CN109453355A - 一种预防孕期三高的组合物、功能饮料及其制备方法 - Google Patents
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Abstract
本发明公开了一种预防孕期三高的组合物,包括:叶酸类化合物0.0002‑0.0005份,维生素B6 0.0003‑0.0025份,大枣2‑3份,山药5‑7.5份,生姜1‑1.5份和竹茹1.6‑2.5份;还提供了包括上述组合物和15‑25重量份甜味剂的功能饮料以及该功能饮料的制备方法。与现有技术相比,本发明预防孕期三高的组合物和功能饮料,可有效减少孕期不良反应,增强孕妇免疫力,提高孕妇体能,有效预防孕期三高,缓解孕期不良反应、增强孕妇体质。
Description
技术领域
本发明属于保健品技术领域,具体涉及一种预防孕期三高的组合物、功能饮料及其制备方法。
背景技术
妊娠是复杂的生理过程,女性在妊娠期的生理状态和代谢都会发生极大的变化,如血浆容量增加、器官体积增大,需要大量能量及营养素的补给,因此极易出现各种不适症状,这是很多孕妇普遍的经历。这些不适症状包括恶心呕吐、胃区不适、背痛、眩晕、痉挛、疲劳乏力、贫血、免疫力低下、孕期“三高”等等,这些不良反应给准妈妈们带来了严重的身体和心理负担。
与此同时,叶酸是神经系统正常发育所必需的重要营养元素,孕妇缺乏叶酸可能导致胎儿出生时出现低体重、唇腭裂、心脏缺陷等。孕前及孕后三个月内补充叶酸可有效预防胎儿神经管畸形。含叶酸的食物很多,但由于叶酸遇光、遇热不稳定,容易失去活性,所以人体真正能从食物中获得的叶酸并不多,因此孕妇需要额外补充叶酸。
目前,孕妇主要通过叶酸制剂补充叶酸,绝大部分为固体口服制剂,市场在售的具有补充叶酸的食品、饮料,种类少,组方各异,功效不一,且没有同时具有补充叶酸并缓解妊娠反应的功能。
目前,市面上已有一些缓解孕期不良反应的药物、食品或保健品,但这类产品存在的问题是功能较为单一,仅仅改善某一方面的不良反应,如中国专利CN105311607A公开了一种治疗妊娠反应的中药组合物,该组合物由孩儿参、素馨花、岗稔根、清半夏、云苓、竹茹、橘皮、佩兰叶、生姜经特定比例制成,可用于治疗妊娠反应。但该专利所述组合物的作用,主要是缓解恶心、头晕、呕吐、乏力这类妊娠不良反应,对于贫血、免疫力降低、孕期三高等不良反应却未有涉及。
因此,针对孕妇群体普遍存在的孕期不良反应,以及对叶酸的需求,亟需研发一种既可以预防孕期三高、缓解孕期不良反应,同时也可以补充叶酸的组合物及其功能饮料。
发明内容
本发明提供了一种具有提高免疫力、提高体能、补血补气、减少妊娠反应、预防孕期三高作用的组合物及其功能饮料,具有不添加防腐剂和色素,口感良好,适合广大女性,尤其是孕期及备孕期女性饮用。同时还提供了上述功能饮料制备方法,对设备要求低、工艺简单,成本低,为功能饮料的规模化生产提供了技术支持。
为了实现上述目的,本发明采用以下技术方案:
一种预防孕期三高的组合物,其特征在于,包括以下重量份的组分:叶酸类化合物0.0002-0.0005份,维生素B6 0.0003-0.0025份,大枣2-3份,山药5-7.5份,生姜1-1.5份和竹茹1.6-2.5份。
优选地,所述叶酸类化合物为叶酸、甲酰四氢叶酸、L-甲基叶酸、叶酸可药用盐、叶酸或叶酸可药用盐的活性代谢产物和可在体内代谢和/或生成叶酸的物质中的至少一种;更优选为叶酸。
大枣为鼠李科植物枣的成熟果实,功能主治为:补脾和胃,益气生津,调营卫,解药毒。治胃虚食少,脾弱便溏,气血津液不足,营卫不和,心悸怔忡,妇人脏躁。
山药为薯蓣科植物薯蓣的块茎,功能主治为:健脾,补肺,固肾,益精。治脾虚泄泻,久痢,虚劳咳嗽,消渴,遗精、带下,小便频数。补脾养胃,生津益肺,补肾涩精。
生姜是姜科多年生草本植物姜的新鲜根茎,味辛,性微温。具有解表散寒、温中止呕、温肺止咳、解毒的功效,常用于风寒感冒,脾胃寒症,胃寒呕吐,肺寒咳嗽,解鱼蟹毒。
竹茹为禾本科植物青秆竹、大头典竹或淡竹的茎秆的干燥中间层,具有清热化痰,除烦,止呕的功效,用于痰热咳嗽,胆火挟痰,惊悸不宁,心烦失眠,中风痰迷,舌强不语,胃热呕吐,妊娠恶阻,胎动不安。
作为另一种优选方案,所述的组合物为,还包括如下重量份的组分:阿胶0.5-1.5份、白芍1-3份、刺五加2-4.5份、党参3-4.5份、杜仲1-3份、甘草0.5-1份、红景天0.5-1.5份、黄精2-4.5份、麦冬1.5-3份、枸杞1.5-3份。
阿胶为马科动物驴的皮去毛后熬制而成的胶块,功能主治为:滋阴补血,安胎。治血虚,虚劳咳嗽,吐血,衄血、便血,妇女月经不调,崩中,胎漏。
白芍为毛茛科植物芍药的干燥根,具有养血调经,敛阴止汗,柔肝止痛,平抑肝阳之功效。常用于血虚萎黄,月经不调,自汗,盗汗,胁痛,腹痛,四肢挛痛,头痛眩晕。
刺五加为五加科植物刺五加的根及根皮,性温,味辛、微苦,益气健脾、补肾安神。
