CN112155207A - 一种类风湿性关节炎医学配方食品及其制备方法 - Google Patents
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Abstract
本发明公开了一种类风湿性关节炎医学配方食品及其制备方法;该产品采用针对类风湿性关节炎调理配伍的多种药食两用本草,采用半仿生或加超声波提取,真空浓缩,醇沉或超滤法去除杂质及农药残留,喷雾干燥的集成创新方法制成本草精华,添加多种益生菌、氨基酸、益生元、短肽、碳水化合物混合制成;该种类风湿性关节炎医学配方食品,能促进益生菌的增殖,调节肠内微生态平衡,促进微量元素的吸收,增强脾胃运动功能,集食疗、预防、调理三重功效于一体的独特优势;此外,本发明还提供了一种类风湿性关节炎医学配方食品的制备方法,解决了中药中药杀菌功能+益生菌共同作用这个世界技术难题;本发明的特殊食品适合类风湿性关节炎的人群食用。
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、碳水化合物、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类风湿性关节炎的医学全营养配方食品及其制备方法。
背景技术
关节炎主要表现为关节部位出现疼痛、红肿、畸形、功能障碍等异常问题,它是由感染、创伤、炎症等原因导致的,是一种炎症疾病;
各个关节的骨关节炎又称退行性关节病、骨关节病;骨质增生,与人体衰老密切相关,多数老人都可能伴有骨质增生,自然容易得骨关节炎;临床数据显示,45岁以下人群骨关节炎患病率仅为2%,而65岁以上人群患病率高达68%;在医生看来人到老年都患有不同程度的骨关节炎;疼痛:是关节炎最主要的表现;肿胀:肿胀是关节炎症的常见表现,与关节疼痛的程度不一定相关;功能障碍:关节疼痛及炎症引起的关节周围组织水肿,导致关节活动受限;慢性关节炎患者由于长期关节活动受限,可能导致永久性关节功能丧失;体征:不同类型的关节炎体征也不同,可出现红斑、畸形、软组织肿胀、关节红肿、渗液、骨性肿胀、骨擦音、压痛、肌萎缩或肌无力、关节活动范围受限及神经根受压等体征;
类风湿性关节炎,常表现为小关节(手指关节、腕关节等)同时出现疼痛,且发病关节呈对称性;类风湿性关节炎患者80%在35~50岁之间,但老人、幼儿同样可发病;因其病因与遗传、感染、环境、免疫有着复杂关系,临床尚无法彻底根治只能通过药物治疗控制病情,维持关节功能;
类风湿性关节炎的病因:类风湿性关节炎是一种自身免疫疾病,中老年是类风湿高发的群体,但是因为人们生活方式的改变以及其他原因,年轻人中类风湿也逐渐高发;1、没有做好保暖措施:身体受到风寒湿邪之气刺激是导致风湿性关节炎发作的一个重要因素,气温忽冷忽热,往往让人防不胜防,湿寒之气的侵入,可能会诱发类风湿或造成病情加重;2、遗传原因:类风湿性关节炎是一种具有遗传性的疾病,有部分患者具有家族病史;遗传是一种不可忽视的引起类风湿性关节炎的因素,所以本身有家族病史的人群在平时更应该积极的做好预防措施;3、内分泌、免疫异常原因:疾病发生与患者的内分泌或免疫系统出现异常有很大关系,雌激素变化会刺激导致类风湿关节炎的发病或者加重,因此这也是一个类风湿性关节炎发病的不可忽视的因素;4、感染诱发:临床中认为感染也是一个与类风湿性关节炎发作有关系的因素,因为很多类风湿性关节炎发病前都发生过感染性疾病,因此平时发生感染性疾病时也要积极进行治疗;
类风湿性关节炎的危害:这种疾病很容易导致多个器官发生损害,很容易引起全身关节疼痛和关节肿胀,如果得这种病的时间长了,很容易出现肺脏病变,就可能会引起肺炎等疾病;如果耽误了最佳治疗时机,或者忽视了治疗就有可能会导致瘫痪,那么给病人带来的痛苦就会更大;
中医对于类风湿性关节炎有着丰富的相关记载和临床治疗经验,类风湿性关节炎在中医学统属于“痹证”范畴,根据其临床表现,与中医古籍所记载的“历节病”“白虎历节”“骨痹”“顽痹”“鹤膝风”等相似;其命名一直没有统一,近代老中医焦树德教授首先提出“尪痹”之诊断,已纳入了《中华人民共和国中医药行业标准·中医病证诊断疗效标准》中;
