CN115177658B - 一种用于降血糖的组合物 - Google Patents
一种用于降血糖的组合物 Download PDFInfo
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- CN115177658B CN115177658B CN202110370825.2A CN202110370825A CN115177658B CN 115177658 B CN115177658 B CN 115177658B CN 202110370825 A CN202110370825 A CN 202110370825A CN 115177658 B CN115177658 B CN 115177658B
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Abstract
本发明涉及一种含有益生菌和桑叶提取物的组合物，其中益生菌选自鼠李糖乳杆菌、唾液乳杆菌、植物乳杆菌的一种或多种，还可以包括其他益生菌。本发明的优点是：该组合物有调节血糖的功效，可以辅助治疗高血糖相关病症，如糖尿病前期、妊娠糖尿病等。
Description
技术领域
本发明涉及一种含有益生菌和桑叶提取物的组合物及其用途，属于大健康领域。
背景技术
糖尿病是一种常见的内分泌代谢性疾病，其特点是慢性高血糖伴随因胰岛素分泌不足或作用缺陷引起的糖、脂肪和蛋白质代谢紊乱。随着生活水平提高、人口老龄化和生活方式改变，我国糖尿病的发病率在逐年上升。据既往调查，我国糖尿病患病率已高达9.7％[Yang W,et al.Prevalence of diabetes among men and women in China.N Engl JMed.2010,362:1090-1101]，据此推算全国糖尿病患者总数近1亿人，预计到2030年患病人数将达到3亿，成为继心血管和恶性肿瘤之后的第三大非传染性疾病，严重危害人类健康。
糖尿病的治疗目标是控制血糖，防止或延缓并发症，降低病死率。除了应用各种降血糖药物和胰岛素外，糖尿病的早期治疗也涉及饮食疗法，即采取辅助治疗或饮食、保健相关的干预措施同样也是不可或缺的。此外，考虑到药物副作用及其对胎儿的潜在影响，妊娠糖尿病患者一般不适合服用各种降血糖药物。因此，开发具有温和调节血糖作用的功能性保健食品能够满足需求，具有临床应用价值。益生菌(Probiotics)被定义为“通过摄入适当的量从而对宿主产生有益作用的活菌”，它们定居在肠道中，具有多种生理功能，包括促进营养物质的消化吸收、提高机体免疫力、维持肠道菌群结构平衡和提高机体抗氧化水平等功能。
桑叶中含有黄酮类、多糖类、生物碱类、植物甾醇类、挥发油、氨基酸、维生素及微量元素等多种化学成分，具有降糖、降脂、降压、抗菌和抗病毒、抗衰老等药理活性，常用于保健产品中。研究表明，桑叶的降血糖作用是通过两个途径实现的：一是通过生物碱DNJ(1-脱氧野尻霉素)对二糖类分解酶活性产生抑制作用，从而抑制小肠对双糖的吸收，降低食后血糖的高峰值(Kimura，1995)；二是通过桑叶生物碱fagomine及桑叶多糖促进β细胞分泌胰岛素，而胰岛素可以促进细胞对糖的利用、肝糖原合成以及改善糖代谢，最终达到降血糖的效果。
本发明精选益生菌和桑叶提取物，组成创新的复合配方，并经实施例证实两类活性成份在降血糖方面具有协同作用，是对现有市场上益生菌或桑叶提取物单一产品的显著改进。
