CN114177271A - 一种调节糖类摄入与控制血糖的组合物及其制备方法 - Google Patents
一种调节糖类摄入与控制血糖的组合物及其制备方法 Download PDFInfo
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Abstract
本发明涉及一种调节糖类摄入与控制血糖的组合物及其制备方法,所述的调节糖类摄入与控制血糖的组合物包括如下原料组分:胰腺低聚肽5‑45份、桑叶提取物15‑35份、白芸豆提取物12‑20份、苦瓜提取物6‑14份。本发明所述的调节糖类摄入与控制血糖的组合物,可有效调节高血糖人群的血糖值,对于多尿、乏力、尿糖、体重减轻、眼睛不适、头晕、腹部胀痛等症状改善有效率达60%。本发明组合物成分安全,无毒副作用,不添加蔗糖、麦芽糊精、色素、香精等辅料,可作为长期食用的调节血糖的功能性食品。
Description
技术领域
本发明属于食品技术领域,具体涉及一种调节糖类摄入与控制血糖的组合物及其制备方法。
背景技术
近年来,危重疾病当中的高血糖反应受到广泛关注,研究表明通过控制高血糖可以减少并发症并降低死亡率。空腹时人的正常血糖值在3.9~6.1毫摩尔/升。糖尿病患者空腹时血糖值大于7毫摩尔/升。糖耐量损伤(属于糖尿病前期,如不加干预,约60%以上者5年后会发展为糖尿病。糖尿病己成为严重危害人类健康的慢性疾病,目前,世界上大约有2.85亿糖尿病患者。占世界人口的6.4%,预计到2030年,将达到4.38亿。且患者主要集中在印度和中国等东南亚国家,中国成年人中糖尿病患者的患病率已经接近10%,从个体水平来说,糖尿病比高血压造成的寿命损失还要严重。据报道有87%的患者在40岁以后发病。糖尿病患者如得不到及时治疗,会并发许多严重的疾患,而缩短患者的期望寿命。糖尿病,尤其是Ⅱ型糖尿病是一类慢性、代谢性疾病,特征为高血糖,主要易感于中老年人群。中老年人认为自己现有的时间很短暂,最容易放开饮食,进而出现血糖偏高的现象。长期高碳水高脂饮食,会引起血糖的剧烈波动,让胰腺不得不“加班”,体内长期处于大量分泌胰岛素的状态,容易导致体内细胞对胰岛素不敏感,也就是胰岛素抵抗,使得血糖居高不下,甚至引发糖尿病。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。对于血糖的控制,尤为重要。
食物中的淀粉经唾液中的α-淀粉酶作用,催化淀粉中α-1,4-糖苷键的水解,产物是葡萄糖、麦芽糖、麦芽寡糖及糊精。由于食物在口腔中停留时间短,淀粉的主要消化部位在小肠。小肠中含有胰腺分泌的α-淀粉酶,催化淀粉水解成麦芽糖、麦芽三糖、α-临界糊精和含分支的异麦芽糖。在小肠黏膜刷状缘上,含有α-糊精酶,此酶催化α-临界糊精的α-1,4-糖苷键及α-1,6-糖苷键水解,使α-临界糊精水解成葡萄糖;刷状缘上还有麦芽糖酶可将麦芽三糖及麦芽糖水解为葡萄糖。小肠黏膜还有蔗糖酶和乳糖酶,前者将蔗糖分解成葡萄糖和果糖,后者将乳糖分解成葡萄糖和半乳糖。其他单糖如甘露糖、果糖和半乳糖从肠道吸收后,必须经肝脏转换为葡萄糖才能加以利用。
目前针对降血糖的产品多集中在阻断碳水化合物转化成葡萄糖的代谢过程,忽略了胰岛素敏感性的改善及胰岛细胞的修复。因此,通过对饮食干预的同时,也需要对已损伤的胰岛细胞进行修复。
发明内容
本发明的目的在于提供一种调节糖类摄入与控制血糖的组合物及其制备方法,所述的组合物从修复胰岛细胞分泌胰岛素功能、改善胰岛素敏感性以及抑制碳水化合物转化单糖等方面入手,通过各组分的相互配合,协同作用,可收到较好的调节血糖的效果。
为实现本发明的上述目的,本发明采用以下技术方案:
一种调节糖类摄入与控制血糖的组合物,包括如下原料组分:胰腺低聚肽5-45份、桑叶提取物15-35份、白芸豆提取物12-20份、苦瓜提取物6-14份。优选的,胰腺低聚肽15-35份、桑叶提取物20-30份、白芸豆提取物14-18份、苦瓜提取物8-12份。进一步优选的,胰腺低聚肽25份、桑叶提取物25份、白芸豆提取物16份、苦瓜提取物10份。
胰腺分为外分泌部和内分泌部两部分。外分泌腺由腺泡和腺管组成,腺泡分泌胰液,腺管是胰液排出的通道。胰液中含有碳酸氢钠、胰蛋白酶原、脂肪酶、淀粉酶等。胰液通过胰腺管排入十二指肠,有消化蛋白质、脂肪和糖的作用。内分泌腺由大小不同的细胞团——胰岛所组成,胰岛主要由4种细胞组成:A细胞、B细胞、D细胞、PP细胞。B细胞分泌胰岛素,降低血糖。胰岛素是大分子蛋白质,肽是构成蛋白质的的原料,胰腺低聚肽为胰岛细胞分泌胰岛素提供原料。胰腺低聚肽含有17种氨基酸,其中必需氨基酸8种,2种半必需氨基酸。小分子胰腺低聚肽进入人体后,能快速吸收并利用,为胰岛细胞的的更新及修复提供必要氨基酸。
桑叶含有多种功能性成分,如食物纤维、矿物质、氨基酸、维生素、植物甾醇、黄酮及其苷类、生物碱类物质、多糖和多种微量元素等。桑叶是很好的功能性食品,它具有降脂、降压、增加机体耐力、抗衰老、降低胆固醇、抑制血栓形成,抑制肠内有害细菌繁殖,抑制有害氧化物形成,抑制癌症以及调节肾上腺素功能等功效,最突出的功能是缓解糖尿病。桑叶的多糖、黄酮、生物碱类物质均有不同程度的降血糖作用。主要是通过抑制a-葡萄糖苷酶的活性,延缓碳水化合物在肠道的消化,延迟来自双糖、低聚糖及多糖的葡萄糖吸收,从而起到降低血糖的作用。
白芸豆,别名白肾豆、白腰豆等,在我国云南、贵州、四川等省份种植面积较大。白芸豆富含a-淀粉酶抑制剂和膳食纤维。a-酶抑制剂能有效抑制口腔和胃肠道内唾液及胰淀粉酶的活性,阻碍食物中碳水化合物的水解和消化。因此能有效阻断高淀粉类食物(米饭、面食、杂粮及相关零食和糕点)中淀粉的分解,阻断大部分热量的摄取,减少人体最大的脂肪来源。同时a-淀粉酶抑制剂,属于糖(苷)水解酶抑制中的一种。a-葡萄糖苷酶抑制剂通过竞争性抑制a-糖苷酶的作用来减少糖类的降解,延缓糖类的吸收,从而有效地降高血糖人群餐后血糖浓度峰值,达到控制血糖的目的。
苦瓜是葫芦科苦瓜属植物苦瓜的果实,在世界范围内广泛分布。作为药食同源植物,具有清热解毒、滋养强壮、明目和消除疲劳之功效。苦瓜含有多种生物活性的植物成分,苷类、蛋白质、多肽、氨基酸、糖类、生物碱类、有机酸、脂类、甾类、萜类、微量元素等。苦瓜蛋白类化合物包括植物蛋白(碱性多肽,由17种氨基酸组成)、a-苦瓜素和B-苦瓜素、r-苦瓜素、苦瓜凝集素、苦瓜素I和苦瓜素II、苦瓜定、抗病毒蛋白MAP30和苦瓜抑制剂等。苦瓜中具有胰岛素样作用的多肽类成分(多肽-P)通过其特有的空间结构,增强胰岛素A链和B链间两个二硫键的稳定性,诱导低活性的胰岛素恢复其活性空间结构,从而激活胰岛素,增强其对细胞膜上胰岛素受体a亚基和B亚基。
根据本发明所述的调节糖类摄入与控制血糖的组合物,所述胰腺低聚肽按如下方法制备得到:取新鲜猪胰腺,清洗干净,沥干水分后研磨均匀,得到胰腺匀浆液;向胰腺匀浆液中加入酶活为10000-30000u/g的木瓜蛋白酶,加酶量1.0-1.5%质量比,30-60℃酶解2-4h,得到酶解液,经过滤、浓缩、调节pH至9.0-10.0、加热至65-70℃并保持10-15min使灭酶,以及再过滤、浓缩、冷冻干燥,即得。
根据本发明所述的调节糖类摄入与控制血糖的组合物,所述桑叶提取物按如下方法制备得到:桑叶洗净沥水后去柄切条,干燥后粉碎,得到桑叶粉;取桑叶粉,按料液比1g:25-45mL加入体积浓度为40-80%乙醇,40-50℃提取40-80min,得到乙醇提取液,经过滤、浓缩、冷冻干燥,即得。
