CN107468725A - 一种具有降糖功效的中药组合物及其应用和由其制成的注射液 - Google Patents
一种具有降糖功效的中药组合物及其应用和由其制成的注射液 Download PDFInfo
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- CN107468725A CN107468725A CN201710701144.3A CN201710701144A CN107468725A CN 107468725 A CN107468725 A CN 107468725A CN 201710701144 A CN201710701144 A CN 201710701144A CN 107468725 A CN107468725 A CN 107468725A
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- Prior art keywords
- ginkgo leaf
- ginkalide
- sequoyitol
- alcohol
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Classifications
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Abstract
本发明提供的中药组合物,包括特定重量份的松醇、红杉醇、总黄酮醇苷、银杏内酯A、B、C将不具有降血糖作用的总黄酮醇苷、银杏内酯A、B、C与松醇和红杉醇相配合,提高了松醇和红杉醇的降血糖的作用,使得本申请的组合物具有显著的降血糖作用。
Description
技术领域
本发明涉及中药组合物领域,具体涉及一种具有降糖功效的中药组合物,及该组合物的制备方法和应用。
背景技术
人体血液中的糖分称为血糖,主要来自于人体摄入的谷物、蔬果等,上述食物经过消化***转化为单糖(如葡萄糖等)进入血液,运送到全身细胞,作为能量的来源。如果一时消耗不了,则转化为糖原储存在肝脏和肌肉中,肝脏可储糖70~120克,约占肝重的6~10%。细胞所能储存的肝糖是有限的,如果摄入的糖份过多,多余的糖即转变为脂肪。正常人在清晨空腹血糖浓度为80~120毫克%,空腹血糖浓度超过130毫克%称为高血糖,如果血糖浓度超过160~180毫克%,就有一部分葡萄糖随尿排出,这就是糖尿。
过快的城市生活节奏,使人们情绪或精神上的压力过重,情绪的起伏波动太大,会使人身体中的某些器官功能不能正常的发挥,造成体内环境紊乱,使血糖升高。加之生活条件的提高,摄食过多甜食或含糖饮料,使人体中的糖分含量明显高于正常标准,同时还会形成血中脂肪增加,导致血糖高。此外,长期饮酒打乱和干扰了正常的饮食,从而抑制糖异生作用,降低胰岛素等降血糖的成分作用,也会造成血糖升高。上述种种原因使得高血糖呈现向低龄化发展的趋势,患者群体日益增大且增速惊人,高血糖、高血压和高血脂症可以引起糖尿病,并容易诱发如动脉粥样硬化、冠心病等其他诸多并发症,逐渐成为了危害人类健康最严重的隐患。据统计,在国内十大死亡原因中,与“三高症”相关的死亡人数占总死亡人数的27%。
红杉醇(Sequoyitol,CAS:523-92-2)别名西曲依醇,其化学名为5-O-methyl-myoinositol(或5-氧-甲基-内消旋肌醇),分子式C7H14O6,分子量194.18,化学结构式如下:
