CN109602893B - 一种改善肝损伤及机体疲劳的组合物及其制剂 - Google Patents
一种改善肝损伤及机体疲劳的组合物及其制剂 Download PDFInfo
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- CN109602893B CN109602893B CN201811444879.3A CN201811444879A CN109602893B CN 109602893 B CN109602893 B CN 109602893B CN 201811444879 A CN201811444879 A CN 201811444879A CN 109602893 B CN109602893 B CN 109602893B
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Abstract
本发明涉及一种改善肝损伤及机体疲劳的组合物及其制剂,属于医药技术及保健食品技术领域。本发明的组合物包含以下重量份的组分:还原型谷胱甘肽200~500份、姜黄提取物30~250份、牛磺酸30~200份。本发明的组合物以还原型谷胱甘肽、姜黄提取物、牛磺酸为主要原料,能增加体内谷胱甘肽水平并使其达到稳态,有效地改善肝损伤及机体疲劳;由本发明的组合物制备的保健食品制剂配方科学、服用方便、功效稳定显著。
Description
技术领域
本发明涉及一种改善肝损伤及机体疲劳的组合物及其制剂,属于医药技术 及保健食品技术领域。
背景技术
谷胱甘肽(Glutathione,GSH)是一种广泛存在生物细胞内的三肽,由谷氨 酸、半胱氨酸及甘氨酸组成,被认为是“抗氧化剂之母”。作为机体细胞中的内源 性物质,谷胱甘肽的含量是衡量细胞氧化-还原状态的一个重要指标,对于维持 细胞氧化还原稳态具有重要作用。一般认为,体内谷胱甘肽水平决定细胞抗氧 化、解毒代谢水平,谷胱甘肽分子中的巯基(-SH)能与细胞自由基、氧化物结 合,以保护细胞免受氧化损伤,促进体内产生高能量,调节细胞物质代谢过程; 谷胱甘肽参与肝脏的解毒过程,能结合多种外源性、内源性有毒物质(机体外 源性摄入的重金属如铅、汞,内源性代谢产物如氨、胆红素等),生成减毒物质并排出体外,是临床中辅助保肝的重要物质。日本一项临床试验显示(试验 号:UMIN000011118),非酒精性脂肪性肝病(NAFLD)患者口服谷胱甘肽300 mg/天,连续服用4个月后,丙氨酸转氨酶水平显着降低,甘油三酯,非酯化脂 肪酸和铁蛋白水平也随谷胱甘肽治疗而降低,可改善烟酰胺腺嘌呤二核苷酸磷 酸导致的肝损伤。Wataru Aoi等研究表明,口服谷胱甘肽可以减少血浆脂肪酸生 成,抑制因运动导致的肌肉pH浓度下降,使骨骼肌PGC-1α和线粒体浓度升高, 从而改善骨骼肌酸性环境并促进有氧代谢,有缓解体力疲劳的作用。
姜黄,为姜科植物姜黄Curcuma longa L.的干燥根茎,一般用作调味香料(咖喱),食用色素和药用植物。自古以来,这种金黄色香料用于中医中药及阿育 吠陀(Ayurveda,印度传统医学)治疗各种疾病。因其药食同源,如今姜黄已被 开发成各种保健食品、营养品,用于辅助治疗胃病、过敏、风湿、高血脂以及 肝脏疾病。现代研究发现,姜黄中姜黄素(Curcumin)是一种安全有效的植物 多酚,具有显著的抗氧化、清除自由基和抑制脂质过氧化功能,通过诱导谷胱 甘肽半胱氨酸连接酶(γ-GCL)的基因表达,增加其催化活性,导致谷胱甘肽水 平上升,从而实现抗氧化及保肝作用;姜黄素能加速骨骼肌线粒体生物合成, 调节了NF-κB和PGC-1α通路,降低丙二醛(Malondialdehyde,MDA)水平, 增加肌肉胞浆含量、NAD+/NADH比值和SIRT1蛋白,帮助受伤肌肉的恢复。
