CN107006856A - 一种增强耐力、提高抗缺氧耐受力营养剂及其制备方法 - Google Patents
一种增强耐力、提高抗缺氧耐受力营养剂及其制备方法 Download PDFInfo
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- Medicines Containing Plant Substances (AREA)
Abstract
高原反应即急性高原病,是人到达一定海拔高度后(一般指海拔高度在2700米以上),身体因为不适应海拔高度而造成的气压差、含氧量少、空气干燥、寒冷、紫外线强烈等的变化,而由此引发一系列症状和机能代谢变化的高原适应不全症。一种增强耐力、提高抗缺氧耐受力营养剂,其特征在于,该营养剂由三七、红景天、刺五加、枸杞多糖、以及可接受的辅料为原料制成。本发明所要解决的技术问题是针对现有技术的不足,一种增强耐力、提高抗缺氧耐受力营养剂及其制备方法,该营养剂能减小可验证副作用,并且效果好。
Description
技术领域
本发明涉及一种增强耐力、提高抗缺氧耐受力营养剂及其制备方法,属于食品领域。
背景技术
高原反应即急性高原病(acute high altitude disease,AHAD),是人到达一定海拔高度后(一般指海拔高度在2700 米以上),身体因为不适应海拔高度而造成的气压差、含氧量少、空气干燥、寒冷、紫外线强烈等的变化,而由此引发一系列症状和机能代谢变化的高原适应不全症。出现高原反应者通常在24h 内出现头疼、头晕、眼花、耳鸣、心慌、气促、全身乏力、行走困难、难以入睡等症状,表现出心率加快、呼吸加深、血压轻度异常、颜面或四肢水肿,口唇紫绀等体征。
目前对高原反应的研究也是本领域具有创新性的课题,现有技术对近年来国内外对高原反应的防治研究进展进行总结(左玉梅,李宁. 高原反应的防治进展 [J]. 中国现代医生,2010, 48(30):12-13.),进入高海拔地区前预防的手段主要有体检、阶梯性适应训练、体能锻炼、高原预适应等方法。通过体检预先排除患有慢性阻塞性肺病、间质性肺病、各种呼吸功能不全、器质性心脏病、脑血管疾病、高血压病、严重贫血、胃肠道疾病、神经与精神性疾病、严重慢性疾病等不宜上高海拔地区的患者,上述患者是高原反应的易感人群;而轻症患者如要进入高原,也最好随身携带氧气及药物,做好预防准备。通过阶梯性适应训练使机体增加对缺氧的耐受力和适应力,一方面减少高原反应发生的几率,一方面也可以在部分体质较弱者高原反应初期给予及时的诊治,不至于造成严重的后果,这也是防治高原反应最有效的手段之一,但通常难以保证每个人都得到充足的适应时间;通过体能训练增强体质,改善机体呼吸循环功能,增加呼吸循环储备,增加对高海拔环境的适应力;通过高原预适应营造机体预缺氧环境,对高海拔地区更持久更严重的缺氧环境造成的损伤发挥有效的保护作用,其机制可能是预缺氧可诱导组织、细胞缺氧诱导因子-1(HIF-1)等转录因子活性增强,从而影响一系列胞内蛋白质的表达,从而产生抗缺氧的耐受能力。
近年来,对于高原反应防治的研究在药物使用方面进展迅速(李鑫,巩江,赵兵等.抗高原反应药物研究概况 [J]. 辽宁中医药大学学报,2013,15(3):113-115),抗高原反应药物主要分为中草药、藏药、西药和中西药结合药物等。国内研究和使用的预防高原病、提高机体抗缺氧耐力的药物有许多,大多以中草药为主。近年来,中药和藏药对于急性高原病的防治研究都取得了很大的进展。其大多由天然植物组成,有着疗效确切、毒副作用小和经济实用等优势。西药方面,开发出了经典药物更加广泛的用途,对乙酰唑胺、磷酸二酯酶抑制剂、沙美特罗等药物的疗效也进行了更为普遍的研究,但是西药制剂具有一定的副作用,如偶有面色潮红、站立头晕等反应。对天然药物的研究大多重在阐明单方作用机理,以期为药品研究提供理论支撑与基础研究,对天然药物联合应用研究比较薄弱,市场也未见相关产品,尤其是药食同源类天然药物产品也鲜有问世。
