CN109620930B - 一种砂仁组合物制剂及其应用 - Google Patents
一种砂仁组合物制剂及其应用 Download PDFInfo
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Abstract
本发明涉及一种砂仁组合物及该组合物在养胃护胃、清除幽门螺杆菌或防治胃病等方面的应用,该组合物天然无副作用,安全温和,能有效维护身体健康。
Description
技术领域
本发明涉及一种砂仁组合物及该组合物在养胃护胃、清除幽门螺杆菌或防治胃病等方面的应用,属于食品和医药领域。
背景技术
目前国内各种慢病高发,国家提倡预防为主,防治慢病、维护健康产品的创研成为研究的热点。中国作为当之无愧的“胃癌人口大国”,胃病的发病率高达80%,其中慢性胃炎发病率为30%,患胃癌人数约占世界的50%。幽门螺杆菌感染是诱发胃癌的重要原因,根除幽门螺杆菌可使胃癌发病率降低40%以上。目前,用以抗生素为基础的四联方治疗幽门螺杆菌感染2周,清除率也仅为70%-75%,即使延长疗程到3周,清除率也仅能提高约5%。长时间抗Hp治疗,四联方含有的大量抗生素造成了肠道菌群严重失调,产生严重的胃肠道副作用,如严重腹泻、便秘、消化及营养吸收不良等,导致“甲病未愈、又添乙病”。急需开发天然无副作用,安全温和,能有效改善症状并消除诱因的产品来解决患者的痛苦。
发明内容
本发明是提供一种维护身体健康的组合物,尤其这种组合物能有效清除幽门螺杆菌,有效改善胃部不适症状,养胃护胃效果佳,预防或治疗胃炎、胃溃疡、胃部不适、功能性胃病、胃癌、幽门螺杆菌感染或反流性食管炎等疾病,天然无副作用,安全温和。
本发明目的是通过如下技术方案实现的:
一种砂仁组合物,主要包括下述重量份的组分:砂仁50-100重量份、其他植物组分150-650重量份、益生元组分150-700重量份、益生菌组分1-20重量份。
优选的,上述组合物中的其他植物组分包括甘草、葡萄皮、山药、山楂中的一种或多种,益生元组分包括水苏糖、低聚果糖、低聚木糖中的一种或多种,益生菌组分包括凝结芽孢杆菌、双歧杆菌、乳酸杆菌、酪酸梭菌中的一种或多种。
优选的,上述组合物还包括γ氨基丁酸1-20重量份,锌0.5-5重量份。
优选的,锌组分包括有机锌化合物、无机锌化合物或生物锌中的一种或多种。
优选的,益生菌组分包含的益生菌总活菌数不低于1×106CFU/g(mL),一般在1×107CFU/g(mL)以上,最高可达到1×1012CFU/g(mL)或1×1012CFU/g(mL)以上。
优选的,上述组合物包括砂仁50-100重量份、甘草10-30重量份、葡萄皮10-50重量份、山药100-300重量份、山楂50-250重量份、水苏糖50-300重量份、低聚果糖100-400重量份、凝结芽孢杆菌1-20重量份,γ氨基丁酸5-20重量份,葡萄糖酸锌1-5重量份。
更优选的,上述组合物包括包括砂仁80重量份、甘草25重量份、葡萄皮40重量份、山药150重量份、山楂100重量份、水苏糖250重量份、低聚果糖150重量份、凝结芽孢杆菌5重量份,γ氨基丁酸15重量份,葡萄糖酸锌3重量份;或砂仁60重量份、甘草20重量份、葡萄皮25重量份、山药200重量份、山楂150重量份、水苏糖250重量份、低聚果糖100重量份、凝结芽孢杆菌10重量份,γ氨基丁酸10重量份,葡萄糖酸锌1重量份;或砂仁100重量份、甘草30重量份、葡萄皮30重量份、山药150重量份、山楂150重量份、水苏糖250重量份、低聚果糖200重量份、凝结芽孢杆菌15重量份,γ氨基丁酸5重量份,葡萄糖酸锌2重量份。
优选的,上述组合物包含的砂仁和其他植物组分还包括各自的提取物。
优选的,上述组合物包括砂仁提取物50-100重量份、甘草提取物10-30重量份、葡萄皮提取物10-50重量份、山药100-300重量份、山楂50-250重量份、水苏糖50-300重量份、低聚果糖100-400重量份、凝结芽孢杆菌1-20重量份,γ氨基丁酸5-20重量份,葡萄糖酸锌1-5重量份。
