CN117462646A - 一种治疗艾滋病相关的慢性腹泻的中药组合物及其中药制剂 - Google Patents
一种治疗艾滋病相关的慢性腹泻的中药组合物及其中药制剂 Download PDFInfo
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Abstract
本发明公开了一种治疗艾滋病相关的慢性腹泻的中药组合物及其中药制剂,具体涉及中药技术领域。所述中药组合物由如下重量份数的原料组成:白术5‑20份、茯苓5‑30份、黄芪15‑50份、党参5‑30份、陈皮5‑20份、炮姜炭1‑10份、山茱萸5‑20份、砂仁1‑10份、扁豆5‑20份、炙甘草5‑15份、石榴皮10‑30份。本发明的一种治疗艾滋病相关的慢性腹泻的中药制剂使用纯中药制剂,避免了对患者胃的刺激和对肝脏产生的毒副作用,经过大量人群实践证实,安全可靠,无明显不良反应,且制备方法简单,对环境无污染,具有极大的推广应用价值。
Description
技术领域
本发明涉及中药技术领域,具体涉及一种治疗艾滋病相关的慢性腹泻的中药组合物及其中药制剂。
背景技术
艾滋病,即获得性免疫缺陷综合征(acquiredimmunodeficiency syndrome,AIDS),其病原体为人类免疫缺陷病毒(human immunodeficiencyvirus,HIV),亦称艾滋病病毒。目前,艾滋病已成为严重威胁我国公众健康的重要公卫生问题。联合国艾滋病规划署(UNAIDS)估计,截至2017年底,全球现存活HIV/AIDS患者3690万例,当年新发HIV感染者180万例,有2170万例正在接受高效联合抗反转录病毒治疗(highly activeantiretroviraltherapy,HAART,俗称“鸡尾酒疗法”,现在又称抗反转录病毒治疗。通过HAART可在较短的时间内控制病毒,使HIV/AIDs患者存活期由原来的几年提高到了数十年,但HAART并不能完全清除病毒。因此,患者需要终生服用抗病毒药物。
HIV/AIDs感染者由于感染后的抵抗力偏低,长期服用药物,也会降低机体的免疫力,患者患有慢性腹泻后不易恢复,增加患者的痛苦程度,因此,发挥中西医结合治疗的优势,从中药中开发出疗效明确治疗艾滋病相关的慢性腹泻的药物,减轻西药的毒副作用,提高HIV/AIDs患者的生存质量有重要意义。
发明内容
为此,本发明提供一种治疗艾滋病相关的慢性腹泻的中药组合物及其中药制剂,以解决现有治疗艾滋病相关慢性腹泻的西药毒副作用等问题。
为了实现上述目的,本发明提供如下技术方案:
根据本发明一方面提供的一种治疗艾滋病相关的慢性腹泻的中药组合物,所述中药组合物由如下重量份数的原料组成:白术5-20份、茯苓5-30份、黄芪15-50份、党参5-30份、陈皮5-20份、炮姜炭1-10份、山茱萸5-20份、砂仁1-10份、扁豆5-20份、炙甘草5-15份、石榴皮10-30份。
进一步的,所述中药组合物由如下重量份数的原料组成:白术6-15份、茯苓8-25份、黄芪20-40份、党参8-25份、陈皮6-15份、炮姜炭2-8份、山茱萸6-15份、砂仁2-8份、扁豆8-15份、炙甘草5-12份、石榴皮12-20份。
进一步的,所述中药组合物由如下重量份数的原料组成:白术10份、茯苓15份、黄芪30份、党参15份、陈皮10份、炮姜炭6份、山茱萸10份、砂仁6份、扁豆10份、炙甘草5份、石榴皮15份。
本发明各原料的作用具体如下:
白术:菊科多年生草本植物白术的干燥根茎,分生白术、土炒白术,别名于术。性味:苦、甘、温,无毒。归经:归脾、胃经。功效主治:一、补气健脾,治疗脾胃气虚证;二、燥湿利水,治疗水肿、痰饮证;三止汗,治疗气虚自汗证;四,安胎,治疗胎动不安证。