为了减少通常生活在低海拔地区的人群进入高海拔地区的不适应症状,尽可能保障其生命健康和行动力,本发明提供一种增强耐力、提高抗缺氧耐受力营养剂,以降低高原反应的发生几率。
发明内容
本发明所要解决的技术问题是针对现有技术的不足,一种增强耐力、提高抗缺氧耐受力营养剂及其制备方法,该营养剂能减小可验证副作用,并且效果好。
本发明所要解决的另一个技术问题是针对现有技术的不足,提出了上述药物的制备方法。
本发明所要解决的技术问题是通过以下的技术方案来实现的。一种增强耐力、提高抗缺氧耐受力营养剂,其特征在于,该营养剂由三七、红景天、刺五加、枸杞多糖、以及可接受的辅料为原料制成。
本发明所要解决的技术问题还可以通过以下的技术方案来进一步实现。以上所述的营养剂,其特征在于,其中各原料的重量配比是,三七200-320份,红景天150-300份,刺五加150-300份,枸杞多糖1.3-2.0份,可接受的辅料200-300份。
本发明所要解决的技术问题还可以通过以下的技术方案来进一步实现。以上所述的营养剂,其特征在于,所述三七、红景天、刺五加分别为其提取物。
本发明所要解决的技术问题还可以通过以下的技术方案来进一步实现。以上所述的营养剂,其特征在于,其中各原料的重量配比是,三七提取物10-20份,红景天提取物15-25份,刺五加提取物15-25份,枸杞多糖1.3-2.0份,可接受的辅料100-200份。
本发明所要解决的技术问题还可以通过以下的技术方案来进一步实现。以上所述的营养剂的制备方法,其特征在于,所述三七提取物的制备步骤如下:取三七,粉碎,加水8-12倍量煎煮1-3次,每次1-3小时,滤过,合并滤液,减压浓缩至相对密度1.15-1.20,加乙醇至含醇量60-80%,静置20-30小时,滤过,减压回收乙醇至无醇味,过滤,滤液上大孔树脂吸附,用50-70%乙醇洗脱,收集洗脱液,回收乙醇,浓缩至稠膏状,干燥,即得三七提取物。
本发明所要解决的技术问题还可以通过以下的技术方案来进一步实现。以上所述的营养剂的制备方法,其特征在于,所述红景天提取物的制备步骤如下:所述红景天提取物的制备步骤如下:取红景天,粉碎,加40~80%乙醇在60~70℃温浸提取,滤过,减压回收乙醇,浓缩,浓缩液通过D101大孔吸附树脂吸附,用去离子水冲洗至流出液无色,用稀乙醇洗脱,收集洗脱液,回收乙醇,减压浓缩,干燥,得红景天提取物。
本发明所要解决的技术问题还可以通过以下的技术方案来进一步实现。以上所述的营养剂的制备方法,其特征在于,所述刺五加提取物的制备步骤如下:取刺五加,粉碎,加8-20倍水煎煮提取1-3次,每次1-3小时,过滤,合并滤液,减压浓缩至相对密度为1.15-1.20,过 D140大孔树脂,用30~95%乙醇洗脱,减压浓缩、干燥,得到刺五加提取物。
本发明所要解决的技术问题还可以通过以下的技术方案来进一步实现。以上所述的营养剂的质量检测方法,其特征在于,制成的营养剂中指标性成分以三七总皂苷、红景天苷、刺五加苷B、总多糖计,含量之和大于25%。
本发明所要解决的技术问题还可以通过以下的技术方案来进一步实现。以上所述的营养剂在制备增强耐力、提高抗缺氧耐受力产品中的用途。
本发明所要解决的技术问题还可以通过以下的技术方案来进一步实现。以上所述的营养剂在制备预防高原反应产品中的用途。
在上述的几项制备方法中,所述的原料三七、红景天、刺五加可以粉碎为粗粉,也可以是其它的形态,但是为了便于提取其中的有效成份,优选的方法是将原料粉碎为粗粉。
