CN109528734A - 一种复合营养组合物及其制备方法 - Google Patents
一种复合营养组合物及其制备方法 Download PDFInfo
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- CN109528734A CN109528734A CN201910069375.6A CN201910069375A CN109528734A CN 109528734 A CN109528734 A CN 109528734A CN 201910069375 A CN201910069375 A CN 201910069375A CN 109528734 A CN109528734 A CN 109528734A
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Abstract
本发明涉及一种复合营养组合物及其制备方法，所述复合营养素组合物包括下述重量百分比的组分：0.01％～50％1,6‑二磷酸果糖、0.01％～50％谷氨酰胺、0.01％～20％a‑硫辛酸、0.01％～20％槲皮素、0.01％～20％复合抗氧化剂、0.01％～50％GABA。本发明采用上述的技术方案，其优点在于：通过合理组合，发挥协同治疗作用，是一项具有创新性及使用价值的发明。
Description
技术领域
本发明涉及营养组合物技术领域，具体是指一种复合营养组合物及其制备方法。
背景技术
糖尿病是一组由多病因引起的以慢性高血糖为特征的终身性代谢性疾病。糖尿病本身不一定造成危害，但长期血糖增高，大血管、微血管受损并危及心、脑、肾、周围神经、眼睛、足等，据世界卫生组织统计，糖尿病并发症高达100多种，是目前已知并发症最多的一种疾病。因糖尿病死亡者有一半以上是心脑血管所致，10％是肾病变所致。因糖尿病截肢是非糖尿病的10～20倍。为此预防糖尿病的并发症是至关重要的社会问题。
脑卒中是一种突然起病的脑血液循环障碍性疾病是指在脑血管疾病的病人，因各种诱发因素引起脑内动脉狭窄，闭塞或破裂，而造成急性脑血液循环障碍，临床上表现为一过性或永久性脑功能障碍的症状和体征。脑卒中是当前老年人致残致痴的主要原因之一，据WHO公布的资料，在57个国家中，有40个国家把卒中的死亡率列入了前三位，其中在日本和中国卒中的死亡率已占首位。而缺血性脑卒中占脑卒中病人总数的60％-70％。研发出一种可以预防治疗性脑卒中的营养素具有重大意义。
目前存在的问题是，已有许多单一药物应用于临床，但疗效并不理想。我们通过对糖尿病及其发病机制、脑卒中及其发病机制的深入研究，发现，这类疾病不是单一致病因素所致，牵涉一系列信号转导通路的节点，因此，需要进行精准有效的复合制剂的制备，从而有效干预上述难治性疾病的进程。
本发明的创新性在于利用糖代谢、血管生成通路上的各重要关键点，对体内存在的营养药物进行合理的组合，发挥协同作用，因此本发明的创新在于，提供了一种可弥补现有药物彼此缺陷，并可协同发挥作用的组合，该组合是一种安全、高效、稳定的抗糖尿病及其并发症、抗脑卒中及其并发症的产品。
发明内容
本发明的目的针对现有技术的不足，提供了一种复合营养组合物及其制备方法，解决了目前单一治疗药物无法达到理想治疗效果的问题。采用该方法制备的组合物，具备了比单一药物更好的抗糖尿病及其并发症、抗脑卒中及其并发症的作用。
本发明提供的技术方案，一种复合营养组合物及其制备方法，所述复合营养素组合物包括下述重量百分比的组分：0.01％～50％1,6-二磷酸果糖、0.01％～50％谷氨酰胺、0.01％～20％a-硫辛酸、0.01％～20％槲皮素、0.01％～20％复合抗氧化剂、0.01％～50％GABA，混合形成组合物。
本发明提供的技术方案之一为一种复合营养素组合物，所述复合营养素组合物包括下述重量百分比的组分：20％1，6-二磷酸果糖、30％谷氨酰胺、10％a-硫辛酸、5％槲皮素、5％复合抗氧化剂、30％GABA，用于抗糖尿病及其并发症的应用。
