CN115989872A - 一种改善肿瘤患者营养状态的组合物及其制备方法 - Google Patents
一种改善肿瘤患者营养状态的组合物及其制备方法 Download PDFInfo
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Abstract
本发明提供一种改善肿瘤患者营养状态的组合物及其制备方法。该组合物包括富锌富硒蛋白粉,小麦胚芽,中链甘油三酯微囊粉,谷氨酰胺,罗勒,蛹虫草,鱼油微囊粉,富锌富硒蛋白肽,葡萄糖酸钙,精氨酸,速溶芦笋粉,姜黄,β‑羟基‑β‑甲基丁酸钙,左旋肉碱,低聚木糖,富硒麦芽粉,牛磺酸,酵母β‑葡聚糖。本发明提供一种改善肿瘤患者营养状态的组合物,通过补充具有抗肿瘤作用的有益成分,达到直接或间接辅助抑制肿瘤组织生长和癌细胞转移,主要是辅助放化疗,减轻治疗的副作用,提高机体免疫力的结果;此外,通过营养素的合理补充,改善机体营养状态和脏器功能,提高抗肿瘤治疗的耐受性,从而提高癌症的生存率。
Description
技术领域
本发明涉及一种改善肿瘤患者营养状态的组合物及其制备方法。
背景技术
2018年全球癌症新发病例1800万例,死亡960万。其中我国新增病例380.4万例,占全球病例21.1%(380.4/1800);死亡229.6万,占全球死亡24%(229.6/960)。与发达国家相比,恶性肿瘤治疗效果仍有明显差距,举例:2005-2015年国内淋巴瘤的五年生存率从44%升至61%,美国则超过90%。调查显示,我国住院恶性肿瘤患者中、重度营养不良发生率高达58%,约20%的肿瘤患者直接死于营养不良。因此,营养支持已成为肿瘤患者抗肿瘤治疗期间的不可或缺的支持治疗手段。
目前,国内的肿瘤营养支持产品多是以中药成分为主,如CN102793900A、CN107596106A,均以当归、黄芪、人参等中药为主要成分,但对于普遍营养状况较差,甚至处于负氮平衡的肿瘤患者来说,很难达到改善营养状态的效果。另外,CN105211857B、CN104522665A和CN110419734A均是以蛋白质和肽类成分为主,添加芦笋,螺旋藻,多种维生素和矿物质,并未添加鱼油,精氨酸,罗勒多糖和谷氨酰胺等免疫营养素,在抑制癌细胞增殖,降低放化疗副作用等方面,未达到最佳效果。截止目前,并未发现既能为肿瘤患者提供营养支持,又能辅助放化疗效果,抑制癌细胞增殖的产品。
发明内容
针对现有技术的不足,本产品的开发,旨在通过补充具有抗肿瘤作用的有益成分,达到直接或间接辅助抑制肿瘤组织生长和癌细胞转移,减轻治疗的副作用,提高机体免疫力的结果;此外,通过营养素的合理补充,改善机体营养状态和脏器功能,提高抗肿瘤治疗的耐受性,从而提高癌症的生存率。
为了解决以上技术问题,本发明的技术方案为:
一方面,一种改善肿瘤患者营养状态的组合物,按其重量份计,由富锌富硒蛋白粉90-110份,小麦胚芽63-78份,中链甘油三酯微囊粉14-17份,谷氨酰胺14-17份,罗勒14-17份,蛹虫草12-15份,鱼油微囊粉8-10.5份,富锌富硒蛋白肽11-14份,葡萄糖酸钙2-3.5份,精氨酸10-12.5份,速溶芦笋粉8-10.5份,姜黄7-8.7份,β-羟基-β-甲基丁酸钙5-7份,左旋肉碱4-5.5份,低聚木糖4-5.5份,富硒麦芽粉2.5-3.5份,牛磺酸0.3-0.5份,酵母β-葡聚糖0.5-0.8份,复配维生素矿物质1-1.6份组成。
优选的,所述复配维生素矿物质,按其重量份数计,由醋酸视黄酯0.0005-0.0015份,胆钙化醇0.00001-0.00005份,dl-a-醋酸生育酚0.03-0.07份,盐酸硫铵素0.005-0.01份,核黄素0.005-0.01份,盐酸吡哆醇0.003-0.007份,氰钴铵0.00001-0.00005、烟酰胺0.03-0.07、D-泛酸钙0.01-0.02、叶酸0.0005-0.001、L-抗坏血酸钠0.03-0.08、葡萄糖酸锌0.005-0.015、焦磷酸铁0.02-0.08组成。
