CN107212401A - 缓解体力疲劳的组合物及其制剂和制备方法 - Google Patents
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Abstract
本发明公开了一种缓解体力疲劳的组合物,主要由下述重量份的原料制得:牡蛎肽8~12份、铁皮石斛7~12份、玛咖6~10份、蛹虫草4~8份、淫羊藿3~7份、肉苁蓉3~7份、巴戟天3~6份、海参2~5份、黄精1~5份。还公开了一种制剂,该制剂由所述组合物和药学上可接受的载体组成。还公开了上述制剂的制备方法:(1)预处理:取牡蛎肽、铁皮石斛、玛咖、蛹虫草、淫羊藿、肉苁蓉、巴戟天、海参、黄精,粉碎;(2)混合:取配方量的麦芽糊精、微晶纤维素、乳糖,与上述混合物混匀;(3)制粒;(4)总混:取硬脂酸镁与混合物混匀;(5)压片。本发明的组合物和制剂抗疲劳作用良好、无毒副作用、安全可靠。
Description
技术领域
本发明涉及保健品领域,尤其涉及一种缓解体力疲劳的组合物及其制剂和制备方法。
背景技术
疲劳又称疲乏,主要是主观上的疲乏无力、倦怠、精力不够等不适的感觉。疲劳是一种生理现象,对人来说是一种保护机制,这是身体向我们发出应该休息的信号,如果不是持久性过度性的疲劳,一般可以通过科学饮食、合理营养等自我保健手段来进行调理、消除。如果对这种信号不管不顾,身体就会受到损害,最后积劳成疾。中医理论认为,精(津)血为体力产生的物质基础,人的耐力也由此而生。引起疲劳的原因可以是作业强度过大、能量代谢率过高、连续作业时间过长、作业条件不良等。因此,长期处于疲劳状态的人应该及时采取相应的预防和控制措施,缓解疲劳、提高机体免疫力,从而达到增进机体健康水平、提高生活质量的目的。科学膳食、合理营养等自我保健手段可以调理、消除疲劳感。
发明内容
本发明的目的是针对上述问题提供一种抗疲劳作用良好、无毒副作用、安全可靠的缓解体力疲劳的组合物及其制剂和制备方法。
本发明实现其目的的技术方案在于:
一种缓解体力疲劳的组合物,主要由下述重量份的原料制得:牡蛎肽8~12份、铁皮石斛7~12份、玛咖6~10份、蛹虫草4~8份、淫羊藿3~7份、肉苁蓉3~7份、巴戟天3~6份、海参2~5份、黄精1~5份。
作为优选地,所述组合物主要由下述重量份的原料制得:牡蛎肽9~11份、铁皮石斛7~10份、玛咖8~10份、蛹虫草4~7份、淫羊藿3~6份、肉苁蓉4~6份、巴戟天3~6份、海参3~5份、黄精2~5份。
一种缓解体力疲劳的组合物的制剂,该制剂由上述组合物和药学上可接受的载体组成。
在上述技术方案中,所述载体包括下述重量份的原料:硬脂酸镁0.5~1.5份、麦芽糊精13~17份、微晶纤维素10~15份、乳糖15~20份。
上述制剂的制备方法,包括如下步骤:
(1)预处理:取配方量的牡蛎肽、铁皮石斛、玛咖、蛹虫草、淫羊藿、肉苁蓉、巴戟天、海参、黄精,粉碎成细粉,过筛;
(2)混合:
a.将步骤(1)所得原料的细粉混合均匀;
b.称取配方量的麦芽糊精、微晶纤维素、乳糖,加入步骤a所得的混合物,混匀;
(3)制粒:将步骤(2)所得的混合物制成颗粒;
(4)总混:称取配方量的硬脂酸镁,与步骤(3)所得的颗粒混合物混匀;
(5)压片:将步骤(4)所得的混合物压片,即得缓解体力疲劳的制剂。
配方中各成分的作用为:
1.牡蛎肽
牡蛎肽的主要成分是牡蛎,牡蛎为常用中药,属软体动物门(Mollusca),双壳纲(Bivalaia),珍珠贝目(Pterioida),牡蛎科(Ostreidae)。味咸、涩、微寒,归肝、肾经,具有收敛固涩、平肝潜阳、软坚散结等功效。近代研究发现,牡蛎含有丰富的糖原、牛磺酸、18种氨基酸、B族维生素、多糖、低分子活性肽、Fe、Zn、Se等矿物质和微量元素。经常食用牡蛎不仅可以增强免疫力,而且还具有降糖的功效。