牛磺酸(Taurine)是人体内的一种特殊氨基酸,含丰富的含磺酸基 (R-SO3H),广泛分布于动物组织,牛磺酸具有许多基本的生物学作用,例如 胆汁酸的结合、抗氧化、渗透调节、膜稳定和钙信号传导调节,对心血管功能, 骨骼肌,视网膜和中枢神经系统的发育和功能至关重要。牛磺酸通过促进胆酸 的合成、分泌和排泄,降低某些游离胆汁酸的细胞毒性,有效清除脂肪肝沉积 物,抗肝纤维化,保护胰岛细胞,减少肝硬化发生率,通过补充牛磺酸来维持 肝脏的牛磺酸稳态,能预防肝脏疾病并改善肝损伤状况。有文献报道慢性肝炎患者(丙氨酸转氨酶、天冬氨酸转氨酶活性是正常人的2~5倍)每天3次,每 次服用2克牛磺酸,持续3个月,肝脏损伤的血清标志物和氧化应激标志物均 显着下降。因日常膳食中含牛磺酸约10~400mg不等,补充额外牛磺酸的有助改 善肝损伤。牛磺酸可以调节中枢神经递质的释放和活性,减少机体脂质过氧化, 降低丙二醛水平,提高或稳定机体内支链氨基酸,能调节心肌收缩,增加血液 输出,促使机体运动能力和抗疲劳能力进一步增加。目前,牛磺酸已成为一种 常见的营养添加剂,广泛应用于婴幼儿食品、运动功能食品及饮料等。
目前,尚没有以还原型谷胱甘肽、姜黄提取物、牛磺酸为主要成分的组合 物及制剂。
单纯口服谷胱甘肽生物利用度低,需长期大量服用才能维持机体谷胱甘肽 水平。目前,国内外谷胱甘肽产品主要通过两种方式来增加谷胱甘肽口服生物 利用度:(1)对谷胱甘肽进行脂质体包封,使其免收胃肠道分解,增加吸收率; (2)补充大量谷胱甘肽前体(N-乙酰半胱氨酸、L-半胱氨酸等)来增加谷胱甘 肽体内合成率。上述方式中,某些细胞类型可能缺乏完整摄取脂质体谷胱甘肽 的能力,未有人体试验明确脂质体谷胱甘肽比常规谷胱甘肽功效更优,而且其 生产成本较高,服用口感差(粘稠油状液体);由于谷胱甘肽的体内合成不仅 需要充足的前体氨基酸,还依赖众多生理因子及细胞内环境(如合成关键辅酶NADPH的活性,合适的pH等),所以体内合成的谷胱甘肽较难维持在稳态水 平,未有实验证据表明补充谷胱甘肽前体有助改善肝脏损伤及机体疲劳状况。
因此,研究一种谷胱甘肽组合物,使机体中谷胱甘肽维持稳态从而改善肝 损伤及机体疲劳成为本发明的方向与重点。
发明内容
本发明的目的在于克服上述现有技术的不足之处而提供一种改善肝损伤及 机体疲劳的组合物及其制剂,本发明的组合物能使体内谷胱甘肽水平达到稳态, 有效地改善肝损伤及机体疲劳。
为实现上述目的,本发明采取的技术方案为:一种改善肝损伤及机体疲劳 的组合物,所述组合物包含以下重量份的组分:还原型谷胱甘肽200~500份、 姜黄提取物30~250份、牛磺酸30~200份。
作为本发明所述改善肝损伤及机体疲劳的组合物的优选实施方式,所述组 合物包含以下重量份的组分:还原型谷胱甘肽300份、姜黄提取物60份、牛磺 酸50份。
作为本发明所述改善肝损伤及机体疲劳的组合物的优选实施方式,所述姜 黄提取物为姜黄粉、类姜黄素、姜黄水提取物中的至少一种。
作为本发明所述改善肝损伤及机体疲劳的组合物的优选实施方式,所述姜 黄粉为姜黄的干燥根茎经研磨而成的干燥粉末,所述类姜黄素为姜黄素、去甲 氧基姜黄素、双去甲氧基姜黄素的至少一种,所述姜黄水提取物为姜黄的干燥 根茎经水浸泡提取、浓缩、干燥而成的粉末。
作为本发明所述改善肝损伤及机体疲劳的胶囊的优选实施方式,所述类姜 黄素的提取方法不限于溶剂回流提取法、酸碱提取法、超声波提取法、超临界 CO2萃取法、微波辅助提取法、酶提取法、渗漉法中的任意一种;所述类姜黄素 的精制方法不限于聚酰胺吸附法、大孔树脂吸附法、硅胶柱吸附法、活性炭柱 层析法、乙酸沉淀法、重结晶法中的任意一种。
