CN107929489A - 一种对胃粘膜损伤具有保护作用的组合物及其中药制剂、应用 - Google Patents
一种对胃粘膜损伤具有保护作用的组合物及其中药制剂、应用 Download PDFInfo
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Abstract
本发明涉及保健品领域，特别涉及一种对胃粘膜损伤具有保护作用的组合物及其中药制剂、应用。本发明提供的组合物包括：发酵大豆粉、库拉索芦荟凝胶冻干粉和猴头菇提取物。实验结果表明，本发明所述组合物对胃粘膜损伤具有显著地保护作用，能够有效地减少损伤发生率。
Description
技术领域
本发明涉及中药领域，具体涉及一种对胃粘膜损伤具有保护作用的组合物及其中药制剂、应用。
背景技术
现代人饮食不规律、油腻、生冷、辛辣、过快，应酬喝酒、暴饮暴食，工作生活压力大，环境因素及遗传因素等易导致胃粘膜受损等胃部不适症状。此类不适症状，现代医学称为胃溃疡，中医属“胃脘痛”、“胃气痛”、“心痛”、“吞酸”等范畴。
胃溃疡(gastric ulcer，GU)，是位于贲门至幽门之间的慢性溃疡，称为消化系统常见疾病，是消化性溃疡的一种。胃溃疡是消化性溃疡中最常见的一种，主要是指胃黏膜被胃消化液自身消化而造成的超过粘膜肌层的组织损伤。其典型表现为饥饿不适、饱胀嗳气、泛酸或餐后定时的慢性中上腹疼痛，严重时可有黑便与呕血。常见病因包括幽门螺杆菌感染、服用非甾体消炎药(NSAID)以及胃酸分泌过多，此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。
胃炎、胃溃疡等胃部疾病的传统治疗方法是中和胃酸或抑制胃酸分泌。过去沿用碱性药物，目前常用Hz受体抑制剂或其他胃酸分泌抑制剂。应用这些抗酸抑酸药物，有利于溃疡的愈合，但是这些药物有一个共同的缺点是，屡愈屡发，一旦停药，不久溃疡便又复发。因此，有些病人要间断性服药，有的则需长期服用维持剂量。目前市场上对胃溃疡具有保护作用的中药组合物还比较少见，具有显著保护作用的更为少见。
发明内容
鉴于此，本发明的目的在于提供一种对胃粘膜损伤具有保护作用的组合物及其中药制剂、应用，该组合物对胃粘膜损伤具有显著地保护作用，能够有效地减少损伤发生率。
为实现上述发明目的，本发明提供如下技术方案：
本发明提供的对胃粘膜损伤具有保护作用的组合物，包括发酵大豆粉、库拉索芦荟凝胶冻干粉和猴头菇提取物。
作为优选，以重量份计，所述组合物包括如下组分：
发酵大豆粉10-50份、库拉索芦荟凝胶冻干粉1-5份和猴头菇提取物1-10份。
作为优选，所述组合物还包括陈皮提取物、山楂提取物、山药提取物和茯苓提取物中的一种或两种以上。
作为优选，以重量份计，所述组合物包括如下组分：
发酵大豆粉10-50份、库拉索芦荟凝胶冻干粉1-5份、猴头菇提取物1-10份、陈皮提取物1～10份、山楂提取物0～20份、山药提取物0～10份和茯苓提取物0～5份。
大豆的营养价值非常高，含有40％蛋白质，20％有及磷酸、维生素和矿物质等，而且大豆中还含有许多具有生物活性的成分，如其含有的异黄酮类物质对人的健康非常有益。但是大豆不经过处理，很多营养成分难于消化、吸收和利用。将大豆进行发酵，能将大豆中的大分子分解成小分子并将一些不溶性化合物分解成可溶性低分子化合物，并由于微生物的自溶作用产生了大豆原来没有的营养成分，大大提高了营养价值。
