CN114848713A - 一种降血糖组合物及其制备方法与应用 - Google Patents
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Abstract
本发明公开了一种降血糖组合物及其制备方法与应用,属于中西医结合医药技术领域;本发明提供的一种降血糖组合物包括石榴皮、蚕茧丝提取物、苦瓜干、乌梅根、人参、西洋参、沙参、白术、茯苓、黄芩、叶酸、三磷酸腺苷、维生素B12、维生素C、α‑硫辛酸、低聚木糖、辅酶Q10、白藜芦醇、罗汉果甜苷;本发明提供的降血糖组合物具有优异的降低血糖的效果,且副作用小,还能够活血抗凝、解毒健胃、健脾除秘、益气养阴、去湿、燥湿、活血、舒肝理气,同时还能够促进代谢机制、抗氧化、增强对ATP利用率、提高免疫力系统功能、均衡营养的作用;且本发明提供的降血糖组合物的制备方法简单、操作简便,能够应用于降血糖制剂的制备上。
Description
技术领域
本发明属于中西医结合医药技术领域,尤其涉及一种降血糖组合物及其制备方法与应用。
背景技术
近年来我国成年人糖尿病患者患病率显著上升,并有低龄化趋势,造成疾病负担沉重。现行的治疗药物包括双胍类、SGLT-2抑制剂、GLP-1受体激动剂、α糖苷酶抑制剂、DPP-4抑制剂、格列奈类、磺脲类、噻唑烷二酮类、胰岛素类、人胰淀素类似物、多巴胺受体激动剂、胆酸螯合剂等。中医治疗以辨证论治方法治疗,主要证型包括气阴两虚证、湿热证、气血不足、气血瘀滞等。但是在药物治疗过程中,现行的治疗药品都存在片面性、单一性的问题还没有解决。
发明内容
本发明的目的在于克服上述现有技术的不足之处而提供一种能够有效提高人体机能及免疫能力、有效的达到恢复胰岛功能的效果的降血糖组合物及其制备方法与应用。
为实现上述目的,本发明采取的技术方案为:一种降血糖组合物,所述降血糖组合物包括石榴皮、蚕茧丝提取物、苦瓜干、乌梅根、人参、西洋参、沙参、白术、茯苓、黄芩、叶酸、三磷酸腺苷、维生素B12、维生素C、α-硫辛酸、低聚木糖、辅酶Q10、白藜芦醇、罗汉果甜苷。
本发明提供的降血糖组合物各组分之间具有协同效果,其中一方面石榴皮、蚕茧丝提取物、苦瓜干、乌梅根、人参、西洋参、沙参、白术、茯苓和黄芩有降血糖、活血抗凝、解毒健胃、健脾除秘、益气养阴、去湿、燥湿、活血、舒肝理气等功效,叶酸、三磷酸腺苷、维生素B12、维生素C、α-硫辛酸、低聚木糖、辅酶Q10、白藜芦醇和罗汉果甜苷具有促进代谢机制、抗氧化、增强对ATP利用率、提高免疫力系统功能、均衡营养之间的作用;另一方面降血糖组合物各组分有机结合,能够达到有效控制、稳定血糖、血压,有效降低糖尿病及其并发证的风险,能够应用于糖尿病的预防和辅助治疗上。
本发明添加的组分中石榴皮、蚕茧丝提取物、苦瓜干和乌梅根为主要作用成份起到了滋阴祛热、收涩敛阴,除烦止渴、清热解毒,利尿控糖的作用。
从各组分具体的功效来说;各组分药理如下:
石榴皮:味酸、涩,性温,归大肠经。功效涩肠止泻,止血,驱虫。主治用于久泻,久痢,便血,脱肛,崩漏,带下,虫积腹痛。
蚕茧:味甘;性温,归脾经。功效止渴;解毒疗疮。主肠风便血;淋痛尿血;妇女血崩;消渴引饮;反胃叶食;痈疽脓成不溃;疳疮。
苦瓜干:味苦,性寒,归心、肝、脾、肺经,功用治烦渴、清热、明目、利尿、清心、壮阳。
乌梅根:味微涩,行平,归肝、胃、肺、脾、大肠经。功效止血;祛风湿;舒筋络。