作为本发明所述改善肝损伤及机体疲劳的组合物的优选实施方式,所述姜 黄粉、类姜黄素、姜黄水提取物为原粉,或原粉经微粉加工处理所得的微粉; 所述微粉加工处理为姜黄粉、类姜黄素、姜黄水提取物原粉经混悬超声处理后, 进行高压均质,再经冷冻干燥后制得微粉,微粉粒径为0.05~100μm。
第二方面,本发明提供了一种保健食品制剂,所述保健食品制剂由上述组 合物与药学或食品上可接受的辅料制成。
作为本发明所述保健食品制剂的优选实施方式,所述保健食品制剂的剂型 为片剂、硬胶囊、软胶囊、丸剂、颗粒剂、粉剂或口服液。
本发明的组合物可以与药用载体或食品载体混合,所述药用载体或食品载 体在本领域是常见的,如口服片剂及硬胶囊,其辅料有乳糖、淀粉、糊精、微 晶纤维素、聚乙烯吡咯烷酮(PVP)、羟丙甲基纤维素(HPMC)、羧甲基淀粉 钠(CMS-Na)、羧甲基纤维素钠(CMC-Na)、二氧化硅、硬脂酸镁、聚乙二 醇-4000、聚乙二醇-6000等;口服软胶囊的赋形剂有PEG-400(聚乙二醇-400)、 PEG-1000(聚乙二醇-1000)、PEG-6000(聚乙二醇-6000)、甘油、丙二醇、 聚乙烯吡咯烷酮、大豆油、玉米油、山梨醇、氢化大豆油、二氧化钛、乙基纤 维素等。
作为本发明所述保健食品制剂的优选实施方式,所述片剂包含以下重量份 的组分:还原型谷胱甘肽300份、姜黄提取物60份、牛磺酸50份、微晶纤维 素15份、乳糖22.5份、微粉硅胶10份、羟丙甲纤维素17.5份、羟丙纤维素5 份、PEG-6000 10份、硬脂酸镁2份、二氧化硅8份、薄膜包衣粉(羟丙基甲基 纤维素9份,PEG-400 1.5份、色素4.5份)。
作为本发明所述保健食品制剂的优选实施方式,所述软胶囊包含以下重量 份的组分:还原型谷胱甘肽300份、姜黄提取物60份、牛磺酸50份、纯化水 20份、甘油4份、PEG-400 35份、PEG-1000 13.5份、PVP 17.5份。
作为本发明所述保健食品制剂的优选实施方式,所述药学或食品上可接受 的辅料为填充剂、粘合剂、崩解剂、润滑剂、表面活性剂、掩味剂、包衣预混 剂中的至少一种。
第三方面,本发明提供了一种药物制剂,所述药物制剂由上述组合物与药 学上可接受的辅料制成。
与现有技术相比,本发明的有益效果为:本发明的组合物以还原型谷胱甘 肽、姜黄提取物、牛磺酸为主要原料,配伍中三者均有改善肝损伤、缓解体力 疲劳的功能;其中,还原型谷胱甘肽为改善肝损伤的主要功效成分,并有一定 的抗疲劳作用,本发明人发现,姜黄提取物与还原型谷胱甘肽相互作用,能够 显著增加体内谷胱甘肽水平,增强还原型谷胱甘肽的改善肝损伤及抗疲劳功效, 牛磺酸与还原型谷胱甘肽、姜黄提取物分别按一定比例配方时,通过补充营养、 改善细胞内pH环境使还原型谷胱甘肽在肝脏及肌肉组织中维持稳态水平。本发 明的组合物能增加体内谷胱甘肽水平并使其达到稳态,有效地改善肝损伤及机 体疲劳;由本发明的组合物制备的制剂配方科学、服用方便、功效稳定显著。
具体实施方式
为更好地说明本发明的目的、技术方案和优点,下面将结合具体实施例对 本发明作进一步说明。
实施例1本发明组合物制备的片剂
按1000片计,片剂各组分的用量及制备方法为:微晶纤维素15g、乳糖22.5g、 微粉硅胶10g、羟丙甲纤维素17.5g、羟丙纤维素5g、PEG-6000 10g、二氧化硅 8g,加入300g还原型谷胱甘肽、50g牛磺酸、60g姜黄提取物及上述辅料混合 均匀,干法制粒,再加入硬脂酸镁2g作为润滑剂,压片、包衣、抛光,得到本 发明组合物制备的片剂。