茯苓:学名:Wolfiporia cocos(F.A.Wolf)Ryvarden&Gilb.是多孔菌科、茯苓属真菌。药性比较平和,具有补益的作用。用于各种各样的脾虚的水肿、腹泻、化不良等表现。有利水、渗湿、健脾、宁心的功效。
黄芪:甘、温,归脾、肺经。具有补气升阳、益卫固表、托毒生肌、利水消肿的作用。用于治疗脾肺气虚和中气下陷之证,具体表现为神疲乏力、气短懒言、语声低微、畏寒多汗、脾虚便溏、子宫下垂、胃下垂等症状。
党参:又名上党人参、防风党参、黄参,是桔梗科植物党参、素花党参、川党参的干燥根。性平味甘,归肺、脾经。有健脾益肺,养血生津的功效。
陈皮:为芸香科植物橘及其栽培变种的成熟果皮。性温,味辛、味苦。入脾经、胃经、肺经。用于理气健脾,调中,燥湿,化痰。主治脾胃气滞之脘腹胀满或疼痛、消化不良。湿浊阻中之胸闷腹胀、纳呆便溏。痰湿壅肺之咳嗽气喘。用于胸脘胀满,食少吐泻,咳嗽痰多。
炮姜炭:来源于姜科植物姜的干燥根茎,经过炮制加工而成。性味辛、热,归脾经、胃经和肾经,其功效与作用是温经止血、温中止痛,用于治疗阳虚失血、吐衄崩漏、脾胃虚寒、腹痛吐泻。炮姜性热,又主入脾经,能温经止血,适用于脾阳不足、脾不统血证。
山茱萸:性微温、味酸。入肝经,心经和肾经这三经。具有补肝肾、涩精固脱、止带、止崩、收敛止汗、生津止渴的功效。
砂仁:为姜科植物阳春砂Amomum villosum Lour.、绿壳砂Amomum villosumLour.var.xanthioides T.L.Wu et Senjen或海南砂Amomum longiligulare T.L.Wu的干燥成熟果实。夏、秋间果实成熟时采收,晒干或低温干燥。砂仁归在脾、胃、肾经;行气调中,和胃,醒脾。治腹痛痞胀,胃呆食滞,噎膈呕吐,寒泻冷痢,妊娠胎动。
扁豆:为豆科植物扁豆的白色种子。甘,平。入脾、胃经。健脾和中,消暑化湿。治暑湿吐泻,脾虚呕逆,食少久泄,水停消渴,赤白带下,小儿疳积。
炙甘草:是用蜜烘制的甘草,系豆科植物,炙甘草是用蜜烘制的甘草,性温,味甘,归心经、肺经、胃经、脾经。其具有滋阴养血,益气通阳,复脉定悸的功效,主治心阴阳两虚证,后世医家在张仲景临床应用基础之上将其扩展用于治疗虚劳、肺痿、肺燥阴伤等证.现代医家则用于治疗心血管疾病及其他系统性疾病。
石榴皮:为石榴科植物石榴Punica granatum L.的干燥果皮,味酸;涩;性温;小毒;具有涩肠止泻,止血,驱虫之功效。常用于久泻,久痢,便血,脱肛,崩漏,带下,虫积腹痛。
根据本发明另一方面提供的一种治疗艾滋病相关的慢性腹泻的中药制剂,所述中药制剂由上述的中药组合物和药学上可接受的载体或稀释剂组成。
进一步的,所述中药制剂为颗粒剂、片剂、胶囊、丸剂、汤剂、糖浆剂。
进一步的,所述药学上可接受的载体或稀释剂是指药学领域常规的药物载体,选自填充剂、粘合剂、崩解剂、润滑剂、表面活性剂或矫味剂中的一种或几种。
进一步的,所述填充剂选自淀粉、蔗糖、乳糖、甘露醇、山梨醇、木糖醇、微晶纤维素或葡萄糖中的一种或几种。
进一步的,所述粘合剂选自纤维素衍生物、藻酸盐、明胶或聚乙烯吡咯烷酮中的一种或几种。
本发明具有如下优点:
本发明一种治疗艾滋病相关慢性腹泻的中药组合物由白术、茯苓、黄芪、党参、陈皮、炮姜炭、山茱萸、砂仁、扁豆、炙甘草、石榴皮11种中草药混合而成,通过这11中中药材之间的相互协同作用,使得到的中药组合物对于艾滋病相关的慢性腹泻具有很好的治疗效果,通过大量的临床试验可以看出本发明的中药组合物疗效确切。
本发明的一种治疗艾滋病相关的慢性腹泻的中药制剂使用纯中药制剂,避免了对患者胃的刺激和对肝脏产生的毒副作用,经过大量人群实践证实,安全可靠,无明显不良反应,且制备方法简单,对环境无污染,具有极大的推广应用价值。
具体实施方式
