CN108771220A - 一种肿瘤患者的全营养伴餐粉 - Google Patents
一种肿瘤患者的全营养伴餐粉 Download PDFInfo
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- CN108771220A CN108771220A CN201810592010.7A CN201810592010A CN108771220A CN 108771220 A CN108771220 A CN 108771220A CN 201810592010 A CN201810592010 A CN 201810592010A CN 108771220 A CN108771220 A CN 108771220A
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Abstract
本发明提供了一种肿瘤患者的全营养伴餐粉。包括以下原料：大豆蛋白、聚葡萄糖、麦芽糊精、全脂乳粉、乳清蛋白、低聚果糖、小麦低聚肽、复合维生素、大豆磷脂、葡萄糖酸锌、碳酸钙、碳酸镁、乙二胺四乙酸铁钠、山楂冻干粉、金芝多糖、铁皮石斛多糖、白首乌提取物、润肺草提取物、富硒花菜冻干粉、绞股蓝皂苷、甜菊糖甙。该伴餐粉原料易得，价格相对较低，可兼顾改善肿瘤患者食欲、控制病症恶化、提高患者生活质量。对消化道肿瘤、肺癌患者术后免疫功能的改善有促进作用，可改善营养状况，控制病症恶化，值得临床推广应用。
Description
技术领域
本发明属于具有特殊医学用途配方食品，具体涉及一种肿瘤患者的全营养伴餐粉。
技术背景
特殊医学用途配方食品(Food for special medical purpose，以下简称特医食品)是指为了满足进食受限、消化吸收障碍、代谢紊乱或特定疾病状态人群对营养素或膳食的特殊需要，专门加工配制而成的配方食品。特医食品作为一种肠内营养制剂，可以起到营养支持的作用和改善病症的作用。
近年来，随着我国老龄化进程不断加快，因生活不规律、饮食不均衡等导致的肿瘤发病率和死亡率持续增高。在我国，恶性肿瘤是最常见的慢性病，其死亡率居第一位。我国每年新发生肿瘤患者总数约有 429 万人，新增肿瘤患者年均增长率在 10% 左右。肿瘤成为危害国民健康的主要杀手，肿瘤发病率的高涨导致抗肿瘤药物市场增速明显，也为居民和国家造成严重的经济负担。各大医疗机构和部分社会资本开始加大对肿瘤科室、肿瘤医院的投入，国内外抗肿瘤药企也纷纷加大新药研发的力度和对中国市场的关注度。然而，药物的使用必然带来巨大的毒副作用，收集北京市药品不良反应监测中心 2010 年 1 月至2012 年 8 月抗肿瘤药监测数据，其中抗肿瘤药物引起的严重不良反应共计 365 例，有些患者甚至因为药物的过度使用而造成死亡。
众所周知，抗肿瘤西药、靶向药物毒副作用较大，对身体的损伤让人难以忍受，而由药食两用中药制成的肿瘤全营养品，无任何毒副作用，还能起到抗肿瘤和调节免疫力的作用，这才是人们所期盼的和社会所需求的，而且一定能够获得良好的社会、经济以及环境效益。