优选的,所述富锌富硒蛋白肽,是以所述富锌富硒蛋白粉为原料,经下述方法制备得到的:
A)投入所述富锌富硒蛋白粉,加水,所述富锌富硒蛋白粉与水的重量比为1:15,搅拌1.5个小时,过胶体磨,均质;
B)调pH 6.8~7.0,温度37℃,加入中性酶,所述中性酶与步骤A中所述富锌富硒蛋白粉的重量比为1:200,酶解时间3小时;调pH 7.5,加温至50℃,加入菠萝酶和木瓜酶,所述菠萝酶和木瓜酶总重量与步骤A中所述富锌富硒蛋白粉的重量比为5:1,酶解6小时;
C)将酶解液pH调至6.0-7.0,加入活性炭,所述活性炭与步骤A中所述富锌富硒蛋白粉的重量比为1:10,升温至60℃保温3小时灭酶处理后,降温至20℃;
D)分别过陶瓷膜、有机膜、浓缩膜;
E)将滤液转移至暂存罐,并降温至4-6℃暂存;
F)喷雾干燥,进风温度150-170℃,出口温度60-80℃。
优选的,所述中性酶与所述菠萝酶、所述木瓜酶的酶活力比为1.5:1:1。
优选的,由以下重量份的原料制成:富锌富硒蛋白粉100份,小麦胚芽70份,中链甘油三酯微囊粉15份,谷氨酰胺15份,罗勒15份,蛹虫草15份,鱼油微囊粉10份,富锌富硒蛋白肽10份,葡萄糖酸钙3份,精氨酸10份,速溶芦笋粉10份,姜黄10份,β-羟基-β-甲基丁酸钙5份,左旋肉碱5份,低聚木糖5份,富硒麦芽粉3份,酵母β-葡聚糖1份,牛磺酸0.5份,复配维生素矿物质1.5份;
优选的,所述复配维生素矿物质按其重量份数计,由醋酸视黄酯0.001份,胆钙化醇0.00003份,dl-a-醋酸生育酚0.05份,盐酸硫铵素0.008份,核黄素0.007份,盐酸吡哆醇0.005份,氰钴铵0.00001、烟酰胺0.05、D-泛酸钙0.01、叶酸0.00075、L-抗坏血酸钠0.05、葡萄糖酸锌0.01份、焦磷酸铁0.055份组成。
另一方面,一种改善肿瘤患者营养状态的组合物的制备方法,包括以下步骤:
(1)预处理:将蛹虫草进行微粉过300目筛,牛磺酸、L-精氨酸、小麦胚芽粉碎,过60目备用;富锌富硒蛋白粉、富锌富硒蛋白肽、左旋肉碱、中链甘油三酯微囊粉、罗勒提取物、芦笋粉、姜黄、β-羟基-β-甲基丁酸钙、富硒麦芽粉、鱼油粉、低聚木糖、黄原胶、酵母β-葡聚糖、L-谷氨酰胺、麦香粉末香精、β-环状糊精、罗汉果甜苷、葡萄糖酸钙、复配维生素矿物质过60目筛;
(2)预混:将黄原胶、酵母β-葡聚糖、复配维生素矿物质、牛磺酸、罗汉果甜苷、麦香粉末香精、β-环状糊精按配方量称取,置称量袋内混合,混合至颜色质地均一,得混合物B;
(3)总混:将蛹虫草、小麦胚芽粉、富锌富硒蛋白粉依次加入至混合机内混合5min,混合后将左旋肉碱、海洋鱼皮胶原低聚肽粉、中链甘油三酯微囊粉、罗勒提取物、L-谷氨酰胺、芦笋粉、L-精氨酸、低聚木糖、鱼油粉、姜黄、β-羟基-β-甲基丁酸钙、葡萄糖酸钙、富硒麦芽粉、混合物B、二氧化硅依次加入混合,混合至颜色均一;
(4)中间品检测:检测总水分不超过5%,各项营养素指标是否在质量标准要求的范围之内;
(5)罐装:洁净区装袋。
配方选择依据:
富锌富硒蛋白粉
研究发现,肿瘤患者尤其是经过放疗的肿瘤患者,都显示血清锌、硒水平均降低,其机制不甚清楚,但许多研究认为,以上变化均系肿瘤存在引起的结果。并解释其机制可能为:癌细胞在快速生长代谢过程中对锌、硒的利用增加;肿瘤诱导锌、硒在肝或其它组织中积累;肿瘤患者对于组织坏死反应的白细胞内慢性调节物可使锌、硒***增加;消化吸收障碍,消化道肿瘤患者因此更易较其他肿瘤患者发生低锌、硒。科学、高效补硒、锌,对提高治疗效果,降低放化疗副作用,增强机体免疫力至关重要。
