CN105614851A - 肝性脑病医学配方食品 - Google Patents
肝性脑病医学配方食品 Download PDFInfo
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- CN105614851A CN105614851A CN201510987046.1A CN201510987046A CN105614851A CN 105614851 A CN105614851 A CN 105614851A CN 201510987046 A CN201510987046 A CN 201510987046A CN 105614851 A CN105614851 A CN 105614851A
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- radix
- polysaccharide
- rhizoma
- fructus
- food
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- Medicines Containing Plant Substances (AREA)
Abstract
本发明属于药食同源类配方与新资源食品技术领域,具体是提供了供肝性脑病患者食用的医学配方食品、特定医学配方食品或非特定医学配方食品;该配方根据《特殊医学用途配方食品通则》的要求,结合肝性脑病患者的体质特征,根据传统中医精髓理论合理配伍多种“药食同源”之中药,采用半仿生提取法提取药食两用的中药提取物精华、多种微胶囊化的益生菌以及生物酶解提取的短肽、益生元、氨基酸、碳水化合物、有保健功能的油脂、多种维生素及矿物质一起混合等工艺加工制成,不仅可作为单一营养来源满足肝性脑病患者的营养需求,还起到了健脾益肺、利胆护肝、滋阴柔肝、柔肝止痛及增强免疫力的功效。
Description
技术领域
本发明属于药食同源类配方与新资源食品技术领域,具体是将“药食同源之中药”的传统中医精髓理论和“多重益生菌”有机结合起来,添加以短肽、益生元、氨基酸、水溶性膳食纤维、有保健功能的油脂、复合维生素、复合矿物质为辅料制成的防治肝性脑病的医学配方食品、特定医学配方食品或非特定医学配方食品。
背景技术
肝性脑病(HE)又称肝性昏迷,是严重肝病引起的、以代谢紊乱为基础的中枢神经系统功能失调的综合病征,其主要临床表现是意识障碍、行为失常和昏迷,有急性与慢性脑病之分;引起肝性脑病的原发病有重症病毒性肝炎、重症中毒性肝炎、药物性肝病、妊娠期急性脂肪肝、各型肝硬化、门-体静脉分流术后、原发性肝癌以及其他弥漫性肝病的终末期,而以肝硬化患者发生肝性脑病最多见,约占70%;诱发肝性脑病的因素很多,如上消化道出血、高蛋白饮食、大量排钾利尿、放腹水,使用安眠、镇静、麻醉药,便秘、尿毒症、感染或手术创伤等,这些因素大体都是通过:①使神经毒质产生增多或提高神经毒质的毒性效应;②提高脑组织对各种毒性物质的敏感性;③增加血-脑脊液屏障的通透性而诱发脑病;
肝性脑病的发病机制目前尚不明了,可能与下列一些因素有关:(一)氨中毒学说:正常情况下,氨的生成和清除保持着动态平衡,从而使血氨水平维持正常,肝功能严重受损时,血氨水平可升高,血氨水平升高可以是氨生成增多或(和)氨清除不足(鸟氨酸循环障碍)所致;(二)假性神经递质学说:儿茶酚胺和多巴胺是神经系统中正常的神经递质,通常血液中的儿茶酚胺不能通过血脑屏障,故脑内儿茶酚胺必须依靠神经组织自身合成,蛋白质饮食中带有苯环的氨基酸如苯丙氨酸和酪氨酸,它们在肠道中经细菌的脱坡作用可形成苯乙胺和酪胺,此类生物胺被肠道吸收后由门静脉人肝;(三)血浆氨基酸失衡学说:正常情况下,血浆中各种氨基酸的含量保持较适当的比例,AAA(芳香族氨基酸)大量进入细胞,使假性神经递质生成增多,并抑制正常神经递质的合成,最终导致肝性脑病的发生,血浆氨基酸失衡学说是假性神经递质学说的补充和发展;(四)由于肝脏受损,导致蛋白质分解吸收不全,或者肝硬化等患者摄入了过量蛋白质,过多的蛋白在肠道内经细菌分解产生氨,导致血氨浓度升高,进而诱发肝昏迷;
肝性脑病的危害:根据患者意识障碍程度、神经系统表现及脑电图改变,参照我国实用内科学,可将肝性脑病分为0-4期,但各期可重叠或相互转化;微型肝性脑病,患者常常无明显异常,只有轻微的神经生理及心理异常,可能会由于注意力不集中而不能很好地完成精细动作,如进行高空作业或驾驶汽车等可能会有安全隐患;重型肝性脑病可能会由于中枢抑制而危及生命,反复发作或治疗依赖性肝性脑病的预后较差,肝昏迷程度越深,预后越差,死亡率越高,其中Ⅲ期、Ⅳ期肝性脑病的存活率小于30%;
“药食同源”是中华原创医学之中对人类最有价值的贡献之一;中医历来强调“药疗不如食疗”,食疗成为现代人追求返璞归真、健康饮食的最佳选择;让人们在享受美食的过程中祛除病痛,避免了打针、吃药,甚至手术之苦;
