CN104288511A - 一种治疗内痔出血的中药栓剂 - Google Patents
一种治疗内痔出血的中药栓剂 Download PDFInfo
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Abstract
本发明涉及治疗内痔出血的中药栓剂,可有效解决非手术期治疗内痔出血的用药问题,方法是,该栓剂是由以下重量计的:黄柏110-120g、黄连110-120g、没药80-90g、乳香80-90g、血竭80-90g、儿茶80-90g、五倍子80-90g、白及160-180g、煅龙骨160-180g、冰片15-20g和甘草30-40g作原料药物制成,原料药物加水浸泡,然后武火煎沸,再文火煎,过滤,滤液浓缩成50℃相对密度1.20-1.30的浸膏,缓缓加入浸膏量的、质量浓度为80-95%的乙醇,搅拌均匀,静置,过滤,回收乙醇,浓缩成50℃相对密度1.40-1.50的稠膏或干膏粉,与基质在45~65℃下混和均匀成糊状,倾入栓模中,冷却,即得,本发明组方科学合理,原料丰富,易生产,使用方便,具有清热泻火,消肿止痛,生肌敛疮,涩肠止血等功效,效果好,有效用于治疗非手术期内痔出血。
Description
技术领域
本发明涉及医药,特别是一种治疗内痔出血的中药栓剂。
背景技术
痔疮是一种常见病、多发病,据有关资料报道,发病率占人口总数40%左右。在普通人群中,痔的发病率为46.26%,以前有“十男九痔,十女十痔”的说法。1997年我国普查资料显示,痔的发病率约占整个肛肠疾病的87.25%。这说明痔是一种多发病,常见病。如果长期得不到治疗,痔核会逐渐加重,可出现便血、疼痛、水肿和脱出等症状,其中出血最为常见,临床多表现为便纸染血、便时或便后滴血、便时喷血和非排便时肛门内大量出血等。严重者反复发作,大便出血而引起继发性贫血,影响着患者的身体健康。
出血是内痔的主要临床表现,其往往表现为大便中或大便后带血,颜色鲜红,有时大便表面附有少量血液,或手纸染血,或排便时滴血,或呈喷射状出血,出血量或多或少,严重者可导致重度贫血,造成不良后果。探究其出血原因,首先是解剖学因素,肛门直肠部的解剖结构上存在着发生内痔出血的主要因素,直肠上静脉无瓣膜,血液不易回流,直肠下端黏膜层以及肛管上皮肛缘皮下的静脉层,又缺乏弹性纤维的支持而容易引起血管扩张而成痔疮出血;另外,人体直立行走的因素,受到地球的引力引用下,直肠静脉层淤血扩张而容易使内痔充血;其次,不良的饮食习惯及排便习惯均可加重出血,经常喜事辛辣刺激性食物,或者大量饮酒,易使直肠粘膜充血,大便时下蹲体位和用力下挣的动作,对直肠静脉回流不利,蹲厕过久,就会加重血管淤血扩张。排便时痔区血管压力增高,或大便摩擦,以致曲张静脉血管破裂,而出现便血,严重者出血喷射状出血,出血量较大。
现代医学对痔的病因病机的认识,尚无一致的定论,目前较为认同的“静脉曲张”、“血管增生”、“肛垫下移”三种学说,临床接受较为广泛的是“静脉曲张”“肛垫下移”学说,而其他几种学说从本质上是对静脉曲张学说和肛垫下移学说的说明、解释。肛垫下移在国内外肛肠外科学界逐渐得到承认,正常肛垫的病理性肥大即谓痔,痔是肛垫病理性肥大、移位及肛周皮下血管丛血流淤滞形成的团块。随着肛垫学说被广泛的认同,对痔的治疗有了新的概念,较多的学者放弃“见痔就治”的理念,更改为对有临床症状的痔病而进行治疗。痔的治疗原则是尽可能的保留肛垫组织,使下移的肛垫复位,减少对肛管解剖的损伤,旨在通过纠正痔的病理生理性改变,而非将肛垫组织全部切除以治疗痔病。痔的治疗目的是消除症状,而非消除痔体,一般认为,内痔出血多采用非手术治疗,通过局部用药,促进直肠粘膜修复,直肠黏膜保护而缓解症状。