“尪”者意指足跛不能行,胫曲不能伸、身体羸弱的废疾;“痹”者闭也,乃闭塞不通之意;《金匮要略·中风历节病脉证并治篇》云:“诸肢节疼痛,肢体尪羸……”其中的尪羸就是指关节、肢体变形、关节不能活动而渐成废人而言;《素问·痹论》篇云:“痹在于骨则重,在于脉则血凝不流,在于筋则屈伸不利,在于肉则不仁,在于皮则寒……凡痹之类,逢寒则急,逢热则纵”;所谓名正则言顺,类风湿性关节炎中医诊断为“尪痹”更能够形象地反映出其临床特点;
类风湿性关节炎是一个临床痼疾,一般多根据《素问·痹论篇》:“风寒湿三气杂至,合而为痹也”;认为风寒湿邪侵袭为本病的病因;一般风寒湿之邪是不会形成尪痹的,只有正气亏虚,风寒湿三邪久滞,深入筋髓、骨骱而成毒,缠绵难愈才会形成本病;而久病又耗损正气而致虚;
中医理论认为:脾藏营而主肉,脾气虚馁,无能生肌长肉,肉失所养而致肌萎无力;肝藏血而主筋,肝血不足,不能濡润滋养宗筋,筋脉失养而致拘挛;肾藏精而主骨,肾精亏损,无以充髓养骨,骨失所养而致疏松变形;所以邪气外侵只是发病的诱因,而肝肾精血不足,气血阴阳交损当为类风湿性关节炎发病之本。所谓:“正气存内,邪不可干;邪之所凑,其气必虚”;
尪痹的正治之法当以补气血、养肝肾,强健筋骨肌肉为主;正如《景岳全书·历节风痛》所云:“若筋脉拘挛,伸缩不利者,此血虚、血燥证也,非养血养气不可”;因此临证强调养气即是养脾,养脾即是养肌肉;养血即是养肝,养肝即是养筋络;养精即是养肾,养肾即是养骨骼;筋强、骨壮、肉丰则顽疾自愈;
“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;
目前市场上还没有发现结合乳腺纤维瘤患者的体质特征,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、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;其可以促进益生菌的增殖,调节肠内微生态平衡,促进微量元素的吸收,增强脾胃运动功能,集食疗、预防、调理三重功效于一体的独特优势;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;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;以食物为药物具有以下几大突出的优点:1.长期使用药物治病往往会产生各种副作用和依赖性,而且还可能对人体的健康造成影响;而食疗相对安全有效,毒副作用小;2.食疗使用的都是我们日常生活中常见的食物,价格低廉,让我们在日常用餐中便达到调理的目的;3.食物为药物还具有无痛苦的优点,让人们在享受美食的过程中祛除病痛,避免了打针、吃药之苦;
近些年来,一些新的中药口服液提取工艺得到应用,提高了药物成分的提取效率和成药质量,这些新的工艺,包括超临界流体提取、 酶解提取、超声波提取等;不过进过深入研究后,发现要使用超临界流体提取工艺,成本较高,操作安全性要求高,酶解提取工艺不复杂,但成本较高,而且操作细节上,必须要注意提取条件以保持生物酶的活性,否则,将影响提取效果;不过因为中药口服液生产当中以目前的技术来看还是存在一些问题,因为现有提取技术大多都是在传统的水提醇沉法上改进来,在浓缩过滤上还有一些问题没有解决,因此还需不断去探索,提高中药口服液提取效率,实现更高药效的中药生产制备方法;近些年来,一些新的中药口服液提取工艺得到应用,提高了药物成分的提取效率和成药质量,这些新的工艺,包括超临界流体提取、 酶解提取、超声波提取等;不过进过深入研究后,发现要使用超临界流体提取工艺,成本较高,操作安全性要求高,酶解提取工艺不复杂,但成本较高,而且操作细节上,必须要注意提取条件以保持生物酶的活性,否则,将影响提取效果;不过因为中药口服液生产当中以目前的技术来看还是存在一些问题,因为现有提取技术大多都是在传统的水提醇沉法上改进来,在浓缩过滤上还有一些问题没有解决,因此还需不断去探索,提高中药口服液提取效率,实现更高药效的中药口服液生产制备方法;