党参为桔梗科植物党参、素花党参、或川党参等的干燥根,味甘,性平,补中益气、止渴、健脾益肺,养血生津。用于脾肺气虚,食少倦怠,咳嗽虚喘,气血不足,面色萎黄,心悸气短,津伤口渴,内热消渴,懒言短气、四肢无力、食欲不佳、气虚、气津两虚、气血双亏以及血虚萎黄等症。
杜仲为杜仲科植物杜仲的树皮,功能主治为:补肝肾,强筋骨,安胎。治腰脊酸疼,足膝痿弱,小便余沥,阴下湿痒,胎漏欲堕,胎动不安,高血压。
甘草为豆科植物甘草、胀果甘草或光果甘草的干燥根和根茎,具有补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药之功效。常用于脾胃虚弱,倦怠乏力,心悸气短,咳嗽痰多,痈肿疮毒,缓解药物毒性、烈性。
红景天为景天科大花红景天的干燥根和根茎,味甘、苦,性平,具有益气活血,通脉平喘之功。主要用于气虚血瘀,胸痹心痛,中风偏瘫,倦怠气喘。
黄精为百合科植物滇黄精、黄精或多花黄精的燥根茎,具有补气养阴,健脾,润肺,益肾之功效。常用于脾胃气虚,体倦乏力,胃阴不足,口干食少,肺虚燥咳,劳嗽咳血,精血不足,腰膝酸软,须发早白,内热消渴。
麦冬为百合科植物麦冬的干燥块根,功能主治为:养阴生津,润肺止咳;用于肺胃阴虚之津少口渴、干咳咯血;心阴不足之心悸易惊及热病后期热伤津液等证。
枸杞为茄科植物宁夏枸杞的成熟果实。性平,味甘,滋补肝肾、益精明目。属补虚药下属分类的补阴药。用治虚劳精亏、腰膝酸痛、眩晕耳鸣、内热消渴、血虚萎黄、目昏不明。
本发明还提供了上述预防孕期三高的组合物在食品和/或保健品中的应用。
本发明还提供了一种预防孕期三高的功能饮料,包括上述的组合物和15-25重量份的甜味剂。
优选地,所述甜味剂为白砂糖、蜂蜜、木糖醇、山梨糖醇、阿斯巴甜中的至少一种。
本发明还提供了上述功能饮料的制备方法,包括以下步骤:
(1)将维生素B6、叶酸和甜味剂以外的组分,按照原料配方的用量,混合,得中药组分;
(2)向步骤(1)得到的中药组分中加水,浸泡、煎煮、过滤,得煎煮液1和药渣;向药渣中再加水,煎煮、过滤,得煎煮液2;
(3)将步骤(1)得到的煎煮液1和煎煮液2合并浓缩,冷却后加入叶酸、维生素B6及甜味剂搅拌均匀,灭菌灌装即可。
优选地,步骤(2)中所述的中药组分和水的质量比为1:(10-20);所述的药渣和水的质量比为1:(10-20)。
优选地,步骤(2)中所述的浸泡为:35-45℃下浸泡30min。
优选地,步骤(2)中所述两次煎煮的条件为:95-100℃下煎煮1-2h。
优选地,步骤(3)中所述的浓缩为:在60-80℃下浓缩至0.5-0.6g中药组分/mL。
优选地,步骤(3)中所述的冷却为:冷却至温度小于45℃。
与现有技术相比,本发明的有益效果为:
(1)本发明所述的组合物通过各成分的合理配比、协同增效,可有效减少孕期不良反应,增强孕妇免疫力,提高孕妇体能,缓解疲劳,同时气血双补,有效预防孕期三高,缓解孕期不良反应、增强孕妇体质;
(2)本发明所述组合物中添加叶酸,使其在减少孕期不良反应、增强孕妇体质的同时,有效为孕妇补充叶酸,预防胎儿神经管畸形;
(3)本发明所述功能饮料将传统的中药材与维生素结合,功效全面,且方便携带,味道可口,人群接受度高,适用于广大女性,尤其是孕妇及备孕期女性。
(4)本发明的功能饮料的制备方法,对设备要求低、工艺简单,适合大规模的生产,为本发明功能饮料的推广应用提供了技术支撑。
具体实施方式
以下通过特定的实施方式,本领域技术人员可由本说明书所揭露的内容轻易地了解本发明的其他优点与功效。本发明还可以通过另外不同的具体实施方式加以实施或应用,本说明书中的各项细节也可以基于不同观点与应用,在没有背离本发明的精神下进行各种修饰或改变。
在进一步描述本发明具体实施方式之前,应理解,本发明的保护范围不局限于下述特定的具体实施方案;还应当理解,本发明实施例中使用的术语是为了描述特定的具体实施方案,而不是为了限制本发明的保护范围。
当实施例给出数值范围时,应理解,除非本发明另有说明,每个数值范围的两个端点以及两个端点之间任何一个数值均可选用。除非另外定义,本文中使用的所有技术和科学术语具有与本发明所属技术领域的普通技术人员通常理解的相同意义。
无特殊说明,本发明所采用的原料均为目前普通的市售产品。
一种预防孕期三高的组合物,其特征在于,包括以下重量份的组分:叶酸类化合物0.0002-0.0005份,维生素B6 0.0003-0.0025份,大枣2-3份,山药5-7.5份,生姜1-1.5份和竹茹1.6-2.5份。
优选地,所述叶酸类化合物为叶酸、甲酰四氢叶酸、L-甲基叶酸、叶酸可药用盐、叶酸或叶酸可药用盐的活性代谢产物和可在体内代谢和/或生成叶酸的物质中的至少一种;更优选为叶酸。
在所述的组合物中,叶酸的用量为按重量份计0.0002-0.0005份;优选为0.0003-0.0005份;更进一步优选为0.0004份。