内痔出血的非手术治疗以中医为主,目前临床主要有内服、熏洗、外敷、塞肛、注射、针灸等等,在这些治疗方法中尤其是塞肛疗法效果最佳,应用最为广泛,将药物制成栓剂,纳入肛内,使药物充分接触病灶,使药物被迅速吸收,提高病变部位的血药浓度,充分发挥药物的局部作用。因其操作简单,见效快,此法在临床应用广泛。
临床上常用的栓剂,虽然有一定的治疗作用,但疗效较为缓慢,远期疗效较差,长期应用均有一定的毒副作用。目前,还没有专门针对内痔出血痔疮类栓剂,因此,治疗内痔出血的栓剂是目前亟需解决的问题。
发明内容
针对上述情况,为解决现有技术之缺陷,本发明之目的就是提供一种治疗内痔出血的中药栓剂,可有效解决非手术期治疗内痔出血的用药问题。
本发明解决的技术方案是,该栓剂是由以下重量计的:黄柏110-120g、黄连110-120g、没药80-90g、乳香80-90g、血竭80-90g、儿茶80-90g、五倍子80-90g、白及160-180g、煅龙骨160-180g 、冰片15-20g和甘草30-40g作原料药物制成,加原料药物重量8-12倍的水浸泡2-12小时,武火煎沸,再文火煎60分钟,过滤,得第一次滤液;药渣再加原料药物重量8-12倍的水,武火煎沸,再文火煎45分钟,过滤,得第二次滤液;药渣再加原料药物重量8-12倍的水,武火煎沸,再文火煎45分钟,过滤,得第三次滤液,合并三次滤液,浓缩成50℃相对密度1.20-1.30的浸膏,缓缓加入浸膏量的、质量浓度为80-95%的乙醇,搅拌均匀,静置12~36小时,过滤,回收乙醇,浓缩成50℃相对密度1.40-1.50的稠膏或干膏粉,与基质在45~65℃下混和均匀成糊状,倾入栓模中,冷却,即得表面光滑,色泽棕黑的栓剂。
所述的基质是半合成脂肪酸甘油酯36型、半合成脂肪酸甘油酯38型、泊洛沙姆、甘油明胶、羊毛脂中的一种或两种以上的组合。
本发明组方科学合理,原料丰富,易生产,使用方便,具有清热泻火,消肿止痛,生肌敛疮,涩肠止血等功效,效果好,有效用于治疗非手术期内痔出血,是治疗痔疮药物上的创新,有良好的经济和社会效益。
具体实施方式
以下结合实施例对本发明的具体实施方式作详细说明。
本发明在具体实施中,可由以下实施例给出。
实施例1
本发明在具体实施中,是由以下重量计的:黄柏114.3g、黄连114.3g、没药85.7g、乳香85.7g、血竭85.7g、儿茶85.7g、五倍子85.7g、白及171.4g、煅龙骨171.4g 、冰片17.1g和甘草34.3g作原料药物制成,加原料药物重量8-12倍的水浸泡2-12小时,武火煎沸,再文火煎60分钟,过滤,得第一次滤液;药渣再加原料药物重量8-12倍的水,武火煎沸,再文火煎45分钟,过滤,得第二次滤液;药渣再加原料药物重量8-12倍的水,武火煎沸,再文火煎45分钟,过滤,得第三次滤液,合并三次滤液,浓缩成50℃相对密度1.20-1.30的浸膏,缓缓加入浸膏量的、质量浓度为80-95%的乙醇,搅拌均匀,静置12~36小时,过滤,回收乙醇,浓缩成50℃相对密度1.40-1.50的稠膏或干膏粉,与基质在45~65℃下混和均匀成糊状,倾入栓模中,冷却,即得表面光滑,色泽棕黑的栓剂。
