CN115364170B - 一种糖代谢调节剂及其制备方法和应用 - Google Patents
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Abstract
本发明属于糖尿病防治技术领域，具体涉及一种糖代谢调节剂及其制备方法和应用，按重量份计，称取山药5‑10份、黑木耳5‑10份、栀子3‑6份、葛根3‑6份、酒炙黄精3‑6份、桑叶3‑6份、普洱熟茶1‑2份、肉桂1‑2份，经水提、醇沉、回流提取，过滤，将滤液减压蒸馏除去乙醇，将精制液浓缩，冷冻干燥或喷雾干燥，粉碎，即得；可按常规成型方法制备为胶囊剂、颗粒剂、片剂、散剂、丸剂或口服液的口服制剂，制备治疗2型糖尿病的药物或具有改善糖代谢紊乱的保健品。该调节剂由药食同源之材组方，基于中医消渴病的治则治法，具有“健脾益胃、清热生津、滋阴活血、益肾助阳”之功，可多靶点调节血糖，显著改善糖代谢紊乱。
Description
技术领域
本发明属于糖尿病防治技术领域，具体涉及一种糖代谢调节剂及其制备方法和应用。
背景技术
糖尿病是一种以高血糖为主要特征的慢性代谢性疾病。通常认为其发病机制与胰岛素分泌不足和/或胰岛抵抗相关。糖尿病主要分为1型糖尿病、2型糖尿病和其他类型糖尿病，其中2型糖尿病患者占患病人数的95%以上。糖代谢异常是糖尿病的典型病理表现之一。中国是糖尿病患病率最高的国家之一，患病总人数已经达到9240万，糖尿病也已成为继肿瘤、心血管疾病之后严重危害我国人群健康的疾病之一。
中国专利申请号202110854135.4公开了“一种治疗2型糖尿病的中药组合物及其制备方法”，按照重量份数计包括以下组分：托盘根1-10份、桑叶5-10份、葛根5-10份、薏米1-10份、山药1-10份。加入7.5倍水煎煮45min，提取、滤过,将滤液浓缩至相对密度1.25-1.35、80℃，得到水提物；将上述水提物加入2倍量乙醇，4℃醇沉12小时，滤过，将滤液减压蒸馏除去乙醇，浓缩至稠膏，真空冷冻干燥，粉碎，即得。该中药组合物能够显著降低2型糖尿病小鼠空腹血糖值,具有较好的降糖效果和很好的改善2型糖尿病的作用，并且能够明显改善胰岛素抵抗指数和明显改善胰腺线粒体功能。
中国专利申请号201510157103.3公开了“一种治疗二型糖尿病的中药及其制备方法”，所述中药组合物的各个组分及其质量份比如下：由下列组分构成，各组分的重量份为：蛹虫草3-5份、灯盏花10-12份、薏苡仁7-9份，红景天7-9份，石斛5-7份、金银花7-9份、白果3-5份、辣木叶5-7份、金木耳3-5份、葛根3-5份、杜仲4-6份、白果4-6份、栀子根3-5份、党参5-7份、雪莲果10-12份。本发明的中药具有生津止渴、清热解毒之功效，能够显著降低二型糖尿病患者血糖，并且稳定在正常范围，同时兼具改善肾功能的效果，且可长期服用，无毒副作用。
中国专利申请号202010339223.6公开了“一种治疗2型糖尿病中药组合物”，由以下原料组成：野生翻白草、野生白茅根、野生海金沙根、人参叶(7年以上)、野生金丝草、野生小荆、冬桑叶、绿茶、野生木耳、玉米须、蒲公英根。本发明中药组合物适用于2型糖尿病及2型糖尿病并发症患者，无不良反应，并且疗效稳定。
中国专利申请号201510849003.7公开了“一种药食同源治疗二型糖尿病的中药组合物，其特征在于组方配伍和各中药重量为：麦苗30g，芋头25g，西瓜皮20g，马齿苋20g，苣卖菜25g，鸡内金15g，猪胰脏10g。本发明舒肝益肾、活血化瘀、疏通经络、调畅气机、并健脾补气，泻火排毒、扶正固本，以上诸药合用，可使胰腺功能得以恢复。