现代科学的发展已经证明:中草药能改变肠道菌群组成及恢复肠道菌群失调,肠道菌群能提高中草药的生物利用率;但是中药的黄酮类及生物碱都具有非常强的杀菌功能,也就是说在肠道内中药的黄酮类及生物碱都具有非常强的杀菌(包括益生菌)作用,我们技术解决中药杀菌功能+益生菌共同作用技术难题。
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,开创性将多种改善类风湿性关节炎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、益生元、碳水化合物、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类风湿性关节炎患者所必需营养素,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,中草药能改变肠道菌群组成及恢复肠道菌群失调,肠道菌群能提高中草药的生物利用率,益生菌能起到调节肠道菌群,毒副作用小、安全有效;但是中药的黄酮类及生物碱都具有非常强的杀菌功能,也就是说在肠道内中药的黄酮类及生物碱都具有非常强的杀菌(包括益生菌)作用,我们通过了20多年的技术攻关,取得了中药杀菌功能+益生菌共同作用技术,解决了这个世界技术难题;并且研发了且人们容易接受的适合乳腺纤维瘤患者食用的医学配方食品、膳食食品、特定医学配方食品或非特定医学配方食品;
本发明的集成创新制备方法为:第1步半仿生加超声波提取,该仿生提取法是从生物药剂学的角度,将整体药物研究法与分子药物研究法相结合,模拟口服药物经胃肠道转运吸收的环境,采用活性指导下的导向分离方法,加超声波提取是利用超声波的特性来实现药材物质分子的加速运动,进而提高药液的浸透力,从而提高提取的效率利用,并且不会改变药材中有效成分的化学性质和结构,第2步提取液真空浓缩后,醇沉或超滤法去除杂质及农药残留来提纯提取液,第3步喷雾干燥的集成创新方法制成本草精华微囊化保护技术,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,再与本发明的目的集成创新的制备方法并微囊化处理后的中药提取物混合均匀的制剂工艺,解决了中药杀菌功能+益生菌共同作用这个世界技术难题。
发明内容
本研发团队采用十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为辅料,不仅可作为单一营养来源满足类风湿性关节炎患者的营养需求,还有增强胰岛素活性,降血糖、降血脂、降脂减肥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:根据类风湿性关节炎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类风湿性关节炎,并选取以下几大类药物进行配伍;其中:乌梢蛇,祛风,通络,止痉,用于风湿顽痹,麻木拘挛,中风口眼歪斜,半身不遂,抽搐痉挛,破伤风,麻风疥癣,瘰疬恶疮;显脉旋覆花,味苦辛咸性微温,能降气、消痰、行水、止呕;人参,味甘微苦性微温,能大补元气、复脉固脱、补脾益肺、生津养血、安神益智;沙棘叶,具有祛痰、利肺、养胃、健脾、活血、化瘀的药理功效;桃仁,破血行瘀,润燥滑肠,治经闭,症瘕,热病蓄血,风痹,疟疾,跌打损伤,瘀血肿痛,血燥便秘,具有祛瘀血、抗炎作用;茯苓,功效非常广泛,不分四季,将它与各种药物配伍,不管寒、温、风、湿诸疾,都能发挥其独特功效;茯苓味甘、淡、性平,入药具有利水;渗湿、益脾和胃、宁心安神之功用;茯苓能增强机体免疫功能,茯苓多糖有明显的抗肿瘤及保肝脏作用;木瓜,味酸性温,能舒筋活络、和胃化湿;甘草,味甘性平,能补脾益气、清热解毒、祛痰止咳、缓急止痛、调和诸药;
2.益生元
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,已广范应用于增强类风湿性关节炎患者抵抗力的治疗;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,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;
