CN116898933A - 一种治疗溃疡性结肠炎的中药组合物及制备方法 - Google Patents
一种治疗溃疡性结肠炎的中药组合物及制备方法 Download PDFInfo
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Abstract
本发明公开一种治疗溃疡性结肠炎的中药组合物及制备方法。中药组合物由以下重量原料组成：人参10‑30份、黄芪10‑30份、茯苓10‑15份、白术6‑15份、薏苡仁10‑30份、仙鹤草6‑15份、白扁豆10‑16份、五味子5‑10份、白头翁10‑16份、地榆炭10‑18份、灶心土15‑30份、木香5‑10份、甘草5‑8份。本发明中药组合物中各组分共奏补气健脾，祛湿滋肾止泻，清热解毒，凉血止血之功。能减轻炎症反应，保护肠道黏膜，加强肠道黏膜屏障功能，修复肠道黏膜，从而治愈溃疡性结肠炎。在100年以上的临床经验基础上，证明所述中药组合物治疗溃疡性结肠炎，起效快，疗效稳定，总有效率高。
Description
技术领域
本发明涉及中药领域，尤其涉及一种治疗溃疡性结肠炎的中药组合物及制备方法。
背景技术
随着生活习惯和饮食习惯的改变，中国的溃疡性结肠炎的发病率日益提高，临床症状表现为腹痛、腹泻、脓血便等，严重影响患者的工作和生活。然而，现有药物治疗溃疡性结肠炎，存在疗程长，总有效率低，容易反复等问题。
因此，现有技术还有待于改进和发展。
发明内容
鉴于上述现有技术的不足，本发明的目的在于提供一种治疗溃疡性结肠炎的中药组合物及制备方法，旨在解决现有药物治疗溃疡性结肠炎，疗程长，总有效率低，容易反复的问题。
本发明的技术方案如下：
本发明的第一方面，提供一种治疗溃疡性结肠炎的中药组合物，其中，所述中药组合物由以下重量的原料组成：
人参10-30份、黄芪10-30份、茯苓10-15份、白术6-15份、薏苡仁10-30份、仙鹤草6-15份、白扁豆10-16份、五味子5-10份、白头翁10-16份、地榆炭10-18份、灶心土15-30份、木香5-10份、甘草5-8份。
可选地，所述中药组合物由以下重量的原料组成：
人参15-25份、黄芪12-25份、茯苓11-14份、白术8-15份、薏苡仁12-28份、仙鹤草8-15份、白扁豆10-14份、五味子6-9份、白头翁10-15份、地榆炭10-17份、灶心土16-28份、木香6-10、甘草5-8份。
可选地，所述中药组合物由以下重量的原料组成：人参25份、黄芪20份、茯苓14份、白术15份、薏苡仁28份、仙鹤草15份、白扁豆14份、五味子9份、白头翁15份、地榆炭17份、灶心土28份、木香10份、甘草8份。
可选地，所述中药组合物由以下重量的原料组成：人参23份、黄芪25份、茯苓13份、白术14份、薏苡仁25份、仙鹤草13份、白扁豆12份、五味子8份、白头翁13份、地榆炭13份、灶心土25份、木香9份、甘草7份。
可选地，所述中药组合物由以下重量的原料组成：人参20份、黄芪23份、茯苓12份、白术13份、薏苡仁22份、仙鹤草12份、白扁豆11份、五味子7份、白头翁12份、地榆炭12份、灶心土22份、木香9份、甘草6份。
可选地，所述中药组合物由以下重量的原料组成：人参15份、黄芪12份、茯苓11份、白术8份、薏苡仁12份、仙鹤草8份、白扁豆10份、五味子6份、白头翁10份、地榆炭10份、灶心土16份、木香6份、甘草5份。
可选地，所述中药组合物为颗粒剂。
本发明的第二方面，提供一种本发明所述的治疗溃疡性结肠炎的中药组合物的制备方法，其中，包括步骤：
人参15-30份粉碎成细粉；
白术6-15份、白头翁10-16份经乙醇加热提取后，过滤，滤液浓缩干燥、粉碎成细粉；
黄芪10-30份、茯苓10-15份、仙鹤草6-15份、白扁豆10-16份和甘草5-8份混合，加水煎煮，过滤，滤液浓缩，加醇搅拌，静置，过滤，滤液浓缩，得到第一清膏；
木香5-10份、地榆炭10-18份和灶心土15-30份混合，加水煎煮，过滤，滤液浓缩，得到第二清膏；
