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CN105497816A - 一种治疗动脉粥样硬化的中药制剂及其制备方法 - Google Patents

一种治疗动脉粥样硬化的中药制剂及其制备方法 Download PDF

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Publication number
CN105497816A
CN105497816A CN201610052679.8A CN201610052679A CN105497816A CN 105497816 A CN105497816 A CN 105497816A CN 201610052679 A CN201610052679 A CN 201610052679A CN 105497816 A CN105497816 A CN 105497816A
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radix
rhizoma
chinese medicine
preparation
medicine preparation
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姜少燕
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Abstract

本发明涉及中医药领域,尤其涉及一种治疗动脉粥样硬化的中药制剂。由绞股蓝、甘草、茯苓、枸杞、益母草、丹参、川穹、酸枣仁、泽泻、决明子、桔梗、薄荷、五味子、黄连、黄芪、夏枯草、鱼腥草、三七、瓜蒌、桂枝、白芍、车前子、钩藤、天麻、玫瑰花、柴胡、姜黄等组成。本发明相对于现有技术具有疗效好、成本低、局限性小、无不良反应等优点。本发明各原料有效成份相互影响、协同作用,对动脉粥样硬化有很好的治疗效果。而且本发明中药制备方法简单、配伍严谨、药性平和、安全无副作用、成本低廉,适宜各类人群服用,便于在临床上大面积推广应用。

Description

一种治疗动脉粥样硬化的中药制剂及其制备方法
技术领域
本发明属于中药学技术领域,具体涉及一种治疗动脉粥样硬化的中药制剂及其制备方法。
背景技术
动脉粥样硬化是一组动脉硬化的血管病中常见的最重要的一种,其特点是受累动脉病变从内膜开始。一般先有脂质和复合糖类积聚、出血及血栓形成,纤维组织增生及钙质沉着,并有动脉中层的逐渐蜕变和钙化,病变常累及弹性及大中等肌性动脉,一旦发展到足以阻塞动脉腔,则该动脉所供应的组织或器官将缺血或坏死。由于在动脉内膜积聚的脂质外观呈黄色粥样,因此称为动脉粥样硬化。
动脉粥样硬化就是动脉壁上沉积了一层像小米粥样的脂类,使动脉弹性减低、管腔变窄的病变。高血压是促进动脉粥样硬化发生、发展的重要因子,而动脉因粥样硬化所致的狭窄又可引起继发性高血压。因此二者之间互相影响,互相促进,形影不离。高血压促进动脉粥样硬化,多发生于大、中动脉,包括心脏的冠状动脉、头部的脑动脉等这些要塞通道。高血压致使血液冲击血管内膜,导致管壁增厚、管腔变细。管壁内膜受损后易为胆固醇、脂质沉积,加重了动脉粥样斑块的形成。因此,高血压是动脉粥样硬化的危险因子。
动脉粥样硬化是动脉硬化的一种,大、中动脉内膜出现含胆固醇、类脂肪等的黄色物质,多由脂肪代谢紊乱,神经血管功能失调引起。常导致血栓形成、供血障碍等。也叫粥样硬化。
