CN104491342A - 一种治疗糖尿病的药物及其制备方法 - Google Patents
一种治疗糖尿病的药物及其制备方法 Download PDFInfo
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Abstract
一种治疗糖尿病的药物及其制备方法，它是由生山药、生黄芪、知母、生鸡内金、葛根、五味子、天花粉按照一定的重量份数配比配伍而成，本发明中药组合物能够补脾养胃，生津益肺，清热生津，消肿排脓对治疗糖尿病有切实疗效，且适合长期服用，对身体无毒副作用。
Description
技术领域
本发明涉及一种由中草药为原料药的中药组合物及其制备方法，具体的说是涉及一种治疗糖尿病的药物及其制备方法。
背景技术
糖尿病是一组以高血糖为特征的代谢性疾病。高血糖是由于胰岛素分泌缺陷或其生物作用受损，或两者兼有引起。糖尿病时长期存在的高血糖，导致各种组织，特别是眼、肾、心脏、血管、神经的慢性损害、功能障碍。随着人们生活水平的日益提高，患有糖尿病的患者也越来越多。糖尿病是一种很难治愈的疾病，患者需要长期服药和控制饮食，糖尿病病例临床表现为：多饮、多尿、多食、消瘦等表现，即“三多一少”症状。目前，还没有一种能够有效治疗糖尿病的药物，多数都是以西药维持病情，但是长期服用西药会产生一定的抗药性和依赖性，而且会对身体产生较大的副作用。医学界一直在探索治疗和预防糖尿病这一影响人们身体健康的顽疾。
发明内容
本发明从临床医疗用药需求及中医组方辩证原则出发，提出一种治疗糖尿病的药物及其制备方法。它是由以下重量份数配比的原料药制备而成的药剂：生山药12-18g、生黄芪7-13g、知母4-8g、生鸡内金3-5g、葛根4-7g、五味子3-5g、天花粉9-15g。优选配比为：生山药15g、生黄芪10g、知母6g、生鸡内金4g、葛根5g、五味子3g、天花粉12g。所述药剂为汤剂、胶囊剂、片剂或丸剂。
所述胶囊剂、片剂、丸剂的制备方法步骤如下：
（1）取方中生山药、生黄芪、知母、生鸡内金、葛根、五味子、天花粉粉碎筛析；
（2）将步骤（1）中筛制的混合物加水煎煮2-3次，合并煎液、过滤，将虑液浓缩成70-80度时，胶囊、丸剂相对密度为1.0-1.6的稠膏，片剂相对密度为1.0-1.4的稠膏；
（3）制作胶囊、丸剂时：
将稠膏分离纯化、干燥，制成干颗粒；将步骤干颗粒混合均匀，填充胶囊内即制成胶囊；将干颗粒喷加炼蜜、混合均匀，制成小丸即制成丸剂；
制作片剂时：
将2-4份淀粉与步骤（2）中的稠膏混合均匀，制成颗粒、干燥，制成干颗粒，将干颗粒压制成片剂，包糖衣，即制成片剂。
步骤（2）中所述的混合物，加水煎煮的优选次数为2次，第一次为60-80分钟，第二次为40-60分钟。
本发明药物原料药的药理如下：
生山药：【性味归经】性平，味甘。【功能主治】补脾养胃，生津益肺，补肾涩精。用于脾虚食少、久泻不啻、肺虚喘咳、肾虚遗精、带下、尿频、虚热解渴，脾虚腹泻、肺虚咳嗽、糖尿病消渴。
生黄芪：味甘，微温，具有补气固表，托疮生肌、利水的功效，主治气血虚弱、自汗、久泻脱肛、子宫脱垂、肾炎浮肿、蛋白尿、糖尿病、慢性溃疡等症。临床用来治疗高血压和急慢性肾炎。
知母：性苦寒，有滋阴降火、润燥滑肠、利大小便之效。属清热下火药，主治：温热病、高热烦渴、咳嗽气喘、燥咳、便秘、骨蒸潮热、虚烦不眠、消渴淋浊。
生鸡内金：具有消积滞，健脾胃，抗癌功效。治食积胀满，呕吐反胃，泻痢，疳积，消渴，遗溺，喉痹乳蛾，牙疳口疮。