实施例2本发明组合物制备的软胶囊
按1000粒计,软胶囊各组分的用量及制备方法为:将纯化水20g、甘油4g、 PEG-40035g、PEG-1000 13.5g、聚乙烯吡咯烷酮17.5g剪切混合,水浴加热至 55℃,在该温度下,加入300g还原型谷胱甘肽、50g牛磺酸,搅拌至溶解,再 加入60g姜黄提取物,搅拌剪切混合,降温至35℃作为软胶囊的内容物待用。 按照如下重量比配制软胶囊囊壳进行化胶:明胶:纯净水:甘油:二氧化钛=1:1.2:0.5:0.005,在此基础上添加7%的PEG-400,常规模制方法制丸、定型干 燥、洗丸、晾丸、捡丸,得到本发明组合物制备的软胶囊。
实施例3本发明组合物制备的硬胶囊
按1000粒计,硬胶囊各组分的用量及制备方法为:称取糊精28g、微晶纤 维素10g、PVP-K30(聚乙烯吡咯烷酮-K30)20g、羟丙甲纤维素20g、二氧化 硅10g,加入300g还原型谷胱甘肽、50g牛磺酸、60g姜黄提取物。所述姜黄提 取物的组成及质量分别为:姜黄粉70%、类姜黄素10%、姜黄水提取物20%。 所述姜黄提取物经微粉化后,其粒径范围为:10~100μm。混合均匀,干法制粒, 再加入硬脂酸镁2g作为润滑剂,装填空心胶囊、抛光,得到本发明组合物制备 的硬胶囊。
实施例4本发明组合物制备的硬胶囊
按1000粒计,硬胶囊各组分的用量及制备方法为:称取糊精48g、微晶纤 维素65g、PVP-K30(聚乙烯吡咯烷酮-K30)15g、羟丙甲纤维素30g、二氧化 硅15g,加入200g还原型谷胱甘肽、200g牛磺酸、30g姜黄提取物。所述姜黄 提取物的组成及质量分别为:姜黄粉20%、类姜黄素20%、姜黄水提取物60%。 所述姜黄提取物经微粉化后,其粒径范围为:0.05~10μm。混合均匀,干法制粒, 再加入硬脂酸镁8g作为润滑剂,装填空心胶囊、抛光,得到本发明组合物制备 的硬胶囊。
实施例5本发明组合物制备的硬胶囊
按1000粒计,硬胶囊各组分的用量及制备方法为:称取糊精20g、微晶纤 维素150g、PVP-K30(聚乙烯吡咯烷酮-K30)50g、羟丙甲纤维素10g、二氧化 硅26g,加入500g还原型谷胱甘肽、30g牛磺酸、250g姜黄提取物。所述姜黄 提取物的组成及质量分别为:姜黄粉50%、类姜黄素15%、姜黄水提取物35%。 混合均匀,干法制粒,再加入硬脂酸镁14g作为润滑剂,装填空心胶囊、抛光, 得到本发明组合物制备的硬胶囊。
效果例1本发明实施例3~5的硬胶囊对化学性肝损伤有辅助保护作用的试验
1.试验条件
(1)仪器与试剂
仪器:CPA225D分析天平(北京赛多利斯科学仪器有限公司),TG16-WS 高速离心机(湖南湘仪实验室仪器开发有限公司),T25高速组织匀浆机(广州 艾卡仪器设备有限公司),日立7170型全自动生化仪(日立高新技术(上海) 国际贸易有限公司)。
试剂:刀豆蛋白A,含量≥99%,购自美国Sigma-Aldrich公司;还原型谷 胱甘肽,含量≥98%,购自广东开平牵牛生化制药有限公司;丙氨酸氨基转移酶 (ALT)测定试剂盒、天门冬氨酸氨基转移酶(AST)测定试剂盒、乳酸脱氢酶 (LDH)测定试剂盒、超氧化物歧化酶(SOD)测定试剂盒、丙二醛(MDA) 测定试剂盒、还原型谷胱甘肽(GSH)测定试剂盒,购自南京建成生物工程研 究所。
实验动物:SPF级ICR小鼠,雄性,4~5周龄,体重18~22g,购自广东省 医学实验动物中心,合格证号:SYXK(粤)2013-0002,适应性饲养1周后进 行实验。
