CN106581180B - 一种治疗腹痛、腹胀、腹泻的中药组合制剂 - Google Patents
一种治疗腹痛、腹胀、腹泻的中药组合制剂 Download PDFInfo
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Abstract
本发明涉及医药领域,尤其涉及一种治疗腹痛、腹胀、腹泻的中药组合制剂,所述中药组合物由以下重量份的药物制成:大果木姜子(苗语:米槁)120‑160份、木香(苗语:磨枪)50‑70份、五倍子(苗语:正哥爬细)50‑70份、丁香(苗语:提枪)80‑120份、肉桂(苗语:嘎你豆)60‑90份、荜茇(苗语:比波)0.8‑1.2份;本发明通过合理配伍,科学方法制备,使其产品药效稳定、药力迅速、使用方便、见效快、疗效显著,具有健胃消脾、解毒消肿、生肌散结、散寒止痛、收敛止泻等功效,且无毒副作用;通过有效活性成分之间的相互作用,使得药物利用度高,协同治疗作用能发挥到最佳。
Description
技术领域
本发明涉及医药领域,尤其涉及一种治疗腹痛、腹胀、腹泻的中药组合制剂。
背景技术
腹胀,是一种常见的消化系统症状。可以是一种主观上的感觉,感到腹部的一部分或全腹部胀满,通常伴有相关的症状,如呕吐、腹泻、嗳气等;也可以是一种客观上的检查所见,发现腹部一部分或全腹部膨隆。中医认为,腹胀者,由阳气外虚、阴气内积故也;阳气外虚受风冷邪气,风冷,阴气也;冷积于府脏之间不散,与脾气相壅,虚则胀,故腹满而气微喘造成的;治宜宽中理气、和胃降逆、健脾消胀、升清降浊、清热祛湿。现有医学认为引起腹胀的原因主要见于胃肠道胀气、慢性肾衰竭,各种原因所致的腹水、腹腔肿瘤等;但由于导致腹胀的机理相对复杂,严重者影响生活质量。
腹胀常引起腹泻现象,众所周知,腹泻是发展中国家发病和死亡的主要原因之一,全球每年有180万人死于腹泻,其中5岁以下儿童占90%,小儿腹泻,属中医“泄泻”范畴,是因脾胃功能失调,引起大便稀薄或如水样,便次增多为其主要的病症,现有治疗方法通常为脐疗法,脐疗法可调整肠胃功能,促进消化吸收,有健脾燥湿、涩肠止泻的功效,同时,还有标本兼治的益处,但由于药物配比不合理,仍旧出现有效率低或治疗时间长的不利发展状况;目前,脐疗法的选材有严格要求,或者药物过多或是价格昂贵,间接地增加了治疗成本。
如专利号为201110366655.7公开了一种治疗小儿腹泻的药剂,取天南星、石菖蒲、苦楝子、葛根、黄芩、木贼草、白芥子、冰片、吴茱萸、陈皮、蛇床子和枯矾,加水在40℃浸泡40分钟,之后,在80℃加热两小时,过滤,使滤液在减压真空干燥至干,过0目筛;取硬脂酸甘油酯,加热熔化,待温度降至45-50℃时加入上述过筛之后的粉末,搅拌均匀,注入模具中,冷却成型,脱模,制成0.5g圆形药片,附着于医用无纺胶布中间,包装即得。
又如专利号为201310573626.7公开了一种治疗小儿腹泻的中药制剂,原料组成:麦芽、茯苓、马铃薯、紫油木、甘蔗、天南星、白芷、冬瓜、八角莲、山楂、肉桂、丁香、葛根、石菖蒲、生姜和陈皮。
再如专利号为201510246978.0公开了一种小儿腹泻的中药脐贴,由以下药用原料制成:葛根、甘草、枳实、柴胡、白芍、黄连、神曲、焦楂、炮姜、吴茱萸、丁香、肉桂、木香、茯苓、夜交藤、泽兰。