特医食品国内近几年实现快速发展，平均年增增速超过37%，有70%的发展空间。国内企业主要有青岛海汇、广州力衡等，占据国内市场份额的 10% 左右，企业的产品批文为“食”字号，主要在各医院营养科使用，国内企业由于进入产业时间晚，大多以仿制国外产品为主，占有市场份额小、自主知识产权少、技术落后、投资规模小、没有品牌影响力。一些本土企业在新产品研发取得了一定进展，如上海冬泽特医有限公司新研发的产品复方营养混悬剂和肠内营养混悬液获得了国药准字的批号，研制的肿瘤病人的肠内营养制剂东泽力市场售价406元/盒，东泽力益生菌粉268元/盒。
发明内容
针对上述问题，本发明提供了一种肿瘤患者的全营养伴餐粉。该伴餐粉原料易得，价格相对较低，可兼顾改善肿瘤患者食欲、控制病症恶化、提高患者生活质量。
一种肿瘤患者的全营养伴餐粉，包括以下重量份数的原料：大豆蛋白10-20份、聚葡萄糖10-20份、麦芽糊精10-20份、全脂乳粉10-20份、乳清蛋白10-20份、低聚果糖5-10份、小麦低聚肽1-5份、复合维生素0.3-0.6份、大豆磷脂2-5份、葡萄糖酸锌0.1-0.5份、碳酸钙0.5-1.5份、碳酸镁0.5-1份、乙二胺四乙酸铁钠0.1-0.2份、山楂冻干粉2-5份、金芝多糖2-5份、铁皮石斛多糖0.3-0.6份、白首乌提取物10-20份、润肺草提取物10-20份、富硒花菜冻干粉10-20份、绞股蓝皂苷0.05-0.2份、甜菊糖甙0.05-0.2份。
所述的山楂冻干粉的制备方法为：山楂去籽，洗净，-10 °C冷冻12h，切片，之后放入冷冻干燥机，物料温度降至-40 °C以下时，开启真空泵；当产品温度上升到0°C，升高压力至30Pa，当温度升至40°C，冻干结束。
所述的白首乌提取物或润肺草提取物的制备方法：白首乌或润肺草洗净，加入8倍量水中，煮沸20min，得滤液1，将滤渣1再加入6倍量水中，煮沸15min，得滤液2，将滤渣2再加入4倍量水，煮沸10min，得滤液3，合并滤液1、2、3，蒸发浓缩，干燥，即得白首乌提取物或润肺草提取物。
所述的富硒花菜冻干粉的制备方法：富硒花菜洗净，-5 °C冷冻12h，之后放入冷冻干燥机，物料温度降至-40 °C以下时，开启真空泵；当产品温度上升到0°C，升高压力至30Pa，当温度升至40°C，冻干结束。
本发明的有益效果
1、控制病症恶化
本发明的伴餐粉对消化道肿瘤患者术后免疫功能的改善有促进作用，可改善营养状况，控制病症恶化，值得临床推广应用。伴餐粉对消化道肿瘤、胃癌、食管癌、小肠癌患者均有恢复效果且超过90%，高于市场已经有的冬泽能对照组。
本发明的伴餐粉对肺癌患者术后免疫功能的改善有促进作用，可改善营养状况，控制病症恶化，值得临床推广应用。伴餐粉对肺癌患者均有恢复效果且超过90%。
同时本伴餐粉也可在制备肿瘤患者术后免疫功能改善药物或保健品中应用。
2、无添加剂，半年内质量不变
原料的山楂含有黄酮类成分再结合甜菊糖甙、铁皮石斛多糖等其他成分共同作为防腐剂，保证伴餐粉半年内不变质。
3、原料营养全面，满足肿瘤患者的营养需求
本发明针对肿瘤患者的情况，提供了一种针对肿瘤患者的伴餐粉，选取的原料易于吸收，且能改善肿瘤患者食欲、控制癌症恶化、提高患者生活质量。采用优质蛋白、脂肪、碳水化合物，配以复合维生素、多种矿物质和药食同源中草药金芝多糖、铁皮石斛多糖、白首乌提取物、润肺草提取物为辅料调配而成，这样通过原料的筛选与配合，使得本发明配方食品中含有人体尤其是肿瘤病人日常所需的适量蛋白质、碳水化合物和脂肪，还含有人体所需的矿物质及维生素，符合肿瘤病人的身体所需，而且营养配比合理，易于消化和吸收。
具体实施方式
实施例1
