CN105596758A - 肛肠科用于医治肛周脓肿的制剂及制法 - Google Patents
肛肠科用于医治肛周脓肿的制剂及制法 Download PDFInfo
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Abstract
本发明了公开了肛肠科用于医治肛周脓肿的制剂,主要由下列原料药制备而成,均为质量份:马齿苋8-12,金线兰6-10,百眼藤7-13,橘络4-8,铁钉菜5-10,黄柏5-9,蜀葵花3-6,蒲公英4-7,榆白皮3-8,荠苨6-11,竹节蓼7-10,狗肝菜2-6,孩儿茶3-7,自消容5-9,石龙刍根6-11,牛毛七5-10,百蕊草4-8。本发明配方科学、作用协同,所得产品具有清热解毒、祛瘀消肿等功效,疗效好,防复发。
Description
技术领域
本发明涉及中医中药领域,特别是涉及一种肛肠科用于医治肛周脓肿的制剂及制法。
背景技术
肛周脓肿是指肛管、直肠周围软组织内或其周围间隙内发生急性化脓性感染,并形成脓肿,另称为肛管、直肠周围脓肿引。常见的致病菌有大肠杆菌、金黄色葡萄球菌、链球菌和绿脓杆菌,偶有厌氧性细菌和结核杆菌,常是多种病菌混合感染。临床症状:先感到肛门周围出现了一个小硬块或肿块,继而疼痛加剧、红肿发热、坠胀不适、坐卧不宁、夜不能眠、大便秘结、排尿不畅成里急后重等直肠刺激症状。并随之出现全身不适、精神疲惫乏力、体温升高、食欲减退、寒战高热等全身中毒症状。一般在1周左右可形成脓肿,在肛门周围成直肠内指诊可摸到柔软、压痛、有波动的肿物,用注射器穿刺可抽出脓汁。若自行溃破或切开排脓后疼痛缓解或消失,体温下降,全身情况好转。但流脓的伤口却不易愈合或暂时愈合后又复发流脓,经久不愈,就成为肛瘘。
公布号CN103432533A(申请号201310406645.0)的中国专利文献公开了及一种治疗肛周脓肿的中药。该中药,由下述重量份配比的原料制成:透骨草20-40、苏木15-30、元胡10-30、秦皮15-40、老虎草11-25、板蓝根30-50、决明子40-50、当归10-25、木香5-20、白芍10-25、柴胡15-30、红藤20-40、杏仁10-25、郁金5-15、青皮20-30、枸杞子15-20、滑石5-10、瞿麦10-15、车前子20-30。公布号CN104784266A(申请号201510210275.2)的中国专利文献公开了一种治疗肛周脓肿的药剂,它是由下述重量配比的物质制成:小鸦葱120份、马蓼100份、井边草100份、五月茶80份、午时花60份、小黑药50份、化肉藤70份、水白蜡50份、东风菜30份和白冷草20份。公布号CN103272192A(申请号201310080287.9)的中国专利文献公开了一种治疗肛周脓肿的药剂,它是由下述重量配比的物质制成:玄参、干姜、山茱萸、桔梗、白芷、旋覆花、王不留行、天仙藤、防风、麻黄、毛诃子、巴戟天、白屈菜、大腹皮、苍耳子、余甘子、九里香、昆布、金沸草、肿节风、断血流、番泻叶、蓝布正、漏芦、一枝黄花、翻白草、锦灯笼、桑白皮、野马追、续断和闹羊花。
手术治疗肛周脓肿虽然见效快,但容易二次复发,给患者身体和经济造成较大损失,因此选择中药治疗,可有效减少患者痛苦,为提高中药治疗肛周脓肿的效果,还需要加强对此方面的研究。
发明内容
针对现有技术的不足,本发明的目的是提供一种疗效可靠、服用安全的肛肠科用于医治肛周脓肿的制剂及制法。
本发明的技术方案是:
肛肠科用于医治肛周脓肿的制剂,主要由下列原料药制备而成,均为质量份:马齿苋8-12,金线兰6-10,百眼藤7-13,橘络4-8,铁钉菜5-10,黄柏5-9,蜀葵花3-6,蒲公英4-7,榆白皮3-8,荠苨6-11,竹节蓼7-10,狗肝菜2-6,孩儿茶3-7,自消容5-9,石龙刍根6-11,牛毛七5-10,百蕊草4-8。
