CN111643608B - 一种治疗胃病的药物组合物及其用途 - Google Patents
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Abstract
本发明公开了一种治疗胃病的药物组合物及其用途。所述药物组合物包括香茅属植物提取物、沙棘果油和紫苏籽油。本发明所述的药物组合物具有较好的抑制幽门螺杆菌生长的作用，可以用于治疗胃部幽门螺杆菌感染、胃溃疡以及萎缩性胃炎等疾病，具有保护胃黏膜的作用，还可增强免疫力，其主要原料来源于天然植物，药食同源，安全有效，毒副作用小；本发明的产品原料来源丰富，制备工艺简单，并可做成软胶囊或胶丸等，使用方便。
Description
技术领域
本发明涉及一种药物组合物，该药物组合物在制备治疗胃病或增强免疫力的药物或保健品中的用途。
背景技术
当今社会胃病频发，幽门螺杆菌感染、饮食规律及结构的不合理、免疫力失调或低下等均是造成胃病的重要原因。胃病是指胃部多种疾病的统称，比如临床常见的胃溃疡、消化不良、急慢性胃炎等等。胃病极易反复，比如幽门螺杆菌(HP)反复感染导致的胃炎、胃溃疡等，长此以往可能会导致癌变。常规治疗方法大多治标不治本，且不良反应时有发生，抗幽门螺杆菌药物易导致耐药菌株的出现，所以，亟需安全有效地治疗胃病、呵护胃部健康、提高机体免疫力的药物或产品。
发明内容
本发明针对以上问题的提出，而研究设计一种药物组合物及其用途和制成的药物。本发明采用的技术手段如下：
一种治疗胃病的药物组合物，包括香茅属植物提取物、沙棘果油和紫苏籽油。
进一步地，所述药物组合物包括以下重量份的组份：香茅属植物提取物1-15份、沙棘果油3-12份和紫苏籽油1-6份。
进一步地，所述药物组合物包括以下重量份的组份：香茅属植物提取物1-15份、沙棘果油3-12份、紫苏籽油1-6份和稳定剂0.5-2份。
进一步地，所述稳定剂为聚甘油脂肪酸酯、蓖麻油和吐温80中的一种或两种以上的组合。
进一步地，香茅属植物提取物1.5-14份、沙棘果油3.43-12份、紫苏籽油1.57-5.5份和聚甘油脂肪酸酯1-2份。
进一步地，包括以下重量份的组份：香茅属植物提取物14份、沙棘果油11份、紫苏籽油2份和聚甘油脂肪酸酯2份。
进一步地，所述香茅属植物提取物来源于爪哇香茅草、柠檬草和芸香草中的一种或两种以上。
本发明所述的治疗胃病的药物组合物在制备治疗胃病或增强免疫力的药物或保健品中的用途。
一种治疗胃病的药物或保健食品，由本发明所述的药物组合物制成。
进一步地，所述治疗胃病的药物或保健食品的剂型为胶囊或胶丸。
与现有技术比较，本发明所述的药物组合物及其在制备治疗胃病或增强免疫力的药物或保健品中的用途具有以下优点：
1、具有较好的抑制幽门螺杆菌生长的作用，可以用于治疗胃部幽门螺杆菌感染、胃溃疡以及萎缩性胃炎等疾病，具有保护胃黏膜的作用，还可增强免疫力，其主要原料来源于天然植物，药食同源，安全有效，毒副作用小；
2、本发明的产品原料来源丰富，制备工艺简单，并可做成软胶囊或胶丸等，使用方便。
附图说明
图1是本发明实施例空白组的病理切片图。
图2是本发明实施例模型组的病理切片图。
图3是本发明实施例1(400mg/kg)的病理切片图。
图4是本发明实施例2(400mg/kg)的病理切片图。
图5是本发明实施例6(400mg/kg)的病理切片图。
图6是本发明实施例7(400mg/kg)的病理切片图。
