CN113413454A - 一种促进胃粘膜损伤修复的组合物及其制备方法 - Google Patents
一种促进胃粘膜损伤修复的组合物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种促进胃粘膜损伤修复和抑制幽门螺杆菌的组合物及其制备方法，该组合物包含下述原料制成：小麦低聚肽、猴头菇、牡蛎肽和岩藻多糖；还可进一步添加石斛、白芨胶和益生菌等原料。本发明组合物在修复胃粘膜同时，能够增强机体的抗氧化能力及免疫力，抑制幽门螺杆菌，减轻炎症反应，促进溃疡的愈合，改善病人症状。
Description
技术领域
本发明属于医药、食品保健领域，具体的涉及一种促进胃粘膜损伤修复的组合物及其制备方法。
背景技术
胃是人体重要器官之一，其主要生理功能是受纳和腐熟水谷，是人类正常生活的基本保障。对人类身心的健康发展具有重要作用。但是在生活节奏日益加快的今天，很多身在职场的人加班、熬夜时频繁采用浓茶和咖啡提神，也有人因为应酬的需要而不加节制地吸烟、喝酒，还有部分人群饮食不规律，常常暴饮暴食，或食用过冷或过烫食物，这些不良生活方式往往对胃粘膜造成损伤，长此以往，会引发各种胃部疾病。因此，对于越来越多具有胃粘膜损伤的亚健康人群而言，为他们提供一种促进胃粘膜损伤修复的组合物，具有积极意义。
公开号为CN110124008A的专利文献《小麦肽和岩藻多糖的组合物、其制备和使用方法》公开了小麦肽和岩藻多糖的组合，其目的缓解糖尿病肾病及过量饮酒后的醉酒症状，降低酒精对胃肠粘膜的损伤或损害。公开号为CN104382954A的专利文献《一种组合物、用途及保健品》公开了一种由猴头菇、壳聚糖和小麦低聚肽组成的防治胃黏膜损伤组合物，但该组合物对幽门螺杆菌无抑制作用。
目前还没有小麦低聚肽、猴头菇、牡蛎肽和岩藻多糖制成的组合物在促进胃粘膜损伤修复、抑制幽门螺杆菌方面的报道。
发明内容
本发明的目的在于提供一种组合物，在修复胃粘膜同时增强机体的抗氧化能力及免疫力，抑制幽门螺杆菌，减轻炎症反应，促进溃疡
的愈合，改善病人症状。
本发明组合物主要由小麦低聚肽、猴头菇、牡蛎肽和岩藻多糖制成，其中猴头菇可为猴头菇干品或猴头菇提取物；本组合物还可进一步加入石斛、白芨胶和益生菌中的一种或多种。
为了实现上述目的，本发明的技术方案为：
一种组合物，其特征在于包含下述重量份的原料制成：小麦低聚肽1-15份，猴头菇0.1-5份，牡蛎肽0.5-10份和岩藻多糖0.1-8份。
优选，所述组合物主要包含小麦低聚肽3-10份，猴头菇0.5-3份，牡蛎肽0.8-5份和岩藻多糖0.5-5份。
更优选，所述组合物主要包含小麦低聚肽5份，猴头菇1份，牡蛎肽1份和岩藻多糖2.5份。
本发明的组合物原料进一步包含石斛1-12份和白芨胶0.5-10份中的一种或两种。
优选，所述组合物原料进一步包含石斛3-10份和白芨胶2-7份中的一种或两种。
更优选，所述组合物原料进一步包含石斛6份和白芨胶4份中的一种或两种。
本发明的组合物原料进一步包含益生菌0.7-4.6份，其中所述益生菌选自嗜酸乳杆菌、干酪乳杆菌、两歧双歧杆菌、嗜热链球菌中的任意一种或多种。
优选的，在所述组合物中，包含所述嗜酸乳杆菌重量份为0.2-0.8份。
