CN105596402A - 一种预防糖尿病及老年痴呆的保健制品 - Google Patents
一种预防糖尿病及老年痴呆的保健制品 Download PDFInfo
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Abstract
本发明涉及一种预防糖尿病及老年痴呆的鱼油制品新配方,属于保健品制备领域。本配方的特色之一是不仅很巧妙地把姜黄素和鱼油结合起来,而且利用可以避光的胶囊外壳和深色的蓝莓素提取物一起很好地保护里面由姜黄素和鱼油组成的混合物。从而减低姜黄素的降解。在新的配方里,姜黄素稳定性会大大提高,同时姜黄素的生物利用度也会保持在最优水平。
Description
技术领域:
本发明涉及一种预防糖尿病及老年痴呆的鱼油保健制品,属于保健品制备领域。
背景技术:
姜黄素是一种从植物姜黄的根茎中提取出的天然黄色色素,它是一种低分子量的分子,具有抗氧化和抗炎活性(DasKC.etal.2002;JurenkaJS.2009;KhopdeSM.etal.1999,NurfinaAN.etal.1997,WrightJS.etal.2002))。几个世纪以来,姜黄素作为一种天然植物成分(KamalakkannanN.etal.Comparativeeffectofcurcuminandanaloqueofcurcuminincarbontetrachlorideinducedhepatoxicityinrats(2005).Basic&clinicalPharmacology&toxicology.97:15-21.),在印度被广泛用作传统饮食烹饪香料、食品防腐剂以及印度治疗各种疾病的草药。在印度70和79岁之间的老年痴呆患者以及帕金森病的发病率都比美国要低得多(Gangguli.M.etal.ApolipoproteinEpolymorphismandAlzheimerdisease:theindo-UScrossnationaldemantisstudy(2000).Archneurol57,824-830.),(两种疾病都与增加的细胞内氧化损伤有关)。实验证实,转基因小鼠Tg2576食用姜黄素(低剂量姜黄素),大脑中不溶性蛋白Aβ沉积量降低了40%(LimGP.etal.ThecurryspicecurcuminregulatesoxidativedamageandamyloidpathologyinanAlzheimertransgenicmouse(2001).J.Neurosci.21:8370-8377.OnoK.etal.Curcuminhaspotentanti-amyloidogeniceffectsforalzheimer′sB-amyloidfibrilsinvitro(2004).J.Neurosci.75:742-750.)。大脑中不溶性蛋白Aβ的降低并非由于其表达的减少而是由于Aβ被降解。体内和体外的研究表明进食或外周注射姜黄素后,姜黄素能穿越血脑屏障并与Aβ,结合,从而抑制Aβ聚集以及Aβ,原纤维和低聚物的形成,进而阻断低聚物的毒性(Yangetal.CurcumininhibitsformationofamyloidBoligomersandfibrils,bindsplaques,andreducesamyloidinvivo(2005).J.Biol.Chem.280,5892-5901.)。不同的姜黄素制剂具有不同的吸收和生物利用度,从而影响建议剂量(AntonyBetal.APilotCross-OverStudytoEvaluateHumanOralBioavailabilityofBCM-95CG(Biocurcumax),ANovelBioenhancedPreparationofCurcumin(2008).IndianJPharmSci.70:445-9.)。姜黄素每天用量从100-1000毫克不等。姜黄素具有高度亲脂性,低生物利用度,在碱性pH和光环境下易产生降解(HjorthH.etal.Studiesofcurcuminandcurcuminoids.XXVII.Cyclodextrincomplexation:solubility.Chemicalandphotochemicalstability(2002).InternaJPharmaceut.244:127-135.)。
