CN106692742A - 一种调节血糖的中药复方药物及其制备方法 - Google Patents
一种调节血糖的中药复方药物及其制备方法 Download PDFInfo
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Abstract
一种调节血糖的中药复方药物及其制备方法,本发明涉及复方植物药，包括有如下重量组分的物质：丹参22‑26％，枸杞子13‑16％，玉米须13‑16％，地黄13‑16％，桑叶4‑20％，米荞4‑5％，莴芦4‑7％，苦瓜3‑4％，马齿苋4‑5％。本发明与现有技术相比，本发明的有益效果在于：有滋肾养肝、清热化痰的作用，可治疗2型糖尿病以及改善胰岛素抵抗；成本低，安全有效，副作用小。
Description
技术领域
本发明涉及复方植物药，特别是调节血糖治疗II型糖尿病，抑制血管紧张素转换酶活性和胰岛素增敏、胰岛素抵抗，保护人体微生态平衡的中药复方药物及制备工艺。
背景技术
中国有着世界上最多的糖尿病病例和糖尿病死亡病例，国际糖尿联合会的数据显示，由于延迟诊断和治疗，2015年中国有130万人死于糖尿病相关疾病。糖尿病是由遗传和环境因素相互作用而引起的一组代谢异常综合症，是不可治愈的慢性疾病，可以通过注射胰岛素和服用降低血糖水平的药物来加以控制。国内外都在不断探索，糖尿病发病的新机制和治疗的新途径。糖尿病人主要可分为两种；第一型糖尿病(Type 1Diabetes)或称胰岛素依赖型糖尿病，其病因是免疫反应造成胰脏的β-细胞破坏而无法生产胰岛素，血中无胰岛素因此病人必须借助于注射胰岛素补充才能治疗糖尿病；第二型糖尿病(Type2Diabetes)或称为非胰岛素依赖型糖尿病病因不明，但是遗传基因为重要因素之一，通常与肥胖和缺乏锻炼等生活方式相关。胰岛素抵抗(Insolin resistance.IR)是指机体对一定量的胰岛素生物学效应低于预计正常水平的一种现象，胰岛素抵抗机理非常复杂，是II型糖尿病的主要特征之一，主要表现为胰岛素抑制肝脏释放葡萄糖的能力及促进周围组织利用葡萄糖的能力下降。为了调节血糖在正常水平，机体代偿性的分泌过多胰岛素即出现高胰岛素血症，从而给机体带来系列不良影响。同时研究表明：胰岛素抵抗与动脉硬化性血管疾病。高血压高血脂内脏型肥胖等疾病的病理机制发病相关，是胰岛素抵抗和代偿性高胰岛素血症“代谢综合症”的中心环节，因此改善II型糖尿病病人胰岛素抵抗，对糖尿病的治疗及减少糖尿病并发其他疾病的发病率具有重大临床意义。
胰岛素增敏剂是针对这一发病机理而出现的一类药物，它通过提高胰岛素靶组织的敏感性，促进外围组织(脂肪、脏器、骨骼机等)对葡萄糖的摄取与消除能力，抑制肝脏的糖异生的作用，从而改善胰岛素抗性，增加胰岛素敏感性。目前治疗糖尿病的主要药物有：磺脲类、双胍类、胰岛素、a-葡萄糖苷酶抑制剂，噻唑烷酮类等，这些药既新陈代谢调节剂在显示一定的增加机体胰岛素敏感性的作用，同时还产生一些不良反应，如引发低血糖、肝毒性、乳酸性酸中毒及腹泻。用TZDS类治疗胰岛素抵抗的II型糖尿病不仅改善了血糖控制，而且使胰岛素抵抗综合症的其他部分失调状况(高胰岛素血糖、脂质代谢絮乱、高尿酸血症、微白蛋白血症等)得到好转，且治疗时不会出现低血糖，备受人们关注。
血管紧张素转换酶抑制剂，是针对血管紧张素转换酶为作用靶点，能扩张冠状动脉，改善心功能，临床治疗心力衰竭，肾功能衰竭及糖尿病肾病的一类新型药物。临床应用价值较高。
胰岛素是胰岛分泌的一种激素，由51个氨基酸组成，分子量大约为6000道尔顿，是人体内最主要的降糖激素。胰岛素与靶细胞上的受体结合，能促进细胞外的葡萄糖进入这些细胞，变为糖原储存起来。胰岛素还能促进蛋白质和脂肪的合成，防止蛋白质和脂肪向葡萄糖转化。所以，人们称胰岛素是一种“合成性”或者“建设性”激素。
