CN106421500A - 一种防治2型糖尿病的中药组合物及其制备方法 - Google Patents
一种防治2型糖尿病的中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明涉及中医药制备技术领域,具体地说是一种防治2型糖尿病的中药组合物及其制备方法,由下述原料制成:仙灵脾、仙茅、金樱子、覆盆子、菟丝子、葫芦巴、僵蚕、地龙、黄连、地骨皮、天花粉、肉桂、黄精、玉竹、玉米须、车前草、鬼箭羽、虎杖、赤芍、丹参。本发明同现有技术相比,生产工艺简单、生产成本低、实施性强,易于大规模工业化生产;用于防治2型糖尿病效果显著,副作用小,可长期服用,对于防治2型糖尿病的发生,以及预防由2型糖尿病导致的各种并发症,具有双重作用;并且所述中药组合物服用量小,服用方便,并且能较好的保证药物稳定性和效果。
Description
技术领域
本发明涉及中医药制备技术领域,具体地说是一种防治2型糖尿病的中药组合物及其制备方法。
背景技术
近 30 年来,我国糖尿病患病率显著增加。在中国目前已有 1.32 亿已患者,5 亿前期患者,18 岁以上人群患病率高达 11.6%。在患病人群中,2型糖尿病的发病率为93.7%,是继心血管疾病、肿瘤后第三大非传染性疾病,是严重威胁人类健康的世界性公共卫生问题。尽管近年来,针对2型糖尿病的新药研发成果不断产生,但是仍然无法阻止或改变2型糖尿病发病率逐年增高,随着西药服用周期增加并发症也明显增加。并发症是导致糖尿病患者死亡的主要因素,尤其是心脑血管并发症。
现代中医认为,2型糖尿病是伏病因子作用机体细胞、组织、器官等,导致其对胰岛素所转化能量利用障碍,引发血糖升高,进而引起体内神经、内分泌、免疫系统紊乱,导致胰岛β细胞受损或功能衰退的一组代谢紊乱综合征。
这里有个关键词就是伏病因子,它是指非人体自身成分异常聚集在人体细胞、组织、器官及体液等中的病理状态,是一组复杂的潜在致病因素,是导致人体疾病的最根本疾病状态,其集簇发生可能与生活方式、工作方式及自然环境改变有关。
当非人体自身成分异常聚集在机体重要脏器、组织中,血液中糖被胰岛素所转化的能量就无法正常利用,一方面引发血糖升高;一方面缺能量的供给的脏器、组织就会向中枢神经系统发出信号,激活升血糖相关激素分泌,引发肝糖原、脂肪分解等机体储能释放,增加血糖供应,同时产生更多内生非自身成分,加剧糖利用障碍;血糖二次升高效应引发胰岛素的异常分泌,引发针对胰岛β细胞的免疫反应,损伤胰岛功能,引起胰岛素分泌减少,胰岛素调控血糖异常。
因此,需要设计一种副作用小且可以预防并发症的防治2型糖尿病的中药组合物及其制备方法。
发明内容
本发明的目的是克服现有技术的不足,提供了一种副作用小且可以预防并发症的防治2型糖尿病的中药组合物及其制备方法。
为了达到上述目的,本发明是一种防治2型糖尿病的中药组合物,其特征在于:由下述重量份数的原料制成:仙灵脾8~15份、仙茅8~15份、金樱子8~15份、覆盆子8~15份、菟丝子8~15份、葫芦巴8~15份、僵蚕8~15份、地龙8~15份、黄连10~15份、地骨皮16~20份、天花粉10~15份、肉桂2~5份、黄精8~15份、玉竹8~15份、玉米须8~15份、车前草8~15份、鬼箭羽8~15份、虎杖10~15份、赤芍10~15份、丹参8~15份。
在所述的重量份数的原料中加入辅料,辅料为可溶性淀粉,木糖醇,阿斯巴甜,可糊精,甜叶素,微晶纤维素中的一种或一种以上的混合物。