一种肿瘤患者的全营养伴餐粉，包括以下重量份数的原料：大豆蛋白10份、聚葡萄糖20份、麦芽糊精20份、全脂乳粉10份、乳清蛋白10份、低聚果糖10份、小麦低聚肽5份、复合维生素0.3份、大豆磷脂5份、葡萄糖酸锌0.5份、碳酸钙1.5份、碳酸镁1份、乙二胺四乙酸铁钠0.2份、山楂冻干粉5份、金芝多糖2份、铁皮石斛多糖0.3份、白首乌提取物20份、润肺草提取物10份、富硒花菜冻干粉10份、绞股蓝皂苷0.2份、甜菊糖甙0.05份。
所述的山楂冻干粉的制备方法为：山楂去籽，洗净，-10 °C冷冻12h，切片，之后放入冷冻干燥机，物料温度降至-40 °C以下时，开启真空泵；当产品温度上升到0°C，升高压力至30Pa，当温度升至40°C，冻干结束。
所述的白首乌提取物或润肺草提取物的制备方法：白首乌或润肺草洗净，加入8倍量水中，煮沸20min，得滤液1，将滤渣1再加入6倍量水中，煮沸15min，得滤液2，将滤渣2再加入4倍量水，煮沸10min，得滤液3，合并滤液1、2、3，蒸发浓缩，干燥，即得白首乌提取物或润肺草提取物。
所述的富硒花菜冻干粉的制备方法：富硒花菜洗净，-5 °C冷冻12h，之后放入冷冻干燥机，物料温度降至-40 °C以下时，开启真空泵；当产品温度上升到0°C，升高压力至30Pa，当温度升至40°C，冻干结束。
实施例2
一种肿瘤患者的全营养伴餐粉，包括以下重量份数的原料：大豆蛋白20份、聚葡萄糖10份、麦芽糊精10份、全脂乳粉20份、乳清蛋白20份、低聚果糖5份、小麦低聚肽1份、复合维生素0.6份、大豆磷脂2份、葡萄糖酸锌0.1份、碳酸钙0.5份、碳酸镁0.5份、乙二胺四乙酸铁钠0.1份、山楂冻干粉2份、金芝多糖5份、铁皮石斛多糖0.6份、白首乌提取物10份、润肺草提取物20份、富硒花菜冻干粉20份、绞股蓝皂苷0.05份、甜菊糖甙0.2份。
所述的山楂冻干粉的制备方法为：山楂去籽，洗净，-10 °C冷冻12h，切片，之后放入冷冻干燥机，物料温度降至-40 °C以下时，开启真空泵；当产品温度上升到0°C，升高压力至30Pa，当温度升至40°C，冻干结束。
所述的白首乌提取物或润肺草提取物的制备方法：白首乌或润肺草洗净，加入8倍量水中，煮沸20min，得滤液1，将滤渣1再加入6倍量水中，煮沸15min，得滤液2，将滤渣2再加入4倍量水，煮沸10min，得滤液3，合并滤液1、2、3，蒸发浓缩，干燥，即得白首乌提取物或润肺草提取物。
所述的富硒花菜冻干粉的制备方法：富硒花菜洗净，-5 °C冷冻12h，之后放入冷冻干燥机，物料温度降至-40 °C以下时，开启真空泵；当产品温度上升到0°C，升高压力至30Pa，当温度升至40°C，冻干结束。
实施例3
一种肿瘤患者的全营养伴餐粉，包括以下重量份数的原料：大豆蛋白10-20份、聚葡萄糖15份、麦芽糊精15份、全脂乳粉15份、乳清蛋白15份、低聚果糖8份、小麦低聚肽3份、复合维生素0.4份、大豆磷脂3份、葡萄糖酸锌0.5份、碳酸钙1.0份、碳酸镁0.8份、乙二胺四乙酸铁钠0.1份、山楂冻干粉4份、金芝多糖4份、铁皮石斛多糖0.4份、白首乌提取物15份、润肺草提取物15份、富硒花菜冻干粉15份、绞股蓝皂苷0.1份、甜菊糖甙0.12份。
所述的山楂冻干粉的制备方法为：山楂去籽，洗净，-10 °C冷冻12h，切片，之后放入冷冻干燥机，物料温度降至-40 °C以下时，开启真空泵；当产品温度上升到0°C，升高压力至30Pa，当温度升至40°C，冻干结束。