五味子5-10份和薏苡仁10-30份混合，加水煎煮，过滤，提取滤液，滤渣加水，二次煎煮，过滤，回收滤液后，合并滤液，得到提取液；
将所述提取液与人参细粉，白术、白头翁细粉，第一清膏，第二清膏混合，干燥，粉碎成细粉，加淀粉及糊精，混匀，以乙醇为润湿剂制成颗粒，干燥，得到所述中药组合物。
可选地，所述白术6-15份、白头翁10-16份经乙醇加热提取的步骤，具体包括：白术6-15份、白头翁10-16份加入乙醇，加热提取，过滤，滤液经减压回收乙醇并干燥浓缩。
可选地，按重量份计，所述淀粉的加入量为1份，所述糊精的加入量为1.5份。
有益效果：
人参甘温，《神农本草经》谓其“主补五藏”，尤善补元气，且主入脾经，大补脾胃之气；黄芪甘微温，具有健脾补中，升阳举陷，益卫固表之功效；茯苓甘淡而平，以利水渗湿为主，且有健脾助运之功，三药相须为用，健脾益气作用大增；且茯苓的利湿作用既兼顾了脾喜燥而恶湿、脾湿易生湿之特点，又可防补益药壅滞之弊，具有补而不壅、补中寓利、相得益彰之妙，故三药共为君药。
白术甘温而兼苦燥之性，甘温补气，苦燥健脾，与人参相协，益气补脾之力显著，与茯苓相伍，互增健脾祛湿之功；薏苡仁甘淡寒，利湿清热而健脾，缓和拘挛；白扁豆甘，微温，归脾、胃经，健脾化湿，和中；五味子甘温，有收敛固涩，滋肾之功效，四药共为臣药，协助君药补气健脾，祛湿补肾止泻。
白头翁苦寒降泄，入胃和大肠经，功善清热解毒，凉血止痢，尤善清大肠湿热，对湿热痢疾有良效；仙鹤草味涩收敛，且药性平和，功长止血，又可止痢；地榆炭苦寒清热，酸涩收敛，既凉血止血，又可解毒敛疮；灶心土，温中止血，止呕，止泻，四药清热解毒，凉血止痢，针对湿热热毒下注大肠，搏结气血而致泻痢，为佐药；木香辛行苦泄温通，醒脾导滞，行气止痛，且与补益药同用，补而不滞，亦为佐药。
甘草甘温益气，合人参、白术可加强益气补中之功，又能调和方中诸药，因此兼佐使之用。
本发明中药组合物中各组分共奏补气健脾，祛湿滋肾止泻，清热解毒，凉血止血之功。能减轻炎症反应，保护肠道黏膜，加强肠道黏膜屏障功能，修复肠道黏膜，从而治愈溃疡性结肠炎。在100多年的临床经验基础上，证明所述中药组合物治疗溃疡性结肠炎，起效快，疗效稳定，总有效率高。
具体实施方式
本发明提供一种治疗溃疡性结肠炎的中药组合物及制备方法，为使本发明的目的、技术方案及效果更加清楚、明确，以下对本发明进一步详细说明。应当理解，此处所描述的具体实施例仅仅用以解释本发明，并不用于限定本发明。
现有药物治疗溃疡性结肠炎，存在疗程长，总有效率低，容易反复等问题。依据国家级非物质文化遗产代表性名录“应氏奇穴疗法”的成果，发明人长期积累的丰富临床经验，针对现有药物在治疗溃疡性结肠炎方面存在的缺陷，研制出一种工艺简单易行、服用携带方便、生物利用度高、安全有效的治疗溃疡性结肠炎的中药组合物。
具体地，本发明实施例提供一种治疗溃疡性结肠炎的中药组合物，其中，所述中药组合物由以下重量的原料组成：
人参10-30份、黄芪10-30份、茯苓10-15份、白术6-15份、薏苡仁10-30份、仙鹤草6-15份、白扁豆10-16份、五味子5-10份、白头翁10-16份、地榆炭10-18份、灶心土15-30份、木香5-10份、甘草5-8份。
在一种实施方式中，所述中药组合物由以下重量的原料组成：
人参15-25份、黄芪12-25份、茯苓11-14份、白术8-15份、薏苡仁12-28份、仙鹤草8-15份、白扁豆10-14份、五味子6-9份、白头翁10-15份、地榆炭10-17份、灶心土16-28份、木香6-10份、甘草5-8份。
发明人集合应氏中医100多年临床治疗脾胃病之经验，临床治愈病例超过10000例，“应氏奇穴疗法”已于2021年被批准为国家级非物质文化遗产代表性名录，本实施例中药组合物治疗慢性溃疡性结肠炎效果特别明显，能够临床治愈溃疡性结肠炎患者，解除患者病痛。
下面对中药组合物中各组分的功能作介绍。
