CN110693990A - 一种药食同源的降糖颗粒及制备方法和应用 - Google Patents
一种药食同源的降糖颗粒及制备方法和应用 Download PDFInfo
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Abstract
本发明公开了一种药食同源的降糖颗粒及制备方法和应用。属于医药保健技术领域。按重量份包括以下原料：黄芪甘草提取物浸膏20‑30份；南瓜粉、甘薯粉、苦瓜粉各7‑10份；辅料40‑60份。制备方法为分别将南瓜、甘薯和苦瓜制成粉料；将黄芪和甘草混合制成黄芪甘草提取物浸膏，与制得的南瓜粉、甘薯粉和苦瓜粉混合，再加入可溶性淀粉、麦芽糊精、柠檬酸钠、山梨酸钾及木糖醇，混匀制备软材，过筛制粒、干燥和整粒即得。本发明的降糖颗粒具有补气补肾、降糖消渴的功效。不仅可以满足药效需求，且使用方法众多，既能发挥药物的有效性，又具有食品的安全性。具有剂量小、便于携带、吸收快、疗效稳定等优点。
Description
技术领域
本发明涉及医药保健技术领域，更具体的说是涉及一种药食同源的降糖颗粒及制备方法和应用。
背景技术
目前，随着社会的不断发展，糖尿病等“富贵病”日益严重。糖尿病是由遗传或后天胰腺分泌胰岛素不足或胰岛素抵抗所致的以糖代谢紊乱为主的慢性综合性疾病。临床上以高血糖为主要特点，典型病例可出现多尿、多饮、多食、消瘦等表现，即“三多一少”症状。
研究表明，引起糖尿病发病的机制有很多，如炎症细胞因子诱发或机体发生紊乱反应等。其中，肿瘤坏死因子(TNF-α)作为一种独立的细胞毒素，可以直接作用于胰岛β细胞，产生一氧化碳，导致胰岛素分泌下降；白细胞介素-6(IL-6)可与其他细胞因子一起对胰岛β细胞产生细胞毒效应，促使β细胞凋亡。紊乱反应是指当机体正常生理稳态被打乱后，出现一些异常生理状态的反应，如：胰岛素抵抗(IR)又被称为胰岛素敏感性下降，是指胰岛素介导的葡萄糖利用率下降，IR是糖尿病发病的主要机制之一，一般涉及不正常的β细胞分泌、过量的胰岛素拮抗剂和靶向组织缺陷三种原因。糖尿病中存在氧化应激，活性氧(ROS)可作为信号分子激活一些应激敏感通路，引起β细胞凋亡或坏死，抑制胰岛素分泌，诱发胰岛素抵抗，进而使糖尿病加重。因此，抗氧化、提高机体免疫力对糖尿病的防治尤为重要。
当前市面上治疗糖尿病的药物主要以西药为主，大多是单从降低血糖角度防治糖尿病，往往缺乏整体的协调性，并且副作用较大，不宜长期服用。而中药制剂治疗糖尿病具有悠久的历史，例如黄芪甘草等中药通过多途径多靶点降低血糖的同时，还能调节机体稳定性，延缓糖尿病并发症，具有副作用小、疗效稳定等优点。可见中药制剂在糖尿病及其并发症的防治方面具有广阔的发展前景。
同时，颗粒剂药物在临床中应用广泛，含有中药成分的颗粒剂不仅能保持原药材汤剂带来的疗效，还可以避免煎煮这一繁琐过程，服用更加方便，并且还具有溶解性高，促进吸收等优点。
因此，依据合理的中药处方配伍原则，发明一种中药降糖颗粒，具有口味佳、溶化速度快、疗效好、副作用小等优点是本领域技术人员亟需解决的问题。
发明内容
有鉴于此，本发明提供了一种药食同源的降糖颗粒及制备方法和应用，制备的药食同源的降糖颗粒，溶解性好、口味佳、疗效稳定、副作用小，服用方便，且溶解后利于机体吸收，适宜人群广，可长期服用。
为了实现上述目的，本发明采用如下技术方案：