所述的白首乌提取物或润肺草提取物的制备方法：白首乌或润肺草洗净，加入8倍量水中，煮沸20min，得滤液1，将滤渣1再加入6倍量水中，煮沸15min，得滤液2，将滤渣2再加入4倍量水，煮沸10min，得滤液3，合并滤液1、2、3，蒸发浓缩，干燥，即得白首乌提取物或润肺草提取物。
所述的富硒花菜冻干粉的制备方法：富硒花菜洗净，-5 °C冷冻12h，之后放入冷冻干燥机，物料温度降至-40 °C以下时，开启真空泵；当产品温度上升到0°C，升高压力至30Pa，当温度升至40°C，冻干结束。
对比例1
一种肿瘤患者的全营养伴餐粉，包括以下重量份数的原料：大豆蛋白10-20份、聚葡萄糖15份、麦芽糊精15份、全脂乳粉15份、乳清蛋白15份、低聚果糖8份、小麦低聚肽3份、复合维生素0.4份、大豆磷脂3份、葡萄糖酸锌0.5份、碳酸钙1.0份、碳酸镁0.8份、乙二胺四乙酸铁钠0.1份、金芝多糖4份、铁皮石斛多糖0.4份、润肺草提取物15份、富硒花菜冻干粉15份、绞股蓝皂苷0.1份、甜菊糖甙0.12份。
所述的山楂冻干粉的制备方法为：山楂去籽，洗净，-10 °C冷冻12h，切片，之后放入冷冻干燥机，物料温度降至-40 °C以下时，开启真空泵；当产品温度上升到0°C，升高压力至30Pa，当温度升至40°C，冻干结束。
所述的润肺草提取物的制备方法：润肺草洗净，加入8倍量水中，煮沸20min，得滤液1，将滤渣1再加入6倍量水中，煮沸15min，得滤液2，将滤渣2再加入4倍量水，煮沸10min，得滤液3，合并滤液1、2、3，蒸发浓缩，干燥，即得白首乌提取物或润肺草提取物。
所述的富硒花菜冻干粉的制备方法：富硒花菜洗净，-5 °C冷冻12h，之后放入冷冻干燥机，物料温度降至-40 °C以下时，开启真空泵；当产品温度上升到0°C，升高压力至30Pa，当温度升至40°C，冻干结束。
对比例2
一种肿瘤患者的全营养伴餐粉，包括以下重量份数的原料：大豆蛋白10-20份、聚葡萄糖15份、麦芽糊精15份、全脂乳粉15份、乳清蛋白15份、低聚果糖8份、小麦低聚肽3份、复合维生素0.4份、大豆磷脂3份、葡萄糖酸锌0.5份、碳酸钙1.0份、碳酸镁0.8份、乙二胺四乙酸铁钠0.1份、山楂冻干粉4份、铁皮石斛多糖0.4份、白首乌提取物15份、富硒花菜冻干粉15份、绞股蓝皂苷0.1份、甜菊糖甙0.12份。
所述的山楂冻干粉的制备方法为：山楂去籽，洗净，-10 °C冷冻12h，切片，之后放入冷冻干燥机，物料温度降至-40 °C以下时，开启真空泵；当产品温度上升到0°C，升高压力至30Pa，当温度升至40°C，冻干结束。
所述的白首乌提取物的制备方法：白首乌洗净，加入8倍量水中，煮沸20min，得滤液1，将滤渣1再加入6倍量水中，煮沸15min，得滤液2，将滤渣2再加入4倍量水，煮沸10min，得滤液3，合并滤液1、2、3，蒸发浓缩，干燥，即得白首乌提取物或润肺草提取物。
所述的富硒花菜冻干粉的制备方法：富硒花菜洗净，-5 °C冷冻12h，之后放入冷冻干燥机，物料温度降至-40 °C以下时，开启真空泵；当产品温度上升到0°C，升高压力至30Pa，当温度升至40°C，冻干结束。
对比例3