人参:味甘、微苦,平。归脾、肺、心经。功用大补元气,复脉固脱,补脾益肺,生津,安神。用于体虚欲脱,肢冷脉微,脾虚食少,肺虚喘咳,津伤口渴,内热消渴,久病虚羸,惊悸失眠,阳痿宫冷;心力衰竭,心原性休克。
西洋参:味甘、微苦,凉。归心、肺、肾经。功用补气养阴,清热生津。用于气虚阴亏,内热,咳喘痰血,虚热烦倦,消渴,口燥咽干。
沙参:甘,凉。功用清热养阴,润肺止咳。主治气管炎,百日咳,肺热咳嗽,咯痰黄稠。
白术:苦、甘,温。归脾、胃经。功用健脾益气,燥湿利水,止汗,安胎。用于脾虚食少,腹胀泄泻,痰饮眩悸,水肿,自汗,胎动不安。土白术健脾,和胃,安胎。用于脾虚食少,泄泻便溏,胎动不安。
茯苓:甘、淡,平。归心、肺、脾、肾经。功用利水渗湿,健脾宁心。用于水肿尿少,痰饮眩悸,脾虚食少,便溏泄泻,心神不安,惊悸失眠。
黄芩:苦,寒。归肺、胆、脾、大肠、小肠经。功用清热燥湿,泻火解毒,止血,安胎。用于湿温、暑温胸闷呕恶,湿热痞满,泻痢,黄疸,肺热咳嗽,高热烦渴,血热吐衄,痈肿疮毒,胎动不安。
叶酸在蛋白质合成及细胞分裂与生长过程中具有重要作用,对正常胰岛beta细胞的形成和胰岛功能恢复有促进作用。
腺苷三磷酸(ATP)是由腺嘌呤、核糖和3个磷酸基团连接而成,水解时释放出能量较多,是生物体内最直接的能量来源。
维生素C为抗体及胶原形成,组织修补(包括某些氧化还原作用),苯丙氨酸、酪氨酸、叶酸的代谢,铁、碳水化合物的利用,脂肪、蛋白质的合成,维持免疫功能,羟化5-羟色胺,保持血管的完整,促进非血红素铁吸收等所必需,同时维生素C还具备有抗氧化,抗自由基,还有许多重要的生物合成过程中也需要维生素C参与作用。
维生素B12可促进蛋白质的生物合成,可以保护叶酸在细胞内的转移和贮存。
α-硫辛酸作为强抗氧化剂对糖尿病患者神经损伤具有有效保护,帮助治疗由于蛋白质沉积在神经细胞中而导致的炎症,并且帮助患者减少对胰岛素和降糖药物的依赖。
低聚木糖可以促进双歧杆菌的增殖并同时产生大量的有机酸。降低肠道内pH值,抑制有害菌的生长,为益生菌的生长创造良好的条件,促进有益菌在肠道内大量的增殖,可以调整肠道功能,对糖尿病患者胃轻瘫引起的便秘,腹泻有较好的预防及治疗作用,并能有效预防糖尿病并发症,如:脂肪肝,高胆固醇症,高血压症,动脉硬化,同时还可以抗衰老,还有抑制肿瘤的功效。
辅酶Q10可以提高糖尿病患者体内能量制造及活化,可以预防心脏疾病,周围神经血管病变,增强免疫功能。
白藜芦醇具有抗氧化、抗炎、抗癌及心血管保护等作用,可以有效预防糖尿病患者神经血管病变。
罗汉果甜苷具有清热润肺镇咳、润肠通便之功效,对肥胖、便秘、糖尿病等具有防治作用。同时,因其甜度远远大于蔗糖,能量低的特点,可以改善保健品的不良口感。
作为本发明所述降血糖组合物的优选实施方式,所述降血糖组合物包括以下重量份的组分:30-50份石榴皮、10-30份蚕茧丝提取物、50-70份苦瓜干、30-50份乌梅根、30-50份人参、30-50份西洋参、30-50份沙参、30-50份白术、50-70份茯苓、30-50份黄芩、1-4份叶酸、5-10份三磷酸腺苷、2-5份维生素B12、2-5份维生素C、3-5份α-硫辛酸、10-15份低聚木糖、2-5份辅酶Q10、2-5份白藜芦醇、5-15份罗汉果甜苷。
当添加的每种组分的质量份在上述范围内时,制备得到的降血糖组合物的降血糖功效显著。
