CN110101691A - 一种具有减肥功能的包含左卡尼汀和琥珀酸的组合物及其应用 - Google Patents
一种具有减肥功能的包含左卡尼汀和琥珀酸的组合物及其应用 Download PDFInfo
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- CN110101691A CN110101691A CN201910405265.2A CN201910405265A CN110101691A CN 110101691 A CN110101691 A CN 110101691A CN 201910405265 A CN201910405265 A CN 201910405265A CN 110101691 A CN110101691 A CN 110101691A
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- Prior art keywords
- levocarnitine
- succinic acid
- composition
- weight
- officinal salt
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Classifications
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
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- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
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Abstract
本发明提供了一种用于减轻体重及减少体脂肪的协同组合物及其在制备用于减轻体重及减少体脂肪的药物或膳食补充剂中的应用。该组合物包含左卡尼汀或乙酰左卡尼汀或其可药用盐和琥珀酸或其可药用盐。本发明所述的组合物具有减肥、减轻体重与体脂肪的功效。
Description
技术领域
本发明提供了一种组合物，尤其包含左卡尼汀或乙酰左卡尼汀或其可药用盐和琥珀酸或其可药用盐以及一种或多种药学上可接受的赋形剂的组合物。本发明也提供了一种所述组合物的应用，尤其提供所述组合物在制备减少体重与体脂肪的膳食补充剂或药物中的应用。本发明关于一种包含所述组合物的膳食补充剂或药物的应用，尤指可用于减少体重及减少体脂肪的膳食补充剂或药物。
背景技术
随着人们物质生活水平的逐渐提高，食品类型与食品供应都非常丰富。生活安逸、快节奏的生活造成的饮食不规律，且由于缺乏运动等，使得机体内能量的摄入大于消耗，脂肪堆积，脂肪细胞增大，肥胖的发生率正在以惊人的速度增长，肥胖问题不容忽视。
肥胖是指体脂肪积累过多而对健康造成负面影响的身体状态，可能导致寿命减短及各种健康问题，肥胖不再被认为是暴饮暴食和缺乏自我控制所导致。世界卫生组织和美国食品药品监督管理局现在都已经见肥胖视为一种由多种环境因素和遗传因素所引起的慢行疾病。
目前用于减肥或减重的各种药物或保健品大多通过降低患者的食欲抑制摄入的脂肪的吸收以减少热量的摄入，这虽然能达到减肥减重的目的，但却是以损害患者的健康和身体机能为代价，而且存在极易复发的缺点，因此市场上亟缺一种安全性更高、副作用低、无心血管风险、可有效减轻体重与减少体脂肪的减肥或减重的膳食补充剂或药物。
左卡尼汀(L-carnitine)，又称肉碱、左旋肉碱或肉毒碱和维生素BT，是哺乳动物能量代谢中必需的体内天然物质，是一种广泛存在于机体组织内的特殊氨基酸，。