富锌富硒蛋白粉是经过日粮、饮水中强化硒等方式,使得蛋鸡体内硒元素含量增加,通过组织循环使机体达到新的动态平衡,硒在生殖***中含量最高,从而转移并富集到鸡蛋中,再经过喷雾干燥制备而成。生物转化技术使得鸡蛋中的锌硒以蛋白态的形式存在(与在人体内的存在形式一致,无需人体再生物转化),因此在生物利用率以及副反应(温和补充,无刺激)方面,具有传统锌硒制剂不可替代的优势。
硒蛋白指硒替换半胱氨酸中的硫原子形成第21种氨基酸-硒代半胱氨酸,利用3个终止密码子之一的UGA作为编码子,***到蛋白质编码序列中所形成的特殊蛋白质。“硒”被公认为“抗癌之王”,因为硒可以控制肿瘤细胞的生长分化,一是清除有害自由基并增强机体免疫力;二是硒能有效抑制癌组织氧化磷酸化过程,从而抑制肿瘤细胞的蛋白质和DNA的合成速率;三是硒可以明显抑制癌细胞的无氧酵解速度。
硒的抗氧化作用主要通过GSH-Px家族、硫氧还蛋白还原酶(TrxR)家族和硒蛋白P(SelP)等硒蛋白实现。GSH-Px家族至少包括6个成员,在保护细胞免受自由基的氧化损伤方面具有重要作用;TrxR是一类具有还原酶活性的硒蛋白,以硫氧还蛋白(Trx)为底物,使氧化型Trx还原为还原型,以清除有害的过氧化氢(H2O2);SelP是一种血浆硒蛋白,可消除炎症反应产生的自由基超氧离子(O2 -)与一氧化氮(NO)反应生成的过氧亚硝酸盐。动物实验显示,放疗后小鼠全血和肝脏中GSH-Px、SOD及CAT的活性降低,补硒后GSH-Px、SOD及CAT的活性均有不同程度增加,表明补硒后,小鼠机体抗氧化能力增强。
硒可降低放化疗的副作用。肿瘤细胞乏氧是导致治疗失败的主要原因之一,克服乏氧所导致的放疗抵抗是提高肿瘤细胞放疗敏感性的重要途径。乏氧时细胞内关键的调节因子低氧诱导因子-1a(HIF-1a)表达上调,作用于下游基因如血管内皮生长因子(VEGF)等。体外实验证明,硒可下调VEGF和HIF-1a的表达,改善乏氧微环境,增加肿瘤灌注和氧合,提高恶性肿瘤对放疗的敏感性。
研究癌症和硒关系的专家GerhaniSchrauzer建议,每天应补充200-300ug硒。癌症患者200-400ug/d,肿瘤放化疗期间600-750ug/d,肿瘤恢复期300-400ug/d。补硒并没有减少放疗的有效性,没有毒性报告,对患者的总体状况和生活质量有积极作用。
锌
锌是人体中分布最广泛必需微量元素,具有3大基本功能:催化功能,结构功能和调节功能。催化功能体现在,锌与90多种酶的合成、200多种酶的活性相关,有试验研究显示,在不影响蛋白质功能时移除锌,酶活性降低,补充锌后酶活性恢复,因此缺锌会降低多种酶的活性。结构功能体现在,锌以锌指的形式存在于各种参与细胞分化和增殖,信号传导,细胞黏附和转录的蛋白中,锌也参与维持酶的结构,如铜锌超氧化物歧化酶中,铜在活性部位,锌维持酶的结构。根据锌代谢的平衡控制理论,补锌以保证机体对总锌需求,才能保证锌指的含量。调节功能体现在,锌参与调节基因启动子来诱导转录,从而正向或负向的调节各种基因表达。锌参与组织(主要是创伤与上皮组织)修复。
锌的缺乏属于II型营养素缺乏,缺锌往往没有特定的临床症状和生化特征改变,而是减少内源性损失和可能的代偿性适应,如降低生长发育或免疫功能作为代偿对锌的需求,长期锌缺乏导致糖皮质激素升高,后者导致胸腺萎缩,B细胞、T细胞和自然杀伤细胞反应受损。有研究表明,锌转运蛋白的表达水平与肿瘤的恶性程度相关,提示细胞内锌稳态的改变可能导致癌症的严重程度。锌缺乏可诱导细胞凋亡或坏死,而充足的锌水平维持细胞自噬。研究发现,癌细胞通过增加锌的纳入,维持癌细胞的存活,这一发现表明,可以通过调控锌水平来促进免疫细胞的存活和/或诱导肿瘤细胞凋亡。
