CN102552796B - 一种治疗慢性胃溃疡的中药组合物 - Google Patents
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Abstract
本发明公开了一种治疗慢性胃溃疡的中药组合物，涉及中医药技术领域。其由如下重量份的中药材制备而成：白及8-12份、白芷15-20份、甘松3-6份、仙鹤草10-15份、槟榔8-12份、当归8-12份、元胡8-12份、徐长卿8-12份、砂仁4-8份、山药20-30份、黄连4-8份、补骨脂8-12份。本发明涉及的中药组合物对慢性胃溃疡具有显著疗效，并可用于健脾理气和消胀止痛、安全性高。
Description
技术领域
本发明涉及中医药技术领域，特别是涉及一种治疗慢性胃溃疡的中药组合物。
背景技术
胃溃疡是消化系统常见病，多发病。比较明显的病因为幽门螺杆菌感染、服用非甾体消炎药(NSATD)以及胃酸分泌过多；另外还可以由遗传因素和情绪波动、过度劳累、饮食失调、吸烟、酗酒等因素引起。胃溃疡由于病情延绵，病情复杂，又与精神情绪有关，病情加重或治疗不及时，还会导致胃出血、胃穿孔、幽门梗阻和癌变等恶劣后果，严重危害人民健康，所以应予以高度的重视。胃溃疡在中医属于“脾虚”、“胃虚”、“脾胃虚寒”、“胃肮痛”、“吐酸”、“呕吐”、“反胃”等范畴。中药以其毒副作用小，安全有效而备受关注。
目前市场上治疗胃溃疡的西药种类很多，如西咪替丁、雷尼替丁、法莫替丁等，这些药品治疗胃溃疡效果显著，但毒副作用太大，对肝肾有损伤，H2受体阻滞剂有不同程度的头昏、嗜睡、腹痛、恶心等不良反应。中成药虽然也有很多，但大多数缓解疼痛的起效时间过长，效果不明显。
发明内容
本发明根据传统中医理论，经过对药物组分的大量筛选、重组、尝试、又通过大量动物实验研究作出的。因此，本发明的目的在于提供了一种更加安全可靠的治疗慢性胃溃疡的中药组合物。
本发明的目的是这样实现的：
一种治疗慢性胃溃疡的中药组合物，由如下重量份的活性成分制备而成：白及8-12份、白芷15-20份、甘松 3-6份、仙鹤草10-15份、槟榔 8-12份、当归8-12份、元胡8-12份、徐长卿8-12份、砂仁4-8份、山药20-30份、黄连4-8份、补骨脂 8-12份。
在一个最优选的实施例中，所述的治疗慢性胃溃疡的中药组合物，由如下重量份的活性成分制备而成：白及10份、白芷18份、甘松 5份、仙鹤草12份、槟榔10份、当归10份、元胡10份、徐长卿10份、砂仁6份、山药25份、黄连6份、补骨脂 10份。
进一步优选地，所述的治疗慢性胃溃疡的中药组合物是口服制剂。
再进一步优选地，所述的治疗慢性胃溃疡的中药组合物是口服液、颗粒剂、片剂和胶囊剂。
通过动物试验研究发现，由上述活性成分组成的药物组合物在治疗慢性胃溃疡模型大鼠方面具有显著的疗效。因此，本发明的第二个目的在于提供一种医药新用途，即上述的中药组合物在制备治疗慢性胃溃疡的中药中的应用。
根据中医药史料记载，上述中药材具有如下药理活性和功能主治：
白及：收敛止血，消肿生肌。用于咳血吐血，外伤出血，疮疡肿毒，皮肤皲裂；肺结核咳血，溃疡病出血。选用兰科植物白及Bletilla striata（Thunb.）Reichb. f.的干燥块茎。仙鹤草又名西洋龙芽草，选用干燥全草。
白芷：祛风湿，活血排脓，生肌止痛。用于头痛、牙痛、鼻渊、肠风痔漏、赤白带下、痈疽疮疡、皮肤瘙痒。选用伞形科植物川白芷的根。
甘松：行气止痛，开郁醒脾。外用祛湿消肿。用于中焦寒凝气滞，脾胃不和，食欲不振，呕吐；外用治牙痛。选用败酱多年生草本甘松Nardostachys jatamansi DC.的干燥根茎及根。