在过去的30年里,许多制药公司和研究机构为研制对抗老年痴呆病的药物投入了巨大的精力。到目前为止,在市场上只有少数几种药物,而且大多化合物是乙酰胆碱酯酶抑制剂,旨在通过稳定突触间隙的乙酰胆碱水平,维持神经传递从而改善患者的症状。最初彻底根治老年痴呆患者的想法,现在被证明是太天真了。随着我们越来越多地了解这种疾病,之前认为可以治愈的老年痴呆的想法可能永远无法实现。老年痴呆病的发生和发展有可能像人体正常衰老的过程一样,是永远无法(对抗自然)将其过程停止的,但是,我们可以推迟老年痴呆病在正常年龄人群中的发病起始时间或减缓老年痴呆病患者的疾病的进展速度。姜黄素目前在印度正在被开发作为用于临床癌症化疗的预防物质(Kelloff.GJ.etal.Progressincancerchemoprevention:developmentofdiet-derivedchemopreventiveagents(2000).J.Nutr.130,467S-471S.)。在癌症患者的临床试验中,在服用高剂量(8000毫克/天)的患者中,未发现明显副作用(Cheng,etal.PhaseIclinicaltrialofcurcumin,achemopreventiveagent,inpatientswithhigh-riskorpre-malignantlesions(2001).AnticancerRes.21:2895-2900.)。基于姜黄素的生物活性(抗氧化,抗炎和抑制Aβ聚集性)和长期使用的历史(PanMH.etal.Biotransformationofcurcuminthroughreductuionanddlucuronidationinmice(1999).GroundMetabolismandDisposition.27:486-494.),姜黄素可能是预防老年痴呆病的最理想和安全的自然物质之一。
蓝莓是一种树种原生从北半球,属越橘和家庭杜鹃花科。它的果实中含有丰富的酚类化合物,如antocianic色素,一种抗氧化剂物质,有助于预防老年性退行性疾病。正因为如此,蓝莓被称为“长寿水果“,蓝莓做为最富含抗氧化剂的新鲜水果广泛用于食品行业的果汁和其他产品的原材料。多酚主要聚集果皮和果核和植物的叶子因为它的合成被光激发。接收多的光趋向于合成更多的这些化合物。
来自雄鹿和麋鹿的不成熟鹿角,称为鹿茸,两千多年来一直被中国人珍视为促进健康的补品。在公元前168年,鹿茸就被用作滋补保健品。第一次记载的证据出现在中国的丝绸卷轴,称为“金角”。鹿茸在钙化之前是软的生长组织,钙化之后鹿茸变得坚硬。在哺乳动物鹿茸是唯一的可再生的器官且生长速度极快。在某些物种它的生长速度可以达到2厘米/天。这意味着软骨,骨骼和支持组织如神经和血管也必须以同样速度增长。虽然再生的确切机理不是完全清楚,鹿茸再生的特性在医学应用上非常有兴趣。鹿茸的生长就像一棵树从顶部越来越大,而不是它的根部,顶部通常是更有价值的。顶尖和中间区域通常用作小儿滋补品,上部和中间部分作为退行性炎性病症,如关节炎和老年性退行性病变。一般来说,整个鹿茸含蛋白质52.5%,矿物质:34.0%,水合物:1.0%,脂肪2.5%。根据中国传统医学的理论,鹿茸补阳,用于阳衰表现为全身疲劳,抑郁症,冷,腰背疼痛,脉搏微弱。在中国使用鹿茸作为传统的增进性功能的药物,导致鹿茸被西方视为春药。研究发现鹿茸能促进身体恢复,加强和保护正常的生理进程。
在发展中国家和发达国家,平均寿命变得越来越长,超过70岁的老龄人中至少有20-30%的人口已经显现出早期老年痴呆病的某些症状,如短期记忆丧失和认知问题,从医疗和经济角度提高老年人口的生活质量,不仅对他们的家人,甚至对他们所处的社会来讲都已经变得越来越重要了。糖尿病做为一种富贵病无论在发展中国家和发达国家变的越来越普及。糖尿病和老年痴呆病的预防变的越来越重要。鱼油和蓝莓作为一种来自北欧国家的天然产品,被认为具有软化血管从而达到预防糖尿病高血压,动脉粥样硬化和老年痴呆病(延长寿命)的作用。姜黄素,印度国家自然药草,由于其抗氧化、抗炎活性以及减缓和阻止淀粉样蛋白沉积的作用,可推迟或延缓老年痴呆病的发生和发展(提高生活质量)。姜黄素的亲脂性利于其与鱼油结合从而产生这两种天然产品的新配方(易存储,吸收)。产自斯堪的纳维亚的蓝莓(预防老年性退行性疾病的长寿水果)和鱼油配合印度产的姜黄素作为自然营养产品的新配方,不但可以延长寿命,同时可以改善高龄人群的生活质量。