以下由特定的具体实施例说明本发明的实施方式,熟悉此技术的人士可由本说明书所揭露的内容轻易地了解本发明的其他优点及功效,显然,所描述的实施例是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
实施例1
一种治疗艾滋病相关的慢性腹泻的中药组合物,其特征在于,所述中药组合物由如下重量份数的原料组成:白术10份、茯苓15份、黄芪30份、党参15份、陈皮10份、炮姜炭6份、山茱萸10份、砂仁6份、扁豆10份、炙甘草5份、石榴皮15份。
实施例2
一种治疗艾滋病相关的慢性腹泻的中药组合物,其特征在于,所述中药组合物由如下重量份数的原料组成:白术5份、茯苓5份、黄芪15份、党参5份、陈皮5份、炮姜炭1份、山茱萸5份、砂仁1份、扁豆5份、炙甘草5份、石榴皮10份。
实施例3
一种治疗艾滋病相关的慢性腹泻的中药组合物,其特征在于,所述中药组合物由如下重量份数的原料组成:白术20份、茯苓30份、黄芪50份、党参30份、陈皮20份、炮姜炭10份、山茱萸20份、砂仁10份、扁豆20份、炙甘草15份、石榴皮30份。
实施例4
一种治疗艾滋病相关的慢性腹泻的中药组合物,其特征在于,所述中药组合物由如下重量份数的原料组成:白术8份、茯苓10份、黄芪20份、党参10份、陈皮8份、炮姜炭4份、山茱萸8份、砂仁3份、扁豆8份、炙甘草10份、石榴皮12份。
实施例5
一种治疗艾滋病相关的慢性腹泻的中药组合物,其特征在于,所述中药组合物由如下重量份数的原料组成:白术15份、茯苓20份、黄芪40份、党参20份、陈皮15份、炮姜炭8份、山茱萸15份、砂仁8份、扁豆15份、炙甘草10份、石榴皮20份。
实施例6
一种治疗艾滋病相关的慢性腹泻的中药制剂,所述中药制剂由实施例1至5所述的中药组合物按照常规方法制成汤剂。
实施例7
一种治疗艾滋病相关的慢性腹泻的中药制剂,所述中药制剂由实施例1至5所述的中药组合物和药学上可接受的载体或稀释剂组成;所述药学上可接受的载体或稀释剂是指药学领域常规的药物载体,选自填充剂、粘合剂、崩解剂、润滑剂、表面活性剂或矫味剂中的一种或几种。所述填充剂选自淀粉、蔗糖、乳糖、甘露醇、山梨醇、木糖醇、微晶纤维素或葡萄糖中的一种或几种。所述粘合剂选自纤维素衍生物、藻酸盐、明胶或聚乙烯吡咯烷酮中的一种
或几种。其制备方法如下:
取实施例1至5所述的中药组合物,将上述原料粉碎后,添加药学上可接受的载体或稀释剂,按照常规方法,整粒,干燥,制得中药颗粒剂。
实施例8
一种治疗艾滋病相关的慢性腹泻的中药制剂,所述中药制剂由实施例1至5所述的中药组合物和药学上可接受的载体或稀释剂组成;所述药学上可接受的载体或稀释剂是指药学领域常规的药物载体,选自填充剂、粘合剂、崩解剂、润滑剂、表面活性剂或矫味剂中的一种或几种。所述填充剂选自淀粉、蔗糖、乳糖、甘露醇、山梨醇、木糖醇、微晶纤维素或葡萄糖中的一种或几种。所述粘合剂选自纤维素衍生物、藻酸盐、明胶或聚乙烯吡咯烷酮中的一种或几种。其制备方法如下:
取实施例1至5所述的中药组合物,将上述原料粉碎后,添加药学上可接受的载体或稀释剂,按照常规方法,制粒,填充胶囊,制得中药胶囊剂。
实施例9
一种治疗艾滋病相关的慢性腹泻的中药制剂,所述中药制剂由实施例1至5所述的中药组合物和药学上可接受的载体或稀释剂组成;所述药学上可接受的载体或稀释剂是指药学领域常规的药物载体,选自填充剂、粘合剂、崩解剂、润滑剂、表面活性剂或矫味剂中的一种或几种。所述填充剂选自淀粉、蔗糖、乳糖、甘露醇、山梨醇、木糖醇、微晶纤维素或葡萄糖中的一种或几种。所述粘合剂选自纤维素衍生物、藻酸盐、明胶或聚乙烯吡咯烷酮中的一种或几种。其制备方法如下:
取实施例1至5所述的中药组合物,将上述原料粉碎后,添加药学上可接受的载体或稀释剂,按照常规塑制法或泛制法,制得中药丸剂。
