CN1097436C - 糖尿病患者的医疗食品 - Google Patents
糖尿病患者的医疗食品 Download PDFInfo
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- CN1097436C CN1097436C CN98803381A CN98803381A CN1097436C CN 1097436 C CN1097436 C CN 1097436C CN 98803381 A CN98803381 A CN 98803381A CN 98803381 A CN98803381 A CN 98803381A CN 1097436 C CN1097436 C CN 1097436C
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Abstract
本发明公开了一种糖尿病患者的医疗食品，它包含作为特征活性成分的γ-亚麻酸和至少一种链烷酰基-L-肉碱，例如乙酰基-L-肉碱和/或丙酰基-L-肉碱。
Description
本发明涉及一种糖尿病患者用的治疗/营养组合物(医疗食品)。
糖尿病是一种起源于不同基因、环境和病原的复杂综合征。
该综合征在任何情况下的特征都是因胰岛素分泌和/或效率减弱而导致的高血糖，伴随着糖尿病性酮酸中毒或非酮症性高血糖高渗压昏迷的危险。在该病的晚期并发症中，值得特别关注的是肾病、视网膜病、冠状动脉粥样硬化、外周动脉病和自主神经系统的神经病。
传统上，胰岛素依赖性糖尿病(I型糖尿病)和非胰岛素依赖性糖尿病(II型糖尿病)之间存在差异。
I型糖尿病通常发生于婴儿期或青春期，其临床上的特征是高血糖和有发生糖尿病性酮酸中毒的倾向。为控制此病需要进行长期的胰岛素治疗。
II型糖尿病临床上的特征是不伴有糖尿病性酮酸中毒倾向的高血糖。在II型糖尿病中，高血糖起源于对葡萄糖的异常胰岛素分泌应答和“胰岛素抗性”，即起源于胰岛素自身的活性降低。
尽管本质上基于施用胰岛素和口服降血糖药对I型和II型糖尿病进行治疗，就能产生实质性功效，但适当的营养治疗对成功地治疗糖尿病来说也是非常重要的。
从治疗/营养的观点看，治疗糖尿病时有三个关键的原则。首先，一方面，糖尿病患者需要保持血液葡萄糖水平尽可能接近正常值，使生理活性与食物摄取之间达到恰当的平衡，另一方面，要服用胰岛素和降血糖药。因此，糖尿病患者应增加对能增强机体代谢葡萄糖和胰岛素能力的营养素的摄取。最后，他们应当增加对能减少糖尿病并发症危险的营养素的摄取。
许多微量营养素具有第二和第三种功能。
广义地说，在适当的代谢控制条件下，糖尿病患者对维生素和无机盐的营养需求与正常人类似，因此应符合食品和营养委员会推荐的量。但是，已发现坚持高纤维含量饮食或患有酸中毒或糖尿的患者，他们的微量营养素不足。另外，实验结果已提示：维生素、无机盐以及其他微量营养素能保护糖尿病人不发生诸如心脏病、外周神经病、视网膜病、肾衰竭、频繁感染以及伤口愈合缓慢等并发症。
迄今为止，人们的注意力特别集中在糖尿病患者的医疗食品的开发上，这些医疗食品能与合适的药理学治疗一起，降低血浆葡萄糖水平。例如，EP 0 659 349 A1(Bristol-Myers Squibb Co.)记载了一种此类型的医疗食品，其中的特征成分是肌醇，其降血糖活性已是众所周知。
糖尿病的另一个特征是必需脂肪酸的异常代谢。
必需脂肪酸，如亚油酸和α-亚麻酸(分别为ω-6和ω-3必需脂肪酸系列的母体酸)，是象维生素一样必须经饮食提供的营养物质，它们不能由机体生物合成。
现已证明，在糖尿病患者中，控制亚油酸在前列腺素前体中的转化动力学的酶-ω-6-去饱和酶的活性降低了，必需脂肪酸的组织浓度也降低了。血管前列环素的生成看上去也减少了。
本发明的一个目的是提供一种糖尿病患者用的医疗食品，使他们能补偿这类患者中比较典型的必需脂肪酸代谢降低。具体而言，本发明的目的是提供这样一种类型的医疗食品，该食品使得有可能绕过因ω-6-去饱和酶的活性降低而引起的酶阻断，这种酶阻断发生于糖尿病患者中，使亚油酸不能充分转化为α-亚麻酸，由此使前列腺素和白三烯前体的产生减少。
本发明用于糖尿病患者的治疗/营养组合物包含以下物质的混合物：
(a)γ-亚麻酸或其药理学上可接受的盐；和
(b)至少一种链烷酰基-L-肉碱，其中该链烷酰基是具有2-6个碳原子的直链或分支的链烷酰基，或其药理学上可接受的盐；其中(a)和(b)的量能有效地产生协同效应，以补偿必需脂肪酸代谢的缺损，预防糖尿病的并发症，特别是糖尿病性神经病，并使其消退。
链烷酰基-L-肉碱优选选自下列成员：乙酰基-、丙酰基-、丁酰基-、戊酰基-、或异戊酰基-L-肉碱，或其药理学上可接受的盐；特别优选乙酰基-L-肉碱和丙酰基-L-肉碱。
