CN105497559A - 具有降低血糖作用的药物组合物 - Google Patents

具有降低血糖作用的药物组合物 Download PDF

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CN105497559A
CN105497559A CN201510948621.7A CN201510948621A CN105497559A CN 105497559 A CN105497559 A CN 105497559A CN 201510948621 A CN201510948621 A CN 201510948621A CN 105497559 A CN105497559 A CN 105497559A
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刘爱华
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Abstract

本申请提供一种具有降低血糖作用的药物组合物,其中包含中药组分和二甲双胍,中药组分的原料药重量配比如下:苍术8份,泽泻4份,赤芍?9份,葛根5份,杜仲12份,黄芪12份,黄连6份,山药3份,茯苓7份,麦冬5份,三七2份,女贞子2份,石斛5份,大黄2份,甘草5份,知母8份,柴胡4份。中药组分原料药与二甲双胍的重量比例为120:1。

Description

具有降低血糖作用的药物组合物
技术领域
本发明属于医药领域,具体涉及一种具有降低血糖作用的药物组合物。
背景技术
糖尿病是最常见的慢性病之一。随着人们生活水平的提高,人口老龄化以及肥胖发生率的增加,糖尿病的发病率呈逐年上升趋势。糖尿病在中国的发病率达到2%,据统计,中国已确诊的糖尿病患者达4000万,并以每年100万的速度递增。
糖尿病是由遗传和环境因素相互作用而引起的常见病,临床以高血糖为主要标志,常见症状有多饮、多尿、多食以及消瘦等。糖尿病若得不到有效的治疗,可引起身体多系统的损害。引起胰岛素绝对或相对分泌不足以及靶组织细胞对胰岛素敏感性降低,引起蛋白质、脂肪、水和电解质等一系列代谢紊乱综合征,其中一高血糖为主要标志。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。
糖尿病分型糖尿病和型糖尿病。其中I型糖尿病多发生于青少年,其胰岛素分泌缺乏,必须依赖胰岛素治疗维持生命。II型糖尿病多见于30岁以后中、老年人,其胰岛素的分泌量并不低甚至还偏高,病因主要是机体对胰岛素不敏感(即胰岛素抵抗)。
发明内容
本发明的目的是提供一种具有降低血糖作用的药物组合物,包含中药组分和二甲双胍。其中中药组分的原料药重量配比如下:
苍术8份,泽泻4份,赤芍9份,葛根5份,杜仲12份,黄芪12份,黄连6份,山药3份,茯苓7份,麦冬5份,三七2份,女贞子2份,石斛5份,大黄2份,甘草5份,知母8份,柴胡4份。
上述中药组分原料药与二甲双胍的重量比例为120:1。
中药组分的制备方法为取以上原料药,放入容器中,加冷水漫过药面,浸泡15~20分钟,再加水没过药面约6厘米,进行煎煮。未沸前采用武火煎煮,沸后用文火煎煮20~25分钟;第二次煎煮,水沸后文火煎煮15~20分钟。两次煎煮去渣取汁,合并。
在一个实施方式中,本发明药物组合物包含二甲双胍。
在一个实施方式中,本发明药物组合物包含上述中药组分。
在一个实施方式中,本发明药物组合物由上述中药组分和二甲双胍组成。
在一个实施方式中,将上述制备得到的中药组分和二甲双胍按比例同时给患者使用。在另一个实施方式中,将上述制备得到的中药组分和二甲双胍按比例按次序给患者使用,可以先使用中药组分再使用二甲双胍,也可以先使用二甲双胍再使用中药组分。
申请人发现,在一个实施方式中,这种特定配方的中药能够降低血糖。在另一个实施方式中,该中药组分和二甲双胍的组合物能够有效地降低糖尿病患者的血糖。在另一个实施方式中,该中药组分和二甲双胍的组合物对于降低患者的血糖浓度具有协同作用。本申请所述的药物组合物可以安全有效地治疗糖尿病,具有极佳的糖尿病治疗效果。如果改变配方原料或者原料的用量都会严重降低对于糖尿病的治疗效果。
具体实施方式
实施例1:
药物组合物中包含中药组分和二甲双胍,其中中药组分原料药和二甲双胍的重量比例为120:1,中药组分原料药60g,二甲双胍0.5g。
中药组分的原料药为苍术8份,泽泻4份,赤芍9份,葛根5份,杜仲12份,黄芪12份,黄连6份,山药3份,茯苓7份,麦冬5份,三七2份,女贞子2份,石斛5份,大黄2份,甘草5份,知母8份,柴胡4份。
中药组分的制备方法为取以上原料药,放入容器中,加冷水漫过药面,浸泡15~20分钟,再加水没过药面约6厘米,进行煎煮。未沸前采用武火煎煮,沸后用文火煎煮20~25分钟;第二次煎煮,水沸后文火煎煮15~20分钟。两次煎煮去渣取汁,合并。
对比实施例1(即实施例1中的中药组分)
原料为苍术8份,泽泻4份,赤芍9份,葛根5份,杜仲12份,黄芪12份,黄连6份,山药3份,茯苓7份,麦冬5份,三七2份,女贞子2份,石斛5份,大黄2份,甘草5份,知母8份,柴胡4份。中药组分原料药共计60g。