左卡尼汀的主要功能是促进脂类代谢，它既能将长链脂肪酸带进线粒体基质,并促进其氧化分解,为细胞提供能量,又能将线粒体内产生的短链脂酰基输出。在缺氧、缺血时，脂酰-CoA堆积，线粒体内的长链脂酰卡尼汀也堆积，游离卡尼汀因大量消耗而减低。左卡尼汀的缺乏直接导致脂肪酸代谢障碍，能量产生障碍，机体所须的ATP生成减少，同时游离脂肪酸增多，临床上出现甘油三脂水平升高，极低密度脂蛋白积聚、载脂蛋白含量增加、高密度脂蛋白下降。脂肪酸蓄积还会抑制多种酶系统的活性，使得乙酰胆碱生成减少、细胞膜稳定性下降、血糖水平增高、乳酸生成增多以及ECG改变。
左卡尼汀通过促进脂肪酸的氧化分解产生能量，可以改善机体器官组织的代谢。具有改善肾脏病患者肾性贫血、改善心肌缺血、改善心功能、保护肝脏、治疗男性不育症等作用，在临床上应用广泛。
琥珀酸(succinate)是一种新陈代谢的产物，能够促进热量的产生，它是三羧酸循环(TAC)的中间产物，寒冷环境应激状态下机体可激活脂肪产热，其代谢特征是琥珀酸的积累。琥珀酸积累是独立于肾上腺素信号机制，足以提升机体褐色脂肪的生热呼吸。
美国和加拿大的科学家发现给食用高脂饮食的小鼠补充琥珀酸后可以防止小鼠肥胖的发生。他们将这一重要发现发表在《Nature》上(Mills EL,Pierce KA,JedrychowskiMP,et al..Accumulation of succinate controls activation of adipose tissuethermogenesis,Nature(2018).Aug；560(7716):102-106.)。研究人员通过一系列的试验研究阐明了琥珀酸可以防止小鼠肥胖发生的机理：(1)给小鼠静脉注射琥珀酸，可快速激活褐色脂肪产热，该作用需要琥珀酸脱氢酶，通过琥珀酸氧化启动活性氧生成，从而驱动生热呼吸；(2)通过饮水给食用高脂饮食的小鼠补充琥珀酸，可增加系统循环中的琥珀酸，驱动依赖于UCP1的褐色脂肪产热，从而使小鼠抵抗饮食诱导的肥胖和血糖问题。
然而单独的左旋肉碱或琥珀酸的功能作用减少体重及减少体脂肪相对较弱，发明人意外地发现，将左旋肉碱和与琥珀酸组合，具有良好的药理协同作用，不仅能发挥左卡尼汀的消脂减肥、降血脂、保护心脑血管等功能，而且左旋肉碱还能与琥珀酸一起发挥协同作用，尤其在预防由高脂饮食引起的肥胖，减少体重与体脂肪等方面具有良好的协同作用。
发明内容
本发明的一个目的是提供一种组合物，包含左卡尼汀或乙酰左卡尼汀或其可药用盐和琥珀酸或其可药用盐。
本发明的另一个目的是提供一种包含左卡尼汀或乙酰左卡尼汀或其可药用盐和琥珀酸或其可药用盐的组合物在制备用于减肥、减少体重与体脂肪的药物中的应用。
本发明的另一个目的是提供一种包含左卡尼汀或乙酰左卡尼汀或其可药用盐和琥珀酸或其可药用盐的组合物在制备用于减肥、减少体重与体脂肪的膳食补充剂中的应用。
本发明的另一个目的是提供一种包含左卡尼汀或乙酰左卡尼汀或其可药用盐和琥珀酸或其可药用盐的药物或膳食补充剂组合物的制备方法。
本发明的一个实施例方案中，所述的药物组合物或膳食补充剂组合物包括脱左卡尼汀和琥珀酸。
在本发明的一个实施例方案中，所述的药物组合物或膳食补充剂组合物包含乙酰左卡尼汀和琥珀酸。
在本发明的一个实施例方案中，所述的药物组合物或膳食补充剂组合物包含左卡尼汀富马酸盐和琥珀酸钠。
在本发明的一个实施例方案中，所述的药物组合物或膳食补充剂组合物包含左卡尼汀和琥珀酸钠。
在本发明的一个实施例方案中，所述的药物组合物或膳食补充剂组合物包含乙酰左卡尼汀富马酸盐和琥珀酸。
本发明的组合物中左卡尼汀或乙酰左卡尼汀或其可药用盐和琥珀酸或其可药用盐的重量比为1(以左卡尼汀计):0.1～0.9(以琥珀酸计)。
