CN107319332A - 一种具有降血糖作用的药食同源组合物及其制备方法 - Google Patents
一种具有降血糖作用的药食同源组合物及其制备方法 Download PDFInfo
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- CN107319332A CN107319332A CN201710411109.8A CN201710411109A CN107319332A CN 107319332 A CN107319332 A CN 107319332A CN 201710411109 A CN201710411109 A CN 201710411109A CN 107319332 A CN107319332 A CN 107319332A
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- peppermint
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- galactooligosaccharide
- mulberry leaf
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Abstract
本发明公开了一种药食同源的组合物在制备降血糖功能食品中的应用。本发明中药组合物主要有麦苗、栀子、葛根、紫苏籽、桑叶、薄荷、低聚果糖、低聚半乳糖等药食同源的原料经超微细胞破壁粉碎制成,发挥复方的整体调节优势,具有显著的降血糖功能,实验证实对糖尿病模型SD大鼠有明显的治疗作用,其降血糖机制可能是通过抑制胰岛β‑细胞凋亡来增加胰岛素分泌。
Description
技术领域
本发明涉及一种具有降血糖作用的药食同源的组合物的制备方法及由该方法制备的组合物的应用。
背景技术
糖尿病(diabetesmellitus,DM)以高血糖为主要标志,是一组由遗传和环境因素相互作用而引起的临床综合征。糖尿病人由于胰岛素分泌绝对不足或相对不足以及靶组织细胞对胰岛素敏感性降低,从而引起糖、蛋白质、脂肪、水和电解质等一系列物质的代谢紊乱。高血糖则是由于胰岛素分泌缺陷或其生物作用受损,或两者兼有而引起。糖尿病患者长期存在的高血糖,会导致各种组织特别是眼、肾、心脏、血管及神经的慢性损害和功能障碍。目前治疗糖尿病的方法主要有药物治疗、运动治疗和饮食治疗等。传统的降血糖药物如胰岛素、磺酰脲类和双胍类物质虽然能短时降低血糖,但往往会产生一些副作用,并且有可能使机体产生依赖性。天然降血糖食品具有来源广泛、副作用小和价格低廉等特点,容易被普通人接受,是日常保健和自我调养的最佳手段。因此,降血糖的功能性食品的研究和开发也越来越受重视。药食同源的中药中含有多糖类、黄酮类、多肽类、生物碱类和皂苷类降血糖活性因子,与膳食纤维、植物蛋白和益生元等组合使用具有良好的降血糖功效。
中药全成分加工服用,药量大,服用不便。在辩证施治处方中药快速加工中,超微破壁粉碎技术的应用,则能克服以上缺点。它在粉碎中药饮片的过程中,使构成中药饮片的动植物细胞壁绝大部分破碎,细胞内容物逸出,有效成分能被人体全部以近似大分子的形式直接吸收利用,减少服用量,提高疗效。由于“贝利”微粉机在粉碎中的固体乳化作用,使其在流态化固相中进行乳化、分散、均质、表面改性等作业。同时,可提高粉碎时的温度,模拟煎煮中药饮片的过程,也可降低粉碎时的温度,保存不稳定成分。亦能安排中药饮片粉碎次序,使之符合汤剂制备中先煎后入等特殊要求。还能利用饮片中的超细纤维作为支撑结构,在不加入任何辅料的情况下形成颗粒。保留了汤剂的制备过程,同时为进一加工水丸、胶囊等剂型提供了理想的原料。