实施例2
本发明在具体实施中,还可由以下重量计的:黄柏112g、黄连118g、没药82g、乳香88g、血竭82g、儿茶88g、五倍子82g、白及178g、煅龙骨162g 、冰片19g和甘草32g作原料药物制成,加原料药物重量8-12倍的水浸泡2-12小时,武火煎沸,再文火煎60分钟,过滤,得第一次滤液;药渣再加原料药物重量8-12倍的水,武火煎沸,再文火煎45分钟,过滤,得第二次滤液;药渣再加原料药物重量8-12倍的水,武火煎沸,再文火煎45分钟,过滤,得第三次滤液,合并三次滤液,浓缩成50℃相对密度1.20-1.30的浸膏,缓缓加入浸膏量的、质量浓度为80-95%的乙醇,搅拌均匀,静置12~36小时,过滤,回收乙醇,浓缩成50℃相对密度1.40-1.50的稠膏或干膏粉,与基质在45~65℃下混和均匀成糊状,倾入栓模中,冷却,即得表面光滑,色泽棕黑的栓剂。
实施例3
本发明在具体实施中,也可由以下重量计的:黄柏118g、黄连112g、没药88g、乳香82g、血竭88g、儿茶82g、五倍子88g、白及162g、煅龙骨178g 、冰片16g和甘草38g作原料药物制成,加原料药物重量8-12倍的水浸泡2-12小时,武火煎沸,再文火煎60分钟,过滤,得第一次滤液;药渣再加原料药物重量8-12倍的水,武火煎沸,再文火煎45分钟,过滤,得第二次滤液;药渣再加原料药物重量8-12倍的水,武火煎沸,再文火煎45分钟,过滤,得第三次滤液,合并三次滤液,浓缩成50℃相对密度1.20-1.30的浸膏,缓缓加入浸膏量的、质量浓度为80-95%的乙醇,搅拌均匀,静置12~36小时,过滤,回收乙醇,浓缩成50℃相对密度1.40-1.50的稠膏或干膏粉,与基质在45~65℃下混和均匀成糊状,倾入栓模中,冷却,即得表面光滑,色泽棕黑的栓剂。
实施例4
本发明在具体实施中,也可由以下重量计的:黄柏113-116g、黄连113-116g、没药83-87g、乳香83-87g、血竭83-87g、儿茶83-87g、五倍子83-87g、白及168-173g、煅龙骨168-173g 、冰片16.5-18g和甘草33.5-36g作原料药物制成,加原料药物重量8-12倍的水浸泡2-12小时,武火煎沸,再文火煎60分钟,过滤,得第一次滤液;药渣再加原料药物重量8-12倍的水,武火煎沸,再文火煎45分钟,过滤,得第二次滤液;药渣再加原料药物重量8-12倍的水,武火煎沸,再文火煎45分钟,过滤,得第三次滤液,合并三次滤液,浓缩成50℃相对密度1.20-1.30的浸膏,缓缓加入浸膏量的、质量浓度为80-95%的乙醇,搅拌均匀,静置12~36小时,过滤,回收乙醇,浓缩成50℃相对密度1.40-1.50的稠膏或干膏粉,与基质在45~65℃下混和均匀成糊状,倾入栓模中,冷却,即得表面光滑,色泽棕黑的栓剂。
上述各实施例所得栓剂每粒重1.5g或3.0g,栓剂融变时间小于30分钟。
本发明栓剂为现代给药剂型,药物可避免因肝脏首过效应而减效,因而药物作用更加充分,药效增加。中药直肠给药能使药物通过直肠黏膜吸收,直达病所,在病变的直肠末端内能有较高的浓度,治疗效果较理想,同时也避免了口服用药和静脉用药的一些不良反应。
