CN1893839A - 用于创伤愈合的营养组合物 - Google Patents
用于创伤愈合的营养组合物 Download PDFInfo
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- CN1893839A CN1893839A CNA2004800371701A CN200480037170A CN1893839A CN 1893839 A CN1893839 A CN 1893839A CN A2004800371701 A CNA2004800371701 A CN A2004800371701A CN 200480037170 A CN200480037170 A CN 200480037170A CN 1893839 A CN1893839 A CN 1893839A
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Abstract
本发明公开了一种用于促进创伤愈合的营养组合物，包含蛋白质来源、脂质来源和碳水化合物来源，其中组合物总热量的仅仅1.8％来源于精氨酸，且其中蛋白质来源包括脯氨酸，其量为组合物总热量的至少3％。该组合物可口服施用，尤其适合于改善压疮，但是也可以有利地用于急性创伤、包括术前和术后急性创伤的营养处理。
Description
发明领域
本发明涉及用于促进创伤愈合、特别是慢性创伤如压疮(pressureulcer)(褥疮)愈合的营养组合物。
发明背景
在正常的创伤愈合中，存在一定程度上交迭的三个阶段。简言之，第一阶段是炎症，其中凝块形成并阻止血液从血管流出，继而单核血细胞溢出，清洁创伤和清除碎片。下一阶段是颗粒化阶段，其中成纤维细胞在创伤处增殖并积聚，产生胶原以帮助创伤闭合。这个阶段的特征是高代谢活性。最后，上皮细胞开始覆盖创伤。
延迟或减弱的创伤愈合对于卫生保健专业人员和患者是一个难题，因为这会导致治疗时间延长、占用卫生保健设备和患者痛苦。由于感染或营养不良等因素，创伤愈合过程可能在上述任何阶段被中断。常常困扰老年人和长期卧床患者的压疮特别受到关注，这类患者常被发现患有营养不良。的确，与未经受此类代谢压力的患者相比，所有患有急性或慢性创伤的患者表现为营养需求增加，显示对营养和能量的需求增加。如果这些患者在遭受创伤之前已经营养不良，创伤可能根本不能治愈。
近年来，更多的关注集中于精氨酸在创伤愈合中的作用。这例如在USP5,053,387中论及，其公开了一种肠营养制剂，其中总能量摄入的1-3％优选由精氨酸提供。与之相似，EP 960572A公开了适合于治疗和预防压疮的营养组合物，其包括精氨酸以及大量的维生素C和E。精氨酸的作用在USP 5,733,884中也被论及，其公开了使用组合物向急性或慢性创伤患者提供营养的方法，所述组合物中至少2％的能量由精氨酸提供，并且相同的量由脯氨酸提供。该专利假设：精氨酸和脯氨酸在促进创伤愈合中具有协同作用。商业方面，存在大量基于含有高水平的精氨酸而被销售为适合于促进创伤愈合的产品，包括CUBITAN和ARGINAID。
精氨酸供给充足显然与创伤愈合过程相关。然而，精氨酸也是用于形成一氧化氮的前体，NO作为血管舒张剂并增加生长激素分泌。对于垂危个体而言，暴露于大量的一氧化氮是不可取的，但如果这类个体接受含有高水平精氨酸的营养组合物，则这将不可避免地发生——参见例如L。Cynober，Curr Opin Clin Nutr Metab Care.6：189-93，2003。而且，极有可能的是：高比例的处于罹患压疮危险中的老年人、长期卧床或垂危患者也将遭受禁忌高水平一氧化氮的病症(J.Takala等，N Engl J Med341：785-792 1999)。
发明概述
第一方面，本发明提供了用于促进创伤愈合的营养组合物，包含蛋白质来源、脂质来源和碳水化合物来源，其中组合物总热量的仅仅1.8％来源于精氨酸，且其中蛋白质来源包括含量为组合物总热量的至少3％的脯氨酸。
第二方面，本发明提供了一种向急性或慢性创伤患者提供营养支持的方法，包括施用治疗有效量的营养组合物的步骤，所述营养组合物包含蛋白质来源、脂质来源和碳水化合物来源，其中组合物总热量的仅仅1.8％来源于精氨酸，且其中蛋白质来源包括含量为组合物总热量的至少3％的脯氨酸。
第三方面，本发明提供蛋白质来源、脂质来源和碳水化合物来源在制备用于促进创伤愈合的治疗制剂中的用途，其中制剂总热量的仅仅1.8％来源于精氨酸，且其中蛋白质来源包括含量为组合物总热量的至少3％的脯氨酸。
发明详述
尽管以上描述的创伤愈合过程的炎性阶段是至关重要的，本发明人相信：从治疗学或/营养学途径去尝试调整该阶段具有高风险，而颗粒化阶段提供了更好的营养干预可能性。在这个阶段，新的结缔组织被合成，超过80％的该组织由胶原组成。胶原富含氨基酸脯氨酸(约22％)和甘氨酸(约33％)，这些氨基酸的存在是胶原形成的限速步，即如果没有足够的这些氨基酸，则胶原不能有效的形成。然而，正常的膳食仅包含全部这些氨基酸的约3％，可以理解，患有创伤的个体可能摄取的更少，特别是脯氨酸通常不被认为是一种必须膳食氨基酸。就那些患有无论任何原因的营养不良个体而言，这些短缺可能特别显著。本发明的组合物因此添加了足以促进胶原合成的量的脯氨酸。其特别适合于改善压疮，但也可以用于处理包括术前和术后的急性创伤。
