CN108523108A - 一种肿瘤全营养支持食品 - Google Patents
一种肿瘤全营养支持食品 Download PDFInfo
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- CN108523108A CN108523108A CN201710119738.3A CN201710119738A CN108523108A CN 108523108 A CN108523108 A CN 108523108A CN 201710119738 A CN201710119738 A CN 201710119738A CN 108523108 A CN108523108 A CN 108523108A
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Abstract
本发明提供了一种肿瘤全营养支持食品、特定全营养配方食品或非全营养配方食品。该配方根据《特殊医学用途配方食品通则》的要求,结合肿瘤患者的体质特征,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)研制而成。该产品采用10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、水溶性膳食纤维、复合维生素、复合矿物质辅料,不仅可作为单一营养来源满足肿瘤患者的营养需求,还有起到软坚散结、清热解毒、活血祛瘀、消肿散结、行气破血及防治肿瘤功效。
Description
技术领域
本发明属于药食同源类配方与食品技术领域,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、复合维生素、复合矿物质为辅料制成的防治肿瘤的全营养支持食品、特定全营养配方食品或非全营养配方食品。
背景技术
肿瘤(Tumor)是机体在各种致癌因素作用下,局部组织的某一个细胞在基因水平上失去对其生长的正常调控,导致其克隆性异常增生而形成的异常病变,学界一般将肿瘤分为良性和恶性两大类,(1)化学致癌因素:a、间接作用的化学致癌物:多环芳烃,芳香胺类与氨基偶氮染料,亚硝胺类,真菌毒素;b、直接作用的化学致癌物:这些致癌物不经体内活化就可致癌,如烷化剂与酰化剂、化学致癌物引起人体肿瘤的作用机制很复杂,少数致癌物质进入人体后可以直接诱发肿瘤,这种物质称为直接致癌物;而大多数化学致癌物进入人体后,需要经过体内代谢活化或生物转化,成为具有致癌活性的最终致癌物,方可引起肿瘤发生,这种物质称为间接致癌物,放射线引起的肿瘤有:甲状腺肿瘤、肺癌、骨肿瘤、皮肤癌、多发性骨髓瘤、淋巴瘤等。(2)物理致癌因素,离子辐射引起各种癌症,长期的热辐射也有一定的致癌作用,金属元素镍、铬、镉、铍等对人类也有致癌的作用,临床上有一些肿瘤还与创伤有关,骨肉瘤、睾丸肉瘤、脑瘤患者常有创伤史,另一类与肿瘤有关的异物是寄生虫;(3)病毒和细菌致癌,a、RNA致瘤病毒:通过转导和插入突变将遗传物质整和到宿主细胞DNA中,并使宿主细胞发生转化,存在两种机制致癌:①急性转化病毒②慢性转化病毒;b、DNA致瘤病毒:常见的有人类乳头状瘤病毒(HPV)与人类上皮性肿瘤尤其是子宫颈和肛门生殖器区域的鳞状细胞癌发生密切相关,Epstein-barr病毒(EBV)与伯基特淋巴瘤和鼻咽癌密切相关,流行病学调查乙型肝炎与肝细胞性肝癌有密切的关系,幽门螺杆菌引起的慢性胃炎与胃低度恶性B细胞性淋巴瘤发生有关,3.影响肿瘤发生、发展的内在因素及其作用机制:(1)遗传因素,1)呈常染色体显性遗传的肿瘤如视网膜母细胞瘤、肾母细胞瘤、肾上腺或神经节的神经母细胞瘤2)呈常染色体隐性遗传的遗传综合征如Bloom综合征易发生白血病和其他恶性肿瘤;毛细血管扩张共济失调症患者易发生急性白血病和淋巴瘤;着色性干皮病患者经紫外线照射后易患皮肤基底细胞癌和磷状细胞癌或黑色素瘤;3)遗传因素与环境因素在肿瘤发生中起协同作用,而环境因素更为重要,决定这种肿瘤的遗传因素是属于多基因的,目前发现不少肿瘤有家族史,如乳腺癌、胃肠癌、食管癌、肝癌、鼻咽癌等,(2)宿主对肿瘤的反应——肿瘤免疫,CD8+的细胞毒性T细胞在细胞免疫中起重要作用(3)其他与肿瘤发病有关的因素,“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;如双岐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;
