无明显异常。各组动物在给药过程中均未见死亡,各阶段各组雄兔体重比较无统计学意义。
表1:正常组、本发明中药组、西药组雄兔用药4周后体重的比较
注:3组动物实验用药4周后体重方面无显著差异
从表1中可见,各组雄兔造模后体重比较均无显著性差异,具有可比性。表2中可见,本发明中药组动物附睾组织湿重比西药抗生素类组要轻,有显著性差异,但较正常组重。
2.2附睾尾部组织肉眼观察
正常组附睾尾部组织表面光滑淡红,质地稍韧,未见灰白色结节及周围组织粘连(见图1)。造模组附睾尾部组织局部均有不同程度的灰白色结节,腺体与周围组织有不同程度粘连(见图2)。
2.3附睾尾部组织病理改变观察
光镜下观察可见,正常组中雄兔附睾尾部组织由不同高度的主细胞和其下方的基细胞组成,还有移动的淋巴细胞,无炎性细胞浸润,无纤维及上皮组织增生(见图3);本发明中药组中可见少量淋巴细胞和浆细胞浸润,轻度纤维及上皮组织增生(见图4);西药抗生素类组中可见附睾尾部组织内疤痕形成,附睾小管闭塞,少量淋巴细胞和浆细胞浸润(见图5);各组雄兔附睾尾部组织病理对比如下,见表3。
表3:各组雄兔附睾尾部组织病理对比如下
注:附睾尾部组织病理学观察标准为:淋巴细胞、浆细胞浸润:无(-),轻度(-)(+),较明显(+),显著(++)或者(+++);纤维、上皮组织增生:无(-),少许(-)(+),少量(+),大量(++)或者(+++)
3结论
本发明药物治疗雄兔慢性***4周后光镜下显示,正常组中雄兔附睾尾部组织由不同高度的主细胞和其下方的基细胞组成,还有移动的淋巴细胞,无炎性细胞浸润,无纤维及上皮组织增生;本发明中药组中可见少量淋巴细胞和浆细胞浸润,轻度纤维及上皮组织增生;西药抗生素类组中可见附睾尾部组织内疤痕形成,附睾小管闭塞,少量淋巴细胞和浆细胞浸润。
综上所述,本发明制备的药物对慢性***兔模型治疗有较好的疗效,该药物具有很好的抗炎作用,可抑制多种炎症介质的释放,尤其在改善附睾尾部炎细胞浸润及纤维上皮组织增生方面效果优于西药组。
临床资料:
典型病例举例:
1、熊某,男,33岁,自由职业。患者上腹疼痛,阴囊坠胀、腹股沟疼痛、高热、生殖器***,辗转不安,去医院就诊,经医生确诊为慢性***,用过许多药物,只起到了暂时性止痛,过段时间就会复发,不能痊愈。服用本发明上述药物,服用1个疗程后,疼痛症状明显消失,服用第2个疗程后痊愈,随访,至今未复发。
2、毛某,男,56岁,教师。患者上腹疼痛,阴囊坠胀、腹股沟疼痛、疼痛难忍,治疗一段时间后不见起色。服用本发明上述药物,服用2个疗程后,疼痛难忍明显减轻,服用第3个疗程后睾丸***治愈。
3、乔某,男,45岁,农民。患者慢性***多年,发病时经常带着小腹和大腿根一起疼,附睾硬结,用过多种方法治疗,疗效很差,严重影响生活。服用本发明药物,服用1个疗程后,疼痛明显减轻,继续服用3个疗程后,***治愈,一年后随访无复发。
4、杨某,男,42岁,个体工商户。患者患有慢性***及高血压,下肢水肿严重并伴眼睑浮肿、腰痛、头晕、乏力、耳鸣等症状,并伴有阴囊坠胀、上腹疼痛。服用本发明药物2个疗程,身体有好转,3个疗程后***痊愈,随访未见复发。
5、王某,男,38岁,工人。患者阴囊坠胀、腹股沟疼痛、高热、生殖器***,辗转不安,曾服用各种药物治疗均无疗效。后患者经医生推荐开始服用本发明中药制剂1个疗程后症状有明显缓解,3个疗程后痊愈,随访,至今未复发。
本发明药物具有清热利湿解毒的功效,能有效杀灭各种病原体感染,还能有效针对支原体和衣原体感染;本药物能行气止痛,有效缓解慢性***导致的阴囊坠胀和疼痛不适,回缩肿胀的附睾。此外,本药物还具有活血化瘀促进患处血液微循环,能有效地消除附睾可见的小结节,帮助炎症的减轻吸收和消散。
Claims (4)
1.一种治疗慢性睾丸***的药物,其特征在于:制成所述药物有效成分的原料组成及重量份数为:
防己80~120份、半枝莲50~80份、三白草50~80份、滇车前30~60份、土牛膝30~60份、小茴香30~60份、少花龙葵20~50份、水豆瓣15~40份、牛蒡20~40份、玉米须10~30份、叶下珠10~35份、头花蓼10~30份、响铃草15~30份和石蝉草10~30份。
2.根据权利要求1所述的一种治疗慢性睾丸***的药物,其特征在于:制成所述药物有效成分的原料组成及重量份数为:
防己85~115份、半枝莲55~75份、三白草55~75份、滇车前35~55份、土牛膝35~55份、小茴香35~55份、少花龙葵25~45份、水豆瓣20~35份、牛蒡25~35份、玉米须15~25份、叶下珠15~30份、头花蓼15~25份、响铃草20~25份和石蝉草15~25份。
3.根据权利要求1所述的一种治疗慢性睾丸***的药物,其特征在于:制成所述药物有效成分的原料组成及重量份数为:
防己100份、半枝莲65份、三白草65份、滇车前45份、土牛膝45份、小茴香45份、少花龙葵35份、水豆瓣28份、牛蒡30份、玉米须20份、叶下珠22份、头花蓼20份、响铃草22份和石蝉草20份。
4.一种如权利要求1~3任一项所述治疗慢性睾丸***的药物的制备方法,其特征在于:包括以下工艺步骤:
(1)将半枝莲、三白草、滇车前、小茴香、少花龙葵、水豆瓣、玉米须、头花蓼和响铃草洗净,放入容器内,加入8~10倍量的蒸馏水,浸泡7~8小时后,煮沸4~5小时,提取;再次加入6~8倍量蒸馏水,煮沸3~4小时,提取;最后,加入4~6倍量蒸馏水,加热煮沸1~2小时,提取;合并三次提取液,过滤,得滤液,浓缩成60℃下相对密度为1.10~1.16的稠膏,备用;
(2)将防己、牛蒡子和石蝉草洗净,浸入10倍量的85%的乙醇溶液浸泡5~6小时,加热回流提取3~4小时,回收乙醇,滤过,将滤液浓缩为60℃环境下相对密度1.20~1.25的稠膏,备用;
(3)将叶下珠带根全草,除去杂质,洗净,切段,放入容器内,煎汤,加糖、滤杂质,留汁液备用;
(4)将土牛膝洗净晒干,进行粉碎处理,研末,过180目细粉,备用;
(5)将上述步骤(1)~(4)所制得的稠膏、汁液以及细粉混合,制成胶囊、片剂或丸剂,即得所述的治疗慢性睾丸***的药物。
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