另外,市售产品虽然治疗腹泻、腹胀和腹痛的外用药和内服药品种繁多,但多数均为主治其任一病症而缓解其他症状,同时治疗腹泻、腹胀和腹痛的药物相对较少,也是未来发展的趋势。而苗药是少数民族地区的特色医药,对一些疾病尤其是腹泻、腹胀和腹痛的治疗有着特别的效果。
发明内容
为解决上述技术问题,本发明利用苗族医药本性真的原则,结合中医学理论及腹痛、腹胀、腹泻的致病原理,提供了一种治疗腹痛、腹胀、腹泻的中药组合制剂,该组合制剂治疗或缓解腹痛、腹泻、腹胀症状,尤其是脾胃虚寒所致的小儿腹泻、腹痛、腹胀症状。
本发明通过以下技术方案得以实现。
本发明提供一种治疗腹痛、腹胀、腹泻的中药组合制剂,其中,所述中药组合物由以下重量份的药物制成:大果木姜子(苗语:米槁)120-160份、木香(苗语:磨枪)50-70份、五倍子(苗语:正哥爬细)50-70份、丁香(苗语:提枪)80-120份、肉桂(苗语:嘎你豆)60-90份、荜茇(苗语:比波)0.8-1.2份。
进一步地,所述中药组合物按重量份计为:大果木姜子(苗语:米槁)140份、木香(苗语:磨枪)60份、五倍子(苗语:正哥爬细)60份、丁香(苗语:提枪)100份、肉桂(苗语:嘎你豆)75份、荜茇1(苗语:比波)份。
本发明中药组合制剂为外用制剂,具体为贴剂。
再进一步的,所述制剂是由中药组合物与基质混合制成;
再进一步的,所述基质为油脂性基质、乳剂型基质、水溶性基质中的任一种;
再进一步的,所述基质为液体石蜡、羊毛脂、三乙醇胺皂、月桂醇硫酸钠、聚山梨酯、明胶、甘油、凡士林中的任一种;
再进一步的,所述基质为凡士林。
本发明还提供了该中药组合制剂的制备方法,步骤如下:
1)取配方量60%的大果木姜子、丁香、肉桂,加入5-7倍量的浓度为70%-80%的乙醇浸泡5-6小时,超声波提取60-90min,抽滤,收集滤液,水蒸气蒸馏法蒸出滤液中的溶剂,收集挥发油,提取后的残渣备用;
2)取配方量60%的木香、五倍子,用6-10倍量的浓度为60%-80%的乙醇回流提取2-3次,每次1-2小时,每次提取后的溶液过滤,滤液合并后浓缩、干燥成细粉,提取后的残渣备用;
3)取所述重量40%的大果木姜子、丁香、木香、五倍子、肉桂以及全量荜茇,粉碎成60-100目的细粉,备用;
4)将步骤1)和步骤2)的提取残渣合并,用6-8倍量的水煎煮提取1-2次,每次1-1.5小时,每次提取后的溶液过滤,滤液合并,然后浓缩、干燥成细粉,备用;
5)取步骤1)的挥发油和步骤2)、3)、4)的细粉,加入基质,混匀,制成所需制剂。
本发明制剂属于外用药,禁止内服,禁止进入眼、鼻、口中,孕妇禁用。贴剂规格为1.5g/片,使用时将其贴于肚脐,一日1次,1次一片,贴2-4h即可;若出现刺激症状或过敏反应,用清水洗净即可,无毒副作用。
本发明的有益效果在于:
本发明主要利用生长于贵州西南部及东南部的药材,其中药组合制剂组方用药具有鲜明的苗医药特色,组成本组方的苗族药用植物及原料均已载入《中国植物志》。大果木姜子、五倍子、丁香已是苗族用了几千年的止痛消肿药材。
本发明采用的各原料的药用性能为:
大果木姜子,苗语Mi gao(音译米槁):生长于贵州西南部及东南部,是贵州苗族民间的常用药物。具有温阳宽胸,理气活血之效,临床防治冠心病、心绞痛等心血管疾病,症见胸闷、胸痛、心悸、气短、形寒,舌质淡或暗,舌苔白,脉沉细。
木香:性味:辛;苦;温。归经:肺;脾;肝;功能主治:行气止痛,调中导滞,主胞胁胀满足,脘腹胀痛,哎吐泄泻,痢疾后重。
五倍子,苗语Zend ghob pab dlid(音译正哥爬细):性味:酸、涩、寒;归经:肺、胃、大肠、肝、肾经;功能主治:敛肺,止汗,涩肠,固精,止血,解毒,主肺虚久咳,自汗盗汗,久痢久泻,脱肛,遗精,白浊,各种出血,痈肿疮疖。
丁香,苗语Tik qiangb(音译提枪):性味:辛、温;归经:胃、脾、肾;功能主治:温脾胃,降逆气。主治胃寒呕逆,吐泻,脘腹作痛。
肉桂,苗语Ghab nix dout(音译嘎你豆):性味:辛、甘、热;归经:心、脾、肝、肾;功能主治:补元阳,暖脾胃,除积冷,通血脉。治命门火衰,肢冷脉微,亡阳虚脱,腹痛泄泻,寒疝奔豚,腰膝冷痛,经闭症瘕,阴疽,流注,及虚阳浮越,上热下寒。
荜茇,苗语Beex hvob(音译比波):性味:辛、热;归经:胃、脾;功能主治:温中散寒,下气止痛。用于脘腹冷痛,呕吐,泄泻,偏头痛;外治牙痛。
本发明通过合理配伍、科学方法制备,使得产品药效稳定、药力迅速、使用方便、见效快、疗效显著,具有健胃消脾、解毒消肿、生肌散结、散寒止痛、收敛止泻等功效。以大果木姜子、丁香为主,作用为行气止痛,脾胃气滞所致的腹胀腹痛、理气疏肝,与木香、肉桂五倍子及荜茇适当配合,利用其相互间协同或拮抗作用,提高疗效,以适应复杂病情的治疗要求,通过合理的制备方法,使得有效成分间协同增效,减少了不良反应,还使得药物奏效迅速,疗效显著持久,作用强,见效和痊愈时间。
本发明对配方量40%的原料药进行粉碎用药,对其余60%的原料药分别进行挥发油提取等提取纯化后用药,既能使药物颗粒与人体皮肤的充分接触,又能通过提取纯化操作提高药物有效成分的利用。通过对主药大果木姜子、丁香以及辅药肉桂采用超声波提取法提取挥发油,利用超声波振动时产生并传递强大的能量,使媒介结构发生变化,促进有效成分进入溶剂中的这一特性,达到既快速提取,又能有效利用其挥发油中1,8-桉叶素、丁香酚、桂皮醛等的目的;对木香、五倍子先进行乙醇回流提取,然后对提取挥发油后的残渣与木香等醇提后的残渣再进一步水煎煮提取,不仅提高主要活性成分的利用率,且还能有效地提取药材中的糖类等极性大的有效成分,药材提取率更高,节约成本,增加药效。因此,本发明制备方法不仅有效活性成分含量高,而且对没食子酸等有效活性成分之间的比例合理控制,使得用量范围内,药物生物利用度高,各有效成分的协同治疗作用能发挥到最佳。经临床应用验证,其未出现毒副作用,药性平和,对腹泻、腹痛、腹胀有治疗效果,尤其可治疗脾胃虚寒所致的小儿腹泻、腹痛、腹胀。
本发明的中药组合物制剂在研究过程中,包含如下内容:
1、配方筛选