根据本发明所述的调节糖类摄入与控制血糖的组合物,所述白芸豆提取物按如下方法制备得到:白芸豆去除杂质,于水中浸泡后去皮,经干燥、粉碎,得到白芸豆粉;取白芸豆粉,按料液比1g:20-40mL加入水,40-60℃恒温搅拌使充分溶解,调节pH值至3-4,保温2-3h,经过滤、浓缩、冷冻干燥,即得。
根据本发明所述的调节糖类摄入与控制血糖的组合物,所述苦瓜提取物按如下方法制备得到:取新鲜苦瓜果实,加入乙醇和少量H2S04(调节pH值,酸性条件下提取率高),所述的苦瓜果实:乙醇=1g:2-5mL,所述的乙醇体积浓度为70-90%,匀浆25-40min,得到匀浆液;调节匀浆液pH至1-2,抽滤,滤液调节pH至2-3,向滤液中加入乙醚和乙醇去除脂溶性物质,所述的滤液:乙醚:乙醇=1g:5-10mL:5-10mL,低温静置使沉淀,依次用丙酮、无水乙醚洗涤沉淀,加水溶解后,搅拌均匀,经过滤、浓缩、冷冻干燥,即得。
本发明所述的调节糖类摄入与控制血糖的组合物的基础上,还可以通过加入辅助性成分制备成为适合内服的各种制剂,优选为将其制成片剂,当将其制成片剂时,所述的辅助性成分包括但不限于常规的填充剂、甜味剂以及润滑剂,所述的填充剂优选为抗性糊精,甜味剂优选为山梨糖醇,润滑剂优选为硬脂酸镁。所述的片剂的制备方法为:将山梨糖醇粉碎后过筛,得到山梨糖醇粉;将山梨糖醇粉与剩余各原料混合均匀后压片,即得。
本发明的有益效果为:
1、本发明所述的调节糖类摄入与控制血糖的组合物,采用胰腺低聚肽、桑叶提取物、白芸豆提取物、苦瓜提取物为活性组分并进行适合的重量配比,一方面,胰腺低聚肽中的小分子肽、氨基酸与苦瓜提取物中的氨基酸为胰岛细胞分泌胰岛素提供原料,同时,苦瓜提取物中的胰岛素样作用的多肽类成分通过其特有的空间结构,增强胰岛素的稳定性,诱导低活性的胰岛素恢复其活性空间结构以激活低活性的胰岛素而进一步强化了胰岛素功能,从而加速了降糖作用;另一方面,桑叶提取物与白芸豆提取物的复配在抑制a-葡萄糖苷酶的活性作用方面产生了协同,从而减少了糖类的降解,延缓了来自双糖、低聚糖及多糖的葡萄糖吸收。通过以上两方面共同作用,本发明组合物可收到较好的调节血糖的效果,试验证明,本发明组合物可有效调节高血糖人群的血糖值,对于多尿、乏力、尿糖、体重减轻、眼睛不适、头晕、腹部胀痛等症状改善有效率达60%。
2、本发明所述的调节糖类摄入与控制血糖的组合物,成分安全,无毒副作用,其制剂不添加蔗糖、麦芽糊精、色素、香精等辅料,可作为长期食用的调节血糖的功能性食品。
3、本发明所述的调节糖类摄入与控制血糖的组合物,其限定方法制备的胰腺低聚肽、桑叶提取物、白芸豆提取物以及苦瓜提取物的活性成分保留好,含量高,易于被人体吸收利用,且制备方法简单,易于实现工业化生产。
具体实施方式
为使本发明的目的、技术方案和优点更加清楚,下面将对本发明的技术方案进行详细的描述。显然,所描述的实施例仅仅是本发明的一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动的前提下所得到的所有其它实施方式,都属于本发明所保护的范围。以下实施例中以1份代表1g。
实施例1
本实施例提供一种调节糖类摄入与控制血糖的组合物,由如下原料组分制成:
胰腺低聚肽5份、桑叶提取物35份、白芸豆提取物12份、苦瓜提取物14份、山梨糖醇14份、抗性糊精20份、硬脂酸镁0.5份。
所述调节糖类摄入与控制血糖的组合物的制备方法,包括以下步骤:
(1)胰腺低聚肽的制备:取新鲜猪胰腺,清洗干净,沥干水分后经恒温水胶体研磨均匀,得到胰腺匀浆液,备用;向胰腺匀浆液中加入酶活为10000u/g的蛋白酶,加酶量1.0%质量比,60℃酶解2h,过滤、浓缩,调节浓缩液pH值为9.0,加热10min(70℃),进行灭酶活性,再过滤、浓缩、冷冻干燥,过筛(80目),得到粉末状胰腺低聚肽。