动脉粥样硬化的治疗常采用:(1)一般治疗:合理饮食:饮食总热量不应过高防止超重;坚持适量的体力活动;合理安排工作及生活;提倡不吸烟,可饮少量酒等;(2)控制易患因素:如患有糖尿病、应及时控制血糖,包括饮食控制。II型糖尿病的降糖药物应以不引起高胰岛素血症为宜;如有高血压则应给降压药,使血压降至适当水平,如有血胆固醇增高,则应控制高胆固醇适当给予降脂药物。(3)降血脂药物治疗:1、他汀类2、消胆胺、3、烟酸。4、不饱和脂肪酸。5、藻酸双酯钠。(4)抗血小板药物治疗:1、阿斯匹林。2、潘生丁等。西药治疗存在副作用大等缺点,而中医药在抑制动脉粥样硬化进程方面具有独特的优势,值得推广应用。
经过大量临床实践及查阅相关文献,发明人认为心、肺、脾、肾脏虚损以及肝失疏泄是AS发生的根本,痰浊、血瘀、热毒是动脉粥样硬化的关键病理因素。动脉粥样硬化的发生、发展是在脏腑虚损的基础上,痰浊、瘀血、热毒内生,凝滞血脉,损伤脉络,久致脉道枯涩,血脉失柔,甚则脉管狭窄,闭塞不通。因此,可以说邪留血脉,脉络损伤,脉道枯涩,血脉失柔是动脉粥样硬化的病机关键。在心肺脾肾虚的基础上,痰浊内盛、瘀血内停是动脉粥样硬化的潜在发病因素,痰湿留聚血脉,瘀血内生,脉络损伤,动脉粥样硬化病理过程随之启动。痰湿浊瘀日久化热毒,复又因实致虚,虚损不断加重。随着病变进一步发展,痰瘀交结,脉络受阻明显,脉道枯涩,脉管狭窄甚则闭塞不通是动脉粥样硬化的最严重阶段。
发明内容
为了克服现有技术中的不足,本发明提供一种治疗动脉粥样硬化的中药制剂,具有显著疗效。
为了解决上述技术问题,本发明采用的技术方案如下:一种治疗动脉粥样硬化的中药制剂,由以下各组分组成:
绞股蓝1-30份、甘草1-30份、茯苓1-30份、枸杞1-30份、益母草1-30份、丹参1-30份、川穹1-30份、酸枣仁1-30份、泽泻1-30份、决明子1-30份、桔梗1-30份、薄荷1-30份、五味子1-30份、黄连1-30份、黄芪1-30份、夏枯草1-30份、鱼腥草1-30份、三七1-30份、瓜蒌1-30份、桂枝1-30份、白芍1-30份、车前子1-30份、钩藤1-30份、天麻1-30份、玫瑰花1-30份、柴胡1-30份、姜黄1-30份、薤白1-30份、熟地黄1-30份、地龙1-30份、鸡血藤1-30份、桃仁1-30份、徐长卿1-30份、红景天1-30份、葛根1-30份、石菖蒲1-30份、半夏1-30份、金银花1-30份、凌霄花1-30份、白薇1-30份。
所述治疗动脉粥样硬化的中药组合物,其所述中药制剂中各种原料药的重量份数可以优选为:绞股蓝1-20份、甘草1-20份、茯苓1-20份、枸杞1-20份、益母草1-20份、丹参1-20份、川穹1-20份、酸枣仁1-20份、泽泻1-20份、决明子1-20份、桔梗1-20份、薄荷1-20份、五味子1-20份、黄连1-20份、黄芪1-20份、夏枯草1-20份、鱼腥草1-20份、三七1-20份、瓜蒌1-20份、桂枝1-20份、白芍1-20份、车前子1-20份、钩藤1-20份、天麻1-20份、玫瑰花1-20份、柴胡1-20份、姜黄1-20份、薤白1-20份、熟地黄1-20份、地龙1-20份、鸡血藤1-20份、桃仁1-20份、徐长卿1-20份、红景天1-20份、葛根1-20份、石菖蒲1-20份、半夏1-20份、金银花1-20份、凌霄花1-20份、白薇1-20份。
