CN100500172C - 用于防止动脉粥样硬化和高脂血症的多草药制剂 - Google Patents
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Abstract
用于防止动脉粥样硬化和高脂血症的多草药制剂,包含穆库尔没药(Commiphora mukul),乳香(Boswellia serrata),Semecarpusanacardium,马钱子(Strychnos nux vomica),三木果(Termenaliaarjuna)和Shankha Bhusma的混合物。
Description
发明领域
本发明涉及用于防止动脉粥样硬化和高脂血症的新多草药制剂。
发明背景
动脉粥样硬化是引起较低年龄死亡的主要问题之一。它是一个炎症和细胞增殖的活性过程。当正常血管功能衰退时它就开始发生。基本上,冠状动脉都会出现阻塞,这将导致心脏疾病发作。这种阻塞可归因于脂类沉积,伤口形成或因斑块爆裂引起的脂类从内皮壁突然释放。动脉内膜层中缓慢和逐渐的脂肪沉积被称为脂肪性损害或斑块。慢慢地,这些脂肪性损害变为组织纤维化,而钙在其中沉积。它最初是可逆性过程,但纤维化后就成为不可逆。实际上,脂肪在血管中的沉积是伴随年龄增长的自然过程,但在部分个体中,其形成速率非常高,并因此引起冠状动脉疾病的病理状态。
这种沉积有数种原因。然而,基本原因被认为是体内的脂类代谢缺陷。高胆固醇食谱或高水平的体内内源性胆固醇合成是动脉粥样硬化的基本原因。当然,也有几种快速致病的(precipitating)病理因素,例如压力、吸烟、糖尿病、高血压、衰老、男性性因素、引起高同型半胱氨酸的家族病史、高血清脂蛋白-a和巨细胞病毒或衣原体的感染。更多自由基的产生引起LDL的快速氧化,接着,氧化后的LDL被巨噬细胞过量摄入引起泡沫细胞的形成,这是基本的病理过程。
现有技术
由于此疾病是多因素性的,因此有几种方法去控制动脉粥样硬化。第一和最重要的是,减少体内的脂类负载,或增加HDL的含量,或减少自由基和氧化后的LDL的负载量,或清除泡沫细胞和脂肪性损害。存在两个主要步骤,(a)防止脂肪性斑块的形成;(b)已形成的斑块的衰退。现在,有两种主要方法控制动脉粥样硬化(1)创伤性技术和(2)非创伤性技术。在非创伤性技术组中,最突出的方法是减少血液脂类,特别是胆固醇和甘油三酯。在这一方法中,主要途径是通过阻断HMG-Co合酶而抑制内源性的胆固醇合成。已知的药物是不同种类的抑制素。在这一方式中,存在从组织到血液的反方向的胆固醇转运,这使得LDL和VLDL减少。几种医用植物产品也可满足促血清脂质减少的要求,例如穆库尔没药(Commiphora mukul),三木果(Termenaliaarjuna),菖蒲(Acorus calamus)等。实际上,印度药草治疗的文献公开了这类植物的名称,但并没有对这些植物进行大量科学研究。
又一种方法是增加血液中的HDL。不幸的是,没有良好的药物能增加血清HDL。锻炼是实现这一目标的唯一方式。黄油/牛奶的应用也显示了将血清HDL升高至一定程度的性质,但它不能在高脂血症和动脉粥样硬化患者中用作药物。
第三种方法是防止在血液中的LDL的氧化,因为氧化后的LDL是泡沫细胞形成和随后它在动脉壁沉积并形成动脉硬化斑块的基本原因。为实现这一目标,抗氧化剂被推荐为食谱的补充。虽然抗氧化剂作为食谱补充物的应用已显著增强了对动脉粥样硬化和其它冠状动脉疾病的控制,但因为其非专一性的作用,它不属于治疗药物的类别。金属螯合剂也被用于防止自由基的形成,因为铁介导的Fenton反应是羟基自由基产生的基本原因之一。
在知道动脉粥样化形成的分子途径之后,基因治疗正被尝试于控制该疾病。有报道称稳定的动脉粥样化并非与不稳定的动脉粥样硬化一样危险。一组已知为MMPs(基质金属蛋白酶)的蛋白酶导致这一不稳定性。实际上,它们降解斑块的纤维帽,并允许脂类从斑块中出来而阻塞动脉血流。
正在尝试将基因引入以抑制这些MMPs。类似地,最新的基因治疗方法是抑制生长因子M-CSF(巨噬细胞集落刺激因子),它引起平滑肌细胞增殖和泡沫细胞快速形成并引起它们沉积。
又一种控制动脉粥样硬化的方法是调节炎性细胞因子和多种酶如脂氧化酶和环加氧酶,因为发炎是导致斑块形成的基本因素之一。
既然动脉粥样硬化是多病原因素疾病,医生就推荐系列药物来控制该疾病,而因为不协调的方法疾病仍然未被控制。然而,没有药物能通过给一片药就同时靶向于几种病原因素。患者被建议一天中服用几种药物,这会给他一种心理压力。当单独给出时,这些药物不对防止动脉粥样硬化形成具有显著影响,因为其它因素变得更为突出。正在研制的基因治疗还处于幼年期,而假如它开始为公众所应用,从根本上讲它将非常昂贵,也有一些副作用,只有时间能验证它是否成功。
有许多防止斑块形成的要求,它们通过减少风险因素,通过采用更多抗氧化剂或通过以应用数种促血清脂质减少药物如抑制素等而减少胆固醇来防止。一旦动脉粥样硬化被检测到,冠脉搭桥等是唯一的治疗法。实际上,没有良好的药物可用来逆转已经形成的斑块。
发明目的
