CN109692194B - 一种治疗糖尿病肾病的复方中药组合物及其制备方法和应用 - Google Patents
一种治疗糖尿病肾病的复方中药组合物及其制备方法和应用 Download PDFInfo
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Abstract
本发明涉及一种治疗糖尿病肾病的中药组合物，制备所述中药组合物的原料包括黄芪、黄蜀葵花和酒萸肉，所述原料中黄芪、黄蜀葵花和酒萸肉的重量比为(1‑3):(1‑3):(1‑3)。本发明的中药组合物通过中药的合理设计与配伍优化，使其对糖尿病肾病具有确切、显著的治疗效果，安全性高。本发明的制备方法采用一步造粒技术，生产工艺简单、自动化程度高，比传统制粒辅料的用量大为减少，且制剂抗吸湿性好，稳定性高。
Description
技术领域
本发明涉及中药领域，具体涉及一种治疗糖尿病肾病的药物。
背景技术
近年来，随着我国经济高速发展和工业化进程的加速，糖尿病和随之而来的合并症已成为严重威胁人们健康和生活质量的最主要的慢性疾病。全国14个省市糖尿病的流行病学调查结果表明，我国20岁以上的成年人糖尿病患病率为9.7％，总数达9240万。
糖尿病肾病是糖尿病最常见且最严重的慢性并发症之一。我国大城市内分泌科住院患者回顾性分析结果显示：1型糖尿病患者中，糖尿病肾病的发病率为22.5％；2型糖尿病患者中，糖尿病肾病的发病率为34.7％。国外资料表明，糖尿病患者中，糖尿病肾病发病率为30-50％。随着糖尿病(特别是2型)发病率的逐年上升，糖尿病肾病的发病人数也相应增加。据美国肾脏资料系统(USRDS)的统计，超过43％的终末期肾衰(ESRD)由糖尿病所致，且糖尿病所致ESRD比例在逐年上升，伴有ESRD的患者5年生存率小于20％。因此，对糖尿病肾病进行早期诊断，并采取有效措施延缓其发展至关重要。
现代医学研究认为，糖尿病肾病的发病机制主要与长期持续高血糖导致的肾脏血流动力学改变、蛋白非酶糖基化、多元醇通路激活、脂代谢紊乱、氧化应激、细胞因子和生长因子等释放、遗传因素等有关，但其确切发病机制仍未阐明。由于糖尿病肾病的发生发展机理的复杂性，故其防治应采取综合措施，控制其进展的措施主要有：高血压的治疗、控制血糖、蛋白饮食限制、降脂治疗等。尽管临床采用了多种治疗措施如降压、抑制肾素-血管紧张素系统活性和各种对因治疗等，但仍无法有效延缓大多数患者肾小球硬化和肾小管间质纤维化的进展速度。因此，目前临床上针对糖尿病肾病尚无确切减少尿蛋白漏出，延缓肾损害加重的药物。
糖尿病肾病属于中医“消渴肾病”范畴，多数学者认为消渴并发水肿，水病和尿浊等与糖尿病肾病相近，《圣济总录》记载“消肾，小便白浊如凝脂，形体羸弱”，明确指出消渴肾病时会出现蛋白尿。消渴肾病是在糖尿病以阴虚为本，气阴两虚为基本证型的基础上进一步演变而来，并认为“气阴两虚”是消渴肾病的重要病机。近年来进一步认识到糖尿病肾病机有以下特点：气阴两虚是糖尿病肾病早期的基本病机；湿热是糖尿病肾病进展的重要因素；瘀血既是糖尿病肾病的病理产物，也是糖尿病肾病进展的关键因素。
参照国内外对糖尿病肾病的研究成果及多年临床研究经验，发明人认为“气阴两虚、湿瘀阻络”是糖尿病肾病的基本病机：消渴日久，损伤脾胃，脾土失于健运，以致湿浊内生，日久郁而化热，湿热壅滞于肾，不断耗伤正气，终至肾气衰败；气虚不能行血，瘀血阻于络，肾失封藏，精微下流，则见蛋白尿。湿热瘀血既是糖尿病肾病的病理产物，又是重要的致病因素。湿热瘀血互结是糖尿病肾病蛋白尿进展的中心环节。