葛根：有解表退热、生津止渴、止泻的功能，并能改善高血压病人的项强、头晕、头痛、耳鸣等症状。有效成分为黄豆甙元(daidzein)、黄甙 (daidzin) 及葛根素 (puerarin)等。现代医学证实，葛根具有解热、消炎、抗菌、免疫、抗凝血、降压、解痉、抗心律失常、改善脑血循环、抗促癌及诱导癌细胞的分化、降血糖、作用，能明显扩张冠状动脉，扩张冠脉血管和改善缺氧状态，增强心肌对缺血耐受性，对支气管平滑肌和肠道平滑肌的收缩均有抑制作用，
五味子：功能主治：敛肺，滋肾，生津，收汗，涩精。治肺虚喘咳，口干作渴，自汗，盗汗，劳伤羸瘦，梦遗滑精，久泻久痢。
天花粉：性味归经：甘、微苦，微寒。归肺、胃经。功效：清热生津，消肿排脓。主治：用于热病烦渴，肺热燥咳，内热消渴，疮疡肿毒。
本发明以生山药为君药，用于补脾养胃，生津益肺，补肾涩精。以天花粉、生黄芪为臣药，清热生津，消肿排脓，补气固表，治糖尿病。佐使以知母、葛根、生鸡内金、五味子，解表退热，生津止渴，解热消炎，抗菌抗凝血，降压解痉，改善高血压病人的项强、头晕、头痛、耳鸣等症状。佐使以，消积滞，健脾胃，敛肺滋肾，生津收汗。本发明所述的药物承中医之精髓、严谨组方，诸药君臣佐使合用，补破结合、相得益彰，符合中医用药规律和辨证施治的原则。
有益效果
本发明中药组合物能够补脾养胃，生津益肺，清热生津，消肿排脓对治疗糖尿病有切实疗效，且适合长期服用，对身体无毒副作用。
急毒性试验：较大剂量和较长疗程服用对大鼠的生长无显著毒性，对大鼠的脑、心、肝、肾等切片形态学检查未见明显毒性损伤改变，试验显示，本药物毒性甚小。
临床试验统计数据
1、筛选病例
2013年，筛选应用本药物治疗的糖尿病患者180例，其中男100例，女80例，平均年龄56岁，随机分为对照A组、对照B组、治疗C组三组，每组60人。
、治疗方法
对照A组：服用二甲双胍缓释片，每日两次，每次2片（1000mg）；
对照B组：服用磺脲类药物优降糖，每日两次，每次1粒；
治疗C组：服用本发明中药组合物（实施例2配方），每日一剂，早晚两次服用。
所有患者服用药物30天后，停止服用，观察30天。
、疗效评价标准
在服用药物1天前，服用药物第30天，和停止服务药物后第30天，对每组分别检测空腹血糖指标；
所有指标用均数± 标准差表示，应用t检测的统计方法对结果进行分析，p<0.05认为具有显著意义。
、统计结果
5、结论
由统计结果可以看出，对照A组、对照B组、治疗C组服用药物第30天，和停止服用药物后第30天的血糖指标比服用前都有明显下降，但可以明显看出，对照A组、对照B组停药30天后，血糖指标反弹较大，而服用本发明药物的治疗C组停药30天后，血糖的指标回升幅度不明显，由此，反应出本发明药物对糖尿病的治疗具有较为明显的优势，且无毒副作用，适合长期服用。
具体实施方式
实施例1：一种治疗糖尿病的药物及其制备方法。它是由以下重量份数配比的原料药制备而成的药剂：生山药12-18g、生黄芪7-13g、知母4-8g、生鸡内金3-5g、葛根4-7g、五味子3-5g、天花粉9-15g。所述药剂为汤剂、胶囊剂、片剂或丸剂。
按照下述重量份数配比称取原料药：
生山药12-18g、生黄芪7-13g、知母4-8g、生鸡内金3-5g、葛根4-7g、五味子3-5g、天花粉9-15g。
所述胶囊剂、片剂、丸剂的制备方法步骤如下：
（1）取方中生山药、生黄芪、知母、生鸡内金、葛根、五味子、天花粉粉碎筛析；