(2)桑叶提取物的制备:桑叶洗净沥水后去柄切条,烘干粉碎后过40目筛,得到桑叶粉,备用;取桑叶粉,按料液比1g:25mL加入体积浓度为80%乙醇,加热搅拌40min(温度50℃),过滤、浓缩、真空冷冻干燥48h,过筛(60目),得到桑叶提取物。
(3)白芸豆提取物制备:白芸豆去除杂质,在4℃水中浸泡12h后去皮,在35℃烘箱中干燥后经粉碎机粉碎,过100目筛,得到白芸豆粉。取白芸豆粉,按料液比1g:20mL加水,在恒定温度(40℃)下不断搅拌使其充分溶解,调节pH值为3,保温2h,过滤,离心,浓缩,真空冷冻干燥12h,得到白芸豆提取物。
(4)苦瓜提取物的制备:取新鲜苦瓜果实,加入乙醇(体积浓度70%)和少量H2S04匀浆25min,所述的苦瓜果实:乙醇=1g:2mL,匀浆液调pH至1,抽滤,滤液用NH3·H20调节pH为2,向滤液中加入乙醚和乙醇,所述的滤液:乙醚:乙醇=1g:5mL:10mL,5℃静置24h,得白色絮状沉淀;过滤,依次用丙酮、无水乙醚洗涤沉淀。加入适量蒸馏水溶解,搅拌均匀,多次过滤,浓缩,真空冷冻干燥,得到苦瓜提取物。
(5)粉碎:将山梨糖醇粉碎后过筛,备用。
(6)混合:将胰腺低聚肽、桑叶提取物、白芸豆提取物、苦瓜提取物、山梨糖醇、抗性糊精和硬脂酸镁均匀混合,得到混合物。
(7)压片:将混合物进行压片,压片后进行包装,得到所述调节糖类摄入与控制血糖的组合物。
实施例2
本实施例提供一种调节糖类摄入与控制血糖的组合物,由如下原料组分制成:
胰腺低聚肽15份、桑叶提取物30份、白芸豆提取物14份、苦瓜提取物12份、山梨糖醇16份、抗性糊精13份、硬脂酸镁0.9份。
所述调节糖类摄入与控制血糖的组合物的制备方法,包括以下步骤:
(1)胰腺低聚肽的制备:取新鲜猪胰腺,清洗干净,沥干水分后经恒温水胶体研磨均匀,得到胰腺匀浆液,备用;向胰腺匀浆液中加入酶活为30000u/g的木瓜蛋白酶,加酶量1.5%质量比,30酶解4h,过滤、浓缩,调节浓缩液pH值为10.0,加热15min(65℃),进行灭酶活性,再过滤、浓缩、冷冻干燥,过筛(80目),得到粉末状胰腺低聚肽。
(2)桑叶提取物的制备:桑叶洗净沥水后去柄切条,烘干粉碎后过40目筛,得到桑叶粉,备用;取桑叶粉,按料液比1g:45mL加入体积浓度为40%乙醇,加热搅拌80min(温度40℃),过滤、浓缩、真空冷冻干燥48h,过筛(60目),得到桑叶提取物。
(3)白芸豆提取物制备:白芸豆去除杂质,在4℃水中浸泡12h后去皮,在35℃烘箱中干燥后经粉碎机粉碎,过100目筛,得到白芸豆粉。取白芸豆粉,按料液比1g:40mL加水,在恒定温度(60℃)下不断搅拌使其充分溶解,调节pH值为4,保温3h,过滤,离心,浓缩,真空冷冻干燥12h,得到白芸豆提取物。
(4)苦瓜提取物的制备:取新鲜苦瓜果实,加入乙醇(体积浓度90%)和少量H2S04匀浆40min,所述的苦瓜果实:乙醇=1g:5mL,匀浆液调pH至2,抽滤,滤液用NH3·H20调节pH为3,所述的滤液:乙醚:乙醇=1g:10mL:5mL,向滤液中加入乙醚和乙醇,5℃静置24h,得白色絮状沉淀;过滤,依次用丙酮、无水乙醚洗涤沉淀。加入适量蒸馏水溶解,搅拌均匀,多次过滤,浓缩,真空冷冻干燥,得到苦瓜提取物。
(5)粉碎:将山梨糖醇粉碎后过筛,备用。
(6)混合:将胰腺低聚肽、桑叶提取物、白芸豆提取物、苦瓜提取物、山梨糖醇、抗性糊精和硬脂酸镁均匀混合,得到混合物。
(7)压片:将混合物进行压片,压片后进行包装,得到所述调节糖类摄入与控制血糖的组合物。
实施例3
本实施例提供一种调节糖类摄入与控制血糖的组合物,由如下原料组分制成:
胰腺低聚肽25份、桑叶提取物25份、白芸豆提取物16份、苦瓜提取物10份、山梨糖醇18份、抗性糊精6份、硬脂酸镁1.3份。