放化疗后口腔粘膜的损伤对患者及照护者是一项艰巨的挑战,Scully等研究表明,补锌有助于缓解口腔粘膜损伤和治疗地图舌。接受放、化疗的肿瘤患者,口腔粘膜细胞结构会遭到破坏,蛋白锌可加速坏死细胞凋亡,维持细胞结构稳定,促进伤口愈合从而保护粘膜组织。
精氨酸
是一种必需氨基酸,研究表明,精氨酸可通过抑制鸟氨酸脱羧酶活性,抑制多胺生物合成,从而抑制肿瘤细胞的生长。临床应用显示,术前7天和术后5天补充含有精氨酸、n-3PUFA的免疫营养素,患者血清蛋白和白蛋白及锌水平明显增加,术后营养状况改善,并发症减少。
罗勒多糖
近年来,罗勒在抗肿瘤、抑制癌细胞迁移及减轻放化疗不良反应等方面的疗效均受到人们的重视。罗勒多糖灌胃剂量(5mg/Kg和2.5mg/Kg,连续15d)在体内外均具有显著的抗肿瘤转移作用;与对照组相比细胞间通讯功能有一定程度恢复;NK细胞的活性明显升高。罗勒多糖对卵巢癌生物学行为的研究发现罗勒多糖治疗组(5mg/Kg和2.5mg/Kg,连续50d)肿瘤的生长及转移行为都受到了明显的抑制,腹腔脏器转移程度积分(腹腔脏器转移程度积分计算方法如下:观察大网膜、肠系膜、肠壁、肝、胃、肾、卵巢、腹壁、后腹壁、横膈、脾等脏器,根据转移至每一脏器的肿瘤结节大小、数量计算"+",分"+"至"++++",每个"+"积5分,合计为模型鼠的肿瘤转移程度积分)显著降低(p<0.01)。罗勒多糖作用后,卵巢癌的基因表达图谱发生明显变化,应用表达谱锌片共筛选出168条差异表达基因。
罗勒多糖对H22荷瘤小鼠化疗增效的影响,发现罗勒多糖(50mg/kg)可显著增强紫杉醇的抑瘤作用以及提高小鼠生存率,并对肝肾无损伤。
蛹虫草
虫草菌丝体干粉治疗气虚证肺癌相关性疲乏临床研究表明,每天4克虫草菌丝体干粉,可加强气虚证肺癌相关性疲乏的疗效,改善生活质量;通过血常规和IL-6检测证实,虫草菌丝体干粉提升肺癌患者免疫力,改善肝功能及纠正贫血。
蛹虫草(每天5克)治疗胃癌、肝癌等多种癌症49例(胃癌11例,肝癌7例,贲门癌8例,肠癌2例,胆囊癌1例,肺癌6例,淋巴瘤癌5例,乳腺癌术后复发2里,多发性骨髓瘤1例,左侧胸膜恶性间皮瘤1例,鼻咽癌1例,***癌1例)。30天为一疗程,用药2-9疗程,其中有效(症状改善)13例,显效(症状明显改善或肿瘤缩小)23例,总有效率为73.5%。
芦笋
研究发现,芦笋活性成分(主要是芦笋皂苷和芦笋多糖)具有抗肿瘤、免疫调节、抗衰老抗疲劳、降血脂、保肝解毒等特殊的生物学功能。芦笋皂苷按一定剂量的灌胃剂量,连续灌胃7天,对S-180荷瘤小鼠的抑瘤率为32.25%,一般认为抑瘤率达到30%,认为药物有效。芦笋皂苷对S180小鼠肿瘤生长均有抑制作用,并呈量效关系,200mg/Kg剂量下的抑瘤率可达44.8%,生命延长率达57%。
β-羟基-β-甲基丁酸
是亮氨酸的代谢产物,具有促进肌肉合成,抑制肌肉分解,减轻肿瘤负荷和延长生存期,改善肿瘤病人的生活质量。此外,HMB在降血糖,改善胰岛素抵抗方面作用被证实。通过抑制血糖上升,减少癌细胞的无氧酵解途径,从而抑制癌细胞的扩散(该功能未被证实,是推理的)。在国外,HMB在肿瘤病人中的应用已有诸多报道。晚期实体瘤和恶液质(结肠癌、卵巢癌、肺癌、胰腺癌和其他癌症)患者,筛选标准为体重减轻超过5%,预计生存期超过3个月。双盲试验随机分为HMB组(HMB 3g/d,精氨酸14g/d,谷氨酰胺14g/d)和非必须氨基酸混合物组。结果显示HMB组4周后体重增加1Kg,而对照组体重减少0.3公斤,表明HMB在维持恶液质病人体质量方面效果显著。
鱼油(n-3PUFA)
n-3PUFA,是一种药理营养素,可调节营养和免疫功能,还可以通过干扰炎症细胞因子的合成改善癌症厌食,刺激食欲。研究发现,使用n-3PUFA的患者可避免丢失更多的体重(手臂0.17Kg,P=0.01;躯干1.44Kg,P=0.03),并且能显著减轻对白介素-8(IL-8)、白介素-10(IL-10)及肿瘤坏死因子α(TNF-α)的应激反应。
