CN116173143B - 一种高耐缺氧能力的咖啡因组合物及其制备方法和其应用 - Google Patents
一种高耐缺氧能力的咖啡因组合物及其制备方法和其应用 Download PDFInfo
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- CN116173143B CN116173143B CN202211604204.7A CN202211604204A CN116173143B CN 116173143 B CN116173143 B CN 116173143B CN 202211604204 A CN202211604204 A CN 202211604204A CN 116173143 B CN116173143 B CN 116173143B
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- caffeine
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- taurine
- rhizoma polygonati
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Abstract
本发明涉及一种高耐缺氧能力的咖啡因组合物,以重量百分比计,组合物中含有咖啡因1‑10%、牛磺酸15‑45%、复合B族维生素0.01‑2%和黄精提取物或人参提取物的任一种1‑15%。本发明的组合物具有质量均一性和稳定性好、生物利用度高、提神醒脑、多重抗疲劳效果、高耐缺氧能力等优点。
Description
技术领域
本发明涉及医药技术领域,具体涉及一种高耐缺氧能力的咖啡因组合物及其制备方法和其应用。
背景技术
现代社会的快生活节奏和高生活压力等因素,导致全球疲劳人群逐年大幅提升。疲劳人群常借助服用咖啡因、牛磺酸、维生素等产品,以期消除疲劳、保持清醒和提高工作效率。
咖啡因作为中枢兴奋药物,能够提高细胞内环磷腺苷的含量,兴奋大脑皮质,振奋精神,提高注意力、自信心、工作效率和积极性;增强警觉性并减少疲乏感,提高警惕性和维持持久的工作能力;缩短快速选择反应时间,增强识别能力,提高瞬时记忆力等作用。
牛磺酸(2-氨基乙磺酸,Taurine,TAU)是含硫氨基酸和条件必需氨基酸,具有广泛的生理药理作用,维持体内环境稳态,具有抗氧化、保护生物膜、清除体内自由基、保护心脏、改善记忆力、改善视觉信号传导等作用,调节机体的糖代谢和脂代谢及调节中枢神经系统、心血管系统、免疫系统、内分泌系统等功能,能促进胎儿、婴儿神经系统的发育,且能提高运动能力、运动耐力并改善运动疲劳,可改善运动性疲劳时出现的脂质过氧化、Ca2+稳态失调、能量代谢紊乱、生物膜损伤等问题。
复合B族维生素用于维持和调节机体新陈代谢,并辅助提高运动能力,有效预防并缓解高强度运动中过度活性氧导致的自由基损伤。维生素B1(硫铵)用于维护神经系统功能并影响糖代谢,促进机体代谢和运动能力并缓解疲劳。维生素B2(核黄素)是同电子转移有关的两种辅酶(FAD、FMD)的组成成分,且与线粒体中发生氧化反应的酶关系密切,进而影响机体的能量消耗、肌肉活动、有氧耐力等方面。维生素B6(吡哆醇)与血红蛋白(Hb)、肌红蛋白(Mb)、细胞色素的生成有关,具有促进运动时糖异生作用,预防运动性低血糖的发生,提高机体的有氧耐力。维生素B12(钴胺素)能促进机体DNA及蛋白质的生物合成,增强神经营养和造血功能,增加红细胞携氧能力,促进红细胞的发育和成熟,维持机体造血系统处于正常状态,增强机体耐受缺氧能力,有利于提高运动耐力并预防恶性贫血的发生。
黄精提取物具有补气养阴、健脾润肺、抗疲劳、调节免疫、保护神经、抗氧化、降血压、降血脂、防止动脉粥样硬化等功效,用于降低机体过氧化水平、增加肝糖原含量、有效清除高强度运动中机体过度产生活性氧所导致的肌肉疲劳、肌肉损伤、机体机能下降、免疫功能低下等问题。
人参提取物富含多种人参皂甙,具有抗冷热应激作用,增强人体表面细胞的活力,抑制衰老、耐缺氧等作用,长期服用增强体力,延年益寿,用于冠心病、心绞痛、心率过缓、过快、室性早博、血压失调、神经衰弱、更年期综合症、疲劳过度、病后、产后、术后身体虚弱,以及提高癌症放化疗患者免疫功能低下等。
