CN112826858B - 治疗溃疡性结肠炎的中药组合物及其中药制剂和应用 - Google Patents
治疗溃疡性结肠炎的中药组合物及其中药制剂和应用 Download PDFInfo
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Abstract
本发明属于中药领域，具体涉及一种治疗溃疡性结肠炎的中药组合物，以质量份计由如下原料组分制成：仙鹤草10‑30g，地榆9‑15g，木香6‑10g，黄连3‑10g，苍术6‑15g，赤芍6‑15g，救必应9‑30g，火炭母9‑30g，水蛭1‑5g。通过UC动物模型验证本发明中药方的药效，结果提示，本发明中药方灌胃干预2周能明显减轻UC模型大鼠的肠黏膜溃疡、炎症及水肿，并能减少模型大鼠肠组织炎症细胞浸润，减轻隐窝损伤，其作用与阳性药美沙拉嗪相当。
Description
技术领域
本发明属于中药领域，具体涉及一种治疗溃疡性结肠炎的中药组合物及其中药制剂和应用。
背景技术
溃疡性结肠炎(ulcerative colitis,UC)是一种病因未明、多因素、多层次的慢性非特异性肠道炎症，属于炎症性肠病范畴，目前尚缺乏明确有效的治疗方法，是现代难治病之一。
UC病理因素主要有：湿邪(热)、瘀热、热毒、痰浊、气滞、血瘀等；病理特征表现：活动期多属实证，主要病机为湿热蕴肠，气血不调，而重度以热毒、瘀热为主，反复难愈者应考虑痰浊血瘀的因素；缓解期多属虚实夹杂，主要病机为脾虚湿恋，运化失健。部分患者可出现肝郁、肾虚、肺虚、血虚、阴虚和阳虚的临床证候特征，因此，临床上会根据不同临床表现判断病机侧重点，给予相应的药物。
对于UC的治疗，一般认为，活动期的治法主要为清热化湿、调气和血、敛疡生肌，缓解期的治法主要为健脾益气、兼以补肾固本，佐以清热化湿。专利CN111407810A公开了一种治疗慢性溃疡性结肠炎中药制剂，该中药制剂添加马齿苋、小叶三点金、金樱子、马兰、枇杷叶、藿香，以实现清热解毒、止泻、行气止痛的效果，对肠道起到舒缓镇静效果；药物的缓释使药物在肠道维持有效浓度的时间长，增强治疗效果。该专利通过药物的舒缓镇静作用以及延长药物维持时间来治疗溃疡性结肠炎，只是对该症状起到缓解作用，治标不治本。
发明内容
根据本发明的一个方面，提供了一种治疗溃疡性结肠炎的中药组合物，以质量份计由如下原料组分制成：仙鹤草10-30g，地榆9-15g，木香6-10g，黄连3-10g，苍术6-15g，赤芍6-15g，救必应9-30g，火炭母9-30g，水蛭1-5g。
优选地，治疗溃疡性结肠炎的中药组合物，以质量份计由如下原料组分制成：仙鹤草15g，地榆10g，木香6g，黄连9g，苍术10g，赤芍15g，救必应15g，火炭母15g，水蛭3g。
申请人通过溯源古籍文献，结合现代理论研究成果，从五脏相关学说探讨溃疡性结肠炎的发病及病机演变规律，总结UC是一种原因不明的直肠和结肠的慢性非特异性炎症性疾病，属于中医学腹痛、泄泻、痢疾、肠癖等范畴，其发病起于脾虚湿困，伤于饮食、情志，本于脾胃，与心、肺、肝肾五脏密切相关。
而，脾主运化，居中土，运四极，脾虚湿蕴，大肠传导失职，清浊不分，邪滞肠道，损伤气机致瘀阻脉络，随着疾病的进展，表现出脾虚湿困-湿热阻滞-湿瘀互结的病机演变规律，脾失健运，湿蕴大肠，气血瘀滞是本病的病理基础，其中“湿”即可作为诱发疾病的外邪，也是疾病发展过程中的病理产物，影响机体的气血运行而促进疾病进一步发展，在疾病的发生和发展过程中起着关键的作用。
因此，申请人提出UC的治疗组方总体以祛湿固本为大法，活动期UC以清热化湿为主，缓解期以祛湿健脾为主。对于本发明而言，提供一种具有清热化湿、凉血活血功效的UC中药方，在前期临床观察发现在其针对轻、中度活动期UC具有确切的疗效。
本发明即依据理论研究成果，以清热祛湿、凉血散瘀为治则确立的治疗活动期UC中药组合。方中黄连清热燥湿、泻火解毒为君；仙鹤草补虚止痢，地榆清热解毒、凉血止血为臣；佐以苍术燥湿健脾，赤芍凉血清热、散瘀止血，救必应清热利湿，火炭母凉血解毒、利湿消滞；木香苦温，既能燥湿行气，又能制诸药之寒为使。
