CN116114882A - 一种促进消化道黏膜修复的组合物 - Google Patents

一种促进消化道黏膜修复的组合物 Download PDF

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CN116114882A
CN116114882A CN202211137393.1A CN202211137393A CN116114882A CN 116114882 A CN116114882 A CN 116114882A CN 202211137393 A CN202211137393 A CN 202211137393A CN 116114882 A CN116114882 A CN 116114882A
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张司晨
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Abstract

本发明公开了一种促进消化道黏膜修复的组合物，主要涉及消化道黏膜领域。包括以下重量份的物质：透明质酸钠10‑200mg、胶原蛋白肽500‑15000mg、增稠物质200‑20000mg。本发明的有益效果在于：口服后能有效修复消化道黏膜，且该组合物为营养食品，副作用小，治疗效果更好。

Description

一种促进消化道黏膜修复的组合物
技术领域
本发明涉及消化道黏膜修复领域，具体是一种促进消化道黏膜修复的组合物。
背景技术
从食管到胃、小肠、结肠都覆盖着黏膜。黏膜一旦出现损伤，就可能导致疾病的发生。食管及胃肠道黏膜损伤在临床上非常常见,在中国有1亿以上的人口都面临这样的问题。但临床现有的黏膜保护药物，对部分人群的疗效不够理想，并且存在一定的副作用；而如果单独使用透明质酸钠、胶原蛋白肽制成的溶液冲剂，通过口服的方式涂抹在消化道黏膜表面，由于这个组合物溶液的黏稠度不够，会快速的通过消化道，导致透明质酸钠暴露在受损的黏膜表面的剂量和作用时间较短，药时曲线下面积AUC减少，导致疗效不够理想。我国法规要求每天口服透明质酸钠剂量不得超过200mg，要求患者通过多次口服的方法，去增加透明质酸钠在受损消化道黏膜表面暴露不可取，因此我们需要一种特殊的药物递送系统，增加透明质酸在受损的黏膜表面的吸附，从而发挥更好疗效。
发明内容
本发明的目的在于提供一种促进消化道黏膜修复的组合物，它口服后能有效修复消化道黏膜，且该组合物为营养食品，副作用小，治疗效果更好。
本发明为实现上述目的，通过以下技术方案实现：
一种促进消化道黏膜修复的组合物，包括以下重量份的物质：透明质酸钠10-200mg、胶原蛋白肽500-15000mg、增稠物质200-20000mg。
进一步的，所述增稠物质为圆苞车前子壳。
进一步的，所述增稠物质包括果胶、黄原胶、卡拉胶、瓜尔豆胶、阿拉伯胶等食品增稠剂。
进一步的，所述增稠物质还包括淀粉。
进一步的，所述淀粉包括藕粉、葛粉、抗性淀粉等。
对比现有技术，本发明的有益效果在于：
本发明组合物中透明质酸钠：通过结合受体CD44，促进成纤维细胞的增殖并迁移到伤口部位；胶原蛋白肽：胶原蛋白为细胞外基质的主要成分，伤口愈合期，细胞外基质需要重建，补充胶原蛋白肽有利于体内合成胶原蛋白，胶原蛋白肽还有招募伤口愈合反应细胞(巨噬细胞，成纤维细胞等)、刺激新血管生成的能力；增稠物质：有很强的黏稠度，对溃疡及炎症表面有强的亲和力。作为药物递送系统，帮助透明质酸钠跟受损的黏膜表面有更持久的结合，从而增加药物在溃疡面的暴露时间，让透明质酸钠更持久地发挥疗效，从而更有效的对消化道黏膜进行修复。并且由于透明质酸钠可使肠道艾克曼菌增殖，起到减肥的作用，圆苞车前子壳可以吸水膨胀产生饱腹感，在这个配方的基础上加入维生素、矿物质、蛋白质，也可作为辅助减肥的代餐食品用途。
具体实施方式
下面结合具体实施例，进一步阐述本发明。应理解，这些实施例仅用于说明本发明而不用于限制本发明的范围。此外应理解，在阅读了本发明讲授的内容之后，本领域技术人员可以对本发明作各种改动或修改，这些等价形式同样落于本申请所限定的范围。
实施例1：一种促进消化道黏膜修复的组合物，包括以下重量份的物质：透明质酸钠80mg、胶原蛋白肽5000mg，圆苞车前子壳5000mg，上述分量为每日1-2份的剂量。
上述组合物的制备方法为：
