CN107307423A - 具有调节增强机体免疫功能的产品及制备方法 - Google Patents
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Abstract
本发明公开了具有调节增强机体免疫功能的产品及制备方法,本发明特征是结合传统与现代中医理论,响应国家对全民大健康产业发展规划,切实改善服用人群生活质量水平的设计初衷。精选名贵药食同源道地药材组方枸杞子善补肝肾精血、心肺脾阴液,也有补肾气作用;山药生津补肾;西洋参生津养阴、健脾益气;马鹿茸粉壮肾阳,益精血。枸杞子配伍马鹿茸粉,补阴液、益精血,温煦肾阳,滋养肾阴;枸杞子、山药配伍西洋参,益精血而滋肝养肾,生津液而濡润心脾。合用相使互补,阴阳气血双补五脏六腑皆益理论基础,达到增强免疫力之功效。应用现代工艺获取功效成分,确保产品具有安全、有效、质量可控。经国家有关权威部门批准测试。有助于提高生活质量。
Description
一、技术领域:
本发明涉及一种属于医药保健食品技术领域,特别是涉及一种具有调节增强免疫力功能的保健食品组合物,属于保健食品及其制备方法技术领域。
二、背景技术介绍:
免疫力是人体自身的防御机制,是人体识别和消灭外来侵入的任何异物(病毒、细菌等);处理衰老、损伤、死亡、变性的自身细胞以及识别和处理体内突变细胞和病毒感染细胞的能力。现代免疫学认为,免疫力是人体识别和排除“异己”的生理反应。由于人类生存的环境中存在着各种病菌,时刻威胁着人类的健康。一旦机体免疫力低下,免疫系统便不能发挥正常的保护作用,从而招致细菌、病毒、真菌的感染,致使机体处于健康与疾病的中间地带,医学上称之为“亚健康”。有资料显示,从50岁开始尤其到60岁以后,人体的各项生理功能逐渐衰退,免疫力下降最为显著。因此保持健康体魄,预防疾病的关键是提高机体免疫力。在快节奏、高压力的现代社会,人们的身心均处在紧张、疲劳的状态中,这就导致人群机体免疫功能不断退减。免疫力低下的各类人群的数量不断增加,为增强免疫力的保健食品提供了广阔的市场空间。
医学研究表明,人类99%的疾病都与免疫系统有关。影响人体免疫力的因素很多,比如,精神因素:工作压力大、工作环境嘈杂、精神紧张、过度劳累、易烦恼、精神消沉情绪烦躁等;心理因素:不良的心理状态可降低人体免疫力,增加疾病发病机率等;药物因素:使用激素、抗生素等药物的不良反应,抑制了免疫力,增加感染和肿瘤的发病率;不良习惯:膳食不合理,蛋白质、维生素、微量元素摄入不足,生活不规律,睡眠不足,缺乏体育锻炼等。据世界卫生组织调查数据表明,全球有75%的人处于亚健康状态。中国社科院亚健康研究中心的一份调查显示,我国城市健康人群占16%,非健康人群占14%,亚健康人群占70%(其中轻度患者约占40%,慢性患者约占30%)。从2003年的非典到2009年的猪流感之后,人们越来越关注自身的健康问题,而如何增强自身免疫力成为重中之重。随着人们保健意识的增强,增强机体免疫力的保健食品的市场空间将不断加大。
目前,市售增强免疫力产品较多,但这类产品多以提高某些机体器官功能或一味以滋补为主。但是免疫力低下往往是由多种综合因素导致,各个环节紧密相连,只针对其中某一个环节或因素是不全面和不彻底的,不能够满足免疫力低下人群的需求。本产品以中医理论为基础,通过对免疫力低下的各种原因进行总结,并结合现代医药研究成果,以枸杞子、山药、西洋参、马鹿茸粉等传统中药为主要原料,通过益气健脾、补肾养精达到增强免疫力的目的。本品药性温和,安全有效,可放心长期服用,对多种因素引起的免疫力低下均能起到很好的增强作用。