图7是本发明阳性对照维酶素组(500mg/kg)的病理切片图。
具体实施方式
治疗胃病的药物组合物实施例及对比例如下表所示：
按照上表所述比例，分别称取沙棘果油、紫苏籽油、香茅属植物提取物、聚甘油脂肪酸酯于配液罐内，混合搅拌均匀后即得本专利所述药物组合物实施例1-8、对比例1-6。
香茅属植物是一类芳香性植物，它们中大部分含芳香油，常用作香精香料提取原料。常见的香茅属植物有柠檬草、爪哇香茅草、芸香草等。香茅属植物提取物为香茅全草经水蒸气蒸馏法提取到的一类挥发油成分，含有丰富的萜类成分，具有良好的抗氧化、抗炎、抗肿瘤、抗菌等功效。
沙棘果油是从珍贵的药食两用植物沙棘的果实中提取的，其内含有大量的不饱和脂肪酸、生育酚、β-类胡萝卜素和甾醇类物质，而且稳定性好，具有增强免疫力、抗肿瘤、抗氧化、心血管系统保护、保肝降酶、抗炎抗辐射损伤、延缓衰老等作用。
紫苏籽油是从药食两用的植物紫苏的籽中提取出的食用植物油，其内含有大量的不饱和脂肪酸和蛋白质，尤其含具有特异性活性的ω-3系脂肪酸，如α-亚麻酸。其具有降低血脂、降低心血管发病率，营养大脑、促进发育、提高记忆力，调节免疫、延缓衰老、预防老年痴呆症，抗癌等作用，具有极高研究价值及保健价值。
本发明提供了一种以香茅属植物提取物、沙棘果油、紫苏籽油为有效成分的药物组合物，本组合物有效成分为天然来源，既可食用又有良好的药用保健作用，可以提高免疫力、帮助消化、抑制幽门螺杆菌、保护胃黏膜、治疗萎缩性胃炎，对各种胃病均有一定治疗作用，全面呵护胃部健康。
幽门螺杆菌(HP)感染是导致慢性胃炎(如慢性萎缩性胃炎)、消化性溃疡甚至胃癌等胃病发生的重要因素，HP通过损害胃粘膜屏障并释放毒素和炎性介质，形成胃及十二指肠的一系列病理改变，结果例1对上述各实施例及对比例的抗HP的作用进行了研究，具体方法及结果如下：
结果例1琼脂二倍稀释法分别检测实施例1-8、对比例1-6的最小抑菌浓度MIC
(1)幽门螺杆菌的提取分离
在胃窦小弯侧距幽门3cm以内取胃粘膜组织，在无菌操作台内用SPL接种环采用划线法接种于选择性抗生素固体培养基表面，放于三气培养箱，微需氧(85％N2，5％O2，10％CO2)，37℃，湿度＞90％的条件下培养3-5天，观察H.pylori菌落的生长情况(透明针尖样)，若有菌落生长，则2-3天传代一次，传代2次后，涂片Gram染色确认H.pylori菌株形态和活力，然后将其保存于含蛋白胨及甘油为主要成份的冻存液中，于-80℃超低温保存。
(2)琼脂二倍稀释法测MIC
将实施例1-8，对比例1-6分别从128μg/mL至4μg/mL作二倍梯度稀释，每个药物组合物设置6个二倍梯度。阿莫西林作为阳性对照，从0.5μg/mL到0.015625μg/mL共6个二倍梯度。使用无菌petri培养皿，每个培养皿含10ml，9ml培养基+1ml抗生素(浇板)。
将冻存的菌株(3种临床菌株)从-80℃超低温冰箱中取出，放至室温后，在无菌操作台上，混匀冻存液，接种于固体培养基上，在三气培养箱中于37℃微需氧条件下培养3-5天后制备幽门螺杆菌菌液(OD600＝1)，每个培养皿接种100ul上述菌液，放于三气培养箱，微需氧(85％N2，5％O2，10％CO2)，37℃，湿度＞90％的条件下培养。48小时后以无菌生长的平皿中所含药物最小的浓度为最小抑菌浓度(MIC)。
表1琼脂稀释法检测实施例1-8、对比例1-6抑制幽门螺杆菌的MIC