优选方案为,马齿苋9-11,金线兰7-9,百眼藤8-12,橘络5-7,铁钉菜6-9,黄柏6-8,蜀葵花4-5,蒲公英5-6,榆白皮5-6,荠苨7-10,竹节蓼8-9,狗肝菜3-5,孩儿茶4-6,自消容6-8,石龙刍根7-10,牛毛七6-9,百蕊草5-7。
更加优选的是,马齿苋10,金线兰8,百眼藤10,橘络6,铁钉菜7.5,黄柏7,蜀葵花4.5,蒲公英5.5,榆白皮5.5,荠苨8.5,竹节蓼8.5,狗肝菜4,孩儿茶5,自消容7,石龙刍根8.5,牛毛七7.5,百蕊草6。
所述的制剂的散剂的制备方法,步骤如下:
(1)取橘络、铁钉菜、蜀葵花和自消容洗净,加入原料药质量2倍的乙醇溶液浸润,中火加热煮干,取出放凉,与冰糖粉混合,碾成细末;
(2)取黄柏和榆白皮除去杂质,加入浓度为60%的食盐水,密闭浸泡25-35分钟(优选的:浸泡28-32分钟;更加优选的:浸泡30分钟),取出切成丝状,淋入原料药质量0.5倍的米酒拌匀,文火炒至干燥,取出;
(3)将百眼藤、荠苨和石龙刍根洗净,置于沸醋水中浸泡10-18分钟(优选的:浸泡12-16分钟;更加优选的:浸泡14分钟),取出切段,置于烤箱内,110℃恒温烘干,取出;
(4)将马齿苋、金线兰、蒲公英、竹节蓼、狗肝菜、牛毛七和百蕊草润洗干净,文火焙干,与步骤(1)(2)(3)所制原料药一起粉碎,制成药粉,加入乙醇溶液,回流提取1-3小时(优选的:回流提取1.5-2.5小时;更加优选的:回流提取2小时),过滤收集滤液,减压回收溶剂;
(5)将步骤(4)所得产物与孩儿茶混合,干燥粉碎,制成药粉,即得散剂。
所述的制剂散剂的制备方法,步骤(4)加入乙醇溶液的量为所提取原料药质量的6-8倍(优选的:加入乙醇溶液的量为所提取原料药质量的7倍)。
所述的制剂的丸剂的制备方法,步骤如下:
(1)取橘络、铁钉菜、蜀葵花和自消容洗净,加入原料药质量2倍的乙醇溶液浸润,中火加热煮干,取出放凉,与冰糖粉混合,碾成细末;
(2)取黄柏和榆白皮除去杂质,加入浓度为60%的食盐水,密闭浸泡25-35分钟(优选的:浸泡28-32分钟;更加优选的:浸泡30分钟),取出切成丝状,淋入原料药质量0.5倍的米酒拌匀,文火炒至干燥,取出;
(3)将百眼藤、荠苨和石龙刍根洗净,置于沸醋水中浸泡10-18分钟(优选的:浸泡12-16分钟;更加优选的:浸泡14分钟),取出切段,置于烤箱内,110℃恒温烘干,取出;
(4)将马齿苋、金线兰、蒲公英、竹节蓼、狗肝菜、牛毛七和百蕊草润洗干净,置于非铁质容器内,加入所煮原料药质量6倍的水,武火煎煮至沸腾,持续6分钟,改文火继续煎煮18-28分钟(优选的:继续煎煮20-26分钟;更加优选的:继续煎煮23分钟),过滤收集滤液,加热浓缩至稠膏;
(5)将孩儿茶与步骤(1)(2)(3)所制原料药一起粉碎过筛,制成药粉,并与步骤(4)所得稠膏混合,制成软材,搓条制丸,分割搓圆,即得丸剂。
所述的制剂丸剂的制备方法,步骤(5)粉碎过60-120目筛(优选的:粉碎过80-100目筛;更加优选的:粉碎过90目筛)。
所述的制剂的胶囊剂的制备方法,步骤如下:
(1)取橘络、铁钉菜、蜀葵花和自消容洗净,加入原料药质量2倍的乙醇溶液浸润,中火加热煮干,取出放凉,与冰糖粉混合,碾成细末;
(2)取黄柏和榆白皮除去杂质,加入浓度为60%的食盐水,密闭浸泡25-35分钟(优选的:浸泡28-32分钟;更加优选的:浸泡30分钟),取出切成丝状,淋入原料药质量0.5倍的米酒拌匀,文火炒至干燥,取出;
(3)将百眼藤、荠苨和石龙刍根洗净,置于沸醋水中浸泡10-18分钟(优选的:浸泡12-16分钟;更加优选的:浸泡14分钟),取出切段,置于烤箱内,110℃恒温烘干,取出;
(4)将马齿苋、金线兰、蒲公英、竹节蓼、狗肝菜、牛毛七和百蕊草润洗干净,置于非铁质容器内,加入所煮原料药质量6倍的水,武火煎煮至沸腾,持续6分钟,改文火继续煎煮18-28分钟(优选的:继续煎煮20-26分钟;更加优选的:继续煎煮23分钟),过滤收集滤液;
