CN106511539A - 脑心通中药组合物在制备降血糖药物中的应用 - Google Patents
脑心通中药组合物在制备降血糖药物中的应用 Download PDFInfo
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Abstract
本发明公开了一种以脑心通胶囊配方为基础的中药组合物在制备降血糖药物中的新应用。所述组合物主要由下列中药材按重量份组成或制成:黄芪60‑72份、赤芍22‑32份、丹参22‑32份、当归22‑32份、川芎22‑32份、桃仁22‑32份、红花10‑16份、制乳香10‑16份、制没药10‑16份、鸡血藤15‑25份、牛膝22‑32份、桂枝15‑25份、桑枝22‑32份、地龙22‑32份、全蝎10‑16份、水蛭22‑32份。该组合物能显著降低血糖水平,为高血糖患者提供了一种毒副作用小、安全有效的新治疗药物。
Description
技术领域
本发明涉及一种以脑心通胶囊配方为基础的中药组合物在制备降血糖药物中的应用。
背景技术
糖尿病是多病因引起的以慢性高血糖为特征的终身性疾病。近年来,我国糖尿病与心血管疾病的发生率均呈上升趋势。持久的高血糖会引起糖脂、蛋白质等代谢紊乱,导致全身微血管、肾脏、肝脏等损害,继发感染和酸中毒等并发症。现阶段糖尿病治疗药物,即临床用降血糖药物,主要有磺脲类药物、双胍类药物、α-葡萄糖苷酶抑制剂、噻唑烷二酮类药物、促胰岛素分泌剂等。这些药物多为西药,虽然能有效控制高血糖,但是其毒副作用大,长期服用会对身体造成其他不良的影响。然而,中医药在治疗此类疾病方面具有作用温和持久,疗效稳定,毒副作用小等优势。
脑心通胶囊是在古方补阳还五汤的基础上加入虫类药发展而来的,是由黄芪、赤芍、丹参、当归、川芎、桃仁、红花、制乳香、制没药、鸡血藤、牛膝、桂枝、桑枝、地龙、全蝎、水蛭等16味药组成的复方中成药制剂,具有益气活血,化瘀通络的功效,主要适应症为气虚血滞、脉络瘀阻证,如中风、胸痹心痛、脑梗塞、冠心病心绞痛等。临床上,脑心通胶囊主要用于各种心脑血管疾病,通过保护血管内皮、抗凝溶栓、稳定和消退动脉粥样硬化、保护神经细胞、防止缺血再灌注损伤等方面起到治疗作用。
本发明人在实验研究过程中意外发现脑心通胶囊具有降血糖的效果,且降糖效果明显优于该复方中具有降糖作用的单方药材。
发明内容
据此,本发明公开了以脑心通胶囊或以其配比为基础的中药组合物在制备降血糖药物方面的新应用。
具体技术方案如下:
本发明的脑心通中药组合物是指以中药制剂脑心通胶囊的配方为基础,按中医用药原理通过组分加减或配比变化所得的配方组合物及其临床上适用的制剂。包括但不限于以下配方的中药组合物。
本发明优选的脑心通中药组合物主要由下列中药材按重量份组成,或制成:
黄芪60-72份、赤芍22-32份、丹参22-32份、当归22-32份、川芎22-32份、桃仁22-32份、红花10-16份、制乳香10-16份、制没药10-16份、鸡血藤15-25份、牛膝22-32份、桂枝15-25份、桑枝22-32份、地龙22-32份、全蝎10-16份、水蛭22-32份。
优选配比为,由下列中药材按重量份组成,或制成:
1、黄芪65-67份、赤芍26-28份、丹参26-28份、当归26-28份、川芎26-28份、桃仁26-28份、红花12-14份、制乳香12-14份、制没药12-14份、鸡血藤19-21份、牛膝26-28份、桂枝19-21份、桑枝26-28份、地龙26-28份、全蝎12-14份、水蛭26-28份。
2、黄芪66份、赤芍27份、丹参27份、当归27份、川芎27份、桃仁27份、红花13份、制乳香13份、制没药13份、鸡血藤20份、牛膝27份、桂枝20份、桑枝27份、地龙27份、全蝎13份、水蛭27份。