对于特殊营养食品,在美国、欧盟等发达国家都有相应的规定和开发应用;而我国GB29922-2013《特殊医学用途配方食品通则》食品安全国家标准中全营养食品明确规定:2.1.1全营养配方食品:可作为单一营养来源满足目标人群营养需求的特殊医学用途配方食品;2.1.2特定全营养配方食品:可作为单一营养来源满足目标人群在特定疾病或医学状况下营养需求的特殊医学用途配方食品;
中医传统医学认为:“脾(即消化系统)为后天之本”,肠胃健康是健康之本,人体营养的99%需要靠肠道吸收,肠内疾病也是万病之源;但随着年龄越大,肠道中有益菌群(益生菌)比例逐渐减少;如双歧杆菌在婴幼儿时期占98%,到中年时降至10%,65岁以后仅占5%;人越老,益生菌越少,肠道功能也随之逐渐下降,越来越多的研究显示,正常菌群在人体消化、免疫和抗病等方面有诸多不可替代的作用;肠道菌群组成的改变与多种疾病,特别是肠道疾病的发生发展密切相关,而从已有临床研究发现:益生菌能起到调节肠道菌群,控制肠道炎症作用,是一种安全有效的干预调节方法;
直接口服益生菌虽有一定效果,但是由于益生菌在肠道内无法定植,且停留、占位很少,易流失,停服后有害菌易复发,相关患者需要长期服用,治疗周期长,往往使用后复发率非常高;为缩短相关患者的治疗周期,减少停药后复发率,本团队通过近三年来对益生菌在肠道内定植机理的关键技术研究,努力寻求改进益生菌在肠道内定植的“药食同源之中药”复方,考虑到益生菌在肠道内定植的几个关键要素:益生元的存在能起到定植作用、肠道pH环境的降低和提高益生菌细胞的肠道粘附能力等,基于上述要素,本课题组从数十种“药食同源之中药”中筛选合适的食材,首次发现了添加山药、薏仁、鸡内金、芡实和菊芋等药食同源之中药成分的提取物及水苏糖,酵母、L-谷氨酰胺等后,对外源益生菌有很强的定植作用,为肠道微生态制剂中益生菌的组方选择提供实验依据;
目前市场上有利用以食源性短肽为主要原料,添加药食两用的玉米须、黄精、百合、葛根的提取物、复合维生素和矿物质,组成复合配方,还有利用益生菌为主要原料的产品,但还没有发现结合肝性脑病患者的体质特征,依据传统中医的精髓理论,因人而异,黄金配伍以十种以上药食两用的中药提取物精华、多种益生菌、益生元为主要原料,以短肽、氨基酸、有保健功能的油脂、水溶性膳食纤维、复合维生素、复合矿物质辅料制成的医学配方食品、特定全营养配方食品或类似产品。
发明目的
本发明的目的是在继承中医精髓理论治病方法上,开创性将多种改善肝性脑病患者的肠道微生态的益生菌与“药食同源之中药”复方的提取物有机结合起来,添加以短肽、氨基酸、碳水化合物、有保健功能的油脂、多种维生素、多种矿物质为辅料,不仅能够补充免疫力低下的肝性脑病患者所必需营养素,改善机体营养状况,还能并利用药食两用中草药中的功能因子调节机体功能,益生菌能起到调节肠道菌群,毒副作用小、安全有效,且人们容易接受的适合肝性脑病患者食用的医学配方食品、特定医学配方食品或非特定医学配方食品。
发明内容
本研发团队根据《特殊医学用途配方食品通则》的要求,结合肝性脑病患者的体质特征,综合当今美国哈佛大学的先进生理学、医药、营养学及临床应用等研究成果,依据“消中寓补”、“均衡调养”的传统中医的精髓理论(肝、脾、肾三脏同调为主原则),采用三种以上或全部药食两用的中药提取物精华及新资源食品、多种益生菌、短肽为主要原料,以益生元、碳水化合物、有保健功能的油脂、氨基酸、多种维生素及矿物质辅料,不仅可作为单一营养来源满肝性脑病患者的营养需求,还有健脾益肺、利胆护肝、滋阴柔肝、柔肝止痛及增强免疫力的功效的医学配方食品、特定医学配方食品或非特定医学配方食品(组合成的复合配方);
本发明配方的主要成分为:
1.中药提取物是根据肝性脑病患者的体质特征从中医理论中的肝、脾、肾三脏同调为主原则,利用药食两用中草药中的功能因子调节机体功能防治肝性脑病,并选取以下几大类药物进行配伍;其中:半夏,具有燥湿化痰,降逆止呕,生用消疖肿作用;泽泻,利水,渗湿,泄热;赤芍,行瘀、止痛、凉血、消肿;大黄,具有攻积滞、清湿热、泻火、凉血、祛瘀、解毒等功效;厚朴,味辛、性温,具有行气化湿、温中止痛、降逆平喘的功效;车前子,能去风毒、肝中风热;黄连,清热燥湿,泻火解毒;羚羊角,平肝息风,清肝明目,凉血解毒;白芍,具有补血养血、平抑肝阳、柔肝止痛、敛阴止汗等功效;黄芩,有清热燥湿、泻火解毒、止血、安胎等功效;金钱草,具有清热解毒,散瘀消肿,利湿退黄的功效;黄芪,具有降低血液黏稠度、减少血栓形成、降低血压、保护心脏、双向调节血糖、抗自由基损伤、抗衰老、抗缺氧、抗肿瘤、增强机体免疫力作用;麦冬,养阴生津,润肺清心;太子参,体润性和、补气生津;石斛,益胃生津,滋阴清热;当归,补血和血,调经止痛,润燥滑肠;熟地黄,味甘,性微温,具有滋阴补血、益精填髓等功效;枳实,破气消积,化