(5)将步骤(4)所得滤液与孩儿茶混合,加热浓缩,烘干后与步骤(1)(2)(3)所制原料药一起粉碎过筛,装填入胶囊内,即得胶囊剂。
所述的制剂胶囊剂的制备方法,步骤(5)粉碎过120-180目筛(优选的:粉碎过140-160目筛;更加优选的:粉碎过150目筛)。
所述的制剂的片剂的制备方法,步骤如下:
(1)取橘络、铁钉菜、蜀葵花和自消容洗净,加入原料药质量2倍的乙醇溶液浸润,中火加热煮干,取出放凉,与冰糖粉混合,碾成细末;
(2)取黄柏和榆白皮除去杂质,加入浓度为60%的食盐水,密闭浸泡25-35分钟(优选的:浸泡28-32分钟;更加优选的:浸泡30分钟),取出切成丝状,淋入原料药质量0.5倍的米酒拌匀,文火炒至干燥,取出;
(3)将百眼藤、荠苨和石龙刍根洗净,置于沸醋水中浸泡10-18分钟(优选的:浸泡12-16分钟;更加优选的:浸泡14分钟),取出切段,置于烤箱内,110℃恒温烘干,取出;
(4)将马齿苋、金线兰、蒲公英、竹节蓼、狗肝菜、牛毛七和百蕊草润洗干净,文火焙干,与步骤(1)(2)(3)所制原料药一起粉碎,制成药粉,加入所提取原料药质量7倍的乙醇溶液,回流提取1-3小时(优选的:回流提取1.5-2.5小时;更加优选的:回流提取2小时),过滤收集滤液,减压回收溶剂;
(5)将步骤(4)所得产物与孩儿茶混合,干燥粉碎,制成药粉,按照片剂的制备方法,挤压制成椭圆形片状剂型,即得片剂。
所述的制剂片剂的制备方法,步骤(5)每粒片剂中所含药粉质量为0.25-0.35g(优选的:每粒片剂中所含药粉质量为0.3g)。
本发明提供的肛肠科用于医治肛周脓肿的制剂不仅组方科学,且制备方法简单,产品服用方便。除此之外,本发明的优良效果还表现在:
1、本发明治疗效果好,标本兼治,可有效防止复发;
2、本组方完全符合中医药原则,具有清热解毒、祛瘀消肿等功效;
3、本发明原料为中药植物材料,廉价易得,成本低,长期服用无明显毒副作用。
具体实施方式
下面结合实施例和实验例详细说明本发明的技术方案,但保护范围不限于此。
实施例1肛肠科用于医治肛周脓肿的制剂,主要由下列原料药制备而成(每份10g):马齿苋8份,金线兰6份,百眼藤7份,橘络4份,铁钉菜5份,黄柏5份,蜀葵花3份,蒲公英4份,榆白皮3份,荠苨6份,竹节蓼7份,狗肝菜2份,孩儿茶3份,自消容5份,石龙刍根6份,牛毛七5份,百蕊草4份。上述肛肠科用于医治肛周脓肿的制剂散剂的制备方法是:
(1)取橘络、铁钉菜、蜀葵花和自消容洗净,加入原料药质量2倍的乙醇溶液浸润,中火加热煮干,取出放凉,与冰糖粉混合,碾成细末;
(2)取黄柏和榆白皮除去杂质,加入浓度为60%的食盐水,密闭浸泡30分钟,取出切成丝状,淋入原料药质量0.5倍的米酒拌匀,文火炒至干燥,取出;
(3)将百眼藤、荠苨和石龙刍根洗净,置于沸醋水中浸泡14分钟,取出切段,置于烤箱内,110℃恒温烘干,取出;
(4)将马齿苋、金线兰、蒲公英、竹节蓼、狗肝菜、牛毛七和百蕊草润洗干净,文火焙干,与步骤(1)(2)(3)所制原料药一起粉碎,制成药粉,加入所提取原料药质量7倍的乙醇溶液,回流提取2小时,过滤收集滤液,减压回收溶剂;
(5)将步骤(4)所得产物与孩儿茶混合,干燥粉碎,制成药粉,即得散剂。
实施例2肛肠科用于医治肛周脓肿的制剂,主要由下列原料药制备而成(每份10g):马齿苋12份,金线兰10份,百眼藤13份,橘络8份,铁钉菜10份,黄柏9份,蜀葵花6份,蒲公英7份,榆白皮8份,荠苨11份,竹节蓼10份,狗肝菜6份,孩儿茶7份,自消容9份,石龙刍根11份,牛毛七10份,百蕊草8份。肛肠科用于医治肛周脓肿的制剂丸剂的制备方法是:
