CN104491420B - 一种治疗溃疡性结肠炎的灌肠中药组合物及其制备方法 - Google Patents
一种治疗溃疡性结肠炎的灌肠中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗溃疡性结肠炎的灌肠中药组合物及其制备方法,属于中药领域。本发明中药组合物由以下各原料药组成:黄芩、黄连、荆芥炭、地榆炭、焦三仙、白术、肉豆蔻、槐花、白头翁、茯苓、双花、连翘、白芍、木香、甘草、白芨。本发明中药组合物直接或间接加入药学上可接受的赋型剂后按照常规制剂工艺制成临床可接受的各种剂型。临床试验证明,本发明能够安全有效治疗溃疡性结肠炎,并且与西药相比无不良反应发生。
Description
技术领域
本发明涉及一种中药组合物,特别涉及一种治疗溃疡性结肠炎的灌肠中药组合物及其制备方法,属于中药领域。
背景技术
溃疡性结肠炎(Ulcerative Colitis,UC)全称为非特异性溃疡性结肠炎,是一种原因复杂的,以局限于结肠的弥漫性黏膜炎症为特点的慢性疾病,常始自左半结肠,可向结肠近端乃至全结肠,以连续方式逐渐进展,多累及直肠和乙状结肠,也可遍及整个结肠,呈阶段性和弥漫性分布。病因尚未完全阐明,主要是侵及结肠黏膜的慢性非特异性炎性疾病,临床症状轻重不一,可有缓解与发作相交替,患者可仅有结肠症状,也可伴发全身症状,该病的主要症状为腹痛、腹泻、黏液脓血便、里急后重等。按临床表现和过程可分4型。(1)初发型:症状轻重不一,既往无溃结史,可转变为慢性复发型或慢性持续型。(2)慢性复发型:症状较轻,临床上最多见,治疗后常有长短不一的缓解期。复发高峰多在春秋季,而夏季较少。在发作期结肠镜检查,有典型的溃结病变,而缓解期检查仅见轻度充血、水肿,黏膜活检为慢性炎症,易误为肠易激综合征。有的患者可转为慢性持续型。(3)慢性持续型:起病后常持续有轻重不等的腹泻、间断血便、腹痛及全身症状,持续数周至数年,其间可有急性发作。本型病变范围较广,结肠病变呈进行性,并发症多,急性发作时症状严重,需行手术治疗。(4)急性暴发型:国内报道较少,约占溃结的2.6%,国外报道占20%。多见于青少年,起病急骤,全身及局部症状均严重,高热、腹泻每天20~30次,便血量多,可致贫血、脱水与电解质紊乱、低蛋白血症,衰弱消瘦,并易发生中毒性结肠扩张,肠穿孔及腹膜炎,常需紧急手术,病死率高。
西医治疗采用抗生素或磺胺类药物仅能获得近期疗效,但远期效果不佳,停药后则腹泻腹痛如故。针对UC局部糜烂、溃疡等病理改变,可给予清热化湿、解毒凉血、敛疮生肌、活血止血等中药灌肠治疗。目前中药灌肠的机制是灌肠药物在肠道内主要以被动转运的方式被吸收,具体来讲,药物是经细胞转运或细胞旁转运而被吸收的。由于大肠的吸收能力很强,药物经灌肠后,药物混合于直肠腺体的分泌液中,透过黏膜后面经直肠上、中、下静脉丛和直肠淋巴系统而被吸收,从而很快地提高病变部位药物浓度和血药浓度,改善局部血运,保护肠道溃疡面,较快促进炎症吸收和溃疡愈合。同时中药灌肠对肠黏膜起到直接的修复和保护作用,解除直肠动力紊乱的状态。中药灌肠治疗UC的机制还在于灌肠液的温热刺激。采用37-39℃的灌肠液直肠给药,由于温热刺激,引起肠粘膜的血管扩张,能促进局部的血液和淋巴循环,增强新陈代谢,改善局部组织的营养和全身机能,并能疏通经络,促进经络的调节活动功能。最近的临床研究表明,中药制剂具有提高机体免疫功能、改善血液流变状况、促进微循环、抗菌消炎、促进溃疡愈合和炎症物质吸收、止血止痛等效果。由此可见,中药灌肠治疗的优点是,可使药效直达病所,可避免药物受胃肠酸碱消化液和消化酶的影响,使药物更好地发挥作用,药物灌肠还可部分避免肝脏循环,减少肝脏的首过效应。