肠道微生态与肿瘤的关系:肠道中的正常菌群以厌氧菌组成为主,正常时与机体处于相对的平衡状态,当这种平衡被打破后大多数的正常菌群变为内源致病菌,产生多种致癌物质,肠道菌群对机体具有双重作用,在一定条件下可促进肿瘤的发生,而另一些条件下则可以抑制肿瘤的发生,一些微生物如BCG、棒状杆菌属,溶血性链球菌或某些细菌代谢产物,通过局部或全身注入,诱导局部炎症反应或增强机体肿瘤免疫力可以抑制肿瘤生长,现知,类杆菌属,梭菌属的细菌增加了肿瘤的发病率和生长率,而乳酸杆菌和双歧杆菌则可以防止肿瘤发生,道菌群抑癌作用的可能机制:(1)细菌及其代的产物对肿瘤细胞的直接细胞毒性,(2)局部炎症反应对肿瘤细胞的非特异性杀伤,(3)细菌免疫可增强机体特异性抗肿瘤的免疫力,(4)上述几种可能途径的联合作用;
目前西医在微生态失调治疗上提倡在去除病因的基础上合理应用微生态调节剂,适当的应用窄谱抗生素,目前所提倡的“促菌”治疗是利用“益生菌”(包括活菌、死菌及代谢产物如乳酸、醋酸短链脂肪酸和酶类)促进或改善微生态平衡,提高正常菌群的生物拮抗能力,达到增强抗感染的目的,但是直接口服益生菌虽有一定效果,但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,本团队通过近叁年来对益生菌在肠道内定植机理的关健技术研究,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值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、陈皮、鸡内金、芡实和菊芋等药食同源之中药成分的提取物及低聚异麦芽糖,松谷膳食纤维、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,添加药食两用的石斛、冬虫夏草、蛹虫草、山药、蒲公英、山楂、乌梢蛇等的提取物、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,但还没有发现结合肿瘤患者的体质特征,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、水溶性膳食纤维、复合维生素、复合矿物质辅料制成的全营养支持食品、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,开创性将多种抗肿瘤益生菌与“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、水溶性膳食纤维、复合维生素、复合矿物质为辅料,不仅能够补充肿瘤患者所必需营养素,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肿瘤患者食用的全营养支持食品、特定全营养配方食品或非全营养配方食品。
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,结合肿瘤患者的体质特征,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10种以上药食两用的中药提取物精华、多种益生菌、短肽、益生元为主要原料,以氨基酸、水溶性膳食纤维、
复合维生素、复合矿物质辅料,不仅可作为单一营养来源满足肿瘤患者的营养需求,还有软坚散结、清热解毒、活血祛瘀、消肿散结、行气破血及防治肿瘤的全营养支持食品、特定全营养配方食品或非全营养配方食品(组合成的复合配方);
本发明配方的主要成分为:
1.中药提取物是根据肿瘤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肿瘤,并选取以下几大类药物进行配伍;其中:
L-谷氨酰胺减轻放、化疗患者胃肠反应,促进免疫功能,增强化疗药物杀瘤效果,降低放、化疗产生的脂质过氧化损害,改善患者整体状况,提高生存能力;诺丽果由于含有丰富的营养物质及多种富含医学生物活性的成分物质,可补充肿瘤病人所需的各种营养物质,并从抗氧化、提高免疫力等方面综合调整肿瘤患者身体机能,发挥对肿瘤的辅助治疗作用。裸藻多糖由于内部多孔结构,可以吸附人体中的多余物质如胆固醇、中性脂肪、重金属、酒精等排出体外,因此具有强效抗氧化、抗病毒、清除自由基的作用;丹凤牡丹花所含多种不饱和脂肪酸及其他营养物质,可补充肿瘤病人所需的脂肪酸等营养物质,并从抗氧化、抑制肿瘤细胞转移方面等方面综合调整肿瘤患者身体机能,在肿瘤治疗与体质改善等方面发挥一定作用。乌梢蛇血清给药小鼠,可对环磷酰胺诱发的NK细胞活性降低有恢复作用。沙棘花青素、苦木素、香豆素、5-二羟色胺等具有明显的抗癌活性及抗肿瘤作用。大鼠体内试验表明沙棘汁可以在体内阻隔断N-乙酰胞壁酸(NAMA)合成,保护大鼠免受NAMA的毒害,沙棘的抗癌试验结果优于同浓度的维生素C,明显推迟肿瘤的发生,延长成活时间,降低癌变范围;