本发明的组合物不需添加精氨酸-当然有些精氨酸可能作为部分蛋白质来源而存在。然而，普遍认为精氨酸在创伤愈合的炎性阶段也发挥作用，因为这个原因，本发明的组合物优选添加少量精氨酸，以达到精氨酸必须占组合物全部热量的仅仅1.8％的要求。
本发明的组合物含有蛋白质、脂质和碳水化合物来源，可经口服或肠内施用。组合物优选提供约1.25kcal/ml。
蛋白质对于愈合是必不可少的，因为组织损伤导致分解代谢反应，其包括较通常人群所需更大比例的总蛋白质热量需求。研究表明：使用大量蛋白质的肠内营养强化能加速内脏蛋白质的合成，因此本发明的蛋白质来源优选构成组合物总能量含量的至少25％，更优选至少28％。
可以使用各种不同的蛋白质来源，包括完整蛋白质来源如酪蛋白或乳清，以及水解蛋白、游离氨基酸，甚至完整和水解蛋白和/或游离氨基酸的混合物，在每种情况下添加游离脯氨酸和任选的游离精氨酸。优选地，所选择的本发明的蛋白质来源在蛋白质中产生最高量的脯氨酸，以使需要作为游离氨基酸加入的量最少。
优选地，脯氨酸构成本发明组合物热量的至少3.5％。在这种对总热量的贡献水平下，组合物将需要添加约3.0％(以蛋白质来源的重量计)的脯氨酸。
本发明组合物的总热量/克氮优选为约160∶1。总非蛋白质热量/克氮优选为约110∶1。
本发明的组合物还包括脂质来源。脂质或脂肪是体内贮存能量的主要来源，来自脂肪代谢的能量用于所有正常细胞功能中。对创伤愈合而言，脂肪代谢导致前列腺素和其它炎性过程调节剂的形成。用于本发明的脂质来源优选构成组合物总能量含量的约20％。在这20％中，优选约8％由脂肪酸的单-和二甘油酯构成。n-6与n-3脂肪酸的比例优选在4∶1和10∶1之间，更优选约7∶1。
本发明的组合物还包括碳水化合物来源。葡萄糖是许多组织的细胞代谢的主要燃料，包括白细胞、巨噬细胞和成纤维细胞，它们均参与创伤愈合过程。对葡萄糖的需求是为了满足创伤愈合中的特定代谢需要。本发明中使用的碳水化合物来源优选构成组合物总能量含量的约50％。适合的碳水化合物来源是麦芽糖糊精和蔗糖。优选地，碳水化合物来源基本上不含乳糖。
维生素、矿物质和痕量元素在创伤愈合过程中也很重要。优选地，本发明的组合物至少符合Dietary Foods for Special Medical Purposes的Directive 1999/21/EC中所列的关于这些微量营养素的组成标准。然而，某些微量营养素对于创伤愈合尤其重要，因此本发明的组合物优选含有超过推荐最低量的维生素C和E、锰、锌和硒。
现通过举例列出根据本发明的液体即用组合物。
实施例1
热量密度 1.25g/ml
蛋白质 kcal的30％
其中(以重量计)：-酪蛋白酸钠 50％
乳蛋白浓缩物 45％
游离L-脯氨酸 3％
游离L-精氨酸 2％
总L-脯氨酸 蛋白质来源的12.4％
总L-精氨酸 蛋白质来源的5.0％
总脯氨酸的热量贡献 3.7％
总精氨酸的热量贡献 1.5％
脂质 kcal的20％
其中： 菜籽油 35％
玉米油 34％
大豆油 20％
脂肪酸的单和二-甘油脂 8％
乳脂 3％
n-6∶n-3 7.2∶1
碳水化合物 kcal的50％
其中： 玉米糖浆 52％
蔗糖 43％
淀粉 3％
乳糖 2％
维生素C 125mg/100ml
维生素E 7.5mg α-生育酚等价物/100ml
锰 1.9mg/100ml
锌 3.7mg/100ml
硒 19μg/100ml
渗透摩尔浓度 470mosm/Kg水
水 80.3％
密度 1.087g/ml
总cal/g氮 160∶1
非蛋白质cal/g氮 110∶1
由以上描述可以理解，组合物也可以含有根据EC Directive1999/21/EC通常可见于肠组合物中的类型的其它微量营养素，以及通常可见于肠组合物中的类型的调味剂如咖啡或香草、乳化剂、增稠剂和稳定剂。
营养组合物可通过常规方法制备。例如，将蛋白质来源和脂质来源溶解在水中，优选已经过反相渗透的水，形成液体混合物。如果需要，在混合前可将乳化剂溶解在脂质来源中。优选地，使用植物来源的食品级乳化剂。
水的温度适宜地为约50℃至约80℃，以有助于各成分的分散。可以使用市售可得的液化剂以形成液体混合物。优选地，液体混合物的pH用食品级氢氧化物调节为约6.3至7。
制备液体混合物后，将碳水化合物来源与其它易溶成分、包括如维生素、矿物质、调味剂和着色剂一起加入。
然后，可将液体混合物热处理以降低细菌负载(巴氏法灭菌)。这可以通过蒸气注射或热交换器、例如板式热交换器进行。
如果需要耐贮存的液体组合物，在预热至50-85℃之后，优选进行超热处理(UHT)。例如，间接UHT处理可在140-155℃、在管式热交换器中进行5至8秒。然后，可将液体混合物冷却至约60℃-约85℃，例如通过快速冷却。然后，将液体混合物均化，所得均化的乳状液体可无菌灌装在合适的容器如200ml杯子中用于口服。容器的无菌灌装可通过冷却液体混合物进行。
如果需要粉状的可复原的配方，可将均化混合物蒸发并干燥至粉末，例如通过喷雾干燥。可以使用常规的操作。