发明内容
为解决现有益生菌和桑叶提取物单一产品存在的不足，本发明提供一种组合物及用途。该组合物具有协同降低血糖作用。
为了实现上述目的,本发明提供以下技术方案：
一种组合物，包含：(1)益生菌，(2)桑叶提取物，和(3)辅料。
在本发明中，所述的组合物，其特征在于，以重量份计，含有桑叶提取物10～500份，益生菌100～1000份；优选桑叶提取物100～500份，益生菌100～500份；更加优选桑叶提取物300～500份。
在本发明中，所述桑叶提取物包括桑叶总黄酮、桑叶总生物碱、桑叶多糖中的一种或多种混合物。
在本发明中，所述益生菌为鼠李糖乳杆菌、唾液乳杆菌、植物乳杆菌、保加利亚乳杆菌和长双歧杆菌中一种或多种。优选为李糖乳杆菌、唾液乳杆菌、植物乳杆菌中一种或多种。
在本发明中，所述组合物还可以含有0.1～0.8份叶酸类物质。所述叶酸类物质选自5-甲基四氢叶酸、甲酰四氢叶酸钙、二氢叶酸、叶酸或叶酸盐的活性代谢物和可在体内释放/生成叶酸类物质中的一种或多种。。
在本发明中，所述的份可以是微克、毫克、克、微升、毫升、分升等。
在本发明组合物中，辅料包括填充剂、甜味剂、助流剂等。
在本发明中，优选地，辅料包括麦芽糖醇450～750份、水溶性膳食纤维450～750份、麦芽糊精450～750份和甜菊糖甙10～50份。
本发明所述的组合物剂型为口服制剂，包括固体饮料、片剂、胶囊剂、凝胶、粉剂、丸剂、果实饮料、糖棒、酸奶饮料、发酵的乳制品、膳食替代物、冰淇淋、奶酪或奶昔。
在本发明中，组合物可以药品组合物、保健品、保健食品或功能食品等形式存在。
本发明提供的组合物具有制备用于预防或辅助治疗高血糖的制品中的用途。
本发明提供的组合物具有制备用于预防或辅助治疗高血糖相关病症的制品中的用途。在本发明中，高血糖相关病症包括糖尿病前期、糖尿病早期、妊娠糖尿病。
本发明提供的组合物制品中的用途，针对高血糖病症，包括糖尿病前期、早期、妊娠糖尿病，具有显著的协同降低血糖作用，作用效果出人意料地强于益生菌单用或桑叶提取物单用。与糖尿病治疗药物相比，本发明提供的组合物具有作用温和、无毒副作用、安全性高等优点。与单一产品相比，本发明提供的组合物产品具有提高服用依从性，减少费用的优点。
本发明的优势还在于提供了一种预防糖尿病、改善高血糖或降低糖尿病风险的组合物，效果显著，满足个体化需求，可为糖尿病前期患者提供有针对性的日常保健、预防手段。
具体实施例
本发明公开了一种组合物，本领域技术人员可以借鉴本文内容,适当改进工艺参数实现。特别需要指出的是,所有类似的替换和改动对本领域技术人员来说是显而易见的，它们都被视为包括在本发明。本发明的方法及应用已经通过较佳实施例进行了描述，相关人员明显能在不脱离本发明内容、精神和范围内对本文所述的方法和应用进行改动或适当变更与组合,来实现和应用本发明技术。
本发明提供的组合物、用途及所用原药与辅料均可有市场购得。其中，桑叶提取物原料购自深圳市森迪生物科技有限公司，叶酸购自DSM公司；益生菌购自杜邦营养食品配料(北京)有限公司，本发明的桑叶提取物与益生菌组合物每个单次服用包装(每个单次服用包装指片剂的单片，胶囊剂的单粒胶囊，颗粒剂的单个颗粒包，固体饮料中的单次服用包装和其他制剂形式的单次服用形式)中含有益生菌不低于1×106CFU/g。
实施例1：本发明组合物对血糖升高的SD大鼠血糖的影响
主要原料剂量：