2.铁皮石斛
铁皮石斛(DendrobiumofficinaleKimuraetMigo)是一种名贵的中药材,是国家重点保护濒危植物,《本草纲目》评价铁皮石斛“强阴益精、补内绝不足、长肌肉、益智除惊、轻身延年”。鹿伟等人通过研究表明铁皮石斛能显著延长小鼠负重游泳时间,降低血乳酸和肌酸激酶水平,提高运动耐力和加速消除疲劳,表明铁皮石斛具有抗疲劳作用。
3.玛咖
玛咖(LepidiummeyeniiWalp)为十字花科(Cruciferae)独行菜属(Lenidium)一年生或两年生草本植物。玛咖中含有丰富的蛋白质、氨基酸、多种矿物质、维生素、玛咖多糖、玛咖烯、玛咖酰胺等成分,经过大量研究证明,玛咖具有缓解体力疲劳、增强免疫力、抗氧化等多方面的保健功能,近年来,已引起国际保健食品领域和医药界的高度重视。
4.蛹虫草
蛹虫草(Cordycepsmilitaris)又名北冬虫夏草、北虫草,是一种能寄生在鳞翅目昆虫幼虫及蛹上的虫菌复合体。赵学敏在《本草纲目拾遗》中把虫草类的药用归之为“能治百虚百损”。多年来的研究表明,蛹虫草含有腺苷、虫草素、虫草酸、多糖等多种有效成分,在增强机体免疫力、巨噬细胞的活性,抗炎、抗癌、抗菌、抗衰老、降血脂、防止动脉硬化、保护心脑组织,镇静催眠等方面都有良好功效。
5.淫羊藿
淫羊藿(Epimediumsagittatum)又称仙灵脾,性味辛、甘、温,归肝、肾经,具有补肾壮阳,坚筋骨,助阳益精,强心力等功效。淫羊藿含有多种生理活性化学成分,主要包括黄酮类化合物、生物碱、多糖、木脂素、及某些必需微量元素等。淫羊藿也是缓解运动性疲劳、提高运动能力的中药类的研究热点,具有调节机体免疫功能、扩张血管、增加冠脉流量、耐缺氧、预防心肌缺血的促进造血***功能等功效。
6.肉苁蓉
肉苁蓉,学名(CistanchedeserticolaMa),别名疆芸、寸芸、苁蓉。素有"沙漠人参"之美誉,具有极高的药用价值,是中国传统的名贵中药材。肉苁蓉味甘、性温,具有补肾壮阳、填精补髓、养血润燥、悦色延年等功效。肉苁蓉药食两用,长期食用可增加体力、增强耐力以及抵抗疲劳,同时又可以增强人类及动物的性能力及生育力。
7.巴戟天
巴戟天为茜草科植物巴戟天(Morindaofficinalishow)的干燥根。近代研究表明,巴戟天具有补肾阳、强筋骨、去风湿的功效,用于阳痿遗精、宫冷***、***、少腹冷痛、风湿痹痛、筋骨痿软。
8.海参
海参属海参纲(Holothuroidea),是重要的海洋食物和药物资源,含有多种生物活性成分,如多糖、腺苷、多肽及蛋白质和脂类等,具有增强免疫力、抗凝血、镇痛、抗肿瘤、抗真菌、抗病毒、抗衰老和抗疲劳等生理功能。
9.黄精
黄精是我国常用的中药材,为百合科(Liliaceae)黄精属(Polygonatum)多年生草本植物根茎的总称。其性味甘、平、归脾、肺、肾经,具补肾益精、滋阴润燥之功,用于滋补强身和治疗肾虚精亏,肺虚燥咳以及脾胃虚弱之证。
本发明的有效效果是:
(1)本发明提供的产品为天然的保健食品,根据传统中医理论对体力疲劳的治疗原则,并结合大量的功能文献及临床文献,筛选了具有缓解体力疲劳的中药原料,切中体力疲劳患者气血、津液亏损、脏腑功能失调的病因病机,促进阴阳平衡、气血调和、脏腑功能协调,达到缓解体力疲劳的功效,且作用持久,原料来源广泛、质量可靠、价格实惠。
(2)所用原料均为安全的保健食品原料,生产工艺符合食品卫生相关要求,因此本发明产品食用安全,无任何毒副作用,可长期食用。
(3)本产品所用原料均是***、国家食品药品监督管理局批准认可使用的保健食品原料,用量上主要参考《中华人民共和国药典》和相关政策法规的要求,且各原料无任何配伍禁忌,十分安全。