实验实施例
将正常人成纤维细胞用胰蛋白酶消化，以10,000细胞/cm3的密度接种于12孔平板上。汇合后，将细胞转移至培养基中，该培养基的氨基酸分布和浓度被设计成尽可能接近地模拟人血清。细胞培养分成两类，一类是对照培养，其中培养基含有0.201mM脯氨酸，以及试验样品，其中培养基含有0.592mM脯氨酸。24小时后，收集经成纤维细胞调节的培养基，其含有100微克/毫升β-氨基丙腈，以防止培养基中胶原分子的交联。将经调节的培养基斑点印迹在硝酸纤维素膜，并用多克隆免疫吸附抗体探测I型胶原含量。添加了脯氨酸的样品所显示的数值是相对于设定为100％的对照的数值。
样品 对照值的％
对照(0.201mM脯氨酸) 100％
添加脯氨酸(0.502mM脯氨酸) 150％±21.9％
本实验实施例表明：人成纤维细胞响应于脯氨酸添加，胶原合成增加50％。在这种添加脯氨酸的培养基中，胶原合成的增加与生长因子或其它刺激胶原转录的介质无关。这表明，对有效的胶原合成而言，底物的需求增加。
Claims (11)
1.一种用于促进创伤愈合的营养组合物，包含蛋白质来源、脂质来源和碳水化合物来源，其中组合物总热量的仅仅1.8％来源于精氨酸，且其中蛋白质来源包括脯氨酸，其量为组合物总热量的至少3％。
2.根据权利要求1的营养组合物，其中组合物总热量的至少3.5％来源于脯氨酸。
3.根据权利要求1或2的营养组合物，其中组合物总热量的1.5％来源于精氨酸。
4.根据任意前述权利要求的营养组合物，其中蛋白质来源构成组合物总热量的至少28％。
5.根据任意前述权利要求的营养组合物，该组合物的能量密度为约1.25kcal/ml。
6.一种向急性或慢性创伤患者提供营养支持的方法，包括施用治疗有效量的营养组合物的步骤，所述营养组合物包含蛋白质来源、脂质来源和碳水化合物来源，其中组合物总热量的仅仅1.8％来源于精氨酸，且其中蛋白质来源包括脯氨酸，其量为组合物总热量的至少3％。
7.根据权利要求6的方法，其中组合物总热量的至少3.5％来源于脯氨酸。
8.根据权利要求6或7的方法，其中组合物总热量的1.5％来源于精氨酸。
9.蛋白质来源、脂质来源和碳水化合物来源在制备用于促进创伤愈合的治疗制剂中的用途，其中组合物总热量的仅仅1.8％来源于精氨酸，且其中蛋白质来源包括脯氨酸，其量为制剂总热量的至少3％。
10.根据权利要求9的用途，其中制剂总热量的至少3.5％来源于脯氨酸。
11.根据权利要求9或10的用途，其中制剂总热量的1.5％来源于精氨酸。
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| CN107319574A (zh) * | 2017-08-03 | 2017-11-07 | 江西美庐乳业集团有限公司 | 一种有益于烧伤创伤人群康复的蛋白组件食品 |
| CN115918914A (zh) * | 2022-12-01 | 2023-04-07 | 宝健（北京）生物技术有限公司 | 一种含复合蛋白的口服营养补充剂，制备及应用 |
| CN116687003A (zh) * | 2022-02-24 | 2023-09-05 | 亚宝药业集团股份有限公司 | 一种用于老年消化道肿瘤切除术后患者的营养组合物 |
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| CA2790018C (en) * | 2006-12-21 | 2015-02-03 | Amgen Inc. | Formulations |
| JP5118915B2 (ja) * | 2007-07-31 | 2013-01-16 | 森永乳業株式会社 | 褥瘡改善剤 |
| TWI561175B (en) * | 2011-03-31 | 2016-12-11 | Meiji Co Ltd | Flowable nutrition composition containing l-arginine and method for producing the same |
| JOP20190146A1 (ar) | 2016-12-19 | 2019-06-18 | Axcella Health Inc | تركيبات حمض أميني وطرق لمعالجة أمراض الكبد |
| CU20200012A7 (es) | 2017-08-14 | 2021-02-04 | Axcella Health Inc | Composiciones de aminoácidos para el tratamiento de enfermedad hepática |
| CN112839643A (zh) | 2018-06-20 | 2021-05-25 | 胺细拉健康公司 | 用于治疗肌肉中脂肪浸润的组合物及方法 |
| DE102018124227A1 (de) | 2018-10-01 | 2020-04-02 | sanaFactur GmbH | Zubereitung zur Verbesserung körpereigener Wundheilung |