方中：
仙鹤草，为蔷薇科植物龙芽草(Agrimonia pilosa Ldb.)的干燥地上部分，性味苦、涩、平，具有止血、健胃、滑肠、止痢、杀虫的功效。
地榆，蔷薇科多年生草本植物地榆Sanguisorba officinalis L.或长叶地榆S.officinalis L.var.longifolia(Bert).Yüet Li的干燥根，性寒，味苦酸，无毒；有凉血止血，清热解毒，培清养阴，消肿敛疮等功效。
木香，为菊科植物木香Aucklandia lappa Decne.的干燥根，性味辛、苦、温，能行气止痛，健脾消食。
黄连，为毛茛科植物黄连Coptis chinensis Franch.、三角叶黄连Coptisdeltoidea C.Y.Cheng et Hsiao或云连Coptis teeta Wall.的干燥根茎，性味苦、寒，清热燥湿，泻火解毒。
苍术，为菊科植物茅苍术Atractylodes lancea(Thunb.)DC.或北苍术Atractylodes chinensis(DC.)Koidz.的干燥根茎，性味辛、苦、温，能燥湿健脾，祛风散寒，明目。
赤芍，为毛茛科植物芍药Paeonia lactiflora Pall.或川赤芍Paeonia veitchiiLynch的干燥根，性味苦、微寒，能清热凉血，散瘀止痛。
救必应，冬青科植物铁冬青的树皮或根皮，性味苦、寒，能清热解毒，利湿，止痛。
火炭母，为蓼科蓼属植物火炭母Polygunum chinense L.，以全草入药，性味微酸、微涩、凉，能清热解毒，利湿消滞，凉血止痒，明目退翳。
水蛭，为水蛭科动物蚂蟥Whitmania pigra Whitman、水蛭Hirudo nipponicaWhitman或柳叶蚂蟥Whitmania acranulata Whitman的干燥全体，性味咸、苦，平，能破血通经，逐瘀消症。
根据本发明的另一个方面，提供了上述的治疗溃疡性结肠炎的中药组合物在制备治疗溃疡性结肠炎药物中的应用。
根据本发明的另一个方面，提供了一种中药制剂，其含有有效量的上述治疗溃疡性结肠炎的中药组合物。
在一些实施方式中，中药制剂还包括医学上可接受的辅料。优选的，辅料为缓释剂、赋形剂、填充剂、粘合剂、湿润剂、崩解剂、吸收促进剂、吸附载体、表面活性剂、润滑剂中的至少一种。本发明所选辅料为中药制药领域的常规辅料，例如，缓释剂、赋形剂可为水，填充剂可为淀粉、蔗糖，粘合剂可为纤维素衍生物、藻酸盐、明胶和聚乙烯吡咯烷酮，湿润剂可为甘油，崩解剂可为琼脂、碳酸钙和碳酸氢钠，吸收促进剂可为季铵化合物，吸附载体可为高岭土和皂粘土，表面活性剂可为十六烷醇，润滑剂可为滑石粉、硬脂酸钙/镁、聚乙二醇。此外还可加入其它辅剂如香味剂、甜味剂等。
本发明的中药制剂的剂型可为汤剂、片剂、胶囊剂、丸剂、散剂、颗粒剂、糖浆剂等常规中药剂型。
对于不同的药物剂型，可以根据现有技术制备得到，示例性地：
当中药制剂的剂型可为汤剂时，可采取下述现有方法制备得到：
加相当于原料药总质量的8～12倍水，加热至沸，保持微沸1～2小时，分离后得第一煎液和药渣；第二次，取第一次煎煮后所得的药渣，加相当于原料药总质量的6～10倍水，加热至沸，保持微沸1～2小时，分离后得第二煎液和药渣；合并第一煎液和第二煎液，即得。
或者，也可以采取下述方式制备得到口服溶液剂：
加水没过原料药并高出2-3cm，武火加热至沸，改为文火，保持微沸30min左右，得第一煎液和药渣；再加水于原料药中，武火加热至沸，改为文火，保持微沸20-30min，得第二煎液，合并第一煎液和第二煎液，即得。
当中药制剂的剂型可为颗粒剂时，可采取下述现有方法制备得到：
根据上述制备口服溶液剂的方法获得滤液，将滤液减压浓缩得清膏后，向清膏中加麦芽糊精，然后喷雾干燥，得干膏粉；接着，再向干膏粉中加麦芽糊精，得混合粉末；然后，向混合粉末中加入体积分数为90％的乙醇-水溶液制软材，将软材过筛，得湿颗粒，最后，将湿颗粒进行干燥，即得。