糖尿病患者由于胰岛功能减退，胰岛素分泌绝对或相对不足，导致降糖能力下降。轻度的糖尿病可以通过饮食控制和适当运动控制血糖，随着病情的加重，部分患者需要用口服药物或胰岛素治疗。中老年人是糖尿病的高发人群，老年人糖尿病血糖标准：空腹：静脉(全血)≥6.1，毛细血管≥6.1，静脉(血浆)≥11.1，静脉(血浆)≥11.1，符合下列之一者可诊断为糖尿病：1、有典型糖尿病症状，任意时间血糖高于11.1mmol/L(200mg/d1)两次以上高于7.8mmol/L(140mg/d1)。
胰岛素抵抗是II型糖尿病的主要病理机制，又是导致多种代谢紊乱以及心血管并发症的首要原因，据统计大约四分之三的糖尿病患者最终死于心脑血管并发症，如冠心病、脑卒中等……
有规律的运动，可提高抗病能力，使人体对胰岛素的敏感性增强，减轻糖尿病患者体内组织对胰岛素的对抗，增加对糖的利用，使血糖下降，保持血糖稳定，降低糖性损害。
而传统中药及天然药物治疗糖尿病是多环节、多途径、多靶点，并具有药源丰富，相对安全且价格低廉等特点，因此从天然药物植物原料中筛选具有胰岛素增敏活性的药,开发纯植物中药对预防和治疗糖尿病具有良好的临床实用价值和市场前景。
发明内容
中医药在慢性病防治方面有着先天优势，中国唐朝医学古籍《备急千金药房》记载了用于治疗糖尿病的多种复方，中医认为“五脏柔弱”、“过食肥甘”是糖尿病的两个基本病因，这与现代医学的糖尿病发病理论不谋而合。大量的临床总结表明：由于抗生素的长期滥用，人体微生态遭到破坏，II型糖尿病，尤其是肥胖者，往往都有明显的胰岛素抵抗，其症特点是肝肾亏虚，痰浊淤热。
本发明的目的是针对这一病症发病机理及现有技术的不足，依据中医“同病异治”与“异病同治”医学理念及中药复方炮制工艺，从调节糖友患者的“神经—内分泌—免疫”中枢系统入手，提供了一种可调剂血糖，抑制血管紧张素转换酶活性治疗II型糖尿病和胰岛素增敏、保护人体微生态平衡的组合植物复方中药制剂及提取方法。
本发明的目的由一下技术方案达到，本发明是一种调节血糖、治疗胰岛素抵抗及II型糖尿病和胰岛素增敏的复方植物药。本发明提供的技术方案如下：
一种调节血糖的中药复方药物的制备方法，所述的制备方法包括如下步骤：
(1)分别准备如下重量组分的物质：丹参22-26％，枸杞子13-16％，玉米须13-16％，地黄13-16％，桑叶4-20％，米荞4-5％，莴芦4-7％，苦瓜3-4％，马齿苋4-5％；
丹参：丹参煎剂可明显降低实验动物血糖，降血脂及血粘稠度。对脆性糖尿病、血糖波动较大效果好。
地黄：(生地、熟地)有明显降糖作用。
玉米须：有明显降糖作用，对糖尿病、高血压、肾病有改善作用。
枸杞子：枸杞子提取物可促进实验动物血糖降低，对血脂升高、视力不佳有改善作用。
桑叶：含有多种有助于调节血糖成分，与其他元素协同降糖。
米荞：又称“天然胰岛素”，对于降血压、降血糖效果良好，含丰富蛋白质、动物蛋白替代。
莴苣：是天然胰岛素激活剂，能促糖代谢、扩血管、利尿等。
苦瓜：维生素及矿物质含量丰富，清热解毒，益气壮阳，隐血糖作用好。
马齿苋：能增加胰岛素敏感度，辅助降糖功效显著。
(2)取地黄，碾碎，加入5～8倍地黄重量的、质量分数为50～70％的乙醇，98-100℃加热回流提取2～4次，每次1.5～2小时，合并提取液，减压回收乙醇，并浓缩至50℃下相对密度1.05～1.3的清膏，得地黄清膏；
(3)取枸杞子，加3～5倍枸杞子重量份的、质量分数为4％～7％的氯化钠溶液，浸润4.5～7.5小时后，蒸馏，收集3～4倍枸杞子重量的初馏液保存；继续蒸馏至蒸馏液不显乳白色为止，继续加氯化钠使其含量达4％～7％，重蒸馏，收集约1倍枸杞子重量的重蒸馏液，重蒸馏液与初馏液合并后，在3～5℃温度下放置12小时以上，至结晶完全析出，滤过，弃去滤液，收集结晶，低温真空干燥，得枸杞子清膏；