本发明的一个目的是提供具有靶向于几个病原途径而最终引导至动脉粥样硬化的能力的新多草药制剂。
本发明的另一个目的是提供新颖的多草药制剂,该制剂抗炎、抗氧化和增加血清HDL,而更特别地,它抑制斑块中的Lox-15、Cox-2和钙沉积,增加慢性斑块中的胶原蛋白,增加血清HDL而减少血清TG。
本发明的又一目的提供增加血清HDL和即使在高血清脂类浓度存在条件下也防止斑块形成的新颖的多草药制剂。
本发明的又一目的是提供新颖的多草药制剂,该制剂可增加显示出趋向稳定斑块的陈旧斑块中的胶原组织。
本发明进一步的目的是提供抑制导致动脉硬化的环加氧酶-2和脂氧化酶-15的新颖的多草药制剂。
本发明仍然进一步的目的是提供新颖的多草药制剂,该制剂是有成木效益的,比其成分医用植物更有效,不具有任何毒性或副作用而具有高治疗安全性的效益。
发明描述
根据本发明,提供了防止动脉粥样硬化和高脂血症的多草药制剂,其包含穆库尔没药(Commiphora mukul),乳香(Boswellia serrata),肉托果(Semecarpus anacardium),马钱子(Strychnos nux vomica),三木果(Termenalia arjuna)和Shankha Bhusma的混合物。
该多草药组合物可进一步包括茜草(Rubia cordifolia),假马齿苋(Bacopa monnieri),Triphala和Trikatu。
根据本发明,所述组分按下列比率存在:
纯化的穆库尔没药 1-4
纯乳香 0.5-4
纯化的肉托果(Semecarpus anacardium) 0.1-0.4
纯化的马钱子粉末 0.4-2
纯的三木果水提取物粉末 0.3-2
Shankha Bhusma 0.5-2
进一步地,下列组分的任意一种或多种被以下列比率添加:
茜草 0.05-1
或假马齿苋 0.5-3
或Triphala 0.5-3
和Trikatu 0.5-3
特别地,有益的比率是:
纯化的穆库尔没药 3.7
纯乳香 3.0
纯化的肉托果(Semecarpus anacardium) 0.1
纯化的马钱子粉末 1.0
纯的三木果皮水提取物粉末 0.7
Shankha Bhusma 1.5
实施例
致动脉粥样化的食物组成:
致动脉粥样化的食物由对照兔同样数量的富含胆固醇的兔饲料(chow),甘蓝和鹰嘴豆组成。致动脉粥样化的食物按下述制得:饲料被粉末化,按下面给出的特定比率与下列各项混合,并再次制成小球。它在烤箱中干燥并在冰箱中保存。食物每次只能制备4天的用量。
食物组成:
兔饲料 57%
奶粉 14%
酵母粉 04%
盐 01%
复合维生素 0.1%
胆固醇 05%
氢化脂肪 17%
胆酸 01%
实验细节:
雄兔被随机分成3组,每组12只动物。它们在实验室条件下保持15天以适应环境。在此期间,每一动物被除去身上的虫,在饮水中加入四环素(Hostacycline)和Vimeral。动物被分成下列组:
对照食物(CD)
致动脉粥样化的食物(AD)
致动脉粥样化的食物-BHUx 60mg/100g体重(AD40)
对照食物由兔饲料、甘蓝和鹰嘴豆(400克/天)和任意水组成。
致动脉粥样化的食物被喂给对照组中的兔子,3个月后,BHUx与致动脉粥样化的食物一起被喂给实验组,又喂养3个月。因此,实验的总持续时间是6个月。每一个月后,在血液中进行脂类特征的测定,实验结束时将动物处死,保存心脏、肝、肾、背主动脉。将这些组织进行组织学研究。切出5微米厚的切片并用不同染料染色。在AD组(实验对照)中,仅2ml的阿拉伯胶蒸馏水悬浮液(5%)以类似方式喂出。应用Zydus Pathline试剂盒(a group and Cadila Healthcare Ltd.)进行脂类胆固醇、TG、LDL和HDL特征的测定。3个月后,处死动物以收集心脏和背主动脉。
(A)组织学:
(1)用背主动脉进行的研究——它在主动脉弓起点处被从心脏分离出来,纵向剖开。用苏丹IV染料染色。对致动脉粥样化的斑点进行追踪后,组织被固定,并被处理以用于阻塞制剂和切片。
(2)用主动脉弓和冠状动脉进行的研究——整个心脏被分成两部分,命名为H1和H2。上半部分H1被切成6微米厚的切片,用苏木精和伊红(H & E)染色。显微镜研究主动脉弓和冠状动脉中涉及内膜增厚的区域。这些切片被分别以特异染料染色,以显示胶原组织和钙沉积。
(3)用肾和肝进行的研究——切片用H&E和AgNO3分别染色以评估纤维化和坏死的程度。
(B)生化试验——选择每一动物的血液,血浆/血清按每一种需要被分离以测定SGOT、SGPT、碱性磷酸酶和完整的脂类特征。
(C)体外测定——为研究本发明制剂对环加氧酶和脂氧化酶的效用,通过应用标准oxygraph方法进行体外酶分析。结果显示本发明的制剂对Cox-2抑制的敏感度高于Cox-1。类似地,在脂氧化酶分析中,它显示出对15-脂氧化酶的敏感度高于其它同工酶。
与结果相关的附图和附表的简述:
图1:显示具有HDL增加的脂类特征的柱状图
Claims (3)
1.用于防止动脉粥样硬化和高脂血症的多草药制剂,其包含穆库尔没药,乳香,肉托果,马钱子,三木果和Shankha Bhusma的混合物,
