CN105963330A - 神秘果制剂及其应用 - Google Patents
神秘果制剂及其应用 Download PDFInfo
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- CN105963330A CN105963330A CN201610289951.4A CN201610289951A CN105963330A CN 105963330 A CN105963330 A CN 105963330A CN 201610289951 A CN201610289951 A CN 201610289951A CN 105963330 A CN105963330 A CN 105963330A
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- Prior art keywords
- synsepalum duleificum
- preparation
- duleificum
- pulp extract
- mass parts
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Abstract
本发明公开了一种神秘果制剂及其用于降血糖的应用。所述神秘果制剂包括神秘果果肉提取物和神秘果素,所述神秘果果肉提取物与所述神秘果素的质量比为(30~50):1。根据本发明的神秘果制剂由于神秘果果肉提取物与神秘果素相结合而对血糖具有协同的降低效果。
Description
技术领域
本发明涉及一种神秘果制剂,具体地,所述神秘果制剂包括神秘果果肉提取物和神秘果素,本发明还涉及所述神秘果制剂的应用。
背景技术
国际糖尿病联盟(IDF)的最新数据显示,全球糖尿病患者已增至3.66亿人,已被世界卫生组织列为三大疑难病之一。其治疗方法主要通过饮食治疗和口服降糖药。目前临床用于口服的降糖药主要是中药和西药两大类,但是这两种降糖药均有其缺点:中药由于主要成分不明,多数对于血糖的控制效果不明显;而西药的几种代表药(胰岛素、磺脲素、双胍素等)均为单一的降糖药,且存在不同程度的副作用。关于如何安全、有效的控制血糖,有学者强调饮食治疗应该是降低血糖的关键。因此,将二者有机的结合起来,寻找具有降血糖作用的天然食品资源,开发既具有显著降血糖效果、又没有副作用的降血糖功能食品已经受到越来越多人的青睐,成为当前人们关注和研究的热点。
神秘果(Synsepalum dulcificum Daniell)为山榄科神秘果属的一种奇特水果。虽原产于西非热带地区,现已在我国热带、亚热带地区广泛种植,一年四季均可结果。其果肉含有丰富奇特的糖蛋白、维生素、有机酸、黄酮、花青素等营养物质。现阶段对于神秘果的研究表明,其具有调节血压、血脂,减轻痛风、尿酸、头痛等功效。由此,神秘果的营养保健作用日益受到关注。但是目前对于神秘果的开发以增甜剂、助食剂和食用色素等为主,主要应用在食品、化妆品等领域。
同时,神秘果中含有的神秘果素是一种天然的物理性的安全变味蛋白,可制成酸性食品的助食剂,也可用于制作糖尿病人需要的甜味变味剂。现阶段对于神秘果素的提取常采用透析法、离心分离法、溶剂沉淀法和色谱法等,这些方法分别具有不足之处:透析法和离心分离法提取率和回收量低,因此对神秘果的利用率也较低;溶剂沉淀法会引入过多的有机溶剂,造成溶剂残留,纯度低等问题;而色谱法虽然获得神秘果素的纯度较高,但是不易操作,神秘果素的活性难保持,同时生产成本过高,不适于大规模的工业生产。
发明内容
本发明的发明人对神秘果提取物的研究表明,神秘果果肉提取物与神秘果素相结合对血糖具有协同的降低效果。
因此,本发明旨在获得一种具有降血糖作用的神秘果制剂,所述神秘果制剂包括神秘果果肉提取物和神秘果素,所述神秘果果肉提取物与所述神秘果素的质量比为(30~50):1。