链烷酰基-L-肉碱的药理学上可接受的盐是指其与酸形成的、不会引起不需要的副作用的任何盐。这些酸是药理学家和药剂学与制药工艺学领域的专家熟知的。
国际药学杂志(Int.J.of Pharm.)第33期(1986年)第201-217页中，公开了FDA批准的药理学上可接受的酸的目录，该文结合在此作为参考。
本发明的组合物还可进一步包含维生素和/或金属。本发明的组合物另外还可包含辅酶和/或有机或无机抗氧化剂或其前体。
优选的是，辅酶为辅酶Q10，有机抗氧化剂选自硫辛酸、白藜芦醇和谷胱甘肽，优选的前体是N-乙酰基-L-半胱氨酸。硒是优选的无机抗氧化剂的例子。
本发明组合物的第一个优选的实施方案中包含下列成分的混合物：γ-亚麻酸或其药理学上可接受的盐；乙酰基-L-肉碱或其药理学上可接受的盐；牛磺酸；双泛酰硫乙胺；维生素A；维生素E；微生物B1；维生素B6；维生素B12；镁；钙；锌；硒；铬；和钒。
组合物的第二个优选实施方案中还包含辅酶Q10、硫辛酸和肌醇。
组合物的第三个优选实施方案中包含第一或第二组合物的所有成分，并用乙酰基-和丙酰基-L-肉碱(摩尔比为10∶1至1∶10)的混合物代替单独的乙酰基-L-肉碱。
为了使营养全面，本发明组合物还可有利地包含足以满足糖尿病患者每日所需热量的脂质源、蛋白质源和碳水化合物源，。
优选地，该营养全面的组合物包含10％至15％的蛋白质、35％至45％的脂质和40％至50％的碳水化合物，这些百分比是根据该组合物的总热量摄取计算的。
无论任何，现已有利地发现：适合单剂给药方案和多剂给药方案的本发明任何一种组合物，都易于提供350-500mg/天的γ-亚麻酸和1.5-2.5g/天的乙酰基-L-肉碱。
令人惊奇和出乎意料的是，γ-亚麻酸和链烷酰基-L-肉碱(即本发明组合物的特征性成分)，在增强对必需脂肪酸代谢缺损的补偿、或防止或逆转糖尿病并发症、特别是糖尿病性神经病这些方面，能协同起作用。
出于以下原因，组合物中的其他成分是有价值的：
牛磺酸，是身体中最富有的氨基酸之一，已在中枢神经系统、骨骼肌肉中发现其存在，并在脑和心脏中非常集中。牛磺酸缺乏与视网膜变性有关。
糖尿病患者在血液和血小板中的牛磺酸水平低于正常水平。
已证明给胰岛素依赖性病人服用牛磺酸能减少血小板凝集，并通过阻止在视网膜血管中形成血块而防止视网膜病。
双泛酰硫乙胺是辅酶A的组分，它能通过增强脂肪酸β氧化作用的代谢途径和形成乙酰辅酶A而促进能量的生成。
近期的临床试验显示，给高脂血的糖尿病患者服用双泛酰硫乙胺能降低血清总胆固醇，增加HDL胆固醇。另外，双泛酰硫乙胺可使血小板体积、微量粘度和脂质组成正常化，并伴随着血小板聚集减少。
维生素A，成年男性的推荐膳食许可量(RDA)为1000μg/天，成年女性为800μg/天。它对胰岛素的释放具有双相浓度依赖作用。低浓度时，维生素A刺激胰岛素释放，而高浓度时，它具有抑制作用，该抑制作用可能是通过胞内葡萄糖氧化的削弱而部分介导的。
给II型糖尿病人服用维生素A能降低胰岛素抗性，通过刺激胶原蛋白合成而加快愈合过程。
糖尿病患者服用维生素A后，可以看到糖尿病性视网膜病的早期征兆发生逆转，并且发展程度较深的增生性视网膜病的进程明显停止或放慢。
男性的维生素E的RDA为10mg/天，女性为8mg/天。多不饱和脂肪酸的摄入越高，对维生素E的需求也会增长。
维生素E是生物膜中存在的最活跃的抗氧化剂，它保护细胞结构免受氧自由基和脂质过氧化反应的活性产物的破坏，从而有助于保持膜的稳定性。
给糖尿病患者补充维生素E可以使血小板活性和二十烷类的生成正常化。
维生素B1的RDA为0.5mg/100千卡路里(推荐最低摄入1mg/天)，它在能量代谢中具有重要的作用。
对维生素B1的日常需求取决于碳水化合物的摄入量。
正常成人的维生素B6的RDA为约2mg/天。
维生素B6以三种形式存在：吡哆素盐酸盐、吡哆醛和吡哆胺。它是大约120种酶的成分。
磷酸吡哆醛，是氨基酸和神经递质的代谢以及糖元的分解中的辅助因子；它可以与类固醇激素受体结合，并可在它们的作用的调节中起作用。
吡哆素与血红蛋白的形成有关。
糖尿病患者的血浆维生素B6经常很低，那些对血液葡萄糖调控能力低下的患者更为明显不足。
人体中吡哆素不足与葡萄糖不耐性有关。维生素B6在葡萄糖体内稳定中的作用已由其对色氨酸代谢的作用得以显示。
维生素B6的药理学剂量可以逆转色氨酸代谢的异常，并可改善对碳水化合物的耐受性。
维生素B12(RDA为2μg/天，一般摄入4-8μg/天)在氨基酸代谢中具有至关重要的作用。B12辅酶能催化氨基和脂肪酸的分解。
维生素B12缺乏特别与胰岛素依赖性糖尿病有关。在同一个体中，作为多腺性自身免疫综合征的一部分，可以发生恶性贫血和糖尿病。
