CN111789837A - 用于预防和治疗幽门螺杆菌轻、中度感染的组合物 - Google Patents
用于预防和治疗幽门螺杆菌轻、中度感染的组合物 Download PDFInfo
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Abstract
用于预防和治疗幽门螺杆菌轻、中度感染的组合物,涉及医疗及食品技术领域,特别是属于一种预防和治疗幽门螺杆菌轻、中度感染的组合物。其特征在于,包含载体、维生素E和抗坏血酸棕榈酸酯,所述载体为含有不饱和脂肪酸的植物油;所述抗坏血酸棕榈酸酯为维生素C的酯化衍生物。按照食品安全规定限量添加相应组分,既有利于杀灭幽门螺杆菌,又不会对人体产生一定的副作用,解决了目前临床上日益严重的耐药性顽疾,且可作为预防和治疗轻、中度幽门螺杆菌感染的药物长期服用。
Description
技术领域
本发明涉及医疗及食品技术领域,特别是属于一种预防和治疗幽门螺杆菌轻、中度感染的组合物。
背景技术
幽门螺杆菌普遍存在于人与动物(猕猴、大鼠、猪、犬等)的胃与十二指肠或口腔中。幽门螺杆菌包含犬幽门螺杆菌、胃螺杆菌、黑氏螺杆菌、拉普尼螺杆菌和萨洛莫尼螺杆菌等,是一种革兰氏阴性杆菌,螺旋形、微需氧、对生长条件要求十分苛刻。1983年首次从慢性活动性胃炎的胃粘膜活检组织中分离成功。据不完全统计,大约有50-60%人们的胃里普遍存在幽门螺杆菌,有些国家几乎90%的人都感染过这种细菌。人们通常在幼年时就受到感染,5岁以下达到50%。这种细菌感染首先引起慢性胃炎,并导致胃溃疡和胃萎缩,严重者则发展为胃癌,甚至被列在一类致癌物清单中,严重影响了人们的身体健康与生命安全。
据统计,初次感染幽门螺杆菌年龄较早的人群萎缩性胃炎及胃癌发生率高,幽门螺杆菌感染与胃癌死亡率的高低呈现平行关系。幽门螺杆菌寄生在胃黏膜组织及口腔当中,67%~80%的胃溃疡和95%的十二指肠溃疡是由幽门螺杆菌引起的。慢性胃炎和消化道溃疡患者的普遍症状为:食后上腹部饱胀、不适或疼痛,常伴有其他不良症状,如嗳气、腹胀、反酸和食欲减退等。有些患者还可出现反复发作性剧烈腹痛、上消化道少量出血等。
幽门螺杆菌生存在人们或动物的胃里,尽管胃酸的PH值达到2-3左右,具有较強酸性,一般细菌不能存活,幽门螺杆菌却不会被胃酸杀灭。因为幽门螺杆菌不仅自身能分泌过氧化物岐化酶(SOD)和过氧化氢酶,保护细菌不受人体白细胞杀伤,还分泌一种尿素酶(脲酶),脲酶在胃中分解尿素水产生氨。氨的PH值达到11.3左右,具有较强碱性。氨在幽门螺杆菌周边与胃酸中和,使之不受胃酸影响而正常生存。脲酶分解尿素的过程放出氨气。氨气有毒,使患者产生口臭,它不仅能使胃及十二指肠黏膜受损,形成溃疡,而且对呼吸道有损害作用,它极易与血红蛋白结合,减弱运氧功能,减弱人体对疾病的抵抗力。
为消除幽门螺旋杆菌对人体的健康的伤害,通常采用三联疗法或四联疗法。目前用于治疗幽门螺杆菌引起疾病的常用药物有六种:两种消炎药加一种质子泵抑制剂加一种铋剂,常用的消炎的青霉素类药物,包括阿莫西林、克拉霉素、甲硝唑、四环素、呋喃唑酮、头孢米诺等。尽管这些药物为治疗因幽门螺杆菌感染而导致的疾病发挥了重要作用,但治好以后,由于幽门螺杆菌极易重新感染且抗药性极强,重新感染后,第二次如用第一次同一药物,由于抗药性产生,其药效逐渐下降。另外,治疗药物的副作用较大,抗生素对人体有益菌亦有误伤,特别是其主要药物铋剂对人体消化功能、泌尿系统、神经系统与骨骼肌肉均产生不能逆转的损伤。故说现有的治疗方法及用上述药物治疗的手段是不完善的。