本发明产品是以中医理论为基础并结合现代医药研究成果,通过对具有增强免疫力作用的传统中药进行筛选,最终选定以枸杞子、山药、西洋参、马鹿茸粉为原料,通过益气健脾、补肾养精,达到增强免疫力的目的。根据各味药材的有效成分,通过提取、浓缩等工艺加工而成,既保证了有效成分的充分提取,也减少了药物服用量。通过毒理及功能实验证明,本品药性缓和,增强免疫力效果好,安全有效,可放心长期食用。
本发明保健功能筛选
(一)中医辨证
免疫力低下属中医“虚劳”范畴。《素问·通评虚实论篇》有“精气夺则虚”视为虚证之提纲。虚劳主要是由于机体气血亏损、阴阳失衡、五脏失养所致。《素问·上古天真论》既有“真气存之,精神内守,病从安来”主张“正气存内,邪不可干”、“邪之所凑,其气必虚”。正气包括气、血、阴、阳。气血阴阳与五脏相互依存,五脏失养致使气血亏损、阴阳失衡,而气血不足、阴阳失衡均可伤及五脏。脾为后天之本,主统血,为气血生化之源,主水谷精微之运化,濡养脏腑经络、四肢百骸,为机体抵抗外邪提供物质基础;“五脏之伤,穷必及肾”,肾为先天之本,主骨生精,藏真阴而寓元阳,为机体动力所在。肾气(又名元气)为正气之根,是激发与推动全身组织器官生理功能的原动力。肾气盛则卫气强,卫气为正气之旗,行于皮肤,分温腠理为机体防御外邪的第一道屏障。肾阴、肾阳为人体阴阳之根本所在,维持机体物质(阴)与功能(阳)之间的平衡。所谓“正盛邪自祛”只有五脏有所养,气血阴阳有所补,五脏各司其职、阴阳气血各守其位,共同抵御外邪,使机体强健,才能达到防御疾病的目的。
本着“益气健脾、补肾养精”的原则,我们选则枸杞子、山药、西洋参及马鹿茸粉为本品主要原料,通过补益先后天之不足,达到增强免疫力的目的。
(二)配方筛选
枸杞子,为茄科植物宁夏枸杞的干燥成熟果实。甘、平,归肝、肾经,具有滋补肝肾、益精明目的作用,主要用于虚劳精亏、腰膝酸痛、眩晕耳鸣、内热消渴等症。枸杞子主要含有、枸杞多糖、莨菪亭、甜菜碱、类胡萝素、维生素C等(钱彦丛等,2000)。杜光(2005) 研究发现枸杞多糖(LBP)对处于不同功能状态的巨嗜细胞均有明显的促进作用,且具有双向调节作用;LBP能增加总T细胞及TH亚群百分比,提高淋巴细胞转化率,提高人外周血单核细胞、白介素(IL-2)和肿瘤坏死因子α基因表达水平;LBP可增强小鼠对TD抗原刺激的抗体反应,增强溶血空斑数并增强巨噬细胞和NK细胞活性。枸杞子能明显促进刀豆蛋白A(ConA)活化,脾淋巴细胞DNA和蛋白质的生物合成。调节免疫实验提示,中、高剂量组抗体积数显著增加,高剂量组溶血空斑数明显升高,高剂量组耳郭肿胀度和中、高剂量组淋巴细胞转化试验吸光度差值显著增加,高剂量组单核一巨噬细胞的吞噬指数显著增加,高剂量组NK细胞活性显著增加。枸杞子对小鼠具有增强免疫作用(潘京一等,2003)。聂继红(2002)研究发现枸杞的水提物肌注,能明显促进网状内皮系统的吞噬功能,提高巨噬细胞吞噬率及吞噬指数,巨噬细胞数量增多、体积增大。枸杞多糖能明显升高环磷酰胺和60Co照射所致小鼠的白细胞数;还能显著增强小鼠腹腔巨噬细胞和受体的数量与活力,并能拮抗环磷酰胺对巨噬细胞和受体的抑制作用;枸杞子水煎剂尚可促进中性粒细胞吞噬活性,增加溶血空斑形成细胞数;枸杞多糖对处于不同状态的巨嗜细胞均有明显的促进作用;枸杞多糖对干扰素的诱生有促进作用;枸杞多糖不仅能明显增强ConA诱导的脾细胞增殖反应,而且单独使用时对脾细胞有直接促增殖作用;增加脾抗体形成细胞数目,增强脾细胞对抗原绵羊红细胞的抗体反应能力。枸杞多糖对小鼠体液免疫及细胞免疫均具有一定的增强作用。实验研究发现,枸杞煎剂对小鼠红细胞免疫有促进作用;促进小鼠肝脏T淋巴细胞分泌刺激因子,提高小鼠血清刺激活性水平(沈学英等,2000)。张凤兰等(2004)研究发现枸杞子水煎剂能使小鼠体内的卵清蛋白抗体显著升高;能使小鼠血清中IL-2生成水平显著升高。说明枸杞子具有增强免疫的作用。