本发明是提供一种药食同源的组合物在降血糖功能食品中的应用。
发明内容
本发明的目的在于提供一种药食同源的组合物在降血糖功能食品中的应用,该组合物由下列重量份的原料药制成:
麦苗20-30,栀子10-14,葛根10-16,紫苏籽6-10,桑叶10-14,薄荷10-14,低聚果糖8-12,低聚半乳糖6-10。
其中麦苗粉是采用小麦或大麦嫩叶为原料,通过高温杀青、超微粉碎等技术制成的翠绿色粉末,富含18种氨基酸、多种维生素、矿物质、蛋白质、叶绿素、活性酵素及膳食纤维,被称为“绿色血液”、“碱性食物之王”。经由医学界研究表明,对增强人体免疫力、延缓衰老、抗疲劳、促进微循环均有积极作用,并具有抗癌、保护肝脏、降糖等保健作用;栀子具有泻火除烦、清热利尿、凉血解毒等多种功效。栀子中含有大量的环烯醚萜类化合物,同时还存在一些有机酸(酯)、黄酮、香豆素、挥发油等化学成份。现代药理研究表明栀子具有降糖降脂的药理活性;葛根为豆科植物野葛的干燥根,味甘、辛,具有解表退热、生津、透疹、升阳止泻等功效,葛根有效成分葛根素等可以有效降低胰岛素抵抗一高血压大鼠的血压、血糖,提高胰岛素敏感性,对改善胰岛素抵抗有着积极的意义;紫苏籽具有降血糖、降低胆固醇、抗癌、提高免疫力、止咳平喘、改善情绪等生理功能;桑叶具有止消渴的功效,现代药理研究证明桑叶可明显抑制血糖升高,具有预防和治疗糖尿病的作用;薄荷具有疏散风热、清热解表、利咽透疹、祛风消肿、利咽止痛之功效,现代药理研究表明薄荷具有降血糖的作用;以低聚果糖和低聚半乳糖为主的功能性低聚糖属低甜度、低热量糖,能够促使血脂正常化,服用后不会使人发胖,不易使人血糖值升高,因此特别适合糖尿病患者服用。
本发明组合物的原料药的重量份比优选为:
麦苗20,栀子14,葛根10,紫苏籽10,桑叶10,薄荷14,低聚果糖8,低聚半乳糖10。
本发明组合物的原料药的重量份比还优选为:
麦苗22,栀子13,葛根11,紫苏籽9,桑叶11,薄荷13,低聚果糖9,低聚半乳糖9。
本发明组合物的原料药的重量份比还优选为:
麦苗24,栀子12,葛根12,紫苏籽8,桑叶12,薄荷12,低聚果糖10,低聚半乳糖8。。
本发明组合物的原料药的重量份比还优选为:
麦苗26,栀子11,葛根13,紫苏籽7,桑叶13,薄荷11,低聚果糖11,低聚半乳糖7。
本发明组合物的原料药的重量份比还优选为:
麦苗28,栀子10,葛根14,紫苏籽6,桑叶14,薄荷10,低聚果糖12,低聚半乳糖6。
本发明组合物的原料药的重量份比还优选为:
麦苗30,栀子12.5,葛根16,紫苏籽7.5,桑叶13.5,薄荷10.5,低聚果糖9.5,低聚半乳糖9.5。
本发明组合物主要有麦苗、栀子、葛根、紫苏籽、桑叶、薄荷等组成,可以明显缓解糖尿病大鼠病情。使大鼠的毛色更为光亮,行动较为敏捷。大鼠的血糖浓度由初始的12~13mmol/L,给药30天后可降到7~8mmol/L,降血糖效果与二甲双胍组接近,胰岛素水平均有明显升高,体质量增加比率也有所上升。大鼠胰岛细胞活性增加,并呈一定的剂量依赖性。药理实验结果表明组合物对糖尿病模型SD大鼠有明显的治疗作用,其降血糖机制可能是通过抑制胰岛β-细胞凋亡来增加胰岛素分泌。
本发明组合物由以下步骤组成:
(1)按照原料药重量比例称取原料(栀子、葛根、紫苏籽、桑叶、薄荷),净选;
(2)分别将药材干燥至水分约为5.5%,混合,将药材粉碎成细粉(过100~150目),备用。
(3)将药材细粉加入料斗中,使用“贝利”超微粉碎机进行超微粉碎,收集微粉(过300目)
(4)将上述微粉与麦苗粉、低聚果糖、低聚半乳糖混合即得。
具体实施方式
下面结合实施例,进一步说明本发明的技术方案。
以下实施例中所使用的原料栀子、葛根、紫苏籽、桑叶、薄荷购自广州市清平药材市场,麦苗粉够自青海净草生物科技有限公司。低聚果糖和低聚半乳糖够自量子高科生物科技有限公司。