(4)将步骤(3)中的枸杞子药渣与丹参、米荞、桑叶、玉米须、莴芦、苦瓜和马齿苋研磨粉碎后混合，用50～70％乙醇98-100℃回流提取混合物2～4次，每次1～3小时，合并提取液，回收乙醇至提取液内无醇味，并浓缩至每毫升含生药量0.4～1克浓缩液，浓缩液与地黄清膏、枸杞子清膏合并，混匀，干燥，碎成细粉，加入0.3％细粉重量份的丹皮酚，得到一种调节血糖的药物。
或者，
步骤(4)步骤如下：将步骤(3)中的枸杞子药渣与丹参、米荞、桑叶、玉米须、莴芦、苦瓜和马齿苋混合后，用50～70％乙醇98-100℃回流提取2～4次，每次1～3小时，合并提取液，将提取液加入已预处理好的大孔树脂柱，大孔树脂柱用量与提取液之比为2:1，预吸附12小时，先用大孔树脂柱体积10倍量水预洗，再用大孔树脂柱体积15倍量的79％乙醇洗脱，出去乙醇，并浓缩至50℃下相对密度1.3，与地黄清膏合并，混匀，干燥，碎成细粉，加入丹皮酚，得到一种调节血糖的药物。
所述的药物可以制成颗粒剂、胶囊、软胶囊或片剂。
将上述植物原材料经干燥并适当的粉碎，以增加药材与溶剂的接触面积，提高效率；原药材的提取溶剂使用水、醇类、或水与醇类的混合物，优选乙醇。水与醇类的混合物，例如含有醇类化合物40％～98％(体积比)的水。提取时溶剂量为原药重量的4-14倍。提取可以在静态或动态下，优选在动态条件下。提取的温度是从室温(例如20℃)到溶剂回流温度的范围内，优选在回流的温度下，提取可连续或间歇进行，间歇提取时可重复1～4次。
上述步骤结束后，合并滤液，滤液在动态状态下，在常压或减压加热浓缩。将滤液合并进一步浓缩，提取物可以经冷冻干燥成干粉。
本发明还涉及含有作为活性成分的本发明提取物和常规药物赋形剂或辅剂的药物组合物。可以根据提取组合物中最后的制剂所含相组分配比指标适时调整。
本发明的目的由以下技术方案来进一步达到，所述的资料II型糖尿病和胰岛素增敏的组合植物药的提取物，其特点是治疗II型糖尿病和胰岛素增敏的组合植物药的提取物，加入药用辅料，制成药剂学所述的口服制剂，包括颗粒剂、胶囊、软胶囊、片剂。
本发明与现有技术相比，本发明的有益效果在于：有滋肾养肝、清热化痰的作用，可治疗2型糖尿病以及改善胰岛素抵抗；成本低，安全有效，副作用小。
实验证明，本发明的组合植物药的提取物及各提取方法制得的制剂，在治疗2型糖尿病以及改善胰岛素抵抗等方面有确切的疗效。体现在如下方面：
1、对实验性糖尿病大鼠糖耐量异常有一定的改善作用。
2、有一定降低实验性糖尿病及肥胖大鼠随机血糖的作用。
3、对实验性糖尿病及肥胖大鼠血脂有一定的调节作用。
具体实施方式：
下面为本发明的实施例，进一步描述本发明的发明内容。本发明所述物质的含量、浓度，未加以标明的，均以重量计。
实施例一
本实施例是一种治疗II型糖尿病和胰岛素增敏的组合植物药及提取物及提取方法，组合植物药提取物原料的重量(克)配方为：
首先准备好如下的材料：丹参26克，地黄13克，莴芦7克，枸杞子15克，桑叶12克，苦瓜4克，玉米须14克，米荞4克，马齿苋5克；
取地黄，加91克的60％的乙醇，加热回流提取3次，每次1.8小时，合并提取液，减压回收乙醇，并浓缩至50℃下相对密度1.25的清膏，得地黄提取物地黄清膏；
取枸杞子，加60克的6％的氯化钠水溶液，浸润6小时候，蒸馏，收集52.5g初馏液量另器保存；继续蒸馏至蒸馏液不显乳白色为止，药渣及残留液备用；续馏液加氯化钠NaC1使其含量达6％，重蒸馏，收集重蒸馏液约一倍药材量，与初馏液合并，在4℃温度下放置18小时，结晶析出，滤过，弃去滤液，收集结晶，低温真空干燥，得枸杞子提取物枸杞子清膏；
枸杞子药渣与丹参、米荞、桑叶、玉米须、莴芦、苦瓜和马齿苋混合后，用60％乙醇回流提取3次，第一次2.5小时，第二次2.5小时，第三次1.5小时，合并提取液，回收乙醇至无醇味，并浓缩至每毫升含生药量0.5克，即加入已预处理好的大孔树脂柱，大孔树脂用量与生药量之比为2:1，预吸附12小时，先用大孔树脂柱体积10倍量水预洗，水洗脱液弃去；再用大孔树脂柱体积15倍量的79％乙醇洗脱，收集洗脱液，回收乙醇，并浓缩至50℃下相对密度1.25，与枸杞子清膏合并，混匀，干燥，碎成细粉，加入丹参酚，得治疗II型糖尿病和胰岛素增敏的组合植物药的提取物。加入药用辅料，制成药剂学所述的颗粒剂、胶囊、软胶囊、片剂。