作为本发明所述降血糖组合物的优选实施方式,所述降血糖组合物包括以下重量份的组分:40份石榴皮、20份蚕茧丝提取物、60份苦瓜干、40份乌梅根、40份人参、40份西洋参、40份沙参、40份白术、60份茯苓、40份黄芩、1份叶酸、5份三磷酸腺苷、5份维生素B12、5份维生素C、5份α-硫辛酸、10份低聚木糖、5份辅酶Q10、5份白藜芦醇、5份罗汉果甜苷。
当添加的每种组分的质量份在上述范围内时,制备得到的降血糖组合物的降血糖功效最优。
作为本发明所述降血糖组合物的优选实施方式,所述蚕茧丝提取物采用水解方式提取,所述提取的pH值>7。
当水解提取的pH值>7时,得到的蚕茧丝提取物与其他组分混合制备得到的降血糖组合物才具有显著的疗效,如水解提取的pH值≤7时,制备得到的降血糖组合物的效果都有不同程度的降低。
作为本发明所述降血糖组合物的优选实施方式,所述蚕茧丝提取物采用水解方式提取,所述提取的pH值为>7且≤9。
当水解提取的pH值为>7且≤9时,得到的蚕茧丝提取物与其他组分混合制备得到的降血糖组合物的疗效更加显著,其中显效率可达95%。
作为本发明所述降血糖组合物的优选实施方式,所述蚕茧丝的水解提取的具体操作步骤包括以下过程:
(1)将蚕茧丝清洗烘干并切割分离;
(2)将切割分离后的蚕茧丝与由1%碳酸氢钠和1.5%氯化钠弱碱混合液(pH值为>7且≤12)分别加入到微波反应器中,在80℃温度的常压下水解120-150min,水解后得到粗丝胶肽溶液和蚕丝蛋白纤维固体,过滤粗丝胶肽溶液除去粗丝胶肽,得到含有丝胶肽蛋白的液体;
(4)将含有丝胶肽蛋白的液体干燥,得到干燥蚕茧丝胶肽蛋白提取物。
作为本发明所述降血糖组合物的优选实施方式,所述蚕茧丝与弱碱混合液的质量比为1:(15-25)。
另外,本发明还提供了一种所述降血糖组合物的制备方法,包括以下步骤:
(1)将石榴皮、苦瓜干、乌梅根、人参、西洋参、沙参、白术、茯苓和黄芩混合粉碎、过筛、蒸制、冷却,冷却后加入蚕茧丝提取物搅拌混合,得混合粉体;
(2)将叶酸、三磷酸腺苷、维生素B12、维生素C、α-硫辛酸、低聚木糖、辅酶Q10、白藜芦醇和罗汉果甜苷加入到步骤(1)所述混合粉体中混合均匀,得降血糖组合物。
作为本发明所述制备方法的优选实施方式,蒸制的温度为100-130℃,蒸制的时间为40-60分钟。
作为本发明所述制备方法的优选实施方式,过筛的筛网大小为120-150目。
另外,本发明还提供了一种降血糖组合物的应用。
作为本发明所述应用的优选实施方式,所述降血糖为降低Ⅱ型糖尿病患者的血糖。
作为本发明所述应用的优选实施方式,所述降血糖复合制剂还包括辅料,所述辅料包括崩解剂、润滑剂、粘合剂。
作为本发明所述应用的优选实施方式,所述降血糖复合制剂的剂型包括片剂、颗粒剂、胶囊剂、丸剂、液体剂。
与现有技术相比,本发明的有益效果为:
第一:本发明提供的降血糖组合物具有优异的降低血糖的效果,且副作用小,还能够活血抗凝、解毒健胃、健脾除秘、益气养阴、去湿、燥湿、活血、舒肝理气,同时还能够促进代谢机制、抗氧化、增强对ATP利用率、提高免疫力系统功能、均衡营养之间的作用;
第二:本发明提供的降血糖组合物的制备方法简单、操作简便,便于实际生产;
第三:本发明提供的降血糖组合物应用于降血糖复合制剂的制备上时,可以通过添加常规的辅料制备成各种不同的剂型,满足不同使用者的需求,并且由于本发明提供的降血糖组合物疗效温和,因此由其制备得到降血糖复合制剂可以作为保健食品食用用来预防糖尿病,也可以作为辅助治疗药物达到降低血糖的目的。