本发明的组合物中左卡尼汀或乙酰左卡尼汀或其可药用盐和琥珀酸或其可药用盐的重量比优选1(以左卡尼汀计):0.2～0.6(以琥珀酸计)。
本发明的组合物中左卡尼汀或乙酰左卡尼汀或其可药用盐和琥珀酸或其可药用盐的重量比更优选1(以左卡尼汀计):0.5(以琥珀酸计)。
本发明所述的药物或膳食补充剂组合物可以以多种形式存在，这些形式包括但不限于液体及固体形式，液体形式包括注射剂、口服溶液剂、混悬剂，固体形式可以为片剂、硬胶囊剂、颗粒剂、丸剂、微丸剂、软胶囊剂、滴丸剂、干混悬剂、冲剂，优选口服溶液剂，硬胶囊剂，片剂，颗粒剂，干混悬剂。
本发明的所述的药物或膳食补充剂组合物中可以添加本领域使用的任何药学上可接受的赋形剂制备成合适的剂型。所述的辅料包括但不限于填充剂、崩解剂、润滑剂、润湿剂、增溶剂、助溶剂、稳定剂、着色剂、黏合剂、助流剂、矫味剂、防腐剂、助悬剂、包衣材料、芳香剂、增塑剂、表面活性剂等。
本发明的实施例试验结果显示本发明所述的药物或膳食补充剂组合物不会影响食欲或排泄，相较于目前市面上其他减肥药物存在不良反应较多的缺点，本发明所述的药物或膳食补充剂组合物更为安全且没有明显副作用。另外，相较于现有技术的减肥药物通过抑制食欲或是阻断脂肪在肠道的吸收，增加脂肪的排泄从而减少机体吸收的热量已达到减重的目的，本发明所述的药物或膳食补充剂组合物通过增加机体棕色脂肪细胞的能量代谢，从而有效抑制体内脂肪细胞的增生，防止机体因脂肪储存剩余能量而发胖。
附图说明
图1：本发明实施例1组合物对前脂肪细胞存活率的影响
图2：本发明实施例2组合物对分化脂肪细胞存活率的影响
图3：本发明实施例3组合物对高脂饲喂诱导肥胖的小鼠体重增重的影响
具体实施例
以下结合实施例为对本发明作进一步的说明，而并非对本发明的限制。
实施例1左卡尼汀和琥珀酸组合物干混悬剂的制备(1000袋处方)
| 左卡尼汀 | 500g |
| 琥珀酸 | 250g |
| 胶态二氧化硅 | 2g |
| 苯甲酸钠 | 10g |
| 草莓味香料 | 4g |
| 三氯蔗糖 | 10g |
| 蔗糖 | 500g |
| 黄原胶 | 5g |
取原辅料，粉碎，分别过200目筛，采用适当的方法干燥，备用；按处方量称取原辅料，采用物理混合法直接混合均匀，过程尽可能迅速，尽量减少水分的进入；将混合均匀后的粉末均匀装入镀铝膜袋中，即得。
实施例2乙酰左卡尼汀富马酸盐和琥珀酸颗粒剂的制备(1000袋处方)
将原料药过80目筛，备用。将蔗糖和阿拉伯胶于高速多功能粉碎机中粉碎，过60目筛备用，其它各辅料分别过60目筛备用。称取处方量的羟丙基纤维素，加入适量的纯化水使其溶解，搅拌均匀，备用。称取处方量的蔗糖、糊精、西黄蓍胶、阿拉伯胶，乙酰左卡尼汀富马酸盐和琥珀酸到湿法制粒机中搅拌均匀，然后加入上述制备的粘合剂，搅拌均匀，制成软材。将上述软材于摇摆颗粒机中(40目筛)制粒。将上述颗粒于60℃流化床中干燥至水分小于2％。将干燥后的颗粒于摇摆颗粒机(24目筛)中整粒。颗粒分装机中进行分装，即得。
实施例3左卡尼汀和琥珀酸钠胶囊剂的制备(1000粒处方)
称取处方量的原辅料，原料过100目筛、辅料分别过80目筛。将左卡尼汀、琥珀酸钠、预胶化淀粉、十二烷基硫酸钠和硬脂酸镁充分混合均匀。调节胶囊灌装机，装量差异控制在±5％，进行灌装，即得。
实施例4乙酰左卡尼汀和琥珀酸口服液的制备(1000支处方)
称取处方量氯化钠、依地酸二钠、糖精钠、羟苯甲酯钠、羟苯丙酯钠、苹果粉末香精、乙酰左卡尼汀和琥珀酸加入到处方体积65％的纯化水中搅拌均匀。加入处方量氨丁三醇或氢氧化钠溶液调pH，补加纯化水至全量。搅拌均匀后过滤，将所得滤液灌装至西林瓶中、轧盖。将灌装好的口服液置于121℃下热压灭菌12分钟，即得。
实施例5左卡尼汀富马酸盐和琥珀酸钠咀嚼片的制备(1000片处方)