黄蜀葵花为锦葵科秋葵属植物黄蜀葵(Abelmoschus manihot L.Medic)的干燥花，黄蜀葵为一年或多年生草本植物，产于我国，原为野生，现可以进行人工栽培，主要产区有江苏江堰，江苏兴化，河北邢台等。《嘉佑本草》记载：味甘、辛，性凉，入肺、肾、膀胱经，主治小便淋及催生，治诸恶疮。《中华本草》记载其主要功效为清利活血，消肿解毒，用于治疗淋病，痈疽肿毒。
黄芪为豆科植物蒙古黄芪Astragalus membranaceus(Fisch)Bge.Var.Monghoicus(Bge)Hisao或膜荚黄芪Astragalus membranaceus(Fisch)Bge.的干燥根，味甘，性微温，具有补气升阳、益卫固表、利尿消肿、托毒生肌之功效。药理研究表明，黄芪具有增强机体的免疫功能，强心、降压、降血糖、利尿等作用。主要用于气虚乏力、食少便溏、中气下陷、久泻脱肛、便血崩漏、表虚自汗、气虚水肿、内热消渴等病。
酒萸肉为山茱萸科植物山茱萸Cornus officinalis Sieb.et Zucc.的干燥成熟果肉。秋末冬初果皮变红时采收果实，用文火烘或置沸水中略烫后，及时除去果核，干燥。药理研究表明，酒萸肉具有补益肝肾，涩精固脱的功效，主要用于眩晕耳鸣、腰膝酸痛、阳痿遗精、遗尿尿频、崩漏带下、大汗虚脱、内热消渴。酒萸肉为山茱萸的炮制品，其炮制方法为：取净山萸肉，用黄酒拌匀，每100斤用黄酒20斤，放罐内或其他容器内，封严，放在加水的锅中，蒸至酒被吸尽，取出晾干。
紫菀(Aster tataricus L.f.)是菊科紫菀属，多年生草本植物。国内主产于河北、内蒙和东北三省等地区，在朝鲜、日本等地亦有分布，通常生长于潮湿的河边地带。紫菀温肺，下气，消痰，止咳，主治风寒咳嗽气喘，虚劳咳吐脓血，喉痹，小便不利，临床上具有祛痰、抗菌、抗病毒、抗肿瘤的功效。
猫爪草(Ranunculus ternatus Thunb.)是毛莨科毛莨属一年生草本植物，分布于中国广西、江苏、浙江、江西、湖南、安徽、湖北、河南等省，日本也有分布。猫爪草甘辛、温、性平、归肝肺经，具有解毒、化痰散结的功效，临床上主治瘰疬、结核、咽炎、疔疮、蛇咬伤、疟疾、偏头痛、牙痛等。
目前，将上述各味中药组合使用治疗糖尿病肾病的文献尚未见报道。
发明内容
本发明的目的是提供一种能治疗糖尿病肾病的复方中药组合物及其制备方法和用途。
为实现上述目的，本发明的第一方面提供一种治疗糖尿病肾病的中药组合物，制备所述中药组合物的原料包括黄芪、黄蜀葵花和酒萸肉。
优选的，所述原料中黄芪、黄蜀葵花和酒萸肉的重量比为(1-3):(1-3):(1-3)。
更优选的，所述原料中黄芪、黄蜀葵花和酒萸肉的重量比为3:3:1。
优选的，所述原料中进一步包括紫菀和猫爪草。
更优选的，所述紫菀和猫爪草的重量比为1:1-1:9。
最优选的，所述紫菀和猫爪草的重量比为1:4。
优选的，所述中药组合物包括药学上可接受的辅料。
更优选的，所述药学上可接受的辅料选自淀粉、乳糖、甘露醇或糊精。
最优选的，所述药学上可接受的辅料为糊精。
优选的，所述中药组合物为片剂、胶囊剂、散剂、颗粒剂、滴丸剂。
更优选的，所述中药组合物为颗粒剂。
本发明进一步提供上述中药组合物的制备方法，具体步骤如下：除黄蜀葵花外，称取处方量的中药原料，加水煎煮，滤过，减压浓缩，加乙醇至醇含量70％，静置滤过，取上清液备用；称取处方量的黄蜀葵花，加95％乙醇煎煮，滤过，减压浓缩，备用；称取处方量的糊精，置流化床中，取上述两部分中药提取物加纯化水稀释，喷雾制粒，干燥，过筛，即得。
优选的，所述加水煎煮的次数为两次，煎煮时加入10倍量的水，每次煎煮1小时。
优选的，所述乙醇煎煮的次数为两次，煎煮时加入18倍量的95％乙醇，每次煎煮1小时。
本发明还提供上述中药组合物在制备治疗糖尿病肾病药物中的应用。
本发明具有积极有益的效果：