为了便于临床使用，可将颗粒剂分装成小包装，每包6-15g。
应该说明的是，上述颗粒剂的制备方式只是示例性的，并不对本发明所保护的范围做限制，当然，为了制备该颗粒剂药物，还可以采用本领域通常使用技术，在此不一一举出。
根据本发明的另一个方面，提供了一种上述的中药制剂在制备治疗溃疡性结肠炎中的应用。
附图说明
图1是各组大鼠疾病活动指数UC-DAI评分比较，与正常组比较##P<0.01，###P<0.001；
图2是各组大鼠肠黏膜损伤肉眼观察；
图3是各组大鼠结肠黏膜形态学评分比较，与模型组比较**P<0.01，***P<0.001，与正常组比较#P<0.05，##P<0.01，###P<0.001；
图4是各组大鼠肠组织病理观察；
图5是各组大鼠肠组织病理学评分比较，与模型组比较**P<0.01，***P<0.001，与正常组比较#P<0.05，##P<0.01，###P<0.001。
具体实施方式
下面结合具体实施例对本发明作进一步详细的说明。
实施例1
治疗溃疡性结肠炎的中药汤剂，由以下组分制备得到：仙鹤草15g，地榆10g，木香6g，黄连9g，苍术10g，赤芍15g，救必应15g，火炭母15g，水蛭3g。
取上述组分，根据现有中药汤剂制备方法制得中药汤剂，该配比为一剂药量，一剂药量约200mL。
示例性地，本实施例的中药汤剂采取下述方法制备得到：
加相当于原料药总质量的8倍水，加热至沸，保持微沸2小时，分离后得第一煎液和药渣；第二次，取第一次煎煮后所得的药渣，加相当于原料药总质量的6倍水，加热至沸，保持微沸1小时，分离后得第二煎液和药渣；合并第一煎液和第二煎液，即得。
上述中药汤剂作为治疗溃疡性结肠炎药物时，给予患者每日一剂，每剂200mL，口服，一日两至三次。
应该说明的是，上述中药汤剂的制备方式只是示例性的，并不对本发明所保护的范围做限制，当然，还可以采用本领域通常使用技术进行制备，在此不一一举出。
实施例2
治疗溃疡性结肠炎的颗粒剂，由以下组分制备得到：仙鹤草15g，地榆10g，木香6g，黄连9g，苍术10g，赤芍15g，救必应15g，火炭母15g，水蛭3g。
取上述组分，根据现有中药颗粒剂制备方法制得中药颗粒剂。
下面，通过动物试验来观察对本发明治疗溃疡性结肠炎的中药组合物对溃疡性结肠炎模型大鼠的治疗作用。附图中，Control代表正常组，Model代表模型组，ZBF-2.95g/kg代表中药方低剂量组，ZBF-5.88g/kg代表中药方中剂量组，ZBF-11.76g/kg代表中药方高剂量组，Mesalazine代表美沙拉嗪组。
先进行造模。选取40只Wistar大鼠，随机分为五组，每组8只，分别标记为正常组、模型组、中药方高剂量组、中药方中剂量组、中药方低剂量组及阳性药美沙拉嗪组；利用TNBS/乙醇溶液灌肠造模[三硝基苯磺酸(tr initro-benzene-sulfonic acid,TNBS)(0.2ml/100g)及乙醇溶液(0.3ml/100g)]。
造模后第2天，中药高、中、低剂量组予实施例2制得的颗粒水溶液分别按11.76g/kg、5.88g/kg及2.95g/kg生药量进行灌胃，每日1次；美沙拉嗪组予美沙拉嗪缓释颗粒混悬液(0.01g/ml)灌胃(1ml/100g)，每日1次；连续灌胃2周；模型组及正常组正常饲养。
接下来，对药效进行评价，评价指标及评价标准如下：
(1)UC疾病活动指数(DAI)评分
治疗周期结束后，观察各组大鼠精神状态、活动、毛色光泽、腹泻、黏液便、血便等一般情况；对大鼠进行DAI评分，包括体质量、大便性状、隐血情况，评分标准按下表进行，计算公式：DAI＝(体质量下降分数+大便性状分数+便血分数)/3，评分细则如表1所示。
表1 UC疾病活动指数评分细则
| 体重量下降(％) | 大便性状 | 隐血及血便 | 计分 |
| 0 | 正常 | 正常 | 0 |
| 1-5 | 1 | ||
| 6-10 | 半稀便 | 隐血(+) | 2 |