本发明以体外清除氧自由基为指标，观察复合营养素组合物组及单独应用20％1.6-二磷酸果糖、30％谷氨酰胺、10％a-硫辛酸、5％槲皮素、5％复合抗氧化剂、30％GAB组的抗氧化作用。采用DPPH氧自由基清除试剂盒，测定氧自由基清除率。氧自由基清除率分别为93％、2.3％、7.5％、36％、58％、79％、4.4％，表明复合营养素组有较好的协同清除氧自由基作用。
本发明以大鼠90只，随机分组，每组10只，除正常组大鼠，按50mg/kg，一次性腹腔注射链脲霉素溶液，72h后从大鼠尾静脉取血，离心分离血清，按试剂盒方法测定空腹血糖。将血糖值≥16mmol/L者确定为糖尿病模型大鼠，再随机分为8组：(2)模型组；(3)复合营养素组合物组；(4)1.6-二磷酸果糖组；(5)谷氨酰胺组；(6)硫辛酸组；(7)槲皮素组；(8)复合抗氧化剂组；(9)GABA组；每天分别灌胃给药100mg/kg，正常组位于同体积蒸馏水，每天一次连续15天。末次药后取血，离心分离血清，测定空腹血糖。结果可见，正常组血糖为5.85mmol/L，模型组血糖为11.5mmol/L，(3)至(9)组血糖分别为7.33mmol/L、8.25mmol/L、9.33mmol/L、8.56mmol/L、8.97mmol/L、8.05mmol/L、10.3mmol/L，提示复合营养素组合物组有协同降糖作用。
本发明采用上述的技术方案，其优点在于：通过合理组合，发挥协同治疗作用，是一项具有创新性及使用价值的发明。
本发明提供的技术方案之二为一种复合营养素组合物，所述复合营养素组合物包括下述重量百分比的组分：10％1，6-二磷酸果糖、30％谷氨酰胺、1％a-硫辛酸、9％槲皮素、0.5％复合抗氧化剂、49.5％GABA，用于抗脑卒中及其并发症的应用。
本发明以大鼠90只，随机分组，每组10只，随机分为8组：(2)模型组；(3)复合营养素组合物组；(4)1.6-二磷酸果糖组；(5)谷氨酰胺组；(6)硫辛酸组；(7)槲皮素组；(8)复合抗氧化剂组；(9)GABA组；每天分别灌胃给药100mg/kg，正常组位于同体积蒸馏水除正常组大鼠，采用线栓法制备脑缺血大鼠模型，于缺血前2小时，给予上述药物，手术后，每天一次给药，连续7天，采用6分法进行行为学评分。然后，处死动物，取脑，TTC染色后，计算脑梗死面积与脑面积(非梗死区+梗死区)之比。
结果可见，(2)至(10)组脑缺血大鼠，脑梗死面积/脑面积分别为0.253±0.015、0.083±0.007、0.189±0.026、0.193±0.056、0.213±0.085、0.157±0.085、0.124±0.036、0.117±0.009。
(1)至(10)组脑缺血大鼠行为学评分分别为：0.156±0.051、4.03±0.88、2.04±0.115、3.75±0.431、3.33±0.521、2.75±0.141、2.93±0.335、3.14±0.237、3.97±0.551。提示复合营养素组合物组有协同抗脑卒中及其并发症的作用。
本发明采用上述的技术方案，其优点在于：通过合理组合，发挥协同治疗作用，是一项具有创新性及使用价值的发明。
具体实施方式
本发明通过以下实施例作进一步说明。
实施例1：
复合营养素组合为：20％1，6-二磷酸果糖、30％谷氨酰胺、10％a-硫辛酸、5％槲皮素、5％复合抗氧化剂、30％GABA。其中复合抗氧剂的比例为：50％花青素、0.5％辅酶Q10、20％原花青素、0.1％维生素C、0.4％维生素E、29％谷胱甘肽。
采用实施例1所述方法，作为复合营养素组合，以DPPH为测定指标，测定组合物的抗氧化能力。
(一)试验方法
复合营养素组合物组及单独应用20％1.6-二磷酸果糖、30％谷氨酰胺、10％a-硫辛酸、5％槲皮素、5％复合抗氧化剂、30％GABA组的抗氧化作用。采用DPPH氧自由基清除试剂盒，测定氧自由基清除率。
(二)统计学处理：采用SPSS10.0如见进行统计分析。计量资料以(χ±S)表示，结果进行t检验；计数资料采用卡方检验。P<0.05为差异显著。
(三)试验结果
氧自由基清除率分别为93％、2.3％、7.5％、36％、58％、79％、4.4％，表明复合营养素组有较好的协同清除氧自由基作用。结果见表1.