姜黄素在酸性环境下不溶于水,但是该化合物在碱性环境中具有水溶性。在碱性条件下酸性离子会分离(7.8,8.5和9.0)。当pH高于中性,姜黄素很容易快速水解。在有机溶剂下,姜黄素也很容易见光分解。分离出很多光降解产物来。由于姜黄素在酸性条件下不溶于水,而在碱性条件下和在有机溶剂见光分解的原因,因此姜黄素的应用受到限制。姜黄素的快速分解是一个复杂的过程,因此姜黄素在不同制剂和条件下的稳定性变的非常重要(力争降低姜黄素的降解或光分解)。到目前为在还没有解决这一问题的有效方法。
发明内容:
本发明的目的在于提供能够降低姜黄素的降解或光分解的保健制品。
本发明首先提供了蓝莓素在制备姜黄素防降解或光分解保护剂中的应用。
本发明提供一种预防糖尿病及老年痴呆的保健制品,所述的保健制品中姜黄素不易降解或光分解。所述的保健制品的配方按重量份计,包括:姜黄素100-300重量份,蓝莓素30-50重量份。
优选的,上述预防糖尿病及老年痴呆的保健制品,姜黄素和蓝霉素可以直接混合制成片剂。
上述预防糖尿病及老年痴呆的保健制品,姜黄素和蓝霉素可以直接混合制成片剂的具体制备方法为:
首先将姜黄素、蓝莓素按比例混合,并加入药剂学上常用辅料(优选为玉米淀粉/片,加入量为30-50毫克/片)进一步充分混合。将将上述混合均匀的组分送入压片机中压制成片剂(可以按配方调整片剂重量)。
在本发明的一个优选实施例中,上述预防糖尿病及老年痴呆的保健制品,还包括100-200重量份的麋鹿鹿角。
优选的,上述含有麋鹿鹿角保健制品为片剂,具体制备方法为:
首先将姜黄素,蓝莓素和麋鹿鹿角按比例混合搅拌均匀(优选重量份比例为1.0:0.3:1.0),并加入药剂学上常用辅料(优选为玉米淀粉/片,加入量为30-50毫克/片)进一步充分混合。将将上述混合均匀的组分送入压片机中压制成片剂(可以按配方调整片剂重量)。
充分混合的时间以20-30分钟为宜。
在本发明的另一个优选实施例中,上述预防糖尿病及老年痴呆的保健制品,还包括1000-2000重量份鱼油(优选挪威深海鱼油)。
优选的,上述预防糖尿病及老年痴呆的保健制品为胶囊制剂,即本发明提供了一种蓝莓素/姜黄素/鱼油胶囊,具体制备方法为:
1.配料制备:将深海鱼油(EPAX鱼油)、姜黄素,蓝莓素按份数配比搅拌混合均匀(配方优选重量份比例为1.0:0.3:0.05),放在不锈钢缸中搅拌均匀。
2.胶液制备:将甘油、水和明胶按重量比例(0.5/1.0/1.0)在胶罐中混合搅拌,加热至70℃~80℃,搅拌均匀;加入焦糖色素(0.05,重量比例)搅拌均匀,抽真空20分钟,备用;
3.将搅拌均匀的混合鱼油和胶液送入胶囊机制出胶丸.经过干燥定型,包装。
在本发明的另一个优选实施例中,上述预防糖尿病及老年痴呆的保健制品,还包括100-200重量份的麋鹿鹿角和1000-2000重量份鱼油(优选挪威深海鱼油)。
优选的,上述预防糖尿病及老年痴呆的保健制品为胶囊制剂,即本发明提供了一种蓝莓素/姜黄素/鱼油/麋鹿鹿角胶囊,具体制备方法为:
1.配料制备:将深海鱼油(EPAX鱼油)、姜黄素,蓝莓素/麋鹿鹿角按份数配比(配方4:1.0/0.3/0.05/0.2),放在不锈钢缸中搅拌均匀。
2.胶液制备:将甘油、水和明胶重量比例(0.5/1.0/1.0)在胶罐中混合搅拌,加热至70℃~80℃,搅拌均匀;加入焦糖色素(0.05,重量比例)搅拌均匀,抽真空20分钟,备用
3.将搅拌均匀的混合鱼油和胶液送入胶囊机制出胶丸.经过干燥定型,包装。
上述姜黄素的制备方法为:新鲜姜黄根状茎用去离子水进行清洗,切片并在阳光下干燥一个星期。然后在50℃热风烘箱中干燥4-6小时以完全干燥。切成小块的干燥根茎,通过电子磨磨成粉末。每公斤粉末中加入5升丙酮(HPLC级)控制在56℃提取5小时。提取结束后,将原始提取物冷却下来,过滤,使用旋转蒸发器浓缩,真空干燥。提取物进一步通过HPLC提纯分离。(上述制备方法可参见文献:RevathySetal.isolation,purificationandidentificationofcurcumoidsfromTurmericbycolumnchromatography(2011).J.Exp.Sci.2:21-25)。