人参：甘温，善入脾胃经而大补脾胃之气。迄今为止，已从人参中分离鉴定了46种人参皂苷，目前，以人参皂苷Rg3为主要原料的人参胶囊已投放市场，人们正在研究开发人参皂苷Rh2作为抗癌新药。对人参皂苷单体化合物的研究多集中在Rg1、Rb1、Rb2、Re等含量较高的成分，如人参皂苷Rb1和Rb2表现为中枢神经抑制，人参皂苷Rg1则表现为中枢神经兴奋，人参皂苷Rb1和Rg1具有益智和抗衰老功能，人参皂苷Re是抗心律失常的有效成分。人参皂甙Rh2能诱导多种肿瘤细胞发生凋亡且途径各不相同。在人肝癌SK-HEP-1细胞中，Rh2作用于凋亡相关蛋白Bcl-2非敏感途径，活化caspase-3蛋白激酶，该酶促使细胞周期相关复合蛋白p21(WAF1/CIP1)裂解并伴有周期素A依赖蛋白激酶CDK2的活化，从而导致细胞发生凋亡。在研究Rh2诱发鼠神经胶质瘤C6Bu-1细胞和人神经母细胞瘤SK-N-BE(2)细胞的凋亡中发现，Rh2诱发SK-N-BE(2)细胞发生凋亡与蛋白激酶C有关，蛋白激酶C亚型α、β、γ、ε、δ、θ水平在细胞凋亡中发生改变，而在C6Bu-1细胞中却没有上述变化，无蛋白激酶C参与，人参皂甙Rh2诱导人恶性黑色素瘤A375-S2细胞凋亡部分依赖caspase-8和caspase-3。
黄芪，甘，微温，具有健脾补中，升阳举陷，益卫固表之功效。黄芪含黄酮、皂甙类成分。黄酮类成分如芒柄花黄素、3'-羟基芒柄花黄素(毛蕊异黄酮)及其葡萄糖甙、2'，3'-二羟基-7，4'-二甲氧基异黄酮、7，2'-二羟基-3'，4'-二甲氧基异黄烷及其葡萄糖甙、7，3'-二羟基-4'，5'-二甲氧基异黄烷、3-羟基-9，10-二甲氧基紫檀烷及其葡萄糖甙等。其中有些成分具较强的抗氧化活性。皂甙类成分有黄芪皂甙Ⅰ～Ⅷ及大豆皂甙Ⅰ；黄芪甲甙(即黄芪皂甙Ⅳ)与黄芪乙甙。黄芪能显著增加血液中的白细胞总数，促进中性粒细胞及巨噬细胞的吞噬功能和杀菌能力。黄芪水煎液小鼠灌胃给药能明显增强脾脏NK细胞的活性，这一过程与诱生干扰素同时发生。黄芪多糖也能刺激NK细胞的增殖，并使细胞体变大。黄芪对NK细胞活性的促进作用主要是通过诱导淋巴细胞产生7-干扰素所介导的，黄芪对NK细胞活性的促进作用与其诱导的抗病毒活性相平行。黄芪在体外与小鼠脾脏细胞一起培养，也能诱生γ-干扰素。对大黄造成的脾虚小鼠黄芪水煎液和黄芪多糖，给药后，均能恢复其脾脏产生IL-2的能力。黄芪并能增强外周血淋巴细胞对IL-2的反应性，使外周血淋巴细胞受IL-2刺激后其增殖指数增高。黄芪能明显增强细胞免疫，促进PHA、COnA、PWM(美洲商陆)引起的淋巴细胞转化。黄芪对6OCo一次性全身照射小鼠脾脏抗体生成细胞释放溶血素量、血清溶菌酶量，有增加作用。对迟发型超敏反应及红细胞C3b受体花环率、红细胞一免疫复合物的花环形成率，均有不同程度的促进或增强作用。
茯苓：味甘、淡，性平，具有利水渗湿，健脾，宁心之功效。茯苓主要化学成分为多糖类和三萜类，还含有甾体类、挥发油、脂肪酸、胆碱、氨基酸及微量元素等。茯苓多糖主要成分是β-(1→3)-D-葡聚糖，同时还含有少量β-(1→6)葡聚糖支链，以及由鼠李糖、木糖、甘露糖、半乳糖、葡萄等构成的酸性杂多糖。目前在茯苓中已分离得到57种三萜类化合物，物质骨架主要有6种：羊毛甾烷型、开环羊毛甾烷型、齿孔甾烷型、羊毛甾－7，9(11)－二烯型、7，8－脱氢羊毛甾烷型和开环齿孔甾烷型。茯苓中还含有甾体类、挥发油、脂肪酸、蛋白质、微量元素等成分，实验发现茯苓总三萜和茯苓酸性多糖均能通过升高血清中表皮生长因子(EGF)和胃组织表皮生长因子受体(EGFR)的表达量来增强脾虚大鼠的胃肠黏膜的修复能力；另外，茯苓水溶性多糖主要通过升高血清EGF含量来增强脾虚大鼠的胃肠黏膜的修复能力。研究表明10个不同产地的茯苓水提物均能不同程度地有效调节脑肠肽的表达，以治疗脾虚。研究发现中、高剂量茯苓多糖可以增强脾虚大鼠的免疫功能和恢复肠道菌群稳态，表明茯苓多糖可能通过调节肠道菌群发挥增强免疫的作用。另外有研究表明，茯苓水煎液对正常小鼠胃肠运动有抑制作用，且抑制作用达到一定的阈值后不再提高。