仙鹤草：收敛止血，止痢，杀虫。广泛用于各种出血之证，例如：吐血、尿血、便血、崩漏、咯血、衄血，赤白痢疾，劳伤脱力，痈肿，跌打，创伤出血等证。
槟榔：驱虫；消积；下气；行水；截疟。虫积；食滞；脘腹胀痛；泻痢后重；脚气；水肿；疟疾。选用棕榈科植物槟榔Areca catechu Linn.的种子。
当归：补血活血，调经止痛，润肠通便。用于血虚萎黄、眩晕心悸、月经不调、经闭痛经、虚寒腹痛、肠燥便秘、风湿痹痛、跌扑损伤、痈疽疮疡。选用伞形科植物当归Angelica sinensis (Oliv.) Diels 的干燥根。
元胡：活血化瘀、行气止痛，用于全身各部气滞血瘀之痛，痛经，经闭，症瘕，产后瘀阻，跌扑损伤，疝气作痛。选用罂粟科(Papaveraceae)植物延胡索或齿瓣延胡索的块茎。
徐长卿：疏风解热，行气活血。治一切痧症和肚痛， 胃气痛，食积，霍乱。选用萝藦科牛皮消属植物徐长卿Cynanchum paniculatum （Bge.）Kitag. 的干燥根及根茎。
砂仁：用于湿浊中阻，脘痞不饥，脾胃虚寒，呕吐泄泻，妊娠恶阻，胎动不安。选用姜科植物阳春砂、绿壳砂或海南砂的干燥成熟果实。
山药：补脾养胃，生津益肺，补肾涩精。 用于脾虚食少，久泻不止，肺虚喘咳，肾虚遗精，带下，尿频，虚热消渴。选用薯蓣科植物薯蓣Dioscorea opposita Thunb. 的干燥根茎。
黄连：清热燥湿，泻火解毒。用于湿热痞满，呕吐吞酸，泻痢，黄疸，高热神昏，心火亢盛，心烦不寐，血热吐衄，目赤，牙痛，消渴，痈肿疔疮；外治湿疹，湿疮，耳道流脓。酒黄连善清上焦火热。选用毛茛科植物黄连Coptis chinensis Franch.三角叶黄连Coptis deltoidea C.Y.Chenget Hsiao或云连Coptis teeta Wall.的干燥根茎。
补骨脂：补肾助阳；纳气平喘；温脾止泻。主肾阳不足；下元虚冷；腰膝冷痛；阳痿遗精；尿频；遗尿；肾不纳气；虚喘不止；脾肾两虚；大便久泻；白癜风；斑秃；银屑病。选用豆科植物补骨脂的果实。
将上述各中药材制备成本发明的复方口服液的制备方法，包括如下步骤：称取清洗干净且干燥的药材合并，加水煎煮两次，合并煎液，减压浓缩至65℃时相对密度为1.15-1.20，加乙醇使含醇量的体积百分比达75-85%，搅拌，静置，过滤，滤液减压浓缩至65℃时相对密度为1.25-1.30并回收乙醇得浓缩液，将浓缩液加水及辅料配制成口服液。
将上述各中药材制备成本发明的复方颗粒剂的制备方法，包括如下步骤：
第一步，制备清膏粉：
1）备料：按处方量称取清洗干净的上述中药材，备用；
2）煎煮：加水煎煮，第一煎每罐加水为药材总量的6-10倍，加热沸腾后保持2-4小时，提取液经过200目过滤器过滤进入沉淀罐；第二煎加入药材量3-5倍的水加热提取，保沸2-4小时，提取液经过200目过滤器过滤进入沉淀罐；
3）沉淀：沉淀罐中提取液沉淀24～36小时，抽取上清液经过200目过滤器过滤至三效蒸发器中，沉淀物按废弃物处理；
4）浓缩：当上清液在三效蒸发器中浓缩至相对密度为1.00～1.10（40℃测定）时，将稀清膏经200目过滤器过滤抽入真空减压浓缩罐中，浓缩并混合至相对密度为1.30～1.32（90℃测定）时出膏，至贮膏桶内，备用；
5）干燥：其中真空度：-0.1MPa，温度：78～82℃，干燥时间20～24小时；
6）打粉：粉碎细度80目筛，得到清膏粉；
第二步，按照清膏粉：糊精： 55%乙醇为1：1～3：0.1～0.3的重量比称取清膏粉、糊精与55%乙醇，其中55%乙醇是指体积浓度为55%的乙醇水溶液；