将淀粉水解寡糖过40目筛，左卡尼汀富马酸盐和琥珀酸钠过80目筛备用。称取处方量的淀粉水解寡糖、左卡尼汀富马酸盐、琥珀酸钠、胶态二氧化硅加入到三维运动混合机中混合20min，混合结束后过24目筛2次，得混合颗粒。加入处方量硬脂酸镁混合3～5min。压片机进行压片，即得。
实施例6本发明的组合物对前脂肪细胞生长抑制试验
样品溶液的配制：
实施例1组合物溶液：取本发明实施例1组合物的内容物适量溶于生理盐水并稀释制成每1ml分别含左卡尼汀50mg和琥珀酸25mg的溶液，过滤，即得。
左卡尼汀溶液：取适量左卡尼汀溶于生理盐水并稀释制成1ml含100mg的溶液。
琥珀酸溶液：取适量琥珀酸溶于生理盐水并稀释制成1ml含50mg的溶液。
在96孔培养板中每孔加入100μl前脂肪细胞3T3-L1悬液，每孔的细胞浓度为2.5×104个/孔。培养板放入于37℃，5％CO2培养箱中培养24小时后，弃去培养液，每孔中加入100μl含有本发明实施例1组合物配制的样品溶液，左卡尼汀溶液，琥珀酸溶液，以不含样品的DMEM10为空白对照，温箱孵育72h。除去培养液后加入含有0.5mg/ml MTT的DMEM10培养基孵育4h，再加入100μl 0.1g/ml SDS溶液过夜，以完全溶解除去MTT紫色结晶物，用酶标仪在570nm波长下测定光密度值(以630nm为参比波长)，试验重复三次，通过下式计算细胞存活率。通过细胞存活率分析各试验物质对前脂肪细胞生长抑制情况，细胞存活率越低，生长抑制越显著。
细胞存活率％＝(A样品570nm-A样品630nm)/(A对照570nm-A对照630nm)×100
结果如图1所示，与对照组相比，本发明实施例1组合物，左卡尼汀和琥珀酸三组均能显著抑制前脂肪细胞生长(p<0.05)，并且实施例1组合物组对前脂肪细胞的生长抑制效果明显比单独施用左卡尼汀或琥珀酸更佳(p<0.05)。
实施例7本发明的组合物对分化中脂肪细胞生长抑制试验
样品溶液的配制：
实施例2组合物溶液：取本发明实施例2组合物的内容物适量溶于生理盐水并稀释制成每1ml分别含乙酰左卡尼汀(以左卡尼汀计)25mg和琥珀酸12.5mg的溶液，过滤，即得。
左卡尼汀溶液：取适量左卡尼汀溶于生理盐水并稀释制成1ml含50mg的溶液。
琥珀酸溶液：取适量琥珀酸溶于生理盐水并稀释制成1ml含25mg的溶液。
在24孔培养板中每孔加入100μl前脂肪细胞3T3-L1悬液，每孔的细胞浓度为2.5×105个/孔。培养板放入于37℃，5％CO2培养箱中培养，配样至第四天改用5μg/ml分化剂胰岛素、1μM的3-异丁基-1-甲基黄嘌呤培养液以诱导脂肪细胞分化。除对照组(DMSO组)外，各组分别加入100μl左卡尼汀溶液，琥珀酸溶液和实施例2组合物样品溶液，温箱孵育48h。除去培养液后加入含有0.5mg/ml MTT的DMEM10培养基孵育4h，再加入100μl 0.1g/ml SDS溶液过夜，以完全溶解除去MTT紫色结晶物，用酶标仪在570nm波长下测定光密度值(以630nm为参比波长)，试验重复三次，通过下式计算细胞存活率。
细胞存活率％＝(A样品570nm-A样品630nm)/(A对照570nm-A对照630nm)×100
结果如图2所示，与对照组相比，本发明实施例2组合物，左卡尼汀和琥珀酸三组均能显著抑制分化中脂肪细胞生长(p<0.05)，并且实施例2组合物组对分化中脂肪细胞的生长抑制效果明显比单独施用左卡尼汀或琥珀酸更佳(p<0.05)。
实施例8本发明组合物对高脂饲喂诱导肥胖的小鼠体重增重的影响
样品溶液的配制：
实施例3组合物溶液：取本发明实施例3组合物的内容物适量溶于生理盐水并稀释制成每1ml分别含左卡尼汀10mg和琥珀酸5mg的溶液，过滤，即得。
左卡尼汀溶液：取适量左卡尼汀溶于生理盐水并稀释制成1ml含20mg的溶液。