本发明所述组合物中，所述大豆发酵粉可通过市售获得，也可由大豆发酵得到。
库拉索芦荟凝胶，以库拉索芦荟叶片为原料，经沥醌清洗、去皮、漂烫、杀菌等步骤制成，芦荟凝胶冻干粉在滋润干燥肌肤、祛斑除痘、削除皱纹、恢复皮肤弹性，提高人体免疫力，清除自由基，缓解发炎和受损皮肤的疼痛等方面有着独特神奇的功效。动物试验中发现，对实验小鼠进行诱导胃溃疡试验之前先服用芦荟胶，试验结果表明，试验组小鼠的胃溃疡发病率比对照组降低了80％。发病后，服用芦荟胶的小鼠康复比对照组小鼠快三倍。试验发现芦荟成分中的三萜类物质可预防胃溃疡的发生。
本发明所述组合物采用库拉索芦荟凝胶冻干粉，所述冻干粉的功效量应与所述原提取物成分份量相等。
猴头菇(Hericium erinaceus)，分类学上隶属菌物界、担子菌门、担子菌纲、猴菌目、猴菌科、猴菌属，因其子实体形状如猴头、颜色如猴毛，故取名“猴头”。子实体和发酵菌丝体均可入药，性平味甘,具有助消化、利五脏的功能,营养丰富，素有/山珍猴头，海味燕窝之说。猴头菌的药效成分主要有多糖、低聚糖、甾醇、脂肪酸、猴头菌素(erinacine)和猴头菌酮(her-icenone)等，具有保肝护胃、降血糖、保护神经、增强人体免疫力、抗癌、抗氧化等功效。
陈皮(Pericarpium citriret iculatae)为芸香科植物橘(Citrusret iculateblanco)及其栽培变种的干燥成熟果皮,又名橘皮,具有理气健脾、燥湿化痰的功能。陈皮气香,味辛、苦,性温,主要含挥发油、黄酮类、生物碱、肌醇等成分,挥发油中主要含柠檬烯(Limonene),黄酮类主要为橙皮苷(Hesperidin)。
山楂为蔷薇科山楂属(Crataegus L.)植物，落叶稀半常绿灌木或小乔木，味酸性温，气血并走，化瘀而不伤新血，行滞气而不伤正气，应用于肉食积滞证，泻痢腹痛，疝气痛、瘀滞胸痛腹痛、恶露不尽、痛经、吐血、便血等
山药，为薯蓣科多年生缠绕性藤本薯蓣(DioscoreaoppositaThunb.)的干燥根茎，始载于《神农本草经》，名薯蓣。《神农本草经》将其列为上品，称薯蓣“主伤中，补虚羸，除寒热邪气，补中益气力，长肌肉。”研究表明，山药及其有效成分具有广泛的药理作用
茯苓，是多孔菌科真菌茯苓Poria cocos(Schw.)Wolf的菌核。主要含有茯苓多糖、纤维素、β—茯苓聚糖等多糖类、茯苓酸等三萜类、各种脂肪酸类等。茯苓性味甘淡，主要功效利水渗湿，健脾，宁心。主要功效利水渗湿，健脾，宁心。主要用于水肿尿少、痰饮眩悸、脾虚食少、便溏泄泻、心神不安、惊悸失眠等。
本发明所述组合物中，所述陈皮提取物、山楂提取物、山药提取物和茯苓提取物为水提物，制备方法为：
取原料，加入相当于原料6～10倍重量的水进行提取，水提2次，每次水提的时间为1～2h，合并提取液，浓缩。
在本发明提供的一些具体实施例中，以重量份计，所述组合物包括如下组分：
发酵大豆粉10份、库拉索芦荟凝胶冻干粉3份、猴头菇提取物10份。
在本发明提供的一些具体实施例中，以重量份计，所述组合物包括如下组分：
发酵大豆粉30份、库拉索芦荟凝胶冻干粉5份、猴头菇提取物1份。
在本发明提供的一些具体实施例中，以重量份计，所述组合物包括如下组分：