实施例二
本实施例是一种治疗II型糖尿病和胰岛素增敏的组合植物药及其提取物及提取方法，组合植物药提取物原料的重量(克)配方为：
丹参22克，枸杞子16克，玉米须16克，地黄14克，桑叶12克，米荞4克，莴芦7克，苦瓜4克，马齿苋5克；
取地黄，加112g的质量分数为60％的乙醇，加热回流提取3次，每次1.8小时，合并提取液，减压回收乙醇，并浓缩至50℃下相对密度1.25的清膏，得地黄提取物地黄清膏；
取枸杞子，加64克的质量分数为6％的氯化钠水溶液，浸润6小时后，蒸馏，收集初馏液64g另器保存；继续蒸馏至蒸馏液不显乳白色为止，枸杞子药渣及残留液备用；续馏液加氯化钠使其含量达6％，重蒸馏，收集重蒸馏液约16g，与初馏液合并，在4℃温度下放置18小时，至结晶完全析出，滤过，弃去滤液，收集结晶，低温真空干燥，得枸杞子清膏；
枸杞子药渣与丹参、米荞、桑叶、玉米须、莴芦、苦瓜和马齿苋混合后，用60％乙醇回流提取3次，第一次2.5小时，第二次2.5小时，第三次1.5小时，合并提取液，回收乙醇至无醇味，并浓缩至每毫升含生药量0.4克，即25℃下的相对密度约为1.05，与地黄清膏、枸杞子清膏合并，混匀，干燥，碎成细粉，加入丹皮酚，得治疗II型糖尿病和胰岛素增敏的组合植物药的提取物，加入要用辅料，制成药剂学所述的颗粒剂、胶囊、软胶囊、片剂。
Claims (3)
1.一种调节血糖的中药复方药物的制备方法，其特征在于，所述的制备方法包括如下步骤：
(1)分别准备如下重量组分的物质：地黄13-16％，丹参22-26％，枸杞子13-16％，玉米须13-16％，桑叶4-20％，米荞4-5％，莴芦4-7％，苦瓜3-4％，马齿苋4-5％；
(2)取地黄，碾碎，加入5～8倍地黄重量的、质量分数为50～70％的乙醇，98-100℃加热回流提取地黄2～4次，每次1.5～2小时，合并提取液，减压回收乙醇，并浓缩至50℃下相对密度1.05～1.3的清膏，得地黄清膏；
(3)取枸杞子，加3～5倍枸杞子重量份的、质量分数为4％～7％的氯化钠溶液，浸润4.5～7.5小时后，蒸馏，收集3～4倍枸杞子重量的初馏液保存；继续蒸馏至蒸馏液不显乳白色为止，继续加氯化钠使其含量达4％～7％，重蒸馏，收集约1倍枸杞子重量的重蒸馏液，重蒸馏液与初馏液合并后，在3～5℃温度下放置12小时以上，至结晶完全析出，滤过，弃去滤液，收集结晶，低温真空干燥，得枸杞子清膏；
(4)将步骤(3)中的枸杞子药渣与丹参、米荞、桑叶、玉米须、莴芦、苦瓜和马齿苋粉碎后混合，用50～70％乙醇98-100℃回流提取混合物2～4次，每次1～3小时，合并提取液，回收乙醇至提取液内无醇味，并浓缩至每毫升含药量0.4～1克浓缩液，浓缩液与地黄清膏、枸杞子清膏合并，混匀，干燥，碎成细粉，加入0.3％细粉重量份的丹皮酚，得到一种调解血糖的药物。
2.如权利要求1所述的制备方法，其特征在于，步骤(4)步骤如下：将步骤(3)中的枸杞子药渣与丹参、米荞、桑叶、玉米须、莴芦、苦瓜和马齿苋混合后，用50～70％乙醇98-100℃回流提取2～4次，每次1～3小时，合并提取液，将提取液加入已预处理好的大孔树脂柱，大孔树脂柱用量与提取液之比为2:1，预吸附12小时，先用大孔树脂柱体积10倍量水预洗，再用大孔树脂柱体积15倍量的79％乙醇洗脱，除去乙醇，并浓缩至50℃下相对密度1.3，与地黄清膏合并，混匀，干燥，碎成细粉，加入丹皮酚，得到一种调解血糖的药物。
3.一种采用如权利要求1或2所述的制备方法制备的一种调节血糖的中药复方药物，其特征在于，所述的药物为颗粒剂、胶囊、软胶囊或片剂。
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