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鱼低聚肽、海洋骨原肽、大豆蛋白肽、乳清蛋白肽、卵白蛋白肽、小麦低聚肽其中一种、几种或全部混合;
4.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,来增强抵抗力;
本发明所述的多种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、长双歧杆菌其中一种、几种或全部混合;乳杆菌是指:嗜酸乳杆菌粉、干酪乳杆菌、保加利亚乳杆菌、德氏乳杆菌、乳亚种格氏乳杆菌、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、约氏乳杆菌其中一种、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的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,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K、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;
9. 本发明以微胶囊、半仿生或生物酶解加超声波提取,真空浓缩,醇沉或超滤法去除杂质及农药残留,喷雾干燥的集成创新方法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,半仿生或生物酶解加超声波提取,真空浓缩,醇沉或超滤法去除杂质及农药残留提取并微囊化处理后的中药提取物混合均匀;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(45度)溶解后,直接饮用或经鼻饲摄入;也可以加入适量附料制成胶囊、片剂或加入甜味剂和黑芝麻粉制成饼干等快速、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,少添加辅料等,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;制作时先将中药提取物、益生元、短肽、多种益生菌、碳水化合物进行第一次混合,混合时间为20-40min,混合速率为30-45r/min;再添加经过严格特定混合工艺:混合速率为12-15r/min,混合时间为20-40min的复合维生素及矿物质进行巴氏灭菌1小时后得到混合均匀的粉状的制剂工艺;
本配方特殊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.本发明配方中所含的益生元及多种益生菌,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,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、碳水化合物与活性多糖等生物活性物质具有协同作用;
2.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,可以有效改善类风湿性关节炎患者的负氮平衡,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;
3.本发明配方中所含中药提取物能够补脾益气、清热解毒、祛痰止咳、缓急止痛、破血行瘀,润燥滑肠;调节机体功能,提升类风湿性关节炎患者抵抗力,促进身体恢复;汉方提取,减少中药草本的各种杂质的摄入,去除重金属残留,有助于减轻肝肾负担;促进肠道菌群平衡;
4. 本发明配方中所含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;
5.本发明配方食品含多种维生素和矿物质,可迅速补充消费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;