第一步：原料准备；
透明质酸钠：使用马链球菌兽疫亚种在培养基种培养，使用乙醇沉淀法分离提纯。最后喷雾干燥制粒；
胶原蛋白肽：使用鱼鳞/鱼皮(或牛骨/牛凝胶等)，将其解冻、清洗灭菌后，使用高温水解+酶解，再提取液过滤。使用食品级活性炭脱色、精滤、浓缩、除菌，最后喷雾干燥制粒；
圆苞车前子壳：以圆苞车前种子外壳为原料，经碾磨后制得；
第二步：混料；
将上述粉末按投料数量准确称量，使用三维运动混合机混合原料一小时；
第三步：灌装；
在十万级净化车间操作，工作人员入场需要经过换鞋、无尘更衣、洗手、消毒、烘干、风淋六道工序，将混合好的原料,加入固体饮料自动分量灌装装置，加入固体饮料包装用卷膜，开始实施生产，生产过程中对半成品进行抽查，打条过程中对生产情况和条袋进行监控。
上述食品食用的时候每日1-2份的剂量。该营养组合物食品，可以应用于辅助治疗食管炎、胃炎、炎性肠病等消化道黏膜损伤疾病。并且由于透明质酸钠可使肠道艾克曼菌增殖，起到减肥的作用，圆苞车前子壳可以吸水膨胀产生饱腹感，在这个配方的基础上加入维生素、矿物质、蛋白质，也可作为辅助减肥的代餐食品用途。
实施例2：一种促进消化道黏膜修复的组合物，包括以下重量份的物质：透明质酸钠30mg、胶原蛋白肽800mg，果胶5000mg，上述分量为每日1-2份的剂量。
上述组合物通过实施例1中的制备方法制得，区别在于，将实施例1中的圆苞车前子壳替换为同样有增稠效果的果胶，也可以是黄原胶、卡拉胶、瓜尔豆胶、阿拉伯胶等；果胶的制备在现有技术中有广泛记载，在此不做赘述。
实施例3：一种促进消化道黏膜修复的组合物，包括以下重量份的物质：透明质酸钠120mg、胶原蛋白肽10000mg，圆苞车前子壳7000mg，淀粉5000mg，上述分量为每日1-2份的剂量。
上述组合物通过实施例1中的制备方法制得，区别在于，增加淀粉作为增稠物质。淀粉具有较好的黏度稳定性、高流变特性及低持水性，通过热水搅拌后成粘稠状，可以作为食品增稠剂使用，如藕粉、葛粉、抗性淀粉等。
以下将通过实验例对本发明所述的组合物做进一步的说明。
试验过程：
试验组合物A：为透明质酸钠、胶原蛋白肽的组合物5.1g，冲150ml温水；
试验组合物B：实验组为透明质酸钠、胶原蛋白肽、圆苞车前子壳组合物10.1g，冲150ml温水；
临床试验：由于圆苞车前子壳对调节肠道有额外益处，所以试验设计只考虑观察胃食管反流病(食管黏膜损伤相关疾病)，试验组合物B是否有更多获益
1、纳入难治性胃食管反流病患者10例，纳入标准为：a.具有胃食管返流病典型的烧心、反酸、胸骨后灼烧等症状；b.胃镜检查有食管炎表现；c.既往口服PPI超过8周，如奥美拉唑20mg，1-2次/日，症状改善差；d.GERD-Q评分>8分。排除标准为：食管癌或胃癌。
2、在原有治疗的基础上，随机增加试验组合物A(对照组)5例，或试验组合物B(治疗组)的治疗5例，给药剂量均为每日1次，每次1袋，治疗30天。
3、症状疗效判定标准：GERD-Q评分下降分数。
结果：治疗前A组的GERD-Q总分为48分，B组48分；治疗后B组的GERD-Q总分为34分，A组42分。B组的疗效要明显优于A组。
治疗后GERD-Q评分改善
治疗前GERD-Q 治疗后GERD-Q
B组-治疗组 9 6
11 10
8 5
9 6
11 7
A组-对照组 8 8
11 9
10 9
9 8
10 8
通过上述实验可知，添加增稠物质后的透明质酸钠、胶原蛋白肽的组合物相较于只有透明质酸钠、胶原蛋白肽的组合物，在消化道黏膜修复上具有显著的效果。

Claims (5)

1.一种促进消化道黏膜修复的组合物，其特征在于：包括以下重量份的物质：透明质酸钠10-200mg、胶原蛋白肽500-15000mg、增稠物质200-20000mg。
2.根据权利要求1所述一种促进消化道黏膜修复的组合物，其特征在于：所述增稠物质为圆苞车前子壳。
3.根据权利要求1所述一种促进消化道黏膜修复的组合物，其特征在于：所述增稠物质包括果胶、黄原胶、卡拉胶、瓜尔豆胶、阿拉伯胶等食品增稠剂。
4.根据权利要求1所述一种促进消化道黏膜修复的组合物，其特征在于：所述增稠物质还包括淀粉。
5.根据权利要求4所述一种促进消化道黏膜修复的组合物，其特征在于：所述淀粉包括藕粉、葛粉、抗性淀粉等。
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