左旋肉碱
具有抑制机体蛋白溶解,弱化胰岛素抵抗,降低肿瘤患者血浆甘油三酯浓度的作用。左旋肉碱75%是在食物中获得,25%在体内由赖氨酸和蛋氨酸,在维生素C、维生素B6、亚铁离子辅助作用下合成。左旋肉碱主要通过促进脂质的合成,降低炎症因子IL-6水平来抑制蛋白质的分解代谢。小鼠实验证明9.01mg/Kg的灌胃剂量可显著降低荷瘤小鼠TNF-a和IL-6水平。
综上所述,本发明具备以下有益技术效果:
本发明提供一种改善肿瘤患者营养状态的组合物及其制备方法,本产品的开发,旨在通过补充具有抗肿瘤作用的有益成分,达到直接或间接辅助抑制肿瘤组织生长和癌细胞转移,减轻治疗的副作用,提高机体免疫力的结果;此外,通过营养素的合理补充,改善机体营养状态和脏器功能,提高抗肿瘤治疗的耐受性,从而提高癌症的生存率。
具体实施方式
实施例1
一种改善肿瘤患者营养状态的组合物,由以下重量份的原料制成:富锌富硒蛋白粉100份,小麦胚芽70份,中链甘油三酯微囊粉15份,谷氨酰胺15份,罗勒15份,蛹虫草15份,鱼油微囊粉10份,富锌富硒蛋白肽10份,葡萄糖酸钙3份,精氨酸10份,速溶芦笋粉10份,姜黄10份,β-羟基-β-甲基丁酸钙5份,左旋肉碱5份,低聚木糖5份,富硒麦芽粉3份,酵母β-葡聚糖1份,牛磺酸0.5份,复配维生素矿物质1.5份;复配维生素矿物质按其重量份数计,由醋酸视黄酯0.001份,胆钙化醇0.00003份,dl-a-醋酸生育酚0.05份,盐酸硫铵素0.008份,核黄素0.007份,盐酸吡哆醇0.005份,氰钴铵0.00001、烟酰胺0.05、D-泛酸钙0.01、叶酸0.00075、L-抗坏血酸钠0.05、葡萄糖酸锌0.01份、焦磷酸铁0.055份组成。
富锌富硒蛋白肽,是以富锌富硒蛋白粉为原料,经下述方法制备得到的:
A)投入富锌富硒蛋白粉100公斤,加水1500公斤,搅拌1.5个小时,过胶体磨,均质;
B)调pH 6.8~7.0,温度37℃,加入中性酶(酶活力150万)500克,酶解时间3小时;调pH 7.5,加温至50℃,加入菠萝酶(酶活力100万)和木瓜酶(酶活力100万)共20公斤,酶解6小时;
C)将酶解液pH调至6.0-7.0,加入活性炭10公斤,升温至60℃保温3小时灭酶处理后,降温至20℃;
D)分别过陶瓷膜、有机膜、浓缩膜;
E)将滤液转移至暂存罐,并降温至4-6℃暂存;
F)喷雾干燥,进风温度150-170℃,出口温度60-80℃。
一种改善肿瘤患者营养状态的组合物的制备方法,制备方法包括以下步骤:
(1)预处理:将蛹虫草进行微粉过300目筛,牛磺酸、L-精氨酸、小麦胚芽粉碎,过60目备用;富锌富硒蛋白粉、富锌富硒蛋白肽、左旋肉碱、中链甘油三酯微囊粉、罗勒提取物、芦笋粉、姜黄、β-羟基-β-甲基丁酸钙、富硒麦芽粉、鱼油粉、低聚木糖、黄原胶、酵母β-葡聚糖、L-谷氨酰胺、麦香粉末香精、β-环状糊精、罗汉果甜苷、葡萄糖酸钙、复配维生素矿物质过60目筛;
(2)预混:将黄原胶、酵母β-葡聚糖、复配维生素矿物质、牛磺酸、罗汉果甜苷、麦香粉末香精、β-环状糊精按配方量称取,置称量袋内混合,混合至颜色质地均一,得混合物B;
(3)总混:将蛹虫草、小麦胚芽粉、富锌富硒蛋白粉依次加入至混合机内混合5min,混合后将左旋肉碱、海洋鱼皮胶原低聚肽粉、中链甘油三酯微囊粉、罗勒提取物、L-谷氨酰胺、芦笋粉、L-精氨酸、低聚木糖、鱼油粉、姜黄、β-羟基-β-甲基丁酸钙、葡萄糖酸钙、富硒麦芽粉、混合物B、二氧化硅依次加入混合,混合至颜色均一;
(4)中间品检测:检测总水分不超过5%,各项营养素指标是否在质量标准要求的范围之内;
(5)罐装:洁净区装袋。
除富锌富硒蛋白粉和富锌富硒蛋白肽为自产外,其余原料均为市购产品。
实施例2