本发明采用中药灌肠方法治疗急性活动期或初发型溃疡性结肠炎,应用清热利湿、调气行血的中药灌肠,直接作用于患处,使病变结肠血液循环改善,促进炎症消散,促进结肠溃疡的修复,抑制结肠炎症反应,取得了良好的治疗效果。
发明内容
本发明旨在提供一种治疗溃疡性结肠炎急性活动期阶段或初发型溃疡性结肠炎的灌肠中药组合物。本病属于中医之“痢疾”、“泄泻”、“肠澼”、“腹痛”、“肠风”等范畴。急性活动期阶段或初发型溃疡性结肠炎以邪实为主,多与饮食有关,肠腹湿热,血络损伤,渐致肝郁脾虚,气滞血瘀,正虚大肠滑泻不固。
本发明的第一个目的在于提供一种治疗溃疡性结肠炎的灌肠中药组合物。
本发明的第二个目的在于提供一种制备上述灌肠中药组合物的方法。
本发明的第三个目的在于提供上述灌肠中药组合物在制备治疗溃疡性结肠炎药物中的用途。
本发明上述目的是通过如下技术方案实现的:
一种治疗溃疡性结肠炎的灌肠中药组合物,由以下各原料药组成:黄芩、黄连、荆芥炭、地榆炭、焦三仙、白术、肉豆蔻、槐花、白头翁、茯苓、双花、连翘、白芍、木香、甘草、白芨。
优选的,各原料药的重量份为:黄芩20-30份、黄连15-25份、荆芥炭10-20份、地榆炭10-20份、焦三仙6-15份、白术10-20份、肉豆蔻15-25份、槐花15-25份、白头翁15-25份、茯苓20-25份、双花9-20份、连翘10-20份、白芍10-20份、木香10-20份、甘草6-15份、白芨10-20份。
进一步优选的,各原料药的重量份为:黄芩25份、黄连20份、荆芥炭15份、地榆炭15份、焦三仙10份、白术15份、肉豆蔻20份、槐花20份、白头翁20份、茯苓20份、双花15份、连翘15份、白芍15份、木香15份、甘草10份、白芨15份。
本发明的灌肠中药组合物的组方中:黄芩清热燥湿;黄连泻火解毒,燥湿厚肠;荆芥炭收敛止血、益气养血;地榆炭凉血止血,泻火敛疮;焦三仙消食导滞,健运脾胃;白术健脾益气,燥湿利水;肉豆蔻温中涩肠,行气消食;槐花凉血止血,清肝泻火;白头翁清热解毒,凉血止痢;茯苓利水渗湿,补中健脾;双花清热解毒,补虚疗风;连翘清热解毒,散结消肿;白芍补血养血,柔肝止痛,敛阴止汗;木香行气,止痛;甘草清热解毒,缓急止痛;白芨收敛止血,消肿生肌。
临床试验证明:本发明的灌肠中药组合物能够安全有效治疗溃疡性结肠炎。
本发明所用到的原料药均可从普通医药商店购买得到,其规格符合国家医药标准。
本发明药物活性组分可以加入制备不同外用剂型时所需的各种辅料,以常规的中药制剂方法制备成任何一种适宜的制剂,该制剂包括但不限于:水煎剂或颗粒剂。
进一步的,本发明提供了一种制备上述灌肠中药组合物的方法,包括以下步骤:
(1)按所述重量份称取各原料药;
(2)将上述原料药混合在一起,加水浸泡1-2小时后进行煎煮,滤渣加水继续进行煎煮,合并滤液浓缩,按本领域常规工艺制剂,制备成水煎剂或颗粒剂。
优选的,步骤(2)中将上述原料药混合在一起,加8倍重量的水浸泡1-2小时后,煎煮1.5小时,滤渣加6倍重量的水,煎煮1小时,合并滤液浓缩,干燥,按本领域常规工艺制剂,制备成水煎剂或颗粒剂。
进一步的,本发明还提供了上述灌肠中药组合物在制备治疗溃疡性结肠炎药物中的用途。
优选的,所述的溃疡性结肠炎为溃疡性结肠炎的急性活动期或初发型溃疡结肠炎。
本发明灌肠中药组合物的用法与用量:本发明灌肠中药组合物的用量取决于具体剂型,以及病人的年龄、体重、健康状况等因素。作为指导:颗粒剂:将一袋药物颗粒溶于150mL温水,灌肠,每日早晚两次灌肠。
本发明的有益效果体现在:
本发明能够安全有效治疗溃疡性结肠炎,并且与西药相比无不良反应发生。