所述调节糖类摄入与控制血糖的组合物的制备方法,包括以下步骤:
(1)胰腺低聚肽的制备:取新鲜猪胰腺,清洗干净,沥干水分后经恒温水胶体研磨均匀,得到胰腺匀浆液,备用;向胰腺匀浆液中加入酶活为20000u/g的木瓜蛋白酶,加酶量1.0%质量比,50℃酶解3h,过滤、浓缩,调节浓缩液pH值为9.2,加热10min(70℃),进行灭酶活性,再过滤、浓缩,进行冷冻干燥,过筛(80目),得到粉末状胰腺低聚肽。经检测,肽含量为70%,胰腺低聚肽平均分子量为500Da。
(2)桑叶提取物的制备:桑叶洗净沥水后去柄切条,烘干粉碎后过40目筛,得到桑叶粉,备用;取桑叶粉,按料液比1g:30mL加入体积浓度为70%乙醇,加热搅拌60min(温度45℃),过滤、浓缩、真空冷冻干燥48h,过筛(60目),得到桑叶提取物。
(3)白芸豆提取物制备:白芸豆去除杂质,在4℃水中浸泡12h后去皮,在35℃烘箱中干燥后经粉碎机粉碎,过100目筛,得到白芸豆粉。取白芸豆粉,按料液比1g:30mL加水,在恒定温度(50℃)下不断搅拌使其充分溶解,调节pH值为3.5,保温2.5h,过滤,离心,浓缩,真空冷冻干燥12h,得到白芸豆提取物。所得白芸豆提取物的α-淀粉酶抑制率达到94.9%。
(4)苦瓜提取物的制备:取新鲜苦瓜果实,加入乙醇(体积浓度80%)和少量H2S04匀浆30min,所述的苦瓜果实:乙醇=1g:2mL,匀浆液调pH至1.4,抽滤,滤液用NH3·H20调节pH为2.3,向滤液中加入乙醚和乙醇,所述的滤液:乙醚:乙醇=1g:5mL:5mL,5℃静置24h,得白色絮状沉淀;过滤,依次用丙酮、无水乙醚洗涤沉淀。加入适量蒸馏水溶解,搅拌均匀,多次过滤,浓缩,真空冷冻干燥,得到苦瓜提取物。其中,得到的苦瓜提取物中多肽含量为62%。
(5)粉碎:将山梨糖醇粉碎后过筛,备用。
(6)混合:将胰腺低聚肽、桑叶提取物、白芸豆提取物、苦瓜提取物、山梨糖醇、抗性糊精和硬脂酸镁均匀混合,得到混合物。
(7)压片:将混合物进行压片,压片后进行包装,得到所述调节糖类摄入与控制血糖的组合物。
实施例4
本实施例提供一种调节糖类摄入与控制血糖的组合物,由如下原料组分制成:
胰腺低聚肽35份、桑叶提取物20份、白芸豆提取物18份、苦瓜提取物8份、山梨糖醇15份、抗性糊精4份、硬脂酸镁17份。
所述调节糖类摄入与控制血糖的组合物的制备方法,包括以下步骤:
(1)胰腺低聚肽的制备:取新鲜猪胰腺,清洗干净,沥干水分后经恒温水胶体研磨均匀,得到胰腺匀浆液,备用;向胰腺匀浆液中加入酶活为20000u/g的木瓜蛋白酶,加酶量1.2%质量比,50℃酶解3h,过滤、浓缩,调节浓缩液pH值为9.5,加热10min(70℃),进行灭酶活性,再过滤、浓缩,进行冷冻干燥,过筛(80目),得到粉末状胰腺低聚肽。
(2)桑叶提取物的制备:桑叶洗净沥水后去柄切条,烘干粉碎后过40目筛,得到桑叶粉,备用;取桑叶粉,按料液比1g:30mL加入体积浓度为70%乙醇,加热搅拌60min(温度45℃),过滤、浓缩、真空冷冻干燥48h,过筛(60目),得到桑叶提取物。
(3)白芸豆提取物制备:白芸豆去除杂质,在4℃水中浸泡12h后去皮,在35℃烘箱中干燥后经粉碎机粉碎,过100目筛,得到白芸豆粉。取白芸豆粉,按料液比1g:30mL加水,在恒定温度(50℃)下不断搅拌使其充分溶解,调节pH值为3.8,保温2.5h,过滤,离心,浓缩,真空冷冻干燥12h,得到白芸豆提取物。
(4)苦瓜提取物的制备:取新鲜苦瓜果实,加入乙醇(体积浓度80%)和少量H2S04匀浆30min,所述的苦瓜果实:乙醇=1g:2mL,匀浆液调pH至1.6,抽滤,滤液用NH3·H20调节pH为2.7,向滤液中加入乙醚和乙醇,所述的滤液:乙醚:乙醇=1g:5mL:5mL,5℃静置24h,得白色絮状沉淀;过滤,依次用丙酮、无水乙醚洗涤沉淀。加入适量蒸馏水溶解,搅拌均匀,多次过滤,浓缩,真空冷冻干燥,得到苦瓜提取物。