白术：苦、甘，温，具有健脾益气，燥湿利水之功效。白术主要有挥发油类、白术多糖(Polysaccharide of atractylodes macrocephala，PAM)、内酯类、氨基酸类、维生素类、树脂类等化学成分。不同的提取方法对挥发油种化合物的成分有很大差别。采用GC－MS对白术挥发油进行分析，提取出大根香叶烯B、石竹烯等12个共有成分；水蒸气蒸馏法提取出长叶烯－(V4)、大根叶香烯、3－甲基－2－(2，4－戊二烯)－2－环戊烯－1－酮等15个成分；超声波提取出1，6二甲基－4(1－甲基乙基)－1a六氢萘、9，10－去氢异长叶烯、1－甲氧基－2－(1－甲基－2－亚甲基环戊基)－苯等20个成分；白术挥发油可以促进肠蠕动和胃排空，并且可以抵抗阿托品导致的肠蠕动及胃排空减弱。
薏苡仁：味甘、淡，性凉；归脾、胃、肺经；有利水渗湿，健脾止泻，除痹，排脓，解毒散结之功效。主要成分有脂肪酸及其脂类、多糖类、三萜类、甾醇类、内酰胺类及薏苡素等。种子含氨基酸(为亮氨酸、赖氨酸、精氨酸、酪氨酸等)、薏苡素、薏苡酯、三萜化合物。据报道，用石油醚浸出的薏苡仁油对蛙的横纹肌及运动神经末梢，低浓度呈兴奋作用，高浓度呈麻痹作用。如注射于蛙的胸淋巴腔或腓肠肌内，能减少肌肉之挛缩，并缩短其疲劳曲线。用离体蛙的神经肌肉标本，证明其作用点不在神经干而在肌肉部分。进一步的研究指出，慧苡仁油或C数在10～18的饱和脂肪酸皆能阻止或降低横纹肌(非神经肌接头部位)之收缩作用，而不饱和脂肪酸(如油酸)则无此作用。薏苡仁油(0.5克/公斤皮下注射于兔)及C数在12以上的脂肪酸皆可使血糖有所下降，此可用丙酮酸拮抗之，血清钙亦有所降低，C数较低的脂肪酸(如癸酸)对血糖、血钙皆无影响。薏苡仁油(主要为棕榈酸及其酯)对呼吸，小量兴奋，大量麻痹(中枢性)；能使肺血管显著扩张。对离体蛙心及离体兔肠，低浓度呈兴奋作用，高浓度呈抑制作用；对家兔及豚鼠子宫一般呈兴奋作用，肾上腺素可反转其兴奋作用；它还有抗利尿作用；其中的薏苡素对横纹肌有抑制作用；它能抑制蛙神经肌肉标本的电刺激所引起的收缩反应及大鼠膈肌的氧摄取和无氧糖酵解，并能抑制肌动球蛋白-三磷酸腺甙系统的反应，还有比较弱的中枢抑制作用，表现为对大鼠及小鼠均有镇静作用，并能与咖啡因相拮抗。在家兔的脑电图上，出现波幅增大，频率减少，显示对中枢神经系统的机能性抑制现象等。在大鼠试验(尾部电刺激法)中，有镇痛作用，强度与氨基比林相似。它还有解热作用，对TTG(菌体的精制复合多糖类)性发热的解热作用较好，对二硝基酚引起之发热无甚作用。此外对多突触反射(猫腓神经-腓肠肌标本)有短暂的抑制作用。它不能降低士的宁或戊四氮的致死作用。对兔静脉注射可引起血压短暂下降，皮下注射可使血糖略有下降，对离体蟾蜍心脏及离体兔肠均呈抑制作用；有报告称薏苡仁对癌细胞有阻止成长及伤害作用。
仙鹤草：性微温，味苦、涩，归心、肝、脾经；具有补虚益气、收敛止血、截疟止痢、解毒杀虫、止痛之功效。仙鹤草的化学成分主要有总黄酮类、酚类、糖苷类、鞣质类、挥发油和微量元素等，主要的成份如下：1、黄酮类，成分是芦丁、花旗松素、香豆素、木犀草素、山柰酚和芹菜素；2、酚类，分别是芳香烃苷、二氢山柰酚3-O-β-D-葡萄糖苷、槲皮苷、阿格列单内酯-6-O-β-D-葡萄糖苷、黑麦草内酯。萜类被认为是其具有抗肿瘤活性的主要化学组份之一。
白扁豆：性甘，微温，归脾、胃经；具有健脾化湿，和中消暑之功效；其化学成分主要包括皂苷类、挥发油类、多糖类及氨基酸等，多糖类、皂苷类、氨基酸类是白扁豆的有效物质基础，其中白扁豆多糖、派可林酸可以作为白扁豆的特有成分。