本发明的中药组合物通过中药的合理设计与配伍优化，使其对糖尿病肾病具有确切、显著的治疗效果，安全性高。本发明的制备方法采用一步造粒技术，生产工艺简单、自动化程度高，比传统制粒辅料的用量大为减少，且制剂抗吸湿性好，稳定性高。
具体实施方式
下面结合实施例对本发明作更进一步的说明，但本发明的实施方式不限于此。下述实施例中所使用的实验方法如无特殊说明，均为常规方法。
实施例1：
称取300g黄芪、100g酒萸肉，加水煎煮两次，第一次加10倍重量水，浸泡1小时，加热煎煮1小时，滤过；第二次加10倍重量水，加热煎煮1小时，滤过。合并两次滤液，在70～80℃，真空度-0.06～-0.04MPa的条件下减压浓缩至60℃时相对密度为1.05，加入乙醇至含醇量70％，静置24h，滤过，滤液离心，取上清液，备用。称取300g黄蜀葵花，加95％乙醇煎煮两次，第一次加18倍重量乙醇，浸泡1小时，加热煎煮1小时，滤过；第二次加18倍量乙醇，加热煎煮1小时，滤过。合并两次滤液，在真空度-0.06～-0.04MPa，温度70～80℃的条件下减压浓缩至适量，备用。称取糊精100g，置流化床中，设置进风温度为85℃，取上述两部分中药提取物加纯化水稀释，当物料温度升至50℃时，开始进液，喷雾结束，70℃继续干燥1小时，过筛，制成中药组合物颗粒(即本发明的“处方1”)。
实施例2：
将黄芪、酒萸肉和黄蜀葵花的处方量依次变为100g、300g和300g，其他制备参数均与实施例1相同，制成中药组合物颗粒(即本发明的“处方2”)。
实施例3：
将黄芪、酒萸肉和黄蜀葵花的处方量依次变为300g、300g和100g，其他制备参数均与实施例1相同，制成中药组合物颗粒(即本发明的“处方3”)。
实施例4：
将黄芪、酒萸肉和黄蜀葵花的处方量依次变为200g、66.7g和200g，同时将116.65g紫菀和116.65g猫爪草(即紫菀与猫爪草的重量比为1:1)与黄芪、酒萸肉一并采取水提醇沉法制备，其他制备参数均与实施例1相同，制成中药组合物颗粒(即本发明的“处方4”)。
实施例5：
将黄芪、酒萸肉和黄蜀葵花的处方量依次变为200g、66.7g和200g，同时将23.33g紫菀和209.97g猫爪草(即紫菀与猫爪草的重量比为1:9)与黄芪、酒萸肉一并采取水提醇沉法制备，其他制备参数均与实施例1相同，制成中药组合物颗粒(即本发明的“处方5”)。
实施例6：
将黄芪、酒萸肉和黄蜀葵花的处方量依次变为200g、66.7g和200g，同时将46.66g紫菀和186.64g猫爪草(即紫菀与猫爪草的重量比为1:4)与黄芪、酒萸肉一并采取水提醇沉法制备，其他制备参数均与实施例1相同，制成中药组合物颗粒(即本发明的“处方6”)。
试验例1、本发明中药组合物对糖尿病肾病模型大鼠保护作用
1、动物模型的建立
选择体重200g±20g雄性SD大鼠80只，适应性饲养1周后，实验前用代谢笼收集大鼠尿液测定尿糖，尿蛋白定性为阴性后开始手术。随机分为2组，空白组10只，造模组70只。
造模组手术前禁食12h后，用10％水合氯醛腹腔注射麻醉，仰卧位固定，剪去腹部手术部位的毛，皮肤消毒后于剑突下1.5cm沿腹中线切开皮肤及肌肉层，右手指深入腹腔摸着肾脏，左手指从腹部外侧配合将肾脏轻轻挤出，用浸有生理盐水的棉花或纱布包住，然后用左右手指将其固定。于左肾近肾门处小心分离左肾动脉后，于其下横穿一条线，并根据动脉粗细程度，选用不同号码的细线，依血管分布方向放于其上，然后将横线打结，结扎后将细线或针灸针抽出，缝合腹部切口，碘酒消毒。
空白组手术前禁食12h后，用10％水合氯醛腹腔注射麻醉，仰卧位固定，剪去腹部手术部位的毛，皮肤消毒后于剑突下1.5cm沿腹中线切开皮肤及肌肉层，不做处理，缝合腹部切口，正常饮食。