具体地,基于100g重量的所述神秘果果肉提取物,所述神秘果果肉提取物包含:抗坏血酸 28~29.8mg,表儿茶素17.5~18.1mg,没食子酸10.5~10.9mg,阿魏酸5.7~5.9mg,丁香酸3.1~3.5mg,芦丁2.7~2.7mg,槲皮素1.0~1.2mg,杨梅黄酮0.7~0.9mg,鞣花酸0.4mg,山奈酚0.3mg,飞燕草素葡萄糖苷0.7~0.9mg,矢车菊素半乳糖苷2.5~2.7mg,锦葵色素半乳糖苷9.4~10.8mg,叶黄素0.4mg,α-生育酚5.5~6.1mg,β-生育酚0.5~0.7mg,γ-生育酚0.9~1.1mg。
根据本发明一个实施方式,所述神秘果果肉提取物通过选自超声波辅助提取、浸泡提取、微波辅助提取、热回流提取的方法提取。所述神秘果果肉提取物的提取采用70 ~ 85%(v/v)乙醇水溶液作为提取溶剂,50 ~ 80℃的提取温度。
优选地,所述神秘果制剂包括所述神秘果果肉提取物150 ~ 500质量份、神秘果素5 ~
10质量份、微晶纤维素(MCC) 80 ~ 280质量份、质量比为1 : 1的聚维酮(PVP) : 聚维酮K30(PVP K30) 30 ~ 70质量份、PEG 6000 5 ~ 15质量份、淀粉5 ~ 15质量份和硬脂酸镁2 ~ 5质量份。
本发明还提供上述神秘果制剂用于降低血糖的应用。
根据本发明的神秘果制剂制作过程简便,且由于神秘果肉提取物与神秘果素的结合降糖效果尤其明显,降糖作用时间长,有效成份安全稳定,生物利用度高,且便于携带。同时,根据本发明的神秘果制剂还具有服用后有甜味感,口感佳等特点。这为神秘果制剂在食品和医药领域的进一步开发和利用提供了更广阔的发展前景。
附图说明
图1 示出了根据本发明的神秘果制剂对小鼠血糖的影响。
图2 示出了根据本发明的神秘果果肉提取物对小鼠血糖的影响。
具体实施方式
神秘果是富含维生素的高碱性水果,其提取物对自由基具有极强的清除力,因而具有很强的抗氧化性能。神秘果素是一种碱性蛋白,单独存在时不稳定,通常表现出使味觉改变的活性。但是,本发明人首次利用神秘果提取物与神秘果素相结合来降低血糖,并且在改善糖尿病患者的口感的同时,还实现良好的稳定性以及协同增强的降糖效果,并延长神秘果果肉提取物中有效成分的作用时间。
本发明提供了一种具有降糖作用的神秘果制剂,其包括神秘果果肉提取物和神秘果素,其中,神秘果果肉提取物与神秘果素的质量比为(30~50):1,优选(35~45):1。
具体地,基于100g重量的神秘果果肉提取物,该神秘果果肉提取物包含:抗坏血酸 28~29.8mg,表儿茶素17.5~18.1mg,没食子酸10.5~10.9mg,阿魏酸5.7~5.9mg,丁香酸3.1~3.5mg,芦丁2.7~2.7mg,槲皮素1.0~1.2mg,杨梅黄酮0.7~0.9mg,鞣花酸0.4mg,山奈酚0.3mg,飞燕草素葡萄糖苷0.7~0.9mg,矢车菊素半乳糖苷2.5~2.7mg,锦葵色素半乳糖苷9.4~10.8mg,叶黄素0.4mg,α-生育酚5.5~6.1mg,β-生育酚0.5~0.7mg,γ-生育酚0.9~1.1mg。
上述神秘果制剂还可进一步包括本领域常用的辅料。优选地,用于根据本发明的神秘果制剂的辅料包括MCC、PVP、PVP K30、PEG 6000、淀粉和硬脂酸镁,优选分别经过120 ~ 160目筛。
优选地,上述神秘果制剂包括上述神秘果果肉提取物150 ~ 500质量份、神秘果素5 ~ 10质量份、MCC 80 ~ 280质量份、质量比为1 : 1的PVP : PVP K30 30 ~ 70质量份、PEG 6000 5 ~ 15质量份、淀粉5 ~ 15质量份和硬脂酸镁2 ~ 5质量份。
具体地,根据本发明的神秘果制剂的制备过程如下:以神秘果果肉(优选无虫蛀、无腐斑的新鲜果肉)为原料,提取获得粉状神秘果果肉提取物;提取残渣用NaCl水溶液提取,再经过超滤后,得到神秘果素;将提取物粉、神秘果素和辅料按照配方的用量称重后混合均匀,以70~ 90%乙醇水溶液为湿润剂制成软材。制备湿粒后,用烘箱鼓风迅速干燥,14~24目筛整粒,加入润滑剂(例如硬脂酸镁)混匀,压片,获得神秘果片剂成品。其中,壁材选用β-环糊精,麦芽糊精,淀粉,纤维素,壳聚糖,海藻酸钠,明胶,琼脂,阿拉伯胶中的一种或几种。