优选的，在所述组合物中，包含所述干酪乳杆菌重量份为0.2-2份。
优选的，在所述组合物中，包含所述两歧双歧杆菌重量份为0.1-1份。
优选的，在所述组合物中，包含所述热链球菌重量份为0.2-0.8份。
在本发明的一个优选实施方案中，本发明的组合物包含下述重量份的原料制成：小麦低聚肽1-15份，猴头菇0.1-5份，牡蛎肽0.5-10份，岩藻多糖0.1-8份和石斛1-12份；优选，小麦低聚肽3-10份，猴头菇0.5-3份，牡蛎肽0.8-5份，岩藻多糖0.5-5份和石斛3-10份；更优选，小麦低聚肽5份，猴头菇1份，牡蛎肽1份，岩藻多糖2.5份和石斛6份。
在本发明的又一个优选实施方案中，本发明的组合物包含下述重量份的原料制成：小麦低聚肽1-15份，猴头菇0.1-5份，牡蛎肽0.5-10份，岩藻多糖0.1-8份和白芨胶0.5-10份；优选，小麦低聚肽3-10份，猴头菇0.5-3份，牡蛎肽0.8-5份，岩藻多糖0.5-5份和白芨胶2-7份；更优选，小麦低聚肽5份，猴头菇1份，牡蛎肽1份，岩藻多糖2.5份和白芨胶4份。
在本发明的另一个优选实施方案中，本发明的组合物包含下述重量份的原料制成：小麦低聚肽1-15份，猴头菇0.1-5份，牡蛎肽0.5-10份，岩藻多糖0.1-8份，石斛1-12份和白芨胶0.5-10份；优选，小麦低聚肽3-10份，猴头菇0.5-3份，牡蛎肽0.8-5份，岩藻多糖0.5-5份，石斛3-10份和白芨胶2-7份；更优选，小麦低聚肽5份，猴头菇1份，牡蛎肽1份，岩藻多糖2.5份，石斛6份和白芨胶4份。
在本发明的再一个优选实施方案中，本发明的组合物包含下述重量份的原料制成：小麦低聚肽1-15份，猴头菇0.1-5份，牡蛎肽0.5-10份，岩藻多糖0.1-8份，石斛1-12份，白芨胶0.5-10份和益生菌0.7-4.6份；优选，小麦低聚肽3-10份，猴头菇0.5-3份，牡蛎肽0.8-5份，岩藻多糖0.5-5份，石斛3-10份，白芨胶2-7份，嗜酸乳杆菌0.2-0.8份，干酪乳杆菌0.2-2份，两歧双歧杆菌0.1-1份和热链球菌0.2-0.8份。
本发明所述小麦低聚肽是从小麦蛋白水解物中分离得到的生物活性肽，具有抗氧化、抑制、吗啡作用、免疫调节等多种功能，能够刺激机体淋巴细胞增殖，增强巨唾细胞吞唾功能，提高机体抵御外界病原体感染的能力，降低机体发病率等作用。近年来不少研究者发现小麦肽与胃肠道健康关系密切，一定剂量的小麦肽能提高大鼠对于蛋白质的吸收与利用，其可能的途径是：促进胃肠道上皮细胞的生长；小肠黏膜氨基肽酶、Na+-K+-ATP酶活力的上调；补充小麦肽可提高高原训练大鼠小肠的抗氧化能力，减少氧自由基的生成，有效地防止长期高原训练引起的小肠粘膜屏障的损伤。
本发明所述猴头菇为齿菌科植物猴头的子实体，是一种高蛋白、低脂肪、富含矿物质和维生素的优良食品，含不饱和脂肪酸，能降低血胆固醇和甘油三酯含量，调节血脂，利于血液循环。据《本草纲目》记载：性平，味甘，有“利五脏，助消化”之功能。现代研究也表明猴头菇具有健脾益胃，降胆固醇，滋补，抗癌，保肝等作用。
本发明所述岩藻多糖，也被称为“褐藻糖胶”，是一种由含硫酸基的岩藻糖（fucose）所构成水溶性多糖物质。岩藻多糖具有多种生物功能，如抗肿瘤、改善胃肠道、抗氧化、增强免疫力、抗血栓、降血压、抗病毒等作用。