发明内容
本发明的目的即在于提供一种用于预防和治疗幽门螺杆菌轻、中度感染的组合物,以达到有效抑制和杀灭幽门螺杆菌的同时,不产生耐药性且对人体无毒副作用的目的。
本发明所提供的用于预防和治疗幽门螺杆菌轻、中度感染的组合物,其特征在于,包含载体、维生素E和抗坏血酸棕榈酸酯,所述载体为含有不饱和脂肪酸的植物油;所述抗坏血酸棕榈酸酯为维生素C的酯化衍生物。
进一步的,所述组合物还包含β-胡萝卜素、维生素C和维生素A的任意组合物。
进一步的,所述植物油由大豆油、火麻油、亚麻籽油和棕榈油中的至少一种构成。
进一步的,所述组合物以植物油为载体,按载体质量的百分比添加以下组分:维生素E 0.0005~0.145%,抗坏血酸棕榈酸酯0.001~0.02%,β-胡萝卜素 0.0003~0.0006%,维生素A 0.00003~0.0017%,维生素C 0.005~1.3%。
维生素E是透明油状液体,无色或几乎无色或浅黄色或浅黄绿色。是有8种形式的脂溶性维生素,其水解产物为生育酚,是最主要的抗氧化剂之一。维生素E包括α、β、γ、δ生育酚和α、β、γ、δ三烯生育酚,α-生育酚是自然界中分布最广泛、含量最丰富、活性最高的维生素E形式。维生素E的抗氧化特性保护机体细胞免受自由基的毒害。通过医学研究和临床实践,证明强抗氧化剂维生素E辅助三联或四联疗法可有效治疗胃幽门螺杆菌,治疗胃及十二指肠溃疡,可根除幽门螺杆菌及对炎症因子起作用。维生素E可直接清除自由基,保护胃上皮细胞缆。维生素E还能传递电子给自由基,从而减少自由基引发的粘膜内脂质过氧化反应, 减轻幽门螺杆菌分泌的过氧化物岐化酶(SOD)和过氧化氢酶的作用,保护胃粘膜;同时维生素E还能维护神经生物膜的完整性,阻止胃及十二指肠粘膜内末梢神经原遭毒性损伤及自由基攻击。
维生素C是强抗氧化剂,水溶性,在体内留存时间较短,但通过对其酯化可形成脂溶性抗坏血酸棕榈酸酯等,可在体内驻留24小时以上,缓慢释放维生素C。维生素C可通过逐级供给电子而转变为半脱氢抗坏血酸和脱氢抗坏血酸的过程清除体内超负氧离子(O2-)、羟自由基(OH-)、有机自由基(R-)和有机过氧基(ROO-)等自由基,可以阻断致癌物N-亚硝基化合物合成,减少氨生成,可降低胃液pH值,中和氨产生的碱性环境。使生育酚自由基重新还原成生育酚,反应生成的抗坏血酸自由基在一定条件下又可被NADH2的体系酶作用下还原为抗坏血酸。高浓度的维生素C有助于食物蛋白质中的胱氨酸还原为半胱氨酸,进而合成抗体,预防癌症。维生素C适宜空腹服用。抗坏血酸棕榈酸酯,为白色或类白色粉末,略有柑橘气味,是维生素C的酯化产物,可溶解于植物油。
β-胡萝卜素也是强抗氧化剂,一种橘黄色的脂溶性化合物,可溶于植物油,在体内50%转化为维生素A。β-胡萝卜素的抗氧化性主要表现在它具有清除自由基的能力,β-胡萝卜素分子中含有多个双键,在光、热、氧气及活泼性较强的自由基离子的存在下,易被氧化,从而保护机体不被破坏。生物体中存在大量的脂质过氧化和自由基反应,从而导致细胞功能下降,机体衰老以及疾病的发生,β-胡萝卜素的存在可减少脂质过氧化。因此,β-胡萝卜素可以清除自由基以及淬灭单线态氧的活性。由β-胡萝卜素转化成的维生素A,可治疗消化性溃疡、应激性溃疡,参与胃内上皮组织的正常代谢,并参与上皮组织间质中粘多糖合成,对人的胃粘膜损伤有保护作用。