研究表明香菇中的香菇多糖(Lentinan,LTN)具有抗肿瘤、调节免疫力、降血糖、抗病毒及抗氧化等生物活性,鱼腥草生物抗肿瘤作用,提高癌细胞中的CAMP而抑制艾氏腹水癌,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;
本发明所述的药食两用中药提取物是乌梢蛇、黄精、蒲公英、金银花、山楂、枸杞子、山药、甘草、陈皮、茯苓、丹凤牡丹花、沙棘叶、香菇采用生物酶解或预水解SBE提取并微胶囊化,经喷雾干燥及冷冻干燥的提取物全部混合;
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,来防治肝性脑病的发生;
本发明所述的多种益生菌是指微胶囊化后的双歧杆菌(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)、乳杆菌(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)、嗜热链球菌其中的四种以上或全部混合;
2.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;
3.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,已广范应用于肝性脑病的治疗;
本发明所述的益生元本是指低聚异麦芽糖、水苏糖、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. 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;
6.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;
7.本发明以微胶囊、生物酶解、预水解SBE、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SBE技术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,使产品防治肿瘤功效与市场同类产品相比大幅提高;
8. 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10 g/包,用约150 ml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,少添加黑芝麻粉等,分装成10-65ml/瓶,每日早、中、晚饭后0.5小时各饮1瓶,所有操作均在洁净干燥环境内进行;
本配方一种肿瘤全营养支持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,结合肿瘤患者的体质特征,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10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,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,可以迅速补充肿瘤患者所需营养,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,还有软坚散结、清热解毒、活血祛瘀、消肿散结、行气破血及防治肿瘤的功效;
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,可以有效改善肿瘤患者负氮平衡,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叁年来对益生菌在肠道内定植机理的关健技术研究的成果, 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;
10.本发明配方食品含多种维生素和矿物质,可迅速补充肿瘤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;
11.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。
临床实验报告