本发明的可接受的辅料,所述辅料可选自崩解剂、粘合剂、润滑剂、填充剂中的一种或几种混合。其中填充剂优选为预胶化淀粉、淀粉、糊精、甘露醇、微晶纤维素、碳酸钙、磷酸氢钙、轻质氧化镁中的一种或几种混合;润滑剂优选为硬脂酸钙、硬脂酸镁、滑石粉或聚乙二醇中的一种或几种混合;崩解剂优选为干淀粉、交联羧甲基纤维素钠、微晶纤维素中的一种或几种混合;粘合剂优选为淀粉浆、糊精、纤维素及其衍生物的一种或几种混合;油类如制大豆油、花生油、橄榄油的一种或几种的混合物;防腐剂如苯甲酸、枸橼酸、维生素C等;优选添加剂用量为0-80%。优选崩解剂用量为0.5%-5%,更优选为0.8%-2%,特别优选为1.0%-1.5%。优选润滑剂用量为0.3%-1.0%,更优选为 0.5%-0.9%。油类用量0-80%,优选20-50%。填充剂用量视制剂规格而定,粘合剂用量视具体生产中颗粒的流动性以及崩解情况而定。
本发明所使用的药物中,三七为五加科植物三七的干燥根和根茎。性温,味甘、微苦,归肝、胃、心、小肠经。具有止血、散瘀、消肿、止痛、补虚、强壮等功效,三七是一味名贵中药,李时珍在《本草纲目》中称其为“金不换”,临床上用于治疗多种疾病。三七用于日常保健可以追溯到唐代,现多以低于临床的剂量用于保健品的开发。三七块根含三七皂甙A(arasaponin A)、三七皂甙B(arasaponin B),二者水解后分别生成皂甙元A,皂甙元B及一分子葡萄糖。三七块根除含有皂甙外,尚含有生物碱和黄酮甙。三七叶含皂甙,水解后其皂甙元以人参二醇较多,可明显检出有齐墩果酸,但人参三醇含量极少。三七块根流浸膏能缩短家兔血液凝固时间,有止血作用;能增加冠状动脉血流量,减慢心率,减少心肌氧消耗的作用;并能对抗因脑垂体后叶素所致的血压升高、冠状动脉收缩的作用;三七灌胃能促进小白鼠肝糖元的积累。此外,三七尚有一定毒性,三七皂甙给猴等物静注,有溶血作用,对小鼠静注其半数致死量为460毫克/公斤。
红景天(Rhodiola)是名贵珍稀的药用植物,大多数生长在海拔3500~5000 米的高地,其作为传统藏药已有千年历史,被誉为“高原人参”。在二十世纪中期,前苏联科学家布列赫曼研究发现,红景天具有“适应原样作用”,为红景天的药用价值提供了强有力的科学依据。现代药理学研究证明红景天能显著提高人体的缺氧耐受力,且副作用很小。红景天的药理活性成分主要为红景天苷(Salidroside)及其苷元酪醇(P-Tyrosol),还有酪萨维(Rosavin 或Rosavidine)、超氧化物歧化酶(SOD)、二苯甲基六氢吡啶(Pyridrde)、红景天素即草质素-7-O-(3-O-β-D 吡喃葡萄糖基)-α-L-吡喃鼠李糖苷(Rhodiosin)和草质素-7-O-α-L-吡喃鼠李糖苷(Rhodionin)。这些活性成分使红景天具有耐缺氧、抗疲劳、抗氧化等功能,从而实现改善心血管系统功能、增强脑机能、增强免疫力、保护器官免受自由基损伤等的药理作用。
刺五加为五加科植物刺五加的干燥根和根茎或茎。辛、微苦,温。归脾、肾、心经。益气健脾,补肾安神。用于脾肾阳虚,体虚乏力,食欲不振,腰膝酸痛,失眠多梦。刺五加的主要化学成分为苷类化合物、多糖和黄酮,还含有香豆素、脂肪酸、挥发油、氨基酸及微量元素等。刺五加根和根茎中主要含有苷类物质,分别为胡萝卜苷A,紫丁香酚苷B,7-羟基-6,8-二甲基香豆精葡萄糖苷B1,乙基半乳糖苷C,紫丁香树脂酚二糖苷D和E,L-芝麻酯素,刺五加多糖ASP-2-1等,此外刺五加叶中存在槲皮苷、金丝桃苷、槲皮素和芦丁等黄酮类成分和Ca、Cu、Mg、Fe、Zn、K、Mn、Na等种矿物质元素。刺五加可增强机体非特异性防御能力,不仅能够调节机体免疫力,具有抗肿瘤,抗辐射,抗疲劳等作用,还能治疗糖尿病,心血管疾病和神经衰弱等症状。刺五加提取物可使脑梗死体积减少,抑制脑缺血炎症和神经胶质活性起到保护神经作用,刺五加皂甙能明显提高衰老神经细胞活性,增强细胞膜的稳定性,降低乳酸脱氢酶活性,使神经细胞损伤明显减轻,延缓神经元细胞的衰老。刺五加注射液可延长常压和低压缺氧条件下小鼠的存活时间,降低心肌耗氧,提高应激能力,保护缺氧心肌。
