CN107752001A - 一种人参小分子口服液及其制备方法 - Google Patents
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Classifications
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- A—HUMAN NECESSITIES
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- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L3/00—Preservation of foods or foodstuffs, in general, e.g. pasteurising, sterilising, specially adapted for foods or foodstuffs
- A23L3/34—Preservation of foods or foodstuffs, in general, e.g. pasteurising, sterilising, specially adapted for foods or foodstuffs by treatment with chemicals
- A23L3/3454—Preservation of foods or foodstuffs, in general, e.g. pasteurising, sterilising, specially adapted for foods or foodstuffs by treatment with chemicals in the form of liquids or solids
- A23L3/3463—Organic compounds; Microorganisms; Enzymes
- A23L3/3481—Organic compounds containing oxygen
- A23L3/3499—Organic compounds containing oxygen with doubly-bound oxygen
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
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- Chemical & Material Sciences (AREA)
- Food Science & Technology (AREA)
- Nutrition Science (AREA)
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- Mycology (AREA)
- Microbiology (AREA)
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- General Chemical & Material Sciences (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
本发明涉及中药保健食品技术领域,具体涉及一种人参提取物的口服制剂及其制备方法。发明采用低温夹层加热的方式利用溶解度差异选择性提取人参中小分子多糖类成分,同时利用皂苷类成分在自身微酸性条件下的水解反应,将难溶性皂苷类成分转化成脱糖基化的小分子皂苷类成分,最后结合乙醇提取获得药材中所有皂苷类成分。该产品药材利用率高,稀有皂苷含量高,产品性质稳定。
Description
技术领域
本发明涉及中药保健食品技术领域,具体涉及一种人参提取物的口服制剂及其制备方法和应用。
背景技术
人参(Panax Ginseng C.A Meyer)是五加科植物人参的干燥根,《神农本草经》中记载人参具有“大补元气,复脉固脱”的作用,在《神农本草经》中被誉为上品。人参中含有的皂苷,多糖,挥发油,无机元素等成分,药理研究表明这些成分对机体具有广泛的药理活性。在中医理论中,中药最重要的作用特点是协同作用,而人参中的成分在机体的代谢、免疫、内分泌以及抗氧化应激,尤其在机体抗疲劳应激刺激,提高免疫力等方面表现出很强的药理活性。围绕着人参的这些药理作用市场上开发了多款人参保健食品,包括胶囊,丸剂,针剂,口服液等,在十九世纪八十年代就开发出了人参蜂王浆,人参口服液,三七口服液等产品。在诸多的人参保健品中,口服液是应用最早,最传统的剂型,因为其服用方便,吸收迅速,人参口服液在市场上应用较多。