所述治疗动脉粥样硬化的中药组合物,其所述中药制剂中各种原料药的重量份数还可以优选为:绞股蓝1-10份、甘草1-10份、茯苓1-10份、枸杞1-10份、益母草1-10份、丹参1-10份、川穹1-10份、酸枣仁1-10份、泽泻1-10份、决明子1-10份、桔梗1-10份、薄荷1-10份、五味子1-10份、黄连1-10份、黄芪1-10份、夏枯草1-10份、鱼腥草1-10份、三七1-10份、瓜蒌1-10份、桂枝1-10份、白芍1-10份、车前子1-10份、钩藤1-10份、天麻1-10份、玫瑰花1-10份、柴胡1-10份、姜黄1-10份、薤白1-10份、熟地黄1-10份、地龙1-10份、鸡血藤1-10份、桃仁1-10份、徐长卿1-10份、红景天1-10份、葛根1-10份、石菖蒲1-10份、半夏1-10份、金银花1-10份、凌霄花1-10份、白薇1-10份。
所述治疗动脉粥样硬化的中药组合物,其所述中药制剂的剂型可以为:片剂、糖衣片剂、薄膜衣片剂、肠溶衣片剂、硬胶囊剂、软胶囊剂、口服液、口含剂、颗粒剂、冲剂、蜜丸剂、散剂、丹剂、溶液剂、注射剂、栓剂、硬膏剂或糖浆剂。
为解决上述技术问题,本发明还提供治疗动脉粥样硬化的中药组合物的制备方法,所述制剂剂型为口服液剂,其制备方法的包括:
a、取原料放入乙醇中浸泡,热提取2次,成膏状,为组分1;
b、药渣水提取2次,浓缩过滤为膏状,为组分2;
c、将上述两种膏状浓缩成糊状,灭菌,加入糊精,然后真空冷冻密封。
所述步骤a中,取原料加入5-10倍量的乙醇中浸泡1-2小时,加热提取2次,每次1-2小时,去上清液,合并提取液,100-180目滤过,再经截流分子量为5000-10000的超滤柱超滤,超滤液减压浓缩相对密度为80℃时1.10的浸膏,加热浓缩至膏状,静置备用,成为组分1。
所述步骤b中,将乙醇提取过的药渣放入10倍量水中,加热回流提取2次,每次提取时间为1~2小时,100-120目滤过,再经截流分子量为5000-10000的超滤柱超滤,超滤液减压浓缩相对密度为80℃时1.10的浸膏,加热浓缩至膏状,静置备用,成为组分2。
所述步骤c中,将上述两种组分膏状浓缩成糊状,浓缩液用CO60灭菌,辐照剂量8k,加入糊精,然后真空罐装密封即得,使用时直接饮用。
为解决上述技术问题,本发明也提供治疗动脉粥样硬化的中药组合物的制备方法,所述制剂剂型为胶囊剂,其制备方法的包括:
a.将所述原料放入粉碎机粉碎后过筛;
b.将过筛后剩下的颗粒物放入乙醇中加热回流提取2次;
c.再取上述乙醇提取后的药渣,加水加热回流提取1次;
d.将上述两种提取液合并,减压回收乙醇并喷雾干燥,得药粉;混合过筛得到的药粉装入胶囊制为胶囊剂。
为解决上述技术问题,本发明也提供治疗动脉粥样硬化的中药组合物的制备方法,所述内服药物的剂型为丸剂,其制备步骤包括:
a.将所述原料药混合,切碎,过120目筛,得细药粉备用;
b.将未过筛的粗粉浸泡乙醇中提取2次;
c.再取上述步骤提取后的药渣,加水加热回流提取2次;
d.将上述两种提取液合并,减压回收乙醇成浸膏,与a步骤得到细药粉合并加入蜂蜜搓成丸剂。
所述治疗动脉粥样硬化的中药组合物,其所述中药的使用方法为,本发明做煎汤剂服用时,每日1剂,水煎分两次服,每10天为一疗程;胶囊剂、片剂、丸剂使用时,每次1片、1粒或1丸,每日三次,每7日为一疗程。