所述的仙茅、金樱子、覆盆子、菟丝子、葫芦巴、僵蚕、地龙、黄连、地骨皮、天花粉、黄精、玉竹、玉米须、车前草、鬼箭羽、虎杖、赤芍、丹参为水提取物或有机溶剂提取物。
一种防治2型糖尿病的中药组合物的制备方法,其特征在于:按如下步骤制备:步骤1,称取所述重量份数的仙灵脾和肉桂,加水浸泡 0.5 ~ 1 小时后,加热回流 2 ~ 3次,每次1 ~ 3 小时,收集挥发油并加入微晶纤维素混合均匀,形成挥发油赋形粉末,药液趁热过滤后,滤液合并,加水后形成滤液一。
步骤2,称取所述重量份数的仙茅、金樱子、覆盆子、菟丝子、葫芦巴、僵蚕、地龙、黄连、地骨皮、天花粉、黄精、玉竹、玉米须、车前草、鬼箭羽、虎杖、赤芍和丹参,加水煎煮 2次,第一次0.5 ~ 2 小时,第二次 1 ~ 3 小时,滤过,形成滤液二。
步骤3,合并滤液一和滤液二,以有机溶剂过滤浓缩后,回收有机溶剂,在25℃-60℃的温度下浓缩成稠膏,减压干燥并粉碎后,加入挥发油赋形粉末及辅料,混合均匀并制成颗粒后,依次进行干燥、整粒和包装,形成中药组合物制剂。
所述的步骤3中,有机溶剂为乙醇。
所述的步骤3中,以有机溶剂过滤浓缩的条件为浓缩至相对密度为 1.08 ~1.28,加入乙醇使含醇量为 50 ~ 70%。
所述的中药组合物制剂中添加稀释剂、润滑剂、粘合剂、崩解剂、甜味剂、稳定剂、防腐 剂等中的一种或一种以上的混合物。
所述的中药组合物制剂为粉剂、片剂、颗粒剂、胶囊剂、软胶囊剂、喷剂中的一种。
本发明同现有技术相比,生产工艺简单、生产成本低、实施性强,易于大规模工业化生产;用于防治 2 型糖尿病效果显著,副作用小,可长期服用,对于防治 2 型糖尿病的发生,以及预防由 2 型糖尿病导致的各种并发症,具有双重作用;并且所述中药组合物服用量小,服用方便,并且能较好的保证药物稳定性和效果。
具体实施方式
现结合实施例对本发明做进一步描述。
实施例一:
称取仙灵脾1500克、仙茅1500克、金樱子1500克、覆盆子1500克、菟丝子1500克、葫芦巴1500克、僵蚕1500克、地龙1500克、黄连1500克、地骨皮1600克、天花粉1500克、肉桂500克、黄精1500克、玉竹1500克、玉米须1500克、车前草1500克、鬼箭羽1500克、虎杖1500克、赤芍1200克、丹参1500克。取肉桂,仙灵脾 2 味药,加 8 倍水量浸泡 0.5 小时,加热回流 3次,每次1小时,收集挥发油并加入微晶纤维素混合均匀,形成挥发油赋形粉末,药液趁热过滤后,滤液合并,加 8 倍水量,形成滤液一。
另取仙茅、金樱子、覆盆子、菟丝子、葫芦巴、僵蚕、地龙、黄连、地骨皮、天花粉、黄精、玉竹、玉米须、车前草、鬼箭羽、虎杖、赤芍、丹参18味中药,第一次加8倍水量, 煎煮 0.5小时,第二次加12 倍水量,煎煮 2 小时,滤过,形成滤液二。
传统的水煎方法所得水煎液能够提取并保留相当量的挥发油,但是再进一步进行干燥、制粒等工序制成片剂、胶囊等固体制剂,则这些固体制剂中的挥发油保留极少。另外,仙灵脾和肉桂中含有挥发油,由于挥发油稳定性差、易挥发,往往导致有效期内的药物中的挥发油含量下降,影响产品质量,同时也使临床疗效得不到保证。采用环糊精包合技术处理后,挥发油的稳定性有所提高。
合并滤液一和滤液二,在25℃的温度下浓缩至相对密度为 1.18,加入乙醇使含醇量为 60%,放置 24 小时,过滤回收乙醇,在60℃的温度下浓缩至密度为 1.35 的稠膏,减压干燥并粉碎后,加入挥发油赋形粉末及可溶性淀108克,木糖醇18克,阿斯巴甜 10 克,混合均匀并制成颗粒后,依次进行干燥、整粒和包装,形成1000 克中药组合物制剂。