本发明有益技术效果是:栓剂经直肠给药后,在体温下迅速软化熔融或溶解于分泌物中,逐渐释放药物而产生作用,本栓剂能够促进直肠粘膜修复,保护直肠粘膜,减轻炎症反应,促进炎症病灶的消退和吸收,治疗内痔糜烂出血等症状。从中医学应用理论描述,本栓剂具有清热泻火,消肿止痛,生肌敛疮,涩肠止血等功效。
肛肠疾患总的病因病机多责之于湿热,故《内经》云:因而饱食,筋脉横解,肠癖为痔。《疮疡经验全书》认为:饮食不节,醉饱无时,恣食肥腻,胡椒辛辣,炙博酽酒,禽兽异物……,乃生五痔。这说明,饮食过饱,过食肥腻以及大量饮用烈酒辛辣等,积生湿热,下注大肠,致使局部气血瘀滞,并可刺激肠粘膜,使之充血灼热疼痛。本方黄连,黄柏味苦性寒,能清热燥湿,泻火解毒;乳香,没药,血竭,儿茶可活血化瘀,消肿止痛,祛腐生肌,敛疮收口;煅龙骨咸,涩,微寒,可增加收敛固涩之功;白及,五倍子可收敛止血,解毒消肿,收湿敛疮;冰片苦寒,可清热消肿止痛;甘草调和诸药。诸药调和外用,可收清热泻火,消肿止痛,生肌敛疮,涩肠止血之功。
现代药理研究表明,黄连,黄柏的提取物中含有小檗碱有抗炎作用;乳香,没药不但具有较强的镇痛作用,而且具有显著的抑菌作用。故《医学衷中参西录》云:外用以粉以敷疮疡,能解毒,消肿,生肌,止疼,虽为开通之品,不至耗伤气,诚良药也。
上述组份科学、合理配伍,互相支持,具有清热泻火,消肿止痛,生肌敛疮,涩肠止血之功效,有效用于治疗内痔出血,疗效好,用药安全,并经临床资料得到了充分证明,有关临床资料如下:
(一)病例选择
收集2012年8月?2013年8月就诊的 336 例Ⅰ期内痔出血病例,Ⅰ期内痔出血的主要症状为: 便时带血、滴血或喷射状出血,血色鲜红,便后出血可自行停止,无内痔脱出。所用患者均符合《中药新药临床研究指导原则》( 2002 版) 及《痔临床诊治指南》( 2006 版)标准。患者年龄范围 18~ 75 岁,采用随机分组的方法将 336例患者分为治疗组和对照组,治疗组 234例中男性126 例,女性108例,平均年龄(36. 87±7.15)岁,病程为(16.36±13.38)月;对照组102例中男性 49例,女性53例,平均年龄(35.25±8.66)岁,病程为(15.24±11.38)个月。两组患者的年龄、性别和病情程度等基线资料无统计学差异( P > 0.05) ,具有可比性。
(二)排除标准:
观察的病例均排除患有结肠炎、上消化道出血、肠癌、肝硬化、肝癌以及其他原因引起便血的患者。
(三)治疗方案
治疗组:将本发明制作成栓剂,规格:1.5g/粒,1粒,纳肛,每日两次,早晚各一次,连用一周。
对照组:马应龙麝香痔疮栓(马应龙药业集团股份有限公司,国药准字Z42021461),1粒,纳肛,每日两次,早晚各一次,连用一周。
观察期间禁止使用其他治疗内痔的药物及与本病治疗相关的其他治疗。
(四)观测指标
临床症状、体征,参照《中药新药临床研究指导原则》 (2002年)的标准制定。便血、痔核充血情况为主要症状、体征,采用4等级6分法。无便血,痔核粘膜正常(0分);便时手纸染血或大便表面附血,痔核粘膜充血 (2分);大便时滴血,痔核粘膜充血,轻度糜烂(4分);大便时喷射状出血,痔核粘膜糜烂(6分)。分别观测两组治疗前、治疗后第3天、第6天临床
(五)疗效评价标准 参照2004年全国肛肠学术会议制定的疗效评价标准,治愈:出血症状消失,肛镜下见肛垫水肿消失,肛垫形态大小、粘膜色泽正常;好转:出血症状改善,肛镜下见肛垫肿胀明显减轻缩小,或向外脱出减轻,粘膜色泽趋于正常;未愈:症状和体征均无变化。