枸杞多糖是由多糖或蛋白质和酸性杂多糖构成。枸杞多糖的总含量大约占枸杞子重量的3.36%。枸杞在祖国的传统医学中具有重要的地位,其药用价值备受历代医家的推崇。它是传统名贵中药材和营养滋补品。枸杞子能够有效抑制癌细胞的生成,可用于癌症的防治。枸杞除了当中药使用外,也是国家卫生部规定的既是食品又是药品的物品。枸杞作为药品其应用已相当广泛。枸杞多糖在体外可以直接清除羟自由基并能抑制自发或由羟自由基引发的脂质过氧化反应。灌服枸杞多糖能提高D-半乳糖致衰老小鼠体内谷胱甘肽过氧化物酶(GSH-Px)和超氧化物歧化酶(SOD)活性,从而可以清除过量的自由基,起到延缓衰老的作用。其能明显增强受损胰岛细胞内SOD的活性,提高了胰岛细胞的抗氧化能力,减轻了过氧化物对细胞的损伤,降低了丙二醛生成量;枸杞多糖对高血脂症兔的血脂有明显影响,能显著降低血清胆固醇(TC)及甘油三脂(TG)含量;枸杞多糖对机体细胞具有较强的保护作用并能使受损细胞恢复正常功能。枸杞多糖除了有以上作用外,研究表明枸杞多糖还具有保护生殖系统、保肝、抗辐射和促进发育等作用。
本发明所公开的组合药物也符合中医药理论,其中,三七活血散瘀,增加冠脉流量,减慢心率,降低机体耗氧量,为君药;红景天有显著的抗缺氧、抗寒冷、抗疲劳等作用,可增强君药治疗主症的效果,此外其还能保护器官免受自由基影响,为臣药;刺五加与枸杞多糖除能抗疲劳增强君药治疗作用外,其所含微量元素和氨基酸类成分还能调节机体免疫能力,还能佐制三七溶血作用,降低其副作用。在本发明的各组分相辅相成,既能发挥各自的作用,同时也可以促进其它药物的药效作用的发挥,配伍使用起到相使、相畏协同作用,是一种新的增强耐力、提高抗缺氧耐受力营养剂。
与现有技术相比,本发明的药物及其制备方法具有以下优点:
一、 本发明药物是一种新的增强耐力、提高抗缺氧耐受力营养剂,它具有疗效高、见效快、副作用小等优点。
二、在制备工艺中采用醇沉与大孔树脂吸附等工艺,所得提取物浸膏有效成分含量高。
三、各原料配伍使用具有协同增效、减少副作用的效果。
四、各原料均为常规药材,来源丰富,简单易的,制备工序简单,易于生产。
具体实施方式
下面的实施例是为让本领域技术人员进一步地理解本发明,而不是对本发明权利的限制。
实施例1
一种增强耐力、提高抗缺氧耐受力营养剂,其中各原料及重量配比是,三七200份,红景天150份,刺五加150份,枸杞多糖1.3份,可接受的辅料200份。
用常规的方法,将其加水进行煎煮,提取出其中的有效成份,加入常规的药用辅料,制成软胶囊制剂。
实施例2
一种增强耐力、提高抗缺氧耐受力营养剂,其中各原料及重量配比是,三七320份,红景天300份,刺五加300份,枸杞多糖2.0份,可接受的辅料300份。
用常规的方法,将其加水进行煎煮,提取出其中的有效成份,加入常规的药用辅料,制成软胶囊制剂。
实施例3
一种增强耐力、提高抗缺氧耐受力营养剂,其中各原料及重量配比是,三七280份,红景天200份,刺五加220份,枸杞多糖1.5份,可接受的辅料300份。
用常规的方法,将其加水进行煎煮,提取出其中的有效成份,加入常规的药用辅料,制成软胶囊制剂。
实施例4
一种增强耐力、提高抗缺氧耐受力营养剂,其中各原料及重量配比是,三七220份,红景天280份,刺五加260份,枸杞多糖1.8份,可接受的辅料260份。
用常规的方法,将其加水进行煎煮,提取出其中的有效成份,加入常规的药用辅料,制成软胶囊制剂。
实施例5
一种增强耐力、提高抗缺氧耐受力营养剂,其中各提取物的制备方法如下:
(1)三七提取物的制备步骤如下:取三七,粉碎,加水8倍量煎煮1次,每次1小时,滤过,合并滤液,减压浓缩至相对密度1.15-1.20,加乙醇至含醇量60%,静置20小时,滤过,减压回收乙醇至无醇味,过滤,滤液上大孔树脂吸附,用50-60%乙醇洗脱,收集洗脱液,回收乙醇,浓缩至稠膏状,干燥,即得三七提取物。