具体实施方式
为更好的说明本发明的目的、技术方案和优点,下面将结合具体实施例对本发明作进一步说明。
实施例1-4和对比例1-6
本发明实施例1-4和对比例1-6的降血糖复合制剂中的降血糖组合物的配方如表1所示;
表1:实施例1-4和对比例1-6的降血糖复合制剂中的降血糖组合物的配方表
本发明实施例1-4和对比例1-6的降血糖复合制剂的制备方法包括以下步骤:
(1)蚕茧丝提取物的制备:将清洗烘干并切割分离的蚕茧丝与由1%碳酸氢钠和1.5%氯化钠弱碱混合液(混合液的pH值为8,混合液与蚕茧丝的质量比为20:1)分别加入到微波反应器中,在温度为80℃的常压下水解140min,水解后得到粗丝胶肽溶液和蚕丝蛋白纤维固体,过滤粗丝胶肽溶液,得到含有丝胶肽蛋白的液体;浓缩、常温吹风干燥,得到干燥蚕茧丝胶肽蛋白提取物;
(2)将石榴皮、苦瓜干、乌梅根、人参、西洋参、沙参、白术、茯苓和黄芩(对比例2-5根据配方相应的去除部分组分)混合粉碎,接着过目数为140目的筛网,收集筛下物于120下蒸制50分钟,待筛下物蒸熟后冷却,冷却后加入蚕茧丝提取物搅拌混合,得混合粉体;
(3)将叶酸、三磷酸腺苷、维生素B12、维生素C、α-硫辛酸、低聚木糖、辅酶Q10、白藜芦醇和罗汉果甜苷(对比例6中无需添加,在步骤(2)中即得降血糖组合物)加入到步骤(1)所述混合粉体中混合均匀,得降血糖组合物;
(4)将降血糖组合物加入至胶囊中,得降血糖复合制剂。
实施例5
本发明实施例与实施例1的唯一区别在于添加的蚕茧丝提取物在pH值为9的条件下水解提取得到。
实施例6
本发明实施例与实施例1的唯一区别在于添加的蚕茧丝提取物在pH值为12的条件下水解提取得到。
对比例7
本对比例与实施例1的唯一区别在于添加的蚕茧丝提取物在pH值为5的条件下水解提取得到。
效果例
本效果例验证实施例1-6和对比例1-7制备得到的降血糖复合制剂的降血糖效果;其中,本发明制备得到降血糖复合制剂胶囊中含有的降血糖组合物的重量为5g。
(1)临床资料:选取140例Ⅱ型糖尿病患者,随机分为14组,组间、组内患者在性别、年龄、病程及临床表现等方面均相似,具有可比性;
(2)使用方法:每日服三次,建议餐前服用,每次两粒降血糖复合制剂胶囊;
(3)疗效判断标准:疗效标准参考治疗糖尿病临床研究指导原则制定;其中:
显效:治疗后症状基本消失,空腹血糖<7.2mmol/L(130mg/dL),餐后2小时血糖<8.3mmol/L(150mg/dL),24小时尿糖定量<10.0g,或血糖24小时尿糖定量较治疗前下降30%以上;
有效:治疗后症状明显改善,空腹血糖<8.3mmol/L(150mg/dL),餐后2小时血糖<10mmol/L(180mg/dL),24小时尿糖定量<25.0g,或血糖24小时尿糖定量较治疗前下降10%以上;
无效:治疗后症状无明显改善,血糖、尿糖下降未达到上述标准。
得到的结果如表2所示,其中安慰组是采用无糖乳清蛋白粉胶囊替代降血糖复合制剂胶囊;
表2:疗效结果表