(1)取橘络、铁钉菜、蜀葵花和自消容洗净,加入原料药质量2倍的乙醇溶液浸润,中火加热煮干,取出放凉,与冰糖粉混合,碾成细末;
(2)取黄柏和榆白皮除去杂质,加入浓度为60%的食盐水,密闭浸泡30分钟,取出切成丝状,淋入原料药质量0.5倍的米酒拌匀,文火炒至干燥,取出;
(3)将百眼藤、荠苨和石龙刍根洗净,置于沸醋水中浸泡14分钟,取出切段,置于烤箱内,110℃恒温烘干,取出;
(4)将马齿苋、金线兰、蒲公英、竹节蓼、狗肝菜、牛毛七和百蕊草润洗干净,置于非铁质容器内,加入所煮原料药质量6倍的水,武火煎煮至沸腾,持续6分钟,改文火继续煎煮23分钟,过滤收集滤液,加热浓缩至稠膏;
(5)将孩儿茶与步骤(1)(2)(3)所制原料药一起粉碎过90目筛,制成药粉,并与步骤(4)所得稠膏混合,制成软材,搓条制丸,分割搓圆,即得丸剂。
典型病例:xxx,女,34岁。主诉:肛门部有包块,疼痛明显,触之即痛;病史:患者一周前,自感排便困难,有坠胀感,大便颜色轻微发红,无法正常坐立,后经医院检查发现,肛门部有包块,肛周红肿,并有脓性分泌物,诊断为肛周脓肿。
经人推荐服用本实施例所得丸剂,每天2次,每次2-3粒,温开水冲服,5天一个疗程。患者服用一周后,疼痛感明显下降,肿物有所缩小,坚持服用两个疗程后,患者排便基本顺畅,无不适感,继续巩固一周后,患者痊愈,肿块消除。
实施例3肛肠科用于医治肛周脓肿的制剂,主要由下列原料药制备而成(每份10g):马齿苋9份,金线兰7份,百眼藤8份,橘络5份,铁钉菜6份,黄柏6份,蜀葵花4份,蒲公英5份,榆白皮5份,荠苨7份,竹节蓼8份,狗肝菜3份,孩儿茶4份,自消容6份,石龙刍根7份,牛毛七6份,百蕊草5份。肛肠科用于医治肛周脓肿的制剂胶囊剂的制备方法是:
(1)取橘络、铁钉菜、蜀葵花和自消容洗净,加入原料药质量2倍的乙醇溶液浸润,中火加热煮干,取出放凉,与冰糖粉混合,碾成细末;
(2)取黄柏和榆白皮除去杂质,加入浓度为60%的食盐水,密闭浸泡30分钟,取出切成丝状,淋入原料药质量0.5倍的米酒拌匀,文火炒至干燥,取出;
(3)将百眼藤、荠苨和石龙刍根洗净,置于沸醋水中浸泡14分钟,取出切段,置于烤箱内,110℃恒温烘干,取出;
(4)将马齿苋、金线兰、蒲公英、竹节蓼、狗肝菜、牛毛七和百蕊草润洗干净,置于非铁质容器内,加入所煮原料药质量6倍的水,武火煎煮至沸腾,持续6分钟,改文火继续煎煮23分钟,过滤收集滤液;
(5)将步骤(4)所得滤液与孩儿茶混合,加热浓缩,烘干后与步骤(1)(2)(3)所制原料药一起粉碎过150目筛,装填入胶囊内,即得胶囊剂。
典型病例:xxx,男,29岁。主诉:肛周红肿,疼痛难忍;病史:患者半月前无明显诱因发现肛门周围有一肿块,开始时无其他不适,后肿块逐渐增大,疼痛加重,排便不畅,下腹有坠胀感,并伴有发热、浑身不适等症状,入院检查,直肠指检可触及压痛性肿块,直肠内穿刺可抽出脓液,确诊为肛周脓肿。
患者不愿意接受手术治疗,遂选择服用本实施例所得胶囊剂,采用每天2次,每次2-3粒,用温开水冲服,5天一个疗程。患者服用一个疗程后,肿块减小,疼痛感减轻,继续服用一个疗程,患者排便顺畅,不适症明显减少,巩固一个疗程后,患者痊愈,随访半年,无复发。
实施例4肛肠科用于医治肛周脓肿的制剂,主要由下列原料药制备而成(每份10g):马齿苋11份,金线兰9份,百眼藤12份,橘络7份,铁钉菜9份,黄柏8份,蜀葵花5份,蒲公英6份,榆白皮6份,荠苨10份,竹节蓼9份,狗肝菜5份,孩儿茶6份,自消容8份,石龙刍根10份,牛毛七9份,百蕊草7份。肛肠科用于医治肛周脓肿的制剂片剂的制备方法是:
(1)取橘络、铁钉菜、蜀葵花和自消容洗净,加入原料药质量2倍的乙醇溶液浸润,中火加热煮干,取出放凉,与冰糖粉混合,碾成细末;
(2)取黄柏和榆白皮除去杂质,加入浓度为60%的食盐水,密闭浸泡30分钟,取出切成丝状,淋入原料药质量0.5倍的米酒拌匀,文火炒至干燥,取出;
