CN113633657B - 一种提高机体抗疲劳、耐缺氧、耐热和耐寒能力的药物组合物及其应用 - Google Patents
一种提高机体抗疲劳、耐缺氧、耐热和耐寒能力的药物组合物及其应用 Download PDFInfo
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- CN113633657B CN113633657B CN202110500385.8A CN202110500385A CN113633657B CN 113633657 B CN113633657 B CN 113633657B CN 202110500385 A CN202110500385 A CN 202110500385A CN 113633657 B CN113633657 B CN 113633657B
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Abstract
本发明涉及一种提高机体抗疲劳、耐缺氧、耐热和耐寒能力的药物组合物及其应用，所述药物组合物由人参皂苷Rh2与枸杞多糖组成，所述人参皂苷Rh2与枸杞多糖的重量比为1:30～1:1500。本发明通过药效学研究发现一定比例组合范围内的人参皂苷Rh2和枸杞(枸杞子)多糖的组合物具有比较明显的抗疲劳以及提高耐缺氧、耐寒和耐热能力的作用，且较人参皂苷Rh2或枸杞多糖单用具有协同增效的作用。本发明所涉及组合物配以适当的药用和食用辅料，可应用于医药和保健品种。
Description
技术领域
本发明涉及药物技术领域，具体地说，涉及人参皂苷Rh2和枸杞(枸杞子)多糖的组合物在抗疲劳以及提高耐缺氧、耐寒和耐热功能上的应用。较单独与人参皂苷Rh2和枸杞多糖相比，具有协同增效的作用。
背景技术
人们在日常生活和生产过程中不可避免地遇到工作能力下降的现象，我们将这种现象称为疲劳，在1982年第5届国际运动生物化学会议上人们将运动型疲劳定义为：“机体的生理过程不能维持其机能在一特定水平和/或不能维持其预定的运动强度”[Allen DG,Lamb GD,Westerblad H.Skeletal Muscle Fatigue:Cellular Mechanisms,Physiological Reviews,2008,88:287-332.]。随着社会竞争的日趋激烈，生活节奏的加快，工作压力的增大，疲劳症的发病率呈现日益增高的趋势。疲劳虽然不像癌症、心血管疾病那样直接危及到人们的生命，但可严重影响人类的生活质量。长期的疲劳会使机体处于一种亚健康的状态，这种亚健康主要表现为疲劳、活力减退、免疫力降低等[Yu-Xiang Yan,You-Qin Liu,Man Li et al,Development and Evaluation of a Questionnaire forMeasuring Suboptimal Health Status in Urban Chinese,J Epidemiol.2009；19:333-341.]。目前缓解疲劳的方法大多通过睡眠、休养进行机体调整，另一方面依靠外在物质的调整提高身体机能。但目前缺乏有效的药物和方法，仅仅通过被动的心理调节或者给予一些提高兴奋度的药物，使绝大多数疲劳程度并没有得到缓解。现代西医药学对这种亚健康状态缺乏有效的治疗手段，而中医药在该方面积累了丰富的经验，显示出独特的优势。
人参自古是滋补强壮的良药，现代研究也显示，人参在抗疲劳中发挥了良好的作用，但是其作用的成分不详。专利200610017063.3公开了人参、咖啡、茶叶组合物的抗疲劳作用。专利200610131959.4公开了人参皂苷Rh2在抗疲劳方面的新用途，且不良反应甚微，是一种理想的抗疲劳药物。
枸杞子系茄科宁夏枸杞的干燥成熟果实，为传统中药，具有滋补强壮、益精气、祛风、壮阳、强筋骨等功能，现代科学研究证明枸杞有效成分为枸杞多糖，具有降血糖、降血脂、提高免疫、抗氧化、抗疲劳等作用。《食疗本草》上记载枸杞具有“坚筋耐劳、陈风，补益筋骨，能益人，去虚劳”的功用。其所含的多糖作为一种天然植物多糖，既具有丰富的生物活性，又无毒副作用[滕俊,袁佳,叶莎莎.枸杞子化学成分及药理作用相关性概述.海峡药学,2014,26:36-37.]，无论在临床应用还是保健类食品开发方面均具有广阔的前景。