茶氨酸具有调节脑血流动、拮抗脑血管收缩、调节情绪、改善认知、使人心绪平静、注意力集中,以及缓解疲劳、紧张、易怒、焦虑等作用,显著提高机体应对不同任务的反应能力和完成任务的准确率,增强高要求任务的认知能力、减少精神疲惫感,显著增强氧气稀薄环境、高强度有氧运动等情况下的耐缺氧和抗疲劳作用。
多款由咖啡因、牛磺酸和复合B族维生素制成的复方咖啡因上市产品存在下述缺陷,一是咖啡因的苦味和涩味影响人群的吞咽和服用的依从性;二是B族维生素用量低,且存在质量均一性和稳定性不佳等缺陷;三是长时间服用咖啡因,易引起焦虑、烦躁、失眠、易怒、精细运动功能受损等不良反应。为此,急需开发抗疲劳效果及耐缺氧能力更佳、质量均一、稳定性更好、安全有效的咖啡因产品,以显著改善疲劳人群的缺氧状态并提高其工作效率。
发明内容
本发明的目的在于提供一种高耐缺氧能力的咖啡因组合物,以重量百分比计,组合物中含有咖啡因1-10%、牛磺酸15-45%、复合B族维生素0.01-2%、黄精提取物或人参提取物的任一种1-15%和药学上可接受的载体,其中,所述复合B族维生素由维生素B1:维生素B2:维生素B6:维生素B12按照质量比为1-5:1-3:1-3:0.001-0.005组成,所述黄精提取物含有10-20%的黄精多糖,人参提取物含有2-6%的人参皂苷,所述药学上可接受的载体选自填充剂、润滑剂、调味剂中的任一种或其组合。
本发明的优选技术方案中,所述复合B族维生素由维生素B1:维生素B2:维生素B6:维生素B12按照质量比为2-4:1-2:1-2:0.001-0.003组成。
本发明的优选技术方案中,以重量百分比计,组合物中含有咖啡因2-9%,牛磺酸20-40%,复合B族维生素0.05-1.5%和黄精提取物或人参提取物的任一种1-10%。
本发明的优选技术方案中,以重量百分比计,组合物中含有咖啡因2-9%、牛磺酸20-40%、黄精提取物或人参提取物的任一种1-10%、维生素B1 0.01-0.5%、维生素B20.01-0.1%、维生素B6 0.01-0.1%和维生素B120.0001-0.001%。
本发明的优选技术方案中,组合物中任选地含有茶氨酸1-10%。
本发明的优选技术方案中,以重量百分比计,组合物中含有咖啡因2-9%、牛磺酸20-40%、黄精提取物或人参提取物的任一种1-10%、茶氨酸2-8%和复合B族维生素0.05-1.5%。
本发明的优选技术方案中,以重量百分比计,组合物中含有咖啡因2-9%、牛磺酸20-30%、黄精提取物或人参提取物的任一种1-10%、茶氨酸2-8%、维生素B1 0.01-0.5%、维生素B2 0.01-0.1%、维生素B6 0.01-0.1%和维生素B12 0.0001-0.001%。
本发明的优选技术方案中,以重量百分比计,组合物中含有填充剂30-70%,所述填充剂选自山梨糖醇、淀粉、甘露醇、赤藓糖醇、麦芽糖醇、木糖醇中的任一种或其组合。
本发明的优选技术方案中,以重量百分比计,组合物中含有填充剂50-70%,优选为55-65%。
本发明的优选技术方案中,以重量百分比计,组合物中含有润滑剂1-10%,所述润滑剂选自硬脂酸镁、硬脂酸钙、硬脂酸钠、硬脂酸钾、硬脂酸、滑石粉、脂肪酸、二氧化硅、二氧化钛、轻质硅酸酐、微粉硅胶、硬脂酰醇富马酸钠、蔗糖脂肪酸酯、单硬脂酸甘油酯、双硬脂酸甘油酯、混合脂肪酸甘油酯、山嵛酸甘油酯的任一种或其组合。
本发明的优选技术方案中,以重量百分比计,组合物中润滑剂1.5-8%,优选为2-5%。
本发明的优选技术方案中,以重量百分比计,组合物中含有调味剂1-15%,所述调味剂选自三氯蔗糖、阿斯巴甜、安赛蜜、甜菊糖苷、薄荷醇、薄荷酰胺、罗汉果甜苷、N-乙基-对薄荷基-3-甲酰胺、N,2,3-三甲基-2-异丙基丁酰胺、2-(4-甲基苯氧基)-N-(1H-吡唑-3-基)-N-(噻吩-2-基甲基)乙酰胺、(1R,2S,5R)-N-(4-甲氧苯基)-5-甲基-2-(1-甲基乙基)环己基甲酰胺、咖啡粉、柠檬酸、柠檬酸钾、柠檬酸钠、枸橼酸、枸橼酸钠、枸橼酸钾、苹果酸、苹果酸钠、苹果酸钾、氢氧化钾、氢氧化钠、碳酸氢钠、碳酸钾、碳酸钠、磷酸、磷酸氢二钠、磷酸二氢钠、磷酸氢二钾、磷酸二氢钾、单乙醇胺、二乙醇胺、三乙醇胺、乳酸、乳酸钠、乳酸钾、醋酸、醋酸钠、醋酸钾、丙酸、丙酸钠、丙酸钾、酒石酸、酒石酸钠、酒石酸钾、富马酸、富马酸钠、富马酸钾、薄荷香精、柠檬香精、桃味香精中的任一种或其组合。