| 10-15 | 3 | ||
| >15 | 稀便 | 肉眼血便 | 4 |
(2)肠道黏膜组织形态学观察
实验取材时，观察肠黏膜充血、出血、水肿溃疡等等形态变化情况并进行评分，评分标准如表2所示。
表2肠道黏膜组织形态评分标准
(3)肠黏膜病理学观察及评分
通过HE染色，光镜下观察视野内肠黏膜病理损伤情况，通过AL-Chaer等的方法判定炎症程度并评分，具体评分标准：每张切片随机挑选5个视野，在视野内进行观察，评分细则如表3所示。
表3肠黏膜病理学评分标准
| 炎细胞浸润 | 病变深度 | 隐窝破坏 | 得分 |
| 无 | 无 | 无 | 0 |
| 轻度 | 黏膜层 | 基底1/3破坏 | 1 |
| 中度 | 黏膜下层 | 基底2/3破坏 | 2 |
| 重度 | 肌层 | 仅有完整表面上皮 | 3 |
| 浆膜层 | 全部隐窝和上皮破坏 | 4 |
注：具体评分标准：每张切片随机挑选5个视野，在视野内进行观察。
评价结果如下：
(1)疾病活动指数UC-DAI比较
如图1所示，模型组DAI评分显著升高，中药方高、中、低剂量组DAI评分较模型组均明显下降，且呈剂量依赖性，中药方高剂量组DAI评分较模型组下降最为明显，作用与美沙拉嗪相当。
(2)肠黏膜观察及损伤分数比较
如图2所示，模型组结肠长度变短，肠黏膜明显充血、水肿、散在糜烂点、并有多处溃疡；中药方组肠黏膜可见较明显充血，及散在的炎症，糜烂和溃疡不明显；西药组(即美沙拉嗪组)肠黏膜水肿、充血均不明显，但有散在小的炎症灶。
模型组肠黏膜损伤分数明显高于正常组，中药方组及西药组较模型组分数明显下降，见图3所示。
(3)肠黏膜组织病理观察及损伤分数比较
模型组肠黏膜组织炎症细胞浸润明显，间质水肿，病变达到了黏膜下层甚至肌层，隐窝形态改变，甚至结构消失；中药各剂量组与模型组比较，隐窝结构尚清楚，无明显隐窝脓肿，炎症细胞浸润减少，中药方高剂量组隐窝形态规则，炎症细胞浸润明显减少，较模型组、低剂量及中剂量损伤明显减轻；美沙拉嗪组炎症细胞浸润较明显，病变多在黏膜层，间质无明显水肿，隐窝形态规则，见图4所示。
如图5所示，模型组病理评分明显高于正常组，中药方中剂量、高剂量及美沙拉嗪组较模型组比较病理评分显著下降；中药方低剂量组病理评分较模型组有下降趋势，但无明显统计学差异。
通过UC动物模型验证本发明中药方的药效，结果提示，本发明中药方灌胃干预2周能明显减轻UC模型大鼠的肠黏膜溃疡、炎症及水肿，并能减少模型大鼠肠组织炎症细胞浸润，减轻隐窝损伤，其作用与阳性药美沙拉嗪相当。因此，本发明中药方具有进一步深入研究及开发的潜力，或可为中医药治疗难治性疾病溃疡性结肠炎提供可选的方案。
上述实施例为本发明较佳的实施方式，但本发明的实施方式并不受上述实施例的限制，其他的任何未背离本发明的精神实质与原理下所作的改变、修饰、替代、组合、简化，均应为等效的置换方式，都包含在本发明的保护范围之内。
Claims (6)
1.治疗溃疡性结肠炎的中药组合物，其特征在于，以质量计由如下原料组分制成：仙鹤草10-30g，地榆9-15g，木香6-10g，黄连3-10g，苍术6-15g，赤芍6-15g，救必应9-30g，火炭母9-30g，水蛭1-5g。
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，以质量计由如下原料组分制成：仙鹤草15g，地榆10g，木香6g，黄连9g，苍术10g，赤芍15g，救必应15g，火炭母15g，水蛭3g。
3.权利要求1或2所述的治疗溃疡性结肠炎的中药组合物在制备治疗溃疡性结肠炎药物中的应用。
4.一种治疗溃疡性结肠炎的中药制剂，其特征在于，其含有有效量的权利要求1或2所述的治疗溃疡性结肠炎的中药组合物。
5.根据权利要求4所述的中药制剂，其特征在于，还包括医学上可接受的辅料。
6.权利要求4或5所述的中药制剂在制备治疗溃疡性结肠炎药物中的应用。
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