数据分析:采用SPSS 25.0统计软件包进行统计分析,多组比较采用单因 素方差分析(One-Way ANOVA),对非正态或方差不齐的数据进行秩和检验。 数据表示为均数±标准差,P<0.05被认为具有显著性意义,P<0.01被认为具 有极显著性意义。
(2)试验方法
适应性喂养1周后的雄性ICR小鼠120只,随机分为12组,即空白对照组、 模型组、单纯谷胱甘肽阳性对照组(300mg/kg),取实施例3~5的硬胶囊内容 物,分别设置实施例3低剂量组(75mg/kg)、实施例3中剂量组(150mg/kg)、 实施例3高剂量组(300mg/kg)、实施例4低剂量组(75mg/kg)、实施例4中 剂量组(150mg/kg)、实施例4高剂量组(300mg/kg)、实施例5低剂量组 (75mg/kg)、实施例5中剂量组(150mg/kg)、实施例5高剂量组(300mg/kg)。 阳性对照组和给药组采用灌胃给药0.2g/10g,连续30天,空白对照组和模型组 给予等体积的生理盐水,于实验结束时,除空白对照组外,其余各组一次性尾 静脉注射15mg/kg刀豆蛋白A(溶解于无热原生理盐水中,浓度为2.5mg/mL), 禁食后8小时后眼眶静脉丛采血,以高速离心机分离血清(3000rpm,15min), 12h后,颈椎脱臼处死小鼠,快速取出各组肝和脾,称重,计算肝脏系数(肝湿 重/禁食后体重,%),并测定血清中ALT(丙氨酸转氨酶)、AST(天冬氨酸 转氨酶)、LDH(乳酸脱氢酶)含量,取肝脏左叶以生理盐水制备匀浆,测定 肝匀浆液中MDA(丙二醛)、SOD(超氧化物歧化酶)、GSH(谷胱甘肽)含 量。
2.试验结果
(1)对小鼠体重及肝脏系数的影响
表1为各组对小鼠体重及肝脏系数的影响(n=10)。由表1可知,给药30 天后,各组动物体重均有增加,实施例3~5各剂量硬胶囊与空白对照组相比体 重无显著差异(P>0.05),表明本发明的硬胶囊对小鼠体重没有影响。研究表 明,刀豆蛋白A可以造成小鼠肝脏系数的明显升高。本实验结果表明:与空白 对照组相比,模型组小鼠肝脏系数显著增加(P<0.05),而给药30天后,实施 例3~5各剂量硬胶囊和阳性对照组均能显著降低小鼠肝脏系数(P<0.01),且 实施例3各剂量硬胶囊降低小鼠肝脏系数的效果最佳。
表1
注:a与空白对照组相比较,差异显著(P<0.05),b与模型组相比较,差异极显著(P<0.01)。
(2)对小鼠血清中ALT、AST和LDH水平的影响
表2为各组对对小鼠血清ALT、AST和LDH含量的影响(n=10)。由表2 可知,与空白对照组相比,模型组的ALT、AST和LDH的水平均明显增高,说 明急性刀豆蛋白A诱导肝损伤模型创建成功(P<0.05);与模型组相比,给予 不同剂量实施例3~5硬胶囊内容物的各组,小鼠血清中ALT、AST和LDH含量 均明显降低(P<0.01),并且实施例3中剂量组接近阳性对照组ALT、AST和 LDH水平,实施例3高剂量组低于阳性对照组ALT、AST和LDH水平。结果 表明:本发明的硬胶囊能够不同程度的抑制急性化学性肝损伤小鼠ALT、AST 和LDH水平的升高,且实施例3各剂量硬胶囊抑制急性化学性肝损伤小鼠ALT、 AST和LDH水平升高的效果最佳。
表2
注:a与空白对照组相比较,差异显著(P<0.05),b与模型组相比较,差异显著(P<0.05)
c与模型组相比较,差异极显著(P<0.01)。
(3)对小鼠肝组织中MDA、SOD和GSH水平的影响