药食同源治疗糖尿病一直是目前研究的热点，如何最大程度提升药食同源药物的有效性及适口性是急需解决的问题。目前的专利中药食同源方子治疗糖尿病，存在药物单一、适用性单一、适口性差的缺点，而本发明在中医辩证的基础上，针对多种证型的糖尿病有改善作用，如脾虚痰湿证、阴阳两亏证、肺热津伤证、胃热炽盛证、气阴亏虚证、肾阴亏虚证等，除此之外，本发明结合网络药理学对该方对糖尿病的作用靶点进行了分析，发现该方能够多靶点有效改善糖尿病糖代谢紊乱，而本发明采用严苛的水提醇沉法炮制，最大程度地保留了药物的有效成分而剔除其杂质，做到了靶向调节糖代谢紊乱；该发明中加入了山药、黑木耳、葛根、肉桂、普洱熟茶等适口性较好的药食同源之品，作为粉剂、汤剂、膏剂或者保健食品都是一个不错的选择，具有较好的市场前景。
中药作用机制具有多靶点、多成分及高协同的特点。中药功能性食物的相关产品研发也呈方兴未艾之势，可见，药食同源成为中医药现代化道路上的重要一环，因此可基于中医学药食同源、多靶点的治疗特点，研制一种糖代谢调节剂。
发明内容
为解决上述技术问题，本发明提供了一种糖代谢调节剂及其制备方法和应用，以用于改善或治疗2型糖尿病病症。
为了实现上述目的，本发明所采用的具体技术方案如下：
一种糖代谢调节剂，按重量份计，包括以下组份：山药5-10份、黑木耳5-10份、栀子3-6份、葛根3-6份、酒炙黄精3-6份、桑叶3-6份、普洱熟茶1-2份、肉桂1-2份。
作为优选，糖代谢调节剂按重量份计，包括以下组份：山药10份、黑木耳10份、栀子6份、葛根6份、酒炙黄精6份、桑叶6份、普洱熟茶2份、肉桂2份。
作为优选，所述黄精为滇黄精。
作为优选，所述桑叶为霜桑叶。
本发明还提供了一种糖代谢调节剂的制备方法，包括以下步骤：
S1备料：按上述重量份称取各组份；
S2水提：加水8-10倍煎煮20-40min，煎煮2-3次，过滤，合并滤液；
S3醇沉：减压浓缩至密度为1.06-1.07g/mL，加入1.5-3倍量无水乙醇，醇沉24-48h后，回流提取1.5h-2h，过滤，将滤液减压蒸馏除去乙醇，得精制液；
S4干燥：将精制液浓缩，真空冷冻干燥或喷雾干燥，粉碎，即得糖代谢调节剂。
作为优选，所述S2水提：加水10倍煎煮30min，煎煮2次，过滤，合并滤液。
作为优选，所述S3醇沉：减压浓缩至密度为1.066g/mL，加入2倍量无水乙醇，醇沉24-48h后，回流提取1.5h，过滤，将滤液减压蒸馏除去乙醇，得精制液。
进一步地，将所述糖代谢调节剂通过常规成型工艺制备成胶囊剂、颗粒剂、片剂、散剂或丸剂的口服制剂，使得本发明产品更便于储存、运输和推广应用。
本发明糖代谢调节剂可用于制备治疗2型糖尿病的药物、具有改善糖代谢紊乱的保健品。
本发明糖代谢调节剂的组方中，山药益气养阴、补脾肺肾；黑木耳清肺润肠、滋阴补血、活血化瘀；葛根解肌退热，透疹，生津止渴，升阳止泻、通经活络；栀子泻火除烦，清热利湿，凉血解毒；酒炙滇黄精补脾润肺、补益气阴、精血；霜桑叶，散风热，清肺燥，疗目疾，凉血，止渴，止汗之功；普洱熟茶清热利水，消食醒神；肉桂补火助阳、散寒止痛、温经通脉、引火归元。共奏“健脾益胃、 清热生津、滋阴活血、益肾助阳”之功。