一种药食同源的降糖颗粒，按重量份包括以下原料：
黄芪为豆科植物蒙古黄芪Astragalus membranaceus(Fisch.)Bge.var.mongholicus(Bge.)Hsiao或膜荚黄芪A.membranaceus(Fisch.)Bge.的干燥根。黄芪为药食同源的药材，即可煎煮入药也可烹饪成美味的菜肴，具有补气固表、利水退肿、增强机体免疫功能、保肝抗炎、抗衰老、抗疲劳等功效。黄芪多糖是黄芪所含有的主要有效成分，它能起到调节蛋白酪氨酸磷酸酶的作用。而蛋白酪氨酸磷酸酶在胰岛素信号转导途径中起着调节作用，通过抑制其活性可以增加胰岛素敏感性，从而有效降低血糖。
甘草为豆科植物甘草Glycyrrhiza uralensis Fisch.、胀果甘草GlycyrrhizainflataBat.或光果甘草Glycyrrhizaglabra L.的干燥根和根茎。气微，味甜而特殊，具有补脾益气、调和诸药的功效，主要用于治疗祛痰止咳、清热祛毒等。甘草的主要的有效成分包括多糖、黄酮类化合物、甘草酸等。其中，黄酮类化合物能有效的抑制α-葡萄糖苷酶的活性，即抑制其水解释放葡萄糖为产物，降低血糖含量。
黄芪与甘草配伍有协同修复胰岛β细胞作用。黄芪多糖可作为免疫调节剂作用于淋巴细胞，纠正非肥胖型糖尿病(NOD)小鼠Ts细胞缺陷，调节免疫失控，阻止T细胞介导的自身免疫性β细胞损坏过程，保护胰岛β细胞。还可作用于肿瘤坏死因子(TNF-α)，预防TNF-α所致的胰岛素抵抗状态，增强胰岛素敏感性。甘草中的黄酮类化合物能够抑制小肠上α-葡萄糖苷酶的活性，从而抑制碳水化合物的分解，延缓小肠对葡萄糖的吸收利用。同时也可通过与过氧化自由基结合形成稳定的化合物和提高机体内抗氧化酶的活性等途径，清除活性氧自由基，发挥抗氧化作用，修复胰岛β细胞。将黄芪和甘草相配伍，即能保护胰岛β细胞，促使其分泌胰岛素，又能减少对葡糖糖的吸收，降糖效果显著增强。
南瓜为葫芦科南瓜属南瓜Cucurbitamoschata的一个种，一年生蔓生草本植物，据《本草纲目》中记载，南瓜性温，味甘，入脾、胃经，能补中益气、消炎杀菌、止痛，而且南瓜在预防和治疗糖尿病、降低胆固醇等方面效果颇佳。南瓜多糖可抑制α-葡萄糖苷酶的活性，禁止其水解释放葡萄糖，减少高血糖对胰腺的刺激，提高胰岛素的敏感性。
甘薯Dioscorea esculenta(Lour.)Burkill，又名红薯、地瓜，是旋花科一年生草本植物。据《本草纲目》记载甘薯有“补虚乏，益气力，健脾胃，强肾阴”的功效，使人“长寿少疾”。还能补中、和血、暖胃、肥五脏等。甘薯中的甘薯多糖可显著提高肝糖原的合成能力，降低糖尿病大鼠的血糖含量及血清中TC、TG、GSP和MDA的含量。甘薯中还含有丰富的纤维素，能在肠中吸收水份增大粪便的体积，达到通便的作用。糖尿病患者在使用甘薯之后，可以提高胰岛素的敏感性，刺激胰岛素分泌，从而降低血糖。
苦瓜Momordica Charantia为葫芦科植物，味甘苦，有清热解毒，滋养益气的功效，具有降血糖、抗氧化等药理活性。苦瓜多糖和苦瓜皂苷具有很好的降糖效果，苦瓜多糖可以修复胰岛β细胞，促进其分泌胰岛素，调节血糖，而苦瓜皂苷可通过激活单磷酸腺苷活化蛋白激酶(AMPK)的活性调节糖代谢，促进葡萄糖的分解，从而降低血糖。