一种肿瘤患者的全营养伴餐粉，包括以下重量份数的原料：大豆蛋白10-20份、麦芽糊精15份、全脂乳粉15份、乳清蛋白15份、低聚果糖8份、小麦低聚肽3份、复合维生素0.4份、大豆磷脂3份、葡萄糖酸锌0.5份、碳酸钙1.0份、碳酸镁0.8份、乙二胺四乙酸铁钠0.1份、山楂冻干粉4份、金芝多糖4份、白首乌提取物15份、润肺草提取物15份、富硒花菜冻干粉15份、绞股蓝皂苷0.1份、甜菊糖甙0.12份。
所述的山楂冻干粉的制备方法为：山楂去籽，洗净，-10 °C冷冻12h，切片，之后放入冷冻干燥机，物料温度降至-40 °C以下时，开启真空泵；当产品温度上升到0°C，升高压力至30Pa，当温度升至40°C，冻干结束。
所述的白首乌提取物或润肺草提取物的制备方法：白首乌或润肺草洗净，加入8倍量水中，煮沸20min，得滤液1，将滤渣1再加入6倍量水中，煮沸15min，得滤液2，将滤渣2再加入4倍量水，煮沸10min，得滤液3，合并滤液1、2、3，蒸发浓缩，干燥，即得白首乌提取物或润肺草提取物。
所述的富硒花菜冻干粉的制备方法：富硒花菜洗净，-5 °C冷冻12h，之后放入冷冻干燥机，物料温度降至-40 °C以下时，开启真空泵；当产品温度上升到0°C，升高压力至30Pa，当温度升至40°C，冻干结束。
选择2017年6 -8月本市三甲医院收治的肿瘤患者240例，为患者随机提供上述实施例及对比例的伴餐粉，观察其在肿瘤患者术后营养状况、病症恶化上的效果比较见表1。
表1实施例及对比例的伴餐粉在肿瘤患者术后效果比较
注：体重变化、转铁蛋白、白蛋白均指的是与治疗前比较。
测试例1 “医心”特医食品伴餐粉（本专利）对上消化道肿瘤患者的临床试验
1资料与方法
1.1病例选择
选择2017年8月—9月本市三甲医院收治的胃癌、食道癌和小肠癌230例，患者随机分为本专利“医心”伴餐粉恢复组、冬泽能伴餐粉对照恢复组，“医心”伴餐粉恢复组115例，冬泽能伴餐粉对照恢复组115例，本试验开始之前，以SAS软件模拟产生随机数字表，进行产品编盲、分药及统计。
1.2临床表现
面色晦暗无华，舌苔黄腻或白腻等。进食受限、消化吸收障碍、代谢紊乱，出现疲乏无力、厌食恶心、口干便秘、口腔溃疡等症状。当然根据肿瘤的部位不同，也有其特殊表现。胸骨后疼痛和进行性吞咽困难，可出现贫血、消瘦、营养不良甚至恶病质，即全身脏器官严重的机能失调状。
1.3治疗方法
“医心”伴餐粉恢复组：服用自制的“医心”特医食品伴餐粉（本专利自制产品），一日2次，连续使用4周为一个疗程。
冬泽能伴餐粉对照恢复组：服用冬泽能伴餐粉（上海冬泽特医食品有限公司，）一日2次，连续使用4周为一个疗程。
1.4统计学处理
计数资料采用卡方检验，不同组之间采用t检验。
2 治疗结果
2.1判断标准
显效（临床控制：n≥70%）：症状消失明显，但仍有不适感。
有效（临床控制：n≥30%<70%）：症状有所缓解，但仍有不适感。
无效（临床控制：n<30%）：症状基本无改善。
注：疗效指数（n）=（试验前积分-试验后积分）/试验前积分×100%。
2.2疗效效果
组患者治疗4周后，“医心”伴餐粉恢复组对疲乏无力、厌食恶心、口干便秘、口腔溃疡总有效率为80%左右，冬泽能伴餐粉对照恢复组总有效率为78.1%，治疗组优于对照组，治疗期间。二组患者均无严重不良反应，临床结果见表1。
表2：“医心”伴餐粉对肿瘤放化疗患者效果比较
消化道肿瘤化疗后效果有效，两组间的疗效均无显明差别，治疗组略优于对照组，“医心”特医食品伴餐粉的效果更为明显，且一天只需服用2次药。
表3：“医心”伴餐粉对消化道肿瘤疾病效果比较
