CN104399039A - 一种治疗溃肠性结肠炎的药物及其制备方法 - Google Patents
一种治疗溃肠性结肠炎的药物及其制备方法 Download PDFInfo
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Abstract
一种治疗溃肠性结肠炎的药物及其制备方法,由炙黄芪、炒白芍、酒炒当归、木香、陈皮、黄芩、炒薏苡仁、木瓜、土茯苓、麸炒白术、防风、黄连、秦皮、盐小茴香、炮姜、甘草、白芷配伍组合而成,具有泻火解毒、止泻止痛、顺气止痢、活血利气、健脾消食、理气和胃、祛病除湿的功效,对溃疡性结肠炎,痢疾等具有标本兼治的作用,效果显著,副作用小。
Description
技术领域
本发明涉及一种由中草药为原料药的中药组合物及其制备方法,具体的说是涉及一种治疗溃肠性结肠炎的药物及其制备方法。
背景技术
溃疡性结肠炎是一种病因尚不十分清楚的结肠和直肠慢性非特异性炎症性疾病,病变局限于大肠黏膜及黏膜下层。病变多位于乙状结肠和直肠,也可延伸至降结肠,甚至整个结肠。病程漫长,常反复发作。本病见于任何年龄,但20~30岁最多见。
除少数患者起病急骤外,一般起病缓慢,病情轻重不一。症状以腹泻为主,排出含有血、脓和黏液的粪便,常伴有阵发性结肠痉挛性疼痛,并里急后重,排便后可获缓解。
轻型患者症状较轻微,每日腹泻不足5次。
重型每日腹泻在5次以上,为水泻或血便,腹痛较重,有发热症状,体温可超过38.5℃,脉率大于90次/分。
发明内容
本发明从临床医疗用药需求及中医组方辩证原则出发,提出一种治疗溃肠性结肠炎的药物及其制备方法。它是由以下重量份数配比的原料药制备而成的药剂:炙黄芪13-17g、炒白芍13-17g、酒炒当归8-12g、木香4-8g、陈皮8-12g、黄芩8-12g、炒薏苡仁28-32g、木瓜8-12g、土茯苓13-17g、麸炒白术8-12g、防风8-12g、黄连2-5g、秦皮13-17g、盐小茴香2-6g、炮姜2-5g、甘草3-7g、白芷8-12g。优选配比为:炙黄芪15g、炒白芍15g、酒炒当归10g、木香6g、陈皮10g、黄芩10g、炒薏苡仁30g、木瓜10g、土茯苓15g、麸炒白术10g、防风10g、黄连3g、秦皮15g、盐小茴香4g、炮姜3g、甘草5g、白芷10g。所述药剂为胶囊剂、片剂或丸剂。
所述胶囊剂、片剂、丸剂的制备方法步骤如下:
(1)取方中炙黄芪、炒白芍、酒炒当归、木香、陈皮、黄芩、炒薏苡仁、木瓜、土茯苓、麸炒白术、防风、黄连、秦皮、盐小茴香、炮姜、甘草、白芷粉碎筛析;
(2)将步骤(1)中筛制的混合物加水煎煮2-3次,合并煎液、过滤,将虑液浓缩成70-80度时,胶囊、丸剂相对密度为1.0-1.6的稠膏,片剂相对密度为1.0-1.4的稠膏;
(3)制作胶囊、丸剂时:
将稠膏分离纯化、干燥,制成干颗粒;将步骤干颗粒混合均匀,填充胶囊内即制成胶囊;将干颗粒喷加炼蜜、混合均匀,制成小丸即制成丸剂;
制作片剂时:
将2-4份淀粉与步骤(2)中的稠膏混合均匀,制成颗粒、干燥,制成干颗粒,将干颗粒压制成片剂,包糖衣,即制成片剂。
步骤(2)中所述的混合物,加水煎煮的优选次数为2次,第一次为60-80分钟,第二次为40-60分钟。
有益效果
本发明药物各原料药药理如下:
炙黄芪:益气补中,用于气虚乏力,食少便溏;
炒白芍:具有补血养血、平抑肝阳、柔肝止痛、敛阴止汗等功效,适用于阴虚发热、月经不调、胸腹胁肋疼痛、四肢挛急,泻痢腹痛、自汗盗汗、崩漏、带下等症;
酒炒当归:具有补血和血,调经止痛,润燥滑肠之功效;
木香:行气,止痛,健脾,消食;
陈皮: 理气健脾,燥湿化痰。用于胸脘胀满,食少吐泻,咳嗽痰多;
黄芩:主治温热病、上呼吸道感染、肺热咳嗽、湿热黄胆、肺炎、痢疾、咳血、目赤、胎动不安、高血压、痈肿疖疮等症;
炒薏苡仁:薏苡仁,中药,别名 米仁、六谷、川谷、菩提子。为禾本科植物薏苡Coix lacryma-jobi L. var. meyuan (Romen.) Stapf的种仁。有健脾渗湿,除痹止泻。用于水肿、脚气、小便不利、湿痹拘挛、脾虚泄泻的功效。性味 性凉,味甘、淡。炒薏苡仁为炮制。
木瓜:有解酒、去痰、顺气、止痢之效;
土茯苓:利湿热解毒,健脾胃,康肿瘤;
麸炒白术:用于脾胃不和,运化失常,食少胀满倦怠乏力,表虚自汗;
防风:防风祛风解表、胜湿止痛、解痉、止痒,主治外感风寒、头痛身痛、风湿痹痛、骨节酸痛、腹痛泄泻、肠风下血、破伤风、风疹瘙痒;
黄连:有清热燥湿,泻火解毒之功效;
秦皮:主治:清热燥湿、清肝明目、平喘止咳。用于热毒泻痢、目赤肿痛、目生翳障;
盐小茴香:散寒止痛,理气和胃。活血、利气、止痛。用于胸胁院腹疼痛、经闭痛经、产后瘀阻、跌扑肿痛。用于寒疝腹痛,睾丸偏坠,痛经,少腹冷痛,脘腹胀痛,食少吐泻,睾丸鞘膜积液;
炮姜:温中散寒,温经止血,用于脾胃虚寒,腹痛吐泻,吐衄崩漏,阳虚失血;
甘草:用于心气虚,心悸怔忡,脉结代,以及脾胃气虚,倦怠乏力等,用于胃痛、腹痛及腓肠肌挛急疼痛,泻下作用及其对胃肠道的刺激,对组胺引起的胃酸分泌过多有抑制作用;并有抗酸和缓解胃肠平滑肌痉挛作用,对消化系统的作用:除去甘草甜素的浸膏及甘草中黄酮甙类对大鼠实验性溃疡有明显保护作用;
白芷: 有祛病除湿、排脓生肌、活血止痛等功能。
本发明药物以炒薏苡仁为君药,健脾渗湿,除痹止泻。
以炙黄芪、炒白芍、土茯苓、秦皮为臣药,止泻痢腹痛,利湿热解毒,热毒泻痢,健脾胃益气补中。
以酒炒当归、陈皮、黄芩、木瓜、麸炒白术、防风、白芷为佐药,润燥滑肠,胸脘胀满,食少吐泻,止痢疾,顺气止痢,食少胀满倦怠乏力,表虚自汗,腹痛泄泻,祛病除湿,活血止痛。
使以木香、甘草,盐小茴香、炮姜、黄连,行气,止痛,健脾,消食,止胃痛、腹痛及腓肠肌挛急疼痛,治溃疡,散寒止痛,理气和胃,活血、利气、止痛,脾胃虚寒,腹痛吐泻,清热燥湿,泻火解毒。
本发明所述的药物承中医之精髓、严谨组方,诸药君臣佐使合用,补破结合、相得益彰,符合中医用药规律和辨证施治的原则。
本发明的中药组合物具有泻火解毒、止泻止痛、顺气止痢、活血利气、健脾消食、理气和胃、祛病除湿的功效,对溃疡性结肠炎,痢疾等具有标本兼治的作用,效果显著,副作用小。
临床试验:
一、 选择病例
溃疡性结肠炎患者84例,对照组42例,治疗组42例;
二、 诊断标准
脓血便:脓血便,血性粘液便,同时伴有或不伴有腹泻,仅有粘液、脓液和血,而没有粪便;
腹痛:出现腹痛的症状,慢性溃疡性结肠炎呈反复发作,腹痛症状表现尤为突出,腹痛经常表现为痉挛性痛或闷痛两种自觉症状,且会表现出排便后腹痛减轻或消失的规律;