实施例二 :
称取仙灵脾1000克、仙茅1000克、金樱子1000克、覆盆子1000克、菟丝子1000克、葫芦巴1000克、僵蚕1000克、地龙1000克、黄连1000克、地骨皮1600克、天花粉1000克、肉桂400克、黄精1000克、玉竹1000克、玉米须1000克、车前草1000克、鬼箭羽1000克、虎杖1000克、赤芍1000克、丹参1000克。取肉桂,仙灵脾 2 味药,加 10倍水量浸泡 1小时,加热回流 3次,每次1小时,收集挥发油并加入微晶纤维素混合均匀,形成挥发油赋形粉末,药液趁热过滤后,滤液合并,加 8 倍水量,形成滤液一。
另取仙茅、金樱子、覆盆子、菟丝子、葫芦巴、僵蚕、地龙、黄连、地骨皮、天花粉、黄精、玉竹、玉米须、车前草、鬼箭羽、虎杖、赤芍、丹参18味中药,第一次加10倍水量, 煎煮1小时,第二次加8 倍水量,煎煮3 小时,滤过,形成滤液二。
合并滤液一和滤液二,在25℃的温度下浓缩至相对密度为 1.10,加入乙醇使含醇量为50%,放置 24 小时,过滤回收乙醇,在50℃的温度下浓缩至密度为 1.30 的稠膏,减压干燥并粉碎后,加入挥发油赋形粉末及可糊精 95 克,木糖醇 15 克,甜叶素 12 克,混合均匀并制成颗粒后,依次进行干燥、整粒和包装,形成1000 克中药组合物制剂。
典型病例:
选70 例患者为抗糖尿病药物组,对抗糖尿病药物组采用本发明的中药组合物制剂治疗 12 周,其中男性 42 例,女性 28 例,年龄 38--81 岁。另选50 例患者为口服降糖药组,口服降糖药组的性别、年龄、病情均与抗糖尿病药物组匹配。
口服降糖药组从小剂量开始,每日 1.25--3.75mg,根据每周血糖变化递增剂量。抗糖尿病药物组每日三次,每次一袋,一袋 25g,餐前 30 分钟服用。抗糖尿病药物用至 75~ 150g,口服降糖药用至1O ~ 15mg。12 周后复查各项指标。统计学处理结果以 X±S 表示,治疗前后比较及组闻采用 t 检验,以 P<0.05 为差异有显著性意义。
分组 | 例数(n) | 年龄(岁) | 性别(男/女) | 体重指数(Kg/L) | 空腹血糖(mmol/l) | 餐后血糖(mmol/l) |
抗糖尿病药物 | 70 | 63.1±1.05 | 42/28 | 25.4±4.8 | 9.72±3.96 | 15.7±5.98 |
口服降糖药 | 50 | 62.7±1.23 | 30/20 | 25.6±5.1 | 9.67±4.03 | 15.9±5.24 |
上表为抗糖尿病药物组和口服降糖药组一般情况比较,两组的年龄、体重指数、血糖等指标差异均不显著 (P>0.05)。抗糖尿病药物组治疗后,体重指数无明显变化,而口服降糖药组的体重指数较治疗前升高,但差异不显著。
上表为治疗前后血脂、C 反应蛋白的变化比较,C 反应蛋白的测定应用免疫比浊法。经治疗后,抗糖尿病药物组的甘油三脂、低密度脂蛋白胆固醇明显下降(P〈0.05),高密度脂蛋白胆固醇有所升高,但无统计学意义(P〉0.05)。口服降糖药组的甘油三脂、低密度脂蛋白胆固醇及高密度脂蛋白胆固醇均无明显变化。C 反应蛋白水平,抗糖尿病药物组较治疗前明显下降(P〈0.05),口服降糖药组治疗后无明显下降(P〉0.05)。
上表为治疗前后血压、肾功能及尿白蛋白排泄率、血液流变学检查变化比较。抗糖尿病药物组治疗后,收缩压、舒张压降低,但无统计学意义(P〉0.05)。口服降糖药组治疗后,收缩压、舒张压无变化。抗糖尿病药物组治疗后,血肌酐、尿白蛋白排泄率、血液流变学检查均有明显下降(P〈0.05)。口服降糖药组治疗后,血肌酐、尿白蛋白排泄率、血液流变学检查无明显变化(P〉0.05)。