(六)统计处理结果
1. 临床疗效比较: 治疗结果显示,234例治疗组中治愈162例(69%),好转70例(30%),总有效率为 99%;102例对照组中治愈41例(40%),好转48(47%),总有效率为87%。治疗组疗效明显优于对照组,组间比较,差异有统计学意义( P < 0.05)。
表1 两组治疗内痔出血疗效的观察结果 (%)
组别 | n | 治愈 | 好转 | 未愈 |
治疗组 | 234 | 162(69%) | 70(30%) | 2(1%) |
对照组 | 102 | 41(40%) | 48(47%) | 13(13%) |
2. 临床症状积分比较:两组治疗后便血及粘膜情况积分明显低于治疗前,具有显著统计学意义(P <0.01),说明两组治疗后均有明显改善;治疗组治疗后症状积分明显少于对照组治疗后,有统计学意义(P <0.05) 。
表2 两组治疗内痔出血症状积分的观察
组别 | 治疗前 | 治疗后 |
治疗组 | 4.7±1.1 | 0.6±1.3 |
对照组 | 4.5±2.3 | 1.8±1.3 |
(七)、结论
由上述可以看出,本发明栓剂组方科学合理,原料丰富,易生产,使用方便,具有清热泻火,消肿止痛,生肌敛疮,涩肠止血等功效,效果好,有效用于治疗非手术期内痔出血,尤其适用于儿童及孕产妇,疗效显著,疗效高达99%,安全性强,无毒副作用,具有很强的临床意义,是治疗痔疮药物上的创新,有良好的经济和社会效益。
Claims (5)
1.一种治疗内痔出血的中药栓剂,其特征在于,由以下重量计的:黄柏110-120g、黄连110-120g、没药80-90g、乳香80-90g、血竭80-90g、儿茶80-90g、五倍子80-90g、白及160-180g、煅龙骨160-180g 、冰片15-20g和甘草30-40g作原料药物制成,加原料药物重量8-12倍的水浸泡2-12小时,武火煎沸,再文火煎60分钟,过滤,得第一次滤液;药渣再加原料药物重量8-12倍的水,武火煎沸,再文火煎45分钟,过滤,得第二次滤液;药渣再加原料药物重量8-12倍的水,武火煎沸,再文火煎45分钟,过滤,得第三次滤液,合并三次滤液,浓缩成50℃相对密度1.20-1.30的浸膏,缓缓加入浸膏量的、质量浓度为80-95%的乙醇,搅拌均匀,静置12~36小时,过滤,回收乙醇,浓缩成50℃相对密度1.40-1.50的稠膏或干膏粉,与基质在45~65℃下混和均匀成糊状,倾入栓模中,冷却,即得表面光滑,色泽棕黑的栓剂;
所述的基质是半合成脂肪酸甘油酯36型、半合成脂肪酸甘油酯38型、泊洛沙姆、甘油明胶、羊毛脂中的一种或两种以上的组合。
2.根据权利要求1所述的治疗内痔出血的中药栓剂,其特征在于,由以下重量计的:黄柏114.3g、黄连114.3g、没药85.7g、乳香85.7g、血竭85.7g、儿茶85.7g、五倍子85.7g、白及171.4g、煅龙骨171.4g 、冰片17.1g和甘草34.3g作原料药物制成,加原料药物重量8-12倍的水浸泡2-12小时,武火煎沸,再文火煎60分钟,过滤,得第一次滤液;药渣再加原料药物重量8-12倍的水,武火煎沸,再文火煎45分钟,过滤,得第二次滤液;药渣再加原料药物重量8-12倍的水,武火煎沸,再文火煎45分钟,过滤,得第三次滤液,合并三次滤液,浓缩成50℃相对密度1.20-1.30的浸膏,缓缓加入浸膏量的、质量浓度为80-95%的乙醇,搅拌均匀,静置12~36小时,过滤,回收乙醇,浓缩成50℃相对密度1.40-1.50的稠膏或干膏粉,与基质在45~65℃下混和均匀成糊状,倾入栓模中,冷却,即得表面光滑,色泽棕黑的栓剂。