里急后重:里急后重这个症状贯穿整个结肠炎病程中;
三、 治疗方案
治疗组应用本发明药物汤剂,早中晚各一剂,服一个疗程,3天为一个疗程;
对照组采用磺胺类、抗生素类常规治疗方案治疗;
四、 疗效评价标准
治愈:症状全部消失,主要理化检测指标正常;
有效:全部症状消除或主要症状消除,理化检测指标基本正常;
无效:主要理化检测指标与治疗前无变化;
总有效率=治愈率+有效率。
五、 数据统计结果
病例数 | 治愈 | 有效 | 无效 | 治愈率 | 总有效率 |
42 | 39 | 3 | 0 | 92.86% | 100% |
42 | 40 | 2 | 0 | 95.24% | 100% |
统计结果显示,本发明药物对溃疡性结肠炎治愈率达到92.86%,总有效率100%,治疗效果显著。
急毒性试验:较大剂量和较长疗程服用对大鼠的生长无显著毒性,对大鼠的脑、心、肝、肾等切片形态学检查未见明显毒性损伤改变,试验显示,本药物毒性甚小。
具体实施方式
实施例1:一种治疗溃肠性结肠炎的药物及其制备方法。它是由以下重量份数配比的原料药制备而成的药剂:炙黄芪13-17g、炒白芍13-17g、酒炒当归8-12g、木香4-8g、陈皮8-12g、黄芩8-12g、炒薏苡仁28-32g、木瓜8-12g、土茯苓13-17g、麸炒白术8-12g、防风8-12g、黄连2-5g、秦皮13-17g、盐小茴香2-6g、炮姜2-5g、甘草3-7g、白芷8-12g。所述药剂为胶囊剂、片剂或丸剂。
按照下述重量份数配比称取原料药:
炙黄芪13-17g、炒白芍13-17g、酒炒当归8-12g、木香4-8g、陈皮8-12g、黄芩8-12g、炒薏苡仁28-32g、木瓜8-12g、土茯苓13-17g、麸炒白术8-12g、防风8-12g、黄连2-5g、秦皮13-17g、盐小茴香2-6g、炮姜2-5g、甘草3-7g、白芷8-12g。
所述胶囊剂、片剂、丸剂的制备方法步骤如下:
(1)取方中炙黄芪、炒白芍、酒炒当归、木香、陈皮、黄芩、炒薏苡仁、木瓜、土茯苓、麸炒白术、防风、黄连、秦皮、盐小茴香、炮姜、甘草、白芷粉碎筛析;
(2)将步骤(1)中筛制的混合物加水煎煮2-3次,合并煎液、过滤,将虑液浓缩成70-80度时,胶囊、丸剂相对密度为1.0-1.6的稠膏,片剂相对密度为1.0-1.4的稠膏;
(3)制作胶囊、丸剂时:
将稠膏分离纯化、干燥,制成干颗粒;将步骤干颗粒混合均匀,填充胶囊内即制成胶囊;将干颗粒喷加炼蜜、混合均匀,制成小丸即制成丸剂;
制作片剂时:
将2-4份淀粉与步骤(2)中的稠膏混合均匀,制成颗粒、干燥,制成干颗粒,将干颗粒压制成片剂,包糖衣,即制成片剂。
步骤(2)中所述的混合物,加水煎煮的优选次数为2次,第一次为60-80分钟,第二次为40-60分钟。
实施例2:一种治疗溃肠性结肠炎的药物及其制备方法。它是由以下重量份数配比的原料药制备而成的药剂:炙黄芪15g、炒白芍15g、酒炒当归10g、木香6g、陈皮10g、黄芩10g、炒薏苡仁30g、木瓜10g、土茯苓15g、麸炒白术10g、防风10g、黄连3g、秦皮15g、盐小茴香4g、炮姜3g、甘草5g、白芷10g。所述药剂为胶囊剂、片剂或丸剂。
按照下述重量份数配比称取原料药:
炙黄芪15g、炒白芍15g、酒炒当归10g、木香6g、陈皮10g、黄芩10g、炒薏苡仁30g、木瓜10g、土茯苓15g、麸炒白术10g、防风10g、黄连3g、秦皮15g、盐小茴香4g、炮姜3g、甘草5g、白芷10g。
所述胶囊剂、片剂、丸剂的制备方法步骤如下:
(1)取方中炙黄芪、炒白芍、酒炒当归、木香、陈皮、黄芩、炒薏苡仁、木瓜、土茯苓、麸炒白术、防风、黄连、秦皮、盐小茴香、炮姜、甘草、白芷粉碎筛析;
(2)将步骤(1)中筛制的混合物加水煎煮2-3次,合并煎液、过滤,将虑液浓缩成70-80度时,胶囊、丸剂相对密度为1.0-1.6的稠膏,片剂相对密度为1.0-1.4的稠膏;
(3)制作胶囊、丸剂时:
将稠膏分离纯化、干燥,制成干颗粒;将步骤干颗粒混合均匀,填充胶囊内即制成胶囊;将干颗粒喷加炼蜜、混合均匀,制成小丸即制成丸剂;
制作片剂时:
将2-4份淀粉与步骤(2)中的稠膏混合均匀,制成颗粒、干燥,制成干颗粒,将干颗粒压制成片剂,包糖衣,即制成片剂。
步骤(2)中所述的混合物,加水煎煮的优选次数为2次,第一次为60-80分钟,第二次为40-60分钟。
实施例3:本发明药物还可以为汤剂、口服液、颗粒剂等。
Claims (5)
1.一种治疗溃肠性结肠炎的药物,其特征在于它是由以下重量份数配比的原料药制备而成的药剂:炙黄芪13-17g、炒白芍13-17g、酒炒当归8-12g、木香4-8g、陈皮8-12g、黄芩8-12g、炒薏苡仁28-32g、木瓜8-12g、土茯苓13-17g、麸炒白术8-12g、防风8-12g、黄连2-5g、秦皮13-17g、盐小茴香2-6g、炮姜2-5g、甘草3-7g、白芷8-12g。
2.根据权利要求1所述的治疗溃肠性结肠炎的药物,其特征在于它是由以下重量份数配比的原料药制备而成的药剂:炙黄芪15g、炒白芍15g、酒炒当归10g、木香6g、陈皮10g、黄芩10g、炒薏苡仁30g、木瓜10g、土茯苓15g、麸炒白术10g、防风10g、黄连3g、秦皮15g、盐小茴香4g、炮姜3g、甘草5g、白芷10g。
3.根据权利要求1或2所述的治疗溃肠性结肠炎的药物,其特征在于:所述药剂为胶囊剂、片剂或丸剂。
4.根据权利要求3所述的治疗溃肠性结肠炎的药物,其特征在于:所述胶囊剂、片剂、丸剂的制备方法步骤如下:
(1)取方中炙黄芪、炒白芍、酒炒当归、木香、陈皮、黄芩、炒薏苡仁、木瓜、土茯苓、麸炒白术、防风、黄连、秦皮、盐小茴香、炮姜、甘草、白芷粉碎筛析;
(2)将步骤(1)中筛制的混合物加水煎煮2-3次,合并煎液、过滤,将虑液浓缩成70-80度时,胶囊、丸剂相对密度为1.0-1.6的稠膏,片剂相对密度为1.0-1.4的稠膏;
(3)制作胶囊、丸剂时:
将稠膏分离纯化、干燥,制成干颗粒;将步骤干颗粒混合均匀,填充胶囊内即制成胶囊;将干颗粒喷加炼蜜、混合均匀,制成小丸即制成丸剂;
制作片剂时:
将2-4份淀粉与步骤(2)中的稠膏混合均匀,制成颗粒、干燥,制成干颗粒,将干颗粒压制成片剂,包糖衣,即制成片剂。
5.根据权利要求4所述的治疗溃肠性结肠炎的药物的制备方法,其特征在于步骤(2)中所述的混合物,加水煎煮的次数为2次,第一次为60-80分钟,第二次为40-60分钟。
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