CN105456704A - 一种用于治疗糖尿病的中药组合物 - Google Patents
一种用于治疗糖尿病的中药组合物 Download PDFInfo
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- CN105456704A CN105456704A CN201510942031.3A CN201510942031A CN105456704A CN 105456704 A CN105456704 A CN 105456704A CN 201510942031 A CN201510942031 A CN 201510942031A CN 105456704 A CN105456704 A CN 105456704A
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- Medicines Containing Plant Substances (AREA)
Abstract
本发明属于医药技术领域，具体涉及一种用于治疗糖尿病的中药组合物及其制备方法。一种用于治疗糖尿病的中药组合物，由如下重量的原料药组成：藕节3-7份、决明子1-5份、桑叶4-8份、地骨皮1-5份、菊花1-5份、蒲黄4-8份、白玉竹1-5份、杜仲1-5份、瓜蒌1-5份、黄芪1-5份、山茱萸1-5份、五倍子1-5份、细毛山药1-5份、辣木根3-7份。本发明利用中药各个组分之间的配伍，使得能够有效激活惰性胰岛素，降低血糖，使得惰性胰岛素恢复活性，正常参与糖代谢，提高了人体自身对血糖的利用和转化能力，达到平稳降低血糖；可保护胰岛细胞，抑制胰岛素衰竭，在可参与糖代谢的胰岛素增多的情况下，胰岛不必像以前那样分泌过多的胰岛素，胰脏负担减轻，获得必要的休整，进而起到保护胰岛，抑制胰岛衰竭的作用。
Description
技术领域
本发明属于医药技术领域，具体涉及一种用于治疗糖尿病的中药组合物。
背景技术
糖尿病是一组由于胰岛素分泌缺陷和/或胰岛素作用障碍所致的以高血糖为特征的代谢性疾病。持续高血糖与长期代谢紊乱等可导致全身组织器官，特别是眼、肾、心血管及神经系统的损害及其功能障碍和衰竭。严重者可引起失水，电解质紊乱和酸碱平衡失调等急性并发症酮症酸中毒和高渗昏迷。
临床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。严重患者可导致感染，心脏病变，脑血管病变，肾功能衰竭，双目失明，下肢坏疽等而成为致死致残。目前全世界对于糖尿病尚没有根治的方法，对于如此复杂的疾病，常用的西药治疗糖尿病的药物主要包括口服降糖类药物和胰岛素，口服降糖类药物包括双胍类，磺脲类，膳食葡萄糖调节剂等，上述药物对糖尿病的治疗均有一定的疗效，但是在临床中其效果不是很明显，有些药物还有毒副作用，疗效不能持久，容易复发，且大部分的西药价格昂贵，不适合长期服用；在中医学上，把糖尿病归属消渴病的范畴，中医古籍对其病因，诊断和治疗早有记载，并提出许多行之有效的消渴方，应用于临床。虽然有不少的中药验方，但是迄今为止，还没有那种药物能够凭一己之力将糖尿患者的各项参数控制在目标分为之内，可见开发一种具有全新作用的新型降糖药物成为亟待解决的重要任务。
发明内容
为了解决上述的技术问题，本发明提供了一种用于治疗糖尿病的中药组合物及其制备方法。
本发明是通过下述的技术方案来实现的：
一种用于治疗糖尿病的中药组合物，由如下重量的原料药组成：藕节3-7份、决明子1-5份、桑叶4-8份、地骨皮1-5份、菊花1-5份、蒲黄4-8份、白玉竹1-5份、杜仲1-5份、瓜蒌1-5份、黄芪1-5份、山茱萸1-5份、五倍子1-5份、细毛山药1-5份辣木根3-7份。