动物：SPF级SD大鼠，雌雄兼用，20-22周龄，购于北京维通利华公司，经过检疫7天后，纳入试验，试验过程期间，温度控制在18-25摄氏度，湿度控制在45％-75％之间，光照进行12h/12h交替，自由饮水。
随机选取10只大鼠(雌雄各半)为正常对照组，除正常组外，其余各组大鼠连续喂饲高脂高糖饲料，于实验开始第2天，大鼠禁食20h，腹腔注射STZ(35mg/kg)(溶媒为0.1mmol/L柠檬酸钠缓冲液内，pH＝(4.0-4.5)，对照组注射等体积的溶媒，一周后检测空腹血糖水平，根据血糖结果决定是否补充再次注射STZ(10～30mg/kg)。末次注射药物1周后，大鼠尾部取血测血糖，选择空腹血糖水平≥11.1mmol/L2型糖尿病大鼠造模成功大鼠。
将造得的复合模型大鼠依据空腹血糖水平随机分组，兼顾雌雄，分别给以下表对应的剂量的益生菌单剂，桑叶提取物单剂，桑叶提取物与益生菌组合。给药4周后测定空腹血糖水平。
结果以表示，采用GraphPad Prism 5统计分析软件进行统计处理；组间比较采用ANOVA检验，设定检验水准为α＝0.05，P<0.05有显著性统计学差异，P>0.05无显著性统计学差异。
通过金正均Q值法计算组合物中各组分之间的相互作用：
金正均Q值法计算组合物相互作用，用如下公式计算Q＝EA+B/(EA+EB-EA×EB)，式中分子代表“实测合并效应”，分母代表“期望合并效应”，Q为两者之比。Q值<0.85时认为两种药物联用为拮抗作用，0.85<Q值<1.15时认为是相加作用，Q值>1.15时认为是协同作用。为满足药理作用关系的分析，将实测值转化为可以直观体现药理作用强弱的效应，计算公式：Ei＝(1-Pi/P模型组)×100％，Pi为各组的实测值，P模型组为模型组的实测值。
饲料配方
表1：本发明组合物给药4周对血糖升高SD模型大鼠空腹血糖水平的影响(n＝8-10)
与对照组比较，#P<0.05，##P<0.01，与模型组比较*P<0.05，**P<0.01。
从上述的试验结果表明，单用益生菌具有一定降低血糖的效果，但是与模型组比较无显著性的差异(P>0.05)。实验中所选益生菌与桑叶提取物组合表现出非常显著地降血糖的作用，与模型组比较，P<0.01。益生菌与桑叶提取物组合经过协同作用的计算，Q值均大于等于1.15,说明所选益生菌与桑叶提取物的组合具有协同降低血糖的效果，较单独给药组比较，具有显著的进一步降低血糖的作用。唾液乳杆菌、植物乳杆菌或鼠李糖乳杆菌与益生菌的组合，与模型组比较，降血糖效果具有非常显著的差异(P<0.01)。
实施例2：本发明组合物对血糖升高孕鼠空腹血糖的影响
动物：雌性SD大鼠，4月龄，购于北京维通利华公司，经过检疫7天后，纳入试验，试验过程期间，温度控制在18-25摄氏度，湿度控制在45％-75％之间，光照进行12h/12h交替，自由饮水。
检疫结束后，随机选取8只雌性大鼠为正常对照组大鼠，给以普通纯化饲料喂养，除对照组外，其余各组大鼠连续喂饲高脂高糖饲料(饲料配方同实施例1所用饲料)，喂养4周后，禁食8h，测定空腹血糖，挑选空腹血糖增加20％以上的雌性大鼠纳入以下试验。
将雌性大鼠采用阴道涂片法确定大鼠的动情周期，将处于动情前期的雌鼠按2:1的比例与SD雄鼠合笼，次晨检查阴道口及垫料，观察是否有阴栓存在，有阴栓者定为怀孕第1天，并将雌、雄鼠分开。