更优选的,上述组合物包括砂仁提取物80重量份、甘草提取物25重量份、葡萄皮提取物40重量份、山药150重量份、山楂100重量份、水苏糖250重量份、低聚果糖150重量份、凝结芽孢杆菌5重量份,γ氨基丁酸15重量份,葡萄糖酸锌3重量份;或砂仁提取物60重量份、甘草提取物20重量份、葡萄皮提取物25重量份、山药200重量份、山楂150重量份、水苏糖250重量份、低聚果糖100重量份、凝结芽孢杆菌10重量份,γ氨基丁酸10重量份,葡萄糖酸锌1重量份;或砂仁提取物100重量份、甘草提取物30重量份、葡萄皮提取物30重量份、山药150重量份、山楂150重量份、水苏糖250重量份、低聚果糖200重量份、凝结芽孢杆菌15重量份,γ氨基丁酸5重量份,葡萄糖酸锌2重量份。
本发明组合物通过各组分称量或提取、筛分(或不筛分)、按比例混合、包装等常规制备方法制得。
本发明组合物可有效预防或治疗相关疾病,包括但不限于预防或治疗胃炎、胃溃疡、胃部不适、功能性胃病、胃癌、幽门螺杆菌感染或反流性食管炎。进一步的,胃炎包括但不限于浅表性胃炎、萎缩性胃炎或慢性胃炎,胃部不适包括但不限于胃痛、嗳气、反酸口苦、烧心、胃胀、恶心呕吐、食欲不振或口臭。
本发明组合物包括但不限于应用于制备养胃护胃、清除幽门螺杆菌或防治胃病制剂中,本发明组合物制成的制剂优选包含添加各种辅料制成药品、特殊医学用途食品、保健食品、功能性食品、食品、糖果、饮料等。
本发明组合物制成的制剂优选包含添加辅料制成粉剂、颗粒剂、片剂、胶囊、软胶囊、口服液或糖果。
本发明组合物制成的制剂所用辅料优选包括填充剂、润滑剂、稳定剂、崩解剂、口味改良剂的一种或一种以上。
本发明组合物制成的制剂所用辅料更优选包括微晶纤维素、羧甲基淀粉钠、淀粉、硬脂酸镁、二氧化硅、木糖醇、结晶果糖、海藻酸钠、甜菊糖苷、植脂末中的一种或一种以上。
与现有技术相比,本发明提供的技术方案具有以下优点:
本发明精选砂仁等植物成分与益生元、益生菌按照一定种类和比例进行配伍,取得了意想不到的协同作用。本发明组合物具有特定的配伍关系,改变配伍关系则无法实现该组方的显著效果。本发明进一步发现,将γ氨基丁酸、锌与上述组合物按照一定比例一起进行配伍,可以获得更佳的养胃护胃效果。
本发明组合物经急性毒性试验、30天喂养试验研究证实本发明组合物未见任何毒副作用。
具体实施方式
制备例说明:下面结合具有实施方式,对本发明的权利要求做进一步的详细说明,但不构成对本发明的任何限制,任何人在本发明权利要求保护范围内所做的有限次的修改,仍在本发明的权利要求保护范围之内。需要说明的是,本发明提供的技术方案中所采用的原料,未特殊说明外,均通过常规手段制备或者通过商业渠道购买。
实施例1
本发明提供的一种组合物,包括下述重量数的组分:砂仁提取物80g、甘草提取物25g、葡萄皮提取物40g、山药150g、山楂100g、水苏糖250g、低聚果糖150g、凝结芽孢杆菌5g。
实施例2
本发明提供的一种组合物,包括下述重量数的组分:砂仁提取物80g、甘草提取物25g、葡萄皮提取物40g、山药150g、山楂100g、水苏糖250g、低聚果糖150g、凝结芽孢杆菌5g,γ氨基丁酸15g,葡萄糖酸锌3g。
实施例3
本发明提供的一种组合物,包括下述重量数的组分:砂仁提取物60g、甘草提取物20g、葡萄皮提取物25g、山药200g、山楂150g、水苏糖250g、低聚果糖100g、凝结芽孢杆菌10g,γ氨基丁酸10g,葡萄糖酸锌1g。
实施例4
本发明提供的一种组合物,包括下述重量数的组分:砂仁提取物100g、甘草提取物30g、葡萄皮提取物30g、山药150g、山楂150g、水苏糖250g、低聚果糖200g、凝结芽孢杆菌15g,γ氨基丁酸5g,葡萄糖酸锌2g。
本发明的组合物的制备方法为:将各组分称量后混合均匀。
实施例说明:为了更好的说明本发明有的优点,下面给出本发明提供的该组合物的功效实验,但不构成对本发明的任何限制。
一、功效实验对比例
对比例1
砂仁提取物80g、甘草提取物25g、葡萄皮提取物40g、山药150g、山楂100g。
对比例2
水苏糖250g、低聚果糖150g、凝结芽孢杆菌5g。
对比例3
γ氨基丁酸15g,葡萄糖酸锌3g。
对比例4
某市售治疗胃炎的口服制剂。
二、功效评价实验