本发明的集成创新制备方法为:第1步半仿生加超声波提取,该仿生提取法是从生物药剂学的角度,将整体药物研究法与分子药物研究法相结合,模拟口服药物经胃肠道转运吸收的环境,采用活性指导下的导向分离方法,加超声波提取是利用超声波的特性来实现药材物质分子的加速运动,进而提高药液的浸透力,从而提高提取的效率利用,并且不会改变药材中有效成分的化学性质和结构,第2步提取液真空浓缩后,醇沉或超滤法去除杂质及农药残留来提纯提取液,第3步喷雾干燥的集成创新方法制成本草精华微囊化保护技术,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,再与本发明的目的集成创新的制备方法并微囊化处理后的中药提取物混合均匀的制剂工艺,解决了中药杀菌功能+益生菌共同作用这个世界技术难题。
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;
实现本发明目的类风湿性关节炎医学配方食品是采用沙棘叶、人参(人工种植)、乌梢蛇、显脉旋覆花、线叶金雀花、牛大力粉、覆盆子、桃仁、薏苡仁、茯苓、木瓜、甘草、肉桂、葛根、白芷、益智仁、小茴香、薤白、蒲公英、沙棘、桑叶、姜、枣10种以上或全部的混合物;益生元选自低聚异麦芽糖、水苏糖、低聚果糖、大豆低聚糖、低聚木糖、菊粉的一种或几种;短肽选自海洋鱼低聚肽、海洋骨原肽、大豆蛋白肽、乳清蛋白肽、卵白蛋白肽、小麦低聚肽的一种或几种;脂肪选自MCT粉、α-亚麻酸、亚油酸、玉米油、大豆油、花生油、葵花籽油、橄榄油、亚麻籽油、胚芽油的一种或几种;维生素预混料选自维生素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、生物素等中的一种或几种;矿物质预混料选自钙、磷、钾、钠、镁、铁、锌、硒、铜、锰、碘、氟、铬、钼等中的一种或几种;
本发明的集成创新制备方法为:第1步半仿生加超声波提取,该仿生提取法是从生物药剂学的角度,将整体药物研究法与分子药物研究法相结合,模拟口服药物经胃肠道转运吸收的环境,采用活性指导下的导向分离方法,加超声波提取是利用超声波的特性来实现药材物质分子的加速运动,进而提高药液的浸透力,从而提高提取的效率利用,并且不会改变药材中有效成分的化学性质和结构,第2步提取液真空浓缩后,醇沉或超滤法去除杂质及农药残留来提纯提取液,第3步喷雾干燥的集成创新方法制成本草精华微囊化保护技术,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,再与本发明的目的集成创新的制备方法并微囊化处理后的中药提取物混合均匀的制剂工艺,解决了中药杀菌功能+益生菌共同作用这个世界技术难题。
实施例一
一种类风湿性关节炎医学配方食品,选择如下的配方及比例制成:可食用多种植物水提浓缩粉(沙棘叶10、人参(人工种植)5、乌梢蛇10、显脉旋覆花10、线叶金雀花8、牛大力粉8、覆盆子10、桃仁8、薏苡仁8、茯苓8、木瓜6、甘草6、肉桂6、葛根6、白芷6、益智仁4、小茴香4、薤白4、蒲公英5、沙棘4、桑叶2、姜2、枣2)15-25,低聚异麦芽糖30-40,复配益生菌(乳双歧杆菌、长双岐杆菌、两岐双岐杆菌、嗜酸乳杆菌、鼠李糖乳杆菌、植物乳杆菌)13-20、海洋鱼低聚肽(5%), L-谷氨酰胺(5%),菊粉(5%),海藻糖3,雪莲培养物(干品,1%),粉末油脂(亚麻籽油、葵花籽油、辛烯基琥珀酸淀粉钠、麦芽糊精、二氧化硅),L-抗坏血酸钠,dl-a-醋酸生育酚,D-泛酸钙,烟酰胺,核黄素,盐酸吡哆醇,盐酸硫胺素,醋酸维生素A,叶酸,碘化钾,维生素D3,氰钴胺,牛磺酸,磷酸二氢钾,碳酸钙,氯化钠,柠檬酸钠,氧化镁,焦磷酸铁,硫酸锌;
制备方法:先将沙棘叶、人参(人工种植)、乌梢蛇、显脉旋覆花、线叶金雀花、牛大力粉、覆盆子、桃仁、薏苡仁、茯苓、木瓜、甘草、肉桂、葛根、白芷、益智仁、小茴香、薤白、蒲公英、沙棘、桑叶、姜、枣全部用半仿生或生物酶解加超声波提取,真空浓缩,醇沉或超滤法去除杂质及农药残留,喷雾干燥的集成创新方法制成本草精华;再进行与水溶性膳食纤维低聚异麦芽糖,复配益生菌(乳双歧杆菌、长双岐杆菌、两岐双岐杆菌、嗜酸乳杆菌、鼠李糖乳杆菌、植物乳杆菌)、海洋鱼低聚肽, L-谷氨酰胺,菊粉,海藻糖,雪莲培养物(干品),粉末油脂(亚麻籽油、葵花籽油、辛烯基琥珀酸淀粉钠、麦芽糊精、二氧化硅),L-抗坏血酸钠,dl-a-醋酸生育酚,D-泛酸钙,烟酰胺,核黄素,盐酸吡哆醇,盐酸硫胺素,醋酸维生素A,叶酸,碘化钾,维生素D3,氰钴胺,牛磺酸,磷酸二氢钾,碳酸钙,氯化钠,柠檬酸钠,氧化镁,焦磷酸铁,硫酸锌混合,混合时间为20min,混合速率为45r/min,得到混合均匀的粉状的制剂产品。