痰散痞;党参,含多种糖类、酚类、甾醇、皂甙及微量生物碱,具有增强免疫力、扩张血管、降压、改善微循环、增强造血功能的作用,能增强机体抵抗力;枳椇子,性味甘酸平,具有清热,止烦渴,补中益气、润五脏、舒筋络的功效;辣木叶,可协助改善、预防疾病,改善睡眠、增强记忆力、延缓衰老,还可用来治疗肝脏、脾脏、经络等特殊部位的疾病,还具有治疗口臭和醒酒等作用;裸藻,对肝脏的防御保护,清除有害胆固醇,缓解慢性疲劳,改善睡眠;乌梢蛇,祛风湿,通经络,熄风止痉,止痒解毒;蒲公英,热水提取物(Tof-CFr)的抗肿瘤作用,Tof-CFr是一种多糖体,具有宿主调节抗肺瘤作用,并与香菇多糖的抗癌作用机理相似,是一种免疫促进剂;鱼腥草,具有清热解毒,消痈排脓功效用;栀子,具有护肝、利胆、降压、镇静、止血、消肿等作用;佛手,入肝、脾、胃三经,有理气化痰、止呕消胀、舒肝健脾、和胃更多种药用功能;茯苓,茯苓多糖有明显的抗肿瘤作用,有利尿作用,能增加尿中钾、钠、氯等电解质的排出,有镇静及保护肝脏增强机体免疫功能,抑制溃疡的发生、降血糖、抗放射等作用;芦根,有清热生津、除烦、止呕、利尿的功效;淡竹叶,有清凉,解热、利尿及催产之效;夏枯草,性寒,味甘、辛、微苦,具有清泄肝火、散结消肿、清热解毒、祛痰止咳、凉血止血的功效;菊花,具有散风热、平肝明目、消咳止痛的功效;乌梅,梅子中含多种有机酸,有改善肝脏机能的作用,故肝病患者宜食之;甘草,功能主治清热解毒、祛痰止咳、脘腹等;枸杞,补肝肾、益精明目和养血、增强人们的免疫力;山药,能促进酶系及免疫系统的功能,改善整体代谢,限制肿瘤生长,具有一定的抗肿瘤作用;薏苡仁,利湿健脾,舒筋除痹,清热排脓;陈皮,理气健脾,调中,燥湿,化痰;龙眼,补心脾,益气血,健脾胃,养肌肉,思虑伤脾,头昏,失眠,心悸怔忡,虚赢,病后或产后体虚,及由于脾虚所致之下血失血症;
本发明所述的药食两用中药提取物及新资源食品是指:石菖蒲、郁金、胆南星、半夏、泽泻、炙远志、沉香、苍术、厚朴、茵陈、赤芍、大黄、竹茹、元参、车前子、黄连、金钱草、黄芩、生地、知母、牡丹皮、羚羊角、白芍、炙龟板、熟地、钩藤、石决明、生石膏、山萸肉、紫雪丹、红参、黄芪、煅龙骨、熟附子、五味子、麦冬、芒硝、六月雪、血盆草、阴行草、毛冬青、千金子、黄柏、太子参、北沙参、石斛、当归、合欢皮、胆星、枳实、党参、枳椇子、辣木叶、裸藻、乌梢蛇、蒲公英、鱼腥草、佛手、栀子、茯苓、芦根、淡竹叶、夏枯草、菊花、煅牡蛎、乌梅、刺梨、黑豆、甘草、枸杞子、生麦芽、山药、干姜、薏苡仁、陈皮、龙眼三种以上或全部的混合物;
2.多种益生菌:使益生菌能大部分通过胃的强酸环境到达肠道,以促进益生菌的增殖,调节肠内微生态平衡,促进对微量元素的吸收,增强脾胃运动功能,加速药效的吸收,改善黏膜表面的微生物群或酶的平衡,或刺激机体特异性或非特异性免疫机制,提高机体定植抗力或免疫力;Xing等用双歧杆菌和乳酸杆菌预处理肝缺血再灌注大鼠,可以明显降低肠源性内毒素血症的水平并预防肝损伤的发生;选择性肠道脱污染也是调整肠道微生态的重要措施,有研究应用肠道不吸收抗生素利福昔明(rifaximin),通过抑制肠道中产尿素酶及产氨细菌的生长,来防治糖尿病的发生;
本发明所述的多种益生菌全部采用微胶囊化后的益生菌,其所述的益生菌为双歧杆菌、乳杆菌、嗜热链球菌、清酒乳杆菌、产丙酸丙酸杆菌、乳酸片球菌其中一种、几种或全部混合;其中双歧杆菌是指青春双歧杆菌、乳双歧杆菌、两歧双歧杆菌、短双歧杆菌、婴儿双歧杆菌、长双歧杆菌、动物双歧杆菌(乳双歧杆菌)其中一种、几种或全部混合;乳杆菌是指:嗜酸乳杆菌、干酪乳杆菌、保加利亚乳杆菌、德氏乳杆菌亚种、格氏乳杆菌、发酵乳杆菌、瑞士乳杆菌、唾液乳杆菌、鼠李糖乳杆菌、罗伊氏乳杆菌、植物乳杆菌、副干酪乳杆菌、约氏乳杆菌、副干酪乳杆菌、卷曲乳杆菌、德氏乳杆菌保加利亚亚种、罗伊氏乳杆菌其中一种、几种或全部混合;
3.短肽:即为低聚肽,是指利用生物酶工程技术从动物或植物蛋白中分离提取的一类小分子蛋白质,其平均分子量在1000Dalton以下,易溶于水,对酸、热稳定,可以不需经过消化而直接吸收,生物利用率高,在吸收和利用上优于游离的氨基酸和完整的蛋白质,可应用于蛋白质补充食品中,尤其对于消化吸收能力低下的人群,短肽是极佳的氮源,除营养功能外,短肽还具有一系列的生理活性功能:提高小肠的消化吸收功能,增强机体免疫力,抗氧化,辅助调节血糖,辅助调节血脂,辅助降血压,抗辐射,促进矿物质吸收,增强药食两用中草药中功能因子的作用效果;
本发明所述的短肽是指海洋胶原肽、海洋骨原肽、大豆蛋白肽、乳清蛋白肽、卵白蛋白肽其中一种、几种或全部混合;