实施例10
一种治疗艾滋病相关的慢性腹泻的中药制剂,所述中药制剂由实施例1至5所述的中药组合物和药学上可接受的载体或稀释剂组成;所述药学上可接受的载体或稀释剂是指药学领域常规的药物载体,选自填充剂、粘合剂、崩解剂、润滑剂、表面活性剂或矫味剂中的一种或几种。所述填充剂选自淀粉、蔗糖、乳糖、甘露醇、山梨醇、木糖醇、微晶纤维素或葡萄糖中的一种或几种。所述粘合剂选自纤维素衍生物、藻酸盐、明胶或聚乙烯吡咯烷酮中的一种或几种。其制备方法如下:
取实施例1至5所述的中药组合物,将上述原料粉碎后,添加药学上可接受的载体或稀释剂,按照常规方法,压制成片,包薄膜衣,制得中药片剂。
实施例11
一种治疗艾滋病相关的慢性腹泻的中药制剂,所述中药制剂由实施例1至5所述的中药组合物和药学上可接受的载体或稀释剂组成;所述药学上可接受的载体或稀释剂是指药学领域常规的药物载体,选自填充剂、粘合剂、崩解剂、润滑剂、表面活性剂或矫味剂中的一种或几种。所述填充剂选自淀粉、蔗糖、乳糖、甘露醇、山梨醇、木糖醇、微晶纤维素或葡萄糖中的一种或几种。所述粘合剂选自纤维素衍生物、藻酸盐、明胶或聚乙烯吡咯烷酮中的一种或几种。其制备方法如下:
取实施例1至5所述的中药组合物,将上述原料粉碎后,添加药学上可接受的载体或稀释剂如蔗糖等,按照常规方法,制得中药糖浆剂。
实验例
经过临床实验证实,本发明提供的中药组合物用于治疗艾滋病相关的慢性腹泻疗效确切。
1、一般资料
在医院长期接受抗逆转录病毒治疗的患者中挑选了120名存在艾滋病相关的慢性腹泻的患者,男性患者95名,女性患者25名;其中,20岁-29岁有43例,30岁-39岁有46例,40岁以上的31例。
2、治疗方法
治疗疗程:4周为一个疗程。
服药方法:将实施例1的中药组合物制成中药汤剂口服,每日两次,早晚各一次,饭前半小时服用,每次200~300毫升。服药期间,忌食油腻、猪肉以及绿豆等性寒食物。
3、诊断标准
同时满足以下两个标准:
3.1艾滋病诊断标准:参照《艾滋病和艾滋病病毒感染诊断标准》(WS293-2008)、《艾滋病诊疗指南(2011版)》,有流行病学史,结合抗HIV阳性,经Western Blot确证试验证实;或仅实验室检查抗HIV阳性即可诊断。
3.2慢性腹泻标准:参照《艾滋病相关慢性腹泻中西医协同治疗专家共识》、2013年《内科学》中慢性腹泻诊断标准。每天慢性腹泻次数均>3次,每天粪便量增加>20g,粪质稀薄(含水量>85%),腹泻持续时间均>4周。可伴有不同程度的腹痛、纳呆、乏力、恶心呕吐及体质量下降。电子肠镜检查排除肠道肿瘤和慢性溃疡性结肠炎患者。
4、疗效评定标准:证候疗效判定标准参照《中药新药临床研究指导原则(试行)》(中国医药科技出版社,2002)制定。
显效:症状、体征明显改善,证候积分减少≥70%;
有效:症状、体征均有好转,证候积分减少≥30%;
无效:症状、体征均无明显改善,甚或加重,证候积分减少不足30%。计算公式(尼莫地平法)为:疗效指数=[(治疗前积分-治疗后积分)÷治疗前积分]×100%。
5、治疗结果
接受治疗的患者中,显效68例,有效32例,无效20例。从治疗结果来看,说明本发明提供的中药组合物用于改善艾滋病相关的慢性腹泻的有效率达83.3%,疗效确切。
典型案例
病例1:王某某,男,33岁,河北承德人。2018年1月于当地医院检查HIV抗体阳性,HIV病载4.2×105copies/ml,全血CD4+T淋巴细胞计数86μL-1。确诊为艾滋病。给予抗HIV治疗,方案为3TC/TDF/EFV。2018年11月出现消瘦,腹痛腹泻,间歇发作,每日4-6次,稀水样便,持续2月余。2019年1月于北京地坛医院就诊,HIV检测不到,CD4+T淋巴细胞正常,根据症状诊断为艾滋病相关慢性腹泻。给予实施例1的中药组合物制成的中药汤剂治疗4周,大便次数减少,腹痛症状减轻。服药8周后大便成形,次数正常,腹痛腹泻症状消失。继续原方案抗HIV治疗。