“劲膳美”公司参与了国家十二五科技支撑项目,项目编号:2012BAI35B00,苏州大学第一附属医院、郑州大学第一附属医院负责本发明肿瘤全营养支持食品的多中心临床评价研究;本研究共纳入病例数200例,分为2组,实验组100例,对照组100例(本研究失随访包含了因各种原因未能完成整个研究过程的患者),共有5例患者失随访,其中实验组2例,对照组3例。失随访原因包括患者未按时按量服用营养制剂、服用营养制剂过程中患者加用其他营养补充剂以及患者在研究结束后未进行相关指标的复查,没有患者因为副作用退出本研究;
本研究共纳入男性患者132名,女性患者68名,男女比例为1.94:1。实验组100例患者中,男性65名,女性35名,胃癌44名,肠癌49名,食管癌7名,平均年龄为59.14±6.98岁,体重指数(BMI)21.83±4.38kg/m2;对照组100例患者中,男性67名,女性33名,胃癌35名,肠癌55名,食管癌10名,平均年龄为60.16±6.79岁,BMI 22.07±3.42 kg/m2。比较两组的性别、年龄、疾病谱及BMI,差异无显著性(P>0.05),具有可比性;
1.肠屏障功能
通过二胺氧化酶、D-乳酸及细菌内毒素的检测评估肠屏障功能。实验组二胺氧化酶干预前平均值2.62±1.35U/L,干预后平均值1.73±1.31 U/L,两者相比差异有统计学意义(P<0.05);D-乳酸干预前平均值28.43±12.03mg/L,干预后平均值21.47±11.09 mg/L,两者相比有统计学差异(P<0.05);细菌内毒素干预前平均值12.10±9.11 U/L,干预后平均值8.67±8.41 U/L,两者相比有统计学差异(P<0.05)。对照组二胺氧化酶干预前平均值2.73±2.29 U/L,干预后平均值2.27±3.01 U/L,两者相比无统计学意义(P>0.05);D-乳酸干预前平均值25.77±17.30 mg/L,干预后平均值19.96±12.96 mg/L,两者相比有统计学差异(P<0.05);细菌内毒素干预前平均值12.35±11.25 U/L,干预后平均值13.84±11.69 U/L,两者相比无统计学差异(P>0.05)。比较实验组及对照组干预前二胺氧化酶、D-乳酸及细菌内毒素间的差异,P值均>0.05,两组间干预前差异无统计学意义。将实验组及对照组干预后二胺氧化酶数据进行比较,两者差别有统计学意义(P<0.05),比较实验组及对照组干预后D-乳酸平均值,两者间差异无统计学意义(P>0.05),实验组干预后的细菌内毒素与对照组干预后的细菌内毒素相比,两者之间有统计学差异(P<0.05);
2.免疫功能相关指标
通过IL-2、IL-6、IL-10、CD4+、CD8+的检测评估免疫功能。实验组IL-2干预前平均值109.69±62.95ng/L,干预后平均值120.53±69.46 ng/L,两者相比差异无统计学意义(P>0.05);IL-6干预前平均值749083.86±4094646.73 ng/L,干预后平均值2542501.90±22871195.10 ng/L,两者相比差异无统计学差异(P>0.05);IL-10干预前平均值202.57±114.31 ng/L,干预后平均值211.69±147.06 ng/L,两者相比差异无统计学差异(P>0.05);CD4+干预前平均值27.18±3.26%,干预后平均值38.88±6.38%,两者相比差异有统计学差异(P<0.01);CD8+干预前平均值33.81±6.63%,干预后平均值29.21±4.46%,两者相比差异有统计学差异(P<0.01)。对照组IL-2干预前平均值108.50±31.20 ng/L,干预后平均值122.08±35.30 ng/L,两者相比差异无统计学意义(P>0.05);IL-6干预前平均值1653583.25±9461086.34 ng/L,干预后平均值5186143.01±32842325.90 ng/L,两者相比差异无统计学差异(P>0.05);IL-10干预前平均值244.36±204.00 ng/L,干预后平均值188.68±37.07 ng/L,两者相比差异有统计学差异(P<0.05);CD4+干预前平均值26.83±3.01%,干预后平均值39.11±5.96%,两者相比差异有统计学意义(P<0.01);CD8+干预前平均值34.44±5.87%,干预后平均值28.53±5.19%,两者相比差异有统计学意义(P<0.01);比较实验组及对照组干预前IL-2、IL-6、IL-10、CD4+、CD8+的差异,P值均>0.05,两组间干预前差异无统计学意义;