本发明的优选技术方案中,以重量百分比计,组合物中含有调味剂2-12%,优选为3-10%。
本发明的优选技术方案中,以重量百分比计,组合物中含有咖啡因2-9%、牛磺酸20-40%、黄精提取物或人参提取物的任一种1-10%、维生素B1 0.01-0.5%、维生素B20.01-0.1%、维生素B6 0.01-0.1%、维生素B120.0001-0.001%、山梨糖醇或甘露醇的任一种或其组合40-65%、三氯蔗糖0.01-1%、罗汉果甜苷0.1-1%、柠檬酸1-10%、N,2,3-三甲基-2-异丙基丁酰胺0.01-1%、香精0.01-1%和硬脂酸镁1.5-8%。
本发明的优选技术方案中,以重量百分比计,组合物中含有咖啡因2-9%、牛磺酸20-40%、黄精提取物或人参提取物的任一种1-10%、茶氨酸1-10%、维生素B1 0.01-0.5%、维生素B2 0.01-0.1%、维生素B6 0.01-0.1%、维生素B12 0.0001-0.001%、山梨糖醇或甘露醇的任一种或其组合40-65%、三氯蔗糖0.1-1%、罗汉果甜苷0.1-1%、柠檬酸1-10%、N,2,3-三甲基-2-异丙基丁酰胺0.1-1%、香精0.01-1%和硬脂酸镁1.5-8%。
本发明的优选技术方案中,以重量百分比计,组合物中包含咖啡因1-5%、牛磺酸20-30%、黄精提取物或人参提取物的任一种1-5%、维生素B1 0.01-0.5%、维生素B2 0.01-0.1%、维生素B6 0.01-0.1%、维生素B120.0001-0.001%和药学上可接受的载体。
本发明的优选技术方案中,以重量百分比计,组合物中含有咖啡因1-5%、牛磺酸20-25%、黄精提取物或人参提取物的任一种1-5%、茶氨酸1-10%、维生素B1 0.01-0.5%、维生素B2 0.01-0.1%、维生素B6 0.01-0.1%、维生素B12 0.0001-0.001%和药学上可接受的载体。
本发明的优选技术方案中,所述组合物选自咀嚼片。
本发明的优选技术方案中,所述咀嚼片中的硬度为100N±5N-120N±5N。
本发明的另一目的在于提供一种高耐缺氧能力的咖啡因组合物的制备方法,以重量百分比计,组合物中含有咖啡因1-10%、牛磺酸15-45%、复合B族维生素0.01-2%、黄精提取物或人参提取物的任一种1-15%和药学上可接受的载体,其中,所述复合B族维生素由维生素B1:维生素B2:维生素B6:维生素B12按照质量比为1-5:1-3:1-3:0.001-0.005组成,所述黄精提取物含有10-20%的黄精多糖,人参提取物含有2-6%的人参皂苷,所述药学上可接受的载体选自填充剂、润滑剂、调味剂中的任一种或其组合,所述方法包括下述步骤:
(1)称取所需量的维生素B1、维生素B2、维生素B6、维生素B12和1/8-1/10的填充剂,将其均匀混合后,制得混合物1;
(2)称取所需量的咖啡因、牛磺酸、黄精提取物或人参提取物的任一种和除润滑剂之外的药学上可接受的载体,搅拌至混合均匀,制得混合物2;
(3)将制得的混合物1按照等量递增法与混合物2均匀混合后,再加入所需量的润滑剂,压片,即得。
本发明的优选技术方案中,将咖啡因、牛磺酸、黄精提取物或人参提取物的任一种和药学上可接受的载体,粉碎,过60-80目筛后,备用。
本发明的优选技术方案中,所述复合B族维生素由维生素B1:维生素B2:维生素B6:维生素B12按照质量比为2-4:1-2:1-2:0.001-0.003组成。
本发明的优选技术方案中,以重量百分比计,组合物中含有咖啡因2-9%,牛磺酸20-40%,复合B族维生素0.05-1.5%和黄精提取物或人参提取物的任一种1-10%。