火麻油,从火麻仁榨取获得,有极高的营养价值。火麻仁又称大麻仁或麻仁,为桑科植物大麻的干燥成熟果实。其味甘、性平,入脾、胃经,能润燥滑肠,滋养补虚。火麻仁含有丰富的蛋白质不饱和脂肪酸,还有卵磷脂、亚麻酸、维生素及钙、铁矿物等人体必需的微量元素,特别是具有ω-6族亚油酸与ω-3族α-亚麻酸2.4 : 1的天然比值,符合国际卫生组织推荐的小于等于4 :1的最佳比值的特点,是最具营养平衡性的油脂且可溶于水。火麻油中含有的亚麻酸、亚油酸等不饱和脂肪酸,能抑制幽门螺杆菌的活动,且不产生耐药作用。食之有润肠胃、滋阴补虚、助消化、明目保肝、祛病益寿之功效,且对便秘、高血压和高胆固醇等疾病有特殊的疗效。国家卫生部将火麻仁列入“既是食品又是药品(药食同源)的清单”。
亚麻籽油,由亚麻籽制取而成,亚麻籽是亚麻科植物亚麻的籽实,亚麻别称胡麻。冷榨亚麻籽油富含植物来源ω-3亚麻酸和ω-6亚油酸等人体必需脂肪酸和其它天然成份,如氨基酸种类齐全,含必需氨基酸量高达5.16%。氨基酸能抑制幽门螺杆菌的活动,且不产生耐药作用。亚麻籽油中α-亚麻酸含量为53%,α-亚麻酸是人体必需脂肪酸,α-亚麻酸有抗肿瘤,抗血栓,降血脂,营养脑细胞,调节植物神经等作用。人体摄入α-亚麻酸能纳入白细胞,当白细胞受到刺激时又被释放出来,并改变白细胞流动性,使白细胞的中性趋化及向内皮细胞粘反应受抑制,具有良好抗炎作用。亚麻籽油的主要微量营养成分为维生素E,具有天生的复合抗氧化剂作用。
维生素E、维生素C和β-胡萝卜素这三种都是强抗氧化物质,对于胃部而言,能起到修复胃黏膜,抑制幽门螺旋杆菌增殖,预防胃部癌变的作用。有慢性胃炎,胃溃疡,萎缩性胃炎,浅表性胃炎,糜烂性胃炎等胃部疾病的人群,可以使用这些抗氧化物质的组合物来调理胃部。这些抗氧化剂需要按照特定比例搭配,维生素E,维生素A都不能补充过量,否则无益健康。经实验发现连续服用维生素E、维生素C和β-胡萝卜素,可显著降低由过氧化氢诱发的DNA损伤。
在正常饮食中,维生素E、抗坏血酸棕榈酸酯、β-胡萝卜素均有食用限量,因此单一使用其中的一种抗氧化剂在超标情况下杀灭幽门螺杆菌会对身体带来一定危害。通过遵守以下食品安全规定限量:GB 2760《食品安全国家标准 食品添加剂使用标准》和GB14880《食品安全国家标准 食品营养强化剂使用标准》以及各相关的增补公告,按组成物的食品限量形成组合物配方,既有利于杀灭幽门螺杆菌,又不会对人体产生副作用,可以健康安全长期服用本产品,以达到预防作用。
以火麻油或亚麻籽油等植物油作为为载体和质量参照物,配方中相关限量如下:维生素E食用限量5~1450mg/kg,抗坏血酸棕榈酸酯食用限量10~200mg/kg(以脂肪中抗坏血酸计),β-胡萝卜素食用限量3~20000mg/kg,维生素C食用限量50~13000 mg/kg,维生素A食用限量300~17000 μg/kg。
本发明所提供的用于预防和治疗幽门螺杆菌轻、中度感染的组合物,具有以下积极效果:
1、组合物选用强抗氧化物质,如维生素E、维生素C和β-胡萝卜素,能起到修复胃粘膜,抑制幽门螺杆菌增殖,预防胃部癌变的作用;同时可显著降低由过氧化氢诱发的DNA损伤;
2、本发明公开的组合物以植物油为载体,按照食品安全规定限量添加相应组分,既有利于杀灭幽门螺杆菌,又不会对人体产生一定的副作用,解决了目前临床上日益严重的耐药性顽疾,且可作为预防和治疗轻、中度幽门螺杆菌感染的药物长期服用。