3.根据权利要求1所述的治疗内痔出血的中药栓剂,其特征在于,由以下重量计的:黄柏112g、黄连118g、没药82g、乳香88g、血竭82g、儿茶88g、五倍子82g、白及178g、煅龙骨162g 、冰片19g和甘草32g作原料药物制成,加原料药物重量8-12倍的水浸泡2-12小时,武火煎沸,再文火煎60分钟,过滤,得第一次滤液;药渣再加原料药物重量8-12倍的水,武火煎沸,再文火煎45分钟,过滤,得第二次滤液;药渣再加原料药物重量8-12倍的水,武火煎沸,再文火煎45分钟,过滤,得第三次滤液,合并三次滤液,浓缩成50℃相对密度1.20-1.30的浸膏,缓缓加入浸膏量的、质量浓度为80-95%的乙醇,搅拌均匀,静置12~36小时,过滤,回收乙醇,浓缩成50℃相对密度1.40-1.50的稠膏或干膏粉,与基质在45~65℃下混和均匀成糊状,倾入栓模中,冷却,即得表面光滑,色泽棕黑的栓剂。
4.根据权利要求1所述的治疗内痔出血的中药栓剂,其特征在于,由以下重量计的:黄柏118g、黄连112g、没药88g、乳香82g、血竭88g、儿茶82g、五倍子88g、白及162g、煅龙骨178g 、冰片16g和甘草38g作原料药物制成,加原料药物重量8-12倍的水浸泡2-12小时,武火煎沸,再文火煎60分钟,过滤,得第一次滤液;药渣再加原料药物重量8-12倍的水,武火煎沸,再文火煎45分钟,过滤,得第二次滤液;药渣再加原料药物重量8-12倍的水,武火煎沸,再文火煎45分钟,过滤,得第三次滤液,合并三次滤液,浓缩成50℃相对密度1.20-1.30的浸膏,缓缓加入浸膏量的、质量浓度为80-95%的乙醇,搅拌均匀,静置12~36小时,过滤,回收乙醇,浓缩成50℃相对密度1.40-1.50的稠膏或干膏粉,与基质在45~65℃下混和均匀成糊状,倾入栓模中,冷却,即得表面光滑,色泽棕黑的栓剂。
5.根据权利要求1所述的治疗内痔出血的中药栓剂,其特征在于,由以下重量计的:黄柏113-116g、黄连113-116g、没药83-87g、乳香83-87g、血竭83-87g、儿茶83-87g、五倍子83-87g、白及168-173g、煅龙骨168-173g 、冰片16.5-18g和甘草33.5-36g作原料药物制成,加原料药物重量8-12倍的水浸泡2-12小时,武火煎沸,再文火煎60分钟,过滤,得第一次滤液;药渣再加原料药物重量8-12倍的水,武火煎沸,再文火煎45分钟,过滤,得第二次滤液;药渣再加原料药物重量8-12倍的水,武火煎沸,再文火煎45分钟,过滤,得第三次滤液,合并三次滤液,浓缩成50℃相对密度1.20-1.30的浸膏,缓缓加入浸膏量的、质量浓度为80-95%的乙醇,搅拌均匀,静置12~36小时,过滤,回收乙醇,浓缩成50℃相对密度1.40-1.50的稠膏或干膏粉,与基质在45~65℃下混和均匀成糊状,倾入栓模中,冷却,即得表面光滑,色泽棕黑的栓剂。
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