本发明的优选技术方案中,以重量百分比计,组合物中含有咖啡因2-9%、牛磺酸20-40%、黄精提取物或人参提取物的任一种1-10%、维生素B1 0.01-0.5%、维生素B20.01-0.1%、维生素B6 0.01-0.1%和维生素B120.0001-0.001%。
本发明的优选技术方案中,组合物中任选地含有茶氨酸1-10%。
本发明的优选技术方案中,以重量百分比计,组合物中含有咖啡因2-9%、牛磺酸20-40%、黄精提取物或人参提取物的任一种1-10%、茶氨酸2-8%和复合B族维生素0.05-1.5%。
本发明的优选技术方案中,以重量百分比计,组合物中含有咖啡因2-9%、牛磺酸20-30%、黄精提取物或人参提取物的任一种1-10%、茶氨酸2-8%、维生素B1 0.01-0.5%、维生素B2 0.01-0.1%、维生素B6 0.01-0.1%和维生素B12 0.0001-0.001%。
本发明的优选技术方案中,以重量百分比计,组合物中含有填充剂30-70%,所述填充剂选自山梨糖醇、淀粉、甘露醇、赤藓糖醇、麦芽糖醇、木糖醇中的任一种或其组合。
本发明的优选技术方案中,以重量百分比计,组合物中含有填充剂50-70%,优选为55-65%。
本发明的优选技术方案中,以重量百分比计,组合物中含有润滑剂1-10%,所述润滑剂选自硬脂酸镁、硬脂酸钙、硬脂酸钠、硬脂酸钾、硬脂酸、滑石粉、脂肪酸、二氧化硅、二氧化钛、轻质硅酸酐、微粉硅胶、硬脂酰醇富马酸钠、蔗糖脂肪酸酯、单硬脂酸甘油酯、双硬脂酸甘油酯、混合脂肪酸甘油酯、山嵛酸甘油酯的任一种或其组合。
本发明的优选技术方案中,以重量百分比计,组合物中润滑剂1.5-8%,优选为2-5%。
本发明的优选技术方案中,以重量百分比计,组合物中含有调味剂1-15%,所述调味剂选自三氯蔗糖、阿斯巴甜、安赛蜜、甜菊糖苷、薄荷醇、薄荷酰胺、罗汉果甜苷、N-乙基-对薄荷基-3-甲酰胺、N,2,3-三甲基-2-异丙基丁酰胺、2-(4-甲基苯氧基)-N-(1H-吡唑-3-基)-N-(噻吩-2-基甲基)乙酰胺、(1R,2S,5R)-N-(4-甲氧苯基)-5-甲基-2-(1-甲基乙基)环己基甲酰胺、咖啡粉、柠檬酸、柠檬酸钾、柠檬酸钠、枸橼酸、枸橼酸钠、枸橼酸钾、苹果酸、苹果酸钠、苹果酸钾、氢氧化钾、氢氧化钠、碳酸氢钠、碳酸钾、碳酸钠、磷酸、磷酸氢二钠、磷酸二氢钠、磷酸氢二钾、磷酸二氢钾、单乙醇胺、二乙醇胺、三乙醇胺、乳酸、乳酸钠、乳酸钾、醋酸、醋酸钠、醋酸钾、丙酸、丙酸钠、丙酸钾、酒石酸、酒石酸钠、酒石酸钾、富马酸、富马酸钠、富马酸钾、薄荷香精、柠檬香精、桃味香精中的任一种或其组合。
本发明的优选技术方案中,以重量百分比计,组合物中含有调味剂2-12%,优选为3-10%。
本发明的优选技术方案中,以重量百分比计,组合物中含有咖啡因2-9%、牛磺酸20-40%、黄精提取物或人参提取物的任一种1-10%、维生素B1 0.01-0.5%、维生素B20.01-0.1%、维生素B6 0.01-0.1%、维生素B120.0001-0.001%、山梨糖醇或甘露醇的任一种或其组合40-65%、三氯蔗糖0.01-1%、罗汉果甜苷0.1-1%、柠檬酸1-10%、N,2,3-三甲基-2-异丙基丁酰胺0.01-1%、香精0.01-1%和硬脂酸镁1.5-8%。
本发明的优选技术方案中,以重量百分比计,组合物中含有咖啡因2-9%、牛磺酸20-40%、黄精提取物或人参提取物的任一种1-10%、茶氨酸1-10%、维生素B1 0.01-0.5%、维生素B2 0.01-0.1%、维生素B6 0.01-0.1%、维生素B12 0.0001-0.001%、山梨糖醇或甘露醇的任一种或其组合40-65%、三氯蔗糖0.1-1%、罗汉果甜苷0.1-1%、柠檬酸1-10%、N,2,3-三甲基-2-异丙基丁酰胺0.1-1%、香精0.01-1%和硬脂酸镁1.5-8%。
本发明的优选技术方案中,以重量百分比计,组合物中包含咖啡因1-5%、牛磺酸20-30%、黄精提取物或人参提取物的任一种1-5%、维生素B1 0.01-0.5%、维生素B2 0.01-0.1%、维生素B6 0.01-0.1%、维生素B120.0001-0.001%和药学上可接受的载体。