本发明的集成创新制备方法为:第1步半仿生加超声波提取,该仿生提取法是从生物药剂学的角度,将整体药物研究法与分子药物研究法相结合,模拟口服药物经胃肠道转运吸收的环境,采用活性指导下的导向分离方法,加超声波提取是利用超声波的特性来实现药材物质分子的加速运动,进而提高药液的浸透力,从而提高提取的效率利用,并且不会改变药材中有效成分的化学性质和结构,第2步提取液真空浓缩后,醇沉或超滤法去除杂质及农药残留来提纯提取液,第3步喷雾干燥的集成创新方法制成本草精华微囊化保护技术,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,再与本发明的目的集成创新的制备方法并微囊化处理后的中药提取物混合均匀的制剂工艺,解决了中药杀菌功能+益生菌共同作用这个世界技术难题。
Claims (2)
1.一种类风湿性关节炎医学配方食品,其特征在于其原料成分含量包括以重量计的下列组分:可食用多种植物水提浓缩粉(沙棘叶10、人参(人工种植)5、乌梢蛇10、显脉旋覆花10、线叶金雀花8、牛大力粉8、覆盆子10、桃仁8、薏苡仁8、茯苓8、木瓜6、甘草6、肉桂6、葛根6、白芷6、益智仁4、小茴香4、薤白4、蒲公英5、沙棘4、桑叶2、姜2、枣2)15-25,低聚异麦芽糖30-40,复配益生菌(乳双歧杆菌、长双岐杆菌、两岐双岐杆菌、嗜酸乳杆菌、鼠李糖乳杆菌、植物乳杆菌)13-20、海洋鱼低聚肽(5%), L-谷氨酰胺(5%),菊粉(5%),海藻糖3,雪莲培养物(干品,1%),粉末油脂(亚麻籽油、葵花籽油、辛烯基琥珀酸淀粉钠、麦芽糊精、二氧化硅),L-抗坏血酸钠,dl-a-醋酸生育酚,D-泛酸钙,烟酰胺,核黄素,盐酸吡哆醇,盐酸硫胺素,醋酸维生素A,叶酸,碘化钾,维生素D3,氰钴胺,牛磺酸,磷酸二氢钾,碳酸钙,氯化钠,柠檬酸钠,氧化镁,焦磷酸铁,硫酸锌;
制备方法:先将沙棘叶、人参(人工种植)、乌梢蛇、显脉旋覆花、线叶金雀花、牛大力粉、覆盆子、桃仁、薏苡仁、茯苓、木瓜、甘草、肉桂、葛根、白芷、益智仁、小茴香、薤白、蒲公英、沙棘、桑叶、姜、枣10种以上或全部的混合物,用半仿生或生物酶解加超声波提取,真空浓缩,醇沉或超滤法去除杂质及农药残留,喷雾干燥的集成创新方法制成本草精华;再进行与水溶性膳食纤维低聚异麦芽糖,复配益生菌(乳双歧杆菌、长双岐杆菌、两岐双岐杆菌、嗜酸乳杆菌、鼠李糖乳杆菌、植物乳杆菌)、海洋鱼低聚肽, L-谷氨酰胺,菊粉,海藻糖,雪莲培养物(干品),粉末油脂(亚麻籽油、葵花籽油、辛烯基琥珀酸淀粉钠、麦芽糊精、二氧化硅),L-抗坏血酸钠,dl-a-醋酸生育酚,D-泛酸钙,烟酰胺,核黄素,盐酸吡哆醇,盐酸硫胺素,醋酸维生素A,叶酸,碘化钾,维生素D3,氰钴胺,牛磺酸,磷酸二氢钾,碳酸钙,氯化钠,柠檬酸钠,氧化镁,焦磷酸铁,硫酸锌混合,混合时间为20min,混合速率为45r/min,得到混合均匀的粉状的制剂产品。
2.第1步半仿生加超声波提取,该仿生提取法是从生物药剂学的角度,将整体药物研究法与分子药物研究法相结合,模拟口服药物经胃肠道转运吸收的环境,采用活性指导下的导向分离方法,加超声波提取是利用超声波的特性来实现药材物质分子的加速运动,进而提高药液的浸透力,从而提高提取的效率利用,并且不会改变药材中有效成分的化学性质和结构,第2步提取液真空浓缩后,醇沉或超滤法去除杂质及农药残留来提纯提取液,第3步喷雾干燥的集成创新方法制成本草精华微囊化保护技术,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,再与本发明的目的集成创新的制备方法并微囊化处理后的中药提取物混合均匀的制剂工艺,解决了中药杀菌功能+益生菌共同作用这个世界技术难题。
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