(3)将百眼藤、荠苨和石龙刍根洗净,置于沸醋水中浸泡14分钟,取出切段,置于烤箱内,110℃恒温烘干,取出;
(4)将马齿苋、金线兰、蒲公英、竹节蓼、狗肝菜、牛毛七和百蕊草润洗干净,文火焙干,与步骤(1)(2)(3)所制原料药一起粉碎,制成药粉,加入所提取原料药质量7倍的乙醇溶液,回流提取2小时,过滤收集滤液,减压回收溶剂;
(5)将步骤(4)所得产物与孩儿茶混合,干燥粉碎,制成药粉,按照片剂的制备方法,挤压制成椭圆形片状剂型,每粒片剂中所含药粉质量为0.3g,即得片剂。
典型病例:xxx,男,48岁。病史:患者平素喜欢吃辛辣食物,且饮食习惯较差,喝水量少,排便困难,大便秘结,曾有得有痔疮,服药后病情缓解,但经常反复,近期患者发觉肛门部红肿,可触及肿块,有压痛,疼痛感逐渐增加,坐卧不安,入院检查,诊断为肛周脓肿伴有痔疮。
患者服用本实施例所得片剂,采用每天2次,每次2-3片,用温开水冲服,5天一个疗程。患者服用一个疗程后,疼痛感有所缓解,肿块缩小至一半,坚持服用三个疗程后,患者肿块消除,排便顺畅,身体恢复至正常,随访一年内,病情无复发。
实施例5肛肠科用于医治肛周脓肿的制剂,主要由下列原料药制备而成(每份10g):马齿苋10份,金线兰8份,百眼藤10份,橘络6份,铁钉菜7.5份,黄柏7份,蜀葵花4.5份,蒲公英5.5份,榆白皮5.5份,荠苨8.5份,竹节蓼8.5份,狗肝菜4份,孩儿茶5份,自消容7份,石龙刍根8.5份,牛毛七7.5份,百蕊草6份。肛肠科用于医治肛周脓肿的制剂散剂的制备方法是:
(1)取橘络、铁钉菜、蜀葵花和自消容洗净,加入原料药质量2倍的乙醇溶液浸润,中火加热煮干,取出放凉,与冰糖粉混合,碾成细末;
(2)取黄柏和榆白皮除去杂质,加入浓度为60%的食盐水,密闭浸泡30分钟,取出切成丝状,淋入原料药质量0.5倍的米酒拌匀,文火炒至干燥,取出;
(3)将百眼藤、荠苨和石龙刍根洗净,置于沸醋水中浸泡14分钟,取出切段,置于烤箱内,110℃恒温烘干,取出;
(4)将马齿苋、金线兰、蒲公英、竹节蓼、狗肝菜、牛毛七和百蕊草润洗干净,文火焙干,与步骤(1)(2)(3)所制原料药一起粉碎,制成药粉,加入所提取原料药质量7倍的乙醇溶液,回流提取2小时,过滤收集滤液,减压回收溶剂;
(5)将步骤(4)所得产物与孩儿茶混合,干燥粉碎,制成药粉,即得散剂。
本发明所用主要中药原料的药理如下:
马齿苋:基原:为马齿苋科植物马齿苋的全草。性味:酸;性寒。归经:大肠;肝经。功能主治:清热解毒;凉血止痢;除湿通淋。主热毒泻痢;热淋;尿闭;赤白带下;崩漏;痔血;疮疡痈疖;丹毒;瘰疬;湿癣;白秃。
金线兰:基原:为兰科开唇兰属植物花叶开唇兰和金线兰的全草。药性:甘,凉。功用主治:凉血祛风,除湿解毒。主治肺热咳嗽,咯血,尿血,小儿惊风,破伤风,水肿,风湿麻痹。
百眼藤:基原:为双子叶植物药茜草科植物细叶巴戟天的全株。性味:甘;凉。归经:肺经。功能主治:清热解毒;散瘀止痛;和胃化湿。主感冒咳嗽;百日咳;消化不良;湿疹;跌打损伤,腰肌劳损。
橘络:基原:为芸香科植物橘及其栽培变种的果皮内层筋络。性味:甘;苦;平。归经:肝;脾经。功能主治:通络;理气;化痰。主经络气滞;久咳胸痛;痰中带血;伤酒口渴。
铁钉菜:基原:为铁钉菜科植物铁钉菜及叶状铁钉菜的藻体。性味:咸;寒。归经:肝经。功能主治:软坚散结;解毒;驱蛔。主颈淋巴结肿;甲状腺肿;喉炎;蛔虫病。
黄柏:基原:为芸香科植物黄柏或黄皮树的树皮。性味与归经:苦,寒。归肾、膀胱经。有清热燥湿,泻火除蒸,解毒疗疮的功效。用于湿热泻痢,黄疸尿赤,带下阴痒,热淋涩痛,脚气痿蹙,骨蒸劳热,盗汗,遗精,疮疡肿毒,湿疹湿疮。
蜀葵花:基原:为锦葵科植物蜀葵的花。性味:甘;咸;凉。归经:肺;大肠;膀胱经。功能主治:和血止血;解毒散结。主吐血;衄血;有经过多;赤白带下;二便不通;小儿风疹;疟疾;痈疽疖肿;蜂蝎螫伤;烫伤;火伤。