术后1周后，造模组给予高糖高脂饮食(配方：基础饲料：蛋黄：猪油：胆酸钠：蔗糖＝63.5:10:8:0.5:18)。2周后造模组按40mg/kg体重腹腔注射2％STZ(链脲佐菌素)。空白组腹腔注射等量柠檬酸钠缓冲液。实验期间动物自由进食、饮水，不使用胰岛素及其他降糖药物。
2、动物分组和给药
STZ造模72h后大鼠尾尖部采血测定血糖；以血糖值11.4mmol/L以上者为合格动物。按照血糖分组，使血糖值各组间无显著差异。80只大鼠被分为8组：空白组(假手术组)、模型组以及6个本发明中药组合物组(分别对应本发明的处方1-6)，每组10只。
取处方1-6(参见实施例1-6)的中药颗粒剂100g，加入蒸馏水至100ml，配制成1g中药颗粒剂/ml的药液，按照1ml/100g的剂量分别向6个本发明中药组合物组的大鼠灌胃给药；空白组(假手术组)和模型组给予同体积蒸馏水，每日一次，连续5周。
3、试验结果
(1)糖尿病肾病大鼠血糖试验
分别于给药前和第四周对各试验组大鼠取血，检测血糖含量，具体试验结果见表1。
表1本发明中药颗粒对糖尿病肾病大鼠血糖的影响
上述试验结果表明，模型组大鼠血糖显著升高，与空白组比较具有显著性差异。本发明中药组合物处方1-6给药四周血糖均有不同程度的降低趋势。值得注意的是，在中药材原料总重相同的基础上，处方1的降糖效果较处方2和3更加显著。
(2)糖尿病肾病大鼠血清肌酐和内生肌酐清除率试验
分别于试验末对各试验组大鼠取血，离心所得血清标本采用全自动生化分析仪检测血中肌酐水平，计算内生肌酐清除率，具体试验结果见表2。
表2本发明中药颗粒对糖尿病肾病大鼠血清肌酐和内生肌酐清除率的影响
上述试验结果表明，模型组大鼠肌酐升高，内生肌酐清除率显著降低，与空白组比较具有显著性差异。本发明中药组合物处方1-6给药四周后肌酐均显著降低，内生肌酐清除率明显升高。
(3)糖尿病肾病大鼠尿蛋白和尿蛋白排泄率试验
分别于试验末收集各试验组大鼠24小时尿液，测定尿液中尿蛋白含量，计算尿蛋白排泄率，具体试验结果见表3。
表3本发明中药颗粒对对糖尿病肾病大鼠尿蛋白和尿蛋白排泄率的影响
上述试验结果表明，模型组大鼠尿蛋白和尿蛋白排泄率显著升高，与空白组比较具有显著性差异。本发明中药组合物处方1-6给药四周后尿蛋白含量和尿蛋白排泄率均有不同程度的降低趋势。
综上所述，试验例1的大鼠药理试验结果证实，本发明中药组合物处方1-6对于治疗糖尿病肾病具有显著疗效，其中处方1的效果明显优于处方2和处方3。在处方4-6中，包含特定重量比的紫菀与猫爪草(1:4)的处方6疗效最为显著，产生了难以预期的优异效果。
Claims (1)
1.一种治疗糖尿病肾病的中药组合物，其特征在于，称取200g黄芪、66.7g酒萸肉、46.66g紫菀和186.64g猫爪草，加水煎煮两次，第一次加10倍重量水，浸泡1小时，加热煎煮1小时，滤过；第二次加10倍重量水，加热煎煮1小时，滤过；合并两次滤液，在70～80℃，真空度-0.06～-0.04MPa的条件下减压浓缩至60℃时相对密度为1.05，加入乙醇至含醇量70％，静置24h，滤过，滤液离心，取上清液，备用；称取200g黄蜀葵花，加95％乙醇煎煮两次，第一次加18倍重量乙醇，浸泡1小时，加热煎煮1小时，滤过；第二次加18倍量乙醇，加热煎煮1小时，滤过；合并两次滤液，在真空度-0.06～-0.04MPa，温度70～80℃的条件下减压浓缩至适量，备用；称取糊精100g，置流化床中，设置进风温度为85℃，取上述两部分中药提取物加纯化水稀释，当物料温度升至50℃时，开始进液，喷雾结束，70℃继续干燥1小时，过筛，制成中药组合物颗粒。
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