对实验组及对照组分别进行组内分析,发现实验组中,干预前后D-乳酸、细菌内毒素、IL-2、CD4+、CD8+水平存在统计学差异,对照组中,D-乳酸、CD4+及CD8+干预前后数据差异有统计学意义;将干预后实验组及对照组的各项数据进行比较,发现细菌内毒素及IL-2存在统计学差异;
3.分析与讨论
一种肿瘤全营养支持食品可以改善胃肠道肿瘤化疗患者肠屏障功能,提高患者免疫力。加强肿瘤化疗患者营养支持可在一定程度上改善患者免疫功能。尚需更长时间的干预来观察该制剂对胃肠道肿瘤化疗患者临床症状、营养状况及预后等的影响;
① 肿瘤全营养制剂(药食同源-诺丽果浆裸藻粉肿瘤型全营养粉)可以改善胃肠道肿瘤化疗患者肠屏障功能,并在一定程度上提高胃肠道肿瘤化疗患者免疫力;
②本研究干预时长为21天,需要更长时间的干预来观察该制剂对胃肠道肿瘤化疗患者临床症状、营养状况及预后等的影响;
综上所述,无论是中医理论还是现代药理研究,均证明诺丽果浆裸藻粉适用于不同阶段的肿瘤患者,可配合手术、放疗、化疗、靶向药物治疗等恶性肿瘤不同治法,以促进机体恢复,也可应用于晚期恶性肿瘤的营养干预以防治恶病质,提高生活质量,延长生存期。
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 实现本发明目的一种肿瘤全营养支持食品其包括以重量计的下列组分:乌梢蛇 15 g、黄精 10 g、蒲公英 10 g、金银花 10 g、山楂 10 g、枸杞子 10 g、山药 5 g、甘草 5 g、陈皮 5 g、茯苓 5 g、丹凤牡丹花 10 g、沙棘叶10 g、香菇5 g、裸藻粉 20 g、诺丽果浆 20 g全部药食两用及新资源食品的提取物混合物,多种益生菌125 g、益生元134.6g、短肽155 g、氨基酸140 g、有保健功能的油脂208.5 g、海藻糖10 g、复合维生素 2.4 g(维生素A 4050 μgRE、维生素D 101.2 μg、维生素 E 91 mg α-TE、维生素K1 630 μg、维生素B1 9.4 mg、维生素B2 10.6 mg、维生素B6 9.6 mg、维生素B12 14.6 μg、烟酸(烟酰胺)19.4mg、叶酸2.9 mg、泛酸42.5 mg、维生素C 1.2 g、生物素168 μg、碘577 μg、牛磺酸0.23 g)、复合宏量矿物质 73 g(钙5.25 g、镁1.17 g、钠5.04 g、钾8.35 g、磷6.75 g、氯4.3 g)、复合微量矿物质 1.5 g(铜3.75 mg、铁60 mg、锌37.5 mg、锰2.25 mg、硒270 μg);
制作时先将乌梢蛇、黄精、蒲公英、金银花、山楂、枸杞子、山药、甘草、陈皮、茯苓、丹凤牡丹花、沙棘叶、香菇浸泡后加入β-环状糊精,用预水解SBE技术提取后,经喷雾干燥而制备的粉状物质,再添加生物酶解提取的短肽、益生元、氨基酸、裸藻粉、诺丽果浆、水溶性膳食纤维、多种维生素及矿物质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(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)、乳杆菌(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)、嗜热链球菌并混合的各种配料混合均匀制成粉状的固体饮料、颗粒剂,并分装成10 g/包,用约150 ml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,分装成10-65ml/瓶,每日早、中、晚饭后0.5小时各饮1瓶,所有操作均在洁净干燥环境内进行;
实施例二
上述一种肿瘤全营养支持食品还包括以重量计的下列组分:乌梢蛇 25 g、山楂20 g、枸杞子 10 g、山药10 g、陈皮 5 g、茯苓 5 g、香菇5 g、裸藻粉 20 g、诺丽果浆 20 g全部药食两用及新资源食品的提取物混合物, L-谷氨酰胺150 g、微胶囊化后的双歧杆菌(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)100g、乳杆菌(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)100g、嗜热链球菌50g、短肽(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)250g、益生元(低聚异麦芽糖、水苏糖、低聚果糖、大豆低聚糖、低聚木糖)100g、复合氨基酸((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)50g、维生素A0.01g、维生素D0.000015g、维生素E0.12g、维生素K0.0075g、维生素K10.00001g、维生素C10.625g、维生素B10.016g、维生素B20.016g、维生素B60.015g、维生素B0.0023g、维生素Be 