山药,为薯蓣科植物薯蓣的干燥根茎。味甘,性平,归脾、肺、肾经,具有补脾养胃,生津益脾,补肾涩精之效。山药主要含有淀粉、蛋白质、多糖、尿囊素,氨基酸、胆甾醇、麦角甾醇等多种化学成分(姜芳婷等,2004)。蒋艳玲(2002)研究发现,山药多糖可明显拮抗 D-半乳糖所致衰老小鼠免疫器官组织的萎缩,使皮质厚度增加,皮质细胞数增加,淋巴细胞数增加。实验发现山药多糖能明显促进正常小鼠腹腔巨噬细胞吞噬功能,使吞噬百分率和吞噬指数均明显提高,明显促进正常小鼠溶血素形成,可使吸光度(OD)值明显提高,明显提高正常小鼠外周血T细胞百分比,明显促进正常小鼠的淋巴细胞转化(苗明三,1996)。研究发现, 山药多糖可不同程度地提高T淋巴细胞的增殖能力、NK细胞活性、血清溶血素活性、血清IgG 含量,也能增强巨噬细胞的吞噬能力,说明山药多糖既具有提高非特异性免疫功能又具有提高特异性细胞免疫和体液免疫功能,对全面改善机体的免疫功能具有重要的意义(赵国华等, 2002;程林等,2006)。赵彦青等(2000)实验发现山药多糖可明显提高环磷酰胺所致免疫功能低下小鼠腹腔巨噬细胞吞噬百分率和吞噬指数,促进其溶血素和溶血空斑的形成以及淋巴细胞转化,并明显提高外周血T淋巴细胞比率。
西洋参,为五加科植物西洋参的干燥根。味甘、微苦,性凉,归心、肺、肾经。具有补气养阴,清热生津之效。主要用于气虚阴亏,虚热烦倦等症。主要含有多糖、皂苷、氨基酸、蛋白质、有机酸、微量元素等。实验发现西洋参的水煎液可以增加小鼠抗体浓度,使其脾重和淋巴细胞转化率增加,西洋参胶囊可以提高免疫球蛋白IgG、IgA、IgM水平,从而增强机体免疫力(王红梅等,2002)。研究发现,西洋参皂苷能使TB淋巴细胞转化率显著提高,促进ConA诱导IL-2产生,显著提高脾脏T细胞百分率及B细胞的抗体产生水平,说明西洋参皂苷具有显著的增强免疫力的作用(包文芳等,1998)。西洋参含片和原粒茶能提高动物血清溶血素体积数、吞噬指数,提高NK细胞活性,提高ConA诱导的小鼠淋巴细胞转化(杨颖等,2003)。研究发现,西洋参多糖能促进淋巴细胞转化(朱伟等,1997)。西洋参等药组成的扶正排毒片可显著提高环磷酰胺所致免疫抑制小鼠腹腔巨噬细胞的吞噬功能,同时促进溶血素、溶血空斑的形成与外周血淋巴细胞的转化(彭勃等,2006)。
马鹿茸粉,为鹿科动物马鹿的雄鹿未骨化密生茸毛的幼角,劈成碎块,粉碎成细粉。甘、咸,温,归肝肾经。具有壮肾阳,益精血,强筋骨,调冲任,托疮毒的作用,主要用于肾阳不足,精血亏虚,阳痿遗精等症。鹿茸主要含有氨基酸、多肽、蛋白质、黏蛋白、黏多糖、氨基己糖、葡萄糖、脂溶性成分以及微量元素等。金光湖等(1993)研究发现,鹿茸提取物可增强迟延性免疫反应,可增加脾细胞中的玫瑰花结细胞数量,显著增加红细胞凝集素和红细胞溶血素,说明鹿茸可增强细胞和体液免疫功能,抑制由氨甲喋呤引发的免疫功能低下。研究发现,鹿茸多糖(PAPS)能增强机体免疫且能调节免疫功能,能够增加免疫功能低下小鼠的抗体形成细胞数,提高溶血素数,增强单核细胞吞噬功能;另外鹿茸多糖可激活免疫功能低下小鼠免疫机制杀伤肿瘤细胞,促进抗肿瘤免疫应答。