据现代药理学研究表明：山药多糖具有较好调节糖脂作用，其作用机制可能与改善胰岛素敏感性及抗氧化作用有关；黑木耳胞外多糖具有明显的调解血糖的作用，并能促进肠道内有益菌群增殖，增加短链脂肪酸含量及上调血清抗炎因子水平的作用；葛根中的葛根素可能通过调节肝脏的胎球蛋白B（Fetuin B）-腺苷酸激活蛋白激酶（AMPK）/乙酰辅酶A羧化酶（ACC）信号通路减轻2型糖尿病小鼠胰岛素抵抗，进一步改善糖脂代谢；栀子水提物对降低血清胰岛素,提高胰岛素敏感指数都有明显疗效；黄精（酒炙）可有效改善高脂饮食喂养大鼠糖脂代谢紊乱状态，所用黄精尤以滇黄精为佳；桑叶多糖降糖、调节胰岛素信号通路、抑制α-糖苷酶，所用桑叶尤以霜桑叶为佳；普洱熟茶标准提取物普洱熟茶片能够降低糖尿病患者空腹血糖水平；肉桂可以降低db/db小鼠血糖，改善小鼠炎症反应及增加短链脂肪酸（SCFAs）含量达到对2型糖尿病的防治作用。根据网络药理学分析，8味药食两用中药的核心成分为薯蓣皂苷元、海风藤酮、槲皮苷、山奈酚、甾醇、槲皮素、β-谷甾醇、大豆苷元、葛根素、原花青素β1。核心靶点为蛋白激酶（AKT1）、核受体亚家族3C组成员1（NR3C1）、V-REL网状内皮增生病毒癌基因同源物A（RELA）、诱导型一氧化氮合酶（NOS2）、血清淀粉样蛋白A1（SAA1）、环加氧酶2（PTGS2）、白细胞介素-6（IL-6）、肿瘤坏死因子（TNF）、糖原合成酶激酶3β（GSK3B）、胱天蛋白酶3（CASP3）、白蛋白（ALB）、过氧化氢酶（CAT）、雄激素受体（AR）、人胰岛素（INS）、人血管内皮生长因子A（VEGFA）。KEGG通路富集的主要通路为缺氧诱导因子1（HIF1）信号通路、癌症途径、调节脂肪细胞中的脂肪分解、血管内皮生长因子信号通路、胞内磷脂酰肌醇激酶（PI3K）-蛋白激酶（Akt）信号通路、胰岛素抵抗、肿瘤坏死因子-α（TNF）信号通路、AMPK信号通路、胰岛素信号通路AGE-RAGE信号通路、白细胞介素-17（IL-17）信号通路等。上述八味药材均为药食同源之品，据现代药理研究都具有调解血糖的作用，多靶点有效改善2型糖尿病糖代谢紊乱。
本发明的有益效果包括：本发明糖代谢调节剂具有“健脾益胃、清热生津、滋阴活血、益肾助阳”之功，由药食同源之材组方，基于中医消渴病的治则治法，又结合现代药理研究基础，可多靶点调节血糖，显著改善糖代谢紊乱，无毒副作用，制备方法简单、易于携带服用，可实现工业化大规模制备。
附图说明
图1为本发明糖代谢调节剂干预2型糖尿病（T2DM）小鼠胰岛素耐量测定及胰岛素抵抗指数计算结果统计示意图。
具体实施方式
下面结合本发明实施例，对本发明的技术方案进行清楚、完整地描述。
实施例1
按重量份计，称取山药7份、黑木耳7份、栀子4份、葛根4份、酒炙黄精4份、桑叶4份、普洱熟茶1份、肉桂1份，加水8倍煎煮20min，煎煮3次，过滤，合并滤液，减压浓缩至密度为1.061g/mL，加入1.5倍量无水乙醇，醇沉24h后，80℃水浴回流提取1.5h，过滤，将滤液减压蒸馏除去乙醇，得精制液，将精制液浓缩，冷冻干燥，粉碎，即得糖代谢调节剂。
实施例2
按重量份计，称取山药10份、黑木耳10份、栀子6份、葛根6份、酒炙滇黄精6份、霜桑叶6份、普洱熟茶2份、肉桂2份，加水10倍煎煮30min，煎煮2次，过滤，合并滤液，减压浓缩至密度为1.066g/mL，加入2倍量无水乙醇，醇沉48h后，加热回流提取1.5h，过滤，将滤液减压蒸馏除去乙醇，得精制液，将精制液浓缩，喷雾干燥，粉碎，即得糖代谢调节剂。
实施例3
按重量份计，称取山药10份、黑木耳10份、栀子6份、葛根6份、酒炙滇黄精6份、霜桑叶6份、普洱熟茶2份、肉桂2份，加水10倍煎煮30min，煎煮2次，过滤，合并滤液，减压浓缩至密度为1.066g/mL，加入2倍量无水乙醇，醇沉48h后，加热回流提取1.5h，过滤，将滤液减压蒸馏除去乙醇，得精制液，将精制液浓缩，冷冻干燥，粉碎，即得糖代谢调节剂。
实施例4
按重量份计，称取山药5份、黑木耳5份、栀子3份、葛根3份、酒炙黄精3份、桑叶3份、普洱熟茶1份、肉桂1份，加水10倍煎煮40min，煎煮2次，过滤，合并滤液，减压浓缩至密度为1.07g/mL，加入3倍量无水乙醇，醇沉48h后，80℃水浴回流提取2h，过滤，将滤液减压蒸馏除去乙醇，得精制液，浓缩，真空冷冻干燥，粉碎，即得糖代谢调节剂。