4、益生元:以促益生菌肠道定植、肠道收敛、降低肠道pH环境,也不被大多数的肠道腐败菌利用,但可以促进人体内有益细菌——乳杆菌、双歧杆菌的生长繁殖,从而可以抑制腐败菌生长,有助于改善和维持肠道正常功能;长期食用可以延缓衰老、通便、提高免疫力、减轻肝脏负担、提高营养素的吸收率,特别是能够改善机体对钙、铁、锌等金属离子的吸收;可选择性地促进有益菌(双歧、乳酸)的生长繁殖外,还可代谢为酸性产物如乳酸等有机酸,使结肠内pH值降低,抑制肠道有害细菌的生长;使小肠内水电解质滞留在肠腔,产生高渗效果,刺激肠蠕动引起缓泻,从而促进肠道内毒素及其他毒性物质的排出,乳果糖还可直接灭活肠道中内毒素、降低肠道pH值,已广范应用于增强肝性脑病抵抗力的治疗;
本发明所述的益生元为山药、茯苓、薏仁、鸡内金、芡实、菊粉的提取物,棉子低聚糖,水苏糖,酵母,低聚异麦芽糖,低聚果糖,大豆低聚糖,低聚木糖其中的一种、几种或全部混合;
5、碳水化合物:碳水化合物是由碳、氢和氧三种元素组成,它是为人体提供热能的三种主要营养素中最廉价的营养素,摄入充足时,在体内可迅速氧化及时提供能量,避免将宝贵的蛋白质用来提供能量,碳水化合物也是细胞膜的糖蛋白、神经组织的糖脂以及传递遗传信息的脱氧核糖核酸(DNA)的重要组成成分,而且碳水化合物中含有的糖原,当其在肝内储备充足时,肝细胞对某些有毒的化学物质和各种致病微生物产生的毒素有较强的解毒能力;
本发明所述的碳水化合物是指L-阿拉伯糖、果糖、蚌肉多糖、黄精多糖,金银花多糖、香菇多糖、白背三七多糖、茶树花多糖、枳椇子多糖、辣木叶多糖、显齿蛇葡萄叶多糖、裸藻多糖、青钱柳叶多糖、山药多糖、甘草多糖、陈皮多糖、茯苓多糖、葛根多糖、陈皮多糖、山楂多糖、灵芝多糖、车前子多糖、五味子多糖、红枣多糖、淮山活性多糖、茶藨子木层孔菌多糖、虫草多糖、石斛多糖、番石榴多糖、当归多糖、芦荟多糖、青钱柳多糖、麦冬多糖、薤白多糖、绿豆多糖、苦瓜多糖、芦笋多糖、胖大海多糖、荔枝果肉多糖、刺五加多糖、鲍鱼菇多糖、黄芪多糖、乌龙茶多糖、龙眼多糖、银杏叶多糖、人参多糖、丹参多糖、仙人掌多糖、铁筷子多糖、杏鲍菇多糖、苦瓜多糖、南瓜多糖、芦笋多糖、龙葵多糖、抗性糊精、壳寡糖、酵母β-葡聚糖、多聚果糖、海藻糖、半乳糖、乳糖、葡萄糖、麦芽糖、水溶性膳食纤维、淀粉、糖元其中的一种、几种或全部混合;
6.有保健功能的油酯是指对人身体有保健作用,并能增加终产品能量,使本发明的终产品每100g所含有的能量应不低于295kJ(70kcal);如鱼油是人体血管的清道夫,还能预防动脉硬化、中风和心脏病。鱼油是高血压、冠心病、脑中风、糖尿病、风湿性关节炎、癌症等疾病;亚麻籽油有减肥、降低胆固醇、改善肾功能等作用;牡丹籽油有降血脂和降血压,增强自身免疫,预防糖尿病,防治癌症的功效;翅果油有防止和治疗高血压,高血脂,血管硬化等病症的功效;
本发明所述的有保健功能的油脂是指亚麻籽油、牡丹籽油、翅果油、水飞蓟籽油、植物甾醇酯、御米油、茶叶籽油、鱼油、鱼油提取物、花生四烯酸油脂、蔗糖聚酯、DHA藻油、磷虾油、盐地碱蓬籽油、美藤果油、盐肤木果油、中链甘油三酯、黄明胶、光皮梾木果油、长柄扁桃油、中长链脂肪酸食用油、元宝枫籽油、表没食子儿茶素没食子酸酯、甘油二酯油、叶黄素酯其中的一种、几种或全部混合;
7.氨基酸:分为必需氨基酸与非必需氨基酸,是构成蛋白质的基本单位,赋予蛋白质特定的分子结构形态,使其具有生化活性;摄取适量的蛋氨酸有助于人体内各种含硫化合物的代谢并且其所含的甲基对有毒物或药物进行甲基化而起到解毒的作用;亮氨酸能够修复肌肉,控制血糖,并给身体组织提供能量,必需氨基酸苯丙氨酸可以抑制癌瘤生长,又可以降低药物的毒副作用;赖氨酸可提高食物蛋白质的吸收和利用,达到均衡营养,促进生长发育;精氨酸有助于将血液中的氨转变为尿素而排泄出去;对于高氨血症,肝脏机能障碍等均有功效;组氨酸降低胃液酸度,缓和胃肠手术的疼痛,减轻妊娠期呕吐及胃部灼热感,抑制由植物神经紧张而引起的消化道溃烂,对过敏性疾病,如哮喘等也有功效;色氨酸可以预防糙皮病、抑郁症,改善睡眠和调节情绪;
本发明所述的氨基酸是指L-谷氨酰胺、γ-氨基丁酸、珠肽粉、蛋氨酸、异亮氨酸、酪氨酸、苯丙氨酸、赖氨酸、精氨酸、组氨酸、色氨酸、瓜氨酸、鸟氨酸、牛磺酸其中的一种、几种或全部混合;
8.维生素和矿物质:维生素和矿物质是人体必需的营养素,本发明中添加的维生素为维生素和矿物质是人体必需的营养素;
本发明中添加的维生素为维生素A、维生素D、维生素E、维生素K1、维生素C、维生素B1、维生素B2、维生素B6、维生素B12、烟酸、叶酸、泛酸、胆碱、生物素其中的一种、几种或全部混合;
本发明中添加的矿物质为钙、磷、钾、钠、镁、氯、铁、锌、硒、铜、锰、碘、氟、铬、钼其中的一种、几种或全部混合,本发明所述的矿物质添加为该矿物质的有机或无机化合物;
本发明中维生素矿物质的添加量参照GB14880《食品营养强化剂使用卫生标准》、GB2760《食品添加剂使用标准》执行;