用于治疗糖尿病的中药组合物：由如下重量的原料药组成：藕节4-6份、决明子2-4份、桑叶5-7份、地骨皮2-4份、菊花2-4份、蒲黄4-8份、白玉竹2-4份、杜仲2-4份、瓜蒌2-4份、黄芪2-4份、山茱萸2-4份、五倍子2-4份、细毛山药2-4份辣木根4-6份。
用于治疗糖尿病的中药组合物，由如下重量的原料药组成：藕节5份、决明子3份、桑叶6份、地骨皮3份、菊花3份、蒲黄6份、白玉竹3份、杜仲3份、瓜蒌3份、黄芪3份、山茱萸3份、五倍子3份、细毛山药3份。
用于治疗糖尿病的中药组合物，所述的中药组合物为颗粒剂、胶囊、片剂或丸剂。
用于治疗糖尿病的中药组合物的制备方法，其特征在于：具体步骤为：
（1）将藕节磨成细粉，过筛，得藕节细粉备用；
（2）将桑叶，菊花，蒲黄，白玉竹，瓜蒌蒸馏1小时提取挥发油，将蒸馏后的水溶液用容器收集；
（3）将将决明子，地骨皮，杜仲，黄芪，山茱萸，五倍子，细毛山药，辣木根与上述蒸馏提取挥发油后的药渣加水煎煮提取三次，第一次加入除藕节粉之外的其余组分总质量的6.5倍的水煎煮2.5小时，第二次加入除藕节粉之外的其余组分总质量的5,5倍水煎煮1.5小时，第三次加除藕节粉之外的其余组分总质量的2.5倍水煎煮提取1小时，将3次煎煮提取的煎液合并；
（4）向合并后的煎液中加入上述蒸馏后的水溶液，过滤，滤液浓缩至在60℃时相对密度为1.12-1.16，放冷至室温，加入乙醇至含醇量达到65%，搅匀，在5-7℃静置24小时，过滤；滤液浓缩至在60℃相对密度1.13-1.15，并在浓缩过程中回收乙醇，再加入与浓缩后的滤液等体积的水稀释，搅匀，在5-7℃静置24小时，过滤；搅拌滤液，并加入步骤（1）中的全部藕节细粉；调节pH值至4.5-6灭菌，即得。
用于治疗糖尿病的中药组合物在制备治疗糖尿病的药物中的应用。
本发明所述的细毛山药为山东淄博桓台新城镇所产。新城细毛山药是山东省桓台县新城镇著名的地方特产，栽培历史悠久，早在明清年间就享有盛誉。因其特殊的水土生长条件，成为山药家族中的上乘之品，并成为宫廷贡品。新城细毛山药具有健脾、补肺、固肾、益精等种功效，集菜品、药品和补品三者于一体。新城细毛山药的主要特点是:茎蔓生，叶绿色、卵圆形，尖端三角锐尖。叶腋间着生气生块茎，俗称"零余子"，深褐色，椭圆形。花淡黄色，雌雄异株。地下块茎棍棒状，长80-100厘米，横径3-5厘米，重400-600克，外皮薄，黄褐色，有红褐色班痣，毛根细，块茎肉质细、面，味香甜，适口性好。经化验，块茎含粗蛋白14.48%，粗脂肪3.78%、淀粉43.7%、全糖1.14%。桓台县地处北纬36°-37°之间，即处在北纬60°以南，适宜短日照作物生长。从4月中旬到8月下旬，桓台县历年的日照时数为1080.3小时，占可照时数的58%，能有效地满足山药的生长需求。新城细毛山药栽培历史悠久，据史书记载，春秋齐桓公称霸时期就有种植，延续到明清年间发展迅猛，成为朝廷贡品，在省内外享有很高的盛誉。《桓台志略》载:"城附近各村多种之，味甘而粉，肥者长大如臂，盖其土壤肥沃深厚与山药最宜，故品质亦佳，不亚怀庆所产，深秋各处贩者络绎不绝"。
本发明的有益效果：本发明利用中药各个组分之间的配伍，使得能够有效激活惰性胰岛素，降低血糖，使得惰性胰岛素恢复活性，正常参与糖代谢，提高了人体自身对血糖的利用和转化能力，达到平稳降低血糖；可保护胰岛细胞，抑制胰岛素衰竭，在可参与糖代谢的胰岛素增多的情况下，胰岛不必像以前那样分泌过多的胰岛素，胰脏负担减轻，获得必要的休整，进而起到保护胰岛，抑制胰岛衰竭的作用。