五味子：性酸、甘，温。有收敛固涩，滋肾，生津之功效。治肺虚喘咳，口干作渴，自汗，盗汗，梦遗滑精，久泻久痢。其果含有五味子素(Schisandrin C23H32O6)及维生素C、树脂、鞣质及少量糖类。有敛肺止咳、滋补涩精、止泻止汗之效。其叶、果实可提取芳香油。种仁含有脂肪油，榨油可作工业原料、润滑油。茎皮纤维柔韧，可供绳索。研究表面从五味子中提取的戈米辛A、B、D、G、H、五味子素、五味子素丙和前戈米辛等木脂素成分对于由PGF2a和CaCl2所引起的离体狗肠系膜动脉收缩所产生的影响，结果发现，这些木脂素成分对于由PGF2a所引起的收缩具有缓解作用，对于由CaCl2所引起的收缩具有抑制作用。戈米辛A、B、D、J和(+)一去氧五味子素对于由去甲肾上腺素引起的收缩具有抑制作用，其中戈米辛J作用最强。此外、末川守等还对人工合成的戈米辛J钠盐进行了研究，戈米辛J钠盐对于狗离体肠系膜动脉由去甲肾上腺素引起的收缩具有抑制作用(ID50＝131.8±0.11×10(-6)mol/L)，对于由PGF2a引起的收缩具有缓解作用(半数有效量＝9.72±0.36×10(-6)mol/L)，另外，对于由CaCl2引起的收缩也有抑制作用(ID50＝6.96±0.16×10(-6)mol/L)。戈米辛J钠盐对于肠鼠离体心脏具有增加冠脉血流的作用，而且还能够使麻醉狗的冠状动脉血流增。体外试验表明，戈米辛H、J、N和G具有抑制Ca2+引起的狗肠系膜动脉收缩的功能，IC值分别为5.3×10(-4)，1.2×10(-5)，1.1×10(-4)和1.0×10(-4)，而且这4种五味子木脂素成分还具有抑制PGF2a引起的狗肠系膜动脉收缩作用。
白头翁：味苦，性寒，归胃、大肠经，具有清热解毒、凉血止痢的功效，可用于治疗热毒血痢、阴痒带下、肛门灼热、温疟寒热、下痢脓血、渴欲饮水、症瘕积聚等病症；其主要化学成分包含三萜酸类和三萜皂苷类，还包含木脂素类、香豆素类和甾醇类等有效成分，其中皂苷类含量最高。三萜皂苷类化合物母核由6个异戊二烯单位缩合而成的萜类化合物和糖组成，三萜酸类化合物主要为羟基白桦酸、白桦酸、白头翁酸、乌苏酸、常春藤酮酸、齐墩果酸、常春藤皂苷元、白头翁三萜酸A等。
地榆炭：苦、酸、涩，微寒；有凉血止血，解毒敛疮之功效；据近代研究报导，地榆有抗菌作用，但经高压消毒后，抗菌力下降，甚至消失；本品能缩短出血时间，对小血管出血有止血作用，其稀溶液作用更显著；对溃疡病大出血及烧伤有较好的疗效，并能控制感染而防止毒血症，减少渗出，促进新皮生长；止血宜炒炭用；重病用量可再稍大些。
灶心土：辛，温。归脾、胃经。具有温中止血，止呕，止泻之功效。主要成分有硅酸、氧化铝及三氧化二铁；还有氧化钠，氧化钾，氧化镁，氧化钙，磷酸钙等。
木香：味辛、苦，性温，归脾、胃、大肠、三焦、胆经。具有疏理肝气、健脾和胃、行气止痛等功效。目前从木香中分离鉴定出的化学成分共250种，按结构类型可分为萜类(倍半萜类142种、单萜类43种、三萜类8种)、蒽醌类2种、黄酮苷4种、木脂素苷4种及其他47种。研究表明，木香醇提物可抑制变异链球菌生长和产酸，降低其黏附性，且能显著抑制非水溶性葡聚糖的合成，表明可抑制变形链球菌所致龋齿的形成。进一步研究发现，DHC和CNL对变异链球菌的生长、产酸、黏附均有一定的抑制作用；木香不同提取物对大肠杆菌、绿脓杆菌、枯草芽孢杆菌、金黄色葡萄球菌、真菌(白色念珠菌)均有抑制作用，且有机溶剂提取物比水提取物抑菌效果好，提示小极性的挥发油或萜类是抗菌的活性物质；木香醇提物和乙醚提取物分别对串珠镰孢菌和幽门螺杆菌株均有一定的抑菌作用。
本实施例中，全部采用中草药组方，科学配比，避免了西药长期应用产生的毒副作用；制得的中药组合物具有突破古方、组合精纯、安全有效、工艺简单、服用携带方便、生物利用度高的优点，因此极具市场竞争力。在超过100年的临床经验基础上，证明所述中药组合物治疗溃疡性结肠炎，起效快，疗效稳定，总有效率高。
在一种实施方式中，所述中药组合物为颗粒剂。颗粒状服用携带方便。
本发明实施例提供一种如上所述的治疗溃疡性结肠炎的中药组合物的制备方法，其中，包括步骤：
人参15-30份粉碎成细粉；
白术6-15份、白头翁10-16份经乙醇加热提取后，过滤，滤液浓缩干燥、粉碎成细粉；
黄芪10-30份、茯苓10-15份、仙鹤草6-15份、白扁豆10-16份和甘草5-8份混合，加水煎煮，过滤，滤液浓缩，加醇搅拌，静置，过滤，滤液浓缩，得到第一清膏；
木香5-10份、地榆炭10-18份和灶心土15-30份混合，加水煎煮，过滤，滤液浓缩，得到第二清膏；
五味子5-10份和薏苡仁10-30份混合，加水煎煮，过滤，提取滤液，滤渣加水，二次煎煮，过滤，回收滤液后，合并滤液，得到提取液；