(2)红景天提取物的制备步骤如下:取红景天,粉碎,加40%乙醇在60℃温浸提取,滤过,减压回收乙醇,浓缩,浓缩液通过D101大孔吸附树脂吸附,用去离子水冲洗至流出液无色,用稀乙醇洗脱,收集洗脱液,回收乙醇,减压浓缩,干燥,得红景天提取物。
(3)刺五加提取物的制备步骤如下:取刺五加,粉碎,加8倍水煎煮提取1次,每次1小时,过滤,合并滤液,减压浓缩至相对密度为1.15-1.20,过D140大孔树脂,用30~80%乙醇洗脱,减压浓缩、干燥,得到刺五加提取物。
实施例6
一种增强耐力、提高抗缺氧耐受力营养剂,其中各提取物的制备方法如下:
(1)三七提取物的制备步骤如下:取三七,粉碎,加水12倍量煎煮3次,每次3小时,滤过,合并滤液,减压浓缩至相对密度1.15-1.20,加乙醇至含醇量80%,静置30小时,滤过,减压回收乙醇至无醇味,过滤,滤液上大孔树脂吸附,用60-70%乙醇洗脱,收集洗脱液,回收乙醇,浓缩至稠膏状,干燥,即得三七提取物。
(2)红景天提取物的制备步骤如下:取红景天,粉碎,加80%乙醇在70℃温浸提取,滤过,减压回收乙醇,浓缩,浓缩液通过D101大孔吸附树脂吸附,用去离子水冲洗至流出液无色,用稀乙醇洗脱,收集洗脱液,回收乙醇,减压浓缩,干燥,得红景天提取物。
(3)刺五加提取物的制备步骤如下:取刺五加,粉碎,加20倍水煎煮提取3次,每次3小时,过滤,合并滤液,减压浓缩至相对密度为1.15-1.20,过D140大孔树脂,用50~70%乙醇洗脱,减压浓缩、干燥,得到刺五加提取物。
实施例7
一种增强耐力、提高抗缺氧耐受力营养剂,其中各提取物的制备方法如下:
(1)三七提取物的制备步骤如下:取三七,粉碎,加水10倍量煎煮3次,每次2小时,滤过,合并滤液,减压浓缩至相对密度1.15-1.20,加乙醇至含醇量75%,静置24小时,滤过,减压回收乙醇至无醇味,过滤,滤液上大孔树脂吸附,用55-65%乙醇洗脱,收集洗脱液,回收乙醇,浓缩至稠膏状,干燥,即得三七提取物。
(2)红景天提取物的制备步骤如下:取红景天,粉碎,加65%乙醇在60℃温浸提取,滤过,减压回收乙醇,浓缩,浓缩液通过D101大孔吸附树脂吸附,用去离子水冲洗至流出液无色,用30-50%乙醇洗脱,收集洗脱液,回收乙醇,减压浓缩,干燥,得红景天提取物。
(3)刺五加提取物的制备步骤如下:取刺五加,粉碎,加12倍水煎煮提取3次,每次2小时,过滤,合并滤液,减压浓缩至相对密度为1.15-1.20,过D140大孔树脂,用40-80%乙醇洗脱,减压浓缩、干燥,得到刺五加提取物。
实施例8
一种增强耐力、提高抗缺氧耐受力营养剂,其中各提取物的制备方法如下:
(1)三七提取物的制备步骤如下:取三七,粉碎,加水10倍量煎煮2次,每次2小时,滤过,合并滤液,减压浓缩至相对密度1.15-1.20,加乙醇至含醇量60-80%,静置24小时,滤过,减压回收乙醇至无醇味,过滤,滤液上大孔树脂吸附,用50-60%乙醇洗脱,收集洗脱液,回收乙醇,浓缩至稠膏状,干燥,即得三七提取物。
(2)红景天提取物的制备步骤如下:取红景天,粉碎,加70%乙醇在70℃温浸提取,滤过,减压回收乙醇,浓缩,浓缩液通过D101大孔吸附树脂吸附,用去离子水冲洗至流出液无色,用40-50%乙醇洗脱,收集洗脱液,回收乙醇,减压浓缩,干燥,得红景天提取物;
(3)刺五加提取物的制备步骤如下:取刺五加,粉碎,加12倍水煎煮提取2次,每次2小时,过滤,合并滤液,减压浓缩至相对密度为1.15-1.20,过D140大孔树脂,用30~40%乙醇洗脱,减压浓缩、干燥,得到刺五加提取物。
实施例9
一种增强耐力、提高抗缺氧耐受力营养剂的制备方法如下:
取上述实施例7制备所得三七提取物、红景天提取物、刺五加提取物,其重量配比分别为三七提取物10份,红景天提取物15份,刺五加提取物15份,枸杞多糖1.3份,可接受的辅料100份。取上述提取物,加入200g精制大豆油、花生油、橄榄油混合物,可接受的辅料,混匀,按照软胶囊制备方法压制成软胶囊。