、维生素Bu、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、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。
Claims (3)
1.一种肿瘤全营养支持食品,其特征在于由下列原料制备而成:乌梢蛇 10-20 g、黄精5-15 g、蒲公英 5-15 g、金银花 5-15 g、山楂 5-15 g、枸杞子 5-15 g、山药 1-10 g、甘草1-10 g、陈皮 1-10 g、茯苓 1-10 g、丹凤牡丹花 5-15 g、沙棘叶5-15 g、香菇1-10 g全部的提取物混合物;裸藻粉20 g、诺丽果浆 20 g、多种益生菌80-150 g、益生元100-200 g、短肽100-200 g、氨基酸100-250 g、有保健功能的油脂150-300 g、海藻糖10-30 g、复合维生素 1-10 g(维生素A 3000-5000 μgRE、维生素D 50-150 μg、维生素 E 50-100 mg α-TE、维生素K1 400-700 μg、维生素B1 5-10 mg、维生素B2 5-15 mg、维生素B6 5-10 mg、维生素B125-15 μg、烟酸(烟酰胺)10-20 mg、叶酸1-5 mg、泛酸30-50 mg、维生素C 1-2 g、生物素50-200 μg、碘0.5-2 mg、牛磺酸0.5-1 g)、复合宏量矿物质 20-100 g(钙2-7 g、镁1-2 g、钠3-6 g、钾5-10 g、磷2-8 g、氯1-5 g)、复合微量矿物质 0.5-2 g(铜1-5 mg、铁40-70 mg、锌10-50 mg、锰0.5-5 mg、硒0.1-1 mg);
制作时先将以是乌梢蛇、黄精、蒲公英、金银花、山楂、枸杞子、山药、甘草、陈皮、茯苓、丹凤牡丹花、沙棘叶、香菇浸泡后加入β-环状糊精,用预水解SBE技术提取后,经喷雾干燥而制备的粉状物质,再添加生物酶解提取的短肽、益生元、氨基酸、裸藻粉、诺丽果浆、多种维生素及矿物质混合后进行巴氏灭菌1小时,然后添加微胶囊化后的多种益生菌混合,各种配料混合均匀制成粉状的固体饮料、颗粒剂,并分装成10 g/包,用约150ml温开水(40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,分装成10-65 ml/瓶,每日早、中、晚饭后0.5小时各饮1瓶,所有操作均在洁净干燥环境内进行。
2.根据权利要求1所述的一种肿瘤全营养支持食品,其特征是在于由下列原料制备而成:乌梢蛇 25 g、山楂20 g、枸杞子 10 g、山药10 g、陈皮 5 g、茯苓 5 g、香菇5 g、裸藻粉20 g、诺丽果浆 20 g全部的提取物混合物;多种益生菌80-150 g、益生元100-200 g、短肽100-200 g、氨基酸100-250 g、有保健功能的油脂150-300 g、海藻糖10-30 g、复合维生素1-10 g(维生素A 3000-5000 μgRE、维生素D 50-150 μg、维生素 E 50-100 mg α-TE、维生素K1 400-700 μg、维生素B1 5-10 mg、维生素B2 5-15 mg、维生素B6 5-10 mg、维生素B12 5-15 μg、烟酸(烟酰胺)10-20 mg、叶酸1-5 mg、泛酸30-50 mg、维生素C 1-2 g、生物素50-200μg、碘0.5-2 mg、牛磺酸0.5-1 g)、复合宏量矿物质 20-100 g(钙2-7 g、镁1-2 g、钠3-6 g、钾5-10 g、磷2-8 g、氯1-5 g)、复合微量矿物质 0.5-2 g(铜1-5 mg、铁40-70 mg、锌10-50mg、锰0.5-5 mg、硒0.1-1 mg)。
3.根据权利要求1所述的一种肿瘤全营养支持食品,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。
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