本公司现有产品助消膏功能主治苗医描述为:漳射挡孟、苣敛挡渣,久代吉噶奴;中医描述为:散寒止痛、收敛止泻,用于脾胃虚寒所致的小儿腹泻、腹痛、腹胀;其原料药为大果木姜子、木香和五倍子,产品是药物粉碎后直接入药,存在有效成分利用率不高的缺点,通过对其进一步优化的过程中,意外发现其加入丁香挥发油后,治疗小儿腹泻的效果得到提高,为达到能治疗腹痛、腹胀、腹泻三者兼顾的效果,我们尝试加入丁香、肉桂、砂仁、石榴皮、鸡内金、山楂、陈皮等十余种药材,进行主次用药的搭配,通过多次的配方筛选,初步确定以大果木姜子为君药,搭配丁香为臣药,木香、五倍子和荜茇进行辅佐,可以达到期望的效果。
进一步地,在原料药的用量上,综合考虑地道药材大果木姜子的疗效特异性,以及药物的配伍、毒性等因素,分别尝试丁香用量为大果木姜子的60%-100%,肉桂、木香、五倍子分别用量为大果木姜子的30%-70%,荜茇用量为大果木姜子的0.5%-1.0%,随机选取值点进行疗效、安全性的验证,结果发现,选择大果木姜子120-160份、木香50-70份、五倍子50-70份、丁香90-110份、肉桂60-80份、荜茇0.8-1.2份,治疗小儿腹痛、腹胀和腹泻的疗效能达到85%以上,且使用安全,其中大果木姜子140份、木香60份、五倍子60份、丁香100份、肉桂70份、荜茇1份效果最佳。
2、工艺筛选
现有技术中,对大果木姜子等原料药有直接用药、提取后用药等多种用药方式,为最大限度地利用各药物的活性成分,考虑大果木姜子、丁香、肉桂等的挥发油含量均较多,因此以先提取挥发油为主。木香等分别对水煎煮提取、乙醇回流提取、乙醇渗漉提取等方式进行考察,结果显示,先进行乙醇回流提取后再将残渣与大果木姜子、丁香、肉桂提取挥发油后的残渣共水提取,可有效地提取药材中的糖类等极性大的有效成分,增加药材的利用率,达到降低药材用量即能起到治疗作用的效果。
另外,分别对药物全部提取后入药、药材部分提取入药(全量30%、40%、50%、60%、70%共5种情况)进行考察,结果显示,当采取全量60%提取后入药的方式,不仅使药物颗粒与人体皮肤充分接触,提取后的大果木姜子挥发油、丁香挥发油、桂皮油、木香酯类提取物、五倍子鞣酸类物质等药物有效成分能发挥最大药效。
3、疗效研究
本发明分别对其疗效和安全性等进行研究,采用临床VAS疼痛评分标准评价,应用本发明制剂所制成的贴片,总有效率为85.7%,有效者占97%,显效者占85%。表明采用本发明的药物配方及工艺制成的组合物制剂,安全有效,能全面地解决腹胀、腹痛和腹泻所带来的不适,且生药用量明显低于原有产品助消膏。
具体实施方式
下面进一步描述本发明的技术方案,但要求保护的范围并不局限于所述。
实施例1
产品配方如下(以每方制成产品1000剂为例):
实施例2:原料提取制备方法一
1)取配方量60%的大果木姜子、丁香、肉桂,加入6倍量的浓度为75%的乙醇浸泡6小时,超声波提取80min,抽滤,收集滤液,水蒸气蒸馏法蒸出滤液中的溶剂,收集挥发油,提取后的残渣备用;
2)取配方量60%的木香、五倍子,用8倍量的浓度为70%的乙醇回流提取3次,每次1小时,每次提取后的溶液过滤,滤液合并后浓缩、干燥成细粉,提取后的残渣备用;
3)取所述重量40%的大果木姜子、丁香、木香、五倍子、肉桂以及全量荜茇,粉碎成60目的细粉,备用;
4)将步骤1)和步骤2)的提取残渣合并,用6倍量的水煎煮提取2次,每次1小时,每次提取后的溶液过滤,滤液合并,然后浓缩、干燥成细粉,备用。
实施例3:原料提取制备方法二