本实施例一种改善肿瘤营养状态的组合物,由以下重量份的原料制成:富锌富硒蛋白粉90份,小麦胚芽63份,中链甘油三酯微囊粉12份,谷氨酰胺12份,罗勒12份,蛹虫草10份,鱼油微囊粉8份,富锌富硒蛋白肽10份,葡萄糖酸钙2份,精氨酸10份,速溶芦笋粉8份,姜黄7份,β-羟基-β-甲基丁酸钙5份,左旋肉碱4份,低聚木糖4份,富硒麦芽粉2份,酵母β-葡聚糖0.5份,牛磺酸0.3份,复配维生素矿物质1.2份。所述复合维生素矿物质醋酸视黄酯0.0009份,胆钙化醇0.00003份,dl-a-醋酸生育酚0.045份,盐酸硫铵素0.007份,核黄素0.006份,盐酸吡哆醇0.005份,氰钴铵0.00001、烟酰胺0.05、D-泛酸钙0.01、叶酸0.0007、L-抗坏血酸钠0.05、葡萄糖酸锌0.01份、焦磷酸铁0.05份。
富锌富硒蛋白肽的制备方法与组合物的制备方法与实施例1相同。
实施例3:
本实施例一种改善肿瘤营养状态的组合物,由以下重量份的原料制成:富锌富硒蛋白粉110份,小麦胚芽78份,中链甘油三酯微囊粉17份,谷氨酰胺17份,罗勒17份,蛹虫草15份,鱼油微囊粉11份,富锌富硒蛋白肽14份,葡萄糖酸钙4份,精氨酸13份,速溶芦笋粉11份,姜黄9份,β-羟基-β-甲基丁酸钙7份,左旋肉碱6份,低聚木糖6份,富硒麦芽粉4份,酵母β-葡聚糖0.8份,牛磺酸0.5份,复配维生素矿物质1.6份。所述复合维生素矿物质由醋酸视黄酯0.001份,胆钙化醇0.00004份,dl-a-醋酸生育酚0.05份,盐酸硫铵素0.008份,核黄素0.007份,盐酸吡哆醇0.005份,氰钴铵0.00001、烟酰胺0.05、D-泛酸钙0.01、叶酸0.0008、L-抗坏血酸钠0.05、葡萄糖酸锌0.01份、焦磷酸铁0.06份组成。
富锌富硒蛋白肽的制备方法与组合物的制备方法与实施例1相同。
对照例1
与实施例1相比,采用速溶豆粉+大豆分离蛋白+大豆肽粉作为蛋白来源,代替实施例1中的富锌富硒蛋白粉+富锌富硒蛋白肽。组合物的制备方法与实施例1相同。
对照例2
与实施例1相比,未添加鱼油微囊粉。组合物的制备方法与实施例1相同。
对照例3
与实施例1相比,未添加蛹虫草。组合物的制备方法与实施例1相同。
对照例4
与实施例1相比,未添加罗勒。组合物的制备方法与实施例1相同。
对照例5
与实施例1相比,未添加谷氨酰胺和精氨酸。组合物的制备方法与实施例1相同。
实验方案
1.实验动物
动物和瘤株:SPF级8-12周龄昆明小鼠240只,120只用于化疗试验,120只用于放疗试验,每组12只。小鼠在实验前适应性饲养,实验期间自由采食饮水。小鼠、饲料和腹水型S180瘤株均采购于济南朋悦实验动物中心。
2.试验方法
(1)化疗中的抑瘤效果试验
S180荷瘤小鼠模型建立
无菌条件下抽取6-7d生长良好的S180小鼠的腹水,用生理盐水按1:3稀释,充分混匀后显微计数,用生理盐水调整细胞数位1.5×107/ml,取0.2ml于每只小鼠右侧腋窝下碘酊消毒后皮下接种,瘤株接种前,均用0.2%台盼蓝染色,计算活细胞数为95%-98%。从抽取腹水开始,到移植完最后1只小鼠的总时间控制在2h内。
分组和给药
化疗药为注射用环磷酰胺,厂家江苏恒瑞医药股份有限公司。
小鼠接种24h后随机分为对照组,环磷酰胺组,实施例1-3+环磷酰胺组和对照例1-5+环磷酰胺组。对照组用生理盐水灌胃,0.5ml/次,1次/天。环磷酰胺组腹腔注射环磷酰胺0.02g/Kg/d,同时生理盐水灌胃0.5ml/d。实施例1-3+环磷酰胺组和对照例1-5+环磷酰胺组,均注射环磷酰胺0.02g/Kg/d和灌胃0.5ml/d相对应的产品(称取适量的相对应样品,按照1:1加入生理盐水搅拌均与即可),连续灌胃15d。
抑瘤率
在无菌环境中,从小鼠腋下完整剥离肿瘤组织,在电子天平称瘤组织质量。