上表为治疗前后血液流变学变化比较。抗糖尿病药物组治疗后,全血比粘度(髙切)、全血比粘度(低切)、血浆比粘度、纤维蛋白原(g/L)均有明显下降(P〈0.05)。口服降糖药组治疗后,全血比粘度(髙切)、全血比粘度(低切)、血浆比粘度、纤维蛋白原(g/L)无明显变化(P〉0.05)。
上述实验结果表明,应用本发明中制备方法制备的一种防治2型糖尿病的中药组合物具有副作用小,服用方便,能较好的保证药物稳定性和效果;且对于防治2型糖尿病的发生,以及预防由2型糖尿病导致的各种并发症,具有良好的作用。
Claims (8)
1.一种防治2型糖尿病的中药组合物,其特征在于:由下述重量份数的原料制成:仙灵脾8~15份、仙茅8~15份、金樱子8~15份、覆盆子8~15份、菟丝子8~15份、葫芦巴8~15份、僵蚕8~15份、地龙8~15份、黄连10~15份、地骨皮16~20份、天花粉10~15份、肉桂2~5份、黄精8~15份、玉竹8~15份、玉米须8~15份、车前草8~15份、鬼箭羽8~15份、虎杖10~15份、赤芍10~15份、丹参8~15份。
2.根据权利要求1所述的一种防治2型糖尿病的中药组合物,其特征在于:在所述的重量份数的原料中加入辅料,辅料为可溶性淀粉,木糖醇,阿斯巴甜,可糊精,甜叶素,微晶纤维素中的一种或一种以上的混合物。
3.根据权利要求1所述的一种防治2型糖尿病的中药组合物,其特征在于:所述的仙茅、金樱子、覆盆子、菟丝子、葫芦巴、僵蚕、地龙、黄连、地骨皮、天花粉、黄精、玉竹、玉米须、车前草、鬼箭羽、虎杖、赤芍、丹参为水提取物或有机溶剂提取物。
4.一种如权利要求1所述的防治2型糖尿病的中药组合物的制备方法,其特征在于:按如下步骤制备:步骤1,称取所述重量份数的仙灵脾和肉桂,加水浸泡 0.5 ~ 1 小时后,加热回流 2 ~ 3 次,每次1 ~ 3 小时,收集挥发油并加入微晶纤维素混合均匀,形成挥发油赋形粉末,药液趁热过滤后,滤液合并,加水后形成滤液一; 步骤2,称取所述重量份数的仙茅、金樱子、覆盆子、菟丝子、葫芦巴、僵蚕、地龙、黄连、地骨皮、天花粉、黄精、玉竹、玉米须、车前草、鬼箭羽、虎杖、赤芍和丹参,加水煎煮 2 次,第一次0.5 ~ 2 小时,第二次 1~ 3 小时,滤过,形成滤液二; 步骤3,合并滤液一和滤液二,以有机溶剂过滤浓缩后,回收有机溶剂,在25℃-60℃的温度下浓缩成稠膏,减压干燥并粉碎后,加入挥发油赋形粉末及辅料,混合均匀并制成颗粒后,依次进行干燥、整粒和包装,形成中药组合物制剂。
5.根据权利要求4所述的一种防治2型糖尿病的中药组合物的制备方法,其特征在于:所述的步骤3中,有机溶剂为乙醇。
6.根据权利要求4所述的一种防治2型糖尿病的中药组合物的制备方法,其特征在于:所述的步骤3中,以有机溶剂过滤浓缩的条件为浓缩至相对密度为 1.08 ~ 1.28,加入乙醇使含醇量为 50 ~ 70%。
7.根据权利要求4所述的一种防治2型糖尿病的中药组合物的制备方法,其特征在于:所述的中药组合物制剂中添加稀释剂、润滑剂、粘合剂、崩解剂、甜味剂、稳定剂、防腐 剂等中的一种或一种以上的混合物。
8.根据权利要求4所述的一种防治2型糖尿病的中药组合物的制备方法,其特征在于:所述的中药组合物制剂为粉剂、片剂、颗粒剂、胶囊剂、软胶囊剂、喷剂中的一种。
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