在所述的组合物中,维生素B6的用量为按重量份计0.0003-0.0025份;优选为0.0004-0.0025份;再进一步优选为0.001份。
在所述的组合物中,大枣的用量为按重量份计2-3份;优选为2份。
在所述组合物中,山药的用量为按重量份计5-7.5份;优选为5份。
在所述组合物中,生姜的用量为按重量份计1-1.5份;优选为1份。
在所述组合物中,竹茹用量为按重量份计1.6-2.5份;优选为2份。
以上技术方案均能够实现本发明所述的技术效果,但在一些优选的实施方案中,所达到的技术效果优于其他方案。
例如:
竹茹与大枣的比例为1:1,其中一个优选的组合物其具体组分用量按重量份计分别为叶酸0.0003份,维生素B6 0.0004份,大枣2.2份,山药7.5份,生姜1.5份和竹茹2.2份。
最为优选的组合物其具体组分用量按重量份计分别为:叶酸0.0004份,维生素B60.001份,大枣2份,山药5份,生姜1份和竹茹2份。
作为另一种优选的方案,所述的预防孕期三高的组合物组合物,还包括如下重量份的组分:阿胶1-1.5份、白芍2-3份、刺五加3-4.5份、党参3-4.5份、杜仲2-3份、甘草0.7-1份、红景天1-1.5份、黄精3-4.5份、麦冬2-3份、枸杞2-3份。
在所述的组合物中,阿胶的用量为按重量份计1-1.5份;优选为1份。
在所述的组合物中,白芍的用量为按重量份计2-3份;优选为2份。
在所述的组合物中,刺加五的用量为按重量份计3-4.5份;优选为3份。
在所述的组合物中,党参的用量为按重量份计3-4.5份;优选为3份。
在所述的组合物中,杜仲的用量为按重量份计2-3份;优选为2份。
在所述的组合物中,甘草的用量为按重量份计0.7-1份;7优选为0.7份。
在所述的组合物中,红景天的用量为按重量份计1-1.5份;优选为1份。
在所述的组合物中,黄精的用量为按重量份计3-4.5份;优选为3份。
在所述的组合物中,麦冬的用量为按重量份计2-3份;优选为2份。
在所述的组合物中,枸杞的用量为按重量份计2-3份;优选为2份。
以上技术方案均能够实现本发明所述的技术效果,但在一些优选的实施方案中,所达到的技术效果优于其他方案。
例如:
阿胶与白芍的比例为1:2,其中一个优选的组合物其具体组分用量按重量份计分别为叶酸0.0004份,维生素B6 0.001份,大枣2份,山药5份,生姜1份,竹茹2份,阿胶0.5份、白芍1份、刺五加2份、党参4.5份、杜仲1份、甘草0.6份、红景天0.5份、黄精2份、麦冬3份和枸杞2份。
最为优选的组合物其具体组分用量按重量份计分别为:叶酸0.0004份,维生素B60.001份,大枣2份,山药5份,生姜1份,竹茹2份,阿胶1份、白芍2份、刺五加3份、党参3份、杜仲2份、甘草0.7份、红景天1份、黄精3份、麦冬2份和枸杞2份。
本发明还提供了上述预防孕期三高的组合物在食品和/或保健品中的应用。
本发明还提供了一种预防孕期三高的功能饮料,包括上述的组合物和15-25重量份的甜味剂。
优选地,所述甜味剂为白砂糖、蜂蜜、木糖醇、山梨糖醇、阿斯巴甜中的至少一种;进一步优选为木糖醇。
本发明还提供了上述功能饮料的制备方法,包括以下步骤:
(1)将维生素B6、叶酸和甜味剂以外的组分,按照原料配方的用量,混合,得中药组分;
(2)按照质量比1:(10-20);向步骤(1)得到的中药组分中加水,浸泡、煎煮、过滤,得煎煮液1和药渣;按照质量比1:(10-20),向药渣中再加水,煎煮、过滤,得煎煮液2;
(3)将步骤(1)得到的煎煮液1和煎煮液2合并,在60-80℃下浓缩至0.5-0.6g中药组分/mL,冷却至温度小于45℃,加入维生素B6、叶酸及甜味剂搅拌均匀,灭菌灌装即可。
步骤(2)中所述的浸泡为:35-45℃下浸泡30min,两次煎煮的条件均为:95-100℃下煎煮1-2h。
实施例1-8及对比例1
表1.实施例1-4及对比例1的组分及含量(重量份)
组分 | 实施例1 | 实施例2 | 实施例3 | 实施例4 | 对比例1 |
叶酸 | 0.0002 | 0.0005 | 0.0003 | 0.0004 | 0.0004 |
维生素B<sub>6</sub> | 0.0003 | 0.0025 | 0.0004 | 0.001 | 0.001 |
大枣 | 2 | 3 | 2.2 | 2 | 1 |
山药 | 5 | 7.5 | 7.5 | 5 | 4 |
生姜 | 1 | 1.5 | 1.5 | 1 | 0.5 |
竹茹 | 1.6 | 2.5 | 2.2 | 2 | 1.5 |
表2.实施例5-8的组分及含量(重量份)
组分 | 实施例5 | 实施例6 | 实施例7 | 实施例8 |
叶酸 | 0.0004 | 0.0004 | 0.0004 | 0.0004 |
维生素B<sub>6</sub> | 0.001 | 0.001 | 0.001 | 0.001 |
大枣 | 2 | 2 | 2 | 2 |
山药 | 5 | 5 | 5 | 5 |