3、黄芪60份、赤芍22份、丹参22份、当归22份、川芎22份、桃仁22份、红花10份、制乳香10份、制没药10份、鸡血藤15份、牛膝22份、桂枝15份、桑枝22份、地龙22份、全蝎10份、水蛭22份。
4、黄芪72份、赤芍32份、丹参32份、当归32份、川芎32份、桃仁32份、红花16份、制乳香16份、制没药16份、鸡血藤25份、牛膝32份、桂枝25份、桑枝32份、地龙32份、全蝎16份、水蛭32份。
本发明通过采用灌胃脂肪乳加小剂量链脲佐菌素溶液注射方法制备糖尿病大鼠模型进行实验,发现本发明的中药组合物能够显著降低血糖水平,以本发明所述的中药组合物为有效成分制备而成的药物(比如脑心通胶囊)具有显著的降血糖作用,为高血糖患者提供了一种毒副作用小、安全有效的新的治疗药物。
具体实施方式
以下结合具体实施例对本发明脑心通中药组合物在制备降血糖药物中的应用作进一步详细说明,但本发明并不仅限于所描述的具体实施例。
实施例1
1.试剂的准备
脑心通胶囊:其原料药及其重量份为:黄芪66份、赤芍27份、丹参27份、当归27份、川芎27份、桃仁27份、红花13份、制乳香13份、制没药13份、鸡血藤20份、牛膝27份、桂枝20份、桑枝27份、地龙27份、全蝎13份、水蛭27份。实验前取脑心通胶囊,加生理盐水配制成混悬液。
2.实验方法
SD大鼠,SPF级,雄性,体重180-220g,由广东省医学实验动物中心提供,动物合格证号:SCXK(粤)2013-0002。取SD大鼠随机分成正常对照组(10只)和造模组(50只),实验动物在饲养环境中适应一周后,正常组大鼠每天灌胃蒸馏水,造模组大鼠每天早晚灌胃自制脂肪乳(1ml/100gBW)。连续灌胃2周后,动物禁食不禁水24h,空白对照组10只尾静脉注射生理盐水,造模组大鼠尾静脉注射30mg/kgBW链脲佐菌素溶液(临用前配制)。注射48h后,禁食不禁水12h,每隔3小时眼球后静脉丛取血,按照血糖测定试剂盒操作测定空腹血糖值,连续测定3次,空腹血糖值≥16.7mmol/L的确定为造模成功的糖尿病大鼠,按血糖的高低随机分组,分别为模型对照组、格列齐特(35.5mg/kg)组、脑心通胶囊低剂量(400mg/kg)组、脑心通胶囊中剂量(800mg/kg)组及脑心通胶囊高剂量(1600mg/kg)组,每组10只大鼠,给药持续一周,末次给药后,动物禁食不禁水12h,眼球后静脉丛取血,按照试剂盒的方法测定血糖值,采用SPSS 19.0版本统计软件,分析并比较各组血糖值及给药前后血糖值的变化情况。
3.实验结果:
如表1所示,结果表明:脑心通胶囊低、中、高剂量组大鼠的血糖水平均比模型组大鼠显著降低,差异具有统计学意义(P<0.05),说明脑心通胶囊具有显著的降血糖作用。
表1各组大鼠血糖值测定结果
注:所有数据都以平均值±SD值表示,n=10。*P<0.05,与模型组相比
实施例2
1.试剂的准备
脑心通胶囊:同实施例1
黄芪、桑枝、赤芍、丹参、当归、红花、川芎、牛膝及桂枝等药材均直接粉碎成细粉,分别使用生理盐水溶解制备成混悬液。
2.实验方法
SD大鼠,SPF级,雄性,体重180-220g,由广东省医学实验动物中心提供,动物合格证号:SCXK(粤)2013-0002。取SD大鼠随机分成正常对照组(10只)和造模组(120只),实验动物在饲养环境中适应一周后,正常组大鼠每天灌胃蒸馏水,造模组大鼠每天早晚灌胃自制脂肪乳(1ml/100gBW)。连续灌胃2周后,动物禁食不禁水24h,空白对照组10只尾静脉注射生理盐水,造模组大鼠尾静脉注射30mg/kgBW链脲佐菌素溶液(临用前配制)。