（2）将步骤（1）中筛制的混合物加水煎煮2-3次，合并煎液、过滤，将虑液浓缩成70-80度时，胶囊、丸剂相对密度为1.0-1.6的稠膏，片剂相对密度为1.0-1.4的稠膏；
（3）制作胶囊、丸剂时：
将稠膏分离纯化、干燥，制成干颗粒；将步骤干颗粒混合均匀，填充胶囊内即制成胶囊；将干颗粒喷加炼蜜、混合均匀，制成小丸即制成丸剂；
制作片剂时：
将2-4份淀粉与步骤（2）中的稠膏混合均匀，制成颗粒、干燥，制成干颗粒，将干颗粒压制成片剂，包糖衣，即制成片剂。
步骤（2）中所述的混合物，加水煎煮的优选次数为2次，第一次为60-80分钟，第二次为40-60分钟。
实施例2：一种治疗糖尿病的药物及其制备方法。它是由以下重量份数配比的原料药制备而成的药剂：生山药15g、生黄芪10g、知母6g、生鸡内金4g、葛根5g、五味子3g、天花粉12g。所述药剂为汤剂、胶囊剂、片剂或丸剂。
按照下述重量份数配比称取原料药：
生山药15g、生黄芪10g、知母6g、生鸡内金4g、葛根5g、五味子3g、天花粉12g。
所述胶囊剂、片剂、丸剂的制备方法步骤如下：
（1）取方中生山药、生黄芪、知母、生鸡内金、葛根、五味子、天花粉粉碎筛析；
（2）将步骤（1）中筛制的混合物加水煎煮2-3次，合并煎液、过滤，将虑液浓缩成70-80度时，胶囊、丸剂相对密度为1.0-1.6的稠膏，片剂相对密度为1.0-1.4的稠膏；
（3）制作胶囊、丸剂时：
将稠膏分离纯化、干燥，制成干颗粒；将步骤干颗粒混合均匀，填充胶囊内即制成胶囊；将干颗粒喷加炼蜜、混合均匀，制成小丸即制成丸剂；
制作片剂时：
将2-4份淀粉与步骤（2）中的稠膏混合均匀，制成颗粒、干燥，制成干颗粒，将干颗粒压制成片剂，包糖衣，即制成片剂。
步骤（2）中所述的混合物，加水煎煮的优选次数为2次，第一次为60-80分钟，第二次为40-60分钟。
实施例3，本发明药物还可以为口服液、颗粒剂等。
Claims (5)
1.一种治疗糖尿病的药物，其特征在于它是由以下重量份数配比的原料药制备而成的药剂：生山药12-18g、生黄芪7-13g、知母4-8g、生鸡内金3-5g、葛根4-7g、五味子3-5g、天花粉9-15g。
2.根据权利要求1所述的治疗糖尿病的药物，其特征在于它是由以下重量份数配比的原料药制备而成的药剂：生山药15g、生黄芪10g、知母6g、生鸡内金4g、葛根5g、五味子3g、天花粉12g。
3.根据权利要求1或2所述的治疗糖尿病的药物，其特征在于：所述药剂为汤剂、胶囊剂、片剂或丸剂。
4.根据权利要求3所述的治疗糖尿病的药物，其特征在于：所述胶囊剂、片剂、丸剂的制备方法步骤如下：
（1）取方中生山药、生黄芪、知母、生鸡内金、葛根、五味子、天花粉粉碎筛析；
（2）将步骤（1）中筛制的混合物加水煎煮2-3次，合并煎液、过滤，将虑液浓缩成70-80度时，胶囊、丸剂相对密度为1.0-1.6的稠膏，片剂相对密度为1.0-1.4的稠膏；
（3）制作胶囊、丸剂时：
将稠膏分离纯化、干燥，制成干颗粒；将步骤干颗粒混合均匀，填充胶囊内即制成胶囊；将干颗粒喷加炼蜜、混合均匀，制成小丸即制成丸剂；
制作片剂时：
将2-4份淀粉与步骤（2）中的稠膏混合均匀，制成颗粒、干燥，制成干颗粒，将干颗粒压制成片剂，包糖衣，即制成片剂。
5.根据权利要求4所述的治疗糖尿病的药物的制备方法，其特征在于步骤（2）中所述的混合物，加水煎煮的次数为2次，第一次为60-80分钟，第二次为40-60分钟。
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