本发明的优选技术方案中,以重量百分比计,组合物中含有咖啡因1-5%、牛磺酸20-25%、黄精提取物或人参提取物的任一种1-5%、茶氨酸1-10%、维生素B1 0.01-0.5%、维生素B2 0.01-0.1%、维生素B6 0.01-0.1%、维生素B12 0.0001-0.001%和药学上可接受的载体。
本发明的优选技术方案中,所述组合物选自咀嚼片。
本发明的优选技术方案中,所述咀嚼片中的硬度为100N±5N-120N±5N。
本发明的另一目的在于提供本发明的咖啡因组合物用于制备抗疲劳和/或能量补给的制品中的应用,所述制品选自药品、食品、保健食品、特医食品的任一种,所述疲劳选自体力疲劳、脑力疲劳中的任一种或其组合。
本发明的优选技术方案中,所述疲劳选自精神不振、注意力不集中、疲乏感、识别能力下降、记忆力下降中的任一种或其组合。
除非另有说明,本发明涉及液体与液体之间的百分比时,所述的百分比为体积/体积百分比;本发明涉及液体与固体之间的百分比时,所述百分比为体积/重量百分比;本发明涉及固体与液体之间的百分比时,所述百分比为重量/体积百分比;其余为重量/重量百分比。
与现有技术相比,本发明具有下述有益技术效果:
1、本发明科学组配组合物中的有效成分(咖啡因、牛磺酸、人参提取物或黄精提取物、复合B族维生素等)及其配比,一是补充具有增强神经营养和造血功能、增加红细胞携氧能力的维生素B12;二是组配具有补气养阴、健脾润肺、抗疲劳、调节免疫、保护神经、抗氧化、降血压、降血脂、防止动脉粥样硬化等作用的黄精提取物或人参提取物;三是组配具有调节脑血流动、拮抗脑血管收缩、调节情绪、改善认知、使人心绪平静、注意力集中、缓解疲劳等作用的茶氨酸,有效缓解长期服用咖啡因所引起的紧张、易怒、焦虑等不良反应,显著提高机体应对不同任务的反应能力和完成任务的准确率,增强高要求任务的认知能力、减少精神疲惫感,显著改善氧气稀薄环境、高强度有氧运动等情况下的耐缺氧和抗疲劳作用,显著降低机体过氧化水平、增加肝糖原含量、有效清除高强度运动中活性氧导致的肌肉疲劳、肌肉损伤、机体机能下降、免疫功能低下等问题,显著提高机体的耐缺氧能力、提高运动耐力并高效补充体能,具有质量均一性和稳定性好、生物利用度高、优异地抗脑力疲劳和体力疲劳、高耐缺氧能力等优点。
2、本发明的复方咖啡因咀嚼片能够快速使人保持清醒,延缓和消除疲劳,适应多种作业场景,便于列装。针对长时间、高强度脑力与体力消耗的作业情景,可用于保持警觉性,恢复精力,缓解疲劳,维持认知力,避免因疲劳、精力涣散导致的事故。口感良好,使用方便,不需要喝水,根据作业环境需要随时随地均可服用,能快速逆转疲劳导致的警觉性、专注力下降,生物利用度高,可长时间地保持振奋饱满精神。适用于改善军事平战时多种作业及作战环境诱发疲劳,如长航、连续作战、夜战、跨区作战等均可造成机体生理节律的紊乱,诱发疲劳并导致认知功能降低、高科技战争,如各种夜视技术、雷达、精确制导武器和先进的探测器在极端条件诱发的疲劳。
3、本发明的制备方法操作简便、产率高、缩短生产周期、成本更优、适合人群广泛、适合工业化生产等优点。
具体实施方式
以下参照实施例说明本发明。但本发明不局限于实施例。
具体实施方式中的黄精提取物和人参提取物购自扶风斯诺特生物科技有限公司。
实施例1本发明咖啡因咀嚼片的制备
咖啡因咀嚼片的组成为:
咖啡因咀嚼片的制备包括下述步骤:
(1)将咖啡因、牛磺酸和药学上可接受的载体,粉碎,过60-80目筛,备用;
(2)称取所需量的维生素B1、维生素B2、维生素B6和维生素B12及1/10量的山梨醇,将其均匀混合后,制得混合物1;
(3)称取所需量的咖啡因、牛磺酸、黄精提取物及除硬脂酸镁之外的药学上可接受的载体,在转速25-50r/min下均匀混合,制得混合物2;
(4)将制得的混合物1按照等量递增法与混合物2均匀混合后,再加入所需量的硬脂酸镁,在转速25-50r/min下至均匀混合,压片,制得1000片(硬度120N±5N)。
实施例2本发明咖啡因咀嚼片的制备
咖啡因咀嚼片的组成为:
咖啡因咀嚼片的制备包括下述步骤:
(1)将咖啡因、牛磺酸和药学上可接受的载体,粉碎,过60-80目筛,备用;
(2)称取所需量的维生素B1、维生素B2、维生素B6和维生素B12,将其均匀混合后,制得混合物1;