注射48h后,禁食不禁水12h,每隔3小时眼球后静脉丛取血,按照血糖测定试剂盒操作测定空腹血糖值,连续测定3次,空腹血糖值≥16.7mmol/L的确定为造模成功的糖尿病大鼠,按血糖的高低随机分组,分别为模型对照组、格列齐特(35.5mg/kg)组、脑心通胶囊(400mg/kg)组、黄芪(400mg/kg)组、桑枝(400mg/kg)组、赤芍(400mg/kg)组、丹参(400mg/kg)组、当归(400mg/kg)组、红花(400mg/kg)组、川芎(400mg/kg)组、牛膝(400mg/kg)组、桂枝(400mg/kg)组,每组10只大鼠,给药持续一周,末次给药后,动物禁食不禁水12h,眼球后静脉丛取血,按照试剂盒的方法测定血糖值,采用SPSS 19.0版本统计软件,分析并比较各组血糖值及给药前后血糖值的变化情况。
3.实验结果:
如表2所示,结果表明:脑心通胶囊组中大鼠的血糖水平均比模型组大鼠显著降低,差异具有统计学意义(P<0.05),黄芪、桑枝、赤芍、丹参、当归、红花、川芎、牛膝及桂枝组大鼠的血糖水平与模型组大鼠相比均没有显著性差异,说明脑心通胶囊降血糖效果明显优于上述单方药材。
表2各组大鼠血糖值测定结果
注:所有数据都以平均值±SD值表示,n=10。*P<0.05,与模型组相比。
实施例3
脑心通胶囊:同实施例1
中药组合物I:其原料药及其重量份为:黄芪60份、赤芍22份、丹参22份、当归22份、川芎22份、桃仁22份、红花10份、制乳香10份、制没药10份、鸡血藤15份、牛膝22份、桂枝15份、桑枝22份、地龙22份、全蝎10份、水蛭22份。实验前取中药组合物I,加生理盐水配制成混悬液。
中药组合物II:其原料药及其重量份为:黄芪72份、赤芍32份、丹参32份、当归32份、川芎32份、桃仁32份、红花16份、制乳香16份、制没药16份、鸡血藤25份、牛膝32份、桂枝25份、桑枝32份、地龙32份、全蝎16份、水蛭32份。实验前取中药组合物II,加生理盐水配制成混悬液。
2.实验方法
SD大鼠,SPF级,雄性,体重180-220g,由广东省医学实验动物中心提供,动物合格证号:SCXK(粤)2013-0002。取SD大鼠随机分成正常对照组(10只)和造模组(50只),实验动物在饲养环境中适应一周后,正常组大鼠每天灌胃蒸馏水,造模组大鼠每天早晚灌胃自制脂肪乳(1ml/100gBW)。连续灌胃2周后,动物禁食不禁水24h,空白对照组10只尾静脉注射生理盐水,造模组大鼠尾静脉注射30mg/kgBW链脲佐菌素溶液(临用前配制)。注射48h后,禁食不禁水12h,每隔3小时眼球后静脉丛取血,按照血糖测定试剂盒操作测定空腹血糖值,连续测定3次,空腹血糖值≥16.7mmol/L的确定为造模成功的糖尿病大鼠,按血糖的高低随机分组,分别为模型对照组、格列齐特(35.5mg/kg)组、脑心通胶囊(400mg/kg)组、中药组合物I(400mg/kg)组、中药组合物II(400mg/kg)组,每组10只大鼠,给药持续一周,末次给药后,动物禁食不禁水12h,眼球后静脉丛取血,按照试剂盒的方法测定血糖值,采用SPSS 19.0版本统计软件,分析并比较各组血糖值及给药前后血糖值的变化情况。
3.实验结果:
如表3所示,结果表明:脑心通胶囊组、中药组合物I组及中药组合物II组大鼠的血糖水平均比模型组大鼠显著降低,差异具有统计学意义(P<0.05)。
表3各组大鼠血糖值测定结果
注:所有数据都以平均值±SD值表示,n=10。*P<0.05,与模型组相比。
实施例4
1.试剂的准备
中药组合物I:同实施例3
黄芪、桑枝、赤芍、丹参、当归、红花、川芎、牛膝及桂枝等药材均直接粉碎成细粉,分别使用生理盐水溶解制备成混悬液。
2.实验方法