表1.复合营养素及各单一营养素对氧自由基清除率的影响
| 序号 | 组别 | 氧自由清除率％ |
| 1 | 复合营养素 | 93±9.87 |
| 2 | 20％1.6-二磷酸果糖 | 2.3±0.55** |
| 3 | 30％谷氨酰胺 | 7.5±1.27** |
| 4 | 10％a-硫辛酸 | 36±4.52** |
| 5 | 5％槲皮素 | 58±3.65** |
| 6 | 5％复合抗氧化剂 | 79±10.2** |
| 7 | 30％GABA | 4.4±0.56** |
**与复合营养素相比P<0.01
实施例2:
复合营养素组合为：20％1，6-二磷酸果糖、30％谷氨酰胺、10％a-硫辛酸、5％槲皮素、5％复合抗氧化剂、30％GABA。其中复合抗氧剂的比例为：0.1％花青素、0.5％辅酶Q10、50％原花青素、1％维生素C、1％维生素E、47.4％谷胱甘肽。
采用实施例2所述方法，作为复合营养素组合，以血糖为测定指标，测定组合物的降糖能力。
(一)试验方法
本发明以大鼠90只，随机分组，每组10只，除正常组大鼠，按50mg/kg，一次性腹腔注射链脲霉素溶液，72h后从大鼠尾静脉取血，离心分离血清，按试剂盒方法测定空腹血糖。将血糖值≥16mmol/L者确定为糖尿病模型大鼠，再随机分为8组：(2)模型组；(3)复合营养素组合物组；(4)1.6-二磷酸果糖组；(5)谷氨酰胺组；(6)硫辛酸组；(7)槲皮素组；(8)复合抗氧化剂组；(9)GABA组；每天分别灌胃给药100mg/kg，正常组位于同体积蒸馏水，每天一次连续15天。末次药后取血，离心分离血清，测定空腹血糖。
(二)统计学处理：采用SPSS10.0如见进行统计分析。计量资料以(χ±S)表示，结果进行t检验；计数资料采用卡方检验。P<0.05为差异显著。
(三)试验结果
结果可见，正常组血糖为5.85mmol/L，模型组血糖为11.5mmol/L，(3)至(9)组血糖分别为7.33mmol/L、8.25mmol/L、9.33mmol/L、8.56mmol/L、8.97mmol/L、8.05mmol/L、10.3mmol/L，提示复合营养素组合物组有协同降糖、将脂作用。结果见表2.
表2.复合营养素及各单一营养素对血糖、血脂的影响
与复合营养素相比*P<0.05、**P<0.01；与模型组相比#P<0.05、##P<0.01。与正常组相比@@P<0.01
实施例3：
复合营养素组合为：10％1，6-二磷酸果糖、30％谷氨酰胺、1％a-硫辛酸、9％槲皮素、0.5％复合抗氧化剂、49.5％GABA组合。其中复合抗氧剂的比例为：50％花青素、0.5％辅酶Q10、28.4％原花青素、20％维生素C、1％维生素E、0.1％谷胱甘肽。
采用实施例3所述方法，作为复合营养素组合，以脑缺血面积和行为学评分为测定指标，测定组合物的抗脑卒中及并发症能力。
(一)试验方法
本发明以大鼠90只，随机分组，每组10只，随机分为8组：(2)模型组；(3)复合营养素组合物组；(4)1.6-二磷酸果糖组；(5)谷氨酰胺组；(6)硫辛酸组；(7)槲皮素组；(8)复合抗氧化剂组；(9)GABA组；每天分别灌胃给药100mg/kg，正常组位于同体积蒸馏水除正常组大鼠，采用线栓法制备脑缺血大鼠模型，于缺血前2小时，给予上述药物，手术后，每天一次给药，连续7天，采用6分法进行行为学评分。然后，处死动物，取脑，TTC染色后，计算脑梗死面积与脑面积(非梗死区+梗死区)之比。
(二)统计学处理：采用SPSS10.0如见进行统计分析。计量资料以(χ±S)表示，结果进行t检验；计数资料采用卡方检验。P<0.05为差异显著。
(三)试验结果
结果可见，(2)至(10)组脑缺血大鼠，脑梗死面积/脑面积分别为0.253±0.015、0.083±0.007、0.189±0.026、0.193±0.056、0.213±0.085、0.157±0.085、0.124±0.036、0.117±0.009。(1)至(10)组脑缺血大鼠行为学评分分别为：0.156±0.051、4.03±0.88、2.04±0.115、3.75±0.431、3.33±0.521、2.75±0.141、2.93±0.335、3.14±0.237、3.97±0.551。提示复合营养素组合物组有协同抗脑卒中及其并发症的作用。结果见表3.