1)取配方量60%的大果木姜子、丁香、肉桂,加入5倍量的浓度为80%的乙醇浸泡5小时,超声波提取60min,抽滤,收集滤液,水蒸气蒸出滤液中的溶剂,收集挥发油,提取后的残渣备用;
2)取配方量60%的木香、五倍子,用6倍量的浓度为80%的乙醇回流提取2次,每次2小时,每次提取后的溶液过滤,滤液合并后浓缩、干燥成细粉,提取后的残渣备用;
3)取所述重量40%的大果木姜子、丁香、木香、五倍子、肉桂以及全量荜茇,粉碎成60目的细粉,备用;
4)将步骤1)和步骤2)的提取残渣合并,用6倍量的水煎煮提取2次,每次1小时,每次提取后的溶液过滤,滤液合并,然后浓缩、干燥成细粉,备用。
实施例4:原料提取制备方法三
1)取配方量60%的大果木姜子、丁香、肉桂,加入7倍量的浓度为70%的乙醇浸泡6小时,超声波提取90min,抽滤,收集滤液,水蒸气蒸出滤液中的溶剂,收集挥发油,提取后的残渣备用;
2)取配方量60%的木香、五倍子,用10倍量的浓度为60%的乙醇回流提取3次,每次1小时,每次提取后的溶液过滤,滤液合并后浓缩、干燥成细粉,提取后的残渣备用;
3)取所述重量40%的大果木姜子、丁香、木香、五倍子、肉桂以及全量荜茇,粉碎成100目的细粉,备用;
4)将步骤1)和步骤2)的提取残渣合并,用8倍量的水煎煮提取1.5小时,提取后的溶液过滤,然后浓缩、干燥成细粉,备用。
实施例5:制剂制备方法一
随机选择实施例1中1-8的配方,按照实施例2-4任一种原料提取方法提取后,将其步骤1)的挥发油和步骤2)、3)、4)的细粉,加入适量液体石蜡、羊毛脂、三乙醇胺皂、月桂醇硫酸钠、聚山梨酯、明胶、甘油或凡士林,混匀,制成每帖重1.5g的贴剂1000贴。
经检测,采用实施例1的配方1-8,每帖含大果木姜子及五倍子以没食子酸计,含量范围为15.3-21.0mg;丁香酚含量范围为1.34-1.62mg。
实施例6:制剂制备方法二
实施例1中的9-10配方,分别采用实施例2的方法制备提取物后,加入适量甘油,同法制成每帖重1.5g的贴剂1000贴。
经检测,配方9、10中没食子酸含量平均为11.6mg、16.2mg,丁香酚含量平均为0.91mg。
试验例1:稳定性与毒性试验
1、将本发明实施例5、6制得的制剂进行稳定性考察,结果经过一年后,本发明产品有效成分含量未降低,各种检查均符合国家药品标准要求,但实施例6中低配方量(配方9)的有效成分含量不理想。
2、本发明实施例5、6制得的制剂进行毒理实验研究,经过动物实验,证明实施例5制得的产品对动物皮肤无刺激性,也未出现过敏反应,各组动物体重、饮食及活动正常,证明毒性小,非常有利于临床使用。但使用实施例6的高配方量(配方10)制得的产品的动物有轻微过敏反应,少数动物表皮出现红肿现象,试涂处出现抓痕,停用后逐渐恢复正常。由此可知,采用本发明的高组份具有一定毒性,不推荐用药。
实验例2:本发明制剂的药效学试验
1、供试样品:选择实施例1中的配方1-3,每种配方分别采用实施例2-4的方法提取,然后加入甘油,制成样品共9份;选择实施例1中的配方9-10,按照本发明实施例6制备,得样品2份;共计11份。
对照样品1:小儿暖脐膏;对照样品2:助消膏。
2、试验内容:
2.1、治疗腹胀评价试验:
方法:选取健康的大鼠84只,随机分成14组,对各组大鼠饲喂高糖高脂饲料加生理盐水的肝癌H22型细胞腹水瘤模型,造模成功后分别用供试样品和对照样品进行治疗,治疗2天后,分别对腹胀程度进行定性分析。
结果:配方1-3制成的9份样品能显著减轻腹部积气量,说明本发明制剂对减轻肝病性腹胀有显著作用。另外,配方9组即低组分用量组治疗作用与对照样品效果无显著性差别,配方10组即高组分用量组作用明显低于配方1-3;因此,表明采用本发明所述的用量范围,作用良好。(结果见表1)。
2.2、治疗腹痛评价试验:
方法:选取大鼠84只,随机分成14组,均用浓度为0.6%的醋酸溶液进行腹腔注射以建立腹部疼痛模型,建模成果后分别用供试样品和对照样品进行治疗,治疗2天后,以小鼠出现舔足的时间作用为痛反应指标,分别对腹痛程度进行定量分析。
结果:配方1-3制成的9份样品能显著减少舔足次数,说明本发明制剂对减轻疼痛感有显著作用。另外,配方9组即低组分用量组治疗作用与对照样品效果无显著性差别;因此,表明采用本发明所述的用量范围,作用良好。(结果见表1)。
2.3、治疗腹泻评价试验:
方法:选取健康的大鼠84只,随机分成14组,对各组大鼠喂食生大黄致泻,腹泻状况出现10min后,分别用供试样品和对照样品进行涂抹,观察涂抹6h内小鼠的及累积腹泻次数及粪便外型,分别对腹泄程度进行定量定性分析。
结果:配方1-3制成的9份样品能显著减少腹泻次数,且粪便多为正常便,说明本发明制剂对治疗腹泻有显著作用。另外,配方10组即低、高组分用量组治疗作用与对照样品效果无显著性差别,但正常便多于对照样品,另外,配方9组即低组分用量组的水样便和粘液便多于配方10组即高组分用量组;因此,表明采用本发明所述的用量范围,作用良好。(结果见表1)。
表1
试验组 | 治疗腹胀 | 治疗腹痛 | 治疗腹泻 |
配方1 | 平均总有效率87.3% | 平均总有效率86.5% | 平均总有效率85.4% |
配方2 | 平均总有效率86.7% | 平均总有效率87.3% | 平均总有效率85.2% |
配方3 | 平均总有效率89.4% | 平均总有效率87.2% | 平均总有效率85.1% |
配方9 | 总有效率65.8% | 总有效率67.8% | 总有效率72.3% |
配方10 | 总有效率79.2% | 总有效率85.9% | 总有效率73.5% |
对照样品1 | 总有效率65.6% | 总有效率67.4% | 总有效率72.7% |
对照样品2 | 总有效率62.4% | 总有效率64.1% | 总有效率73.8% |
本发明临床病例:
1、刘某,男,5岁,左侧发育性髋关节脱位术后4小时,患儿自述脘腹胀痛,给予本发明贴片30min,疼痛明显减轻,继续给予一日一次治疗,2日后症状完全消失,随访1个月未见任何不良反应。
2、王某,女,7岁,右手臂肘关节手术后8小时,患儿自述脘腹胀痛,给予本发明贴片40min,疼痛明显减轻,继续给予一日一次治疗,2日后症状完全消失,随访3周未见任何不良反应。
3、蒋某,男,8岁,左股骨干骨折术后6小时,患儿自述肚腹胀痛,给予本发明贴片20min,疼痛明显减轻,继续给予一日一次治疗,3日后症状完全消失,随访2个月未见任何不良反应。