(3)称取所需量的咖啡因、牛磺酸、人参提取物及除硬脂酸镁之外的药学上可接受的载体,在转速25-50r/min下均匀混合,制得混合物2;
(4)将制得的混合物1按照等量递增法与混合物2均匀混合后,再加入所需量的硬脂酸镁,在转速25-50r/min下至均匀混合,压片,制得1000片(硬度120N±5N)。
实施例3本发明咖啡因咀嚼片的制备
咖啡因咀嚼片的组成为:
咖啡因咀嚼片的制备包括下述步骤:
(1)将咖啡因、牛磺酸和药学上可接受的载体,粉碎,过60-80目筛,备用;
(2)称取所需量的维生素B1、维生素B2、维生素B6和维生素B12,将其均匀混合后,制得混合物1;
(3)称取所需量的咖啡因、牛磺酸、黄精提取物、茶氨酸及除硬脂酸镁之外的药学上可接受的载体,在转速25-50r/min下均匀混合,制得混合物2;
(4)将制得的混合物1按照等量递增法与混合物2均匀混合后,再加入所需量的硬脂酸镁,在转速25-50r/min下至均匀混合,压片,制得1000片(硬度100N±5N)。
实施例4本发明咖啡因咀嚼片的制备
咖啡因咀嚼片的组成为:
咖啡因咀嚼片的制备包括下述步骤:
(1)将咖啡因、牛磺酸和药学上可接受的载体,粉碎,过60-80目筛,备用;
(2)称取所需量的维生素B1、维生素B2、维生素B6和维生素B12,将其均匀混合后,制得混合物1;
(3)称取所需量的咖啡因、牛磺酸、人参提取物、茶氨酸及除硬脂酸镁之外的药学上可接受的载体,在转速25-50r/min下均匀混合,制得混合物2;
(4)将制得的混合物1按照等量递增法与混合物2均匀混合后,再加入所需量的硬脂酸镁,在转速25-50r/min下至均匀混合,压片,制得1000片(硬度100N±5N)。
实施例5本发明咖啡因咀嚼片的制备
咖啡因咀嚼片的组成为:
咖啡因咀嚼片的制备包括下述步骤:
(1)将咖啡因、牛磺酸和药学上可接受的载体,粉碎,过60-80目筛,备用;
(2)称取所需量的维生素B1、维生素B2、维生素B6和维生素B12,将其均匀混合后,制得混合物1;
(3)称取所需量的咖啡因、牛磺酸、黄精提取物及除硬脂酸镁之外的药学上可接受的载体,在转速25-50r/min下均匀混合,制得混合物2;
(4)将制得的混合物1按照等量递增法与混合物2均匀混合后,再加入所需量的硬脂酸镁,在转速25-50r/min下至均匀混合,压片,制得1000片(硬度120N±5N)。
实施例6本发明咖啡因咀嚼片的制备
咖啡因咀嚼片的组成为:
咖啡因咀嚼片的制备包括下述步骤:
(1)将咖啡因、牛磺酸和药学上可接受的载体,粉碎,过60-80目筛,备用;
(2)称取所需量的维生素B1、维生素B2、维生素B6和维生素B12,将其均匀混合后,制得混合物1;
(3)称取所需量的咖啡因、牛磺酸、黄精提取物及除硬脂酸镁之外的药学上可接受的载体,在转速25-50r/min下均匀混合,制得混合物2;
(4)将制得的混合物1按照等量递增法与混合物2均匀混合后,再加入所需量的硬脂酸镁,在转速25-50r/min下至均匀混合,压片,制得1000片(硬度120N±5N)。
对比例1咖啡因咀嚼片的制备
咖啡因咀嚼片的组成为:
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咖啡因咀嚼片的制备包括下述步骤:
(1)将咖啡因、牛磺酸和药学上可接受的载体,粉碎,过60-80目筛,备用;
(2)称取所需量的维生素B1、维生素B2、维生素B6和维生素B12,将其均匀混合后,制得混合物1;
(3)称取所需量的咖啡因、牛磺酸、人参粉及除硬脂酸镁之外的药学上可接受的载体,在转速25-50r/min下均匀混合,制得混合物2;
(4)将制得的混合物1按照等量递增法与混合物2均匀混合后,再加入所需量的硬脂酸镁,在转速25-50r/min下至均匀混合,压片,即得1000片,硬度120N。
试验例1本发明咖啡因组合物的抗体力疲劳作用研究
选取体重(20±2)g的健康雄性Ba l b/c小鼠144只(购于维通利华实验动物中心),同室分笼适应性饲养一周,环境温度控制在25±2℃,光照12h。