本发明相对于现有技术具有疗效好、成本低、局限性小、无不良反应等优点。本发明各原料有效成份相互影响、协同作用,对动脉粥样硬化患者有很好的治疗效果。而且本发明中药制备方法简单、配伍严谨、药性平和、安全无副作用、成本低廉,适宜各类人群服用,便于在临床上大面积推广应用。
具体实施方式
中医中药在治疗动脉粥样硬化方面有其自身独特的优势,中药能够多靶点、全方位地稳定斑块,降低血脂、保护受损的内皮细胞、抑制炎症状态和发挥抗凝作用,口服药物治疗无副作用,而且有些中药能够通过其软坚散结的作用促使斑块面积的减小或消退。随着社会的发展,生活节奏的加快,饮食结构的变化,肥胖、高血压、高脂血症、糖尿病等疾病的发生率逐渐上升,动脉硬化症的发生率亦明显升高。动脉硬化问题亟待解决。但现有的中药治疗动脉硬化的药物一般原料配方较多,制备工艺复杂,质量控制困难,服用量较多,疗效不满意等。
绞股蓝:性味:味苦;微甘;性凉。归经:归肺;脾;肾经。功能主治:清热;补虚;解毒。主体虚乏力;虚劳失精;白细胞减少症;高脂血症;病毒性肝炎;慢性胃肠炎;慢性气管炎。
甘草:性味:甘,平。归经:归心、肺、脾、胃经。功能主治:补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。用于脾胃虚弱,倦怠乏力,心悸气短,咳嗽痰多,脘腹、四肢挛急疼痛,痈肿疮毒,缓解药物毒性、烈性。
茯苓:性味:甘淡,平。①《本经》:″味甘,平。"②《医学启源》:"《主治秘诀》云,性温,味淡。"归经:入心、脾、肺经。①《汤液本草》:"入手大阴,足大阳、少阳经。"②《本草蒙筌》:″入膀胱、肾、肺。"③《雷公炮制药性解》:"入肺、脾、小肠三经。"④《本草经疏》:"入手足少阴,手太阳,足太阴、阳明经。"功能主治:渗湿利水,益脾和胃,宁心安神。治小便不利,水肿胀满,痰饮咳逆,呕哕,泄泻,遗精,淋浊,惊悸,健忘。
枸杞:性味:甘,平。①《别录》:"微寒,无毒。″②《药性论》:″味甘,平。"③《食疗本草》:"寒,无毒。"归经:入肝、肾经。①《本草汇言》:"入足少阴、足厥阴经。"②《本草经解》:″入足少阴肾经、手少阴心经。"③《要药分剂》:"入肝、胃二经,兼入肺经。"功能主治:滋肾,润肺,补肝,明目。治肝肾阴亏,腰膝酸软,头晕,目眩,目昏多泪,虚劳咳嗽,消渴,遗精。①陶弘景:″补益精气,强盛阴道。″②《药性论》:″能补益精诸不足,易颜色,变白,明目,安神。③《食疗本草》:″坚筋耐老,除风,补益筋骨,能益人,去虚劳。"④王好古:"主心病嗌干,心痛,渴而引饮,肾病消中。"⑤《纲目》:"滋肾,润肺,明目。″
益母草:性味:辛苦,凉。①《本草拾遗》:″寒。″②《本草蒙筌》:″味辛甘,气微温,无毒。"③《纲目》:″味辛微苦,无毒。"④《本草正》:"味微苦、微辛。微寒,性滑。″归经:入心包、肝经。①《本草汇言》:"手、足厥阴经。″②《药品化义》:"入肝、脾、包络三经。″③《本草再新》:"入心、脾、肾三经。″功能主治:活血,祛瘀,调经,消水。治月经不调,胎漏难产,胞衣不下,产后血晕,瘀血腹痛,崩中漏下,尿血,泻血,痈肿疮疡。①《本经》:"主瘾疹痒。″②《唐本草》:"敷丁肿,服汁使丁肿毒内消;又下子死腹中,主产后胀闷;诸杂毒肿,丹游等肿;取汁如豆滴耳中,主聤耳;中虺蛇毒,敷之。"③《本草拾遗》:″捣苗,敷乳痈恶肿痛者;又捣苗绞汁服,主浮肿下水,兼恶毒肿。″④《本草衍义》:″治产前产后诸疾,行血养血;难产作膏服。″