将所述提取液与人参细粉，白术、白头翁细粉，第一清膏，第二清膏混合，干燥，粉碎成细粉，加淀粉及糊精，混匀，以乙醇为润湿剂制成颗粒，干燥，得到所述中药组合物。
在一种实施方式中，所述白术6-15份、白头翁10-16份经乙醇加热提取的步骤，具体包括：白术6-15份、白头翁10-16份加入乙醇，加热提取，过滤，滤液经减压回收乙醇并干燥浓缩。
在一种实施方式中，所述黄芪10-30份、茯苓10-15份、仙鹤草6-15份、白扁豆10-16份和甘草5-8份混合，加水煎煮，过滤，滤液浓缩，加醇搅拌，静置，过滤，滤液浓缩，得到第一清膏的步骤，具体包括：
黄芪10-30份、茯苓10-15份、仙鹤草6-15份、白扁豆10-16份和甘草5-8份混合，加水煎煮1-3次(如2次)，每次1-2小时(如1.5小时)，合并煎液，过滤，滤液浓缩至相对密度为1.10-1.20(50℃下)，加乙醇(乙醇重量占体系50％)，搅拌，静置8-12小时，过滤，滤液回收乙醇，浓缩至相对密度为1.25-1.30(50℃下)，得到第一清膏。
在一种实施方式中，将所述提取液与人参细粉，白术、白头翁细粉，第一清膏，第二清膏混合，干燥，粉碎成细粉，加淀粉及糊精，混匀，以乙醇为润湿剂制成颗粒，干燥，得到所述中药组合物的步骤，具体包括：
将所述提取液与人参细粉，白术、白头翁细粉，第一清膏，第二清膏混匀，于70-90℃(如80℃)下减压干燥，粉碎成细粉，加淀粉及糊精，混匀，以乙醇为润湿剂制成颗粒，于30-50℃(如40℃)下低温干燥，得到所述中药组合物。
在一种实施方式中，按重量份计，所述淀粉的加入量为1份，所述糊精的加入量为1.5份。
本实施例的治疗溃疡性结肠炎的中药组合物的使用方法：每次1袋(每袋为5克)，3次/d，1个月为1个疗程，使用1-6个疗程。
下面通过具体的实施例对本发明作进一步地说明。
实施例1
本实施例中治疗溃疡性结肠炎的中药组合物的原料及重量份数为：
人参25份、黄芪20份、茯苓14份、白术15份、薏苡仁28份、仙鹤草15份、白扁豆14份、五味子9份、白头翁15份、地榆炭17份、灶心土28份、木香10份、甘草8份。
上述治疗溃疡性结肠炎的中药组合物的制备方法，包括步骤：
以上十三味中，人参粉碎成细粉；
白术、白头翁加乙醇加热提取2次，过滤，减压回收乙醇并干燥浓缩，粉碎成细粉备用；
黄芪、茯苓、仙鹤草、白扁豆和甘草五味加水煎煮2次，每次1.5小时，合并煎液。过滤，滤液浓缩至相对密度为1.10-1.20(50℃)，加乙醇使含醇重量达50％，搅拌，静置过夜，过滤，滤液回收乙醇，浓缩至相对密度为1.25-1.30，得到第一清膏；
木香、地榆炭、灶心土(单独包)三味，加水煎煮，过滤，滤液浓缩，得到第二清膏；
最后，五味子、薏苡仁两味加水煎煮，过滤，提取滤液，滤渣加水，二次煎煮，过滤，回收滤液后，合并滤液，得到提取液；
将所述提取液与人参细粉，白术、白头翁细粉，第一清膏，第二清膏混匀，80℃减压干燥，粉碎成细粉，加淀粉1份及糊精1.5份，混匀，以乙醇为润湿剂制成颗粒，40℃低温干燥。
实施例2
本实施例中治疗溃疡性结肠炎的中药组合物的原料及重量份数为：
人参23份、黄芪25份、茯苓13份、白术14份、薏苡仁25份、仙鹤草13份、白扁豆12份、五味子8份、白头翁13份、地榆炭13份、灶心土25份、木香9份、甘草7份。
本实施例中的治疗溃疡性结肠炎的中药组合物的制备方法与实施例1中的制备方法相同，在此不再赘述，详细内容请参见实施例1中的制备方法。
实施例3
本实施例中治疗溃疡性结肠炎的中药组合物的原料及重量份数为：
人参20份、黄芪23份、茯苓12份、白术13份、薏苡仁22份、仙鹤草12份、白扁豆11份、五味子7份、白头翁12份、地榆炭12份、灶心土22份、木香9份、甘草6份。
本实施例中的治疗溃疡性结肠炎的中药组合物的制备方法与实施例1中的制备方法相同，在此不再赘述，详细内容请参见实施例1中的制备方法。
实施例4
本实施例中治疗溃疡性结肠炎的中药组合物的原料及重量份数为：