琥珀酸溶液：取适量琥珀酸溶于生理盐水并稀释制成1ml含10mg的溶液。
8周龄B6系雄性小鼠随机分为正常对照组、肥胖对照组、左卡尼汀组(剂量为500mg/kg体重)、琥珀酸组(剂量为250mg/kg体重)和本发明实施例3组合物组(剂量相当于左卡尼汀500mg/kg体重+琥珀酸250mg/kg体重)，每组各8只动物。试验期间，除正常对照组饲喂正常饲料外，其余各组饲喂高脂饲料，连续饲喂8周以诱导肥胖症状，同时每日灌胃给予试验物质8周，肥胖对照组则灌胃给予等体积纯化水，评估各组小鼠体重变化的差异。试验过程中记录每只动物的体重与平均摄食量，试验完成后，将小鼠颈椎脱臼处死。
试验结果如图3所示，肥胖对照组动物的平均体重要明显高于正常对照组(p<0.05)，说明诱导动物肥胖模型成功。喂食本发明实施例3组合物、左卡尼汀和琥珀酸的小鼠平均体重增重均明显降低(p<0.05)，较肥胖对照组体重增重幅度分别下降43.2％、21.6％和26.9％，因此本发明实施例3组合物可有效达到减轻体重的效果，且较单独给予左卡尼汀或琥珀酸的小鼠减轻体重增重的效果更明显(p<0.05)。
Claims (9)
1.一种组合物，其包含左卡尼汀或乙酰左卡尼汀或其可药用盐和琥珀酸或其可药用盐，以及一种或多种药学上可接受的赋形剂。
2.根据权利要求1所述的组合物，其特征在于其中所述左卡尼汀或乙酰左卡尼汀或其可药用盐和琥珀酸或其可药用盐的重量比为1(以左卡尼汀计):0.1～0.9(以琥珀酸计)。
3.根据权利要求1所述的组合物，其特征在于其中所述左卡尼汀或乙酰左卡尼汀或其可药用盐和琥珀酸或其可药用盐的重量比为1(以左卡尼汀计):0.2～0.6(以琥珀酸计)。
4.根据权利要求1所述的组合物，其特征在于其中所述左卡尼汀或乙酰左卡尼汀或其可药用盐和琥珀酸或其可药用盐的重量比为1(以左卡尼汀计):0.5(以琥珀酸计)。
5.根据权利要求1-4中任一项所述的组合物在制备具有减肥功能的膳食补充剂中的用途。
6.根据权利要求1-4中任一项所述的组合物在制备具有减肥功能的药物中的用途。
7.根据权利要求1-4中任一项所述的组合物，其特征在于其剂型包括注射剂、口服液剂、硬胶囊剂、软胶囊剂、片剂、颗粒剂、干混悬剂。
8.根据权利要求1-4中任一项所述的组合物的其制备方法，包括将左卡尼汀或乙酰左卡尼汀或其可药用盐和琥珀酸或其可药用盐按比例混合，再添加药学上可接受的赋形剂，混合均匀后压制成片剂或制成注射剂、口服溶液剂、颗粒剂、胶囊剂或干混悬剂。
9.根据权利要求1-4中任一项所述的组合物用于减肥、减少体重与体脂肪的用途。
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| CN101564378A (zh) * | 2009-05-19 | 2009-10-28 | 邵爱霞 | 左卡尼汀口服溶液及其制备方法 |
| CN109674696A (zh) * | 2018-03-27 | 2019-04-26 | 上海同柏生物科技有限公司 | 一种用于腹部脂肪降解技术及其制剂与应用 |
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| CN101564378A (zh) * | 2009-05-19 | 2009-10-28 | 邵爱霞 | 左卡尼汀口服溶液及其制备方法 |
| CN109674696A (zh) * | 2018-03-27 | 2019-04-26 | 上海同柏生物科技有限公司 | 一种用于腹部脂肪降解技术及其制剂与应用 |
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