实施例1
处方:
麦苗20,栀子14,葛根10,紫苏籽10,桑叶10,薄荷14,低聚果糖8,低聚半乳糖10。
制备方法:
(1)按照原料药重量比例称取原料(栀子、葛根、紫苏籽、桑叶、薄荷),净选。
(2)分别将药材干燥至水分约为5.5%,混合,将药材粉碎成细粉(过100~150目),备用。
(3)将药材细粉加入料斗中,使用“贝利”粉碎机进行超微粉碎,收集微粉(过300目),即得。
(4)将上述微粉与麦苗粉、低聚果糖、低聚半乳糖混合即得。
实施例2
处方:
麦苗22,栀子13,葛根11,紫苏籽9,桑叶11,薄荷13,低聚果糖9,低聚半乳糖9。
制备方法:
(1)按照原料药重量比例称取原料(栀子、葛根、紫苏籽、桑叶、薄荷),净选。
(2)分别将药材干燥至水分约为5.5%,混合,将药材粉碎成细粉(过100~150目),备用。
(3)将药材细粉加入料斗中,使用“贝利”粉碎机进行超微粉碎,收集微粉(过300目),即得。
(4)将上述微粉与麦苗粉、低聚果糖、低聚半乳糖混合即得。
实施例3
处方:
麦苗24,栀子12,葛根12,紫苏籽8,桑叶12,薄荷12,低聚果糖10,低聚半乳糖8。
制备方法:
(1)按照原料药重量比例称取原料(栀子、葛根、紫苏籽、桑叶、薄荷),净选。
(2)分别将药材干燥至水分约为5.5%,混合,将药材粉碎成细粉(过100~150目),备用。
(3)将药材细粉加入料斗中,使用“贝利”粉碎机进行超微粉碎,收集微粉(过300目),即得。
(4)将上述微粉与麦苗粉、低聚果糖、低聚半乳糖混合即得。
实施例4
处方:
麦苗26,栀子11,葛根13,紫苏籽7,桑叶13,薄荷11,低聚果糖11,低聚半乳糖7。
制备方法:
(1)按照原料药重量比例称取原料(栀子、葛根、紫苏籽、桑叶、薄荷),净选。
(2)分别将药材干燥至水分约为5.5%,混合,将药材粉碎成细粉(过100~150目),备用。
(3)将药材细粉加入料斗中,使用“贝利”粉碎机进行超微粉碎,收集微粉(过300目),即得。
(4)将上述微粉与麦苗粉、低聚果糖、低聚半乳糖混合即得。
实施例5
处方:
麦苗28,栀子10,葛根14,紫苏籽6,桑叶14,薄荷10,低聚果糖12,低聚半乳糖6。
制备方法:
(1)按照原料药重量比例称取原料(栀子、葛根、紫苏籽、桑叶、薄荷),净选。
(2)分别将药材干燥至水分约为5.5%,混合,将药材粉碎成细粉(过100~150目),备用。
(3)将药材细粉加入料斗中,使用“贝利”粉碎机进行超微粉碎,收集微粉(过300目),即得。
(4)将上述微粉与麦苗粉、低聚果糖、低聚半乳糖混合即得。
实施例6
处方:
麦苗30,栀子12.5,葛根16,紫苏籽7.5,桑叶13.5,薄荷10.5,低聚果糖9.5,低聚半乳糖9.5。
制备方法:
(1)按照原料药重量比例称取原料(栀子、葛根、紫苏籽、桑叶、薄荷),净选。
(2)分别将药材干燥至水分约为5.5%,混合,将药材粉碎成细粉(过100~150目),备用。
(3)将药材细粉加入料斗中,使用“贝利”粉碎机进行超微粉碎,收集微粉(过300目),即得。
(4)将上述微粉与麦苗粉、低聚果糖、低聚半乳糖混合即得。
为了证实本发明组合物降血糖的疗效,用按实施例6方法制得的组合物粉末,进行了一下动物实验研究:
1实验材料
实施例6组合物粉末(ZHW),链脲佐菌素(美国Sigma公司),艾塞那肽(美国百特制药),盐酸二甲双胍片(中美上海施贵宝制药有限公司),雄性SD大鼠,体质量(180±20)g,血糖仪(德国罗氏血糖仪),大鼠胰岛细胞(上海美轩生物科技有限公司),MTT检测试剂盒(上海纪宁实业有限公司),胰岛素ELISA试剂盒(上海恒远生物科技有限公司)。
2实验方法