上述神秘果果肉提取物可通过选自超声波辅助提取、浸泡提取、微波辅助提取、热回流提取的方法提取。优选地,上述神秘果果肉提取物的提取采用70 ~ 85%(v/v)乙醇水溶液作为提取溶剂,50 ~ 80℃的提取温度。
具体地,提取溶剂为70 ~ 85%(v/v)乙醇水溶液,提取所用的溶剂体积为固体质量的8 ~ 15倍,提取温度为50 ~ 80℃。所得提取物经真空冷冻干燥得到疏松多孔粉红色固体,经超微粉碎后备用。所述真空冷冻干燥处理的温度为-35 ~ -50 ℃,干燥时间为24 ~ 48小时。提取残渣收集用于神秘果素的提取。
优选地,神秘果素提取方法如下:将收集的提取残渣依次进行提取、离心、超滤、真空干燥处理。提取步骤采用0.5 mol的NaCl水溶液进行超声波辅助提取、浸泡提取、微波辅助提取或热回流提取;超滤步骤采用超滤系统进行浓缩和分离蛋白,超滤2次,先以5~8倍体积pH=4的蒸馏水分三次清洗,去除部分杂质,再以3~5倍体积pH=4的0.5 mol NaCl溶液清洗,得到神秘果素溶液,真空干燥后获得神秘果素。
按给定的重量份数添加辅料:神秘果果肉提取物150 ~ 500质量份、神秘果素5 ~ 10质量份、MCC 80 ~ 280份、PVP : PVP K30(1 :
1) 30 ~ 70份、PEG 6000 5 ~ 15份、淀粉5 ~ 15份。加入70 ~ 90%乙醇水溶液作为湿润剂制成软材,过18 ~ 24 目筛制成湿粒。然后,将湿粒铺于托盘上,厚度不超过2 cm,在40~ 60℃的温度下进行干燥。干燥后的颗粒含水量在5%以下,加入硬脂酸镁,均匀混入干燥后的颗粒中,压片,即得神秘果片剂成品。
利用根据本发明的制备神秘果片剂的方法获得的神秘果片剂具有良好的溶解性、流动性,能够使得神秘果中的活性成分均匀分散和吸附。
根据本发明的包括神秘果果肉提取物和神秘果素的神秘果制剂具有显著的降低血糖含量的作用,且不易产生耐药性,可用于辅助降低血糖。该神秘果制剂的有效成份安全稳定,辅助降糖效果明显、生物利用度高,且便于携带;同时服用后有甜味感,具有口感佳的特点,具有很高的营养保健价值和广阔的市场前景。
实施例1:神秘果制剂的制备
称取神秘果果肉400 g,加入85%(v/v)乙醇水溶液,溶剂体积为固体质量的15倍,进行超声波辅助提取,提取温度为50℃。按上述方法提取3次,合并提取液后真空浓缩至无醇味。将所得到的浓缩液加入5倍体积的50℃的水,超声振荡分散60 min,静止30 min。分离去除非匀相杂质后,在温度为-50℃,干燥时间为48小时的条件下进行真空冷冻干燥,得到为疏松多孔粉红色固体的神秘果果肉提取物,经超微粉碎后,过120目筛备用。
将神秘果果肉残渣采用0.5 mol的NaCl水溶液进行超声波辅助提取;离心后取上清液,采用超滤系统进行浓缩和分离蛋白,超滤2次,先以5倍体积pH=4的蒸馏水分三次清洗,去除部分杂质,再以5倍体积pH=4的0.5 mol NaCl溶液清洗,得到神秘果素溶液,真空干燥后,得到神秘果素备用。
将得到的神秘果素和神秘果果肉提取物按照配方给出的重量份数添加辅料:神秘果果肉提取物150 ~ 500质量份、神秘果素5 ~ 10质量份、MCC 80份、PVP : PVP K30(1 :
1) 30份、PEG 6000 8份、淀粉15份。加入90%乙醇水溶液作为湿润剂制成软材,过20目筛制成湿粒。然后铺于托盘上,厚度不超过2 cm,温度为60℃,进行干燥。干燥后的颗粒含水量在5%以下,向干燥后的颗粒中加入硬脂酸镁,混匀,压片,即得神秘果片剂成品。
外观:未见松裂,成型完整,颜色均一,粉红色片剂;平均片重618(±2%) mg ;溶出度:93.7%。
实施例2 :小鼠体内降血糖活性实验
小鼠:C57雄性小鼠,8周龄,SPF级,建立Ⅱ型糖尿病小鼠模型,购买自上海斯莱克实验动物有限公司。
实验材料:由实施例1制得的神秘果果肉提取物和神秘果片剂;生理盐水,哈尔滨三联药业;盐酸二甲双胍,中美上海施贵宝制药有限公司。
实验方法:
(1)模型小鼠喂养高脂饲料,自由饮水,1天1次喂食,通风,自然采光,喂养 4 周后均禁食12 h,称每只小鼠体重,并根据每只小鼠体重,左下腹腔一次性注射链脲佐菌素(STZ)柠檬酸-柠檬酸钠注射液(50 mg/kg)。注射链脲佐菌素(STZ) 3天后,禁食12 h,尾静脉取血测其空腹血糖,以空腹血糖≥11.1 mmol/L为Ⅱ型糖尿病小鼠模型建立成功。
(2)将模型建立成功的小鼠分为6组,各组小鼠血糖均值差≤1.0 mmol/L,相同数量健康小鼠为空白对照组。
(3)将神秘果果肉提取物,神秘果片剂以生理盐水分别配置成受试物混悬液;二甲双胍也配置成药液,备用。
(4)6组模型小鼠用相应受试物混悬液灌胃,神秘果果肉提取物:高剂量组(H)300mg/Kg/d,低剂量组(L)100mg/Kg/d;神秘果片剂:高剂量组(H)1800mg/Kg/d(约3片),低剂量组(L)600mg/Kg/d(约1片);二甲双胍130mg/Kg/d,每天上午灌胃一次,空白对照组健康小鼠每天等体积生理盐水灌胃,给药体积按体重0.1 mL/10g。
(5)连续给药0、14、28、42天后,禁食(不禁水)12h,末次给药l h后剪尾取血,离心分离血清,分别测空腹血糖,结果示于图1和图2中。
参见图1和图2,上述实验结果表明,100mg/kg/d神秘果果肉提取物、600mg/kg/d神秘果片剂有明显稳定血糖的作用,且与二甲双胍相比,无耐药性,可以使血糖基本保持稳定在一个水平。同时神秘果片剂的降糖效果明显优于单独的神秘果果肉提取物,同等用量的情况下,神秘果素的加入与神秘果果肉提取物起到了协同的降糖效果,并且可以延长降糖作用的时间,使血糖更长久地处于低水平状态,从而降低药物的使用频率。因此,根据本发明的神秘果片剂对糖尿病具有非常良好的辅助治疗作用。
综上所述,根据本发明的神秘果制剂具有以下优点:
1.本发明的神秘果制剂采用神秘果为原料,材料新颖,既可以起到变味剂的效果,也可以作为食品和医药的添加剂,其提取物更有改善机体对血糖的调节能力,起到降糖的效果。其次,本发明对于神秘果素的提取方法简便,容易实现,且提取率高,不易失活;同时制成神秘果提取物微粒后活性保持时间长,降糖效果明显。
2.本发明产品不仅可以解决不能进食糖类病人和不愿意禁糖食的减肥者的饮食瓶颈,同时也可以作为降低血糖的辅助治疗食品。
3.本发明的制作过程简便,产品降糖效果明显、有效成份安全稳定、生物利用度高且便于携带。
Claims (6)
1.一种神秘果制剂,其特征在于,所述神秘果制剂包括神秘果果肉提取物和神秘果素,所述神秘果果肉提取物与所述神秘果素的质量比为(30~50):1。
2.根据权利要求1所述的神秘果制剂,基于100g重量的所述神秘果果肉提取物,所述神秘果果肉提取物包含:抗坏血酸 28~29.8mg,表儿茶素17.5~18.1mg,没食子酸10.5~10.9mg,阿魏酸5.7~5.9mg,丁香酸3.1~3.5mg,芦丁2.7~2.7mg,槲皮素1.0~1.2mg,杨梅黄酮0.7~0.9mg,鞣花酸0.4mg,山奈酚0.3mg,飞燕草素葡萄糖苷0.7~0.9mg,矢车菊素半乳糖苷2.5~2.7mg,锦葵色素半乳糖苷9.4~10.8mg,叶黄素0.4mg,α-生育酚5.5~6.1mg,β-生育酚0.5~0.7mg,γ-生育酚0.9~1.1mg。
3.根据权利要求1所述的神秘果制剂,所述神秘果果肉提取物通过选自超声波辅助提取、浸泡提取、微波辅助提取、热回流提取的方法提取。
4.根据权利要求3所述的神秘果制剂,所述神秘果果肉提取物的提取采用70 ~ 85%(v/v)乙醇水溶液作为提取溶剂,50 ~ 80℃的提取温度。
5.根据权利要求1所述的神秘果制剂,所述神秘果制剂包括所述神秘果果肉提取物150 ~
500质量份、神秘果素5 ~ 10质量份、微晶纤维素 80 ~ 280质量份、质量比为1 : 1的聚维酮: 聚维酮K30 30 ~ 70质量份、PEG 6000 5 ~ 15质量份、淀粉5 ~ 15质量份和硬脂酸镁2 ~ 5质量份。
6.根据权利要求1至5中任一项所述的神秘果制剂用于降低血糖的应用。
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