在人参药材中主要有效成分是人参皂苷和人参多糖,皂苷含量占人参干重的 5%左右[申请号为201610352278.4一种人参五味子保健品及其制备方法],多糖含量为30%左右。目前市场上的人参产品,均以皂苷或多糖为主,没有同时涵盖皂苷和多糖类成分的产品。以皂苷为主要成分的产品中多以乙醇为提取溶剂,而以多糖为有效成分的溶剂中多以低温浸提为主,无法获得其中的皂苷类成分,这种提取工艺下容易造成药材的利用率低。传统的水煎煮方法在加热过程中可以提取大量分子量较大的糖类,这类成分不但不能被机体吸收,而且会影响产品的澄清度,使产品的质量差。
发明内容
针对现有技术人参口服液产品澄清度差,药材利用效率低的问题,本发明提供一种小分子人参口服液及其制备方法,该产品中包含人参皂苷和多糖类成分,其中人参稀有皂苷含量高,固形物含量高,产品的澄清度好,质量稳定。
在对人参药材提取过程中发现,由于水提取液呈微酸性,皂苷类成分会发生水解,发明人借助Q-Tof LC/MS液质联用技术对口服液中的稀有皂苷成分进行痕量检测,发现了对人参药材提取效率和稀有皂苷水解的作用规律,进一步通过改变提取时间和提取温度提高稀有皂苷的收率。发明人提出通过控制提取过程中的温度和时间,利用药材中水提取液自身微酸性的环境,降解药材中皂苷类成分,获得人参中稀有皂苷类成分,进而最大程度的获得人参药材中的活性成分的方法。
相对于目前市场上人参类产品该发明的有益效果有以下三点:
1.产品固形物含量高,澄清度高:低温水提取过程中避免加热煎煮,避免了人参中淀粉样葡聚糖(一种大分子多糖)的过分溶解,产品后续处理过程简单,存放过程中不易出现沉淀;同时经过低温水提取过程可以获得人参中的皂苷和天然配比的寡糖,产品的固形物含量高,药材利用率高。
2.皂苷提取率高:第一步的低温水溶液提取温度可以提取药材中溶解度较高的皂苷如mRd,mRb2,mRc等,这类皂苷的溶解度好,可以在胃肠道内很快吸收,达到药理作用,同时低温水浸提可以获得提取其中大部分小分子多糖类成分;
3.稀有皂苷的含量高:对于药材中较难溶解的皂苷类成分特别是分子量较大的皂苷类成分,由于这类皂苷成分在常规水溶而言提取过程中难以获得,而且即使得到其产品(如采用乙醇提取)由于溶解度的差异生物利用度也较差,疗效不好,我们采用适当长时间的水浴加热,使药材中的皂苷类成分在药材自身pH (4.5-5.5)的微酸性条件下发生温和水解,生成脱糖基的小分子皂苷,提高提取物中稀有皂苷的含量,提高了其生物利用度和药材的利用效率。
具体实施方式:
实施例1:
称取人参药材50g,置圆底烧瓶中,按1:8的固液比例90℃水浴回流加热2h,重复提取三次,用抽滤瓶趁热过滤,合并滤液,减压浓缩至500mL,过滤,得到人参小分子提取物1,在提取物中加入2%的低聚果糖,0.2%的防腐剂苯甲酸钠即得人参小分子活性液1。
实施例2:
称取人参药材50g,置圆底烧瓶中,按1:8的固液比例85℃水浴回流加热3h,重复提取三次,用抽滤瓶趁热过滤,合并滤液,减压浓缩至500mL,过滤,得到人参小分子提取物2,在提取物中加入10%的甜味剂甜菊苷,0.3%的防腐剂尼泊金甲酯即得人参小分子活性液2。
实施例3:
称取人参药材50g,置圆底烧瓶中,按1:8的固液比例80℃水浴回流加热1h,重复提取三次,用抽滤瓶趁热过滤,合并滤液,减压浓缩至500mL,过滤,得到人参小分子提取物3,在提取物中加入5%的甜味剂阿斯巴甜,0.5%的防腐剂尼泊金丙酯即得人参小分子活性液3。
实施例4:
样品处理方法:精密量取提取液5mL,加蒸馏水5mL混匀,置分液漏斗中,加20mL乙醚脱脂三次,弃去乙醚层。向水层中加入20mL水饱和正丁醇萃取三次,合并正丁醇层,水浴蒸干,用适量的色谱甲醇将其溶解,并定容至10mL 容量瓶中,得样品溶液备用。溶液过0.45μm微孔滤膜得到样品溶液。
总皂苷含量测定方法:样品溶液中总皂苷参照中华人民共和国国家标准 (GB/T19506-2009)以Re标准品采用香草醛冰醋酸法测定。量取100μL 2.1项下样品溶液至15mL具塞刻度试管中,氮气吹干(40℃,10min)。加入新鲜配制的5%的香草醛-冰醋酸溶液0.2mL,摇匀后加入高氯酸0.8mL,60℃水浴加热 10min,立即转入冰水浴冷却10min,取出加入冰醋酸5mL终止反应。得到样品溶液,于560nm处测吸光度值。对照品同法测定以Re计算样品中总皂苷含量。
皂苷单体测定方法:提取物中的皂苷单体采用液质联用的方法检测,色谱条件:采用二元线性梯度洗脱:流动相A为0.1%甲酸水溶液,B为乙腈;梯度设置:0-5min,15%-19%B;5-10min,19%B;10-28min,19%-26%B;28-38min,26%-60%B;38-42min,60%-100%B,流速为0.5mL/min,进样量5μL,柱温 35℃。质谱条件:采用电喷雾电离源(ESI),负离子模式,扫描范围m/z 200-1500。雾化器温度:300℃;干燥气(N2)流速:9L/min;干燥气温度:350℃;雾化器压力:45psi。
实施例5:
作为对比实验,我们将药材粉碎,平均分成三份,按实施例1-3进行提取,获得人参提取物1-3,并按照传统的水提取方法获得人参提取物4,按传统的70%乙醇提取方法获得人参提取物5,将人参提取物1-5按实施例4中总皂苷和皂苷单体的测定方法进行了比对,得到结果如表1中所示。
表1:不同提取条件下人参提取物对比
*冻干粉质量是指将提取液进行冻干处理后得到的粉末质量。
由表1中我们可以看出,采用本发明所提供的技术方案,可以在皂苷含量和冻干粉质量以及稀有皂苷含量方面明显优于传统的水提取和乙醇提取工艺所获得的人参口服液。
实施例6:
提取物中多糖类成分的分子量测定:取1mg项下人参提取物的冻干粉样品,水溶液定容至10mL,进样分析,进样体积20μL,检测波长225nm,洗脱,根据保留时间RT计算样品分子量。
保留时间为RT=19.50分钟,由多糖分子量标准曲线线性方程 y=-0.1404x+0.9036(R2=0.9992)计算得出样品中多糖分子量为2500。
实施例7:人参口服液抗疲劳活性测定
人参口服液抗疲劳功能活性测定实验参照卫生部《保健食品功能学评价程序和检验方法》中《抗疲劳作用检验方法》进行。实验动物为昆明种雄性小鼠,高中低剂量,每组12只,空白组灌胃生理盐水,连续给药15天,末次给药1h后,小鼠单只放入装水的有机玻璃桶内15min,诱导无助状态,有机玻璃桶高25cm,直径12cm,水深10cm,水温控制在23±2℃。适应2min后,记录4min内累计不动的时间。即:停止挣扎,呈漂浮状态,仅有偶尔的肢体运动保持头部浮在水面的持续时间。再过5min后摘眼球取血,置于肝素钠处理过的离心管,4000r·min-1离心8min,分离血清,检测小鼠血浆中尿素氮,乳酸生化指标,并分离肝脏和后肢肌肉,测定肝糖原和肌糖原含量。由表2中可知,人参口服液的中剂量和高剂量组可以对抗小鼠疲劳,具有明显的抗疲劳作用。
表2.人参口服液对抗小鼠疲劳实验结果(mean±SD,n=12)
注:与对照组比较,*P<0.05;**P<0.01
以下结合图来详细说明本发明:
附图1、总离子流色谱图中皂苷单体的分布
Fig.1Saponin distribution in total ion profile
1:Glc-Rf;2:noto-R1;3:Rg1;4:Re;5:Rf;6:F3;7:Rg2;8:Ra1;9:Rb1;10:Ro; 11:Rc;12:Ra2;13:mRc;14:Rb2;15:Rb3;16:mRb2;17:AceRb1,18:Rd; 19:Rs1;20:mRd;21:Rs2;;22:20-(S)Rg3;23:20-(R)Rg3
附图2、提取物中皂苷单体总离子流色谱图A:市售参比制剂;B:专利产品
Fig 2.Total Ion Chromatograms of the samples with differentExtraction temperatures. A:reference preparation;B:Patented product
附图3、不同提取温度下皂苷单体的变化曲线
Fig3.Changes of Content of Different Saponin with DifferentExtraction Temperatures
附图4、提取物中多糖成分的保留时间
Fig4.The retention time of the polysaccharide component in theextract
附图5、口服液制备工艺路线图
Fig5.Preparation Process of the oral liquid 。
Claims (10)
1.一种人参口服液,其特征在于口服液由人参提取物,防腐剂和甜味剂组成,有效成分包括人参皂苷和人参多糖。
2.如权利要求1所述的人参口服液,其特征在于提取液经过水提取提取过程完成。
3.如权利要求2所述的水提取过程,其特征在于提取方式为夹套加热的方式提取,提取次数为2-3次。
4.如权利要求3所述的水提取过程,其特征在于提取的温度为70-90℃,优选为80℃。
5.如权利要求4所述的水提取过程,其特征在于每次提取的时间为1-3h,优选为2h。
6.如权利要求1所述的人参口服液,其特征在于包括后续对提取液浓缩的过程,浓缩体积为原体积的8-10倍。
7.如权利要求1所述的人参口服液,其特征在于甜味剂可以是蔗糖,果糖,木糖,阿斯巴甜,安赛蜜中的一种或几种,优选为低聚果糖。
8.如权利要求7所述的甜味剂,含量在0.1%-10%之间,优选为5%。
9.如权利要求1所述的人参口服液,其特征在于防腐剂可以是苯甲酸钠,尼泊金中的一种或几种,优选为苯甲酸钠。
10.如权利要求9所述的防腐剂,含量在0.1%-0.5%之间,优选为0.2%。
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