2.1动物模型建立及分组给药
组合物的制备:将实施例6组合物加入蒸馏水配置成不同质量浓度的药液备用。所有药品均当天配制使用。
糖尿病动物模型建立:雄性SD大鼠80只适应性喂养3d,禁食3-5h,测空腹血糖,作为动物基础血糖值。随后随机选取60只大鼠禁食24h(自由饮水),腹腔注射链脲佐菌素50mg/kg,5d后禁食3-5h,测空腹血糖,血糖值大于11.1mmol/L为高血糖模型成功动物。
高血糖模型大鼠降血糖实验:选取高血糖模型动物按禁食3-5h的血糖水平分组,每组10只,模型对照组(灌胃蒸馏水)、低剂量(300mg/kg)、中剂量(600mg/kg)、高剂量(1800mg/kg)、盐酸二甲双胍阳性对照组(84.0mg/kg),剩余20只正常大鼠为空白对照组(灌胃蒸馏水)和高剂量组(1800mg/kg),分笼饲养,空腹灌胃,每天的灌胃时间固定(下午14:00-15:00),连续30d,分别在第8、15、22、30天测空腹血糖值和体重。
糖耐量实验:实验的第30天,各组动物禁食3-5h,测定给予葡萄糖前血糖值,二甲双胍、高、中、低剂量组、正常高剂量组分别给予药物灌胃,模型对照组和正常对照组给予等剂量体积蒸馏水灌胃,15~20min后各组经口给予葡萄糖2.0g/kg BW,测定给葡萄糖后各组0.5、2.0h的血糖值,观察各组给葡萄糖后各时间点血糖值及血糖曲线下面积。
胰岛素检测:实验第30天,利用胰岛素ELISA试剂盒对大鼠胰岛素进行检测。
2.2细胞实验
培养液的制备,将将实施例6粉末混合均匀,加入80℃适量的热水,超声波萃取3次,用3倍体积的95%乙醇进行沉淀,减压干燥得到提取物粉末,用超纯水进行溶解配成低中高(20,40,80nmol/L)3种不同浓度的溶液,高压灭菌后加入DMEM培养基(含双抗)中。
细胞活性检测:将购买的大鼠胰岛β-细胞接种于96孔微量培养板中,37℃培养12h后,加入不同浓度的提取液,艾塞那肽和超纯水作为阳性和阴性对照培养48h,细胞活性采用MTT检测法。MTT溶液(5g/L,20μL)加入到每个孔中,并在37℃下培养4h后弃上清液,加入终止溶液的DMSO(100μL/孔)震荡10min,在490nm由酶标仪检测吸光度值来确定细胞活性。
2.3统计学方法 用SPSS 19.0软件进行数据分析,计量资料均以表示,各组间均数比较采用最小显著差法检验,以P<0.05为差异有统计学意义。
3实验结果
3.1状态观察 给药7d后观察,模型对照组较其他组的大鼠精神状态较差,皮毛失去光泽,身体消瘦,动作迟缓,反应迟钝,饮水量和食物摄入量均显著增加。阳性对照组和给药组大鼠的状态类似,程度明显减轻。
3.2组合物的降血糖作用 30d灌胃实验结果表明,高中低剂量组从给药第7天起就有降血糖作用,并且降血糖效果随着治疗时间的延长作用明显增强,血糖浓度由初始的11.7、11.6、12.1mmol/L,给药30天后降到6.6、7.7、7.8mmol/L,降血糖效果与二甲双胍组的6.6mmol/L接近,且各剂量组之间没有明显的统计学差异。高剂量组的正常大鼠血糖水平无明显变化。糖尿病大鼠模型给药30d的空腹血糖变化见表1。
表1组合物对大鼠血糖的影响(n=10,mmol/L)
3.3糖尿病模型大鼠的糖耐量变化 与模型对照组AUC的39.0相比,高、中、低3种剂量的组合物均能明显降低糖尿病大鼠AUC,分别为18.4、22.6、17.6,且效果与二甲双胍对照组AUC的20.1相近,在统计学上无明显差异。与空白对照组相比,正常大鼠的高剂量组的AUC值无明显变化。总之,组合物可以有效地降低糖尿病大鼠的糖耐量,见表2。
表2大鼠糖耐量及AUC值(n=10)
3.4糖尿病模型大鼠胰岛素水平变化