而目前未见人参皂苷Rh2和枸杞(枸杞子)多糖联用在提高机体抗疲劳、耐缺氧、耐热和耐寒能力方面的报道。
发明内容
本发明的目的是针对现有技术中的不足，提供一种药物组合物。
本发明的第二个目的是，提供所述药物组合物的用途。
为实现上述目的，本发明采取的技术方案是：
一种药物组合物，所述药物组合物由人参皂苷Rh2与枸杞多糖组成，所述人参皂苷Rh2与枸杞多糖的重量比为1:30～1:1500。
进一步，所述人参皂苷Rh2与枸杞多糖的重量比为1:30～1:40。
进一步，所述人参皂苷Rh2与枸杞多糖的重量比为1:40。
为实现上述第二个目的，本发明采取的技术方案是：
如上任一所述药物组合物在制备抗疲劳的药物中的应用。
进一步，所述药物根据需要加入药物可接受的基质辅料制备成任何药用剂型。
进一步，所述药物的剂型为胶囊、颗粒、片剂、口服液或合剂。
进一步，所述药物可接受的基质辅料包括但不限于：羧甲基纤维素钠、甘露醇、山梨醇、焦亚硫酸钠、亚硫酸氢钠、硫代硫酸钠、盐酸半胱氨酸、巯基乙酸、蛋氨酸、维生素C、EDTA二钠、EDTA钙钠，一价碱金属的碳酸盐、醋酸盐、磷酸盐或其水溶液、盐酸、醋酸、硫酸、磷酸、氨基酸、氯化钠、氯化钾、乳酸钠、木糖醇、麦芽糖、葡萄糖、果糖、右旋糖苷、甘氨酸、淀粉、蔗糖、乳糖、甘露糖醇、硅衍生物、纤维素及其衍生物、藻酸盐、明胶、聚乙烯吡咯烷酮、甘油、土温80、琼脂、碳酸钙、碳酸氢钙、表面活性剂、聚乙二醇、环糊精、β-环糊精、磷脂类材料、高岭土、滑石粉、硬脂酸钙、硬脂酸镁。
如上任一所述的药物组合物在制备提高动物个体的耐缺氧能力的药物中的应用。
如上任一所述的药物组合物在制备提高动物个体的抗寒能力的药物中的应用。
如上任一所述的药物组合物在制备提高动物个体的抗热能力的药物中的应用。
进一步，所述动物为哺乳动物。
进一步，所述哺乳动物选自人、大鼠、小鼠、猴、狗、兔或猪。
本发明优点在于：
1、本发明的药物组合物是发明人经过大量对比试验筛选的，其中，人参皂苷Rh2虽然有较好的抗疲劳活性，但其在药材中含量较低，且价格昂贵，不适合大剂量使用，而枸杞多糖对抗疲劳作用并不显著。本发明通过人参皂Rh2与枸杞多糖的协同作用，显著降低人参皂Rh2的使用比例，降低药物成本，显著增强药物的抗疲劳活性。
2、本发明的药物组合物可以提高动物个体的耐缺氧、耐寒和耐热能力，且人参皂Rh2与枸杞多糖表现出协同作用。这对提高极端气候条件下动物个体的生存能力具有重要意义。
具体实施方式
下面结合具体实施方式，进一步阐述本发明。应理解，这些实施例仅用于说明本发明而不用于限制本发明的范围。此外应理解，在阅读了本发明记载的内容之后，本领域技术人员可以对本发明作各种改动或修改，这些等价形式同样落于本申请所附权利要求书所限定的范围。
本发明所用术语“可接受的”，指一个处方组分或活性成分对一般治疗目标的健康没有过分的有害影响。
本发明所用术语“药学上可接受”这里指一种物质，如载体或稀释液，不会使化合物的生物活性或性质消失，且相对无毒，如，给予个体某物质，不会引起不想要的生物影响或以有害的方式与任何其含有的组分相互作用。
实施例1本发明的药物组合物(一)
按重量份配比称取人参皂苷Rh2 1份、枸杞多糖10份，混合均匀。
实施例2本发明的药物组合物(二)
按重量份配比称取人参皂苷Rh2 1份、枸杞多糖20份，混合均匀。
实施例3本发明的药物组合物(三)
按重量份配比称取人参皂苷Rh2 1份、枸杞多糖40份，混合均匀。
实施例4本发明的药物组合物(四)
按重量份配比称取人参皂苷Rh2 2份、枸杞多糖10份，混合均匀。
实施例5本发明的药物组合物(五)
按重量份配比称取人参皂苷Rh2 2份、枸杞多糖20份，混合均匀。
实施例6本发明的药物组合物(六)
按重量份配比称取人参皂苷Rh2 2份、枸杞多糖40份，混合均匀。
实施例7本发明人参皂苷Rh2与枸杞多糖的胶囊剂的制备
人参皂苷Rh2 8克，枸杞多糖1600克，加乳糖羧甲基纤维素钠混匀，过80目筛，加入5％聚维酮K30的70％乙醇溶液适量制备得软材，过40目筛，制粒，装入胶囊，即得胶囊剂。
实施例8本发明人参皂苷Rh2与枸杞多糖的片剂的制备
人参皂苷Rh2 8克，枸杞多糖1600克，加乳糖羧甲基纤维素钠混匀，过80目筛，加入5％聚维酮K30的70％乙醇溶液适量制备得软材，过20目筛，再加入适量的硬脂酸镁，混合均匀，压片，得到片剂。