(5)粉碎:将山梨糖醇粉碎后过筛,备用。
(6)混合:将胰腺低聚肽、桑叶提取物、白芸豆提取物、苦瓜提取物、山梨糖醇、抗性糊精和硬脂酸镁均匀混合,得到混合物。
(7)压片:将混合物进行压片,压片后进行包装,得到所述调节糖类摄入与控制血糖的组合物。
实施例5
本实施例提供一种调节糖类摄入与控制血糖的组合物,由如下原料组分制成:
胰腺低聚肽45份、桑叶提取物15份、白芸豆提取物20份、苦瓜提取物6份、山梨糖醇22份、抗性糊精2份、硬脂酸镁2份。
所述调节糖类摄入与控制血糖的组合物的制备方法,包括以下步骤:
(2)胰腺低聚肽的制备:取新鲜猪胰腺,清洗干净,沥干水分后经恒温水胶体研磨均匀,得到胰腺匀浆液,备用;向胰腺匀浆液中加入酶活为20000u/g的木瓜蛋白酶,加酶量1.2%质量比,50℃酶解3h,过滤、浓缩,调节浓缩液pH值为9.2,加热10min(70℃),进行灭酶活性,再过滤、浓缩,进行冷冻干燥,过筛(80目),得到粉末状胰腺低聚肽。
(2)桑叶提取物的制备:桑叶洗净沥水后去柄切条,烘干粉碎后过40目筛,得到桑叶粉,备用;取桑叶粉,按料液比1g:30mL加入体积浓度为70%乙醇,加热搅拌60min(温度45℃),过滤、浓缩、真空冷冻干燥48h,过筛(60目),得到桑叶提取物。
(3)白芸豆提取物制备:白芸豆去除杂质,在4℃水中浸泡12h后去皮,在35℃烘箱中干燥后经粉碎机粉碎,过100目筛,得到白芸豆粉。取白芸豆粉,按料液比1g:30mL加水,在恒定温度(50℃)下不断搅拌使其充分溶解,调节pH值为3.4,保温2.5h,过滤,离心,浓缩,真空冷冻干燥12h,得到白芸豆提取物。
(4)苦瓜提取物的制备:取新鲜苦瓜果实,加入乙醇(体积浓度80%)和少量H2S04匀浆30min,所述的苦瓜果实:乙醇=1g:2mL,匀浆液调pH至1.8,抽滤,滤液用NH3·H20调节pH为2.2,向滤液中加入乙醚和乙醇,所述的滤液:乙醚:乙醇=1g:5mL:5mL,5℃静置24h,得白色絮状沉淀;过滤,依次用丙酮、无水乙醚洗涤沉淀。加入适量蒸馏水溶解,搅拌均匀,多次过滤,浓缩,真空冷冻干燥,得到苦瓜提取物。
(5)粉碎:将山梨糖醇粉碎后过筛,备用。
(6)混合:将胰腺低聚肽、桑叶提取物、白芸豆提取物、苦瓜提取物、山梨糖醇、抗性糊精和硬脂酸镁均匀混合,得到混合物。
(7)压片:将混合物进行压片,压片后进行包装,得到所述调节糖类摄入与控制血糖的组合物。
对比例1
本对比例与实施例3的原料组成相同,区别仅在于白芸豆提取物的制备方法不同,具体的,本对比例白芸豆提取物按如下方法制备得到:
白芸豆去除杂质,在4℃水中浸泡12h后去皮,在35℃烘箱中干燥后经粉碎机粉碎,过100目筛,得到白芸豆粉。取白芸豆粉,按料液比1g:30mL加水,调节pH值为6.2,在恒定温度(50℃)下不断搅拌提取2.5h,过滤,离心,浓缩,真空冷冻干燥12h,得到白芸豆提取物。
对比例2
本对比例在实施例3的基础上,保持活性组分的原料总量不变,同时去掉胰腺低聚肽。具体的,本对比例提供一种调节糖类摄入与控制血糖的组合物,由如下原料组分制成:桑叶提取物34份、白芸豆提取物24份、苦瓜提取物18份、山梨糖醇18份、抗性糊精6份、硬脂酸镁1.3份。
所述调节糖类摄入与控制血糖的组合物的制备方法,包括以下步骤:
(1)桑叶提取物的制备:桑叶洗净沥水后去柄切条,烘干粉碎后过40目筛,得到桑叶粉,备用;取桑叶粉,按料液比1g:30mL加入体积浓度为70%乙醇,加热搅拌60min(温度45℃),过滤、浓缩、真空冷冻干燥48h,过筛(60目),得到桑叶提取物。