制备方法同实施例1。
对比实施例2(仅中药组分,同实施例1相比,成分相同,用量不同)
原料为苍术3份,泽泻2份,赤芍2份,葛根20份,杜仲7份,黄芪5份,黄连8份,山药6份,茯苓7份,麦冬4份,三七3份,女贞子7份,石斛5份,大黄2份,甘草5份,知母3份,柴胡4份。中药组分原料药共计60g。
制备方法同实施例1。
对比实施例3(仅中药组分,同实施例1相比,成分不同,用量不同)
原料为泽泻12份,人参3份,枸杞子5份,黄芪10份,山药5份,杜仲15份,知母2份,芍药7份,石斛11份。中药组分原料药共计60g。
制备方法同实施例1。
对比实施例4(药物组合物,中药组分同实施例1相比,成分相同,用量不同)
药物组合物中包含中药组分和二甲双胍,其中中药组分原料药和二甲双胍的重量比例为120:1。中药组分原料药60g,二甲双胍0.5g。
中药组分的原料药为苍术3份,泽泻2份,赤芍2份,葛根20份,杜仲7份,黄芪5份,黄连8份,山药6份,茯苓7份,麦冬4份,三七3份,女贞子7份,石斛5份,大黄2份,甘草5份,知母3份,柴胡4份。
制备方法同实施例1。
对比实施例5(药物组合物,中药组分与二甲双胍重量比例与实施例1不同)
药物组合物中包含中药组分和二甲双胍,其中中药组分原料药和二甲双胍的重量比例为100:1。中药组分原料药60g,二甲双胍0.6g。
中药组分的原料药及制备方法同实施例1。
对比实施例6
药物组合物中包含中药组分和二甲双胍,其中中药组分原料药和二甲双胍的重量比例为150:1。中药组分原料药60g,二甲双胍0.4g。
中药组分的原料药及制备方法同实施例1。
注:对比实施例1-6是在实施例1药物组合物的基础上改变原料药的成分、用量或者中药组分与二甲双胍的重量比得到的,其目的是为了证明本申请特定成分和用量的药物组合物对于治疗糖尿病具有预料不到的优异效果。
药理学试验:
实施例2:
为阐明本发明中药对糖尿病的治疗活性,用实施例1、二甲双胍和对比实施例药物进行了下列临床试验以证明其疗效,但其不能对本发明的范围构成任何限制。
1资料与方法
(1)一般资料:全部病例均选自四川省人民医院病房患者,将患者随机分为治疗组1-8,每组各20例,平均年龄为(55.12±5.85)岁,病程平均为(26.13±3.96)个月。经统计,各组在性别、年龄、病程等方面无显著性差异(P>0.05),具有可比性。
(2)病例选择入选标准:符合《内科学》中2型糖尿病诊断标准。排除标准:(1)1型糖尿病患者;(2)伴有严重心、肝、肾功能不全及急性感染患者;(3)哺乳期、妊娠期妇女;(4)年龄不足18岁和>65岁的患者。
(3)治疗方法:组别和药物用量见下表1。疗程均为2个月。
表1
(4)观察指标:治疗前后分别检查FPG(空腹血糖)、P2hPG(餐后2小时血糖)。
(5)疗效判定标准:参照卫生部1993年《中药新药临床研究指导原则》进行疗效判断。显效:治疗后症状基本消失,空腹血糖<7.2mmol/L,餐后2h血糖<8.3mmol/L;有效:空腹血糖<8.0mmol/L,餐后2h血糖<10.0mmol/L;无效:治疗后症状无改善,且空腹血糖及餐后血糖未达到上述标准者。症状疗效评定按四级评分法分级:0(无症状)、1(须经提醒时方能感觉症状存在)、2(有时有症状)、3(症状明显),并进行症状计分和积分。
(6)统计学处理采用SPSS13.0统计软件进行数据处理,计量资料以均数±标准差(x±s)表示,采用t检验,计数资料采用x2检验。
2临床疗效结果见表2。
表2患者临床疗效比较(%)
组别 例数 显效 有效 无效 总有效率
治疗组1 20 19 20 0 100%
治疗组2 20 15 18 2 90%
治疗组3 20 13 15 5 75%
治疗组4 20 10 13 7 65%
治疗组5 20 2 6 14 30%
治疗组6 20 7 16 4 80%
治疗组7 20 9 12 8 60%
治疗组8 20 4 8 12 40%
结论:本发明所述的中药组分具有降低血糖的作用。含有中药组分和二甲双胍的药物组合物不仅具有降低血糖的作用,而且相对于单独使用二甲双胍或者中药组分具有协同降血糖作用。

Claims (4)

1.一种具有降低血糖作用的药物组合物,其中包含二甲双胍。
2.如权利要求1所述的药物组合物,其中包含中药组分和二甲双胍,中药组分的原料药重量配比如下:苍术8份,泽泻4份,赤芍9份,葛根5份,杜仲12份,黄芪12份,黄连6份,山药3份,茯苓7份,麦冬5份,三七2份,女贞子2份,石斛5份,大黄2份,甘草5份,知母8份,柴胡4份。
3.如权利要求2所述的药物组合物,其中中药组分原料药与二甲双胍的重量比例为120:1。
4.如权利要求2或3所述的药物组合物,其中中药组分的制备方法为取以上原料药,放入容器中,加冷水漫过药面,浸泡15~20分钟,再加水没过药面约6厘米,进行煎煮;未沸前采用武火煎煮,沸后用文火煎煮20~25分钟;第二次煎煮,水沸后文火煎煮15~20分钟;两次煎煮去渣取汁,合并。
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