人参15份、黄芪12份、茯苓11份、白术8份、薏苡仁12份、仙鹤草8份、白扁豆10份、五味子6份、白头翁10份、地榆炭10份、灶心土16份、木香6份、甘草5份。
本实施例中的治疗溃疡性结肠炎的中药组合物的制备方法与实施例1中的制备方法相同，在此不再赘述，详细内容请参见实施例1中的制备方法。
对照样品：艾迪莎(美沙拉秦缓释颗粒)，规格为0.5g×10袋，生产企业为上海爱的发制药有限公司。批准文号：国药准字H20143164。该对照样品是一种用于治疗溃疡性结肠炎的西药颗粒。
下面通过临床资料来说明本发明中的中药组合物的治疗效果，用实施例1至实施例4制成的中药组合物治疗溃疡性结肠炎患者，并将其分别记为实施例1中药组合物、实施例2中药组合物、实施例3中药组合物、实施例4中药组合物，经临床测试，与对照样品相比较如下所示：
1、病例选择：
作为治疗溃疡性结肠炎的中药组合物，选择经过肠镜检查确诊的溃疡性结肠炎患者200例，随机分为5组，每组40例。并进行临床观察，溃疡性结肠炎患者的年龄在30-70岁不等。
2、药物选择：
在5组溃疡性结肠炎患者中选择4组分别使用实施例1-4中的中药组合物，每袋5克，每次1袋，3次/d，1个月为1个疗程，使用3个疗程；剩余一组为对照样品组：使用对照样品，每袋0.5g，每次1袋，3次/d，1个月为1个疗程，使用3个疗程。
3、疗效判定：
治愈：临床症状消失；肠镜检查、肠粘膜检查恢复正常。
见效：临床症状减轻或消失，肠镜检查、肠粘膜病变较前明显改善，大便常规检查有少量红、白细胞。
无效：达不到有效标准病例，症状无改善者。
治疗结果见下表1。
表1、溃疡性结肠炎患者使用中药组合物和对照样品(美沙拉秦缓释颗粒)的治疗情况
以上结果显示，使用了本发明中的中药组合物的治愈例数、见效例数和有效率明显高于对照组。可见，本发明中的实施例1中药组合物至实施例4中药组合物对于溃疡性结肠炎患者具有较好的疗效，治愈率更高，治愈效果更好。
4、典型病例举例：
(1)修先生，1983年生，黑龙江省哈尔滨市人，2003年4月初诊。患者3年来，腹泻、腹痛、脓血便、消瘦、舌淡苔白、脉细弱。肠镜检查诊断为：溃疡性结肠炎。口服本发明中的中药组合物颗粒剂，每次5g，3次/d。治疗一月，腹泻、腹痛减轻，脓血便减少，6疗程后，临床症状消失，随访至2021年2月未复发。
(2)王先生，1949年生，黑龙江省黑河市人，2007年9月初诊。患者4个月来，脓血便、腹痛。肠镜检查诊断为：溃疡性结肠炎。口服本发明中的中药组合物颗粒剂，每次5g，3次/d。治疗一月，脘闷减轻，4疗程后，临床症状消失，随访至2021年未复发。
(3)张女士，1961年生，吉林省长春市人，2014年6月初诊。患者20年来，腹痛、脓血便。肠镜检查诊断为：溃疡性结肠炎。口服本发明中的中药组合物颗粒剂，每次5g，3次/d。治疗一月，腹痛灼痛减轻，3疗程后，临床症状消失，随访至2020年未复发。
(4)费先生，1957年生，浙江省杭州市人，2005年6月初诊。患者3年来，腹泻、腹痛、脓血便、胸胁胀闷、嗳气食少。肠镜检查诊断为：溃疡性结肠炎。口服本发明中的中药组合物颗粒剂，每次5g，3次/d。治疗一月，腹痛减轻，5疗程后，临床症状消失，随访至2020年未复发。
(5)吴先生，1974年生，辽宁省营口市人，2014年7月初诊。患者1年来，腹痛、腹泻。肠镜检查诊断为：溃疡性结肠炎。口服本发明中的中药组合物颗粒剂，每次5g，3次/d。治疗一月，腹痛减轻，4疗程后，临床症状消失，随访至2021年未复发。
综上所述，本发明提供的一种治疗溃疡性结肠炎的中药组合物，所述中药组合物包括以下重量的原料：人参10-30份、黄芪10-30份、茯苓10-15份、白术6-15份、薏苡仁10-30份、仙鹤草6-15份、白扁豆10-16份、五味子5-10份、白头翁10-16份、地榆炭10-18份、灶心土15-30份、木香5-10份、甘草5-8份。本发明全部采用中草药组方，科学配比，无西药长期应用产生的毒副作用；制得的新药具有突破古方、组合精纯、安全有效、工艺先进、服用携带方便、生物利用度高的优点，因此极具市场竞争力。本发明经过临床实验，中药组合物在临床上使用超过25年，应用病例超过2000例，证明治疗溃疡性结肠炎总有效率超过87.5％。