实验例
本实验以上述实施例2所得糖代谢调节剂为药物样品，以二甲双胍为对照样品，按如下步骤具体开展本发明糖代谢调节剂的作用机理研究。
（1）2型糖尿病小鼠模型的构建
C57/BL6雄性小鼠60只(成都硕达实验动物有限公司)适应性饲养1周后，给予高脂饲料【60 kCal fat Research Diets D12492*12.5kg】（购自成都派尚飞克生物科技有限公司）喂养6周后，禁食不禁水12h，按100mg/kg单次腹腔注射链脲佐菌素（STZ）诱发小鼠2型糖尿病，诱导l周后，用三诺血糖测定仪检测空腹血糖；空腹血糖值连续2天≥11.1mmoL/L的小鼠认定2型糖尿病小鼠模型制备成功。
（2）动物分组给药
按血糖随机分为6组：空白组，模型组，给药组：低剂量给药组、中剂量给药组、高剂量给药组，对照组：二甲双胍组。根据人与小鼠体表面积的转换公式（人体平均体重约为70kg，记录人体剂量为X mg/kg，小鼠剂量=X mg/kg×70kg×0.0026/24g=X mg/kg×70kg×0.0026/0.024kg=7.59×X mg/kg），分别换算成临床等效剂量的1/2倍、1倍和2倍，计算得到低、中、高剂量的生药剂量为3g/kg/d、6g/kg/d、12g/kg/d，在此基础上，将生药剂量与实施例2制备糖代谢调节剂的当量相乘计算得到低、中、高剂量的给药剂量。以适量生理盐水溶解后进行灌胃处理，二甲双胍组给予0.25g/kg/d以同等体积生理盐水溶解后进行灌胃处理，空白组及模型组每日给予同等体积生理盐水灌胃，干预6周。以基础饲料、高脂饲料正常饲养各对应组小鼠，维持到实验结束。
（3）空腹血糖实验
实验开始后，每天在同一个时间给药一次，连续6周，检测各组小鼠空腹l2h血糖值，检测结果见表1。
如表1所示，其中中药组合物各组均能够显著降低2型糖尿病小鼠空腹血糖值，由此说明本发明的糖代谢调节剂有较好的降糖效果，能够用于调节2型糖尿病小鼠糖代谢紊乱。
（4）糖耐量实验
实验第6周末，将小鼠禁食12h后，灌胃给予20%葡萄糖2g/kg(每lkg体重的小鼠给予2g葡萄糖)；用三诺血糖仪分别测定空腹及服糖后30、60、90及120min的血糖含量，检测结果见表2。
表2 糖耐量实验结果表
表2中，模型组与空白组比较，##P<0.01；各给药组及二甲双胍组与模型组比较，**P<0.01。
如表2所示，给药组与二甲双胍组效果相当，显著降低了模型小鼠的血糖含量，由此说明本发明的糖代谢调节剂具有良好的改善2型糖尿病糖耐量异常的作用。
（5）胰岛素耐量测定及胰岛素抵抗指数（HOMA-IR）计算
给小鼠灌胃6周后，将各组小鼠禁食不禁水12h，迅速断尾采血测空腹血糖，记作0min血糖，配制（0.5IU/10g体质量）浓度的胰岛素，通过腹腔注射，在注射后30min、60min、90min、120min时分别检测血糖值，记录并绘制血糖折线图计算AUC面积；酶联免疫吸附剂测定（Elisa测定）小鼠空腹胰岛素水平，结合实验小鼠的空腹血糖，按以下计算公式测定计算HOMA-IR数值：
测算结果见表3-表6，将表3-表6相关数据可视化，绘制成示意图，结果见图1。
图1中，NC代表空白组，DC代表模型组，HSZ代表高剂量组、MSZ代表中剂量组、LSZ代表低剂量组，DME代表二甲双胍组。
表3 胰岛素耐量试验（ITT）实验结果表
表3中，模型组与空白组比较，##P<0.01；各给药组及二甲双胍组与模型组比较，**P<0.01。