将上述已经喂养高脂高糖饮食且已经确认怀孕的雌性大鼠，尾尖采血测定其空腹血糖水平，依据空腹血糖水平随机分组，按照下表给予相应剂量的受试物，灌胃体积按照10ml/kg,每天1次，给药2周后测定孕鼠空腹血糖水平。
实验数据的统计分析，以及组分间协同作用的Q值计算，同实施例1。
表2：本发明组合物对伴有妊娠期高血糖的孕鼠空腹血糖水平的影响
与对照组比较，#P<0.05，##P<0.01，与模型组比较*P<0.05，**P<0.01。
从上述的试验结果可以看出，桑叶提取物(30)mg/kg与三种益生菌鼠李糖乳杆菌+唾液乳杆菌+植物乳杆菌+叶酸组合(25+15+5+0.08)mg/kg，在降低血糖偏高的雌性孕鼠空腹血糖具有协同作用，Q＝1.35，(Q≥1.15)。桑叶提取物+鼠李糖乳杆菌+唾液乳杆菌+植物乳杆菌+叶酸(50+20+10+0.01)mg/kg的剂量组合，也产生了显著的降血糖效果(P<0.01)。
继续观察监测，给予益生菌和桑叶提取物孕鼠生产后的仔鼠及母鼠均生长正常。
实施例3-11：本发明益生菌与桑叶提取物组合的固体饮料的制备
第一步：按照上表列表中的配方份数称取相应的益生菌与桑叶总黄酮、桑叶总生物碱和桑叶多糖，柠檬酸3份、低聚果糖10份，用搅拌机搅拌10min，混合均匀，水分控制在小于0.2，制得混合物，备用；
第二步：称取乳清蛋白粉10份、麦芽糊精2份加入到第一步中制备的混合物中，搅拌5分钟后，再加入甜味剂3份搅拌5分钟，保证搅拌方向始终相同，然后进行减菌处理。
第三步，所有原料和益生菌发酵混合后真空冻干，粉碎过筛。
第四步：取酸味剂2份、增稠剂2份、食用香精5份与第二步中制得的混合物搅拌均匀，相对湿度小于28％，将该混合物通过粉剂包装机进行包装，装量2g/袋，即得到益生菌固体饮料。
Claims (9)
1.一种辅助降血糖组合物，其特征在于，由以下组成：（1）以重量份计，100～1000份益生菌，（2）以重量份计，10～500份桑叶提取物，（3）辅料；其中，所述益生菌为鼠李糖乳杆菌、唾液乳杆菌、植物乳杆菌、保加利亚乳杆菌和长双歧杆菌中的一种或多种。
2.根据权利要求1所述的组合物，其特征在于，所述益生菌100～500份，所述桑叶提取物100～500份。
3.根据权利要求2所述的组合物，其特征在于，所述桑叶提取物300～500份。
4.根据权利要求1-3任一项所述的组合物，其特征在于，所述桑叶提取物包括桑叶总黄酮、桑叶总生物碱、桑叶多糖中的一种或多种混合物。
5.一种辅助降血糖组合物，其特征在于，由以下组成：（1）以重量份计，100～1000份益生菌，（2）以重量份计，10～500份桑叶提取物，（3）以重量份计，0.1～0.8份叶酸类物质，（4）辅料；其中，所述益生菌为鼠李糖乳杆菌、唾液乳杆菌、植物乳杆菌、保加利亚乳杆菌和长双歧杆菌中的一种或多种，所述叶酸类物质选自5-甲基四氢叶酸或叶酸中的一种或多种。
6.根据权利要求1或5所述的组合物，其特征在于，组合物剂型为口服制剂，其制备形式包括片剂、胶囊剂、凝胶、粉剂、丸剂、饮料、糖棒、发酵的乳制品、膳食替代物、冰淇淋或奶昔。
7.根据权利要求1至6任一项所述的组合物在制备用于预防或辅助治疗高血糖或高血糖相关病症的药物中的用途。
8.根据权利要求7所述的用途，其特征在于，所述高血糖相关病症包括糖尿病前期、糖尿病早期、妊娠糖尿病。
9.根据权利要求1至6任一项所述的组合物在制备用于辅助降血糖的保健品中的用途。
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