具体实施方式
下面通过实验并结合实施例对本发明做进一步说明,应该理解的是,这些实施例仅用于例证的目的,决不限制本发明的保护范围。
实施例1水煎剂的制备
按以下重量称取各原料药:黄芩25g,黄连20g,荆芥炭15g,地榆炭15g,焦三仙10g,白术15g,肉豆蔻20g,槐花20g,白头翁20g,茯苓20g,双花15g,连翘15g,白芍15g,木香15g,甘草10g,白芨15g;将上述原料药混合在一起,加8倍重量的水浸泡1-2小时后,用水煎煮1.5小时,滤渣加6倍量水,煎煮1小时。合并滤液,约为300mL,即得符合正常成人的1天用量的药液。
实施例2水煎剂的制备
按以下重量称取各原料药:黄芩20g,黄连15g,荆芥炭10g,地榆炭10g,焦三仙6g,白术10g,肉豆蔻15g,槐花15g,白头翁15g,茯苓20g,双花9g,连翘10g,白芍10g,木香10g,甘草6g,白芨10g;将上述原料药混合在一起,加8倍重量的水浸泡1-2小时后,用水煎煮1.5小时,滤渣加6倍量水,煎煮1小时。合并滤液,约为300mL。
实施例3水煎剂的制备
按以下重量称取各原料药:黄芩30g,黄连25g,荆芥炭20g,地榆炭20g,焦三仙15g,白术20g,肉豆蔻25g,槐花25g,白头翁25g,茯苓25g,双花20g,连翘20g,白芍20g,木香20g,甘草15g,白芨20g;将上述原料药混合在一起,加8倍重量的水浸泡1-2小时后,用水煎煮1.5小时,滤渣加6倍量水,煎煮1小时。合并滤液,约为300mL。
实施例4颗粒剂的制备
按以下重量称取各原料药:黄芩25g,黄连20g,荆芥炭15g,地榆炭15g,焦三仙10g,白术15g,肉豆蔻20g,槐花20g,白头翁20g,茯苓20g,双花15g,连翘15g,白芍15g,木香15g,甘草10g,白芨15g;将上述原料药混合在一起,加8倍重量的水浸泡1-2小时后,用水煎煮1.5小时,滤渣加6倍量水,煎煮1小时。合并滤液,浓缩,干燥,按本领域常规工艺制剂,分2袋包装,即可制得符合正常成人的1天用量的颗粒。
实施例5颗粒剂的制备
按以下重量称取各原料药:黄芩20g,黄连15g,荆芥炭10g,地榆炭10g,焦三仙6g,白术10g,肉豆蔻15g,槐花15g,白头翁15g,茯苓20g,双花9g,连翘10g,白芍10g,木香10g,甘草6g,白芨10g;将上述原料药混合在一起,加8倍重量的水浸泡1-2小时后,用水煎煮1.5小时,滤渣加6倍量水,煎煮1小时。合并滤液,浓缩,干燥,按本领域常规工艺制剂,分2袋包装,即可制得符合正常成人的1天用量的颗粒。
实施例6颗粒剂的制备
按以下重量称取各原料药:黄芩30g,黄连25g,荆芥炭20g,地榆炭20g,焦三仙15g,白术20g,肉豆蔻25g,槐花25g,白头翁25g,茯苓25g,双花20g,连翘20g,白芍20g,木香20g,甘草15g,白芨20g;将上述原料药混合在一起,加8倍重量的水浸泡1-2小时后,用水煎煮1.5小时,滤渣加6倍量水,煎煮1小时。合并滤液,浓缩,干燥,按本领域常规工艺制剂,分2袋包装,即可制得符合正常成人的1天用量的颗粒。
试验例1本发明灌肠中药组合物治疗溃疡性结肠炎临床总结报告
1、临床资料
发明人共收集130例溃疡性结肠炎的门诊患者,年龄15-69岁。采用随机方法,分为治疗组:80例,对照组:50例。两组年龄、病情等资料无显著差异,具有可比性。
诊断标准:常为粘液脓血便,镜检有红细胞、白细胞与巨噬细胞,反复检查(常规、培养、孵化等)均无特异病原体发现;结肠镜检查:1.轻度:粘膜充血、水肿、分泌物增多,有密集分布的小出血点,并见散在渗血及出血;2.中度:黏膜充血、水肿明显;3.重度:黏膜出血,水肿显著,病变部位几乎无正常黏膜,黏膜呈粗细不等的颗粒状及假性息肉。