生姜 | 1 | 1 | 1 | 1 |
竹茹 | 2 | 2 | 2 | 2 |
阿胶 | 1 | 1.2 | 1.5 | 0.4 |
白芍 | 2 | 2.8 | 3 | 1.5 |
刺加五 | 3 | 4.5 | 4 | 2.5 |
党参 | 3 | 3.5 | 4.5 | 2.5 |
杜仲 | 2 | 3 | 2.5 | 1.5 |
甘草 | 0.7 | 1 | 0.8 | 0.5 |
红景天 | 1 | 1.5 | 1.8 | 0.7 |
黄精 | 3 | 4.5 | 4 | 2.5 |
麦冬 | 2 | 2.5 | 3 | 1.5 |
枸杞 | 2 | 3 | 2.5 | 1.5 |
将实施例1-8和对比例1的组合物与15份甜味剂混合制备成功能饮料,其具体制备方法,包括以下步骤:
(1)将维生素B6、叶酸和甜味剂以外的组分,按照原料配方的用量,混合,得中药组分;
(2)按照质量比1:20;向步骤(1)得到的中药组分中加水,浸泡、煎煮、过滤,得煎煮液1和药渣;按照质量比1:20,向药渣中再加水,煎煮、过滤,得煎煮液2;
(3)将步骤(1)得到的煎煮液1和煎煮液2合并,在60℃下浓缩至0.6g中药组分/mL,冷却至温度小于45℃,加入维生素B6、叶酸及甜味剂搅拌均匀,灭菌灌装即可。
步骤(2)中所述的浸泡为:45℃下浸泡30min,两次煎煮的条件均为100℃下煎煮2h。
一、抵抗力功能评价
检测依据:卫生部《保健食品检验与评价技术规范》(2003年版)。
1、实验动物
选用广东省医学实验动物中心繁殖的SPF级健康成年昆明种雄性小鼠300只,体重为18~22g。动物室温度:22-25℃,相对湿度:55-70%。
2、免疫力功能评价
剂量分组及受试样品给予时间
本组合物人体推荐量为每人每日50mL(0.83mL/kg),小鼠实验用剂量设置低、正常、高3个剂量水平,即每日4.15、8.30和24.90mL/kg(分别相当于人体推荐量的5、10、30倍),同时设置阴性对照组,将实验小鼠按照体重随机分成9批,每批4组,每组10只。
各称取5.25mL、10.50mL和31.25mL上述实施例1-8和对比例1制备的功能饮料,分别加纯水至50mL,分别配成0.11mL/mL、0.21mL/mL和0.63mL/mL浓度溶液,灌胃体积为0.2mL/10g体重,每天灌胃2次,阴性对照组给予等体积的纯水,连续30d。
2.1细胞免疫功能
1、ConA诱导的小鼠脾淋巴细胞转化实验(MTT法)
无菌取脾,制成细胞悬液。将每一份脾细胞悬液分两孔加入24孔培养板中,每孔1mL,一孔加75μL ConA液(相当于7.5μg/mL),另一孔作为对照,置5%CO2,37℃CO2孵箱中培养72h。培养结束前4h,每孔轻轻吸去上清液0.7mL,加入0.7mL不含小牛血清的RPMI1640培养液,同时加入MTT(5mg/mL)50μL/孔,继续培养4h。培养结束后,每孔加入1mL酸性异丙醇,超声震荡(2秒),使紫色结晶完全溶解。然后分装到96孔培养板中,每个孔分装3孔作为平行样,用酶联免疫检测仪,以570nm波长测定光密度值。用加ConA孔的光密度值减去不加ConA孔的光密度值代表淋巴细胞的增殖能力,受试样品组的光密度差值显著高于对照组的光密度差值,可判定该项实验结果阳性。
2、迟发型变态反应(DTH)
灌胃第26天,给小鼠腹腔注射2%绵羊红细胞(SRBC)0.2mL用于致敏,于免疫后第4天,右耳均匀涂抹1%DNFB溶液20μL攻击,左耳作对照,注射后于24h处死小鼠,取左右相同大小耳片称重,其重量之差作为肿胀度。以肿胀度来表示DTH的程度。受试样品组的差值显著高于对照组的差值,可判定该项实验结果阳性。同时取小鼠的胸腺及脾脏称重,计算脏器/体重比值。
2.2体液免疫功能
1、抗体生成细胞检测(Jerne改良玻片法)
于灌胃的第26天给每只小鼠腹腔注射0.2mL的2%(v/v)压积SRBC,将SRBC免疫4-5天后的小鼠颈椎脱臼处死,无菌取脾脏,以完全培养基RPMI1640制备成5×106个细胞/mL的脾细胞悬液。并制作琼脂糖玻片,将其放入37℃、5%的CO2培养箱中孵育1h,然后每孔加入500μl以完全培养基稀释的补体(v/v,1:10),继续孵育2h,计数每张琼脂薄层玻片上形成的溶血空斑数,用空斑数/106脾细胞来表示抗体生成细胞数。
2、半数溶血值(HC50)的测定
将压积SRBC用生理盐水配成2%(v/v)的细胞悬液,每只鼠腹腔注射0.2mL进行免疫。4d后,摘除眼球取血于离心管内,放置约1h,将凝固血与管壁剥离,使血清充分析出,2000r/min离心10min,收集血清。取血清用SA缓冲液稀释200倍。将稀释后的血清1mL置试管内,依次加入0.5mL的10%(v/v)SRBC,补体1mL(用SA液按1:8稀释)。另设不加血清的对照管(以SA缓冲液代替)。置37℃恒温水浴中保温20min后,冰浴终止反应。2000r/min离心10min。取上清液1mL,加都氏试剂3mL,同时取0.25mL的10%(v/v)SRBC加都氏试剂至4mL,充分混匀,放置10min后,于540nm处以对照管作空白,分别测定各管光密度值。