镁(成年男性的RDA为350mg/天，女性为280mg/天)，在许多酶促反应，如磷酸基团的转移、辅酶A的酰化、磷酸盐和焦磷酸盐的水解中，具有实质性的作用。它对于氨基酸的活化、核糖体的聚集、DNA的合成与降解都很重要。
镁在多个层面上参与葡萄糖的体内稳定：它是血浆膜葡萄糖转运系统的辅助因子；在多种与葡萄糖氧化有关的酶的活性中具有重要的作用，可能在胰岛素释放中起一定作用，并可调整从高能磷酸键进行能量转移的机制。
糖尿病与尿中镁的丧失增加有关，在高血糖不能很好地控制时尤为如此。糖尿病患者的血浆镁浓度降低了。特别值得关注的是，在糖尿病性酮酸中毒过程中，大量尿镁的丧失导致低镁血症，可对心肌、骨骼肌产生危及生命的影响，并与胰岛素耐受性有关。
镁缺乏与糖尿病的两种常见并发症，即视网膜病和局部缺血性心脏病有关。
钙(成年男女的RDA约为1g/天)是人体中最常见的无机物，它具有结构、电生理学和调节方面的功能。
可能是由于尿钙丧失增加，糖尿病人患骨质疏松症的危险也增加了。
饮食钙会竞争性地抑制镁的吸收，因此它只能与补充镁联合给药。
锌(男性的RDA为15mg/天，女性为12mg/天)具有结构、酶促和调节方面的作用。它参与了60种以上酶的活性，诸如羧肽酶、碳酸酐酶和醇脱氢酶。它在神经元活性和记忆中有一定作用，是保持正常的血浆维生素A水平所必需的。
糖尿病可能会导致锌缺乏，在I型和II型糖尿病的起始阶段均有关于低血锌和高锌尿的报道。
现已完全确认，锌在伤口愈合和皮肤完整性的维护中起一定作用，因为它能促进蛋白合成、细胞复制和胶原形成的活性。
高浓度或高剂量的锌在体内和体外都有抗氧化剂样作用。
硒(成年男性的RDA为70μg/天，成年女性为55μg/天)是谷胱甘肽过氧化物酶的固有部分，所以它能对由脂质代谢产生的过氧化物引起的组织损伤起保护作用。
人体缺乏硒会导致谷胱甘肽过氧化物酶活性的降低和心肌病。并且，增加硒的摄入可以减少患心血管病的危险，逆转糖尿病性视网膜病的早期征兆，使发展程度较深的增生性视网膜病的进程明显停止或放慢。
铬估计的安全足够的日常饮食摄入量(ESADDI)对于成年男女都为50至200mg/天。
铬是正常的碳水化合物和脂质代谢所需要的必需营养素，它是生物活性的葡萄糖耐受性因子的成分。铬的缺乏与某些形式的葡萄糖不耐受性和糖尿病的发病机理有关。
糖尿病患者的尿铬排泄有增加的趋向。
钒的ESADDI约为100μg/天；其生物可利用率非常低，通常低于1％。
在胰岛素依赖性糖尿病患者中，钒具有胰岛素样的行为。它能模拟胰岛素的作用，或者增加其效率，降低葡萄糖和胰岛素水平。
给II型糖尿病患者服用钒，可改善葡萄糖耐受性，降低血液葡萄糖水平，并降低血液胆固醇水平。
Claims (8)
1、一种用于糖尿病患者的治疗/营养组合物，它包含以下物质的混合物：
(a)γ-亚麻酸或其药理学上可接受的盐；和
(b)乙酰基-L-肉碱或其药理学上可接受的盐；
其中(a)和(b)的量适于通过该组合物的给药，提供350-500mg/天的(a)和1.5-2.5g/天的(b)，在补偿必需脂肪酸代谢的缺损、预防糖尿病的并发症并使其消退方面能有效地产生协同效应。
2、权利要求1所述的组合物，它进一步包含维生素和金属。
3、权利要求2所述的组合物，它包含下列成分的混合物：
γ-亚麻酸或其药理学上可接受的盐；
乙酰基-L-肉碱或其药理学上可接受的盐；
牛磺酸；
双泛酰硫乙胺；
维生素A；
维生素E；
维生素B1；
维生素B6；
维生素B12；
镁；
钙；
锌；
硒；
铬；和
钒。
4、权利要求1-3任一项所述的组合物，它进一步包含辅酶和/或无机或有机抗氧化剂或其前体。
5、权利要求4所述的组合物，其中该辅酶是辅酶Q10，有机抗氧化剂选自硫辛酸、白藜芦醇或谷胱甘肽，而前体是N-乙酰基-L-半胱氨酸。
6、权利要求3所述的组合物，它进一步包含辅酶Q10、硫辛酸和肌醇。
7、权利要求1所述的组合物，它作为一种营养全面的组合物，进一步包含脂质成分、蛋白质成分和碳水化合物成分，适于向糖尿病患者提供每日所需的热量摄取。
8、权利要求7所述的组合物，它包含10％至15％的蛋白质，35％至45％的脂质，和40％至50％的碳水化合物，这些百分比是根据该组合物的总热量摄取计算的。
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT97RM000155A IT1291113B1 (it) | 1997-03-20 | 1997-03-20 | Composizione nutritiva terapeutica per soggetti affetti da diabete mellito |
| ITRM97A000155 | 1997-03-20 |
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| Publication Number | Publication Date |