南瓜、甘薯和苦瓜均为具有一定功效的食品，也是中草药，南瓜多糖可通过抑制胰岛α细胞分泌胰高血糖素、促进肝糖原的合成及增加胰岛素受体敏感性等机理降低血糖；甘薯能显著提高肝糖原的合成能力，提高胰岛素的敏感性，刺激胰岛素分泌，从而降低血糖。甘薯还含有丰富的纤维素，促进肠道蠕动，达到通便的作用。苦瓜能修复胰岛β细胞，促进胰岛素分泌，素有植物胰岛素之称。三者合用有协同降糖作用，并且三种食物营养均衡，均为糖尿病患者最适宜的食品。
本发明依据中药处方配伍原则，以黄芪、甘草、南瓜、甘薯和苦瓜为原材料，可溶性淀粉、麦芽糊精等为辅料，采用湿法制粒制成一种药食同源的降糖颗粒。处方中，黄芪和甘草既能降低机体内葡萄糖含量又能增加胰岛素的分泌，再与南瓜、甘薯和苦瓜相配伍，在降低葡萄糖含量的同时，还可增加机体对葡萄糖的利用，修复受损的胰岛细胞，增加胰岛素的分泌。从中医角度来讲，苦瓜性寒，南瓜性温，甘薯性味甘平，将三者按照一定比例协同作用，不仅可平衡苦瓜寒性、还可补虚乏、健脾胃、强肾阴，配伍后，各原料之间相辅相成，使降糖效果更佳。所添加的黄芪和甘草为二者1:1配比的提取物浸膏，多糖等有效成分含量高，而南瓜、甘薯和苦瓜则为各自的粉料，由于其内含有维生素、蛋白质、淀粉和氨基酸等丰富的营养物质，使得本发明所含营养均衡，并且在发挥药物有效性的同时，也保证了食品的安全性和营养性。
不同剂型的药物有着各自的优点，颗粒剂是日常生活中比较受老百姓喜欢的一类药物制剂，不仅能够减少药品飞散性，还能降低附着性和吸湿性。它与散剂相比具有不易吸湿、不易离析、运输携带方便等优点；与片剂相比具有粒度合适、硬度适中、容易溶化等特点。本发明的降糖颗粒服用方便，既可作为固体饮料直接冲服，也可作为伴侣加入豆粉、奶粉、咖啡中一起冲服，或加入麦片、米糊、米粥中随餐食用，因此，本发明不仅适宜普通患者，也可满足有吞咽困难的患者的需求。另外，所选用的黄芪甘草等原料均为药食同源的材料，既能发挥药物的有效性，又具有食品的安全性。
优选的：辅料按重量份包括以下原料：：
辅料中可溶性淀粉33-50份、麦芽糊精6-10份与黄芪甘草提取物浸膏20-30份、南瓜粉7-10份、甘薯粉7-10份、苦瓜粉7-10份的比例混合制成的软材，才既能保证降糖效果，又能使颗粒剂成型率达到85％以上，才能使吸湿率、水分、溶解性等相应指标达到颗粒剂生产质量规范。柠檬酸钠0.1-0.2份、山梨酸钾0.05-0.1份、木糖醇1-3份是根据《中华人民共和国食品安全国家标准》所添加，按此质量分数能在不影响药效的条件下保证口感和食品的安全性。
进一步的：一种药食同源的降糖颗粒的制备方法，包括以下步骤：
(1)分别将干燥后的南瓜、甘薯和苦瓜粉碎，过筛，得南瓜粉、甘薯粉、苦瓜粉；
(2)将黄芪和甘草洗净后按质量比1:1混合进行水提取，再过滤、浓缩，得到黄芪甘草提取物浸膏；
(3)将黄芪甘草提取物浸膏、南瓜粉、甘薯粉和苦瓜粉混合均匀，再加入可溶性淀粉、麦芽糊精、柠檬酸钠、山梨酸钾及木糖醇，混匀制备软材，并经过筛制粒、干燥、整粒即得。
优选的：步骤(1)的具体操作：
(11)将新鲜的南瓜、甘薯和苦瓜切成2-3cm3的小块，放入75-85℃的烘箱干燥6-7h，至其含水量在5％以下；
(12)将干燥后的南瓜、甘薯、苦瓜分别放入粉碎机中粉碎，并过150目筛，使其粒径均为90±4.6μm，即得南瓜粉、甘薯粉和苦瓜粉。
优选的：步骤(2)的具体操作：