本发明所述牡蛎肽是牡蛎蛋白经酶解后制成，具有多种生理活性，如抗氧化作用、ACE抑制作用、抗炎、抑菌及增强免疫力等。研究者采用超滤手段从牡蛎的原生质（Plasma）分离出分子量小于10 kDa的多肽，通过抗菌实验发现其具有一定的抗菌作用，这表明牡蛎多肽具有抗菌作用；分子量在 3 kDa 以下的牡蛎活性肽能抑制淋巴细胞的功能， 具有免疫抑制作用。
本发明提供的一种促进胃粘膜损伤修复的组合物的制备方法，包括如下步骤：
（1）按量称取小麦低聚肽、猴头菇、牡蛎肽、岩藻多糖、石斛、白芨胶和益生菌后混合，得到混料；
（2）采用药学上可接受的载体或赋形剂按药剂学常规工艺制成的颗粒剂、片剂、胶囊剂、软胶囊剂、滴丸剂、丸剂或口服液；或者采用食品上可接受的赋形剂或食品添加剂，按常规食品制备工艺制成的各种形态食品。
与现有技术相比，本发明的有益效果在于：能提高机体免疫力，抑制幽门螺杆菌，减轻炎症反应，促进溃疡的愈合。
以下通过实验进一步说明本发明的有益效果。
实验一：本发明对胃粘膜损伤的保护作用临床研究
1、受试者的选择标准
符合慢性浅表性胃炎诊断标准且经胃镜筛选确诊为胃粘膜损伤的自愿受试者。
慢性浅表性胃炎诊断标准：病程迁延，有不同程度的消化不良、上腹痛、烧心、嗳气、反酸、腹胀等临床症状，可有上腹部轻度压痛。符合慢性浅表性胃炎纤维胃镜诊断标准及活体组织检查诊断标准。排除胃溃疡患者。
2、分组及服用情况
受试者180例进行食用治疗，其中男性94人，女性86人，平均年龄38.5(25～60)岁，随机将受试者分成6组，按组分别服用不同受试物，服用方式为口服，每次100 mL，一日1次，连续服用30天。
3、受试物
受试物1：小麦低聚肽5g、猴头菇1g、牡蛎肽1g、岩藻多糖2.5g溶于纯化水中，加适量甜味剂，定容至100 mL，即得。
受试物2：小麦低聚肽5g、猴头菇1g、石斛4g、牡蛎肽1g、岩藻多糖2.5g、嗜酸乳杆菌0.5g、两歧双歧杆菌0.5g、干酪乳杆菌0.8g、嗜热链球菌0.45g溶于纯化水中，加适量甜味剂，定容至100 mL，即得。
受试物3：罗伊氏乳杆菌菌粉0.5g、鼠李糖乳杆菌2.9g、低聚果糖3g、小麦低聚肽0.5g、茶多酚1g、黄芪提取物1.5g、沙参提取物0.5g、碳酸氢钠0.1g溶于纯化水中，加适量甜味剂，定容至100 mL，即得。
受试物4：小麦低聚肽0.5g、猴头菇1.252g、壳聚糖1g溶于纯化水中，加适量甜味剂，定容至100 mL，即得。
受试物5：小麦低聚肽5g、岩藻多糖7.5g溶于纯化水中，加适量甜味剂，定容至100mL，即得。
受试物6:松花粉肽2.8 g、海参肽0.6 g、牡蛎肽0.7 g、大豆肽0.4 g、大米肽0.3g、小麦肽0.3 g、阿胶肽0.6 g、豌豆肽0.4 g、黄芪0.2 g、岩藻多糖0.2 g、白及0.6 g、干姜0.5 g、旋覆花0.7g，各物料过40目筛后溶于纯化水中，加入适量甜味剂，定容至100mL ，即得。
4、主要观察指标：①临床症状的改善情况。详细记录治疗前后的胃脘胀满、疼痛、泛酸、呃逆嗳气、舌脉等症状、体征。②治疗前后胃镜检查 , 观察胃粘膜的色泽、出血点、充血及糜烂损伤程度, 比较前后变化。
5、疗效标准：显效：胃脘痛及其它症状消失，胃镜检查好转。好转：胃脘痛及其它症状好转，胃镜检查好转。无效:胃脘痛及其它症状无改变，胃镜检查无改变。