上述蓝莓素为蓝霉素提取液,优选瑞典本地蓝莓提取液具体制备方法为:采用最新的加压液体提取技术(pressurizedliquidextraction,PLE),也被称为加速溶剂萃取(acceleratedsolventextraction,ASE),一种替代传统提取和分馏天然产物一个清洁技术,通过调整其技术参数该方法可以选择性提取一组化合物的可能性。从蓝莓的果皮和果核提取含有抗氧化性的酚类化合物无疑增加蓝莓加工业的附加值(副产品)。蓝莓的果皮和果核经冷冻干燥-40-602-3天,干燥后经电磨磨碎。加入储存提取罐中,使用50%的水(pH2.0)和50%乙醇(99%)做为PLE提取溶剂,在一个封闭的提取罐的高压环境有助于提高被提取物在溶剂中的溶解度。通过控制温度(40-50℃),压力(20-40兆帕)和流速(10-20毫升/分钟)收集提取物。提取后的萃取液在在真空下30℃蒸发,得到纯的提取物。所有过程在避光下进行。(上述制备方法可参见文献:Meireles,M.A.2008.,WiboonsirikulJ.&Adachi.S.2008,Monrad,J.K.2010,JulianaPetal.2013)。
上述麋鹿鹿角,为麋鹿鹿角粉,其制备方法为:冷冻干燥法用于制备原料鹿角粉。鹿茸被冻结收割之后。切掉根部末端约1厘米,清洁。将剩余的部分在不锈钢托盘中切碎,迅速冷冻(-1℃)干燥,干燥的空气以减少据有生物活性的营养成分的损失和防止病原体污染。将干燥后的碎化物在液氮冷却后粉碎然后研磨成细粉末。(上述制备方法可参见文献:YudinA,etal.AGuideforthePreparationandStorageofUncalcifiedMaleAntlersasaMedicinalRawMaterial.In:ReindeerAntlers.AcademyofSciencesoftheUSSR.Vladivostock:FarEastScienceCenter;1974.)
上述鱼油优选挪威深海鱼油,本产品采用挪威EPAX鱼油(Ndustriveien33,NO-1337Sandvika)。此产品通常用于食品添加成分。Epax获深海鱼油领域所有最高认证:FRIENDOFSEA,欧盟REACH,GOEDOMEGA3PROUDMEMBER,欧盟GMP。同时EPAX制定鱼油欧米茄3浓度标准。
本发明的有益效果在于:
本配方把具有极强抗氧化性能的物质结合在一起。从而对糖尿病潜在人群、糖尿病患者及早期老年痴呆病人群和老年痴呆病患者起到预防效果。从稳定性的实验数据来看,该配方姜黄素的稳定性大为增加。
本配方的特色之一是,不仅胶囊的非透明深色外壳可以避免光,而且深颜色的蓝莓提取物可进一步保护里面由姜黄素和鱼油的混合物(从而保护姜黄素的降解)。在这种方式下,姜黄素稳定性会大大提高,同时姜黄素的生物利用度也保持在最优水平。我们的结果清楚表明配方中的姜黄素比单独姜黄素要稳定的多(表1和2)。一年后,超过90%的姜黄素仍保持完整,水解,降解和光降解相对较少。我们的配方很有效地解决了姜黄素的稳定性的问题,使得姜黄素存储时间大为增加。
随着年龄的增加,男性性功能逐渐减弱,鹿茸能促进身体恢复,加强和保护正常的生理进程,从而改善和提高性功能。在配方二和四里添加鹿茸除了起到预防老年性退行性疾病还能改善和提高性功能(适用于中老年男性)。
在本发明的一个优选实施例中,本发明的保健制品为蓝莓素/姜黄素/鱼油/麋鹿鹿角四种成份组方,最大的创新在于不仅很巧妙地把姜黄素和鱼油结合起来,而且利用蓝霉素来进一步保护姜黄素。即发挥了蓝霉素的作用,又保护了胶囊内的姜黄素。使两种有抗氧化性功能的天然物质有机地结合起来,一起发挥预防老年性退行性疾病的作用。
具体实施方式:
以下结合具体实施例,对本发明作进一步说明。应理解,以下实施例仅用于说明本发明而非用于限定本发明的范围。
实施例1:姜黄素的稳定性(水解降解和光解)的体外实验
实验材料