本发明以微胶囊,生物酶解,预水解、半仿生提取法、喷雾干燥及冷冻干燥集成创新,构成的产业化生产的关键技术;微囊化保护技术,有效解决了口服过程中高温以及强酸胃液对益生菌的灭活;采用三层蛋白质深埋微胶囊技术,再与经生物酶解或预水解、半仿生提取法提取并微囊化处理后的中药提取物混合均匀,以解决“多重益生菌”与“药食同源之中药”组分的共存问题,具有一定的抗高温和强酸特性,有利于益生菌通过口服顺利通过胃液到达肠道内停留定植,使产品防治肝性脑病的功效与市场同类产品相比大幅提高;
9.采用上述集成创新工艺将各种配料混合均匀制成粉状的固体饮料、颗粒剂,并分装成10g/包,用约150ml温开水溶解后,直接饮用或经鼻饲摄入;或加入适量辅料制成胶囊、片剂或加入甜味剂和黑芝麻粉制成快速、方便食品便于外出携带食用,若做成饮料则省去经喷雾干燥、少添加辅料,分装成10-65ml/瓶,每日早、中、晚饭后0.5小时各饮1瓶,所有操作均在符合《特殊医学用途配方食品良好生产规范》要求的洁净干燥环境内进行;
本配方医学配方食品的特性及其对机体的作用主要表现在以下几个方面:
1.本发明是根据《特殊医学用途配方食品通则》的要求,结合肝性脑病患者的体质特征,综合当今美国哈佛大学的先进生理学、医药、营养学及临床应用等研究成果研制的,因人而异,黄金配伍;
2.本发明依据“消中寓补”、“均衡调养”的传统中医的精髓理论(肝、脾、肾三脏同调为主原则),采用多种药食两用的中药提取物精华、多种益生菌、益生元为主要原料,以短肽、氨基酸、有保健功能的油脂、复合维生素、复合矿物质辅料,各种配料的有机组合,将各种功能进行融合,并通过有效成分之间的协同作用,增强作用效果;
3.具有高效吸收性,利用本发明配方,各种组分采用适宜的比例搭配制备的食品,经一定量水溶解后呈等渗状态,能快速通过胃到达小肠,吸收快速、完全,可以迅速补充肝性脑病患者所需营养,不增加肝肾负担;
4.本发明配方中采用各种药食两用中草药的提取物,含有多种功能活性成分,不仅提高了功能因子的浓度,减少各种杂质的摄入,有助于减轻肝肾负担,具有增强人体抵抗力的作用,还有健脾益肺、利胆护肝、滋阴柔肝、柔肝止痛及增强免疫力的功效;
5.本发明配方中所含的益生菌,多种益生菌能够维护肠道正常细菌菌群平衡,抑制病原菌的生长,防止胃肠障碍等,在肠道内合成维生素、氨基酸和提高机体对钙离子的吸收,增强人体免疫机能,预防抗生素的副作用,提高宿主对放射线的耐受性,乳杆菌显著增加肠粘膜免疫球蛋白A(SIgA)含量,对机体肠粘膜局部免疫具有调节作用,调节胃、肠微生态,能提高钙、磷、铁的利用率,促进铁和维生素D的吸收,产生维生素K及维生素B,还可以减少胆固醇的吸收;
6.本发明配方食品以多种来源的食源性生物活性短肽为氮源,因为短肽不需消化即可吸收,更有利于机体的利用,可以有效改善肝性脑病患者负氮平衡,而且食源性短肽能够改善肠粘膜上皮细胞的结构和功能,提高肠粘膜的吸收能力;
7.本组方采用了本团队通过近三年来对益生菌在肠道内定植机理的关键技术研究的成果,改进益生菌在肠道内定植的“药食同源之中药”复方,结合了益生元的存在能起到定植作用、肠道pH环境的降低和提高益生菌细胞的肠道粘附能力等要素,因此该食品配方的组成大大增强了对外源益生菌的定植作用;
8.本发明配方中所含的益生元,通过促进肠内益生菌的生长繁殖,抑制腐败菌的生长,同时在肠粘膜表面形成一道保护屏障,可以抵御肠道腐败菌对肠粘膜的损伤,减少肠内有害物质的吸收,还可以促进肠道蠕动,加速肠内残留物质的排出,可以防止便秘,而且通过促进肠道益生菌的生长繁殖也可以增强机体免疫力,短肽与活性多糖等生物活性物质具有协同作用;
9.本发明配方中所含的碳水化合物是为人体提供热能的三种主要营养素,在体内可迅速氧化及时提供能量,避免将宝贵的蛋白质用来提供能量,碳水化合物也是细胞膜的糖蛋白、神经组织的糖脂以及传递遗传信息的脱氧核糖核酸(DNA)的重要组成成分,而且碳水化合物中含有的糖原,当其在肝内储备充足时,肝细胞对某些有毒的化学物质和各种致病微生物产生的毒素有较强的解毒能力;
10.本发明配方中所含的有保健功能的油脂不仅对人身体有保健作用,并为人体提供正常生活所需的能量,使本发明的终产品每100g所含有的能量应不低于295kJ(70kcal);
11、本发明配方中所含的氨基酸,是构成蛋白质的基本单位,赋予蛋白质特定的分子结构形态,使其具有生化活性,有助于人体内各种含硫化合物的代谢并且其所含的甲基对有毒物或药物进行甲基化而起到解毒的作用,能够修复肌肉,控制血糖,并给身体组织提供能量,还可提高食物蛋白质的吸收和利用,达到均衡营养,促进生长发育;
12、本发明配方食品含多种维生素和矿物质,可迅速补充肝性脑病患者所需的微量营养素,短肽通过与钙、铁、锌等的螯合后,更增加了矿物质元素的吸收率;
13、本发明配方中不含脂肪和胆固醇,能够在补充蛋白质、微量营养素的同时,不会增加脂肪、胆固醇的摄入,避免了肉、蛋等髙蛋白食物的不利影响。
具体实施方式
下面通过以下实施例对本发明作进一步说明,它将有助于理解本发明;
实施案例一