丹参:性味:苦,微温。①《本经》;"味苦,微寒,无毒。″②《吴普本草》:"岐伯:咸。″③李当之《药录》:″大寒。″④《本草经疏》:"味苦,平,微温。″归经:入心、肝经。①《纲目》:″手少阴、厥阴血分药。"②《本草经疏》:″入手足少阴、足厥阴经。″③《本草正》:″心、脾、肝、肾血分之药。"功能主治:活血祛瘀,安神宁心,排脓,止痛。治心绞痛,月经不调,痛经,经闭,血崩带下,症瘕,积聚,瘀血腹痛,骨节疼痛,惊悸不眠,恶疮肿毒。①《本经》:″主心腹邪气,肠鸣幽幽如走水,寒热积聚;破症除瘕,止烦满,益气。″②《吴普本草》:"治心腹痛。"③《别录》:"养血,去心腹痼疾结气,腰脊强,脚痹;除风邪留热,久服利人。"④陶弘景:"渍酒饮之,疗风痹。"
川穹:性味:辛,温。①《本经》:″味辛,温。″②《吴普本草》:"黄帝、岐伯、雷公:辛,无毒,香。扁鹊:酸,无毒。李氏:生温,熟寒。″③《唐本草》:″味苦辛。″④《本草正》:"味辛微甘,气温。″归经:入肝、胆经。①《汤液本草》:″入手足厥阴经、少阳经。″②《药品化义》:″入肝、脾、三焦三经。"功能主治:行气开郁,法风燥湿,活血止痛。治风冷头痛旋晕,胁痛腹疼,寒痹筋挛,经闭,难产,产后瘀阻块痛,痈疽疮疡。用于月经不调,经闭痛经,瘕腹痛,胸胁刺痛,跌扑肿痛,头痛,风湿痹痛。①《本经》:″主中风入脑头痛,寒痹,筋挛缓急,金创,妇人血闭无子。"②《别录》:″除脑中冷动,面上游风去来,目泪出,多涕唾,忽忽如醉,诸寒冷气,心腹坚痛,中恶,卒急肿痛,胁风痛,温中内寒。″
酸枣仁:性味:甘,平。①《本经》:″味酸,平。″②《别录》:″无毒。"③《本草衍义》:"微温。"④《饮膳正要》:″味酸甘,平。″归经:入心、脾、肝、胆经。①《纲目》:"足厥阴、少阳。"②《雷公炮制药性解》:"入心、脾、肝、胆四经。"功能主治:养肝,宁心,安神,敛汗。治虚烦不眠,惊悸怔忡,烦渴,虚汗。①《本经》:"主心腹寒热,邪结气聚,四肢酸疼,湿痹。"②《别录》:″主烦心不得眠,脐上下痛,血转久泄,虚汗烦渴,补中,益肝气,坚筋骨,助阴气,令人肥健。″③《药性论》:″主筋骨风,炒末作汤服之。″④《本草拾遗》:″睡多生使,不得睡炒熟。"⑤王好古:"治胆虚不眠,寒也,炒服;治胆实多睡,热也,生用。"⑥《本草汇言》:"敛气安神,荣筋养髓,和胃运脾。″
泽泻:性味:甘,寒。①《本经》:"味甘,寒。"②《别录》:"咸,无毒。″⑨《药性论》:″味苦。"④《医学启源》:"气平,味甘。″⑤《本草蒙筌》:"甘酸,气寒。"归经:入肾、膀胱经。①《汤液本草》:"入手太阳、少阴经。″②《本草衍义补L遗》:″入足太阳、少阴经。"③《雷公炮制药性解》:″入膀胱、肾、三焦、小肠四经。″④《本草经巯》:"入肾、脾。"功能主治:利水,渗湿,泄热。治小便不利,水肿胀满,呕吐,泻痢,痰饮,脚气,淋病,尿血。(1)利水渗湿:用于水湿内停之尿少、水肿、泻痢及湿热淋浊等证。治胃内停水常配白术。治尿道涩痛、小便不利常配木通、茯苓。
决明子:性味:苦甘,凉。①《本经》:"味咸,平。″②《别录》:″苦甘,微寒,无毒。"③《本草正》:″味微苦微甘,性平,微凉。″归经:入肝、肾经。①《雷公炮制药性解》:"入肝经。"②《本草经疏》:"足厥阴肝,亦入胆、肾。"功能主治:清肝,明目,利水,通便。治风热赤眼,青盲,雀目,高血压,肝炎,肝硬化腹水,习惯性便秘。①《本经):″治青盲,目淫肤赤白膜,眼赤痛,泪出,久服益精光。"②《别录》:″疗唇口青。″③《药性论》:"利五脏,除肝家热。"④《日华子本草》:″助肝气,益精水;调末涂,消肿毒,熁太阳穴治头痛,又贴脑心止鼻衄;作枕胜黑豆,治头风,明目。"⑤《本草衍义补遗》:″解蛇毒。"⑥《生草药性备要》:″治小儿五疳,擦癣癞。"