鹿茸醇提物可增强机体免疫,促进蛋白质合成及机体生长发育;还可提高因环磷酰胺所致免疫功能低下动物模型的非特异性免疫功能及红细胞免疫功能(晋大鹏等,2009;齐艳萍等,2008)。燕飞等(2008)通过实验发现鹿茸口服液可显著增加正常小鼠溶血素水平,其中鹿茸口服液0.4mL、0.2mL、0.1mL三个剂量组均能显著提高免疫抑制小鼠溶血素抗体水平;鹿茸口服液0.4mL、0.1mL、0.05mL 三个剂量组对正常小鼠T淋巴细胞转化都有较强的促进作用,鹿茸口服液0.1mL剂量组能够显著提高免疫抑制小鼠T淋巴细胞转化功能,0.4mL剂量鹿茸口服液在促进免疫抑制小鼠B淋巴细胞转化上也体现出明显的效果;其次灌服鹿茸口服液能够增加正常小鼠脾指数,说明鹿茸能够提高正常小鼠和免疫抑制小鼠机体的免疫功能。
以西洋参、鹿茸等药组成的蜜炼鲜西洋参补液可使环磷酰胺所致免疫低下小鼠的免疫器官的发育得到改善,腹腔巨噬细胞酸性磷酸酶活力显著增强,说明其具有一定的增强免疫力的作用(李海军,2009)。以枸杞、山药等组成的扶正冲剂能改善机体免疫功能,促进活性E 玫瑰花结的增加(叶明波等,1983)。实验发现以枸杞、山药等组成的枸杞地黄汤能增加SOD 的活性,提高胸腺、脾指数,具有一定的增强免疫力的作用(陈四平等,2003)。以枸杞、西洋参等组成的枸杞袋泡茶能显著提高电离辐射小鼠的外周血白细胞数、淋巴细胞百分数、淋巴细胞绝对值、脏器指数和ConA刺激小鼠淋巴细胞增殖能力,说明复方枸杞袋泡茶对电离辐射所致的小鼠免疫功能损伤有保护作用(徐志毅,2011)。
功效成分及标志性成分选定:本产品所用原料中,多数药材含有皂苷类、多糖类成分,且皂苷类、多糖类成分为其发挥增强免疫力作用的主要药效成分,所以我们选总皂苷、粗多糖作为本品的标志性成分。
本发明产品按照药监部门及卫生部公布的关于进一步规范保健食品原料管理的通知(卫法监发[2002]51号)进行组方,原料均符合中国药典质量标准和卫生学要求。因本品需长期食用,考虑其安全性、有效性及稳定性,设计考虑到配方中药性搭配及各药材配伍可产生协同加强作用。经安全性毒理学评价试验、动物功能试验证明,本品安全有效,适用于免疫力低下人群食用。
综上所述,结合传统与现代中医理论,响应国家对全民大健康产业发展规划,切实改善服用人群生活质量水平的设计思路。本发明本着“益气健脾、补肾养精”的原则,以名贵药食同源道地药材组方枸杞子善补肝肾精血、心肺脾阴液,也有补肾气作用;山药生津补肾;西洋参生津养阴、健脾益气;马鹿茸粉壮肾阳,益精血。枸杞子配伍马鹿茸粉,补阴液、益精血,温煦肾阳,滋养肾阴;枸杞子、山药配伍西洋参,益精血而滋肝养肾,生津液而濡润心脾。四药合用,相使互补,阴阳气血双补,五脏六腑皆益,通过益气健脾、补肾养精达到增强免疫力之效。采用现代化加工提取制备工艺获取功效成分群并确保产品具有安全性、有效性、质量可控性。经国家有关权威部门批准并进行的安全有效测试。其药性温和有助于提高生活质量。
发明内容
本发明的目的在于,提供一种安全有效的达到调节增强服用人群免疫力之功效产品。
本发明提供的产品的原料组方包括:枸杞子、山药、西洋参、马鹿茸粉。
本发明提供的组方原料重量比包括:枸杞子100-800份、山药100-600份、西洋参100-600 份、马鹿茸粉30-200份。
根据本发明的原料重量比优选,对应包含枸杞子100份、山药100份、西洋参100份、马鹿茸粉30份。