红杉醇最初由红豆杉中提取而得,由于红豆杉生长较慢,用来制药并不符合经济效率,因此有许多人试着从其他植物中取得红杉醇,现研究发现其还存在于其它裸子植物(例如,银杏)、豆科三叶草属、马兜铃科等植物中。红杉醇是肌醇的甲基衍生物,早期研究表明红杉醇能显著降低糖尿病模型高血糖、抑制肝糖原分解和葡萄糖吸收、降低血脂、改善自由基代谢和保护胰岛β细胞。
松醇(D-pinitol CAS号:10284-63-6),分子式C7H14O6,分子量194.18,化学结构式如下:
D-松醇为白色颗粒状的结晶,易溶解于水,无臭味,味微甜,难溶于甲醇、乙醇,不溶于氯仿、***、丙酮等有机溶剂,目前对于D-松醇的制备,主要采用化学合成和从天然资源中提取两种方法。其在自己界中具有广泛的植物来源,近年来研究发现,其具有多种生理活性,如胰岛素增敏作用、降血糖、抗肿瘤、免疫调节、抗炎抗水肿等。
虽然红杉醇和松醇均具有降血糖的功效,但单一成分的作用并不显著,且两者混合形成的组合物的降血糖作用也没有明显的提高,而其能够与何种原料药复配以提高其降血糖的功效,由于中药组合物配伍不同其最终药效并不相同,即使相同功效的原料相互配合,也不能完全保证不产生拮抗作用而使降糖作用减弱或产生其它严重的副作用,从而使以松醇和红杉醇为原料药的具有显著降血糖作用的组合物的筛选变得异常困难。
发明内容
因此,本发明的目的在于提供一种包含红杉醇和松醇的具有降糖作用的中药组合物,旨在对红杉醇、和松醇进行更加深入的研究,扩大其应用范围,进一步的,本申请还提供了包含该中药组合物的注射液及其制备方法。
为此,本申请采取的技术方案为,
一种具有降血糖功效的中药组合物,包括如下重量份的组分,松醇16-24份、红杉醇2-4份、总黄酮醇苷7-15份、银杏内酯A 0.7-2份、银杏内酯B 0.3-1份、银杏内酯C 0.4-1份。
上述具有降血糖功效的中药组合物中,所述松醇或红杉醇由银杏叶中提取制得。
上述具有降血糖功效的中药组合物中,所述总黄酮醇苷、银杏内酯A、银杏内酯B和银杏内酯C由银杏叶中提取制得。
一种包括上述任一所述的组合物的制剂,所述组合物加入常规辅料,按照常规工艺,制成临床上可接受的片剂、胶囊剂、散剂、合剂、丸剂、颗粒剂、口服液、糖浆剂、膏剂、冲剂、酒剂、注射剂、饮料、饼干、糖果、糕点食品或方便食品。
上述任一所述的组合物或所述的组合物的制剂在制备具有降血糖作用的药品中的应用。
一种制备包含上述任一所述组合物的注射液的方法,包括将红杉醇、黄酮醇苷、银杏内酯A、银杏内酯B、银杏内酯C与水、辅料混合制成无菌溶液,其中所述红杉醇在所述无菌溶液中的含量为0.1-3mg/ml。
一种制备包含上述任一所述组合物的注射剂的方法,包括,
(1)银杏叶粉碎后,加85-90%乙醇回流提取3或4次,每次回流提取时间1-1.5小时,加入的乙醇量为银杏叶重量的6-9倍,过滤将滤液浓缩至银杏叶重量的0.2倍,冷藏48小时;
(2)刮去浮油,取下层液;
(3)加注射用水至银杏叶重量的0.5倍,冷藏48小时,过滤,滤液减压浓缩至银杏叶重量的0.2倍,放至室温,加90%-95%乙醇,使含醇量至80%,将醇沉后的溶液依次进行冷藏、过滤和浓缩,重复进行2次;
(4)浓缩后的滤液加注射用水至银杏叶重量的0.2倍,先后通过阳离子树脂及阴离子树脂进行吸附处理,其中阳离子树脂用量为银杏叶的2.5-3.5倍量,阴离子树脂用量为银杏叶的0.8-1.2倍量;
(5)吸附处理后的药液加入辅料及水,制成无菌溶液,所述无菌溶液中红杉醇的含量为0.1-3mg/ml。
上述制备注射剂的方法中,所述阳离子树脂用量为银杏叶的3倍量,所述阴离子树脂用量为银杏叶的1倍量。
上述制备注射剂的方法中,所述无菌溶液的pH值为4.0-7.0。
一种上述任一所述方法制备形成的注射液。
本发明技术方案,具有如下优点:
1、本发明提供的中药组合物,包括特定重量份的松醇、红杉醇、总黄酮醇苷、银杏内酯A、B、C将不具有降血糖作用的总黄酮醇苷、银杏内酯A、B、C与松醇和红杉醇相配合,提高了松醇和红杉醇的降血糖的作用,使得本申请的组合物具有显著的降血糖作用。
2、本发明采用特定的方法从银杏叶中提取得到含有红杉醇、银杏内酯A、银杏内酯B、银杏内酯C和总黄酮醇苷的药液,并最终制得红杉醇的含量为0.1-3mg/L的无菌溶液,从而使其具有降血糖的功效,扩大了银杏叶的使用范围,提高了其药用价值。
具体实施方式
本申请中使用的松醇、红杉醇、银杏内酯A、银杏内酯B、银杏内酯C和总黄酮醇苷可以是市售的,也可以是按现有工艺从植物中提取得到的,为便于说明,本发明以下实施例中,松醇、红杉醇、银杏内酯A、银杏内酯B、银杏内酯C和总黄酮醇苷均为市售品。
实施例1
本实施例具有降血糖作用的组合物的原料组成为:松醇为16g、红杉醇为4g、总黄酮醇苷为7g、银杏内酯A为2g、银杏内酯B为0.3g和银杏内酯C为1g。
将上述红杉醇、黄酮醇苷、银杏内酯A、银杏内酯B、银杏内酯C与水、辅料混合制成pH值为7.0的无菌溶液,其中所述红杉醇在所述无菌溶液中的含量为0.1mg/ml。
实施例2
本实施例具有降血糖作用的组合物的原料组成为:松醇为24g、红杉醇为2g、总黄酮醇苷为15g、银杏内酯A为0.7g、银杏内酯B为1g和银杏内酯C为0.4g。
将上述红杉醇、黄酮醇苷、银杏内酯A、银杏内酯B、银杏内酯C与水、辅料混合制成pH值为6.0的无菌溶液,其中所述红杉醇在所述无菌溶液中的含量为1.5mg/ml。
实施例3
本实施例具有降血糖作用的组合物的原料组成为:松醇为18g、红杉醇为3g、总黄酮醇苷为10g、银杏内酯A为0.8g、银杏内酯B为0.4g和银杏内酯C为0.5g。
将上述红杉醇、黄酮醇苷、银杏内酯A、银杏内酯B、银杏内酯C与水、辅料混合制成pH值为7.0的无菌溶液,其中所述红杉醇在所述无菌溶液中的含量为1mg/ml。
实施例4
本实施例具有降血糖作用的组合物的原料组成为:松醇为20g、红杉醇为4g、总黄酮醇苷为12g、银杏内酯A为1.5g、银杏内酯B为0.6g和银杏内酯C为0.8g。
将上述红杉醇、黄酮醇苷、银杏内酯A、银杏内酯B、银杏内酯C与水、辅料混合制成pH值为4.0的无菌溶液,其中所述红杉醇在所述无菌溶液中的含量为2mg/ml。
实施例5
本实施例具有降血糖作用的组合物的原料组成为:松醇为22g、红杉醇为2g、总黄酮醇苷为14g、银杏内酯A为1.2g、银杏内酯B为0.8g和银杏内酯C为0.9g。
将上述红杉醇、黄酮醇苷、银杏内酯A、银杏内酯B、银杏内酯C与水、辅料混合制成pH值为5.0的无菌溶液,其中所述红杉醇在所述无菌溶液中的含量为3mg/ml。
实施例6
(1)银杏叶粉碎后,加85%乙醇回流提取4次,每次回流提取时间1h,加入的乙醇量为银杏叶重量的9倍,过滤将滤液浓缩至银杏叶重量的0.2倍,冷藏48小时;
(2)刮去浮油,取下层液。
(3)加注射用水至银杏叶重量的0.5倍,冷藏48小时,过滤。滤液减压浓缩至银杏叶重量的0.2倍,放至室温,加95%乙醇,使含醇量至80%,将醇沉后的溶液依次进行冷藏、过滤和浓缩,重复进行2次。
(4)浓缩后的滤液加注射用水至银杏叶重量的0.2倍,先后通过阳离子树脂及阴离子树脂进行吸附处理。其中阳树脂用量为银杏叶药材的3倍量,阴离子树脂用量为银杏叶药材的1倍量。
(5)吸附处理后的药液加入辅料及药液质量4倍的水,制成pH值为6.0的无菌水溶液。
采用高效液相色谱进行检测,上述无菌水溶液中,其松醇3.6mg/ml、红杉醇1mg/ml、总黄酮醇苷2mg/ml、银杏内酯A为0.31mg/mL、银杏内酯B为0.11mg/ml、银杏内酯C为0.08mg/ml。