(4)经过动物试验证明,本发明提供的组合物无毒性、具有缓解体力疲劳的功效。
具体实施方式
实施例1制备缓解体力疲劳的组合物及其制剂
制备各组分重量份数比如表1所示的缓解体力疲劳的组合物及其制剂,制备方法按照如下步骤操作:
(1)预处理:取配方量的牡蛎肽、铁皮石斛、玛咖、蛹虫草、淫羊藿、肉苁蓉、巴戟天、海参、黄精,粉碎成细粉,过80目筛;
(2)混合:
a.将步骤(1)所得原料直接加入到混合机内混合15min;
b.称取配方量的麦芽糊精、微晶纤维素、乳糖分别过80目筛,再将过筛后的麦芽糊精、微晶纤维素、乳糖及步骤a所得的混合物直接加入到混合机内混合15min;
(3)制粒:将步骤(2)所得的最后的混合物通过制粒机制成颗粒,再通过16目筛;
(4)总混:称取配方量的硬脂酸镁过80目筛,再将过筛后的硬脂酸镁和步骤(3)所得的混合物加入到混合机内混合15min;
(5)压片:将步骤(4)所得的混合物压片,每片的重量为0.5g/片,控制每片的重量误差≤5%;
(6)内包装,检验,外包装即得产品。
表1本发明缓解体力疲劳的组合物及其制剂的配方
实施例2本发明制剂药效动物实验
1.材料和方法
1.1样品
样品为实施例1制得的样品3,试验时样品通过蒸馏水溶解稀释。
1.2实验动物及饲养
SPF级雄性KM小鼠,体重18g~22g,由成都达硕生物科技有限公司提供(动物合格证号:SCXK(川)2008-24号)。饲养条件:屏蔽级动物房(许可证号:SYXK(川)2011-011号)。
1.3主要仪器与试剂
SBA-生物传感分析仪、UNICO-7200型分光光度计、匀浆机、离心机、电子天平。
1.4实验方法
将实验动物按体重随机分为空白对照组和三个样品实验组。受试物剂量分别为467mg/kg.bw、933mg/kg.bw、1400mg/kg.bw(分别相当于人体推荐摄入量的10、20、30倍)。灌胃液配制:称取1.4g、2.8g、4.2g样品,分别溶于60mL蒸馏水中,按20mL/kg.bw灌胃。空白对照组动物以蒸馏水灌胃,各实验组动物以相应剂量的样品,每日一次,连续灌胃30天后分别进行以下实验。
1.4.1负重游泳实验
末次给予受试物30min后,将尾根部负荷5%体重铅皮的小鼠置于游泳箱中游泳。箱中水深不少于30cm,水温25℃±1℃,记录小鼠自游泳开始至死亡的时间。
1.4.2血乳酸测定
末次给予受试物30min后,将动物置温度为30℃的水中不负重游泳10min,并于游泳前、游泳后立即、游泳后休息20min各采眼球血20uL测定乳酸含量。并按以下公式计算乳酸曲线下面积,以判断运动后血乳酸变化情况。
血乳酸曲线下面积=5×(游泳前血乳酸值+3×游泳后0min血乳酸值+2×游泳后休息20min血乳酸值)
1.4.3血清尿素氮测定
末次给予受试物30min后,将小鼠置温度为30℃的水中不负重游泳90min,休息60min后采眼球血0.5mL,血凝固后取血清用二乙酰—肟法测定血清尿素氮含量。
1.4.4肝糖原测定
末次给予受试物30min后处死动物,取肝脏经生理盐水漂洗后用滤纸吸干后置于冰面上的平皿内,迅速称取肝脏100mg,测定肝糖原含量(蒽酮法)。
1.5实验数据统计
实验数据用PEMSforWindows3.1统计软件包进行方差分析,方差不齐者用秩和检验统计。
2结果
2.1样品对小鼠体重的影响:见表2~表5。
表2~表5显示,各组小鼠实验开始、实验中期体重和实验结束时体重无显著性差异。
表2样品对小鼠体重的影响(体重游泳实验)
**与空白对照组比较,P<0.01
表3样品对小鼠体重的影响(血乳酸测定)
*与空白对照组比较,P<0.05**与空白对照组比较,P<0.01