根据本发明的原料重量比还优选,对应包含枸杞子600份、山药500份、西洋参400份、马鹿茸粉150份。
根据本发明的原料重量比还优选,对应包含枸杞子350份、山药300份、西洋参200份、马鹿茸粉70份。
根据本发明的原料重量比还优选,对应包含枸杞子800份、山药600份、西洋参600份、马鹿茸粉200份。
本发明具体由以下步骤的制备
1.枸杞子、山药、西洋参,三味药材分别净制,检验合格后备用。
2.马鹿茸粉经检验合格后,用5kGy剂量的60Co辐照灭菌后,备用。
3.取处方量半量西洋参干燥(60℃)后粉碎,过100目筛,收取细粉,用5kGy剂量的60Co 辐照灭菌后,备用。
4.取枸杞子、山药、剩余西洋参加水煎煮2次,每次加12倍量水,每次1.5小时,滤过(药渣弃),合并两次滤液,滤液减压浓缩(-0.065Mpa~-0.075Mpa,75℃)至相对密度为1.30~1.35(60℃测)的清膏,于65℃减压(-0.085Mpa)干燥,粉碎,过80目筛,得干膏粉。
5.将马鹿茸粉、西洋参细粉与干膏粉,混合均匀,用85%乙醇制软材,16目筛制粒,55~60℃干燥,14目筛整粒,装入0号胶囊,抛光,包装,检验,即得成品。
本发明提供的除胶囊剂型外也可以根据工艺制成片剂、胶囊或颗粒剂泡腾剂以及软胶囊等。
具体实施方式
下述实施例用于举例说明本发明的制备,但其不能对本发明的范围构成任何限制。
实施例1:
为了便于本发明产品应用,将该配方制备成胶囊剂:
原料药配比:枸杞子100g、山药100g、西洋参100g、马鹿茸粉30g。
制备方法:
(1)枸杞子、山药、西洋参,三味药材分别净制,检验合格后备用。
(2)马鹿茸粉经检验合格后,用5kGy剂量的60Co辐照灭菌后,备用。
(3)取50g西洋参干燥(60℃)后粉碎,过100目筛,收取50g细粉,用5kGy剂量的60Co辐照灭菌后,备用。
(4)取枸杞子、山药、剩余西洋参加水煎煮2次,每次加12倍量水,每次1.5小时,滤过 (药渣弃),合并两次滤液,滤液减压浓缩(-0.065Mpa~-0.075Mpa,75℃)至相对密度为1.30~1.35(60℃测)的清膏,于65℃减压(-0.085Mpa)干燥,粉碎,过80目筛,得干膏粉。
(5)将马鹿茸粉、西洋参细粉与干膏粉,混合均匀,用85%乙醇制软材,16目筛制粒,55~ 60℃干燥,14目筛整粒,装入0号胶囊,抛光,包装,检验,即得成品。
实施例2:
为了便于本发明保健食品的应用,将该保健食品制备成胶囊剂:
原料药配比:枸杞子600g、山药500g、西洋参400g、马鹿茸粉150g。
制备方法:
(1)枸杞子、山药、西洋参,三味药材分别净制,检验合格后备用。
(2)马鹿茸粉经检验合格后,用5kGy剂量的60Co辐照灭菌后,备用。
(3)取200g西洋参干燥(60℃)后粉碎,过100目筛,收取200g细粉,用5kGy剂量的60Co 辐照灭菌后,备用。
(4)取枸杞子、山药、剩余西洋参加水煎煮2次,每次加12倍量水,每次1.5小时,滤过(药渣弃),合并两次滤液,滤液减压浓缩(-0.065Mpa~-0.075Mpa,75℃)至相对密度为1.30~1.35(60℃测)的清膏,于65℃减压(-0.085Mpa)干燥,粉碎,过80目筛,得干膏粉。
(5)将马鹿茸粉、西洋参细粉与干膏粉,混合均匀,用85%乙醇制软材,16目筛制粒,55~ 60℃干燥,14目筛整粒,装入0号胶囊,抛光,包装,检验,即得成品。
实施例3:
为了便于本发明保健食品的应用,将该保健食品制备成胶囊剂:
原料药配比:枸杞子350g、山药300g、西洋参200g、马鹿茸粉70g。
制备方法:
(1)枸杞子、山药、西洋参,三味药材分别净制,检验合格后备用。
(2)马鹿茸粉经检验合格后,用5kGy剂量的60Co辐照灭菌后,备用。
(3)取100g西洋参干燥(60℃)后粉碎,过100目筛,收取100g细粉,用5kGy剂量的60Co 辐照灭菌后,备用。
(4)取枸杞子、山药、剩余西洋参加水煎煮2次,每次加12倍量水,每次1.5小时,滤过(药渣弃),合并两次滤液,滤液减压浓缩(-0.065Mpa~-0.075Mpa,75℃)至相对密度为1.30~1.35(60℃测)的清膏,于65℃减压(-0.085Mpa)干燥,粉碎,过80目筛,得干膏粉。
(5)将马鹿茸粉、西洋参细粉与干膏粉,混合均匀,用85%乙醇制软材,16目筛制粒,55~ 60℃干燥,14目筛整粒,装入0号胶囊,抛光,包装,检验,即得成品。
实施例4:
为了便于本发明保健食品的应用,将该保健食品制备成胶囊剂:
原料药配比:枸杞子800g、山药600g、西洋参600g、马鹿茸粉200g。
制备方法:
(1)枸杞子、山药、西洋参,三味药材分别净制,检验合格后备用。
(2)马鹿茸粉经检验合格后,用5kGy剂量的60Co辐照灭菌后,备用。
(3)取300g西洋参干燥(60℃)后粉碎,过100目筛,收取300g细粉,用5kGy剂量的60Co 辐照灭菌后,备用。
(4)取枸杞子、山药、剩余西洋参加水煎煮2次,每次加12倍量水,每次1.5小时,滤过 (药渣弃),合并两次滤液,滤液减压浓缩(-0.065Mpa~-0.075Mpa,75℃)至相对密度为1.30~1.35(60℃测)的清膏,于65℃减压(-0.085Mpa)干燥,粉碎,过80目筛,得干膏粉。
(5)将马鹿茸粉、西洋参细粉与干膏粉,混合均匀,用85%乙醇制软材,16目筛制粒,55~ 60℃干燥,14目筛整粒,装入0号胶囊,抛光,包装,检验,即得成品。
试验例
为阐明本发明保健食品具有治疗高血压的效果,按实施例方法所制得的保健食品药物进行了下列试验。
1、经疾病预防控制中心进行注册检验功效成分检测、稳定性实验、卫生学检测。
实验结果均符合设计要求,并符合保健食品的注册要求。
2、保健食品安全性评价
按照《保健食品检验与评价技术规范》2003年版(毒理学检验方法)
小鼠急性经口毒性试验、骨髓细胞微核试验、精子畸形试验和大鼠30天喂养试验
检测结论:
2.1本发明产品对两种性别的SPF级昆明种小鼠急性经口毒性试验,累计两次灌胃剂量达20g/KgBW(相当于人群推荐日摄入量0.035g/kgBW的571倍),在14天的观察期内动物未见明显中毒症状和死亡,该受试样品MTD>20g/kgBW,依据急性毒性分级评价标准规定,该受试样品属无毒级;
2.2二项致突变试验小鼠骨髓细胞微核试验和精子畸形试验结果均为阴性;
2.3 30天喂养试验结果表明:将受试样品按0.875,1.750,3.500g/kg BW剂量(分别相当于人群推荐日摄入量0.0358/kgBW的25,50,100倍)对SPF级Wistar大鼠连续给予30天,动物未见明显的中毒症状和死亡。受试样品各剂量组大鼠体重、进食量、食物利用率、血液学、血液生化、脏器重量、脏/体比值以及病理组织学等指标写阴性对照组比较,差异均无显著性,结果为:未发现该受试样品有明显的毒性作用。
2.4 Ames试验对鼠伤寒沙门氏菌TA97、TA98、TAlOO、TA102四株试验菌株,在加与不加S9时,0.2、0.5、1.0、2.5、5.0mg/皿5个剂量组回变菌落数均未超过阴性对照菌落数2倍,亦无剂量一反应关系,Ames试验结果阴性。