溶血素的量以半数溶血值(HC50)表示,按下列公式计算:
受试样品组的HC50显著高于对照组的HC50,可判定该项实验结果阳性。
2.3单核-巨噬细胞功能
1、小鼠碳廓清实验
从小鼠尾静脉注入稀释的印度墨汁,按每10g体重0.1mL计算。待墨汁注入,立即计时。注入墨汁后2、10min,分别从内眦静脉丛取血20μL,并立即将其加到2mL的1%Na2CO3溶液中,测OD600nm脾脏,用滤纸吸干脏器表面血污,称重。
以吞噬指数表示小鼠碳廓清的能力。
K=(lgOD2min-1gOD10min)/(10min-2min)
受试样品组的吞噬指数显著高于对照组的吞噬指数,可判定该项实验结果阳性。
2、小鼠腹腔巨噬细胞吞噬鸡红细胞实验(滴片法)
给每只小鼠腹腔注射2%(v/v)压积SRBC0.2mL激活腹腔巨噬细胞,5d后处死小鼠,腹腔注射加小牛血清Hank’s液4mL/鼠,轻轻按揉腹部20次,吸取腹腔洗液与等量的1%鸡红细胞混匀。吸取1mL混合液,滴片,37℃孵育20min,冲洗,固定,Giemsa液染色,镜检,计数吞噬率和吞噬指数(吞噬率为每100个巨噬细胞中吞噬鸡红细胞的巨噬细胞所占的百分率;吞噬指数为平均每个巨噬细胞吞噬鸡红细胞的个数)。
2.4NK细胞活性测定
1、乳酸脱氢酶(LDH)测定法
无菌取脾,制成单个细胞悬液作为效应细胞。取靶细胞和效应细胞各100μL(效靶比50:1),加入U型96孔培养板中;靶细胞自然释放孔加靶细胞和培养液各100μL,靶细胞最大释放孔加靶细胞和2.5%Triton各100μL;上述各项均设三个复孔,于37℃、5%CO2培养箱中培养4h,然后将96孔培养板以1500r/min离心5min,每孔吸取上清100μL置平底96孔培养板中,同时加入LDH基质液100μL,反应3min,每孔加入1mol/L的HCl 30μL,在酶标仪490nm处测定光密度值(OD)。
受试样品组的NK细胞活性显著高于对照组的NK细胞活性,即可判定该项实验结果阳性。
4、实验结果
实施例1的免疫功能评价实验结果如表3.1和表3.2所示。
表3.1小鼠细胞免疫功能、体液免疫功能各项试验检测结果(n=10)
注:*P<0.05,表示与对照组相比具有显著性差异。
由表3.1可见,中、高剂量组的耳廓肿胀度增重高于对照组,具有显著性差异(P<0.05);中、高剂量组的半数溶血值高于对照组,具有显著性差异(P<0.05)。
表3.2样品对小鼠单核—巨噬细胞与NK细胞活性测定结果(n=10)
注:*P<0.05,表示与对照组相比具有显著性差异。
实施例2的免疫功能评价实验结果如表4.1和表4.2所示。
表4.1小鼠细胞免疫功能、体液免疫功能各项试验检测结果(n=10)
注:*P<0.05,表示与对照组相比具有显著性差异。
由表4.1可见,中、高剂量组的耳廓肿胀度增重高于对照组,具有显著性差异(P<0.05);中、高剂量组的半数溶血值高于对照组,具有显著性差异(P<0.05)。
表4.2样品对小鼠单核—巨噬细胞与NK细胞活性测定结果(n=10)
注:*P<0.05,表示与对照组相比具有显著性差异。
实施例3的免疫功能评价实验结果如表5.1和表5.2所示。
表5.1小鼠细胞免疫功能、体液免疫功能各项试验检测结果(n=10)
注:*P<0.05,表示与对照组相比具有显著性差异;**P<0.01,表示与对照组相比具有极显著性差异。
由表5.1可见,中剂量组的耳廓肿胀度增重高于对照组,具有显著性差异(P<0.05),高剂量组的耳廓肿胀度增重高于对照组,具有极显著性差异(P<0.01);中剂量组的半数溶血值高于对照组,具有显著性差异(P<0.05);高剂量组的半数溶血值高于对照组,具有极显著性差异(P<0.01)。
表5.2样品对小鼠单核—巨噬细胞与NK细胞活性测定结果(n=10)
注:*P<0.05,表示与对照组相比具有显著性差异。
实施例4的免疫功能评价实验结果如表6.1和表6.2所示。
表6.1小鼠细胞免疫功能、体液免疫功能各项试验检测结果(n=10)
注:*P<0.05,表示与对照组相比具有显著性差异。
由表6.1可见,低、中剂量组的耳廓肿胀度增重高于对照组,具有显著性差异(P<0.05),高剂量组的耳廓肿胀度增重高于对照组,具有极显著性差异(P<0.01);低剂量组的半数溶血值高于对照组,具有显著性差异(P<0.05);中、高剂量组的半数溶血值高于对照组,具有极显著性差异(P<0.01)。
表6.2样品对小鼠单核—巨噬细胞与NK细胞活性测定结果(n=10)
注:*P<0.05,表示与对照组相比具有显著性差异;**P<0.01,表示与对照组相比具有极显著性差异。
实施例5的免疫功能评价实验结果如表7.1和表7.2所示。