2、试验方法
2.1治疗组:使用本发明实施例1制得的水煎剂灌肠,早、晚各一次,灌肠时药液温度以37-39℃为宜,取左侧卧位30min,以便灌肠液更好的吸收,疗程4周。
2.2对照组:使用美沙拉嗪栓1.0g,每日1次,疗程4周。
3、疗效标准与治疗结果
3.1疗效标准
观察指标:1.症状:腹痛、腹胀,大便次数及性状;2.结肠镜检查:观察肠粘膜充血水肿、溃疡的改变情况;3.随访:全部患者进行随访;4.不良反应。
疗效判定标准:痊愈:临床症状全部消失,实验室检查正常,复查肠镜肠粘膜充血水肿消失,溃疡愈合;好转:临床症状减轻,大便成形,每天2-3次,复查肠镜肠粘膜充血水肿明显好转,溃疡基本愈合,实验室检查改善或正常;无效:临床症状无明显好转或加重,复查肠镜粘膜充血无改善,溃疡无愈合。
3.2统计学方法
将所得数据用软件处理,计数资料应用X2检验。
3.3统计治疗结果见表1。
表1 两组患者治疗效果比较
组别 | 病例数(n) | 痊愈 | 好转 | 无效 | 不良反应 | 总有效率(%) |
治疗组 | 80 | 39 | 37 | 4 | 0 | 95% |
对照组 | 50 | 20 | 15 | 15 | 30 | 70% |
两组患者治疗效果比较说明,治疗组有效率显著高于对照组(P<0.01),说明本发明制得的药物能够有效治疗溃疡性结肠炎,并且与西药相比无不良反应发生。
以上所述仅为本发明的优选实施例,对本发明而言仅是说明性的,而非限制性的;本领域普通技术人员理解,在本发明权利要求所限定的精神和范围内可对其进行许多改变,修改,甚至等效变更,但都将落入本发明的保护范围内。
Claims (8)
1.一种治疗溃疡性结肠炎的灌肠中药组合物,其特征在于,由以下重量份的原料药组成:黄芩20-30份、黄连15-25份、荆芥炭10-20份、地榆炭10-20份、焦三仙6-15份、白术10-20份、肉豆蔻15-25份、槐花15-25份、白头翁15-25份、茯苓20-25份、双花9-20份、连翘10-20份、白芍10-20份、木香10-20份、甘草6-15份、白芨10-20份。
2.根据权利要求1所述的灌肠中药组合物,其特征在于,各原料药的重量份为:黄芩25份、黄连20份、荆芥炭15份、地榆炭15份、焦三仙10份、白术15份、肉豆蔻20份、槐花20份、白头翁20份、茯苓20份、双花15份、连翘15份、白芍15份、木香15份、甘草10份、白芨15份。
3.根据权利要求1或2所述的灌肠中药组合物,其特征在于,按照中药制剂制备成临床上适宜的制剂。
4.根据权利要求3所述的灌肠中药组合物,其特征在于,所述制剂包括水煎剂或颗粒剂。
5.一种制备权利要求1或2所述的灌肠中药组合物的方法,其特征在于,包括以下步骤:
(1)按所述重量份称取各原料药;
(2)将上述原料药混合在一起,加水浸泡1-2小时后进行煎煮,滤渣加水继续进行煎煮,合并滤液浓缩,按本领域常规工艺制剂,制备成水煎剂或颗粒剂。
6.根据权利要求5所述的方法,其特征在于,步骤(2)中将上述原料药混合在一起,加8倍重量的水浸泡1-2小时后,煎煮1.5小时,滤渣加6倍重量的水,煎煮1小时,合并滤液浓缩,干燥,按本领域常规工艺制剂,制备成水煎剂或颗粒剂。
7.权利要求1或2所述的灌肠中药组合物在制备治疗溃疡性结肠炎药物中的用途。
8.根据权利要求7所述的用途,其特征在于,所述的溃疡性结肠炎为溃疡性结肠炎的急性活动期或初发型溃疡结肠炎。
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