(2)白芸豆提取物制备:白芸豆去除杂质,在4℃水中浸泡12h后去皮,在35℃烘箱中干燥后经粉碎机粉碎,过100目筛,得到白芸豆粉。取白芸豆粉,按料液比1g:30mL加水,在恒定温度(50℃)下不断搅拌使其充分溶解,调节pH值为3.5,保温2.5h,过滤,离心,浓缩,真空冷冻干燥12h,得到白芸豆提取物。
(3)苦瓜提取物的制备:取新鲜苦瓜果实,加入乙醇(体积浓度80%)和少量H2S04匀浆30min,所述的苦瓜果实:乙醇=1g:2mL,匀浆液调pH至1.4,抽滤,滤液用NH3·H20调节pH为2.3,向滤液中加入乙醚和乙醇,所述的滤液:乙醚:乙醇=1g:5mL:5mL,5℃静置24h,得白色絮状沉淀;过滤,依次用丙酮、无水乙醚洗涤沉淀。加入适量蒸馏水溶解,搅拌均匀,多次过滤,浓缩,真空冷冻干燥,得到苦瓜提取物。
(4)粉碎:将山梨糖醇粉碎后过筛,备用。
(5)混合:将胰腺低聚肽、桑叶提取物、白芸豆提取物、苦瓜提取物、山梨糖醇、抗性糊精和硬脂酸镁均匀混合,得到混合物。
(6)压片:将混合物进行压片,压片后进行包装,得到所述调节糖类摄入与控制血糖的组合物。
试验例
征集有高血糖一般症状(多尿、乏力、抽搐、体重减轻、眼睛不适、头晕、腹部胀痛等症状)中至少有一项者,150人,年龄在30-75岁之间,男性60名,女性90名,随机分为3组,分别为试验组,对照组1和对照组2,试验组50人,对照组1 50人,对照组2 50人。试验组志愿者食用实施例3得到的组合物,每天2次,每次2片;对照组1志愿者食用对比例1得到的组合物,每天2次,每次2片;对照组2志愿者食用对比例2得到的组合物,每天2次,每次2片;连续食用3个月,对各组志愿者进行检查记录,统计结果,结果见表1。
显效:多尿、乏力、抽搐、体重减轻、眼睛不适、头晕、腹部胀痛7种主要临床症状有1种以上改善,且无其他不良反应。
无效:多尿、乏力、抽搐、体重减轻、眼睛不适、头晕、腹部胀痛7种主要临床症状没有改善,或者是有不良反应。
有效率为显效与每组总人数的百分比。
表1试验结果
组别 | 显效(人) | 无效(人) | 有效率(%) |
试验组 | 41 | 9 | 82% |
对照组1 | 37 | 13 | 74% |
对照组2 | 30 | 20 | 60% |
从表1的结果可以看出,本发明所提供的调节糖类摄入与控制血糖的组合物对高血糖人群具有明显的改善作用,而对照组中由于仅仅含有其中的部分组分,其功效远远不及试验组的效果,与对照组1相比,试验组的有效率提高8%,与对照组2相比,试验组的有效率提高22%,效果显著。可见,本发明实施例3组合物较对比例1、对比例2组合物原料配伍和制备方法更合理,各组分协同提高了对高血糖人群的降糖效果。
典型案例
1、陈某,女,47岁,糖尿病史3年,乏力,伴有睡眠障碍。服用本发明实施例3得到的降血糖的组合物,每天4片,连续服用27天后,血糖由10mmol/L降至8mmol/L;睡眠时间由每次的4h增加至5-6h;白天有劲了,可以去户外走走了。
2、韩某,男,60岁,头晕,起夜次数3-4次,血糖不稳定、伴有抽搐,服用本发明实施例3得到的降血糖的组合物,每天早晚各2片,服用13天,头不晕了,起夜次数减少了,尿频也改善了。服用25天,血糖值降低了1.4mmol/L,不再出现抽搐症状。
3、王某,女,53岁,乏力、没有精神,腹部胀痛,服用本发明实施例1得到的降血糖的组合物,每天早晚各2片,连续服用14天后,身体乏力感减弱,可以适量运动了,且腹部胀痛感减弱,排便顺畅了。
4、秦某,女,40岁,厌食、乏力,服用本发明实施例2得到的降血糖的组合物,每天早晚各2片,连续服用18天,乏力感减弱,有精神了。继续服用7天,食欲增强,便秘得到改善,体重增长,也有劲了。