具体实施方式
本发明所公开的用于预防和治疗幽门螺杆菌轻、中度感染的组合物,包含载体、维生素E和抗坏血酸棕榈酸酯,载体为含有不饱和脂肪酸的植物油,其中,植物油是由大豆油、火麻油、亚麻籽油和棕榈油中的至少一种构成。抗坏血酸棕榈酸酯为维生素C的酯化衍生物。此外,组合物还包含β-胡萝卜素、维生素C和维生素A三者的任意组合物。由于抗坏血酸棕榈酸酯在人体内会缓慢分解出维生素C,β-胡萝卜素在人体内约有50%转化为维生素A,即β-胡萝卜素、维生素C和维生素A作为补充添加的物质。
上述组合物以植物油为载体,并添加以下物质:维生素E 0.0005~0.145%,抗坏血酸棕榈酸酯0.001~0.02%,β-胡萝卜素 0.0003~0.0006%,维生素A 0.00003~0.0017%,维生素C 0.005~1.3%。上述的质量百分比为添加物质量与载体质量的比值。
根据下述实施例,可以更好地理解本发明。然而,本领域的技术人员容易理解,实施例所描述的内容仅用于说明本发明,而不应当也不会限制权利要求书中所详细描述的本发明。
实施例:
(一)组合物制备及其服用方法
以纯化水将食用明胶和增塑剂化胶,生成明胶液,按以下比例配制(以1000丸为例):火麻油1000g、维生素E 1g、抗坏血酸棕榈酸酯200mg、β-胡萝卜素1g,混合均匀,置于压丸机内压丸成形,洗丸,低温、低湿干燥,拣丸。将内包装材料消毒,铝塑、装瓶,添加外包装,入库,即得组合物成品。
服用方法:每日早、晚餐前半小时用水吞服1丸软胶囊, 30天为一疗程。
如口臭严重,说明口腔内含有幽门螺杆菌较多,服用时,在早、晚餐前半小时,嚼碎软胶囊,使软胶囊内火麻油等植物油充分在口腔内浸润,然后咽下,连续数天,直至口臭现象消失,再恢复用水吞服方式。
(二)抗菌性实验
在琼脂培养基上,预孵育幽门螺杆菌株,密度为107-108CFU/mL,按胃幽门螺杆菌最终浓度为0.3mg/mL的比例,将实施例所得组合物成品去除胶囊外壳,添加至盛有2ml细胞悬浮液的塑料管中,接触60min,量取0.1mL加入到平板上,培养5天,菌落计数,与空白组对照。实验结果详见表1。
表 1 本组合物对幽门螺杆菌的杀灭作用
实验结果表明,本组合物具有良好的幽门螺杆菌杀灭效果。
Claims (4)
1.一种用于预防和治疗幽门螺杆菌轻、中度感染的组合物,其特征在于,包含载体、维生素E和抗坏血酸棕榈酸酯,所述载体为含有不饱和脂肪酸的植物油;所述抗坏血酸棕榈酸酯为维生素C的酯化衍生物。
2.根据权利要求1所述的用于预防和治疗幽门螺杆菌轻、中度感染的组合物,其特征还在于,所述组合物还包含β-胡萝卜素、维生素C和维生素A的任意一种或多种。
3.根据权利要求1所述的用于预防和治疗幽门螺杆菌轻、中度感染的组合物,其特征还在于,所述植物油由大豆油、火麻油、亚麻籽油和棕榈油中的至少一种构成。
4.根据权利要求1或2所述的用于预防和治疗幽门螺杆菌轻、中度感染的组合物,其特征还在于,所述组合物以植物油为载体,按质量百分比添加以下组分:维生素E 0.0005~0.145%,抗坏血酸棕榈酸酯0.001~0.02%,β-胡萝卜素 0.0003~0.0006%,维生素A0.00003~0.0017%,维生素C 0.005~1.3%。
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