6、结果
由以上结果可知，本发明组合物能提高机体免疫力，抑制幽门螺杆菌，有效促进胃粘膜的修复。
实验二：本发明的体内抗幽门螺旋杆菌实验
1、Hp感染小鼠模型制备及分组：取昆明种小鼠适应性饲养１周，禁食禁水12h，随机选取15只作为正常对照组，其余小鼠进行造模：每只小鼠灌胃乙醇0.2mL消毒，2h后恢复正常饮食饮水。然后将预处理过的小鼠禁食12h，再每只小鼠灌胃Hp菌混悬液0.5mL（菌液数为1×10９CFU·mL－１），每间隔12小时重复一次，共４次。距末次灌胃2h后恢复饮食饮水。５周后取尾静脉血用尿素酶法进行血清学检查，Hp抗体阳性者视为造模成功。将造模成功小鼠随机分为7个组，每组15只，分别为模型对照组、受试物1～6组（各受试物配方同实验1）。
2、给药情况：正常对照组及模型组给予等量生理盐水，其它给药组给予相应受试物，每天１次，连续5周。
3、检测指标：末次给药后禁食24h，处死小鼠，眼球取血做快速尿素酶试验；在无菌条件下取出鼠胃，沿胃大弯剪开，用无菌生理盐水冲洗残留物后沿纵轴截取胃窦部分取胃窦部组织进行细菌学涂片检查、组织学检查以确定Hp是否存在。
1)尿素酶试验：在测试板样本孔中加100ul血清或血浆；15～20min内观察结果。
2)涂片镜检：将小鼠胃窦部黏膜面贴于载玻片上进行涂片，革兰染色后镜检。
3)组织学检查：将胃组织块用4%甲醛固定，组织切片分别作HE染色和Giemsa染色。
用SPSS软件对实验数据进行统计学分析。
4、结果：
注：与正常组比组，※P<0.01，与模型组比较，*P<0.05，**P<0.01。
以上结果表明：与正常对照组比较，模型对照组的阴性率有显著性意义（P<0.01），说明造模成功。与模型对照组比较，本发明组合物能有效清除小鼠胃内的HP，其差异具有显著性意义。
具体实施方式
下面结合实例进一步描述本发明：
实施例1
按以下重量配比称取原料：小麦低聚肽5份、猴头菇1份、牡蛎肽1份、岩藻多糖2.5份。
制备方法：采用药学上可接受的载体或赋形剂按药剂学常规工艺制成的颗粒剂、片剂、胶囊剂、软胶囊剂、滴丸剂、丸剂或口服液；
或者采用食品上可接受的赋形剂或食品添加剂，按常规食品制备工艺制成的各种形态食品。
实施例2
按以下重量配比称取原料：小麦低聚肽1份、猴头菇提取物0.1份、牡蛎肽0.5份、岩藻多糖0.1份。制备方法同实施例1。
实施例3
按以下重量配比称取原料：小麦低聚肽3份、猴头菇0.5份、牡蛎肽0.8份、岩藻多糖0.5份。制备方法同实施例1。
实施例4
按以下重量配比称取原料：小麦低聚肽10份、猴头菇提取物3份、牡蛎肽5份、岩藻多糖5份。制备方法同实施例1。
实施例5
按以下重量配比称取原料：小麦低聚肽15份、猴头菇5份、牡蛎肽10份、岩藻多糖8份。制备方法同实施例1。
实施例6
按以下重量配比称取原料：小麦低聚肽5份、猴头菇提取物0.5份、牡蛎肽2份、岩藻多糖2.5份。制备方法同实施例1。
实施例7
按以下重量配比称取原料：小麦低聚肽5份、猴头菇1份、石斛4份、牡蛎肽1份、岩藻多糖2.5份。制备方法同实施例1。
实施例8
按以下重量配比称取原料：小麦低聚肽5份、猴头菇提取物1份、牡蛎肽1份、岩藻多糖2份、白芨胶0.5份。制备方法同实施例1。