抑瘤率=(1-治疗组平均瘤质量/对照组平均瘤质量)×100%。
数据分析
(2)放疗试验中抑瘤效果试验
S180荷瘤小鼠模型建立
无菌条件下抽取6-7d生长良好的S180小鼠的腹水,用生理盐水按1:3稀释,充分混匀后显微计数,用生理盐水调整细胞数位1.5×107/ml,取0.2ml于每只小鼠背部近中线处碘酊消毒后皮下接种,瘤株接种前,均用0.2%台盼蓝染色,计算活细胞数为95%-98%。从抽取腹水开始,到移植完最后1只小鼠的总时间控制在2h内。
分组与放疗
小鼠接种24h后随机分为对照组,放疗组,实施例1-3+放疗组和对照例1-5+放疗组。
对照组用生理盐水灌胃,0.5ml/只。
放疗组用生理盐水灌胃,0.5ml/只。
实施例1-3+放疗组和对照例1-5+放疗组用相对应的样品,按食用量计算为成人体重(70Kg)用量的10倍,0.5ml/只(称取适量的相对应样品,按照1:1加入生理盐水搅拌均与即可)。
在灌胃的第7天和第14天,各组动物轻微麻醉,用固定装置固定小鼠,10mm低熔点铅遮蔽头胸部,X射线加速器下照射250mm×250mm,剂量率300cGy/min,源皮距100mm,剂量3.5Gy/次,对照组以相似方法假照射。于第15天处死动物,剥取肿瘤称重。
数据分析
3.实验结论:根据以上数据,实施例1的抑癌效果最显著,实施例1-3+放疗组和对照例1-5+放疗组相比,瘤重减轻,抑瘤率明显升高。
1.实验方案:本研究采用多中心联合,共同招募100名已出现营养不良状况的肿瘤患者,随机分为实验组和对照组。其中对照组平均年龄57±17岁,男性27名,女性23名;实验组平均年龄58±9岁,男性25名,女性25名。
在临床营养师指导下,实验组给予实施例1所述的产品,对照组给予对照例1所述的产品,疗程90天,每次30克,每天3次。
2.观察指标和观察频率
3.统计学分析:数据采用SPSS 17.0统计软件进行处理及分析。计量数据用均数±标准差(x±s)表示,组内资料进行配对t检验,组间数据进行独立样本t检验,P<0.05为差异有统计学意义。
4.实验结论:检测结果如下表所示,各项指标表明,实验组与对照组均对肿瘤患者的营养状态和免疫功能有显著改善,且白蛋白、视黄醇结合蛋白、总不饱和游离脂肪酸指标来看,实验组的改善效果显著优于对照组。炎症因子指标和抑制患者病灶进展方面,实验组显著优于对照组。
肿瘤病人营养指标及检测结果
注:*与干预前比,P﹤0.05,#与对照组比,P﹤0.05。
以上所描述的实施例是本发明的优选实施方式,而不是全部的实施例。本发明的实施例的详细描述并非旨在限制要求保护的本发明的范围,而是仅仅表示本发明的选定实施例。基于本发明中的实施例,本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
Claims (7)
1.一种改善肿瘤患者营养状态的组合物,其特征在于,按重量份计,由富锌富硒蛋白粉90-110份,小麦胚芽63-78份,中链甘油三酯微囊粉14-17份,谷氨酰胺14-17份,罗勒14-17份,蛹虫草12-15份,鱼油微囊粉8-10.5份,富锌富硒蛋白肽11-14份,葡萄糖酸钙2-3.5份,精氨酸10-12.5份,速溶芦笋粉8-10.5份,姜黄7-8.7份,β-羟基-β-甲基丁酸钙5-7份,左旋肉碱4-5.5份,低聚木糖4-5.5份,富硒麦芽粉2.5-3.5份,牛磺酸0.3-0.5份,酵母β-葡聚糖0.5-0.8份,复配维生素矿物质1-1.6份组成。