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| CN1250352A CN1250352A (zh) | 2000-04-12 |
| CN1097436C true CN1097436C (zh) | 2003-01-01 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN98803381A Expired - Fee Related CN1097436C (zh) | 1997-03-20 | 1998-03-10 | 糖尿病患者的医疗食品 |
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| US (1) | US6063820A (zh) |
| EP (1) | EP0971600B1 (zh) |
| JP (1) | JP4125791B2 (zh) |
| KR (1) | KR100496957B1 (zh) |
| CN (1) | CN1097436C (zh) |
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| DK (1) | DK0971600T3 (zh) |
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| HK (1) | HK1025483A1 (zh) |
| HU (1) | HUP0002196A3 (zh) |
| IL (1) | IL131548A (zh) |
| IT (1) | IT1291113B1 (zh) |
| NZ (1) | NZ337129A (zh) |
| PL (1) | PL190526B1 (zh) |
| PT (1) | PT971600E (zh) |
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| IT1245699B (it) * | 1991-05-29 | 1994-10-14 | Sigma Tau Ind Farmaceuti | Derivati della l-carnitina quali agenti terapeutici per il trattamento delle miopatie, della degenarazione neuronale e per inibire la proteolisi |
| IT1258491B (it) * | 1992-09-24 | 1996-02-26 | Sigma Tau Ind Farmaceuti | Impiego di l-carnitina e acil l-carnitine nel trattamento di pazienti affetti da aids e sindromi correlate e di pazienti asintomatici hiv- sieropositivi. |
| IT1263004B (it) * | 1992-10-08 | 1996-07-23 | Sigma Tau Ind Farmaceuti | Impiego della l-carnitina e acil l-carnitine nel trattamento a lungo termine di pazienti diabetici non insulino-dipendenti. |
| IT1263013B (it) * | 1992-10-20 | 1996-07-23 | Avantgarde Spa | Esteri della l-carnitina e di alcanoil l-carnitine con l'acido glicolico o suoi esteri e composizioni farmaceutiche contenenti tali per il trattamento di affezioni cutanee. |
| IT1261688B (it) * | 1993-05-28 | 1996-05-29 | Avantgarde Spa | Uso di esteri sull'ossidrile della l-carnitina per produrre composizioni farmaceutiche per il trattamento di affezioni cutanee. |