与模型对照组相比,高、中、低剂量给药组和阳性药物对照组糖尿病大鼠的血清胰岛素水平有所上升,高、中、低剂量组(8.8%-12.7%)略低于阳性药物对照组(21.1%),由此推测组合物使糖尿病大鼠血糖下降和提高胰岛素水平有关。高血糖大鼠血清胰岛素变化见表3。
表3组合物对大鼠胰岛素水平的影响(n=10)
3.5糖尿病模型大鼠体质量的变化
正常大鼠空白对照组和正常大鼠高剂量组的大鼠体质量增加非常明显增加了56.8%和56.4%。与模型对照组相比,高、中、低剂量组能明显改善糖尿病大鼠的暴饮暴食,并能改善糖尿病引起的大鼠极度消瘦,提高大鼠体质量,体质量增加比率分别为24.8%、26.9%和33.6%,较阳性对照组的增加47.5%相比,剂量组显示可适当控制体质量增加。给药组之间并无明显的统计学差异,见表4。
表4混合物对大鼠体质量的影响(n=10)
3.6大鼠胰岛β-细胞增殖影响
组合物能够很好地抑制大鼠胰岛β-细胞凋亡,提高细胞活力,与空白对照相比,给药组和阳性药物对照组的细胞活力上升,见表5。
表5混合物对大鼠胰岛β-细胞的细胞活力影响(n=10)
4实验结论
上述实验证实了组合物对链脲佐菌素致病的糖尿病模型大鼠有良好的降血糖效果。体内实验表明,组合物能够很好地提高糖尿病大鼠体内胰岛素水平,降低血糖水平,缓解糖尿病大鼠暴饮暴食、消瘦的症状,并能控制体重增长。体外实验通过对不同浓度提取物条件下细胞活力的检测,可以推测其降血糖的机制可能是通过抑制细胞凋亡来增加胰岛细胞数量,进而提高体内胰岛素水平来达到降血糖的效果。因此,组合物具有降血糖的功效。
Claims (10)
1.一种药食同源的组合物在制备降血糖的功能食品中的应用,其特征在于由下列重量份的原料制成:麦苗20-30,栀子10-14,葛根10-16,紫苏籽6-10,桑叶10-14,薄荷10-14,低聚果糖8-12,低聚半乳糖6-10。
2.根据权利要求1所述的应用,其特征在于由下列重量份的原料药组成:
麦苗20,栀子14,葛根10,紫苏籽10,桑叶10,薄荷14,低聚果糖8,低聚半乳糖10。
3.根据权利要求1所述的应用,其特征在于由下列重量份的原料药组成:
麦苗22,栀子13,葛根11,紫苏籽9,桑叶11,薄荷13,低聚果糖9,低聚半乳糖9。
4.根据权利要求1所述的应用,其特征在于由下列重量份的原料药组成:
麦苗24,栀子12,葛根12,紫苏籽8,桑叶12,薄荷12,低聚果糖10,低聚半乳糖8。
5.根据权利要求1所述的应用,其特征在于由下列重量份的原料药组成:
麦苗26,栀子11,葛根13,紫苏籽7,桑叶13,薄荷11,低聚果糖11,低聚半乳糖7。
6.根据权利要求1所述的应用,其特征在于由下列重量份的原料药组成:
麦苗28,栀子10,葛根14,紫苏籽6,桑叶14,薄荷10,低聚果糖12,低聚半乳糖6。
7.根据权利要求1所述的应用,其特征在于由下列重量份的原料药组成:
麦苗30,栀子12.5,葛根16,紫苏籽7.5,桑叶13.5,薄荷10.5,低聚果糖9.5,低聚半乳糖9.5。
8.根据权利要求1-7任一项所述的应用,其特征在于所述组合物由以下步骤组成:
(1)按照原料药重量比例称取原料(栀子、葛根、紫苏籽、桑叶、薄荷),净选;
(2)分别将药材干燥至水分约为5.5%,混合,将药材粉碎成细粉(过100~150目),备用。
(3)将药材细粉加入料斗中,使用“贝利”超微粉碎机进行超微粉碎,收集微粉(过300目)。
(4)将上述微粉与麦苗粉、低聚果糖粉、低聚半乳糖粉混合即得。
9.根据权利要求8所述的组合物,其特征在于:组合物的剂型为口服粉末或制剂。
10.根据权利要求9所述的组合物,其特征在于:口服制剂选自片剂、胶囊剂、颗粒剂。
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