5、李某,男,57岁,血糖高、多尿、眼睛不适,服用本发明实施例3得到的降血糖的组合物,每天早晚各2片,服用15天,糖尿病并发症引起的眼睛不适有所改善,视力清晰;血糖从空腹12mmol/L降至10mmol/L;尿频次数减少,多尿得到改善。
以上所述,仅为本发明的具体实施方式,但本发明的保护范围并不局限于此,任何熟悉本技术领域的技术人员在本发明揭露的技术范围内,可轻易想到变化或替换,都应涵盖在本发明的保护范围之内。因此,本发明的保护范围应以所述权利要求的保护范围为准。
Claims (10)
1.一种调节糖类摄入与控制血糖的组合物,其特征在于,包括如下原料组分:
胰腺低聚肽5-45份、桑叶提取物15-35份、白芸豆提取物12-20份、苦瓜提取物6-14份。
2.根据权利要求1所述的调节糖类摄入与控制血糖的组合物,其特征在于,包括如下原料组分:
胰腺低聚肽15-35份、桑叶提取物20-30份、白芸豆提取物14-18份、苦瓜提取物8-12份。
3.根据权利要求1所述的调节糖类摄入与控制血糖的组合物,其特征在于,包括如下原料组分:
胰腺低聚肽25份、桑叶提取物25份、白芸豆提取物16份、苦瓜提取物10份。
4.根据权利要求1所述的调节糖类摄入与控制血糖的组合物,其特征在于,所述的胰腺低聚肽按如下方法制备得到:
取新鲜猪胰腺,清洗干净,沥干水分后研磨均匀,得到胰腺匀浆液;向胰腺匀浆液中加入酶活为10000-30000u/g的木瓜蛋白酶,加酶量1.0-1.5%质量比,30-60℃酶解2-4h,得到酶解液,经过滤、浓缩、调节pH至9.0-10.0、加热至65-70℃并保持10-15min使灭酶,以及再过滤、浓缩、冷冻干燥,即得。
5.根据权利要求1所述的调节糖类摄入与控制血糖的组合物,其特征在于,所述的桑叶提取物按如下方法制备得到:
桑叶洗净沥水后去柄切条,干燥后粉碎,得到桑叶粉;取桑叶粉,按料液比1g:25-45mL加入体积浓度为40-80%乙醇,40-50℃提取40-80min,得到乙醇提取液,经过滤、浓缩、冷冻干燥,即得。
6.根据权利要求1所述的调节糖类摄入与控制血糖的组合物,其特征在于,所述的白芸豆提取物按如下方法制备得到:
白芸豆去除杂质,于水中浸泡后去皮,经干燥、粉碎,得到白芸豆粉;取白芸豆粉,按料液比1g:20-40mL加入水,40-60℃恒温搅拌使充分溶解,调节pH值至3-4,保温2-3h,经过滤、浓缩、冷冻干燥,即得。
7.根据权利要求1所述的调节糖类摄入与控制血糖的组合物,其特征在于,所述的苦瓜提取物按如下方法制备得到:
取新鲜苦瓜果实,加入乙醇,所述的苦瓜果实:乙醇=1g:2-5mL,所述的乙醇体积浓度为70-90%,匀浆25-40min,得到匀浆液;调节匀浆液pH至1-2,抽滤,滤液调节pH至2-3,向滤液中加入乙醚和乙醇,所述的滤液:乙醚:乙醇=1mL:5-10mL:5-10mL,低温静置使沉淀,依次用丙酮、无水乙醚洗涤沉淀,加水溶解后,搅拌均匀,经过滤、浓缩、冷冻干燥,即得。
8.根据权利要求1所述的调节糖类摄入与控制血糖的组合物,其特征在于,所述的组合物是以胰腺低聚肽、桑叶提取物、白芸豆提取物、苦瓜提取物为活性成分,通过加入辅助性成分制备而成的制剂。
9.根据权利要求8所述的调节糖类摄入与控制血糖的组合物,其特征在于,所述辅助性成分为填充剂、甜味剂以及润滑剂;优选的,所述填充剂为抗性糊精,所述甜味剂为山梨糖醇,所述润滑剂为硬脂酸镁。
10.一种制备权利要求9所述的调节糖类摄入与控制血糖的组合物的方法,其特征在于,将山梨糖醇粉碎后过筛,得到山梨糖醇粉;将山梨糖醇粉与剩余各原料混合均匀后压片,即得。
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