其中组分以下列比率存在:
纯化的穆库尔没药 1-4
纯乳香 0.5-4
纯化的肉托果 0.1-0.4
纯化的马钱子粉末 0.4-2
纯的三木果水提取物粉末 0.3-2
Shankha Bhusma 0.5-2。
2.按照权利要求1的多草药制剂,包含茜草,假马齿苋,Triphala和Trikatu,
其中下列组分以下列比率加入:
茜草 0.05-1
或假马齿苋 0.5-3
或Triphala 0.5-3
和Trikatu 0.5-3。
3.按照权利要求1的多草药制剂,其中组分以下列比率存在:
纯化的穆库尔没药 3.7
纯乳香 3.0
纯化的肉托果 0.1
纯化的马钱子粉末 1.0
纯的三木果皮水提取物粉末 0.7
Shankha Bhusma 1.5。
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PCT/IN2003/000399 WO2004062566A2 (en) | 2002-01-13 | 2003-12-26 | Polyherbal preparation for the prevention of atherosclerosis and hyperlipidemia |
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CN110785211A (zh) * | 2017-05-16 | 2020-02-11 | 穆尼亚尔阿尤韦迪克研究中心 | 用于管理代谢紊乱的草药制剂及其制备方法 |
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CN1435237A (zh) * | 2002-11-28 | 2003-08-13 | 孙秀梅 | 治疗脑血管疾病的中药散剂 |
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FR2465484A1 (fr) | 1979-09-21 | 1981-03-27 | Urwerg Suzanne | Extrait vegetal a proprietes antidiabetiques et son procede de preparation |
US5411733A (en) * | 1992-04-27 | 1995-05-02 | Hozumi; Toyoharu | Antiviral agent containing crude drug |
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- 2003-12-26 EP EP03768094A patent/EP1583499B1/en not_active Expired - Lifetime
- 2003-12-26 WO PCT/IN2003/000399 patent/WO2004062566A2/en not_active Application Discontinuation
- 2003-12-26 DE DE60328527T patent/DE60328527D1/de not_active Expired - Lifetime
- 2003-12-26 CN CNB200380109770XA patent/CN100500172C/zh not_active Expired - Fee Related
- 2003-12-26 AU AU2003292512A patent/AU2003292512A1/en not_active Abandoned
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CN1435237A (zh) * | 2002-11-28 | 2003-08-13 | 孙秀梅 | 治疗脑血管疾病的中药散剂 |
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AU2003292512A8 (en) | 2004-08-10 |
WO2004062566A3 (en) | 2005-10-06 |
AU2003292512A1 (en) | 2004-08-10 |
DE60328527D1 (de) | 2009-09-03 |
EP1583499B1 (en) | 2009-07-22 |
WO2004062566A2 (en) | 2004-07-29 |
EP1583499A2 (en) | 2005-10-12 |
US7416743B2 (en) | 2008-08-26 |
CN1787827A (zh) | 2006-06-14 |
US20060147555A1 (en) | 2006-07-06 |
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