藕节：凉，甘，生品清热生津，凉血止血;熟用补益脾胃，益血生肌；决明子：清热明目，润肠通便。用于目赤涩痛，羞明多泪，头痛眩晕，目暗不明，大便秘结。归肝、肾、大肠经。有减肥之功效。治风热赤眼，青盲，雀目，高血压，肝炎，肝硬化腹水，习惯性便秘；桑叶：疏散风热、清肺润燥、平抑肝阳、清肝明目、凉血止血；地骨皮：地骨皮，性味:性寒，味甘，功能主治:凉血除蒸，清肺降火，用于阴虚潮热、骨蒸盗汗、肺热咳嗽、咯血、衄血。内热消渴；菊花：功效作用方面，性甘、微寒，具有散风热、平肝明目、消咳止痛的功效；蒲黄：味甘、微辛；性平，入肝；心；脾经；功效：止血；祛瘀；利尿；杜仲：补肝肾，强筋骨，安胎。治腰脊酸疼，足膝痿弱，小便余沥，阴下湿痒，胎漏欲堕，胎动不安，高血压；瓜蒌：性味归经：气微，味甘、微苦涩；功能主治：润肺化痰，滑肠通便。用于咳燥痰粘，肠燥便秘；黄芪：味甘性微温。归肺、脾、肝、肾经；补齐固表，托疮生肌。主治体虚自汗，久泻，脱肛，子宫脱垂，慢性肾炎，体虚浮肿，慢性溃疡，疮口久不愈合；五倍子性味归经：味酸，涩，性寒。归肺、大肠、肾经，功效：敛肺；止汗；涩肠；固精；止血；解毒；山茱萸：功用补益肝肾，收敛固涩固精缩尿止带止崩止汗此外还有生津止渴；用于，腰膝酸痛头晕耳鸣，健忘遗精滑精，遗尿尿频，崩漏带下月经不调，大汗虚脱，内热消渴。新城细毛山药：补肾益气，健脾养胃；辣木根：辣木根在降低血脂、血压，血糖减肥瘦身，调节肠胃，护肝戒酒，增强人体免疫力。
具体实施方式
下面结合具体实施例对本发明作更进一步的说明，以便本领域的技术人员更了解本发明，但并不因此限制本发明。
实施例1
一种用于治疗糖尿病的中药组合物：由如下重量的原料药组成：藕节3份、决明子1份、桑叶4份、地骨皮1份、菊花1份、蒲黄4份、白玉竹1份、杜仲1份、瓜蒌1份、黄芪1份、山茱萸1份、五倍子1份、细毛山药1份辣木根3份。
5.如权利要求1-3所述的用于治疗糖尿病的中药组合物的制备方法，其特征在于：具体步骤为：
（1）按上述重量份备料：将藕节磨成细粉，过筛，得藕节细粉备用；
（2）将桑叶，菊花，蒲黄，白玉竹，瓜蒌蒸馏1小时提取挥发油，将蒸馏后的水溶液用容器收集；
（3）将将决明子，地骨皮，杜仲，黄芪，山茱萸，五倍子，细毛山药，辣木根与上述蒸馏提取挥发油后的药渣加水煎煮提取三次，第一次加入除藕节粉之外的其余组分总质量的6.5倍的水煎煮2.5小时，第二次加入除藕节粉之外的其余组分总质量的5,5倍水煎煮1.5小时，第三次加除藕节粉之外的其余组分总质量的2.5倍水煎煮提取1小时，将3次煎煮提取的煎液合并；
（4）向合并后的煎液中加入上述蒸馏后的水溶液，过滤，滤液浓缩至在60℃时相对密度为1.12-1.16，放冷至室温，加入乙醇至含醇量达到65%，搅匀，在5-7℃静置24小时，过滤；滤液浓缩至在60℃相对密度1.13-1.15，并在浓缩过程中回收乙醇，再加入与浓缩后的滤液等体积的水稀释，搅匀，在5-7℃静置24小时，过滤；搅拌滤液，并加入步骤（1）中的全部藕节细粉；调节pH值至4.5-6灭菌，即得.实施例2
一种用于治疗糖尿病的中药组合物：由如下重量的原料药组成：藕节7份、决明子5份、桑叶8份、地骨皮5份、菊花5份、蒲黄8份、白玉竹5份、杜仲5份、瓜蒌5份、黄芪5份、山茱萸5份、五倍子5份、细毛山药5份辣木根7份。
制备方法同实施例1。
实施例3
所述的用于治疗糖尿病的中药组合物：由如下重量的原料药组成：藕节4份、决明子2份、桑叶5份、地骨皮2份、菊花2份、蒲黄4份、白玉竹2份、杜仲2份、瓜蒌2份、黄芪2份、山茱萸2份、五倍子2份、细毛山药2份辣木根4份。
制备方法同实施例1。
实施例4
用于治疗糖尿病的中药组合物：由如下重量的原料药组成：藕节6份、决明子4份、桑叶7份、地骨皮4份、菊花4份、蒲黄8份、白玉竹4份、杜仲4份、瓜蒌4份、黄芪4份、山茱萸4份、五倍子4份、细毛山药4份辣木根6份。
制备方法同实施例1。
实施例5