(21)将黄芪和甘草洗净，以质量比1:1混合，混合后与饮用水以1:(10-15)的体积比进行混合，浸泡3-4h，在90-100℃条件下加热浸提，提取两次，每次2-3h；
(22)每次提取完毕后，在90-98℃范围内趁热过滤，合并两次滤液，在25℃4000r/min离心10min，收集上清液；
(23)在59-61℃加热上清液浓缩至相对水密度1.2～1.3倍得黄芪甘草提取物浸膏。
优选的：步骤(3)所述软材过16目筛制粒，在60-80℃干燥，整粒即得。
60-80℃的干燥温度可使所制颗粒硬度适中，成型率高。
进一步的：降糖颗粒在保健食品和功能食品中的应用。
经由上述的技术方案可知，本发明公开提供了一种药食同源的降糖颗粒、制备方法和应用，将黄芪和甘草合并进行提取，根据药材特性，严格控制提取和浓缩的温度，防止有效成分或有效部位长时间受热不稳定，引起化学结构破坏，最终浓缩成黄芪甘草提取物浸膏，并向其中混入干燥的南瓜粉、甘薯粉、苦瓜粉，再投入辅料制软材，制软材过程中，做到“手握成团、轻压即散”。与现有技术相比，具有如下技术优点：
(1)本发明以黄芪、甘草、南瓜、甘薯、苦瓜五种药食同源材料为原料，营养均衡，不仅可以发挥药物有效性，还可满足食品安全性。
(2)本发明的制备方法简单，对工艺设备要求比较低。
(3)本发明采用可溶性淀粉和麦芽糊精二者搭配使用，解决了麦芽糊精黏性较大，直接与提取物浸膏混合时容易成团导致无法制粒的问题。
(4)本发明以木糖醇代替糖类作为矫味剂，不仅口感极佳并且降低了糖的摄取量，适合糖尿病人群。
(5)本发明具有剂量小、服用方便、溶解性好、吸收快、疗效稳定、副作用小等显著优点。
(6)本发明不仅适宜普通糖尿病患者，还可以满足有吞服困难的患者，具有较大市场。
附图说明
为了更清楚地说明本发明实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本发明的实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据提供的附图获得其他的附图。
图1附图为本发明提供的体外模拟降糖实验测定结果示意图。
具体实施方式
下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，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前提下所获得的所有其他实施例，都属于本发明保护的范围。
本发明实施例公开了一种药食同源的降糖颗粒及制备方法和应用
实施例1
一种药食同源的降糖颗粒，按重量份包括以下原料：黄芪甘草提取物浸膏25g；南瓜粉8g；甘薯粉8g；苦瓜粉8g；可溶性淀粉42g；麦芽糊精7g；柠檬酸钠0.2g；山梨酸钾0.1g；木糖醇1.7g。
其制备方法，包括以下步骤：
(1)将新鲜的南瓜、甘薯和苦瓜切成2-3cm3小块，放入75℃的烘箱干燥6.5h，含水量<5％；分别放入粉碎机中粉碎，再将得到的各组分粉料分别过150目筛，使其粒径均为90±4.6μm；
(2)将黄芪和甘草按质量比为1:1混合，再与饮用水以料液体积比为1:10-15的比例进行混合，浸泡3.5h后，在95℃条件下加热浸提，提取两次，每次2.5h，其中第一次提取加15倍的水，第二次提取加10倍的水；并90℃趁热过滤，合并两次滤液，离心(10min,4000r/min,25℃)，收集上清液，60℃加热浓缩至相对水密度为1.2～1.3倍得黄芪甘草提取物浸膏；