蒲公英:基原:为菊科植物蒲公英、碱地蒲公英、东北蒲公英、异苞蒲公英、亚洲蒲公英、红梗蒲公英等同属多种植物的全草。性味:味苦;甘;性寒。归经:归肝;胃经。功能主治:清热解毒;消痈散结。主乳痈;肺痈;肠痈;痄腮;疔毒疮肿;目赤肿痛;感冒发热;咳嗽;咽喉肿痛;胃火;肠炎;痢疾;肝炎;胆吓炎;尿路感染;蛇虫咬伤。
榆白皮:基原:为榆科植物榆树的树皮、根皮。性味:甘;性微寒。归经:肺;脾;膀胱经。功能主治:利水通淋;祛痰;消肿解毒。主小便不利;淋浊;带下;咳喘痰多;失眠;内外出血,难产胎死不下;痈疬;秃疮;疥癣。
荠苨:基原:为桔梗科植物荠苨的根。化学成份:含β-谷甾醇和胡萝卜甾醇等。性味:甘,寒。归经:归肺;脾经。功能主治:润燥化痰;清热解毒。主肺燥咳嗽;咽喉肿痛;消渴;疔痈疮毒;药物中毒。
竹节蓼:基原:为蓼科植物竹节蓼的全草。性味:甘;淡;性平。归经:肝;肺经。功能主治:清热解毒;去瘀消肿。主痈疽肿毒;跌打损伤;蛇;虫咬伤。
狗肝菜:基原:为爵床科植物狗肝菜的全草。性味:味甘;微苦;性寒。归经:归心;肝;肺经。功能主治:清热;凉血;利湿;解毒。主感冒发热;热病发斑;吐衄血;便血;尿血;崩漏;肺热咳嗽;咽喉肿痛;肝热目赤;小儿惊风;小便淋沥;带下;带状疱疹;痈肿疔疖;蛇犬咬伤。
孩儿茶:基原:为豆科植物儿茶心材或去皮枝干煎制而成的干燥浸膏。性味:苦涩;凉;无毒。归经:心;肺。功能主治:收湿敛疮,止血定痛,清热化痰。主疮疡,久溃不敛,湿疮流水,牙疳,口疮,咯血,吐血,尿血,便血,血崩,外伤出血,痔疮痈肿,痰热咳嗽。
自消容:基原:为豆科植物大猪屎豆的茎叶。性味:淡;寒;有毒。归经:肺;脾经。功能主治:清热解毒,凉血止血,利水消肿。主小儿头疮,口疮,牙痛,肺热咳嗽咯血,跌打损伤,外伤出血,水肿,肾结石,膀胱炎,风湿骨痛。
石龙刍根:基原:为灯心草科植物灯心草的根茎及根。性味:甘;涩;微寒。归经:归脾;心;肝经。功能主治:清热利湿;凉血止血。主淋浊;心烦失眠;鹤膝风;目赤肿痛;齿痛;鼻衄;便血;崩漏;白带。
牛毛七:基原:为曲尾藓科植物山毛藓的全草。性味:甘;淡;平。归经:心;肺经。功能主治:养阴清热;安神定志;祛风除湿;止血镇痛。主骨蒸潮热;神经衰弱;风湿麻木;筋骨疼痛;癫狂;外伤出血。
百蕊草:基原:为檀香科植物百蕊草的全草。性味:辛;微苦;性寒。归经:脾;肾经。功能主治:清热解毒,补肾涩精。治急性乳腺炎,肺炎,肺脓疡,扁桃体炎,上呼吸道感染;肾虚腰痛,头昏,遗精,滑精。
试验例1本发明所得肛肠科用于医治肛周脓肿的制剂(实施例5)的临床应用:
选取人群:2014年12月-2015年6月,依据就诊病历,筛选在四所医院收治的肛周脓肿患者326例,年龄22-60岁,平均年龄39.4±1.8岁,病程7天-2个月,其中男性患者169例,女性患者157例。诊断依据:1、肛门烧灼痛或跳痛,排便或行走时加重,少数有排尿困难。2、可伴有发冷、发热、全身不适等症状。3、B超可测及脓腔。4、血白细胞及中性粒细胞计数增多。5、肛门周围有硬结或肿块,局部温度增高、压痛或有波动。位于肛提肌以上的脓肿,直肠指检可触及压痛性肿块,直肠内穿刺可抽出脓液。
试验前,将患者随机分为两组,实验组200例和对照组126例,两组在性别、年龄、病程、病情等方面无显著差异。实验组服用本发明所得产品,每次3-5g,一天两次,温开水冲服,5天为一个疗程;对照组使用其他常规药物(马应龙痔疮膏、痔速宁胶囊、马应龙麝香痔疮栓等)。用药期间对两组患者进行连续观察,记录症状及变化。
疗效判定标准:参照文献疗效标准,(1)治愈:临床症状及体征消除,脓肿肿块消失;(2)好转:临床症状及体征明显改善,脓肿肿块减轻;(3)无效:临床症状及体征无变化。
临床结果:经三个疗程的治疗后,两组的治疗结果如下所示:
实验组:治愈患者为143例,治愈率为71.5%,好转患者为51例,好转率为25.5%,总有效率为97.0%;
对照组:治愈患者为78例,治愈率为61.9%,好转患者为31例,好转率为24.6%,总有效率86.5%。
由此可知,对照组的治疗效果明显低于实验组,说明本发明所得产品疗效显著,治疗效果好。一年内随访,记录两组的复发情况,实验组复发8例,复发率为5.6%,而对照组复发11例,复发率为14.1%,因此可知本发明产品可有效根除病症,防止复发。
本发明中所使用的中药,马齿苋清热解毒,金线兰除湿解毒,百眼藤散瘀止痛,橘络通络理气,铁钉菜软坚散结,黄柏、石龙刍根清热燥湿,蜀葵花和血止血,蒲公英消痈散结,榆白皮利水通淋,荠苨润燥化痰,竹节蓼去瘀消肿,狗肝菜利湿解毒,孩儿茶收湿敛疮,自消容利水消肿,牛毛七养阴清热,百蕊草补肾涩精,多种药材协同作用,共奏清热解毒、祛瘀消肿之功效。
应当指出的是,具体实施方式只是本发明比较有代表性的例子,显然本发明的技术方案不限于上述实施例,还可以有很多变形。本领域的普通技术人员,以本发明所明确公开的或根据文件的书面描述毫无异议的得到的,均应认为是本专利所要保护的范围。
Claims (10)
1.肛肠科用于医治肛周脓肿的制剂,其特征在于,主要由下列原料药制备而成,均为质量份:马齿苋8-12,金线兰6-10,百眼藤7-13,橘络4-8,铁钉菜5-10,黄柏5-9,蜀葵花3-6,蒲公英4-7,榆白皮3-8,荠苨6-11,竹节蓼7-10,狗肝菜2-6,孩儿茶3-7,自消容5-9,石龙刍根6-11,牛毛七5-10,百蕊草4-8。
2.如权利要求1所述的肛肠科用于医治肛周脓肿的制剂,其特征在于,马齿苋9-11,金线兰7-9,百眼藤8-12,橘络5-7,铁钉菜6-9,黄柏6-8,蜀葵花4-5,蒲公英5-6,榆白皮5-6,荠苨7-10,竹节蓼8-9,狗肝菜3-5,孩儿茶4-6,自消容6-8,石龙刍根7-10,牛毛七6-9,百蕊草5-7(优选的是:马齿苋10,金线兰8,百眼藤10,橘络6,铁钉菜7.5,黄柏7,蜀葵花4.5,蒲公英5.5,榆白皮5.5,荠苨8.5,竹节蓼8.5,狗肝菜4,孩儿茶5,自消容7,石龙刍根8.5,牛毛七7.5,百蕊草6)。
3.如权利要求1-2任一所述的制剂的散剂的制备方法,其特征在于,步骤如下:
(1)取橘络、铁钉菜、蜀葵花和自消容洗净,加入原料药质量2倍的乙醇溶液浸润,中火加热煮干,取出放凉,与冰糖粉混合,碾成细末;
(2)取黄柏和榆白皮除去杂质,加入浓度为60%的食盐水,密闭浸泡25-35分钟(优选的:浸泡28-32分钟;更加优选的:浸泡30分钟),取出切成丝状,淋入原料药质量0.5倍的米酒拌匀,文火炒至干燥,取出;
(3)将百眼藤、荠苨和石龙刍根洗净,置于沸醋水中浸泡10-18分钟(优选的:浸泡12-16分钟;更加优选的:浸泡14分钟),取出切段,置于烤箱内,110℃恒温烘干,取出;
(4)将马齿苋、金线兰、蒲公英、竹节蓼、狗肝菜、牛毛七和百蕊草润洗干净,文火焙干,与步骤(1)(2)(3)所制原料药一起粉碎,制成药粉,加入乙醇溶液,回流提取1-3小时(优选的:回流提取1.5-2.5小时;更加优选的:回流提取2小时),过滤收集滤液,减压回收溶剂;
(5)将步骤(4)所得产物与孩儿茶混合,干燥粉碎,制成药粉,即得散剂。
4.如权利要求3所述的制剂散剂的制备方法,其特征在于,步骤(4)加入乙醇溶液的量为所提取原料药质量的6-8倍(优选的:加入乙醇溶液的量为所提取原料药质量的7倍)。
5.如权利要求1-2任一所述的制剂的丸剂的制备方法,其特征在于,步骤如下:
(1)取橘络、铁钉菜、蜀葵花和自消容洗净,加入原料药质量2倍的乙醇溶液浸润,中火加热煮干,取出放凉,与冰糖粉混合,碾成细末;