应当理解的是，本发明的应用不限于上述的举例，对本领域普通技术人员来说，可以根据上述说明加以改进或变换，所有这些改进和变换都应属于本发明所附权利要求的保护范围。
Claims (10)
1.一种治疗溃疡性结肠炎的中药组合物，其特征在于，所述中药组合物由以下重量的原料组成：
人参10-30份、黄芪10-30份、茯苓10-15份、白术6-15份、薏苡仁10-30份、仙鹤草6-15份、白扁豆10-16份、五味子5-10份、白头翁10-16份、地榆炭10-18份、灶心土15-30份、木香5-10份、甘草5-8份。
2.根据权利要求1所述的治疗溃疡性结肠炎的中药组合物，其特征在于，所述中药组合物由以下重量的原料组成：
人参15-25份、黄芪12-25份、茯苓11-14份、白术8-15份、薏苡仁12-28份、仙鹤草8-15份、白扁豆10-14份、五味子6-9份、白头翁10-15份、地榆炭10-17份、灶心土16-28份、木香6-10份、甘草5-8份。
3.根据权利要求2所述的治疗溃疡性结肠炎的中药组合物，其特征在于，所述中药组合物由以下重量的原料组成：人参25份、黄芪20份、茯苓14份、白术15份、薏苡仁28份、仙鹤草15份、白扁豆14份、五味子9份、白头翁15份、地榆炭17份、灶心土28份、木香10份、甘草8份。
4.根据权利要求2所述的治疗溃疡性结肠炎的中药组合物，其特征在于，所述中药组合物由以下重量的原料组成：人参23份、黄芪25份、茯苓13份、白术14份、薏苡仁25份、仙鹤草13份、白扁豆12份、五味子8份、白头翁13份、地榆炭13份、灶心土25份、木香9份、甘草7份。
5.根据权利要求2所述的治疗溃疡性结肠炎的中药组合物，其特征在于，所述中药组合物由以下重量的原料组成：人参20份、黄芪23份、茯苓12份、白术13份、薏苡仁22份、仙鹤草12份、白扁豆11份、五味子7份、白头翁12份、地榆炭12份、灶心土22份、木香9份、甘草6份。
6.根据权利要求2所述的治疗溃疡性结肠炎的中药组合物，其特征在于，所述中药组合物由以下重量的原料组成：人参15份、黄芪12份、茯苓11份、白术8份、薏苡仁12份、仙鹤草8份、白扁豆10份、五味子6份、白头翁10份、地榆炭10份、灶心土16份、木香6份、甘草5份。
7.根据权利要求1所述的治疗溃疡性结肠炎的中药组合物，其特征在于，所述中药组合物为颗粒剂。
8.一种权利要求1-7任一项所述的治疗溃疡性结肠炎的中药组合物的制备方法，其特征在于，包括步骤：
人参15-30份粉碎成细粉；
白术6-15份、白头翁10-16份经乙醇加热提取后，过滤，滤液浓缩干燥、粉碎成细粉；
黄芪10-30份、茯苓10-15份、仙鹤草6-15份、白扁豆10-16份和甘草5-8份混合，加水煎煮，过滤，滤液浓缩，加醇搅拌，静置，过滤，滤液浓缩，得到第一清膏；
木香5-10份、地榆炭10-18份和灶心土15-30份混合，加水煎煮，过滤，滤液浓缩，得到第二清膏；
五味子5-10份和薏苡仁10-30份混合，加水煎煮，过滤，提取滤液，滤渣加水，二次煎煮，过滤，回收滤液后，合并滤液，得到提取液；
将所述提取液与人参细粉，白术、白头翁细粉，第一清膏，第二清膏混合，干燥，粉碎成细粉，加淀粉及糊精，混匀，以乙醇为润湿剂制成颗粒，干燥，得到所述中药组合物。
9.根据权利要求8所述的治疗溃疡性结肠炎的中药组合物的制备方法，其特征在于，所述白术6-15份、白头翁10-16份经醇加热提取的步骤，具体包括：白术6-15份、白头翁10-16份加入乙醇，加热提取，过滤，滤液经减压回收乙醇并干燥浓缩。
10.根据权利要求8所述的治疗溃疡性结肠炎的中药组合物的制备方法，其特征在于，按重量份计，所述淀粉的加入量为1份，所述糊精的加入量为1.5份。
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