(3)在烧杯中加入步骤(2)得到的黄芪甘草提取物浸膏25g，并混入步骤(1)所得的南瓜粉、甘薯粉和苦瓜粉，重量分别为：南瓜粉8g、甘薯粉8g、苦瓜粉8g，再投入7g的麦芽糊精，42g的可溶性淀粉，0.1g的山梨酸钾，0.2g的柠檬酸钠和1.7g的木糖醇，混匀后手工制备软材，过16目筛制粒，放入70℃烘箱干燥，整粒即可。
实施例2
一种药食同源的降糖颗粒，按重量份包括以下原料：黄芪甘草提取物浸膏22g；南瓜粉8g；甘薯粉7g；苦瓜粉7g；麦芽糊精8g；可溶性淀粉46g；山梨酸钾0.1g；柠檬酸钠0.2g；木糖醇1.7g。
其制备方法，包括以下步骤：
(1)将新鲜的南瓜、甘薯和苦瓜切2-3cm3小块，放入80℃的烘箱干燥6h，含水量<5％；分别放入粉碎机中粉碎，再将得到的各组分粉料分别过150目筛，使其粒径均为90±4.6μm；
(2)将黄芪和甘草按质量比为1:1混合，再与饮用水以料液体积比为1:10-15的比例进行混合，浸泡3h后，在90℃条件下加热浸提，提取两次，每次2h,其中第一次提取加15倍的水，第二次提取加10倍的水；并95℃趁热过滤，合并两次滤液，离心(10min,4000r/min,25℃)，收集上清液，59℃加热浓缩至相对水密度为1.2～1.3倍得黄芪甘草提取物浸膏；
(3)在烧杯中加入步骤(2)得到的黄芪甘草提取物浸膏，并混入步骤(1)所得的南瓜粉、甘薯粉和苦瓜粉，再投入麦芽糊精，可溶性淀粉，山梨酸钾，柠檬酸钠和木糖醇，混匀后手工制备软材，过16目筛制粒，放入60℃烘箱干燥，整粒即可。
实施例3
一种药食同源的降糖颗粒，按重量份包括以下原料：黄芪甘草提取物浸膏25g；南瓜粉7g；甘薯粉10g；苦瓜粉9g；麦芽糊精7g；可溶性淀粉40g；山梨酸钾0.1g；柠檬酸钠0.2g；木糖醇1.7g。
其制备方法，包括以下步骤：
(1)将新鲜的南瓜、甘薯和苦瓜切2-3cm3小块，放入85℃的烘箱干燥7h，含水量<5％；分别放入粉碎机中粉碎，再将得到的各组分粉料分别过150目筛，使其粒径均为90±4.6μm；
(2)将黄芪和甘草按质量比为1:1混合，再与饮用水以料液体积比为1:10-15的比例进行混合，浸泡4h后，在100℃条件下加热浸提，提取两次，每次2h,其中第一次提取加15倍的水，第二次提取加10倍的水；并98℃趁热过滤，合并两次滤液，离心(10min,4000r/min,25℃)，收集上清液，61℃加热浓缩至相对水密度为1.2～1.3倍得黄芪甘草提取物浸膏；
(3)在烧杯中加入步骤(2)得到的黄芪甘草提取物浸膏，并混入步骤(1)所得的南瓜粉、甘薯粉和苦瓜粉，再投入麦芽糊精，可溶性淀粉，山梨酸钾，柠檬酸钠和木糖醇，混匀后手工制备软材，过16目筛制粒，放入80℃烘箱干燥，整粒即可。
实施例4
与实施例1的区别仅在于按重量份包括以下原料：黄芪甘草提取物浸膏26g；南瓜粉7g；甘薯粉8g；苦瓜粉8g；麦芽糊精7g；可溶性淀粉42g；山梨酸钾0.1g；柠檬酸钠0.2g；木糖醇1.7g。其他步骤同实施例1相同，制备时按此用量进行适应性调整即可。
实施例5
与实施例2的区别仅在于按重量份包括以下原料：黄芪甘草提取物浸膏30g；南瓜粉7g；甘薯粉10g；苦瓜粉7g；麦芽糊精7.8g；可溶性淀粉37g；山梨酸钾0.1g；柠檬酸钠0.1g；木糖醇1g。其他步骤同实施例2相同，制备时按此用量进行适应性调整即可。