实施例10
一种增强耐力、提高抗缺氧耐受力营养剂的制备方法如下:
取上述实施例7制备所得三七提取物、红景天提取物、刺五加提取物,其重量配比分别为三七提取物14份,红景天提取物20份,刺五加提取物20份,枸杞多糖1.3份,可接受的辅料160份。取上述提取物,加入200g精制大豆油、花生油、橄榄油混合物,可接受的辅料,混匀,按照软胶囊制备方法压制成软胶囊。
实施例11
一种增强耐力、提高抗缺氧耐受力营养剂的制备方法如下:
取上述实施例7制备所得三七提取物、红景天提取物、刺五加提取物,其重量配比分别为三七提取物20份,红景天提取物25份,刺五加提取物25份,枸杞多糖2.0份,可接受的辅料200份。取上述提取物,加入200g精制大豆油、花生油、橄榄油混合物,可接受的辅料,混匀,按照软胶囊制备方法压制成软胶囊。
实施例12
一种增强耐力、提高抗缺氧耐受力营养剂的制备方法如下:
取上述实施例7制备所得三七提取物、红景天提取物、刺五加提取物,其重量配比分别为三七提取物18份,红景天提取物20份,刺五加提取物24份,枸杞多糖1.8份,可接受的辅料180份。取上述提取物,加入200g精制大豆油、花生油、橄榄油混合物,可接受的辅料,混匀,按照软胶囊制备方法压制成软胶囊。
为验证4种有效组分之间协同作用,在实施例12的基础上,设置对照实验组,具体为实施例13-16,每一组实施例中,依次减去三七提取物、红景天提取物、刺五加提取物和枸杞多糖,相应的改变可接受辅料的量,使其他成份单位百分含量保持不变,具体如下:
实施例13
一种增强耐力、提高抗缺氧耐受力营养剂的制备方法如下:
取上述实施例7制备所得红景天提取物、刺五加提取物,其重量配比分别为红景天提取物20份,刺五加提取物24份,枸杞多糖1.8份,可接受的辅料198份。取上述提取物,加入200g精制大豆油、花生油、橄榄油混合物,可接受的辅料,混匀,按照软胶囊制备方法压制成软胶囊。
实施例14
一种增强耐力、提高抗缺氧耐受力营养剂的制备方法如下:
取上述实施例7制备所得三七提取物、刺五加提取物,其重量配比分别为三七提取物18份,刺五加提取物24份,枸杞多糖1.8份,可接受的辅料200份。取上述提取物,加入200g精制大豆油、花生油、橄榄油混合物,可接受的辅料,混匀,按照软胶囊制备方法压制成软胶囊。
实施例15
一种增强耐力、提高抗缺氧耐受力营养剂的制备方法如下:
取上述实施例7制备所得三七提取物、红景天提取物,其重量配比分别为三七提取物18份,红景天提取物20份,枸杞多糖1.8份,可接受的辅料204份。取上述提取物,加入200g精制大豆油、花生油、橄榄油混合物,可接受的辅料,混匀,按照软胶囊制备方法压制成软胶囊。
实施例16
一种增强耐力、提高抗缺氧耐受力营养剂的制备方法如下:
取上述实施例7制备所得三七提取物、红景天提取物、刺五加提取物,其重量配比分别为三七提取物18份,红景天提取物20份,刺五加提取物24份,可接受的辅料182份。取上述提取物,加入200g精制大豆油、花生油、橄榄油混合物,可接受的辅料,混匀,按照软胶囊制备方法压制成软胶囊。
实施例17
为验证本发明效果,进行如下验证实验:
样品:实施例3、实施例12、实施例13-16所得样品,另加空白组样品为可接受辅料制成,样品人体推荐剂量为2.0g/人/日。
实验动物:试验动物及分组:选用SPF级健康雄性小鼠210只,体重18.9~21.0g。小鼠按体重随机分为三组,各组70只,其中第1组组进行营养剂对小鼠常压耐缺氧实验;第2组进行营养剂对小鼠在减压低氧条件下游泳存活时间影响;第3组小进行急性脑缺血性缺氧实验。
1、常压耐缺氧实验:小鼠分为7组,每组10只,连续灌胃一个月,末次给样1h后,将小鼠分别放入盛有5g钠石灰的250mL磨口瓶内(每瓶1只),用凡士林封瓶口,盖严,使之不漏气,立即计时,直至呼吸停止,记录小鼠因缺氧而死亡的时间。