发酵大豆粉50份、库拉索芦荟凝胶冻干粉1份、猴头菇提取物5份。
在本发明提供的一些具体实施例中，以重量份计，所述组合物包括如下组分：
发酵大豆粉30份、库拉索芦荟凝胶冻干粉3份、猴头菇提取物3份、陈皮提取物2份、山楂提取物2份、山药提取物1份、茯苓提取物1份。
在本发明提供的一些具体实施例中，以重量份计，所述组合物包括如下组分：
发酵大豆粉10份、库拉索芦荟凝胶冻干粉5份、猴头菇提取物1份、陈皮提取物10份。
在本发明提供的一些具体实施例中，以重量份计，所述组合物包括如下组分：
发酵大豆粉50份、库拉索芦荟凝胶冻干粉1份、猴头菇提取物10份、陈皮提取物1份、山楂提取物20份、山药提取物10份、茯苓提取物5份。
本发明还提供了所述组合物在制备对胃粘膜损伤具有保护作用的药物中的应用。
本发明还提供了一种对胃粘膜损伤具有保护作用的中药制剂，由上述组合物和药学上可接受的辅料制成。
作为优选，所述药学上可接受的辅料选自异麦芽酮糖醇、脱脂奶粉、柠檬酸、柠檬酸钠、奶味香精、山楂香精、三氯蔗糖、安赛蜜、硬脂酸镁、微晶纤维素、羧甲淀粉钠、二氧化硅和食用玉米淀粉中的一种或两种以上。
作为优选，所述中药制剂的剂型为片剂、胶囊剂、丸剂、颗粒剂、粉剂、口服液剂。
本发明还提供了一种对胃粘膜损伤具有保护作用的保健品，由上述组合物和保健品种可接受的辅料制成。本领域技术人员公知的辅料均在本发明的保护范围之内，本发明在此不做限定。
实验结果表明，本发明选用发酵大豆粉、库拉索芦荟凝胶冻干粉和猴头菇提取物这三种天然药食两用植物提取物组成的组合物对胃粘膜损伤的保护表现出协同增效作用，显著减少损伤发生率。在上述几味药材的基础上，添加陈皮提取物、山楂提取物、山药提取物和茯苓提取物能够进一步增强对胃粘膜损伤的保护作用。
具体实施方式
本发明公开了一种对胃粘膜损伤具有保护作用的组合物及其中药制剂、应用，本领域技术人员可以借鉴本文内容，适当改进工艺参数实现。特别需要指出的是，所有类似的替换和改动对本领域技术人员来说是显而易见的，它们都被视为包括在本发明。本发明的方法及应用已经通过较佳实施例进行了描述，相关人员明显能在不脱离本发明内容、精神和范围内对本文所述的方法和应用进行改动或适当变更与组合，来实现和应用本发明技术。
对所公开的实施例的说明，使本领域专业技术人员能够实现或使用本发明。对这些实施例的多种修改对本领域的专业技术人员来说将是显而易见的，本文中所定义的一般原理可以在不脱离本发明的精神或范围的情况下，在其它实施例中实现。因此，本发明将不会被限制于本文所示的这些实施例，而是要符合与本文所公开的原理和新颖特点相一致的最宽的范围。
下面结合实施例，进一步阐述本发明：
实施例1本发明组合物
发酵大豆粉10份、库拉索芦荟凝胶冻干粉3份、猴头菇提取物10份。
实施例2本发明组合物
发酵大豆粉30份、库拉索芦荟凝胶冻干粉5份、猴头菇提取物1份。
实施例3本发明组合物
发酵大豆粉50份、库拉索芦荟凝胶冻干粉1份、猴头菇提取物5份。
实施例4本发明组合物
发酵大豆粉30份、库拉索芦荟凝胶冻干粉3份、猴头菇提取物3份、陈皮提取物2份、山楂提取物2份、山药提取物1份、茯苓提取物1份。
实施例5本发明组合物
发酵大豆粉10份、库拉索芦荟凝胶冻干粉5份、猴头菇提取物1份、陈皮提取物10份。
实施例6本发明组合物