试验小鼠随机分成安静对照组(灌胃生理盐水)、运动对照组(灌胃生理盐水)、阳性对照组(以咖啡因计,将对比例1的咀嚼片制成浓度为1mg/mL的混悬液灌胃)、复方咖啡因的低剂量组(以咖啡因计,将实施例1的咀嚼片制成浓度为0.5mg/mL的混悬液灌胃)、中剂量组(以咖啡因计,将实施例1的咀嚼片制成浓度为1mg/mL的混悬液灌胃)和高剂量组(以咖啡因计,将实施例1的咀嚼片制成浓度为2mg/mL的混悬液灌胃),每组24只。试验动物以10mL/kg量灌胃,每日灌胃一次,连续灌胃7天。试验期间,试验动物可自由饮水和进食。
末次灌胃30min后,每组随机取出6只小鼠进行负重游泳试验,在小鼠尾部绑上其体重5%的铅皮,放入水深30cm左右、水温25℃±0.5℃的水箱中游泳,记录小鼠自游泳开始至死亡的时间,将其作为小鼠力竭游泳时间。
末次灌胃30min后,每组随机取出6只试验小鼠,置于25℃±0.5℃的水中无负重游泳90min后取出,休息60min后,眼眶取血0.1mL。3000转/分离心3min,取上清液待测。按照南京建成试剂盒测定尿素氮含量(mmol/L)。取“血清尿素氮的测定”中小鼠血浆上清液,按南京建成试剂盒要求测定血浆中的CK酶活。
末次灌胃30min后,每组随机取出6只小鼠,负重2%体重在25℃±0.5℃的水中游泳60min,安静15min后眼眶取血0.1mL,3000转/分离心3min,取上清液待测,按照南京建成试剂盒测定血乳酸含量(mmol/L)。取“血乳酸测定”中小鼠血浆上清液,按南京建成试剂盒要求测定血浆中的LDH酶活。
末次灌胃30min后,每组随机取出6只小鼠,无负重置于水温25℃±0.5℃的水中游泳90min后,立即颈椎脱臼处死,取出肝脏,生理盐水漂洗后进行冷冻研磨,按南京建成试剂盒要求测定肝糖原含量(mg/g)。取“肝糖原测定”中小鼠的肝脏约0.1g,用预冷过的生理盐水漂洗,除去血液,滤纸擦干,称重,放入10mL的离心管中。用微量移液器移取预冷的生理盐水,重量为组织重的9倍,倒入盛有组织块的离心管中,机械匀浆30s。将匀浆液3000r/min离心10min,取上清备用,按南京建成试剂盒要求测定肝脏SDH(U/mg)。
实验数据采用SPSS23.0软件处理,以均数±标准差(x0±s)表示,结果采用方差分析进行组间检验。结果见表1(x0±s,n=6)。本发明组合物具有优异地抗体力疲劳作用。
试验例2本发明咖啡因组合物抗脑力疲劳作用研究
体重(20±2)g的健康雄性Balb/c小鼠72只(购于维通利华实验动物中心),同室分笼适应性饲养一周,环境温度控制在25±2℃,光照12h,黑暗12h。试验小鼠随机分成6组,每组12只。睡眠对照组(灌胃生理盐水)、睡眠剥夺组(灌胃生理盐水)、阳性对照组(以咖啡因计,将对比例1的咀嚼片制成浓度为1mg/mL的混悬液灌胃)、复方咖啡因低剂量组(以咖啡因计,将实施例2的咀嚼片制成浓度为0.5mg/mL的混悬液灌胃)、中剂量组(以咖啡因计,将实施例2的咀嚼片制成浓度为1mg/mL的混悬液灌胃)、高剂量组(以咖啡因计,将实施例2的咀嚼片制成浓度为2mg/mL的混悬液灌胃)。试验动物以10mL/kg量灌胃。睡眠对照组常规饲养,不造模。其他各组建立睡眠剥夺模型,各组连续睡眠剥夺72h。在睡眠剥夺期间,每天进行各组的给药。每天早晚九点各灌胃给药一次,睡眠剥夺期间连续灌胃3天。试验动物可自由饮水和进食。
在睡眠剥夺开始前,对各组小鼠进行水迷宫训练。在72h睡眠剥夺结束后,各组小鼠再次进行Morr i s水迷宫实验,记录定位航行试验结果和空间探查试验结果,评价各组小鼠睡眠剥夺后的学习记忆能力。结果见表2(x0±s,n=12)。
睡眠对照组小鼠一般情况良好,毛发致密有光泽,尾巴、爪子颜色色红有光泽,精神良好,反应灵敏,摄食、饮水和大小便未见明显异常。睡眠剥夺及给药期间,与睡眠对照组比较,睡眠剥夺组小鼠摄食稍有增加,烦躁易激怒,毛发光泽暗淡,精神萎靡,神情呆滞。与睡眠剥夺组比较,各给药组小鼠毛发较致密,精神较振奋,警觉性有所增加。
表2
注:与睡眠剥夺组相比,*P<0.05,**P<0.01;与睡眠对照组相比,#P<0.05,##P<0.01。