实现本发明目的肝性脑病医学配方食品是以结合肝性脑病患者的体质特征,依据传统中医的精髓理论,因人而异,黄金配伍以三种以上或全部的药食两用中药提取物精华及新资源食品、多种益生菌、短肽为主要原料,以益生元、碳水化合物、氨基酸、有保健功能的油酯多种维生素、多种矿物质为辅料制成的医学配方食品;
按下列原料及其用量进行配方,药食两用的提取物及新资源食品:石菖蒲20g、郁金20g、胆南星20g、半夏20g、泽泻19g、炙远志19g、沉香19g、苍术19g、厚朴18g、茵陈18g、赤芍18g、大黄18g、竹茹17g、元参17g、车前子17g、黄连17g、金钱草16g、黄芩16g、生地16g、知母16g、牡丹皮15g、羚羊角15g、白芍15g、炙龟板15g、熟地14g、钩藤14g、石决明14g、生石膏14g、山萸肉13g、紫雪丹13g、红参13g、黄芪13g、煅龙骨12g、熟附子12g、五味子12g、麦冬12g、芒硝11g、六月雪11g、血盆草11g、阴行草11g、毛冬青10g、千金子10g、黄柏10g、太子参10g、北沙参10g、石斛9g、当归9g、合欢皮9g、胆星9g、枳实9g、党参8g、枳椇子8g、辣木叶8g、裸藻8g、乌梢蛇7g、蒲公英7g、鱼腥草7g、佛手7g、栀子6g、茯苓6g、芦根6g、淡竹叶6g、夏枯草5g、菊花5g、煅牡蛎5g、乌梅5g、刺梨4g、黑豆4g、甘草4g、枸杞子3g、生麦芽3g、山药3g、干姜2g、薏苡仁2g、陈皮1g、龙眼1g上述三种以上或全部的混合物;再添加多种益生菌300g、短肽200g、益生元100g、多种氨基酸100g、碳水化合物100g、有保健功能的油酯100g、维生素A0.01g、维生素D0.000015g、维生素E0.12g、维生素K10.00001g、维生素C0.63g、维生素B10.016g、维生素B20.016g、维生素B60.015g、维生素B120.0023g、烟酸0.2g、叶酸0.003g、泛酸0.051g、胆碱2.5g、生物素0.000057g、钙6.2g、磷4.5g、钾10g、钠16.17g、镁1.7g、氯0.15g、铁0.15g、锌6.2g、硒0.00012g、铜0.007g、锰0.018g、碘0.00001g、氟0.00001g、铬0.00001g、钼0.00001g;
制作时先将石菖蒲、郁金、胆南星、半夏、泽泻、炙远志、沉香、苍术、厚朴、茵陈、赤芍、大黄、竹茹、元参、车前子、黄连、金钱草、黄芩、生地、知母、牡丹皮、羚羊角、白芍、炙龟板、熟地、钩藤、石决明、生石膏、山萸肉、紫雪丹、红参、黄芪、煅龙骨、熟附子、五味子、麦冬、芒硝、六月雪、血盆草、阴行草、毛冬青、千金子、黄柏、太子参、北沙参、石斛、当归、合欢皮、胆星、枳实、党参、枳椇子、辣木叶、裸藻、乌梢蛇、蒲公英、鱼腥草、佛手、栀子、茯苓、芦根、淡竹叶、夏枯草、菊花、煅牡蛎、乌梅、刺梨、黑豆、甘草、枸杞子、生麦芽、山药、干姜、薏苡仁、陈皮、龙眼上述三种以上或全部浸泡后加入β-环状糊精,用预水解、半仿生提取法提取后,经喷雾干燥而制备的粉状物质,再添加短肽、益生元、氨基酸、碳水化合物、有保健功能的油脂、多种维生素及矿物质一起粉碎混合后进行巴氏灭菌1小时,然后添加微胶囊化后的双歧杆菌、微胶囊化后的乳杆菌、微胶囊化后的嗜热链球菌并混合均匀制成粉状的固体饮料、颗粒剂,并分装成10g/包,用约150ml温开水溶解后,直接饮用或经鼻饲摄入;或加入适量辅料制成胶囊、片剂或加入甜味剂和黑芝麻粉制成快速、方便食品便于外出携带食用,若做成饮料则省去经喷雾干燥、少添加辅料,分装成10-65ml/瓶,每日早、中、晚饭后0.5小时各饮1瓶,所有操作均在符合《特殊医学用途配方食品良好生产规范》要求的洁净干燥环境内进行;
本发明以微胶囊,生物酶解,预水解、半仿生提取法,喷雾干燥及冷冻干燥集成创新,构成的产业化生产的关键技术;微囊化保护技术,有效解决了口服过程中高温以及强酸胃液对益生菌的灭活;采用三层蛋白质深埋微胶囊技术,再与经生物酶解或预水解、半仿生提取法提取并微囊化处理后的中药提取物混合均匀,以解决“多重益生菌”与“药食同源之中药”组分的共存问题,具有一定的抗高温和强酸特性,有利于益生菌通过口服顺利通过胃液到达肠道内停留定植,使产品防治肝性脑病的功效与市场同类产品相比大幅提高。
实施案例二
上述肝性脑病医学配方食品还包括以重量计的下列组分:药食两用的提取物及新资源食品:枳椇子10g、辣木叶10g、裸藻10g、乌梢蛇9g、蒲公英9g、鱼腥草9g、佛手8g、栀子8g、茯苓8g、芦根7g、淡竹叶7g、夏枯草7g、菊花6g、煅牡蛎6g、乌梅6g、刺梨5g、黑豆5g、甘草4g、枸杞子4g、生麦芽3g、山药3g、干姜2g、薏苡仁2g、陈皮1g、龙眼1g上述三种以上或全部的混合物;再添加微胶囊化后的多种益生菌300g、益生元250g、短肽150g、多种氨基酸100g、碳水化合物100g、有保健功能的油酯100g、水溶性膳食纤维100g、维生素和矿物质25g。