第三步，将清膏粉与糊精投入槽型混合机中，搅拌20分钟，边搅拌边缓缓加入55%乙醇，至制成软材，用12目不锈钢筛制粒，65～75℃干燥2小时，取出，放凉即得所述的颗粒剂。
与现有技术相比，本发明具有如下优点和显著地进步：（1）疗效好。本发明的中药组合物能显著减小慢性胃溃疡模型大鼠的溃疡体积和溃疡面积，可促进溃疡愈合，对慢性胃溃疡大鼠有良好的治疗作用。（2）安全性高。由于本发明的药物由采用传统中药材制备而成，毒性低，患者用药更安全。
具体实施方式
下面通过实施例进一步说明本发明。本发明的实施例仅仅是用于说明本发明，而不是对本发明的限制，在本发明的构思前提下对本发明制备方法的简单改进都属于本发明要求保护的范围。
实施例1
生药处方：白及8份、白芷15份、甘松 5份、仙鹤草15份、槟榔12份、当归8份、元胡8份、徐长卿12份、砂仁8份、山药20份、黄连6份、补骨脂 8份。
制备方法：称取上述处方量的药材合并，加水煎煮两次，第一次加水为药材重量的10倍量，煎煮2h，第二次加水为药材重量的8倍量，煎煮1.5h，合并煎液，0.08MPa、65℃下减压浓缩至65℃时相对密度为1.15，加95%(v/v)乙醇使含醇量达85%(v/v)， 搅拌， 静置过夜，过滤，滤液在0.08MPa、65℃条件下减压浓缩成至65℃时相对密度为1.30，加水及蔗糖配制成口服液。
实施例2
生药处方：白及10份、白芷18份、甘松 5份、仙鹤草12份、槟榔10份、当归10份、元胡10份、徐长卿10份、砂仁6份、山药25份、黄连6份、补骨脂 10份。
制备方法：
第一步，制备清膏粉：
1）备料：按处方量称取清洗干净的上述中药材，备用；
2）煎煮：加水煎煮，第一煎每罐加水为药材总量的6倍，加热沸腾后保持4小时，提取液经过200目过滤器过滤进入沉淀罐；第二煎加入药材量6倍的水加热提取，保沸4小时，提取液经过200目过滤器过滤进入沉淀罐；
3）沉淀：沉淀罐中提取液沉淀30小时，抽取上清液经过200目过滤器过滤至三效蒸发器中，沉淀物按废弃物处理；
4）浓缩：当上清液在三效蒸发器中浓缩至相对密度为1.05（40℃测定）时，将稀清膏经200目过滤器过滤抽入真空减压浓缩罐中，浓缩并混合至相对密度为1.30～1.32（90℃测定）时出膏，至贮膏桶内，备用；
5）干燥：其中真空度：-0.1MPa，温度：78～82℃，干燥时间24小时；
6）打粉：粉碎细度80目筛，得到清膏粉；
第二步，按照清膏粉：糊精： 55%乙醇为1：2：0.2的重量比称取清膏粉、糊精与55%乙醇，其中55%乙醇是指体积浓度为55%的乙醇水溶液；
第三步，将清膏粉与糊精投入槽型混合机中，搅拌20分钟，边搅拌边缓缓加入55%乙醇，至制成软材，用12目不锈钢筛制粒， 75℃干燥2小时，取出，放凉即得所述的颗粒剂。
实施例3 本发明中药组合物对慢性胃溃疡大鼠的影响
SD大鼠随机取10只作空白组，乙醚麻醉后于剑突下经腹壁正中线做1. 5cm的切口，暴露胃后即缝合行假手术处理；其余大鼠暴露胃后用内径7mm 的玻璃圆筒按在胃小弯角切迹下方约5mm的胃前壁浆膜面上，将99. 9%的乙酸0.25m1注入圆筒内，l min后滤纸吸净乙酸，移开圆筒，生理盐水局部冲洗，大网膜包裹受侵蚀胃壁，还纳胃体逐层缝合。术后常规抗感染3天，5天后选取存活造模大鼠48只，随机分为模型对照组、中药低、高剂量组、阳性对照组。术后第5天开始，给药组和阳性对照组分别按表1中的剂量灌胃给药，每日2次，共3周；空白和模型组灌胃给予等量生理盐水，每日2次，共3周。