实施例6
与实施例3的区别仅在于按重量份包括以下原料：黄芪甘草提取物浸膏20g；南瓜粉7g；甘薯粉7g；苦瓜粉7g；麦芽糊精6g；可溶性淀粉50g；山梨酸钾0.05g；柠檬酸钠0.2g；木糖醇2.75g。其他步骤同实施例3相同，制备时按此用量进行适应性调整即可。
对比例1
与实施例1的区别在于按重量份包括以下原料：黄芪甘草提取物浸膏34g；南瓜粉12g；甘薯粉6g；苦瓜粉10g；麦芽糊精5g；可溶性淀粉31g；山梨酸钾0.1g；柠檬酸钠0.2g；木糖醇1.7g。本实施例中的其他技术特征均与实施例1相同。
对比例2
与实施例1的区别仅在于步骤(3)制备参数进行调整：制粒后，放入55℃烘箱干燥，整粒。
取实施例1-6和对比例1-2获得的药食同源的降糖颗粒进行理化指标检测，结果如表1所示。
表1
由表1可知，实施例1-6中，成型率均达到91％以上，且各项指标均符合标准，即此配方条件下颗粒剂的产量高。而对比例1-2所制颗粒的成型率、水分含量、吸湿率、溶解性等理化指标，均不符合国家质量标准。如对比例1中药提取物质量分数过大，辅料的质量分数过小，制成的软材和颗粒粘度大，不易干燥，而且吸潮，含水量大，在制粒时成型率低。
实施例7
申请人分别提取了黄芪提取物浸膏、甘草提取物浸膏、黄芪甘草(1:1)提取物浸膏、按实施例1制得的降糖颗粒剂提取物浸膏，进行体外模拟降血糖的实验，检测结果见图1。
其中体外模型的建立：采用PNPG法，其原理是：以对硝基酚-α-葡萄糖苷为底物，利用α-葡萄糖苷酶将其分解成对硝基酚(PNP)和葡萄糖，而对硝基酚(PNP)在碱性条件下显色，在400nm处测其吸光度值，在酶催化反应的稳态阶段用光吸收值OD值表征酶促反应初速度。
样品活性的测定：以对硝基酚-α-葡萄糖苷为底物，取0.2mL0.2mol·L-1的PBS(pH＝6.8)于试管中，加入0.2mL待测样品，摇匀，再加0.2mL0.5U·mL-1α-葡萄糖苷酶溶液，在37℃恒温水浴锅中反应15min后，加入5mL0.1mol·L-1的Na2CO3溶液终止反应，测其在400nm处的吸光度值，记为A样品。由于提取物浸膏有颜色，所以实验同时做一个本底扣除，即用0.2mLPBS代替α-葡萄糖苷酶溶液，记为A本底。用0.2mLPBS代替样品溶液作为空白，记为A空白。抑制率的计算方法如下公式：
式中，A空白——以0.2mLPBS代替样品作为空白，在400nm下测得的吸光度值；
A样品——加入0.2mL样品，在400nm下测得的吸光度值；
A本底——以用0.2mLPBS代替α-葡萄糖苷酶溶液，在400nm下测得的吸光度值。
由图1可知，黄芪浸膏的抑制率为25.2％，甘草浸膏的抑制率为38.7％，黄芪甘草(1:1)浸膏的抑制率为58.9％，降糖颗粒浸膏的抑制率为79.8％，通过体外模拟降糖实验表明，黄芪和甘草配伍具有协调作用，再与三瓜配伍即降糖颗粒，可明显提高其对α-葡萄糖苷酶活性的抑制，使降糖作用更佳。
实施例8
分别给予小鼠特定剂量的黄芪甘草提取物、南瓜甘薯苦瓜提取物、黄芪甘草+三瓜提取物，观察对糖尿病小鼠的血糖值、小鼠脏器指数、IL-6、TNF-α、丙二醛(MDA)、超氧化物歧化酶(SOD)的影响：
1.建立糖尿病小鼠模型