SD大鼠,SPF级,雄性,体重180-220g,由广东省医学实验动物中心提供,动物合格证号:SCXK(粤)2013-0002。取SD大鼠随机分成正常对照组(10只)和造模组(120只),实验动物在饲养环境中适应一周后,正常组大鼠每天灌胃蒸馏水,造模组大鼠每天早晚灌胃自制脂肪乳(1ml/100gBW)。连续灌胃2周后,动物禁食不禁水24h,空白对照组10只尾静脉注射生理盐水,造模组大鼠尾静脉注射30mg/kgBW链脲佐菌素溶液(临用前配制)。注射48h后,禁食不禁水12h,每隔3小时眼球后静脉丛取血,按照血糖测定试剂盒操作测定空腹血糖值,连续测定3次,空腹血糖值≥16.7mmol/L的确定为造模成功的糖尿病大鼠,按血糖的高低随机分组,分别为模型对照组、格列齐特(35.5mg/kg)组、中药组合物I(400mg/kg)组、黄芪(400mg/kg)组、桑枝(400mg/kg)组、赤芍(400mg/kg)组、丹参(400mg/kg)组、当归(400mg/kg)组、红花(400mg/kg)组,川芎(400mg/kg)组、牛膝(400mg/kg)组、桂枝(400mg/kg)组,每组10只大鼠,给药持续一周,末次给药后,动物禁食不禁水12h,眼球后静脉丛取血,按照试剂盒的方法测定血糖值,采用SPSS 19.0版本统计软件,分析并比较各组血糖值及给药前后血糖值的变化情况。
3.实验结果:
如表4所示,结果表明:中药组合物I组中大鼠的血糖水平均比模型组大鼠显著降低,差异具有统计学意义(P<0.05),黄芪、桑枝、赤芍、丹参、当归、红花、川芎、牛膝及桂枝组大鼠的血糖水平与模型组大鼠相比均没有显著性差异。
表4各组大鼠血糖值测定结果
注:所有数据都以平均值±SD值表示,n=10。*P<0.05,与模型组相比
实施例5
1.试剂的准备
中药组合物II:同实施例3
黄芪、桑枝、赤芍、丹参、当归、红花、川芎、牛膝及桂枝等药材均直接粉碎成细粉,分别使用生理盐水溶解制备成混悬液。
2.实验方法
SD大鼠,SPF级,雄性,体重180-220g,由广东省医学实验动物中心提供,动物合格证号:SCXK(粤)2013-0002。取SD大鼠随机分成正常对照组(10只)和造模组(120只),实验动物在饲养环境中适应一周后,正常组大鼠每天灌胃蒸馏水,造模组大鼠每天早晚灌胃自制脂肪乳(1ml/100gBW)。连续灌胃2周后,动物禁食不禁水24h,空白对照组10只尾静脉注射生理盐水,造模组大鼠尾静脉注射30mg/kgBW链脲佐菌素溶液(临用前配制)。注射48h后,禁食不禁水12h,每隔3小时眼球后静脉丛取血,按照血糖测定试剂盒操作测定空腹血糖值,连续测定3次,空腹血糖值≥16.7mmol/L的确定为造模成功的糖尿病大鼠,按血糖的高低随机分组,分别为模型对照组、格列齐特(35.5mg/kg)组、中药组合物II(400mg/kg)组、黄芪(400mg/kg)组、桑枝(400mg/kg)组、赤芍(400mg/kg)组、丹参(400mg/kg)组、当归(400mg/kg)组、红花(400mg/kg)组、川芎(400mg/kg)组、牛膝(400mg/kg)组、桂枝(400mg/kg)组,每组10只大鼠,给药持续一周,末次给药后,动物禁食不禁水12h,眼球后静脉丛取血,按照试剂盒的方法测定血糖值,采用SPSS 19.0版本统计软件,分析并比较各组血糖值及给药前后血糖值的变化情况。
3.实验结果:
如表5所示,结果表明:中药组合物II组中大鼠的血糖水平均比模型组大鼠显著降低,差异具有统计学意义(P<0.05),黄芪、桑枝、赤芍、丹参、当归、红花、川芎、牛膝及桂枝组大鼠的血糖水平与模型组大鼠相比均没有显著性差异。
表5各组大鼠血糖值测定结果
注:所有数据都以平均值±SD值表示,n=10。*P<0.05,与模型组相比。
实施例6
1.试剂的准备
脑心通胶囊:同实施例1
补阳还五汤:依据补阳还五汤的原方组成及比例(黄芪120g,当归6g,赤芍4.5g,川芎3g,桃仁3g,红花3g,地龙3g),水煎煮2次,每次30分钟,过滤,合并煎煮液浓缩至生药浓度为3g/ml。
2.实验方法