病例2:张某某,男,28岁,北京顺义人,同性恋者。2019年3月无明显诱因出现胸闷,乏力、腹痛腹泻,稀水样便,持续2月余。2019年5月于当地医院初筛HIV阳性。随后于北京地坛医院就诊,检查HIV抗体阳性,HIV病载4.8×106copies/ml,全血CD4+T淋巴细胞计数97μL-1。诊断为艾滋病、艾滋病相关腹泻。给予抗HIV治疗,方案3TC/TDF/EFV。同时给予实施例1的中药组合物制成的中药汤剂治疗腹泻4周,患者症状明显减轻。服药12周后,腹痛腹泻、乏力症状消失,服药期间无明显不适。复查HIV病载检测不到,CD4+T淋巴细胞为211μL-1。继续服用原方案进行抗HIV治疗。
病例3:林某某,女,36岁,北京密云人。2020年6月于当地医院确诊艾滋病,HIV病载4.1×105copies/ml,全血CD4+T淋巴细胞计数70μL-1。给予3TC/TDF/EFV抗HIV治疗方案。2021年4月出现乏力,恶心,腹痛腹泻,间歇性发作,每日4-7次。随后于北京地坛医院就诊,检查HIV病载检测不到,全血CD4+T淋巴细胞计数101μL-1,诊断为艾滋病相关慢性腹泻。给予实施例1的中药组合物制成的中药汤剂治疗8周,腹泻症状明显减轻。12周后,大便次数正常,腹痛腹泻症状消失。继续原方案进行抗HIV治疗。
虽然,上文中已经用一般性说明及具体实施例对本发明作了详尽的描述,但在本发明基础上,可以对之作一些修改或改进,这对本领域技术人员而言是显而易见的。因此,在不偏离本发明精神的基础上所做的这些修改或改进,均属于本发明要求保护的范围。
Claims (8)
1.一种治疗艾滋病相关的慢性腹泻的中药组合物,其特征在于,所述中药组合物由如下重量份数的原料组成:白术5-20份、茯苓5-30份、黄芪15-50份、党参5-30份、陈皮5-20份、炮姜炭1-10份、山茱萸5-20份、砂仁1-10份、扁豆5-20份、炙甘草5-15份、石榴皮10-30份。
2.如权利要求1所述的一种治疗艾滋病相关的慢性腹泻的中药组合物,其特征在于,所述中药组合物由如下重量份数的原料组成:白术6-15份、茯苓8-25份、黄芪20-40份、党参8-25份、陈皮6-15份、炮姜炭2-8份、山茱萸6-15份、砂仁2-8份、扁豆8-15份、炙甘草5-12份、石榴皮12-20份。
3.如权利要求2所述的一种治疗艾滋病相关的慢性腹泻的中药组合物,其特征在于,所述中药组合物由如下重量份数的原料组成:白术10份、茯苓15份、黄芪30份、党参15份、陈皮10份、炮姜炭6份、山茱萸10份、砂仁6份、扁豆10份、炙甘草5份、石榴皮15份。
4.一种治疗艾滋病相关的慢性腹泻的中药制剂,其特征在于,所述中药制剂由权利要求1-3任一项所述的中药组合物和药学上可接受的载体或稀释剂组成。
5.如权利要求4所述的中药制剂,其特征在于,所述中药制剂为颗粒剂、片剂、胶囊、丸剂、汤剂、糖浆剂。
6.如权利要求4所述的中药制剂,其特征在于,所述药学上可接受的载体或稀释剂是指药学领域常规的药物载体,选自填充剂、粘合剂、崩解剂、润滑剂、表面活性剂或矫味剂中的一种或几种。
7.如权利要求6所述的中药制剂,其特征在于,所述填充剂选自淀粉、蔗糖、乳糖、甘露醇、山梨醇、木糖醇、微晶纤维素或葡萄糖中的一种或几种。
8.如权利要求6所述的中药制剂,其特征在于,所述粘合剂选自纤维素衍生物、藻酸盐、明胶或聚乙烯吡咯烷酮中的一种或几种。
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