选取健康的昆明小鼠，雌雄各半。适应性饲养7天后，禁食不禁水16h，随机选取10只作为空白组，其余小鼠进行腹腔注射链脲霉素(STZ)，给药剂量为200mg/kg BW，注射后正常饮食饮水，72h后，采用尾部取血测小鼠空腹血糖值(取血前禁食12h)，血糖值高于11.1mmol/L者即为造模成功的糖尿病小鼠。
2.剂量设置与分组
共分6组，造模成功小鼠随机分为5组，空白对照1组，每组10只，各组灌胃时间相同，灌胃28天，给药剂量如表2所示。
表2小鼠分组情况与给药剂量
3.检测指标及时间
3.1小鼠空腹血糖值测定
给药前及给药期间第7天、14天、21天、28天进行尾静脉取血。取血前,将所有小鼠禁食不禁水12h，用血糖仪检测血糖值。
3.2小鼠脏器指数测定
实验结束后，将所有小鼠脱颈处死，快速取出小鼠的肝脏和肾脏，称重，计算小鼠肝脏指数和肾脏指数。肝脏指数＝(肝脏重量/体重)×100％；肾脏指数＝(肾脏重量/体重)×100％。
3.3小鼠血清指标测定
取得小鼠血液，静置，待其分层后，以3000r/min离心10min，取上清液得血清。严格按照试剂盒说明书操作，测定血清中IL-6、TNF-α的浓度。
3.4小鼠肝脏抗氧化指标测定
准确剪切一定质量的肝脏组织，按质量体积比(g/mL)1:9加入冰生理盐水，研磨成匀浆，于冷冻离心机4℃、3000r/min下离心10min，收集上清液，严格按照试剂盒说明书操作，对小鼠肝脏组织中MDA、SOD活性进行测定。
4.结果
4.1各组对空腹血糖值的影响
由表3可知，与空白小鼠相比，糖尿病小鼠(模型组)的血糖值显著升高(P﹤0.05)，证明造模成功。黄芪甘草组、三瓜组、黄芪甘草+三瓜组均具有一定程度降低血糖值的作用，随用药时间延长效果越好(P﹤0.05)，且黄芪甘草+三瓜组明显优于其它两用药组(P﹤0.01)，与阳性药物(二甲双胍)作用相当。
表3各组空腹血糖值的测定结果
注：*与模型组比较(P﹤0.05)；**与模型组比较(P﹤0.01)；#与空白组比较(P﹤0.05)
4.2各组对小鼠脏器指数的影响
由表4可知，与空白小鼠相比糖尿病小鼠(模型组)的肝肾都受到了不同程度的损伤，出现肿大现象。与模型组相比，黄芪甘草组、三瓜组、黄芪甘草+三瓜组均能降低小鼠肝脏指数和肾脏指数，且黄芪甘草+三瓜组效果优于阳性药物，说明黄芪甘草与三瓜配伍具有很好的协同作用，本发明的降糖颗粒有效缓解糖尿病小鼠的肝脏和肾脏肿大(P﹤0.01)，减轻糖尿病对内脏的损伤。
表4各组小鼠脏器指数的测定结果
注：*与模型组比较(P﹤0.05)；**与模型组比较(P﹤0.01)；#与空白组比较(P﹤0.05)
4.3各组对血清中IL-6、TNF-α的影响
由表5可知，与空白组小鼠相比，糖尿病小鼠(模型组)血清中的IL-6、TNF-α水平增大，表明模型组小鼠炎性因子水平升高。而黄芪甘草组、三瓜组、黄芪甘草+三瓜组和阳性对照组均能使IL-6、TNF-α水平下调，且黄芪甘草+三瓜组效果优于阳性药物，说明黄芪甘草与三瓜配伍具有很好的协同作用，本发明的降糖颗粒可显著降低血清中炎症因子的表达水平(P﹤0.01)，延缓糖尿病肾病的进展。
表5各组小鼠IL-6、TNF-α的测定结果
注：*与模型组比较(P﹤0.05)；**与模型组比较(P﹤0.01)；#与空白组比较(P﹤0.05)
4.4各组对肝脏组织中MDA、SOD的影响