发酵大豆粉50份、库拉索芦荟凝胶冻干粉1份、猴头菇提取物10份、陈皮提取物1份、山楂提取物20份、山药提取物10份、茯苓提取物5份。
实施例7对胃粘膜损伤有辅助保护功效检测试验
1、材料与方法
1.1实验动物
SPF级SD大鼠100只，雄性，200g±20g饲养于SPF级实验室。采用被毛染色法,使用饱和苦味酸对SD大鼠进行编号，在SD大鼠体表不同部位的被毛涂染斑点，以示不同号码。
动物饲养条件：群养，5只/箱，采用10h:14h昼夜间断照明；饲养室条件始终保持稳定，以保证试验结果的可靠性。试验期间动物均按实验要求喂以相应颗粒饲料，动物自由进食饮水。
1.2实验试剂
1)无水乙醇，广州市中南化学试剂有限公司，批号：151020；
2)甲醛溶液，广州市中南化学试剂有限公司，批号：151108；
3)石蜡，茂名市大川特种蜡厂有限公司，批号：20151021；
4)环保透明剂，上海宏兹实业有限公司，批号：150805；
5)95％乙醇，广州中南化学试剂有限公司，批号：151028；
7)曙红(水溶)，广州中南化学试剂有限公司，批号：141102；
8)苏木素，Biological Stain Commission,Inc.Lot Number：6995；
9)环保封片胶，海宏兹实业有限公司，批号：20150325。
1.3仪器
电子天平，游标卡尺，RM2235型轮转切片机，ASP300S型全自动脱水机，EG1150型生物组织包埋机，CS-VI型摊片烤片机，湖北孝感医用仪器有限公司；AutoStainer-XL型自动染色机，BX43型生物显微镜，日本CellSensStandard显微图像软件。
1.4方法
实验方法参照《保健食品检验与评价技术规范》中对胃粘膜损伤有辅助保护功能检验方法进行。
1.5分组与给药方案
各组分组和给药方案如表1所示。
表1各组给药方案
1.6试验方法
给药组分别灌胃给予相应浓度的供试品液，灌胃体积为10mL/kg体重，1次/天，连续30天，正常对照组和模型组同法给予同体积纯净水。末次给药后，动物严格禁食不禁水24h。动物禁食不禁水24h后，灌胃给予无水乙醇，灌胃体积为1.0mL/kg体重。1h后，动物腹腔注射20％乌来糖麻醉，注射剂量为6mL/kg体重，放血处死。暴露完整胃，结扎幽门，灌注适量10％甲醛溶液(甲醛充满胃为宜)，固定20min，然后沿胃大弯剪开，洗净胃内容物，展开胃粘膜，在立体显微镜下或肉眼下用游标卡尺测量出血点或出血带的长度和宽度，按照表2进行评分及求得总积分，并根据以下公式求得损伤发生率(％)和损伤抑制率。
损伤发生率(％)＝某组出现出血或溃疡的大鼠数量/该组大鼠数量×100％
损伤抑制率(％)＝(A-B)/A×100％(A、B分别为模型组与试验组的损伤积分)
表2急性胃黏膜损伤评分标准及总积分计算
1.7病理组织学观察
评分结束后，将每只动物胃粘膜损伤最严重的部位切下(周围稍保留正常组织)，固定于10％甲醛溶液，常规制片，HE染色，镜下观察。注意选择胃粘膜正横切面，包括粘膜全层的区域观察。评分方法：以充血、出血、粘膜细胞变性坏死在整个粘膜上皮层的累及程度分为5级。充血权重为1，出血权重为2，上皮细胞变性坏死权重为3，评分标准及病变总积分公式见表3。
表3评分标准及病变总积分公式
实验数据采用表示，应用SPSS21.0软件进行统计分析。计量资料数据若方差齐，或方差不齐，但经转换后方差齐，则采用单因素方差分析，组间比较用LSD法；若数据经转换后方差仍不齐，则采用秩和检验进行统计分析，检验水平α＝0.05。