2.根据权利要求1所述的一种改善肿瘤患者营养状态的组合物,其特征在于:所述复配维生素矿物质,按重量份数计,由醋酸视黄酯0.0005-0.0015份,胆钙化醇0.00001-0.00005份,dl-a-醋酸生育酚0.03-0.07份,盐酸硫铵素0.005-0.01份,核黄素0.005-0.01份,盐酸吡哆醇0.003-0.007份,氰钴铵0.00001-0.00005、烟酰胺0.03-0.07、D-泛酸钙0.01-0.02、叶酸0.0005-0.001、L-抗坏血酸钠0.03-0.08、葡萄糖酸锌0.005-0.015、焦磷酸铁0.02-0.08组成。
3.根据权利要求1所述的一种改善肿瘤患者营养状态的组合物,其特征在于:所述富锌富硒蛋白肽,是以所述富锌富硒蛋白粉为原料,经下述方法制备得到的:
A)投入所述富锌富硒蛋白粉,加水,所述富锌富硒蛋白粉与水的重量比为1:15,搅拌1.5个小时,过胶体磨,均质;
B)调pH 6.8~7.0,温度37℃,加入中性酶,所述中性酶与步骤A中所述富锌富硒蛋白粉的重量比为1:200,酶解时间3小时;调pH 7.5,加温至50℃,加入菠萝酶和木瓜酶,所述菠萝酶和木瓜酶总重量与步骤A中所述富锌富硒蛋白粉的重量比为5:1,酶解6小时;
C)将酶解液pH调至6.0-7.0,加入活性炭,所述活性炭与步骤A中所述富锌富硒蛋白粉的重量比为1:10,升温至60℃保温3小时灭酶处理后,降温至20℃;
D)分别过陶瓷膜、有机膜、浓缩膜;
E)将滤液转移至暂存罐,并降温至4-6℃暂存;
F)喷雾干燥,进风温度150-170℃,出口温度60-80℃。
4.根据权利要求3所述的一种改善肿瘤患者营养状态的组合物,其特征在于:所述中性酶与所述菠萝酶、所述木瓜酶的酶活力比为1.5:1:1。
5.根据权利要求1所述的一种改善肿瘤患者营养状态的组合物,其特征在于:按重量份数计,由富锌富硒蛋白粉100份,小麦胚芽70份,中链甘油三酯微囊粉15份,谷氨酰胺15份,罗勒15份,蛹虫草15份,鱼油微囊粉10份,富锌富硒蛋白肽10份,葡萄糖酸钙3份,精氨酸10份,速溶芦笋粉10份,姜黄10份,β-羟基-β-甲基丁酸钙5份,左旋肉碱5份,低聚木糖5份,富硒麦芽粉3份,酵母β-葡聚糖1份,牛磺酸0.5份,复配维生素矿物质1.5份组成。
6.根据权利要求2所述的一种改善肿瘤患者营养状态的组合物,其特征在于:所述复配维生素矿物质,按重量份数计,由醋酸视黄酯0.001份,胆钙化醇0.00003份,dl-a-醋酸生育酚0.05份,盐酸硫铵素0.008份,核黄素0.007份,盐酸吡哆醇0.005份,氰钴铵0.00001、烟酰胺0.05、D-泛酸钙0.01、叶酸0.00075、L-抗坏血酸钠0.05、葡萄糖酸锌0.01份、焦磷酸铁0.055份组成。
7.一种改善肿瘤患者营养状态的组合物的制备方法,其特征在于:制备方法包括以下步骤:
(1)预处理:将蛹虫草进行微粉过300目筛,牛磺酸、L-精氨酸、小麦胚芽粉碎,过60目备用;富锌富硒蛋白粉、富锌富硒蛋白肽、左旋肉碱、中链甘油三酯微囊粉、罗勒提取物、芦笋粉、姜黄、β-羟基-β-甲基丁酸钙、富硒麦芽粉、鱼油粉、低聚木糖、黄原胶、酵母β-葡聚糖、L-谷氨酰胺、麦香粉末香精、β-环状糊精、罗汉果甜苷、葡萄糖酸钙、复配维生素矿物质过60目筛;
(2)预混:将黄原胶、酵母β-葡聚糖、复配维生素矿物质、牛磺酸、罗汉果甜苷、麦香粉末香精、β-环状糊精按配方量称取,置称量袋内混合,混合至颜色质地均一,得混合物B;
(3)总混:将蛹虫草、小麦胚芽粉、富锌富硒蛋白粉依次加入至混合机内混合5min,混合后将左旋肉碱、海洋鱼皮胶原低聚肽粉、中链甘油三酯微囊粉、罗勒提取物、L-谷氨酰胺、芦笋粉、L-精氨酸、低聚木糖、鱼油粉、姜黄、β-羟基-β-甲基丁酸钙、葡萄糖酸钙、富硒麦芽粉、混合物B、二氧化硅依次加入混合,混合至颜色均一;
(4)中间品检测:检测总水分不超过5%,各项营养素指标是否在质量标准要求的范围之内;
(5)罐装:洁净区装袋。
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