实施案例三
上述肝性脑病医学配方食品还包括以重量计的下列组分:药食两用的提取物:几种药食两用的中药提取物精华及新资源食品400g、益生菌250g、短肽200g、碳水化合物150g、有保健功能的油脂150g、益生元100g、多种氨基酸100g。
实施案例四
上述肝性脑病医学配方食品还包括以重量计的下列组分:几种药食两用的中药提取物精华及新资源食品400g、益生元350g、短肽350g、碳水化合物300g、有保健功能的油脂300g、多种氨基酸100g、复合维生素和矿物质25g;每100g所含有的能量应不低于295kJ(70kcal)。
实施案例五
上述肝性脑病医学配方食品还包括以重量计的下列组分:益生元700g、短肽500g、碳水化合物300g、多种益生菌300g、多种氨基酸100g、复合维生素和矿物质25g;每100g所含有的能量应不低于295kJ(70kcal)。
实施案例六
上述肝性脑病医学配方食品还包括以重量计的下列组分:碳水化合物800g、短肽500g、有保健功能的油酯300g、多种氨基酸100g、复合维生素和矿物质25g;每100g所含有的能量应不低于295kJ(70kcal)。
Claims (10)
1.肝性脑病医学配方食品,其特征是结合肝性脑病患者的体质特征,依据传统中医的精髓理论,因人而异,黄金配伍以三种以上或全部的药食两用中药提取物精华及新资源食品、多种益生菌、短肽为主要原料,以益生元、碳水化合物、氨基酸、有保健功能的油脂、多种维生素、多种矿物质为辅料制成的医学配方食品;
按下列原料及其用量进行配方,药食两用的提取物及新资源食品:石菖蒲20g、郁金20g、胆南星20g、半夏20g、泽泻19g、炙远志19g、沉香19g、苍术19g、厚朴18g、茵陈18g、赤芍18g、大黄18g、竹茹17g、元参17g、车前子17g、黄连17g、金钱草16g、黄芩16g、生地16g、知母16g、牡丹皮15g、羚羊角15g、白芍15g、炙龟板15g、熟地14g、钩藤14g、石决明14g、生石膏14g、山萸肉13g、紫雪丹13g、红参13g、黄芪13g、煅龙骨12g、熟附子12g、五味子12g、麦冬12g、芒硝11g、六月雪11g、血盆草11g、阴行草11g、毛冬青10g、千金子10g、黄柏10g、太子参10g、北沙参10g、石斛9g、当归9g、合欢皮9g、胆星9g、枳实9g、党参8g、枳椇子8g、辣木叶8g、裸藻8g、乌梢蛇7g、蒲公英7g、鱼腥草7g、佛手7g、栀子6g、茯苓6g、芦根6g、淡竹叶6g、夏枯草5g、菊花5g、煅牡蛎5g、乌梅5g、刺梨4g、黑豆4g、甘草4g、枸杞子3g、生麦芽3g、山药3g、干姜2g、薏苡仁2g、陈皮1g、龙眼1g上述三种以上或全部的药食两用的提取物混合物;再添加益生菌300g、短肽200g、益生元100g、多种氨基酸100g、碳水化合物100g、有保健功能的油酯100g、维生素A0.01g、维生素D0.000015g、维生素E0.12g、维生素K10.00001g、维生素C0.63g、维生素B10.016g、维生素B20.016g、维生素B60.015g、维生素B120.0023g、烟酸0.2g、叶酸0.003g、泛酸0.051g、胆碱2.5g、生物素0.000057g、钙6.2g、磷4.5g、钾10g、钠16.17g、镁1.7g、氯0.15g、铁0.15g、锌6.2g、硒0.00012g、铜0.007g、锰0.018g、碘0.00001g、氟0.00001g、铬0.00001g、钼0.00001g;
制作时先将石菖蒲、郁金、胆南星、半夏、泽泻、炙远志、沉香、苍术、厚朴、茵陈、赤芍、大黄、竹茹、元参、车前子、黄连、金钱草、黄芩、生地、知母、牡丹皮、羚羊角、白芍、炙龟板、熟地、钩藤、石决明、生石膏、山萸肉、紫雪丹、红参、黄芪、煅龙骨、熟附子、五味子、麦冬、芒硝、六月雪、血盆草、阴行草、毛冬青、千金子、黄柏、太子参、北沙参、石斛、当归、合欢皮、胆星、枳实、党参、枳椇子、辣木叶、裸藻、乌梢蛇、蒲公英、鱼腥草、佛手、栀子、茯苓、芦根、淡竹叶、夏枯草、菊花、煅牡蛎、乌梅、刺梨、黑豆、甘草、枸杞子、生麦芽、山药、干姜、薏苡仁、陈皮、龙眼上述三种以上或全部浸泡后加入β-环状糊精,用半仿生提取法提取后,经喷雾干燥而制备的粉状物质,再短肽、益生元、氨基酸、碳水化合物、有保健功能的油脂、多种维生素及矿物质一起粉碎混合后进行巴氏灭菌1小时,然后添加微胶囊化后的双歧杆菌、微胶囊化后的乳杆菌、微胶囊化后的嗜热链球菌并混合均匀制成粉状的固体饮料、颗粒剂,并分装成10g/包,用约150ml温开水溶解后,直接饮用或经鼻饲摄入;或加入适量辅料制成胶囊、片剂或加入甜味剂和黑芝麻粉制成快速、方便食品便于外出携带食用,若做成饮料则省去经喷雾干燥、少添加辅料,分装成10-65ml/瓶,每日早、中、晚饭后0.5小时各饮1瓶,所有操作均在符合《特殊医学用途配方食品良好生产规范》要求的洁净干燥环境内进行;