表7.1小鼠细胞免疫功能、体液免疫功能各项试验检测结果(n=10)
注:*P<0.05,表示与对照组相比具有显著性差异;**P<0.01,表示与对照组相比具有极显著性差异。
由表7.1可见,低、中剂量组的耳廓肿胀度增重高于对照组,具有显著性差异(P<0.05),高剂量组的耳廓肿胀度增重高于对照组,具有极显著性差异(P<0.01);低剂量组的半数溶血值高于对照组,具有显著性差异(P<0.05);中、高剂量组的半数溶血值高于对照组,具有极显著性差异(P<0.01)。
表7.2样品对小鼠单核—巨噬细胞与NK细胞活性测定结果(n=10)
注:*P<0.05,表示与对照组相比具有显著性差异。
由表7.2可见,中剂量组的NK细胞活性高于对照组,具有显著性差异(P<0.05),高剂量组的NK细胞活性高于对照组,具有极显著性差异(P<0.01)。
实施例6的免疫功能评价实验结果如表8.1和表8.2所示。
表8.1小鼠细胞免疫功能、体液免疫功能各项试验检测结果(n=10)
注:*P<0.05,表示与对照组相比具有显著性差异;**P<0.01,表示与对照组相比具有极显著性差异。
由表8.1可见,低、中剂量组的耳廓肿胀度增重高于对照组,具有显著性差异(P<0.05),高剂量组的耳廓肿胀度增重高于对照组,具有极显著性差异(P<0.01);低剂量组的半数溶血值高于对照组,具有显著性差异(P<0.05);中、高剂量组的半数溶血值高于对照组,具有极显著性差异(P<0.01)。
表8.2样品对小鼠单核—巨噬细胞与NK细胞活性测定结果(n=10)
注:*P<0.05,表示与对照组相比具有显著性差异。
由表8.2可见,高剂量组的NK细胞活性高于对照组,具有显著性差异(P<0.05),
实施例7的实验结果如表9.1和9.2所示。
表9.1小鼠细胞免疫功能、体液免疫功能各项试验检测结果(n=10)
注:*P<0.05,表示与对照组相比具有显著性差异。
由表9.1可见,低、中剂量组的耳廓肿胀度增重高于对照组,具有显著性差异(P<0.05),高剂量组的耳廓肿胀度增重高于对照组,具有极显著性差异(P<0.01);低剂量组的半数溶血值高于对照组,具有显著性差异(P<0.05);中、高剂量组的半数溶血值高于对照组,具有极显著性差异(P<0.01)。
表9.2样品对小鼠单核—巨噬细胞与NK细胞活性测定结果(n=10)
注:*P<0.05,表示与对照组相比具有显著性差异。
由表9.2可见,中、高剂量组的NK细胞活性高对照组,具有显著性差异(P<0.05)
对比例1的实验结果如表10.1和10.2所示。
表10.1样品对小鼠细胞及体液免疫功能的影响(n=10)
注:*P<0.05,表示与对照组相比具有显著性差异。
由表10.1可见,高剂量组的耳廓肿胀度增重高于对照组,具有显著性差异(P<0.05),;高剂量组的半数溶血值高于对照组,具有显著性差异(P<0.05)。
表10.2样品对小鼠单核—巨噬细胞与NK细胞活性测定结果(n=10)
注:*P<0.05,表示与对照组相比具有显著性差异。
实施例8的实验结果如表11.1和11.2所示。
表11.1样品对小鼠细胞及体液免疫功能的影响(n=10)
注:*P<0.05,表示与对照组相比具有显著性差异。
由表11.1可见,低、中剂量组的耳廓肿胀度增重高于对照组,具有显著性差异(P<0.05),高剂量组的耳廓肿胀度增重高于对照组,具有极显著性差异(P<0.01);低剂量组的半数溶血值高于对照组,具有显著性差异(P<0.05);中、高剂量组的半数溶血值高于对照组,具有极显著性差异(P<0.01)。
表11.2样品对小鼠单核—巨噬细胞与NK细胞活性测定结果(n=10)
注:*P<0.05,表示与对照组相比具有显著性差异。
本申请中均采用正常动物实验。在细胞免疫功能、体液免疫功能、单核-巨噬细胞功能及NK细胞活性四个方面测定中,任两个方面试验结果为阳性,可以判定该受试样品具有增强免疫力作用。其中细胞免疫功能测定项目中两个实验的结果均为阳性,或任一实验的两个剂量组结果为阳性,判定细胞免疫功能试验结果阳性。体液免疫功能测定项目中两个实验的结果均为阳性,或任一实验的两个剂量组结果为阳性,判定体液免疫功能试验结果阳性。单核—巨噬细胞功能测定项目中两个实验的结果均为阳性,或任一实验的两个剂量组结果为阳性,判定单核—巨噬细胞功能试验结果阳性。NK细胞活性测定实验的一个以上剂量结果阳性,判定NK细胞活性结果阳性。
实施例1-8均能起到增强免疫力的效果,但实施例5、7、4和3中组合物的免疫力的效果更优。其中,实施例5的组合物的免疫效果最好。通过实施例5-7可以发现,添加阿胶、白芍、刺五加、党参、杜仲、甘草、红景天、黄精、麦冬和枸杞,可以显著增加本组合物的免疫效果,同时,通过实施例5和7可以发现,当阿胶与白芍的比例为1:2时,可以显著提高组合物NK细胞活性,从而发挥更好的免疫作用。
二、抗疲劳功能评价