SD大鼠,SPF级,雄性,体重180-220g,由广东省医学实验动物中心提供,动物合格证号:SCXK(粤)2013-0002。取SD大鼠随机分成正常对照组(10只)和造模组(40只),实验动物在饲养环境中适应一周后,正常组大鼠每天灌胃蒸馏水,造模组大鼠每天早晚灌胃自制脂肪乳(1ml/100gBW)。连续灌胃2周后,动物禁食不禁水24h,空白对照组10只尾静脉注射生理盐水,造模组大鼠尾静脉注射30mg/kgBW链脲佐菌素溶液(临用前配制)。注射48h后,禁食不禁水12h,每隔3小时眼球后静脉丛取血,按照血糖测定试剂盒操作测定空腹血糖值,连续测定3次,空腹血糖值≥16.7mmol/L的确定为造模成功的糖尿病大鼠,按血糖的高低随机分组,分别为模型对照组、格列齐特(35.5mg/kg)组、脑心通胶囊(400mg/kg)组,补阳还五汤(12.84g生药/kg)组每组10只大鼠,给药持续一周,末次给药后,动物禁食不禁水12h,眼球后静脉丛取血,按照试剂盒的方法测定血糖值,采用SPSS 19.0版本统计软件,分析并比较各组血糖值及给药前后血糖值的变化情况。
3.实验结果:
如表6所示,结果表明:脑心通胶囊组中大鼠的血糖水平均比模型组大鼠显著降低,差异具有统计学意义(P<0.05),补阳还五汤组中大鼠的血糖水平与模型组大鼠相比并没有显著性差异,说明脑心通胶囊的降血糖效果明显优于补阳还五汤。
表6各组大鼠血糖值测定结果
注:所有数据都以平均值±SD值表示,n=10。*P<0.05,与模型组相比。
Claims (7)
1.脑心通中药组合物在制备降血糖药物中的应用,所述的脑心通中药组合物主要由下列中药材按重量份组成,或制成:
黄芪60-72份、赤芍22-32份、丹参22-32份、当归22-32份、川芎22-32份、桃仁22-32份、红花10-16份、制乳香10-16份、制没药10-16份、鸡血藤15-25份、牛膝22-32份、桂枝15-25份、桑枝22-32份、地龙22-32份、全蝎10-16份、水蛭22-32份。
2.如权利要求1所述的应用,所述的脑心通中药组合物由下列中药材按重量份组成,或制成:
黄芪65-67份、赤芍26-28份、丹参26-28份、当归26-28份、川芎26-28份、桃仁26-28份、红花12-14份、制乳香12-14份、制没药12-14份、鸡血藤19-21份、牛膝26-28份、桂枝19-21份、桑枝26-28份、地龙26-28份、全蝎12-14份、水蛭26-28份。
3.如权利要求1所述的应用,所述的脑心通中药组合物由下列中药材按重量份组成,或制成:
黄芪66份、赤芍27份、丹参27份、当归27份、川芎27份、桃仁27份、红花13份、制乳香13份、制没药13份、鸡血藤20份、牛膝27份、桂枝20份、桑枝27份、地龙27份、全蝎13份、水蛭27份。
4.如权利要求1所述的应用,所述的脑心通中药组合物由下列中药材按重量份组成,或制成:
黄芪60份、赤芍22份、丹参22份、当归22份、川芎22份、桃仁22份、红花10份、制乳香10份、制没药10份、鸡血藤15份、牛膝22份、桂枝15份、桑枝22份、地龙22份、全蝎10份、水蛭22份。
5.如权利要求1所述的应用,所述的脑心通中药组合物由下列中药材按重量份组成,或制成:
黄芪72份、赤芍32份、丹参32份、当归32份、川芎32份、桃仁32份、红花16份、制乳香16份、制没药16份、鸡血藤25份、牛膝32份、桂枝25份、桑枝32份、地龙32份、全蝎16份、水蛭32份。
6.如权利要求1所述的应用,所述的脑心通中药组合物为:以脑心通胶囊配方为基础,按中医用药原理通过组分加减所得配方。
7.如权利要求1所述的应用,所述的脑心通中药组合物为脑心通胶囊。
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