与睡眠对照组比较,睡眠剥夺组小鼠上平台潜伏期和游泳总路程显著增加(P<0.01)。与睡眠剥夺组比较,各给药组小鼠上平台潜伏期和游泳总路程均有不同程度减少(P<0.01)。本发明组合物显著改善睡眠剥夺诱发的学习记忆损害,缓解睡眠缺乏造成的脑力疲劳。
试验例3本发明咖啡因组合物耐缺氧作用研究
体重(20±2)g的健康雄性Balb/c小鼠50只(购于维通利华实验动物中心),同室分笼适应性饲养一周,环境温度控制在25±2℃,光照12h。试验小鼠随机分成空白对照组(灌胃生理盐水)、阳性对照组(以咖啡因计,将对比例1的咀嚼片制成浓度为1mg/mL的混悬液灌胃)、复方咖啡因低剂量组(以咖啡因计,将实施例4的咀嚼片制成浓度为0.5mg/mL的混悬液灌胃)、中剂量组(以咖啡因计,将实施例4的咀嚼片制成浓度为1mg/mL的混悬液灌胃)和高剂量组(以咖啡因计,将实施例4的咀嚼片制成浓度为2mg/mL的混悬液灌胃),每组10只。各组试验小鼠以10mL/kg量灌胃。每日灌胃一次,连续灌胃30天。试验期间,试验动物可自由饮水和进食。
末次灌胃后1h,将各组小鼠分别放入装有5g钠石灰的250ml广口瓶中,每瓶中放入1只,用凡士林涂瓶口、用封口膜封严瓶口使之不漏气。立即计时至小鼠停止呼吸为止,以最后一次呼吸为指标,记录小鼠常压耐缺氧存活时间。小鼠停止呼吸后,立即取出,以微量取血管从小鼠心脏采血,取10μl血液,加入盛有2ml稀释液的EP管中,上下颠倒混匀。检测前将待检血样颠倒3~5次,充分混匀后送入全血分析仪中检测,测定小鼠血液中血红蛋白的含量。
实验数据采用SPSS23.0软件处理,以均数±标准差(x0±s)表示,结果采用方差分析进行组间检验。结果见表3。
表3
注:与空白对照组相比,*P<0.05,**P<0.01。
本发明的咖啡因组合物显著延长常压缺氧小鼠的存活时间,显著改善其耐缺氧能力(P<0.01),显著缓解焦虑紧张等情绪。
以上对本发明具体实施方式的描述并不限制本发明,本领域技术人员可以根据本发明作出各种改变或变形,只要不脱离本发明的精神,均应属于本发明权利要求保护的范围。
表1
注:与运动对照组相比,*P<0.05,**P<0.01。与安静对照组相比,#P<0.05,##P<0.01。
Claims (6)
1.一种高耐缺氧能力的咖啡因组合物,以重量百分比计,组合物中含有咖啡因2-9%、牛磺酸20-40%、黄精提取物或人参提取物的任一种1-10%、维生素B1 0.01-0.1%、维生素B20.01-0.1%、维生素B6 0.01-0.1%、维生素B12 0.0001-0.001%、山梨糖醇或甘露醇的任一种或其组合40-60%、三氯蔗糖0.01-1%、柠檬酸1-10%、N,2,3-三甲基-2-异丙基丁酰胺0.01-1%、香精0.01-1%和硬脂酸镁1.5-8%,所述黄精提取物含有10-20%的黄精多糖,人参提取物含有2-6%的人参皂苷。
2.一种高耐缺氧能力的咖啡因组合物,以重量百分比计,组合物中含有咖啡因2-9%、牛磺酸20-40%、黄精提取物或人参提取物的任一种1-10%、茶氨酸1-10%、维生素B1 0.01-0.1%、维生素B2 0.01-0.1%、维生素B6 0.01-0.1%、维生素B12 0.0001-0.001%、山梨糖醇或甘露醇的任一种或其组合40-60%、三氯蔗糖0.1-1%、柠檬酸1-10%、N,2,3-三甲基-2-异丙基丁酰胺0.1-1%、香精0.01-1%和硬脂酸镁1.5-8%,所述黄精提取物含有10-20%的黄精多糖,人参提取物含有2-6%的人参皂苷。
3.如权利要求1或2所述的咖啡因组合物,所述组合物选自无水吞服颗粒、咀嚼片中的任一种。
4.如权利要求3所述的咖啡因组合物,所述咀嚼片中的硬度为100N±5N-120N±5N。
5.如权利要求1-4任一项所述的咖啡因组合物用于制备抗疲劳和/或能量补给的制品中的应用,所述制品选自药品、食品的任一种,所述疲劳选自体力疲劳、脑力疲劳中的任一种或其组合。
6.如权利要求5所述的应用,所述疲劳选自精神不振、注意力不集中、疲乏感、识别能力下降、记忆力下降中的任一种或其组合。
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