实施例9本发明人参皂苷Rh2与枸杞多糖的口服液的制备
吐温-80适量，人参皂苷Rh2 8克，枸杞多糖1600克，研磨制成初乳，再加水至4000ml，即得溶液(口服)。
实施例10本发明药物组合物的动物实验
1.材料
1.1实验动物
清洁级小鼠，18-20g，购自第二军医大学动物实验中心。许可证号：SCXK(沪)2013-0003。
1.2药物
人参皂苷Rh2，购自本素医药科技有限公司，含量≥99％。
枸杞多糖，购自本素医药科技有限公司，含量≥35％。
2.方法
2.1动物分组与给药
按体重随机分组，每组40只。阴性对照：溶剂对照。给药剂量：人参皂苷Rh2，1mg/Kg，2mg/Kg(R1，R2)；枸杞多糖：10mg/Kg，20mg/Kg，40mg/Kg(LBP-L，LBP-M，LBP-H)。人参皂苷Rh2+枸杞多糖：1mg/Kg+10mg/Kg，1mg/Kg+20mg/Kg，1mg/Kg+40mg/Kg(R1+LBP-L，R1+LBP-M，R1+LBP-H)；人参皂苷Rh2+枸杞多糖：2mg/Kg+10mg/Kg，2mg/Kg+20mg/Kg，2mg/Kg+40mg/Kg(R2+LBP-L，R2+LBP-M，R2+LBP-H)。
药物配制：称取一定量的人参皂苷Rh2，加入少量0.3％CMC-Na，研磨制成混悬液，并用CMC-Na稀释至所需的浓度。在人参皂苷Rh2混悬液中加入枸杞多糖配制成相应浓度的组合物。枸杞多糖分别配制成1，2，4g/L的溶液。给药方法：采用灌胃法每日以不同剂量给小鼠灌胃给药，每日1次，连续给药15天。
2.2常压耐缺氧实验
每组取出10只小鼠，在第15天末次灌胃1h后，放入盛有10g钠石灰的300mL广口瓶中，瓶盖涂以凡士林密封，使之不漏气，记录小鼠存活时间。
2.3负重游泳实验
每组取出10只小鼠，末次灌胃1h后，给小鼠尾部施加5％其自身体质量的铅皮，放置于水深30cm的玻璃游泳箱内游泳，水温保持(25±1)℃，记录小鼠的游泳存活时间。
2.4耐寒实验
每组取出10只小鼠，末次灌胃1h后，分别装入4个铁丝笼中，置于-20℃的冰箱中，以4组小鼠总数中死亡20只为界，记录每组小鼠的死亡数量。
2.5耐热实验
每组取出10只小鼠，末次灌胃1h后，分别装入4个铁丝笼中，置于50℃的烘箱中，以4组小鼠总数中死亡30只为界，记录每组小鼠的死亡数量。
2.6统计学处理
所有实验数据用SPSS11.0统计软件进行数据处理分析，计量资料以均数±标准差表示，各组间比较用t检验，以P＜0.05为差异有统计学意义。
3.结果
表1不同组合物对强迫游泳小鼠和耐缺氧小鼠的影响
注，与空白对照组比较：*:P<0.05；**:P<0.01
表2不同组合物对小鼠耐寒和耐热能力的影响
注，与空白对照组比较：*:P<0.05；**:P<0.01
实验结果如表1及表2所示。结果显示：不同剂量组合的组合物均能延长小鼠的负重游泳时间，延长小鼠的耐缺氧时间，增加小鼠在高寒和高热环境下的存活率，与空白对照组比较，有较明显的统计学意义(P<0.05或P<0.01)。
4.结论
人参皂苷Rh2和枸杞多糖组合物(参杞)具有明显延长小鼠耐缺氧时间，小鼠负重游泳时间的作用及小鼠抗寒冷与高热环境下的存活率，即表现出明显的抗疲劳作用和提高个体对极端环境适应能力的作用。本发明在实验前期还设计了对比试验，在相同给药剂量及相同实验条件下，人参皂苷Rh2与枸杞多糖组合对小鼠抗疲劳以及耐缺氧、耐寒、耐热能力的提高作用显著高于人参皂苷Rh2或枸杞多糖单独给药，说明人参皂苷Rh2与枸杞多糖组合具有显著的协同作用。
以上所述仅是本发明的优选实施方式，应当指出，对于本技术领域的普通技术人员，在不脱离本发明方法的前提下，还可以做出若干改进和补充，这些改进和补充也应视为本发明的保护范围。
Claims (2)
1.一种药物组合物在制备提高动物个体的抗寒能力的药物中的应用，其特征在于，所述药物组合物由人参皂苷Rh2与枸杞多糖组成，所述人参皂苷Rh2与枸杞多糖的重量比为1:30～1:40。
2.根据权利要求1所述的应用，其特征在于，所述人参皂苷Rh2与枸杞多糖的重量比为1:40。
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