表3.复合营养素及各单一营养素对脑缺血及行为学评分的影响
与复合营养素相比*P<0.05、**P<0.01；与模型组相比#P<0.05、##P<0.01。与正常组相比@@P<0.01
实施例4：
复合营养素制备：9.9％1，6-二磷酸果糖、0.05％谷氨酰胺、0.05％a-硫辛酸、20％槲皮素、20％复合抗氧化剂、50％GABA。其中复合抗氧化剂为：由0.05％花青素、0.45％辅酶Q10、15％原花青素、14.5％维生素C、20％维生素E、50％谷胱甘肽。
实施例5:
复合营养素制备：50％1，6-二磷酸果糖、40％谷氨酰胺、1％a-硫辛酸、1％槲皮素、5％复合抗氧化剂、3％GABA。其中复合抗氧化剂为：由50％花青素、0.5％辅酶Q10、19％原花青素、10％维生素C、20％维生素E、0.5％谷胱甘肽。
实施例6:
复合营养素制备：29％1，6-二磷酸果糖、0.5％谷氨酰胺、0.5％a-硫辛酸、10％槲皮素、10％复合抗氧化剂、50％GABA。其中复合抗氧化剂为：由50％花青素、30％辅酶Q10、10％原花青素、5％维生素C、4％维生素E、1％谷胱甘肽。
虽然，上文中已经用一般性说明及具体实施方案对本发明作了详尽的描述，但在本发明基础上，可以对之作一些修改或改进，这对本领域技术人员而言是显而易见的。因此，在不偏离本发明精神的基础上所做的这些修改或改进，均属于本发明要求保护的范围。
Claims (4)
1.一种复合营养组合物及其制备方法，其特征在于，所述复合营养素组合物包括下述重量百分比的组分：0.01％～50％1,6-二磷酸果糖、0.01％～50％谷氨酰胺、0.01％～20％a-硫辛酸、0.01％～20％槲皮素、0.01％～20％复合抗氧化剂、0.01％～50％GABA，混合形成组合物。
2.根据权利要求1所述的一种复合营养组合物及其制备方法，其特征在于：所述复合营养素组合物包括下述重量百分比的组分，20％1，6-二磷酸果糖、30％谷氨酰胺、10％a-硫辛酸、5％槲皮素、5％复合抗氧化剂、30％GABA，所述复合营养组合物的制备应用于糖尿病及其并发症中。
3.根据权利要求1所述的一种复合营养组合物及其制备方法，其特征在于：所述复合营养素组合物包括下述重量百分比的组分，10％1，6-二磷酸果糖、30％谷氨酰胺、1％a-硫辛酸、9％槲皮素、0.5％复合抗氧化剂、49.5％GABA，所述复合营养组合物的制备应用于脑卒中及其并发症中。
4.根据权利要求1所述的一种复合营养组合物及其制备方法，其特征在于：所述复合抗氧化剂包括下述重量百分比的组分：0.01％～50％花青素、0.01％～30％辅酶Q10、0.01％～20％原花青素、0.01％～20％维生素C、0.01％～20％维生素E、0.01％～50％谷胱甘肽，混合形成复合抗氧化剂。
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