表1营养剂对小鼠常压耐缺氧存活时间的影响(0.30g/kg, s)
分组 | 存活时间(分) |
空白组 | 35.98 3.98 |
实施例3组 | 44.084.02** |
实施例12组 | 46.383.98** |
实施例13组 | 38.124.10* |
实施例14组 | 41.183.888 |
实施例15组 | 39.884.13* |
实施例16组 | 40.254.03* |
**代表p<0.01,*代表p<0.05
上述结果显示,与空白组比较,实验组小鼠均表现出较好的耐缺氧能力;在营养剂处理组之间,分别减少4种活性组份的实施例13-16相较含有全部活性成分的实施例3和实施例12,其耐缺氧能力较低;此外,简单煎煮制成的营养剂产品与采用提取物配伍制成的营养剂比较,采用精制方法得到的提取物组也表现出一定的优良效果。
2、营养剂对小鼠在减压低氧条件下游泳存活时间影响:小鼠分为7组,每组10只,连续灌胃一个月,减压低氧游泳前1h进行末次给样,将小鼠置于模拟海拔10000m低压氧仓的游泳缸里让其游泳,缸直径25cm,水深23cm,水温28-32℃,每缸10只,记录小白鼠存活时间。
表2营养剂对小鼠在减压低氧条件下游泳存活时间影响(0.30g/kg,s)
分组 | 存活时间(分) |
空白组 | 60.024.14 |
实施例3组 | 75.324.03** |
实施例12组 | 78.024.05** |
实施例13组 | 68.444.31* |
实施例14组 | 70.854.22* |
实施例15组 | 71.884.14* |
实施例16组 | 71.054.27* |
**代表p<0.01,*代表p<0.05
上述结果显示,与空白组比较,实验组小鼠均表现出较好的存活能力;在营养剂处理组之间,分别减少4种活性组份的实施例13-16相较含有全部活性成分的实施例3和实施例12,小鼠存活能力较低;此外,简单煎煮制成的营养剂产品与采用提取物配伍制成的营养剂比较,采用精制方法得到的提取物组也表现出一定的优良效果。
3、急性脑缺血性缺氧实验:小鼠分为7组,每组10只,连续灌胃一个月,末次给样1h后,自颈部逐只断头,立即按秒表记录小鼠断头后至张口喘气停止时间。
表3营养剂对小鼠急性脑缺血性缺氧喘气时间的影响(0.30g/kg,s)
分组 | 存活时间(秒) |
空白组 | 15.30.5 |
实施例3组 | 16.40.6* |
实施例12组 | 16.50.2* |
实施例13组 | 15.80.3 |
实施例14组 | 15.90.5 |
实施例15组 | 15.90.2 |
实施例16组 | 16.00.3 |
*代表p<0.05
上述结果显示,与空白组比较,实验组小鼠急性脑缺血性缺氧喘气时间有一定延长,其中实施例3和实施例12所制得营养剂与空白组比较差异显著。
4、70例运动员运动结束后心率恢复比较
受试者随机分为7组,用量为4粒/天,上下午各2粒,每粒装0.5克,连续服用1个月,整个试验期间,禁服其他具有相似作用食品和药品(包括天然药物)。运动前先做准备活动1分钟,然后持续蹬车60分钟,停止后,立即测定心率,并在3分钟后再次测定心率,比较各组心率恢复情况。
表4运动结束3分钟后心率恢复比较(次/分,s)
分组 | 运动结束后即刻心率 | 运动结束后3分钟恢复心率 |
空白组 | 145.325.32 | 130.353.33 |
实施例3组 | 140.224.12 | 105.126.87** |
实施例12组 | 138.566.65 | 101.366.33** |
实施例13组 | 142.557.41 | 115.328.01* |
实施例14组 | 143.676.36 | 120.274.79* |