表3为各组对小鼠肝组织MDA、SOD和GSH的影响(n=10)。由表3可 知,与空白对照组相比,模型组的MDA水平均显著升高(P<0.05),而SOD、 GSH含量显著下降(P<0.05),说明一次性灌胃给予大剂量刀豆蛋白A可以导 致氧化应激损伤,表明急性刀豆蛋白A诱导肝损伤模型成功建立(P<0.05); 与模型组相比,给予不同剂量实施例3~5硬胶囊内容物的各组,小鼠的MDA水 平随着给药剂量的增加而逐渐降低,并有显著性差异(P<0.05),实施例3高 剂量组与阳性对照组降低MDA水平相当(P<0.01);而SOD、GSH的含量随 着给予实施例3~5硬胶囊剂量的增加均有显著提升并呈一定的剂量关系(P< 0.01)。结果表明:本发明的硬胶囊能够有效调节急性肝损伤小鼠肝组织中MDA、 SOD和GSH水平,维持肝脏的GSH稳态,改善氧化应激损伤,且实施例3、 实施例5各剂量硬胶囊调节急性肝损伤小鼠肝组织中MDA、SOD和GSH水平 的效果比实施例4更佳,从样本标准差可以看出,实施例3各剂量硬胶囊比实 施例5、阳性对照组能更稳定地维持急性肝损伤小鼠肝组织中GSH水平。
表3
注:a与空白对照组相比较,差异显著(P<0.05),b与模型组相比较,差异显著(P<0.05),
c与模型组相比较,差异极显著(P<0.01)。
效果例2本发明实施例3~5的硬胶囊缓解体力疲劳作用的试验
1.试验条件
(1)仪器与试剂
仪器:CPA225D分析天平(北京赛多利斯科学仪器有限公司),AG/22331 高速离心机(艾本德(上海)国际贸易有限公司),T25高速组织匀浆机(广州 艾卡仪器设备有限公司),连续光谱扫描式酶标仪SpectraMax Plus384(美国分 子生物仪器公司),日立7170型全自动生化仪(日立高新技术(上海)国际贸 易有限公司),小鼠恒温游泳箱(河南精迈仪器仪表有限公司),TU-19系列紫 外可见分光光度计(北京普析通用仪器有限责任公司)。
试剂:尿素氮(BUN)测试盒、乳酸(LAC)测定试剂盒,购自南京建成生 物工程研究所;其他试剂为分析纯。
实验动物:SPF级ICR小鼠,雄性,4~5周龄,体重18~22g,购自广东省 医学实验动物中心,合格证号:SYXK(粤)2013-0002,适应性饲养1周后进 行实验。
数据分析:采用SPSS 25.0统计软件包进行统计分析,统计方法采用单因 素方差分析(One-Way ANOVA),对非正态或方差不齐的数据进行秩和检验。 数据表示为均数±标准差,P<0.05被认为具有统计学意义,P<0.01被认为具 有极显著性意义。
(2)试验方法
适应性喂养1周后的雄性ICR小鼠150只,随机分为10组,即空白对照组、 实施例3低剂量组(75mg/kg)、实施例3中剂量组(150mg/kg)、实施例3高 剂量组(300mg/kg)、实施例4低剂量组(75mg/kg)、实施例4中剂量组 (150mg/kg)、实施例4高剂量组(300mg/kg)、实施例5低剂量组(75mg/kg)、 实施例5中剂量组(150mg/kg)、实施例5高剂量组(300mg/kg)。采用灌胃 给药0.2g/10g,连续30天,空白对照组给予等体积的生理盐水。①负重游泳试 验:末次灌胃给予受试物30min后,将尾根部负重5%体重铅皮的小鼠置于水深 40cm、水温25±1.0℃的游泳箱中游泳,记录小鼠自游泳开始至死亡的时间,即 小鼠负重游泳时间;②血清尿素氮:末次给予受试物30min后,置小鼠分别在 水温30℃水中游泳90min,运动后休息60min,采眼球血0.5mL;4℃冰箱放置 3小时后,离心1500rpm、15min分离血清,用试剂盒测定尿素氮(脲酶法); ③血乳酸:末次给予受试物30min后,采眼球血20μL后即放于水温30℃游泳 10min,分别于运动后0min、20min再采血20μL,用生化仪测定乳酸,其中: 血乳酸曲线下面积=1/2×(游泳前血乳酸值+游泳后0min血乳酸值)×10+1/2× (游泳后0min血乳酸值+游泳后休息20min血乳酸值)×20。