检测依据:卫生部《保健食品检验与评价技术规范》(2003年版)。
1、实验动物
选用广东省医学实验动物中心繁殖的SPF级健康成年昆明种雌性小鼠,体重为18~22g。动物室温度:22-25℃,相对湿度:55-70%。
2、抗疲劳功能评价
剂量分组及受试样品给予时间
本组合物人体推荐量为每人每日50mL(0.83mL/kg),小鼠实验用剂量设置低、正常、高3个剂量水平,即每日4.15、8.30和24.90mL/kg(分别相当于人体推荐量的5、10、30倍),同时设置对照组,将实验小鼠按照体重随机分成5批,每批4组,每组10只。
各称取5.25mL、10.50mL和31.25mL上述实施例1-4和对比例1制备的功能饮料,分别加纯水至50mL,分别配成0.11mL/mL、0.21mL/mL和0.63mL/mL浓度溶液,灌胃体积为0.2mL/10g体重,每天灌胃2次,阴性对照组给予等体积的纯水,连续30d。
负重游泳实验具体是将负重5%的小鼠放入游泳箱内进行负重游泳,记录游泳时间,记录负重游泳时间的平均值,实验结果见表12-16。
表12实施例1功能饮料的小鼠抗疲劳实验
注:*P<0.05,表示与对照组相比具有显著性差异;**P<0.01,表示与对照组相比具有极显著性差异。
表13实施例2功能饮料的小鼠抗疲劳实验
组别 | 游泳时间/s |
对照组 | 498 |
低剂量组 | 518 |
中剂量组 | 585* |
高剂量组 | 648* |
注:*P<0.05,表示与对照组相比具有显著性差异;**P<0.01,表示与对照组相比具有极显著性差异。
表14实施例3功能饮料的小鼠抗疲劳实验
组别 | 游泳时间/s |
对照组 | 515 |
低剂量组 | 556* |
中剂量组 | 618* |
高剂量组 | 691** |
注:*P<0.05,表示与对照组相比具有显著性差异;**P<0.01,表示与对照组相比具有极显著性差异。
表15实施例4功能饮料的小鼠抗疲劳实验
组别 | 游泳时间/s |
对照组 | 528 |
低剂量组 | 588* |
中剂量组 | 663** |
高剂量组 | 740** |
注:*P<0.05,表示与对照组相比具有显著性差异;**P<0.01,表示与对照组相比具有极显著性差异。
表16对比例1功能饮料的小鼠抗疲劳实验
注:*P<0.05,表示与对照组相比具有显著性差异;**P<0.01,表示与对照组相比具有极显著性差异。
从表12-16的实验数据可知,本发明提供的功能饮料可以延长小鼠的负重游泳时间,表明本发明的功能饮料具有抗疲劳、提升精力的作用。其中,实施例3和4组功能饮料的小鼠的负重游泳时间相比实施例1和2显著延长,表明:当竹茹与大枣的比例为1:1时,可以显著提高本发明功能饮料的抗疲劳效果。
三、辅助降血脂功能检验方法
实验依据:保健食品检验与评价技术规范(2003)
试验方法:选取SD大鼠150只,雌性,体重180-270g,随机分为10组,每组10只,其中一组给予正常饲料喂养,其余大鼠均饲喂高脂饲料,连续15天后禁食16小时,取尾血,测定血清总胆固醇(TC)、甘油三酯(TG)和高密度脂蛋白胆固醇(HDL-C)水平,根据血清总胆固醇(TC)水平选择造模成功的实验动物80只。
将模型动物称体重,按照TC水平,随机分成8组,每组10只,其中,1-5组每天灌胃实施例4-8制备的功能饮料,剂量均为5.2mL/kg/d;阳性对照组灌胃辛伐他汀片,剂量为0.1g/kg/d;模型对照组灌胃与功能饮料相同剂量的饮用水,正常对照组正常饲料喂养,其他均继续喂高糖高脂饲料。将大鼠每天灌胃1次,连续灌胃4周,实验结束称体重禁食16小时,测定血清TC、TG、HDL-C水平,血清TC、TG和HDL-C水平检测结果见下表。
表17对高血脂动物血清TC的影响(单位mmol/L)
注:与正常对照组相比,##p<0.01,具有极显著性差异;与模型对照组相比,*P<0.05,具有显著性差异,**p<0.01,具有极显著性差异。
表18对高血脂动物血清TG的影响(单位mmol/L)
实验前 | 实验后 | |
正常对照组 | 0.53±0.17 | 0.55±0.16 |
模型对照组 | 0.69±0.36 | 1.65±0.71## |
阳性对照组 | 0.67±0.32 | 0.91±0.59** |
实施例4 | 0.70±0.44 | 1.21±0.26* |
实施例5 | 0.67±0.32 | 0.91±0.59** |
实施例6 | 0.68±0.22 | 1.19±0.29* |
实施例7 | 0.72±0.38 | 1.15±0.42** |
实施例8 | 0.68±0.33 | 1.23±0.33* |
注:与正常对照组相比,##p<0.01,具有极显著性差异;与模型对照组相比,*P<0.05,具有显著性差异;**p<0.01,具有极显著性差异。
表19对高血脂动物血清HDL-C的影响(单位mmol/L)