表4样品对小鼠体重的影响(尿素氮测定)
表5样品对小鼠体重的影响(肝糖原测定)
2.2样品对小鼠负重游泳时间的影响:结果见表6。
如表6所示,样品三个剂量组小鼠负重游泳时间显著长于空白对照组(P<0.05)。
表6样品对小鼠负重游泳时间的影响
***与空白对照组比较,P<0.05
2.3样品对小鼠血乳酸含量的影响:见表7。
表7样品对小鼠血乳酸含量的影响
如表7所示,样品933mg/kg.bw剂量组三个时点血乳酸曲线下面积低于空白对照组(P<0.05)。
2.4样品对小鼠肝糖原含量的影响:见表8。
如表8所示,样品三个剂量组肝糖原含量与空白对照组相比无显著性差异。
表8样品对小鼠肝糖原含量的影响
2.5样品对小鼠血清尿素氮含量的影响:见表9。
如表9所示,样品933mg/kg.bw剂量组血清尿素氮含量低于空白对照组(P<0.05)。
表9样品对小鼠血清尿素氮含量的影响
3结论
采用SPF级雄性KM小鼠,样品按人体剂量的10、20、30倍连续灌胃30天,结果表明:本发明三个剂量组小鼠负重游泳时间显著长于空白对照组(P<0.01),933mg/kg.bw剂量组三个时点血乳酸下面积低于空白对照组(P<0.05),933mg/kg.bw剂量组血清尿素氮含量低于空白对照组(P<0.05)。依据评价标准,本发明具有缓解体力疲劳功能。
本申请人经过长期研究,发现将特定量的牡蛎肽、铁皮石斛、玛咖、蛹虫草、淫羊藿、肉苁蓉、巴戟天、海参、黄精为主要原料制成的组合物及其制剂,无毒副作用,且具有优异的缓解体力疲劳的功能。并且根据保健食品功能学检验的相关规定,参照***《保健食品检验与评价技术规范》2003版所述的抗疲劳作用要求进行动物试验,采用SPF级雄性KM小鼠,本发明按人体推荐剂量的10、20、30倍连续灌胃30天,实验结束后测定小鼠负重游泳时间、肝糖原、血乳酸和尿素氮。结果表明,本发明三个剂量组小鼠负重游泳时间显著长于空白对照组,933mg/kg.bw剂量组三个时点血乳酸下面积低于空白对照组,933mg/kg.bw剂量组血清尿素氮含量低于空白对照组。依据评价标准,本发明具有缓解体力疲劳功能。
Claims (5)
1.一种缓解体力疲劳的组合物,其特征在于,主要由下述重量份的原料制得:牡蛎肽8~12份、铁皮石斛7~12份、玛咖6~10份、蛹虫草4~8份、淫羊藿3~7份、肉苁蓉3~7份、巴戟天3~6份、海参2~5份、黄精1~5份。
2.如权利要求1所述的缓解体力疲劳的组合物,其特征在于,主要由下述重量份的原料制得:牡蛎肽9~11份、铁皮石斛7~10份、玛咖8~10份、蛹虫草4~7份、淫羊藿3~6份、肉苁蓉4~6份、巴戟天3~6份、海参3~5份、黄精2~5份。
3.一种权利要求1或2所述的缓解体力疲劳的组合物的制剂,其特征在于,该制剂由所述组合物和药学上可接受的载体组成。
4.如权利要求3所述的缓解体力疲劳的组合物的制剂,其特征在于,所述载体包括下述重量份的原料:硬脂酸镁0.5~1.5份、麦芽糊精13~17份、微晶纤维素10~15份、乳糖15~20份。
5.一种如权利要求4所述的制剂的制备方法,其特征在于,包括如下步骤:
(1)预处理:取配方量的牡蛎肽、铁皮石斛、玛咖、蛹虫草、淫羊藿、肉苁蓉、巴戟天、海参、黄精,粉碎成细粉,过筛;
(2)混合:
a.将步骤(1)所得原料的细粉混合均匀;
b.称取配方量的麦芽糊精、微晶纤维素、乳糖,加入步骤a所得的混合物,混匀;
(3)制粒:将步骤(2)所得的混合物制成颗粒;
(4)总混:称取配方量的硬脂酸镁,与步骤(3)所得的颗粒混合物混匀;
(5)压片:将步骤(4)所得的混合物压片,即得缓解体力疲劳的制剂。
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