从表2中可以看出,当采用本发明技术方案制备得到的产物时,得到的有效率都在80%以上,得到的显效率都在70%以上,从实施例1和实施例5、6以及对比例7中可以看出,当改变添加的蚕茧丝提取物的水解提取参数时,得到的蚕茧丝提取物作为降血糖组合物的组分时,会明显影响得到的降血糖复合物的降血糖效果,其中当pH值小于7时,得到的产物的降血糖效果显著下降,有效率从100%降低至了60%;从实施例1和对比例1中可以看出,当添加的组分的质量份不在本发明给出的范围内时,得到的产物的疗效也有一定程度的降低;从实施例1和对比例2-4中可以看出,本发明技术方案中添加的石榴皮、蚕茧丝提取物、苦瓜干和乌梅根这四种组分缺一不可,当减少其中的两种或四种时,得到的降血糖复合制剂胶囊的疗效呈现出下降的趋势;从实施例1和对比例5-6中也可以看出,当不添加本发明技术方案中的某些组分时,都会明显降低产物的疗效。
最后应当说明的是,以上实施例以说明本发明的技术方案而非对本发明保护范围的限制,尽管参照较佳实施例对本发明作了详细说明,本领域的普通技术人员应当理解,可以对本发明的技术方案进行修改或者等同替换,而不脱离本发明技术方案的实质和范围。
Claims (10)
1.一种降血糖组合物,其特征在于,所述降血糖组合物包括石榴皮、蚕茧丝提取物、苦瓜干、乌梅根、人参、西洋参、沙参、白术、茯苓、黄芩、叶酸、三磷酸腺苷、维生素B12、维生素C、α-硫辛酸、低聚木糖、辅酶Q10、白藜芦醇、罗汉果甜苷。
2.根据权利要求1所述的降血糖组合物,其特征在于,所述降血糖组合物包括以下重量份的组分:30-50份石榴皮、10-30份蚕茧丝提取物、50-70份苦瓜干、30-50份乌梅根、30-50份人参、30-50份西洋参、30-50份沙参、30-50份白术、50-70份茯苓、30-50份黄芩、1-4份叶酸、5-10份三磷酸腺苷、2-5份维生素B12、2-5份维生素C、3-5份α-硫辛酸、10-15份低聚木糖、2-5份辅酶Q10、2-5份白藜芦醇、5-15份罗汉果甜苷。
3.根据权利要求2所述的降血糖组合物,其特征在于,所述降血糖组合物包括以下重量份的组分:40份石榴皮、20份蚕茧丝提取物、60份苦瓜干、40份乌梅根、40份人参、40份西洋参、40份沙参、40份白术、60份茯苓、40份黄芩、1份叶酸、5份三磷酸腺苷、5份维生素B12、5份维生素C、5份α-硫辛酸、10份低聚木糖、5份辅酶Q10、5份白藜芦醇、5份罗汉果甜苷。
4.根据权利要求1-3任一项所述的降血糖组合物,其特征在于,所述蚕茧丝提取物采用水解方式提取,所述提取的pH值>7。
5.如权利要求1-4任一项所述的降血糖组合物的制备方法,其特征在于,包括以下步骤:
(1)将石榴皮、苦瓜干、乌梅根、人参、西洋参、沙参、白术、茯苓和黄芩混合粉碎、过筛、蒸制、冷却,冷却后加入蚕茧丝提取物搅拌混合,得混合粉体;
(2)将叶酸、三磷酸腺苷、维生素B12、维生素C、α-硫辛酸、低聚木糖、辅酶Q10、白藜芦醇和罗汉果甜苷加入到步骤(1)所述混合粉体中混合均匀,得降血糖组合物。
6.根据权利要求5所述的制备方法,其特征在于,蒸制的温度为100-130℃,蒸制的时间为40-60分钟。
7.如权利要求1-4任一项所述的降血糖组合物在制备降血糖复合制剂上的应用。
8.根据权利要求7所述的应用,其特征在于,所述降血糖为降低Ⅱ型糖尿病患者的血糖。
9.根据权利要求7所述的应用,其特征在于,所述降血糖复合制剂还包括辅料,所述辅料包括崩解剂、润滑剂、粘合剂。
10.根据权利要求7所述的应用,其特征在于,所述降血糖复合制剂的剂型包括片剂、颗粒剂、胶囊剂、丸剂、液体剂。
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