3、保健食品功能检查
检测依据《保健食品检验与评价技术规范》(功能学评价检验方法)
检测结论:
本发明产品提供的人体推荐日摄入量2.1g/60kg BW(即0.035g/kg BW)扩大10,20,30 倍设置低、中、高三个剂量组,即0.35g/kg BW,0.70g/kg BW,1.05g/kg BW,另设阴性对照组。采用SPF级昆明种小鼠,连续经口灌胃给予,30天后开始实验。实验结果以P<0.05判断为显著性差异,各剂量组与阴性对照组比较,结果显示:
1)各剂量组小鼠体重、淋巴器官/体重比值差异均无显著性;
2)各剂量组没有显著增强ConA诱导的小鼠脾淋巴细胞增殖反应的能力:
3)高剂量组能显著增强二硝基氟苯诱导的小鼠迟发型变态反应;
4)高剂量组能显著升高小鼠血清溶血素含量;
5)高剂量组能显著增强小鼠腹腔巨噬细胞吞噬鸡红细胞功能;
6)高剂量组能显著增强小鼠碳廓清能力;
7)高剂量组能显著增强抗体生成细胞能力;
8)各剂量组没有显著增强小鼠NK细胞活性能力。
按照增强免疫力功能作用评价程序规定,该受试物具有增强免疫力功能作用。
附图说明
图1:本发明的工艺制备流程图。
Claims (8)
1.一种具有具有调节增强机体免疫功能性产品及制备方法,其特征在于所述配方由枸杞子、山药、西洋参、马鹿茸粉组成。
2.根据权利要求1所述的功能性产品,其特征在于所述原料的重量比例为:枸杞子100-800份、山药100-600份、西洋参100-600份、马鹿茸粉30-200份。
3.根据权利要求2所述的功能性产品,其特征在于所述原料的重量比例为:枸杞子100份、山药100份、西洋参100份、马鹿茸粉30份。
4.根据权利要求2所述的功能性产品,其特征在于所述原料的重量比例为:枸杞子600份、山药500份、西洋参400份、马鹿茸粉150份。
5.根据权利要求2所述的功能性产品,其特征在于所述原料的重量比例为:枸杞子350份、山药300份、西洋参200份、马鹿茸粉70份。
6.根据权利要求2所述的功能性产品,其特征在于所述原料的重量比例为:枸杞子800份、山药600份、西洋参600份、马鹿茸粉200份。
7.根据权利要求2-6任一所述的功能性产品的活性成分制备方法,其特征在于所述活性成分的制备方法由以下步骤制成:
(1).枸杞子、山药、西洋参,三味药材分别净制,检验合格后备用;
(2).马鹿茸粉经检验合格后,用5kGy剂量的60Co辐照灭菌后,备用;
(3).取处方量半量西洋参干燥(60℃)后粉碎,过100目筛,收取细粉,用5kGy剂量的60Co辐照灭菌后,备用;
(4).取枸杞子、山药、剩余西洋参加水煎煮2次,每次加12倍量水,每次1.5小时,滤过(药渣弃),合并两次滤液,滤液减压浓缩(-0.065Mpa~-0.075Mpa,75℃)至相对密度为1.30~1.35(60℃测)的清膏,于65℃减压(-0.085Mpa)干燥,粉碎,过80目筛,得干膏粉。
(5).将马鹿茸粉、西洋参细粉与干膏粉,混合均匀,用85%乙醇制软材,16目筛制粒,55~60℃干燥,14目筛整粒,装入0号胶囊,抛光,包装,检验,即得成品。
8.根据权利要求2-7任一所述的保健食品的活性成分制备方法,其特征在于所述保健食品的制剂剂型同时也可开发为片剂、丸剂、颗粒剂、口服液或保健饮料。
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