表1. 实验动物分组及给药
| 分组 | 样本量（只） | 剂量 |
| 空白对照组 | 10 | 同体积的生理盐水 |
| 模型对照组 | 12 | 同体积的生理盐水 |
| 阳性对照组 | 12 | 0.1g·kg-1·d-1盐酸雷尼替丁 |
| 中药低剂量组 | 12 | 1.5g·kg-1·d-1清膏粉（实施例2制备） |
| 中药高剂量组 | 12 | 3.0g·kg-1·d-1清膏粉（实施例2制备） |
标本收集及指标检测方法：颈椎脱臼法处死大鼠，打开腹腔，分离鼠胃，沿胃大弯
剪开，生理盐水洗净后置平皿中，用微量进样器向溃疡凹内注生理盐水，以所能容纳的液体量，作为溃疡体积；用游标卡尺测溃疡最大直径((D)与宽度(d)，用公式s = (Dｘd) ｘ兀/4求出溃疡面积。然后，沿溃疡周围切下约1cmｘ1cm的胃壁，4%甲醛固定5h，脱水，石蜡包埋切片，苏木精-伊红染色，光镜下观察再生黏膜组织，评价溃疡愈合质量。
实验结果：模型组出现显著的溃疡，说明造模成功。中药组及阳性对照组的溃疡体积和溃疡面积显著小于模型组（P＜0.05或P＜0.01)，详细结果见表2。
溃疡愈合质量：（1）模型组：再生黏膜明显较正常变薄，腺体数量少，大小不等，明显扭曲及囊状扩张，排列不规则，腺细胞形态不规则，黏膜下水肿，大量炎症细胞浸润，成纤维细胞、新生血管少，再生胶原纤维少且排列无规则。（2）阳性对照组：再生黏膜薄，腺体数量少，大小相似，囊状扩张明显，排列尚整齐，腺细胞较大，黏膜下大量炎症细胞浸润，成纤维细胞、新生血管较少，再生胶原纤维及少量再生肌纤维排列紊乱。（3）中药高剂量组：再生黏膜轻度变薄，腺体数量较多，大小相似，轻度囊状扩张，排列较整齐，腺细胞形态近似正常；黏膜下炎症细胞浸润相对轻，成纤维细胞、新生血管较多，再生胶原纤维及少量再生肌纤维排列较整齐；溃疡愈合质量优于阳性对照组。
表2 本发明药物对慢性胃溃疡大鼠的影响(x±sd)
| 组别 | 溃疡体积（μl） | 溃疡面积(mm2) |
| 空白对照组 | 0 | 0 |
| 模型对照组 | 21.03±3.15 | 23.16±6.92 |
| 阳性对照组 | 17.27±3.96￥ | 16.82±4.15￥￥ |
| 中药低剂量组 | 16.15±2.42￥￥ | 16.16±5.61￥￥ |
| 中药高剂量组 | 14.31±2.83￥￥* | 15.60±3.82￥￥ |
与模型对照组比较，￥ P＜0.05，￥￥ P＜0.01；
与阳性药组比较，*P＜0.05，**P＜0.01。
Claims (4)
1.一种治疗慢性胃溃疡的中药组合物，其特征在于：由如下重量份的活性成分制备而成：白及8-12份、白芷15-20份、甘松 3-6份、仙鹤草10-15份、槟榔 8-12份、当归8-12份、元胡8-12份、徐长卿8-12份、砂仁4-8份、山药20-30份、黄连4-8份、补骨脂 8-12份。
2.根据权利要求1所述的治疗慢性胃溃疡的中药组合物，其特征在于：由如下重量份的活性成分制备而成：白及10份、白芷18份、甘松 5份、仙鹤草12份、槟榔10份、当归10份、元胡10份、徐长卿10份、砂仁6份、山药25份、黄连6份、补骨脂 10份。
3.根据权利要求1或2所述的治疗慢性胃溃疡的中药组合物，其特征在于：所述中药组合物是口服制剂。
4.根据权利要求3所述的治疗慢性胃溃疡的中药组合物，其特征在于：所述中药组合物是口服液、颗粒剂、片剂或胶囊剂中的任一种。
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