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| US5053387A (en) * | 1987-02-20 | 1991-10-01 | Shriners Hospitals For Crippled Children | Omega-3 fatty acids in traumatic injury treatment |
| US5198465A (en) * | 1991-06-19 | 1993-03-30 | Dioguardi Francesco S | Compositions based on amino acids for preventing and treating precursor deficiencies in the synthesis of collagen |
| DE4214724C2 (de) * | 1992-05-04 | 1995-05-18 | Starck H C Gmbh Co Kg | Feinteiliges Oxid-Keramikpulver |
| US5384308A (en) * | 1993-06-14 | 1995-01-24 | Henkin; R. I. | Composition and method for enhancing wound healing |
| US5714472A (en) * | 1993-12-23 | 1998-02-03 | Nestec Ltd. | Enternal formulation designed for optimized nutrient absorption and wound healing |
| US5827874A (en) * | 1995-05-05 | 1998-10-27 | Meyer; Hans | Methods of treating pain and inflammation with proline |
| US5733884A (en) * | 1995-11-07 | 1998-03-31 | Nestec Ltd. | Enteral formulation designed for optimized wound healing |
| US6194379B1 (en) * | 1998-05-01 | 2001-02-27 | Abbott Laboratories | Elemental enteral formula |
| GB0009056D0 (en) * | 2000-04-12 | 2000-05-31 | Nestle Sa | Composition comprising free amino acids |
| IT1318556B1 (it) * | 2000-06-07 | 2003-08-27 | Solartium Establishment | Composizione farmaceutica a base di prolina, glicina e lisina utilenella terapia per la cicatrizzazione delle ferite e delle lesioni |
| GB0016045D0 (en) * | 2000-06-29 | 2000-08-23 | Laxdale Limited | Therapeutic combinations of fatty acids |
| ITTO20010804A1 (it) * | 2001-08-08 | 2003-02-08 | Professional Dietetics Srl | Composizioni a base di aminoacidi, idonee alla terapia per la cicatrizzazione e/o riparazione di ferite e lesioni, in particolare per l'appl |
| AU2003214719A1 (en) * | 2002-03-08 | 2003-09-22 | Universiteit Leiden | Use proline and its functional equivalentsfor quenching ros and/ or radicals |
| DE10221403A1 (de) * | 2002-05-14 | 2003-12-04 | Kyberg Pharma Vertriebs Gmbh & | Diätetische und pharmazeutische Zusammensetzungen, ihre Herstellung und ihre Verwendung |
| US20040087490A1 (en) * | 2002-09-20 | 2004-05-06 | Troup John P. | Nutritional compositions |
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2003