2.1临床观察结果
实验期间，各组动物体形、被毛、皮肤、粪便、肌肉张力、步态、精神、呼吸等未见异常，体重、摄食量均无统计学差异，其中体重情况见表4。
表4临床观察结果
2.2对胃黏膜损伤的观察结果
表5各组对胃黏膜损伤的观察结果
与空白对照组比较，▲P<0.05，▲▲P<0.01；与模型组比较，*P<0.05，**P<0.01；与单剂组和对比例1～3组比较，#P<0.05，##P<0.01。
结果显示，与正常对照组比较，模型组动物胃黏膜损伤大体观察评分升高，具有统计学差异(P<0.01)；与模型组比较，单剂组和对比例1～3组动物胃黏膜损伤大体观察评分降低，具有显著差异(P<0.05)，实施例1～实施例4组动物胃黏膜损伤评分显著降低，有极显著差异(P<0.01)；与单剂组、对比例1～3组相比，实施例1～4组均表现出显著性差异(P<0.05)。
2.3病理组织学观察结果
病理组织学观察发现，模型组动物胃黏膜充血，局部黏膜出血、上皮细胞坏死脱落，黏膜下层水肿、炎细胞浸润，部分动物可见黏膜下层出血。各试验组均可见上述症状不同程度的减轻，实验结果见表6。
表6各组病理组织学观察结果
与空白对照组比较，▲P<0.05，▲▲P<0.01；与模型组比较，*P<0.05，**P<0.01；与单剂组和对比例1～3组比较，#P<0.05，##P<0.01。
结果显示，与正常对照组比较，模型组动物胃黏膜病理组织学评分升高，具有统计学差异(P<0.01)。其中，与模型组比较，实施例1～4组评分下降，具有统计学差异(P<0.01)，单剂组和对比例1～3组没有显著差异。与单剂组和对比例1～3组相比，实施例1～4组均具有显著差异(P<0.05)。表明本发明组合物对胃粘膜损伤具有显著地保护作用。
实施例8咀嚼片剂的制备
(1)制备粘合剂：将0.5份羧甲淀粉钠溶于水，配成0.1％的羧甲淀粉钠溶液，加入1份柠檬酸钠、0.05份奶味香精、0.05份安赛蜜、0.5份脱脂奶粉，搅拌溶解，备用。
(2)制粒：将实施例4所述组合物、异麦芽酮糖醇25份置于沸腾制粒机中，喷粘合剂进行制粒。
(3)混合：将制好的颗粒与5份微晶纤维素进行混合25min，加入0.9份硬脂酸镁，混合5min，出料。
(4)压片：采用18*9mm椭圆形模具压片，压片过程注意控制片重控制范围、崩解时限、素片硬度、压片机主压。
(5)包装：检验合格后，包装。按企业标准抽取样品检验，合格后入库。实施例9片剂的制备
(1)制备粘合剂：将羧甲淀粉钠溶于水，配成0.1％的羧甲淀粉钠溶液，备用。
(2)制粒：将实施例4所述组合物、异麦芽酮糖醇20份置于沸腾制粒机中，喷粘合剂进行制粒。
(3)混合：将制好的颗粒与微晶纤维素5份进行混合25min，加入硬脂酸镁0.9份，混合5min，出料。
(4)压片：采用18*9mm椭圆形模具压片，压片过程注意控制片重控制范围、崩解时限、素片硬度、压片机主压。
(5)包衣：采用棕色薄膜包衣粉1.2份进行包衣。
(6)包装：检验合格后，包装。按企业标准抽取样品检验，合格后入库。实施例10粉剂的制备
(1)混合：按实施例4所述组合物、脱脂奶粉0.5份、异麦芽酮糖醇1份、柠檬酸钠0.05份、奶味香精0.05份、安赛蜜0.9份、二氧化硅(244FP)置于三维混合机中，混合30min，出料，采用3层PE袋密封保存。