(2)取黄柏和榆白皮除去杂质,加入浓度为60%的食盐水,密闭浸泡25-35分钟(优选的:浸泡28-32分钟;更加优选的:浸泡30分钟),取出切成丝状,淋入原料药质量0.5倍的米酒拌匀,文火炒至干燥,取出;
(3)将百眼藤、荠苨和石龙刍根洗净,置于沸醋水中浸泡10-18分钟(优选的:浸泡12-16分钟;更加优选的:浸泡14分钟),取出切段,置于烤箱内,110℃恒温烘干,取出;
(4)将马齿苋、金线兰、蒲公英、竹节蓼、狗肝菜、牛毛七和百蕊草润洗干净,置于非铁质容器内,加入所煮原料药质量6倍的水,武火煎煮至沸腾,持续6分钟,改文火继续煎煮18-28分钟(优选的:继续煎煮20-26分钟;更加优选的:继续煎煮23分钟),过滤收集滤液,加热浓缩至稠膏;
(5)将孩儿茶与步骤(1)(2)(3)所制原料药一起粉碎过筛,制成药粉,并与步骤(4)所得稠膏混合,制成软材,搓条制丸,分割搓圆,即得丸剂。
6.如权利要求5所述的制剂丸剂的制备方法,其特征在于,步骤(5)粉碎过60-120目筛(优选的:粉碎过80-100目筛;更加优选的:粉碎过90目筛)。
7.如权利要求1-2任一所述的制剂的胶囊剂的制备方法,其特征在于,步骤如下:
(1)取橘络、铁钉菜、蜀葵花和自消容洗净,加入原料药质量2倍的乙醇溶液浸润,中火加热煮干,取出放凉,与冰糖粉混合,碾成细末;
(2)取黄柏和榆白皮除去杂质,加入浓度为60%的食盐水,密闭浸泡25-35分钟(优选的:浸泡28-32分钟;更加优选的:浸泡30分钟),取出切成丝状,淋入原料药质量0.5倍的米酒拌匀,文火炒至干燥,取出;
(3)将百眼藤、荠苨和石龙刍根洗净,置于沸醋水中浸泡10-18分钟(优选的:浸泡12-16分钟;更加优选的:浸泡14分钟),取出切段,置于烤箱内,110℃恒温烘干,取出;
(4)将马齿苋、金线兰、蒲公英、竹节蓼、狗肝菜、牛毛七和百蕊草润洗干净,置于非铁质容器内,加入所煮原料药质量6倍的水,武火煎煮至沸腾,持续6分钟,改文火继续煎煮18-28分钟(优选的:继续煎煮20-26分钟;更加优选的:继续煎煮23分钟),过滤收集滤液;
(5)将步骤(4)所得滤液与孩儿茶混合,加热浓缩,烘干后与步骤(1)(2)(3)所制原料药一起粉碎过筛,装填入胶囊内,即得胶囊剂。
8.如权利要求7所述的制剂胶囊剂的制备方法,其特征在于,步骤(5)粉碎过120-180目筛(优选的:粉碎过140-160目筛;更加优选的:粉碎过150目筛)。
9.如权利要求1-2任一所述的制剂的片剂的制备方法,其特征在于,步骤如下:
(1)取橘络、铁钉菜、蜀葵花和自消容洗净,加入原料药质量2倍的乙醇溶液浸润,中火加热煮干,取出放凉,与冰糖粉混合,碾成细末;
(2)取黄柏和榆白皮除去杂质,加入浓度为60%的食盐水,密闭浸泡25-35分钟(优选的:浸泡28-32分钟;更加优选的:浸泡30分钟),取出切成丝状,淋入原料药质量0.5倍的米酒拌匀,文火炒至干燥,取出;
(3)将百眼藤、荠苨和石龙刍根洗净,置于沸醋水中浸泡10-18分钟(优选的:浸泡12-16分钟;更加优选的:浸泡14分钟),取出切段,置于烤箱内,110℃恒温烘干,取出;
(4)将马齿苋、金线兰、蒲公英、竹节蓼、狗肝菜、牛毛七和百蕊草润洗干净,文火焙干,与步骤(1)(2)(3)所制原料药一起粉碎,制成药粉,加入所提取原料药质量7倍的乙醇溶液,回流提取1-3小时(优选的:回流提取1.5-2.5小时;更加优选的:回流提取2小时),过滤收集滤液,减压回收溶剂;
(5)将步骤(4)所得产物与孩儿茶混合,干燥粉碎,制成药粉,按照片剂的制备方法,挤压制成椭圆形片状剂型,即得片剂。
10.如权利要求9所述的制剂片剂的制备方法,其特征在于,步骤(5)每粒片剂中所含药粉质量为0.25-0.35g(优选的:每粒片剂中所含药粉质量为0.3g)。
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