1.片剂:姜黄素/蓝莓素
配方1.片剂,每片含100毫克姜黄素+30毫克蓝莓素
配方2.片剂:每片含100毫克姜黄素+30毫克蓝莓素+100毫克麋鹿鹿角
对照品:姜黄素片剂,每片含100毫克姜黄素。
2.胶囊:蓝莓素/姜黄素/鱼油
配方3:每粒含1000毫克鱼油+300毫克姜黄素+50毫克蓝莓提取物
配方4:每粒含1000毫克鱼油+300毫克姜黄素+50毫克蓝莓提取物+200毫克麋鹿鹿角
对照品:姜黄素/鱼油胶囊,每粒含1000毫克鱼油+300毫克姜黄素。
上述片剂的制备方法:首先将姜黄素、蓝莓素(和麋鹿鹿角)按配方1、2混合搅拌均匀,加入30-50毫克/片的玉米淀粉做为辅料,进一步充分混合20-30分,将将上述混合均匀的组分送入压片机中压片。
上述胶囊的制备方法:
1.配料制备:将深海鱼油、姜黄素、蓝莓素(和麋鹿鹿角)按配方3、4放在不锈钢缸中搅拌均匀。
2.胶液制备:将甘油、水和明胶重量比例(0.5/1.0/1.0)在胶罐中混合搅拌,加热至70℃~80℃,搅拌均匀;加入焦糖色素(0.05,重量比例)搅拌均匀,抽真空20分,备用
3.将搅拌均匀的混合鱼油和胶液送入胶囊机制出胶丸.经过干燥定型,包装。
姜黄素光稳定性的测定实验:
所有样品都保存在正常室温下不具有光保护。
1.姜黄素含量分以下4个时间点来测定:一个月,三个月,六个月和十二个月。
2.用100-500毫克/毫升姜黄素构建的标准曲线,比较峰面面积来计算姜黄素的总量。姜黄素的浓度通过反相HPLC测定和分离。姜黄素在350nm波段处检测。姜黄素含量的百分比是通过使用高效液相色谱法(15cmx3.9毫米的NovaPak柱,紫外350nm波段)与标准的姜黄素溶液(标准值为100)比较进行测定。
3.姜黄素含量是来自测定10个样本的数据的统计平均值。
实验结果如表1、表2所示。
表1.姜黄素在不同的配方中的稳定性(片剂,降解和光分解)
表2.姜黄素在不同的配方中的稳定性(胶囊,降解和光分解)
实验结果清楚表明,配方中的姜黄素比单独姜黄素要稳定的多(表1和2)。一年后,超过90%的姜黄素仍保持完整,水解,降解和光降解相对较少。我们的配方很有效地解决了姜黄素的稳定性的问题,使得姜黄素存储时间大为增加。从上述表格可以看出,蓝莓素能有效的保持姜黄素的稳定性,解决可姜黄素光降解的问题。
以上已对本发明创造的较佳实施例进行了具体说明,但本发明创造并不限于所述实施例,熟悉本领域的技术人员在不违背本发明创造精神的前提下还可作出种种的等同的变型或替换,这些等同的变型或替换均包含在本申请权利要求所限定的范围内。
Claims (10)
1.一种预防糖尿病及老年痴呆的保健制品,所述保健制品的配方按重量份计,包括:
姜黄素100-300重量份,和
蓝莓素30-50重量份。
2.根据权利要求1所述的预防糖尿病及老年痴呆的保健制品,其特征在于,所述的保健制品还包括麋鹿鹿角100-200重量份。
3.根据权利要求1或2所述的预防糖尿病及老年痴呆的保健制品,其特征在于,所述的保健制品包括鱼油1000-2000重量份。
4.根据权利要求2所述的预防糖尿病及老年痴呆的保健制品,其特征在于,所述的保健制品配方中,以重量份计,姜黄素:蓝莓素:麋鹿鹿角为1.0:0.3:1.0。
5.根据权利要求3所述的预防糖尿病及老年痴呆的保健制品,其特征在于,所述的保健制品配方中,以重量份计,鱼油:姜黄素:蓝莓素为1.0:0.3:0.05。
6.根据权利要求3所述的预防糖尿病及老年痴呆的保健制品,其特征在于,所述的保健制品配方中,以重量份计,鱼油:姜黄素:蓝莓素:麋鹿鹿角为1.0:0.3:0.05:0.2。
7.根据权利要求1或2所述的预防糖尿病及老年痴呆的保健制品,其特征在于,所述的保健制品为片剂。
8.根据权利要求3所述的预防糖尿病及老年痴呆的保健制品,其特征在于,所述的保健制品为胶囊制剂。
9.根据权利要求1所述的预防糖尿病及老年痴呆的保健制品,其特征在于,所述的蓝莓素为蓝霉素提取液,是用加压液体提取技术从蓝莓的果皮和果核提取获得的,使用50%的pH2.0的水和50%乙醇作为提取溶剂。
10.蓝莓素在制备姜黄素防降解或光分解保护剂中的应用。
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