实施例9
按以下重量配比称取原料：小麦低聚肽10份、猴头菇5份、石斛6份、牡蛎肽1份、岩藻多糖2份、白芨胶7份。制备方法同实施例1。
实施例10
按以下重量配比称取原料：小麦低聚肽15份、猴头菇1份、牡蛎肽1份、岩藻多糖2份、干酪乳杆菌2份、两歧双歧杆菌1份。制备方法同实施例1。
实施例11
按以下重量配比称取原料：小麦低聚肽5份、猴头菇提取物1份、牡蛎肽1份、岩藻多糖2.5份、嗜酸乳杆菌0.2份，干酪乳杆菌0.2份，两歧双歧杆菌0.4份和热链球菌0.6份。制备方法同实施例1。
实施例12
按以下重量配比称取原料：小麦低聚肽5份、猴头菇1份、石斛4份、白芨胶4份、牡蛎肽1份、岩藻多糖2.5份、嗜酸乳杆菌0.8份，干酪乳杆菌2份，两歧双歧杆菌1份和热链球菌0.8份。制备方法同实施例1。
实施例13
按以下重量配比称取原料：小麦低聚肽5份、猴头菇1份、石斛3份、白芨胶2份、牡蛎肽1份、岩藻多糖0.5份、嗜酸乳杆菌0.2份，干酪乳杆菌0.2份，两歧双歧杆菌0.1份和热链球菌0.2份。制备方法同实施例1。
实施例14
按以下重量配比称取原料：小麦低聚肽15份、猴头菇4份、石斛12份、白芨胶10份、牡蛎肽10份、岩藻多糖8份、嗜酸乳杆菌0.5份，干酪乳杆菌1份，两歧双歧杆菌0.5份和热链球菌0.5份。制备方法同实施例1。
Claims (13)
1.一种组合物，其特征在于包含下述重量份的原料制成：小麦低聚肽1-15份，猴头菇0.1-5份，牡蛎肽0.5-10份和岩藻多糖0.1-8份。
2.根据权利要求1所述的组合物，其特征在于包含下述重量份的原料制成：小麦低聚肽3-10份，猴头菇0.5-3份，牡蛎肽0.8-5份和岩藻多糖0.5-5份。
3.根据权利要求2所述的组合物，其特征在于包含下述重量份的原料制成：小麦低聚肽5份，猴头菇1份，牡蛎肽1份和岩藻多糖2.5份。
4.根据权利要求1所述的组合物，其特征在于所述组合物进一步包含下述重量份的原料：石斛1-12份和白芨胶0.5-10份中的一种或两种。
5.根据权利要求4所述的组合物，其特征在于所述组合物进一步包含下述重量份的原料：石斛3-10份和白芨胶2-7份中的一种或两种。
6.根据权利要求5所述的组合物，其特征在于所述组合物进一步包含下述重量份的原料：石斛6份和白芨胶4份中的一种或两种。
7.根据权利要求1所述的组合物，其特征在于所述组合物进一步包含益生菌0.7-4.6份，其中所述益生菌选自嗜酸乳杆菌、干酪乳杆菌、两歧双歧杆菌、嗜热链球菌中的任意一种或多种。
8.根据权利要求7所述的组合物，其特征在于所含嗜酸乳杆菌重量份为0.2-0.8份。
9.根据权利要求7所述的组合物，其特征在于所含干酪乳杆菌重量份为0.2-2份。
10.根据权利要求7所述的组合物，其特征在于所含两歧双歧杆菌重量份为0.1-1份。
11.根据权利要求7所述的组合物，其特征在于所含热链球菌重量份为0.2-0.8份。
12.权利要求1-11任一所述的组合物在制备促进胃粘膜损伤修复食品或药品中的应用。
13.权利要求1-11任一所述的组合物在制备抑制幽门螺杆菌食品或药品中的应用。
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