实施例15组 | 142.967.77 | 119.224.99* |
实施例16组 | 143.568.05 | 121.956.35* |
**代表p<0.01,*代表p<0.05
上述结果显示,与空白组比较,实验组心率恢复明显;在营养剂处理组之间,分别减少4种活性组份的实施例13-16相较含有全部活性成分的实施例3和实施例12,其心率恢复较慢;此外,简单煎煮制成的营养剂产品与采用提取物配伍制成的营养剂比较,采用精制方法得到的提取物组也表现出一定的优良效果。
5、安全性毒理学评价
(1)急性经口毒性试验:SD大鼠和昆明种小鼠的急性经口MTD值均大于15g/kg.bw,按急性毒性分级属无毒级。
(2)遗传毒性试验:三项遗传毒性试验(Ames试验、小鼠骨髓嗜多染红细胞微核试验以及小鼠精子畸形试验)结果致突变作用。
(3)大鼠30 d喂养试验:最高剂量为人体推荐量的100倍。可见动物生长发育正常,体重持续增长,体态活泼,大、小便未见异常改变。试验期间未见动物出现中毒症状及死亡。
综上,本发明营养剂可增加组织对缺氧缺血的耐受性,通过扩张血管、抑制血栓形成、改善机体对氧的利用度,使机体适应低氧环境,各成分之间协同作用,而且本发明营养剂安全,可验证毒理学评价安全。
在不脱离本发明范围的情况下,还可以对发明进行各种变换及等同代替,因此,本发明专利不局限于所公开的具体实施过程,而应当包括落入本发明权利要求范围内的全部实施方案。
Claims (10)
1.一种增强耐力、提高抗缺氧耐受力营养剂,其特征在于,该营养剂由三七、红景天、刺五加、枸杞多糖、以及可接受的辅料为原料制成。
2.根据权利要求1所述营养剂,其特征在于,其中各原料的重量配比是,三七200-320份,红景天150-300份,刺五加150-300份,枸杞多糖1.3-2.0份,可接受的辅料200-300份。
3.根据权利要求2所述营养剂,其特征在于,所述三七、红景天、刺五加分别为其提取物。
4.根据权利要求3所述营养剂,其特征在于,其中各原料的重量配比是,三七提取物10-20份,红景天提取物15-25份,刺五加提取物15-25份,枸杞多糖1.3-2.0份,可接受的辅料100-200份。
5.根据权利要求3-4任一项所述营养剂的制备方法,其特征在于,所述三七提取物的制备步骤如下:取三七,粉碎,加水8-12倍量煎煮1-3次,每次1-3小时,滤过,合并滤液,减压浓缩至相对密度1.15-1.20,加乙醇至含醇量60-80%,静置20-30小时,滤过,减压回收乙醇至无醇味,过滤,滤液上大孔树脂吸附,用50-70%乙醇洗脱,收集洗脱液,回收乙醇,浓缩至稠膏状,干燥,即得三七提取物。
6.根据权利要求3-4任一项所述营养剂的制备方法,其特征在于,所述红景天提取物的制备步骤如下:取红景天,粉碎,加40~80%乙醇在60~70℃温浸提取,滤过,减压回收乙醇,浓缩,浓缩液通过D101大孔吸附树脂吸附,先用去离子水冲洗至流出液无色,再用稀乙醇洗脱,收集洗脱液,回收乙醇,减压浓缩,干燥,得红景天提取物。
7.根据权利要求3-4任一项所述营养剂的制备方法,其特征在于,所述刺五加提取物的制备步骤如下:取刺五加,粉碎,加8-20倍水煎煮提取1-3次,每次1-3小时,过滤,合并滤液,减压浓缩至相对密度为1.15-1.20,过D140大孔树脂,用30~95%乙醇洗脱,减压浓缩、干燥,得到刺五加提取物。
8.一种如权利要求1-4所述增强耐力、提高抗缺氧耐受力营养剂的质量检测方法,其特征在于,制成的营养剂中指标性成分以三七总皂苷、红景天苷、刺五加苷B、总多糖计,含量之和大于25%。
9.权利要求1-4任一项所述营养剂在制备增强耐力、提高抗缺氧耐受力产品中的用途。
10.权利要求1-4任一项所述营养剂在制备预防高原反应产品中的用途。
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