MDA是脂质过氧化反应产物，其含量可以体现氧自由基的含量和脂质过氧化程度，而SOD的活性高低间接反映了机体清除自由基的能力。由表6可知，与空白组小鼠相比，糖尿病小鼠(模型组)MDA水平显著升高，SOD活性显著降低，表明糖尿病小鼠出现严重的氧化损伤。而黄芪甘草组、三瓜组、黄芪甘草+三瓜组均能使小鼠肝脏组织的SOD活性升高(P﹤0.01)，MDA水平降低(P﹤0.01)。说明本发明的降糖颗粒能够清除氧自由基，抑制体内脂质过氧化进程，能够有效预防糖尿病小鼠的氧化损伤。
表6各组小鼠MDA、SOD的测定结果
注：*与模型组比较(P﹤0.05)；**与模型组比较(P﹤0.01)；#与空白组比较(P﹤0.05)
本说明书中各个实施例采用递进的方式描述，每个实施例重点说明的都是与其他实施例的不同之处，各个实施例之间相同相似部分互相参见即可。
对所公开的实施例的上述说明，使本领域专业技术人员能够实现或使用本发明。对这些实施例的多种修改对本领域的专业技术人员来说将是显而易见的，本文中所定义的一般原理可以在不脱离本发明的精神或范围的情况下，在其它实施例中实现。因此，本发明将不会被限制于本文所示的这些实施例，而是要符合与本文所公开的原理和新颖特点相一致的最宽的范围。
Claims (7)
1.一种药食同源的降糖颗粒，其特征在于，按重量份包括以下原料：
2.根据权利要求1所述的一种药食同源的降糖颗粒，其特征在于，所述的辅料按重量份包括以下原料：
3.根据权利要求2所述的一种药食同源的降糖颗粒的制备方法，其特征在于，包括以下步骤：
(1)分别将干燥后的南瓜、甘薯和苦瓜粉碎，过筛，得南瓜粉、甘薯粉、苦瓜粉；
(2)将黄芪和甘草洗净后按质量比1:1混合进行水提取，再过滤、浓缩，得到黄芪甘草提取物浸膏；
(3)将黄芪甘草提取物浸膏、南瓜粉、甘薯粉和苦瓜粉混合均匀，再加入可溶性淀粉、麦芽糊精、柠檬酸钠、山梨酸钾及木糖醇，混匀制备软材，并经过筛制粒、干燥、整粒即得。
4.根据权利要求3所述的一种药食同源的降糖颗粒的制备方法，其特征在于，所述步骤(1)的具体操作：
(11)将新鲜的南瓜、甘薯和苦瓜切成2-3cm3的小块，放入75-85℃的烘箱干燥6-7h，至其含水量在5％以下；
(12)将干燥后的南瓜、甘薯、苦瓜分别放入粉碎机中粉碎，并过150目筛，使其粒径均为90±4.6μm，即得南瓜粉、甘薯粉和苦瓜粉。
5.根据权利要求3所述的一种药食同源的降糖颗粒的制备方法，其特征在于，所述步骤(2)的具体操作：
(21)将黄芪和甘草洗净，以质量比1:1混合，混合后与饮用水以1:(10-15)的体积比进行混合，浸泡3-4h，在90-100℃条件下加热浸提，提取两次，每次2-3h；
(22)每次提取完毕后，在90-98℃范围内趁热过滤，合并两次滤液，在25℃4000r/min条件下离心10min，收集上清液；
(23)在59-61℃加热上清液浓缩至相对水密度1.2～1.3倍得黄芪甘草提取物浸膏。
6.根据权利要求3所述的一种药食同源的降糖颗粒的制备方法，其特征在于，步骤(3)所述软材过16目筛制粒，在60-80℃干燥，整粒即得。
7.一种药食同源降糖颗粒的应用，其特征在于，根据权利要求3-6任一所述的方法制备的降糖颗粒在保健食品和功能食品中的应用。
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