实验前 | 实验后 | |
正常对照组 | 1.90±0.17 | 1.90±0.16 |
模型对照组 | 1.17±0.14 | 1.16±0.35## |
阳性对照组 | 1.15±0.22 | 1.72±0.59** |
实施例4 | 1.16±0.44 | 1.25±0.27* |
实施例5 | 1.17±0.71 | 1.79±0.45** |
实施例6 | 1.18±0.26 | 1.26±0.71* |
实施例7 | 1.19±0.32 | 1.59±0.38* |
实施例8 | 1.15±0.28 | 1.16±0.71 |
注:与正常对照组相比,##p<0.01,具有极显著性差异;与模型对照组相比,*P<0.05,具有显著性差异;**p<0.01,具有极显著性差异。
结果判断:血清总胆固醇、甘油三酯、高密度脂肪胆固醇三项指标检验中血清总胆固醇和甘油三酯两项指标阳性,可以判定功能饮料辅助降血脂功能动物实验结果为阳性,即证明本发明的组合物具有辅助降血脂的功效。
由表17-19可知,实施例4-7均能起到辅助降血脂的效果,但实施例5和7中组合物的辅助降血脂的效果更优,表明:当组合物中阿胶与白芍的比例为1:2时,可以显著提高本发明功能饮料的辅助降血脂的效果。
四、减少妊娠反应实验
1.疗效标准:
采用《中医妇科病证诊断疗效标准》中妊娠恶阻的诊断依据、证侯分类、疗效
2.评定:
治愈:呕吐停止,诸症消除,停药后无反复。
好转:呕吐等症减轻。或呕吐诸症消除,但停药后又见复发。
未愈(无效):呕吐诸症均无改善。
选取500例妊娠反应患者,随机选取400例作为治疗组,另外100例作为对照组,将治疗组随机分成4组,每组100例,治疗组1服用实施例4制备的功能饮料,治疗组2服用实施例5制备的功能饮料,治疗组3服用实施例6制备的功能饮料,治疗组4服用实施例7制备的功能饮料,每日早、晚服用两次功能饮料,每次25mL,对照组的患者采用内服维生素B6配合饮食调理。
治疗结果如下表:
对比组 | 治愈/人 | 好转/人 | 无效/人 | 治愈率/% | 有效率/% |
治疗组1 | 66 | 21 | 13 | 66 | 87 |
治疗组2 | 79 | 15 | 6 | 79 | 94 |
治疗组3 | 67 | 22 | 11 | 67 | 89 |
治疗组4 | 75 | 18 | 7 | 75 | 93 |
对照组 | 35 | 37 | 28 | 35 | 72 |
从以上数据表可以看出,治疗组有效率治愈率明显高于对照组,治疗组2的治愈率有效率最高,其次为治疗4组,以上表明阿胶与白芍的比例为1:2时的功能饮料可以明显改善孕期的妊娠反应。
Claims (10)
1.一种预防孕期三高的组合物,其特征在于,包括以下重量份的组分:叶酸类化合物0.0002-0.0005份,维生素B6 0.0003-0.0025份,大枣2-3份,山药5-7.5份,生姜1-1.5份和竹茹1.6-2.5份。
2.根据权利要求1所述的组合物,其特征在于,所述叶酸类化合物为叶酸、甲酰四氢叶酸、L-甲基叶酸、叶酸可药用盐、叶酸或叶酸可药用盐的活性代谢产物和可在体内代谢和/或生成叶酸的物质中的至少一种。
3.根据权利要求2所述的组合物,其特征在于,还包括如下重量份的组分:阿胶1-1.5份、白芍2-3份、刺五加3-4.5份、党参3-4.5份、杜仲2-3份、甘草0.7-1份、红景天1-1.5份、黄精3-4.5份、麦冬2-3份和枸杞2-3份。
4.一种预防孕期三高的功能饮料,其特征在于,包括权利要求1-3任意一项所述的组合物和15-25重量份的甜味剂。
5.根据权利要求4所述的功能饮料,其特征在于,所述甜味剂为白砂糖、蜂蜜、木糖醇、山梨糖醇、阿斯巴甜中的至少一种。
6.一种制备权利要求4或5所述的功能饮料的方法,其特征在于,所述的制备方法包括以下步骤:
(1)将维生素B6、叶酸和甜味剂以外的组分,按照原料配方的用量,混合,得中药组分;
(2)向步骤(1)得到的中药组分中加水,浸泡、煎煮、过滤,得煎煮液1和药渣;向药渣中再加水,煎煮、过滤,得煎煮液2;
(3)将步骤(1)得到的煎煮液1和煎煮液2合并浓缩,冷却后加入叶酸、维生素B6及甜味剂搅拌均匀,灭菌灌装即可。
7.根据权利要求6所述的制备方法,其特征在于,步骤(2)中所述的中药组分和水的质量比为1:(10-20);所述的药渣和水的质量比为1:(10-20)。
8.根据权利要求6所述的制备方法,其特征在于,步骤(2)中所述的浸泡为:35-45℃下浸泡30min。
9.根据权利要求6所述的制备方法,其特征在于,步骤(2)中所述两次煎煮的条件为:95-100℃下煎煮1-2h。
10.根据权利要求6所述的制备方法,其特征在于,步骤(3)中所述的浓缩为:在60-80℃下浓缩至0.5-0.6g中药组分/mL。
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