本发明制作工艺其特征是以微胶囊、生物酶解、半仿生提取法、喷雾干燥及冷冻干燥集成创新,构成的产业化生产的关键技术;微囊化保护技术,有效解决了口服过程中高温以及强酸胃液对益生菌的灭活;采用三层蛋白质深埋微胶囊技术,再与经生物酶解或半仿生提取法提取并微囊化处理后的中药提取物混合均匀,以解决“多重益生菌”与“药食同源之中药”组分的共存问题,具有一定的抗高温和强酸特性,有利于益生菌通过口服顺利通过胃液到达肠道内停留定植,使产品防治肝性脑病的功效与市场同类产品相比大幅提高。
2.根据权利要求1所述的肝性脑病医学配方食品,其特征是所述的药食两用中草药提取物及新资源食品为:石菖蒲、郁金、胆南星、半夏、泽泻、炙远志、沉香、苍术、厚朴、茵陈、赤芍、大黄、竹茹、元参、车前子、黄连、金钱草、黄芩、生地、知母、牡丹皮、羚羊角、白芍、炙龟板、熟地、钩藤、石决明、生石膏、山萸肉、紫雪丹、红参、黄芪、煅龙骨、熟附子、五味子、麦冬、芒硝、六月雪、血盆草、阴行草、毛冬青、千金子、黄柏、太子参、北沙参、石斛、当归、合欢皮、胆星、枳实、党参、枳椇子、辣木叶、裸藻、乌梢蛇、蒲公英、鱼腥草、佛手、栀子、茯苓、芦根、淡竹叶、夏枯草、菊花、煅牡蛎、乌梅、刺梨、黑豆、甘草、枸杞子、生麦芽、山药、干姜、薏苡仁、陈皮、龙眼其中的三种以上或全部的混合物。
3.根据权利要求1所述的肝性脑病医学配方食品,特征在于按照所述配方混合可制备成粉状、胶囊状、片剂状、饮料类食品。
4.根据权利要求1所述的肝性脑病医学配方食品,还包括以重量计的下列组分:几种药食两用的中药提取物精华及新资源食品400g、益生元350g、短肽350g、碳水化合物300g、有保健功能的油脂300g、多种氨基酸100g、复合维生素和矿物质25g;每100g所含有的能量应不低于295kJ(70kcal)。
5.根据权利要求1所述的肝性脑病医学配方食品,其特征是所述的益生菌全部采用微胶囊化后的益生菌,除嗜热链球菌外,其中双歧杆菌是指青春双歧杆菌、乳双歧杆菌、两歧双歧杆菌、短双歧杆菌、婴儿双歧杆菌、长双歧杆菌、动物双歧杆菌(乳双歧杆菌)其中一种、几种或全部混合;乳杆菌是指:嗜酸乳杆菌、干酪乳杆菌、保加利亚乳杆菌、德氏乳杆菌亚种、格氏乳杆菌、发酵乳杆菌、瑞士乳杆菌、唾液乳杆菌、鼠李糖乳杆菌、罗伊氏乳杆菌、植物乳杆菌、副干酪乳杆菌、约氏乳杆菌、副干酪乳杆菌、卷曲乳杆菌、德氏乳杆菌保加利亚亚种、罗伊氏乳杆菌其中一种、几种或全部混合。
6.根据权利要求1所述的肝性脑病医学配方食品,其特征是所述的益生元为山药、茯苓、薏仁、鸡内金、芡实、菊粉的提取混合物,棉子低聚糖,水苏糖,酵母,低聚异麦芽糖,低聚果糖,大豆低聚糖,低聚木糖其中的一种、几种或全部混合。
7.根据权利要求1所述的肝性脑病医学配方食品,其特征是所述的氨基酸为L-谷氨酰胺、γ-氨基丁酸、珠肽粉、蛋氨酸、异亮氨酸、酪氨酸、苯丙氨酸、赖氨酸、精氨酸、组氨酸、色氨酸、瓜氨酸、鸟氨酸、牛磺酸其中的几种或全部混合。
8.根据权利要求1所述的肝性脑病医学配方食品,其特征是所述的碳水化合物为本发明所述的碳水化合物是指L-阿拉伯糖、果糖、蚌肉多糖、黄精多糖,金银花多糖、香菇多糖、白背三七多糖、茶树花多糖、枳椇子多糖、辣木叶多糖、显齿蛇葡萄叶多糖、裸藻多糖、青钱柳叶多糖、山药多糖、甘草多糖、陈皮多糖、茯苓多糖、葛根多糖、陈皮多糖、山楂多糖、灵芝多糖、车前子多糖、五味子多糖、红枣多糖、淮山活性多糖、茶藨子木层孔菌多糖、虫草多糖、石斛多糖、番石榴多糖、当归多糖、芦荟多糖、青钱柳多糖、麦冬多糖、薤白多糖、绿豆多糖、苦瓜多糖、芦笋多糖、胖大海多糖、荔枝果肉多糖、刺五加多糖、鲍鱼菇多糖、黄芪多糖、乌龙茶多糖、龙眼多糖、银杏叶多糖、人参多糖、丹参多糖、仙人掌多糖、铁筷子多糖、杏鲍菇多糖、苦瓜多糖、南瓜多糖、芦笋多糖、龙葵多糖、抗性糊精、壳寡糖、酵母β-葡聚糖、多聚果糖、海藻糖、半乳糖、乳糖、葡萄糖、麦芽糖、水溶性膳食纤维、淀粉、糖元其中的一种、几种或全部混合。
9.根据权利要求1所述的肝性脑病医学配方食品,其特征是所述的有保健功能的油脂为亚麻籽油、牡丹籽油、翅果油、水飞蓟籽油、植物甾醇酯、御米油、茶叶籽油、鱼油、鱼油提取物、花生四烯酸油脂、蔗糖聚酯、DHA藻油、磷虾油、盐地碱蓬籽油、美藤果油、盐肤木果油、中链甘油三酯、黄明胶、光皮梾木果油、长柄扁桃油、中长链脂肪酸食用油、元宝枫籽油、表没食子儿茶素没食子酸酯、甘油二酯油、叶黄素酯其中的一种、几种或全部混合。
10.根据权利要求1所述的肝性脑病医学配方食品,其特征是所述的短肽为海洋胶原肽、玉米低聚肽、小麦低聚肽、海洋骨原肽、大豆蛋白肽、乳清蛋白肽、卵白蛋白肽其中一种、几种或全部混合。
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