1、测试样品:取实施例1-4以及对比例1-3制备的组合物,添加玉米淀粉至1000g,混匀后灌装小包,每包2g。
2、功效评价实验
2.1实验方法:选择经13C呼气试验检测,确认有幽门螺杆菌感染,且根据胃部不适症状分级表(见表1)检查伴有胃部不适症状的患者90例,各组之间临床数据无统计学差异(P>0.05)。每组10人,实施例1-4以及对比例1-3各组按每日3次,每次1包,饭前服用的方式连续服用四周,对比例4组按说明书服用方法连续服用四周。空白组服用玉米淀粉制成的安慰剂。服用四周后再次进行13C呼气试验检测,并记录胃部不适症状和不良反应发生情况。
表1胃部不适症状分级表
2.2实验结果:每组经13C呼气试验检测阴性人数除以该组总人数既得幽门螺杆菌清除率,具体数据如表2所示。根据胃部不适症状分级表,患者主要胃部不适症状改善或消失且无其他胃部不适症状新增或加重记为胃部不适症状有效改善,各组胃部不适症状有效改善人数除以该组总人数既得胃部不适症状改善率,具体数据如表2所示。由表2可得,实施例1-4各组幽门螺杆菌清除率和胃部不适症状改善率均显著高于对比例1-4组(P<0.05),且无任何不良反应发生。对比例4有2例患者反应服药期间有胃肠道不适症状,发生便秘或腹泻症状。
表2试吃4周后各组胃部指标改善率(n=10)
2.3讨论:上述实验结果表明实施例1-4所代表的组合物具有显著突出的清除幽门螺杆菌和改善胃部不适症状作用,其作用显著好于对比例1-4所代表的组方,具有统计学差异,且服用期间无任何不良反应发生。患者主诉胃痛、烧心、口臭等各项胃部不适症状均有明显改善,肠胃舒畅,胃口佳、精神好。
上述实验案例表明,本组合物天然无副作用,安全温和,能有效养胃护胃、清除幽门螺杆菌,在预防或治疗胃炎、胃溃疡、胃部不适、功能性胃病、胃癌、幽门螺杆菌感染或反流性食管炎中有良好且巨大的应用前景。
Claims (5)
1.一种砂仁组合物,其特征在于,所述组合物由以下组分组成:砂仁提取物50-100重量份、甘草提取物10-30重量份、葡萄皮提取物10-50重量份、山药100-300重量份、山楂50-250重量份、水苏糖50-300重量份、低聚果糖100-400重量份、凝结芽孢杆菌1-20重量份,γ氨基丁酸5-20重量份,葡萄糖酸锌1-5重量份。
2.如权利要求1所述的组合物,其特征在于,所述组合物由以下组分组成:砂仁提取物80重量份、甘草提取物25重量份、葡萄皮提取物40重量份、山药150重量份、山楂100重量份、水苏糖250重量份、低聚果糖150重量份、凝结芽孢杆菌5重量份,γ氨基丁酸15重量份,葡萄糖酸锌3重量份;
或砂仁提取物60重量份、甘草提取物20重量份、葡萄皮提取物25重量份、山药200重量份、山楂150重量份、水苏糖250重量份、低聚果糖100重量份、凝结芽孢杆菌10重量份,γ氨基丁酸10重量份,葡萄糖酸锌1重量份;
或砂仁提取物100重量份、甘草提取物30重量份、葡萄皮提取物30重量份、山药150重量份、山楂150重量份、水苏糖250重量份、低聚果糖200重量份、凝结芽孢杆菌15重量份,γ氨基丁酸5重量份,葡萄糖酸锌2重量份。
3.如权利要求1或2所述的组合物在制备养胃护胃、清除幽门螺杆菌或防治胃病制剂中的应用。
4.如权利要求3所述的应用,其特征在于,所述胃病为胃部不适。
5.如权利要求3所述的应用,其特征在于,所述组合物制剂包含药品或食品。
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CN104839693A (zh) * | 2015-04-23 | 2015-08-19 | 劲膳美生物科技股份有限公司 | 胃溃疡、十二指肠溃疡医学配方食品 |
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CN105029405A (zh) * | 2015-04-14 | 2015-11-11 | 劲膳美生物科技股份有限公司 | 慢性胃炎医学配方食品 |
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