(2)袋包：采用颗粒机，选用60mm铝箔膜进行袋包。注意：检查、保证袋包装量稳定性、袋包密封性。
(3)包装：检验合格后，包装。按企业标准抽取样品检验，合格后入库。实施例11口服液的制备
(1)配液：称取实施例4所述组合物，搅拌溶解后，加热至70-90℃，保温30-50min，放凉至60℃加入1份柠檬酸、0.1份山楂香精、0.02份三氯蔗糖，搅拌均匀，备用。
(2)过滤：20-100um过滤后，取过滤液备用。
(3)均质：过滤液通过均质机。
(4)灭菌：溶液通过UHT设备，温度125-140℃，时间10-30秒。
(5)罐装：趁热罐装，采用100-250ml棕色玻璃瓶、铝盖罐装。注意检查罐装密封性。
(6)灭菌：灌装产品通过巴氏灭菌设备，其中85-90℃维持10-20分钟。
(7)包装：检验合格后，包装。按企业标准抽取样品检验，合格后入库。实施例12胶囊剂的制备
(1)称取实施例4所述组合物、食用玉米淀粉7份、硬脂酸镁0.9份、二氧化硅0.9份，将各物料置于三维混合机中，混合30min，出料，采用3层PE袋密封保存。
(2)胶囊填充：采用胶囊机，选用0#胶囊壳进行填充，控制填充装量的稳定性、崩解时限。
(3)包装：检验合格后，包装。按企业标准抽取样品检验，合格后入库。
以上所述仅是本发明的优选实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也应视为本发明的保护范围。
Claims (10)
1.一种对胃粘膜损伤具有保护作用的组合物，其特征在于，包括发酵大豆粉、库拉索芦荟凝胶冻干粉和猴头菇提取物。
2.根据权利要求1所述的组合物，其特征在于，以重量份计，包括如下组分：
发酵大豆粉10-50份、库拉索芦荟凝胶冻干粉1-5份和猴头菇提取物1-10份。
3.根据权利要求2所述的组合物，其特征在于，以重量份计，包括如下组分：
发酵大豆粉30份、库拉索芦荟凝胶冻干粉1-5份和猴头菇提取物1-10份。
4.根据权利要求1或2所述的组合物，其特征在于，还包括陈皮提取物、山楂提取物、山药提取物和茯苓提取物中的一种或两种以上。
5.根据权利要求2所述的组合物，以重量份计，包括如下组分：
发酵大豆粉10-50份、库拉索芦荟凝胶冻干粉1-5份、猴头菇提取物1-10份、陈皮提取物1～10份、山楂提取物0～20份、山药提取物0～10份和茯苓提取物0～5份。
6.如权利要求1至5中任一项所述的组合物在制备对胃粘膜损伤具有保护作用的药物中的应用。
7.一种对胃粘膜损伤具有保护作用的中药制剂，其特征在于，由权利要求1～5所述的组合物及药学上可接受的辅料制成。
8.据权利要求7所述的中药制剂，其特征在于，所述药学上可接受的辅料选自异麦芽酮糖醇、脱脂奶粉、柠檬酸、柠檬酸钠、奶味香精、山楂香精、三氯蔗糖、安赛蜜、硬脂酸镁、微晶纤维素、羧甲淀粉钠、二氧化硅、食用玉米淀粉中的一种或两种以上。
9.根据权利要求8所述的中药制剂，其特征在于，其剂型为片剂、胶囊剂、丸剂、颗粒剂、粉剂、口服液剂。
10.一种对胃粘膜损伤具有保护作用的保健品，其特征在于，由权利要求1～5任一项所述的组合物和保健品中可接受的辅料制成。
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