2.试验结果
(1)对小鼠负重游泳时间的影响
表4为各组对小鼠负重游泳时间的影响。由表4可知,实施例3~5各剂量 组的小鼠负重游泳时间延长,与空白对照组比较,差异有极显著性意义(P< 0.01),说明本发明的硬胶囊能增加小鼠负重游泳时间,增加小鼠运动耐力;且 实施例3、实施例4各剂量硬胶囊增加小鼠负重游泳时间的效果比实施例5更佳, 从样本标准差可以看出,实施例3比实施例4各剂量硬胶囊能更稳定地增加小 鼠负重游泳时间。
表4
注:各剂量组与空白对照组相比较,*差异显著(P<0.05),**差异极显著(P<0.01)。
(2)对小鼠运动后血清尿素氮水平的影响
表5为各组对小鼠运动后血清尿素氮水平的影响(n=15)。由表5可知, 实施例3~5各剂量组的血清尿素氮水平略有降低,实施例3高剂量组与空白对 照组比较,有显著性意义(P<0.05),说明实施例3高剂量组能降低小鼠运动 后血清尿素氮,有助疲劳回复及减轻运动负荷作用。
表5
注:高剂量组与空白组相比较,*差异显著(P<0.05)。
(3)对小鼠运动前、后血乳酸水平的影响
表6为各组对小鼠运动前、后血乳酸水平的影响(n=15)。由表6可知, 各剂量组的血乳酸曲线下面积减少,其中,实施例3低、中、高剂量组与空白 对照组比较,有极显著性意义(P<0.01)。结果表明:本发明的硬胶囊能显著 降低小鼠运动后血乳酸水平,改善因运动造成的体力疲劳;且实施例3各剂量 硬胶囊降低小鼠运动后血乳酸水平的效果最佳。
表6
注:*与空白组相比较,*差异显著(P<0.05),**差异极显著(P<0.01)。
最后所应当说明的是,以上实施例仅用以说明本发明的技术方案而非对本 发明保护范围的限制,尽管参照较佳实施例对本发明作了详细说明,本领域的 普通技术人员应当理解,可以对本发明的技术方案进行修改或者等同替换,而 不脱离本发明技术方案的实质和范围。
Claims (7)
1.一种改善肝损伤及机体疲劳的组合物,其特征在于,按重量份计,所述组合物由还原型谷胱甘肽200份、姜黄提取物30份、牛磺酸200份组成;所述姜黄提取物的组成及质量分别为:姜黄粉20%、类姜黄素20%、姜黄水提取物60%。
2.如权利要求1所述的改善肝损伤及机体疲劳的组合物,其特征在于,所述姜黄粉为姜黄的干燥根茎经研磨而成的干燥粉末,所述类姜黄素为姜黄素、去甲氧基姜黄素、双去甲氧基姜黄素的至少一种,所述姜黄水提取物为姜黄的干燥根茎经水浸泡提取、浓缩、干燥而成的粉末。
3.如权利要求2所述的改善肝损伤及机体疲劳的组合物,其特征在于,所述姜黄粉、类姜黄素、姜黄水提取物为原粉,或原粉经微粉加工处理所得的微粉;所述微粉加工处理为姜黄粉、类姜黄素、姜黄水提取物原粉经混悬超声处理后,进行高压均质,再经冷冻干燥后制得微粉,微粉粒径为0.05-100μm。
4.一种保健食品制剂,其特征在于,所述保健食品制剂由权利要求1-3任一项所述的组合物与药学或食品上可接受的辅料制成。
5.如权利要求4所述的保健食品制剂,其特征在于,所述保健食品制剂的剂型为片剂、硬胶囊、软胶囊、丸剂、颗粒剂、粉剂或口服液。
6.如权利要求4所述的保健食品制剂,其特征在于,所述药学或食品上可接受的辅料为填充剂、粘合剂、崩解剂、润滑剂、表面活性剂、掩味剂、包衣预混剂中的至少一种。
7.一种药物制剂,其特征在于,所述药物制剂由权利要求1-3任一项所述的组合物与药学上可接受的辅料制成。
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