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- 2003-12-20 DK DK03029505.9T patent/DK1543735T3/en active
- 2003-12-20 EP EP03029505.9A patent/EP1543735B1/en not_active Expired - Lifetime
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2004
- 2004-12-03 CN CN2004800371701A patent/CN1893839B/zh not_active Expired - Fee Related
- 2004-12-03 JP JP2006544267A patent/JP2007515417A/ja active Pending
- 2004-12-03 CA CA002546472A patent/CA2546472A1/en not_active Abandoned
- 2004-12-03 WO PCT/EP2004/013787 patent/WO2005060768A1/en active Application Filing
- 2004-12-03 US US10/596,159 patent/US20070087035A1/en not_active Abandoned
- 2004-12-03 BR BRPI0417875-0A patent/BRPI0417875A/pt active Search and Examination
- 2004-12-17 TW TW093139499A patent/TWI403276B/zh not_active IP Right Cessation
- 2004-12-20 AR ARP040104799A patent/AR046969A1/es unknown
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- 2006-07-19 ZA ZA200605983A patent/ZA200605983B/xx unknown
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- 2011-05-26 US US13/116,827 patent/US20110230400A1/en not_active Abandoned
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107319574A (zh) * | 2017-08-03 | 2017-11-07 | 江西美庐乳业集团有限公司 | 一种有益于烧伤创伤人群康复的蛋白组件食品 |
| CN116687003A (zh) * | 2022-02-24 | 2023-09-05 | 亚宝药业集团股份有限公司 | 一种用于老年消化道肿瘤切除术后患者的营养组合物 |
| CN115918914A (zh) * | 2022-12-01 | 2023-04-07 | 宝健（北京）生物技术有限公司 | 一种含复合蛋白的口服营养补充剂，制备及应用 |
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| Publication number | Publication date |
|---|---|
| WO2005060768A1 (en) | 2005-07-07 |
| JP2007515417A (ja) | 2007-06-14 |
| IL175478A0 (en) | 2006-09-05 |
| CN1893839B (zh) | 2010-06-09 |
| US20110230400A1 (en) | 2011-09-22 |
| EP1543735A1 (en) | 2005-06-22 |
| TWI403276B (zh) | 2013-08-01 |
| TW200528035A (en) | 2005-09-01 |
| BRPI0417875A (pt) | 2007-04-27 |
| EP1543735B1 (en) | 2015-10-07 |
| DK1543735T3 (en) | 2015-11-02 |
| CA2546472A1 (en) | 2005-07-07 |
| ES2550608T3 (es) | 2015-11-11 |
| US20070087035A1 (en) | 2007-04-19 |
| US20140357553A1 (en) | 2014-12-04 |
| ZA200605983B (en) | 2007-12-27 |
| AR046969A1 (es) | 2006-01-04 |
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