| IT1261696B (it) * | 1993-06-02 | 1996-05-29 | Avantgarde Spa | Uso di esteri sull'ossidrile della l-carnitina con acidi aromatici perprodurre composizioni farmaceutiche per il trattamento di affezioni cutanee. |
| IT1261984B (it) * | 1993-06-22 | 1996-06-11 | Avantgarde Spa | Uso di esteri della l-carnitina o di acil l- carnitine con idrossiacidi per produrre composizioni farmaceutiche per il trattamento di affezioni cutanee. |
| IT1272290B (it) * | 1994-06-20 | 1997-06-16 | Avantgarde Spa | Sale della l-carnitina e composizioni farmaceutiche che lo contengono per il trattamento di affezioni cutanee |
| IT1274156B (it) * | 1994-09-08 | 1997-07-15 | Avantgarde Spa | "sale della l-carnitina e composizioni farmaceutiche che lo contengonoper il trattamento di affezioni cutanee" |
| IT1274157B (it) * | 1994-09-08 | 1997-07-15 | Avantgarde Spa | "sale della l-carnitina e composizioni farmaceutiche che lo contengonoper il trattamento di affezioni cutanee" |
| IT1276225B1 (it) * | 1995-10-17 | 1997-10-27 | Sigma Tau Ind Farmaceuti | Composizioni farmaceutiche contenenti l-carnitina e alcanoil l- carnitine in associazione con resveratrolo o suoi derivati utili per |
| IT1277953B1 (it) * | 1995-12-21 | 1997-11-12 | Sigma Tau Ind Farmaceuti | Composizione farmaceutica contenente l-carnitina o una alcanoil l- carnitina e un acido poliinsaturo della serie 3-omega utile per |
-
1997
- 1997-03-20 IT IT97RM000155A patent/IT1291113B1/it active IP Right Grant
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1998
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- 1998-03-10 BR BR9808348-1A patent/BR9808348A/pt not_active Application Discontinuation
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2000
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0400547A1 (en) * | 1989-06-02 | 1990-12-05 | Abbott Laboratories | Parenteral nutrition product |
| EP0659349A1 (en) * | 1993-12-22 | 1995-06-28 | Bristol-Myers Squibb Company | Treatment of diabetes by administration of myo-inositol |
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