表4 胰岛素耐量试验峰面积（ITT AUC）计算结果表
表4中，模型组与空白组比较，***P<0.001；各给药组及二甲双胍组与模型组比较，###P<0.001。
表5 血清空腹胰岛素（INS）测定结果表
表5中，模型组与空白组比较，空腹胰岛素分泌量有下降趋势；各给药组及二甲双胍组与模型组比较，空腹胰岛素分泌量有上升趋势。
表6 胰岛素抵抗指数（HOMA-IR）计算结果表
表6中，模型组与空白组比较，***P<0.001；各给药组及二甲双胍组与模型组比较，###P<0.001，##P<0.01。
如表3-表6，以及图1所示：胰岛素糖耐量试验（ITT）进一步评估了本发明糖代谢调节剂对实验小鼠胰岛素抵抗及胰岛功能的改善情况，对比模型组，经本发明的糖代谢调节剂干预后的给药组，其浓度-时间曲线下面积（AUC）得到显著降低，其降低效果与二甲双胍组相当；对各组小鼠血清胰岛素水平进行测定后发现：给药组可提升T2DM小鼠的胰岛素分泌水平结合实验小鼠的空腹血糖，根据稳态模型HOMA-IR公式计算HOMA-IR值，结果显示，T2DM小鼠的HOMA-IR升高，给药组均有下降，其降低效果与二甲双胍组相当。
综上，根据实验例的实验结论，本发明糖代谢调节剂能调节血糖，显著改善糖代谢紊乱。
可以预见的是，将上述实施例1-4所得糖代谢调节剂，按常规成型方法制备为胶囊剂、颗粒剂、片剂、散剂、丸剂或口服液的口服制剂，使得本发明糖代谢调节剂更便于储存、运输和推广应用，可用于制备治疗2型糖尿病的药物或具有改善糖代谢紊乱的保健品。
以上所述仅为本发明的较佳实施例而已，并不用以限制本发明，凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。
Claims (9)
1.一种糖代谢调节剂，其特征在于，按重量份计，由以下组份组成：山药5-10份、黑木耳5-10份、栀子3-6份、葛根3-6份、酒炙黄精3-6份、桑叶3-6份、普洱熟茶1-2份、肉桂1-2份。
2.根据权利要求1所述的糖代谢调节剂，其特征在于，按重量份计，由以下组份组成：山药10份、黑木耳10份、栀子6份、葛根6份、酒炙黄精6份、桑叶6份、普洱熟茶2份、肉桂2份。
3.根据权利要求1所述的糖代谢调节剂，其特征在于：所述黄精为滇黄精。
4.根据权利要求3所述的糖代谢调节剂，其特征在于：所述桑叶为霜桑叶。
5.一种糖代谢调节剂的制备方法，其特征在于，包括以下步骤：
S1备料：按权利要求1-4任一项所述重量份称取各组份；
S2水提：加水8-10倍煎煮20-40min，煎煮2-3次，过滤，合并滤液；
S3醇沉：减压浓缩至密度为1.06-1.07g/mL，加入1.5-3倍量无水乙醇，醇沉24-48h后，回流提取1.5h-2h，过滤，将滤液减压蒸馏除去乙醇，得精制液；
S4干燥：将精制液浓缩，真空冷冻干燥或喷雾干燥，粉碎，即得糖代谢调节剂。
6.根据权利要求5所述的糖代谢调节剂的制备方法，其特征在于，所述S2水提：加水10倍煎煮30min，煎煮2次，过滤，合并滤液。
7.根据权利要求5所述的糖代谢调节剂的制备方法，其特征在于，所述S3醇沉：减压浓缩至密度为1.066g/mL，加入2倍量无水乙醇，醇沉24-48h后，回流提取1.5h，过滤，将滤液减压蒸馏除去乙醇，得精制液。
8.根据权利要求5所述的糖代谢调节剂的制备方法，其特征在于：将所述糖代谢调节剂通过常规成型工艺制备成胶囊剂、颗粒剂、片剂、散剂、丸剂或口服液的口服制剂。
9.权利要求1-4任一项所述的糖代谢调节剂在制备治疗2型糖尿病的药物中的应用。
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