用于治疗糖尿病的中药组合物：由如下重量的原料药组成：藕节5份、决明子3份、桑叶6份、地骨皮3份、菊花3份、蒲黄6份、白玉竹3份、杜仲3份、瓜蒌3份、黄芪3份、山茱萸3份、五倍子3份、细毛山药3份。
制备方法同实施例1。
根据《药物临床试验质量管理规范》和《中药新药临床研究指导原则》对本发明的中药进行了治疗糖尿病的临床研究。参照《中药新药临床研究指导原则》，中药新药治疗糖尿病临床研究指导原则及疗效判定标准。临床痊愈：中医临床症状体征消失或基本消失，症候积分减少大于≥90%；显效：中医临床症状体征明显改善，症候积分减少大于≥70%；空腹血糖和餐后2小时血糖下降至正常范围。降超过治疗前40%，糖化血红蛋白下降至6.2%以下，或下降超过治疗前30%。有效：中医临床症状体征均有好转，症候积分减少大于≥30%；空腹血糖和餐后2小时血糖下降超过治疗前20%，但未达到显效标准，糖化血红蛋白下降超过治疗前10%，但未达到显效标准。无效：空腹血糖和餐后2小时血糖，糖化血红蛋白无下降，或下降未达到有效标准。
临床疗效：本发明的用于糖尿病的中药组合物，治疗糖尿病患者100例，2个疗程14天治愈显效80例，有效19例，无效1例，总效率99%。
Claims (6)
1.一种用于治疗糖尿病的中药组合物，其特征在于：由如下重量的原料药组成：藕节3-7份、决明子1-5份、桑叶4-8份、地骨皮1-5份、菊花1-5份、蒲黄4-8份、白玉竹1-5份、杜仲1-5份、瓜蒌1-5份、黄芪1-5份、山茱萸1-5份、五倍子1-5份、细毛山药1-5份辣木根3-7份。
2.如权利要求1所述的用于治疗糖尿病的中药组合物，其特征在于：由如下重量的原料药组成：藕节4-6份、决明子2-4份、桑叶5-7份、地骨皮2-4份、菊花2-4份、蒲黄4-8份、白玉竹2-4份、杜仲2-4份、瓜蒌2-4份、黄芪2-4份、山茱萸2-4份、五倍子2-4份、细毛山药2-4份辣木根4-6份。
3.如权利要求1所述的用于治疗糖尿病的中药组合物，其特征在于：由如下重量的原料药组成：藕节5份、决明子3份、桑叶6份、地骨皮3份、菊花3份、蒲黄6份、白玉竹3份、杜仲3份、瓜蒌3份、黄芪3份、山茱萸3份、五倍子3份、细毛山药3份。
4.如权利要求1-3任一权利要求所述的用于治疗糖尿病的中药组合物，其特征在于：所述的中药组合物为颗粒剂、胶囊、片剂或丸剂。
5.如权利要求1-3所述的用于治疗糖尿病的中药组合物的制备方法，其特征在于：具体步骤为：
（1）将藕节磨成细粉，过筛，得藕节细粉备用；
（2）将桑叶，菊花，蒲黄，白玉竹，瓜蒌蒸馏1小时提取挥发油，将蒸馏后的水溶液用容器收集；
（3）将将决明子，地骨皮，杜仲，黄芪，山茱萸，五倍子，细毛山药，辣木根与上述蒸馏提取挥发油后的药渣加水煎煮提取三次，第一次加入除藕节粉之外的其余组分总质量的6.5倍的水煎煮2.5小时，第二次加入除藕节粉之外的其余组分总质量的5,5倍水煎煮1.5小时，第三次加除藕节粉之外的其余组分总质量的2.5倍水煎煮提取1小时，将3次煎煮提取的煎液合并；
（4）向合并后的煎液中加入上述蒸馏后的水溶液，过滤，滤液浓缩至在60℃时相对密度为1.12-1.16，放冷至室温，加入乙醇至含醇量达到65%，搅匀，在5-7℃静置24小时，过滤；滤液浓缩至在60℃相对密度1.13-1.15，并在浓缩过程中回收乙醇，再加入与浓缩后的滤液等体积的水稀释，搅匀，在5-7℃静置24小时，过滤；搅拌滤液，并加入步骤（1）中的全部藕节细粉；调节pH值至4.5-6灭菌，即得。
6.权利要求1-3任一权利要求所述的用于治疗糖尿病的中药组合物在制备治疗糖尿病的药物中的应用。
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