实施例7
(1)银杏叶粉碎后,加90%乙醇回流提取3次,每次回流提取时间1.5小时,加入的乙醇量为银杏叶重量的6倍,过滤将滤液浓缩至银杏叶重量的0.2倍,冷藏48小时;
(2)刮去浮油,取下层液。
(3)加注射用水至银杏叶重量的0.5倍,冷藏48小时,过滤。滤液减压浓缩至银杏叶重量的0.2倍,放至室温,加90%乙醇,使含醇量至80%,将醇沉后的溶液依次进行冷藏、过滤和浓缩,重复进行2次。
(4)浓缩后的滤液加注射用水至银杏叶重量的0.2倍,先后通过阳离子树脂及阴离子树脂进行吸附处理。其中阳树脂用量为银杏叶药材的2.5倍量,阴离子树脂用量为银杏叶药材的0.8倍量。
(5)吸附处理后的药液加入辅料及药液质量4倍的水,制成pH值为4.0的无菌水溶液。
采用高效液相色谱进行检测,上述无菌水溶液中,其松醇4mg/ml、红杉醇0.8mg/ml、黄酮醇苷1.8mg/ml、银杏内酯A为0.26mg/mL、银杏内酯B为0.08mg/ml、银杏内酯C为0.11mg/ml。
实施例8
(1)银杏叶粉碎后,加87%乙醇回流提取3次,每次回流提取时间70min,加入的乙醇量为银杏叶重量的7倍,过滤将滤液浓缩至银杏叶重量的0.2倍,冷藏48小时;
(2)刮去浮油,取下层液。
(3)加注射用水至银杏叶重量的0.5倍,冷藏48小时,过滤。滤液减压浓缩至银杏叶重量的0.2倍,放至室温,加95%乙醇,使含醇量至80%,将醇沉后的溶液依次进行冷藏、过滤和浓缩,重复进行2次。
(4)浓缩后的滤液加注射用水至银杏叶重量的0.2倍,先后通过阳离子树脂及阴离子树脂进行吸附处理。其中阳树脂用量为银杏叶药材的3.5倍量,阴离子树脂用量为银杏叶药材的1.2倍量。
(5)吸附处理后的药液加入辅料及药液质量1倍的水,制成pH值为7.0的无菌水溶液。
采用高效液相色谱进行检测,上述无菌水溶液中,其松醇18mg/ml、红杉醇2mg/ml、总黄酮醇苷9mg/ml、银杏内酯A为0.8mg/mL、银杏内酯B为0.6mg/ml、银杏内酯C为0.6mg/ml。
实验例本发明中组合物对血糖的影响
受试样品:按照实施例3和实施例6的方法制得。
实验动物:普通级Wistar大白鼠120只,雄性,体重(200±10)g。由河北省实验动物中心提供,许可证号:SCXK(冀)2008-1-003。
主要试剂与仪器
四氧嘧啶(sigma公司),盐酸二甲双胍片(中美上海施贵宝制药有限公司),葡萄糖测定试剂盒(南京森贝伽生物科技有限公司),高速台式离心机(北京时代北利离心机有限公司),0.9%生理盐水(石药银湖制药有限公司),电子天平(哈尔滨众汇衡器有限公司)。
实验方法
糖尿病大鼠模型的建立
取健康大鼠120只,适应性喂养1-2天待平稳后,随机取10只为一组正常对照组,其余110只大鼠禁食18h后,以四氧嘧啶生理盐水溶液180mg/kg(现配现用)腹腔注射造成糖尿病模型。注射4h后灌胃50%葡萄糖溶液4ml/只。6天后禁食4h尾静脉采血,立新分离血清,测定葡萄糖含量,血糖值为15-35mmol/L定为糖尿病模型成功动物。
组合物对四氧嘧啶致糖尿病大鼠空腹血糖试验
随机抽取60只大鼠分成六组,每组10只。二组模型对照组,三组盐酸二甲双胍片组,四组组合物(ZHW)组。一组和二组灌胃双蒸水,三组灌胃盐酸二甲双胍片的水溶液(10mg/ml),四组灌胃实施例3制备的无菌水溶液,五组灌胃实施例6制备的无菌水溶液,六组灌胃红杉醇与松醇混合物的无菌水溶液(红杉醇1mg/ml、松醇6mg/ml),七组灌胃银杏内酯A、B、C和总黄酮醇苷混合物的无菌水溶液(银杏内酯A、B、C分别为0.31、0.11和0.08mg/ml、总黄酮醇苷2mg/ml)。