“医心”特医食品伴餐粉对消化道肿瘤胃癌、食管癌、小肠癌患者均有恢复效果且超过90%,高于市场已经有的冬泽能对照组。
测试例2 “医心”特医食品伴餐粉（本专利）对肺癌患者的临床试验
1资料与方法
1.1病例选择
选择2017年8月—9月本市三甲医院收治的肺癌190例，患者随机分为本专利“医心”伴餐粉组95例、源乐伴餐粉对照组95例，本试验开始之前，以SAS软件模拟产生随机数字表，进行产品编盲、分药及统计。
1.2临床表现
咳嗽气喘、痰中带血、纳差、失眠、乏力、胸痛、头痛、水肿、贫血、消瘦等。
1.3治疗方法
“医心”伴餐粉组：服用 “医心”特医食品伴餐粉（本专利自制产品），一日2次，连续使用4周为一个疗程。
源乐伴餐粉对照组：服用源乐伴餐粉（无限极(中国)有限公司），一日2次，连续使用4周为一个疗程。
1.4统计学处理
计数资料采用卡方检验，不同组之间采用t检验。
2 治疗结果
2.1判断标准
显效（临床控制：n≥70%）：症状消失明显，但仍有不适感。
有效（临床控制：n≥30%<70%）：症状有所缓解，但仍有不适感。
无效（临床控制：n<30%）：症状基本无改善。
注：疗效指数（n）=（试验前积分-试验后积分）/试验前积分×100%。
2.2疗效效果
组患者治疗4周后，“医心”伴餐粉恢复组对咳嗽气喘、痰中带血、纳差、失眠、乏力、胸痛、头痛、水肿、贫血、消瘦总有效率为92%左右，冬泽能伴餐粉对照恢复组总有效率为85%，治疗组优于对照组，治疗期间。二组患者均无严重不良反应，临床结果见表4。
表4：“医心”伴餐粉对肿瘤患者效果比较
Claims (4)
1.一种肿瘤患者的全营养伴餐粉，其特征在于，包括以下重量份数的原料：大豆蛋白10-20份、聚葡萄糖10-20份、麦芽糊精10-20份、全脂乳粉10-20份、乳清蛋白10-20份、低聚果糖5-10份、小麦低聚肽1-5份、复合维生素0.3-0.6份、大豆磷脂2-5份、葡萄糖酸锌0.1-0.5份、碳酸钙0.5-1.5份、碳酸镁0.5-1份、乙二胺四乙酸铁钠0.1-0.2份、山楂冻干粉2-5份、金芝多糖2-5份、铁皮石斛多糖0.3-0.6份、白首乌提取物10-20份、润肺草提取物10-20份、富硒花菜冻干粉10-20份、绞股蓝皂苷0.05-0.2份、甜菊糖甙0.05-0.2份。
2.根据权利要求1所述的伴餐粉，其特征在于，所述的山楂冻干粉的制备方法为：山楂去籽，洗净，-10 °C冷冻12h，切片，之后放入冷冻干燥机，物料温度降至-40 °C以下时，开启真空泵；当产品温度上升到0°C，升高压力至30Pa，当温度升至40°C，冻干结束。
3.根据权利要求1所述的伴餐粉，其特征在于，所述的白首乌提取物或润肺草提取物的制备方法：白首乌或润肺草洗净，加入8倍量水中，煮沸20min，得滤液1，将滤渣1再加入6倍量水中，煮沸15min，得滤液2，将滤渣2再加入4倍量水，煮沸10min，得滤液3，合并滤液1、2、3，蒸发浓缩，干燥，即得白首乌提取物或润肺草提取物。
4.根据权利要求1所述的伴餐粉，其特征在于，所述的富硒花菜冻干粉的制备方法：富硒花菜洗净，-5°C冷冻12h，之后放入冷冻干燥机，物料温度降至-40°C以下时，开启真空泵；当产品温度上升到0°C，升高压力至30Pa，当温度升至40°C，冻干结束。
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