从上述表格可以看出，作用48小时后，实施例1-6的最小抑菌浓度在4-16μg/ml，其中菌株3的敏感性最强，表明实施例1-6均具有抑制幽门螺杆菌生长的作用。其中，实施例6最小抑菌浓度(MIC)为4μg/ml，且三种菌株对其都比较敏感，效果最优。实施例1和实施例2的抑菌浓度紧随其后。对比例1-6最小抑菌浓度均大于实施例1-8的该数值，表明其抑制幽门螺杆菌生长需要更高的浓度才能发挥作用。
结果例2药物组合物对大鼠萎缩性胃炎的治疗作用
根据结果例1的实验结果，选取实施例1、2、6、7进一步研究其对萎缩性胃炎的作用。
SD大鼠70只，分为7组(空白对照组、模型组、实施例1组(400mg/kg)、实施例2组(400mg/kg)、实施例6组(400mg/kg)、实施例7组(400mg/kg)、阳性对照维酶素组(500mg/kg)，除空白对照组除外，其余6组采用下述方法构建萎缩性胃炎模型：大鼠第1周自由饮用20mm/L脱氧胆酸钠溶液后正常饮水；第6-12周自由饮用5mm/L脱氧胆酸钠溶液，溶液每隔3d更换1次；同时前4周每5d，后8周每7d按10ml/kg剂量，用60％的乙醇溶液，水浴恒温55℃灌胃；试验期间配合饥饱失常法，即一日饱食，一日禁食。造模8周，实验第8周末各组随机抽检1只大鼠，检查造模情况，确定造模成功；造模成功后，在继续造模的基础上开始灌胃给药，空白组及模型组给予蒸馏水，每日1次，连续给药4周。
给药结束后，大鼠腹腔注射350mg/kg(10ml/kg)水合氯醛麻醉，分离胃组织，冲洗胃内容物，并制作病理切片观察病变改善情况。
如图1所示，正常组大鼠胃黏膜上皮清晰可见，固有层厚，腺体排列整齐，呈分枝管状；
如图2所示，模型组大鼠胃黏膜上皮可见缺损，固有层较薄，腺体数量较正常组减少，排列紊乱，黏膜肌层略有增厚；
如图3所示，实施例1组，固有层变薄，胃黏膜腺体排列稍显紊乱，腺体数量略微减少；
如图4所示，实施例2组，大鼠胃表面黏液较少腺体排列稍显紊乱，数量基本正常；
如图5所示，实施例6组黏膜上皮较完整，腺体排列较整齐，数量正常；
如图6所示，实施例7组胃黏膜上皮减少，固有层变薄，腺体排列稍显紊乱，部分大鼠胃黏膜上皮可见缺损；
如图7所示，维酶素组中，黏膜上皮可见，腺体排列较整齐，大鼠胃黏膜结构清晰，厚度基本正常，腺体无明显减少。
实验结论：实施例1、2、6、7对大鼠萎缩性胃炎具有一定治疗作用，其中实施例6的效果最优。
以上所述的实施例仅仅是对本发明的优选实施方式进行描述，并非对本发明的范围进行限定，在不脱离本发明设计精神的前提下，本领域普通技术人员对本发明的技术方案做出的各种变形和改进，均应落入本发明权利要求书确定的保护范围内。
Claims (5)
1.一种治疗胃病的药物组合物，其特征在于，由以下重量份的原料制成：香茅属植物提取物14份、沙棘果油11份、紫苏籽油2份和聚甘油脂肪酸酯2份。
2.根据权利要求1所述的治疗胃病的药物组合物，其特征在于，所述香茅属植物来源于爪哇香茅草、柠檬草和芸香草中的一种或两种以上。
3.权利要求1至2中任意一项所述的药物组合物在制备治疗胃病的药物中的用途。
4.一种治疗胃病的药物，其特征在于，由权利要求1至2中任意一项所述的药物组合物制成。
5.根据权利要求4所述的治疗胃病的药物，其特征在于其剂型为胶囊。
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