每组灌胃等剂量的受试品2.5ml。给药后禁食0h、2h和4h后尾静脉采血,离心分离血清,测定葡萄糖含量。
实验结果
表4组合物对血糖的影响
注:算数平均数,s标准偏差,**P<0.01与y一组比较,**P<0.01给药后与二组比较。
由表4可知,二至七组大鼠空腹血糖含量与一组比较极显著升高(P<0.01)。与二组比较,给药2h时三组、四组和五组血糖含量有一定的下降,给药4h时三组、四组和五组血糖含量显著降低(P<0.01)。进一步的七组效果与二组基本没区别,表明银杏内酯A、B、C和总黄酮醇苷混合物不具有降糖效果,六组血糖含量有一定的下降,但效果与三组、四组和五组差异明显,表明表明松醇和红杉醇混合物虽可以降血糖,但效果并不显著。
显然,上述实施例仅仅是为清楚地说明所作的举例,而并非对实施方式的限定。对于所属领域的普通技术人员来说,在上述说明的基础上还可以做出其它不同形式的变化或变动。这里无需也无法对所有的实施方式予以穷举。而由此所引伸出的显而易见的变化或变动仍处于本发明创造的保护范围之中。
Claims (10)
1.一种具有降血糖功效的中药组合物,其特征在于,包括如下重量份的组分,
松醇 16-24份
红杉醇 2-4份;
总黄酮醇苷 7-15份;
银杏内酯A 0.7-2份;
银杏内酯B 0.3-1份;
银杏内酯C 0.4-1份。
2.根据权利要求1所述的具有降血糖功效的中药组合物,其特征在于,所述松醇或红杉醇由银杏叶中提取制得。
3.根据权利要求1或2所述的具有降血糖功效的中药组合物,其特征在于,所述总黄酮醇苷、银杏内酯A、银杏内酯B和银杏内酯C由银杏叶中提取制得。
4.一种包括权利要求1-3任一项所述的组合物的制剂,其特征在于,
所述组合物加入常规辅料,按照常规工艺,制成临床上可接受的片剂、胶囊剂、散剂、合剂、丸剂、颗粒剂、口服液、糖浆剂、膏剂、冲剂、酒剂、注射剂、饮料、饼干、糖果、糕点食品或方便食品。
5.权利要求1-3任一项所述的组合物或权利要求4所述的组合物的制剂在制备具有降血糖作用的药品中的应用。
6.一种制备包含权利要求1-3任一所述组合物的注射液的方法,其特征在于,包括,将红杉醇、黄酮醇苷、银杏内酯A、银杏内酯B、银杏内酯C与水、辅料混合制成无菌溶液,其中所述红杉醇在所述无菌溶液中的含量为0.1-3mg/ml。
7.一种制备包含权利要求1-3任一所述组合物的注射剂的方法,其特征在于,包括,
(1)银杏叶粉碎后,加85-90%乙醇回流提取3或4次,每次回流提取时间1-1.5小时,加入的乙醇量为银杏叶重量的6-9倍,过滤将滤液浓缩至银杏叶重量的0.2倍,冷藏48小时;
(2)刮去浮油,取下层液;
(3)加注射用水至银杏叶重量的0.5倍,冷藏48小时,过滤,滤液减压浓缩至银杏叶重量的0.2倍,放至室温,加90%-95%乙醇,使含醇量至80%,将醇沉后的溶液依次进行冷藏、过滤和浓缩,重复进行2次;
(4)浓缩后的滤液加注射用水至银杏叶重量的0.2倍,先后通过阳离子树脂及阴离子树脂进行吸附处理,其中阳离子树脂用量为银杏叶的2.5-3.5倍量,阴离子树脂用量为银杏叶的0.8-1.2倍量;
(5)吸附处理后的药液加入辅料及水,制成无菌溶液,所述无菌溶液中红杉醇的含量为0.1-3mg/ml。
8.根据权利要求7所述的制备注射剂的方法,其特征在于,所述阳离子树脂用量为银杏叶的3倍量,所述阴离子树脂用量为银杏叶的1倍量。
9.根据权利要求6-8任一所述的制备注射液的方法,其特征在于,所述无菌溶液的pH值为4.0-7.0。
10.一种由权利要求6-9任一所述方法制备形成的注射液。
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