4、苏某,女,2岁,症状:腹泻数天,每天6-10次,大便清稀,多泡沫,肠鸣腹痛,舌淡,苔薄白;给予本发明贴片30min,腹泻明显减少,继续给予一日一次治疗,1周后腹泻痊愈。
5、王某,男,4岁,症状:大便稀溏,色淡不臭,面色萎黄,形体消瘦,神疲倦怠,舌淡苔白;给予本发明贴片40min,腹泻明显减少,继续给予一日一次治疗,3天后腹泻痊愈。
6、谢某,男,6岁,症状:每天6-8次,便稀溏,夹有乳凝块,气味酸臭,舌苔微黄;给予本发明贴片20min,腹泻明显减少,继续给予一日一次治疗,3天后腹泻痊愈。
Claims (8)
1.一种治疗腹痛、腹胀、腹泻的中药组合制剂,其特征在于:所述中药组合物由以下重量份的药物制成:大果木姜子120-160份、木香50-70份、五倍子50-70份、丁香80-120份、肉桂60-90份、荜茇0.8-1.2份;所述大果木姜子的苗语:米槁;所述木香的苗语:磨枪;所述五倍子的苗语:正哥爬细;所述丁香的苗语:提枪;所述肉桂的苗语:嘎你豆;所述荜茇的苗语:比波。
2.如权利要求1所述的治疗腹痛、腹胀、腹泻的中药组合制剂,其特征在于:所述中药组合物由以下重量份的药物制成:大果木姜子140份、木香60份、五倍子60份、丁香100份、肉桂75份、荜茇1份;所述大果木姜子的苗语:米槁;所述木香的苗语:磨枪;所述五倍子的苗语:正哥爬细;所述丁香的苗语:提枪;所述肉桂的苗语:嘎你豆;所述荜茇的苗语:比波。
3.如权利要求1或2所述的治疗腹痛、腹胀、腹泻的中药组合制剂,其特征在于:所述制剂为外用制剂。
4.如权利要求3所述的治疗腹痛、腹胀、腹泻的中药组合制剂,其特征在于:所述制剂为贴剂。
5.如权利要求3所述的治疗腹痛、腹胀、腹泻的中药组合制剂,其特征在于:所述制剂是由中药组合物与基质混合制成。
6.如权利要求5所述的治疗腹痛、腹胀、腹泻的中药组合制剂,其特征在于:所述基质为液体石蜡、羊毛脂、三乙醇胺皂、月桂醇硫酸钠、聚山梨酯、明胶、甘油、凡士林中的任一种。
7.如权利要求6所述的治疗腹痛、腹胀、腹泻的中药组合制剂,其特征在于:所述基质为甘油。
8.如权利要求3所述的治疗腹痛、腹胀、腹泻的中药组合制剂,其特征在于:制备方法包括如下步骤:
1)取配方量60%的大果木姜子、丁香、肉桂,加入5-7倍量的浓度为70%-80%的乙醇浸泡5-6小时,超声波提取60-90min,抽滤,收集滤液,水蒸气蒸馏法蒸出滤液中的溶剂,收集挥发油,提取后的残渣备用;
2)取配方量60%的木香、五倍子,用6-10倍量的浓度为60%-80%的乙醇回流提取2-3次,每次1-2小时,每次提取后的溶液过滤,滤液合并后浓缩、干燥成细粉,提取后的残渣备用;
3)取所述重量40%的大果木姜子、丁香、木香、五倍子、肉桂以及全量荜茇,粉碎成60-100目的细粉,备用;
4)将步骤1)和步骤2)的提取残渣合并,用6-8倍量的水煎煮提取1-2次,每次1-1.5小时,每次提取后的溶液过滤,滤液合并,然后浓缩、干燥成细粉,备用;
5)取步骤1)的挥发油和步骤2)、3)、4)的细粉,加入基质,混匀,制成所需制剂。
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