桔梗:性味:苦辛,平。①《本经》:″辛,微温。″②《别录》:"苦,有小毒。"③《药性论》:"苦,平,无毒。"归经:入肺、胃经。①《汤液本草》:″入足少阴、手太阴。"②《品汇精要》:"行足太阴经。"③《本草经疏》:″入手太阴、少阴,兼入足阳明胃经。"功能主治:开宣肺气,祛痰排脓。治外感咳嗽,咽喉肿痛,肺痈吐脓,胸满胁痛,痢疾腹痛。①《本经》:″主胸胁痛如刀刺,腹满,肠鸣幽幽,惊恐悸气。″②《别录》:″利五脏肠胃,补血气,除寒热、风痹,温中消谷,疗喉咽痛。″③《药性论》:"治下痢,破血,去积气,消积聚,痰涎,主肺热气促嗽逆,除腹中冷痛,主中恶及小儿惊痫。"④《日华子本草》:"下一切气,止霍乱转筋,心腹胀痛,补五劳,养气,除邪辟温,补虚消痰,破症瘕,养血排脓,补内漏及喉痹。"
薄荷:性味:辛,凉。①《医学启源》:″《主治秘要》云,性凉,辛。″②《医林纂要》:"辛,寒。"归经:入肺、肝经。①《汤液本草》:″手大阴、厥阴经药。"②《纲目》:"入手少、太阴,足厥阴。"③《本草新编》:"入肺与包络二经,亦能入肝、胆。″功能主治:疏风,散热,辟秽,解毒。治外感风热,头痛,目赤,咽喉肿痛,食滞气胀,口疮,牙痛,疮疥,瘾疹。①《药性论》:"去愤气,发毒汗,破血止痢,通利关节。″②《千金·食治》:″却肾气,令人口气香洁。主辟邪毒,除劳弊。″③孙思邀:″煎汤洗漆疮。"④《唐本草》:″主贼风,发汗。(治)恶气腹胀满。霍乱。宿食不消,下气。"⑤《食疗本草》:″杵汁服,去心脏风热。″
五味子:性味:酸,温。①《本经》:″味酸,温。"②《别录》:"无毒。"③《唐本草》:"皮肉甘酸,核中辛苦,都有咸味。"④《长沙药解》:″味酸微苦咸,气涩。"归经:入肺、肾经,①《汤液本草》:"入手太阴,足少阴经。"②《纲目》:″入肝、心。″功能主治:敛肺,滋肾,生津,收汗,涩精。治肺虚喘咳,口干作渴,自汗,盗汗,劳伤赢瘦,梦遗滑精,久泻久痢。①《本经》:"主益气,咳逆上气,劳伤赢度,补不足,强阴,益男子精。"②《别录》:″养五脏,除热,生阴中肌。″③《日华子本草》:″明目,暖水脏,治风,下气,消食,霍乱转筋,痃癖奔豚冷气,消水肿,反胃,心腹气胀,止渴,除烦热,解酒毒,壮筋骨。″④李杲:"生津止渴。治泻痢,补元气不足,收耗散之气,瞳子散大。"⑤王好古:″治喘咳燥嗽,壮水镇阳。"
黄连:性味:苦,寒。归经:归心、脾、胃、肝、胆、大肠经。功能主治:清热燥湿,泻火解毒。用于湿热痞满,呕吐吞酸,泻痢,黄疸,高热神昏,心火亢盛,心烦不寐,血热吐衄,目赤,牙痛,消渴,痈肿疔疮;外治湿疹,湿疮,耳道流脓。酒黄连善清上焦火热。用于目赤,口疮。姜黄连清胃和胃止呕。用于寒热互结,湿热中阻,痞满呕吐。萸黄连舒肝和胃止呕。用于肝胃不和,呕吐吞酸。
黄芪:性味:甘,温。归经:归肺、脾经。功能主治:补气固表,利尿托毒,排脓,敛疮生肌。用于气虚乏力,食少便溏,中气下陷,久泻脱肛,便血崩漏,表虚自汗,气虚水肿,痈疽难溃,久溃不敛,血虚痿黄,内热消渴;慢性肾炎蛋白尿,糖尿病。
夏枯草:性味:辛、苦,寒。归经:归肝、胆经。功能主治:清火,明目,散结,消肿。用于目赤肿痛,目珠夜痛,头痛眩晕,瘰疬,瘿瘤,乳痈肿痛;甲状腺肿大,淋巴结结核,乳腺增生,高血压。
鱼腥草:性味:辛,寒。①《别录》:″味辛,微温。″②《履巉岩本草》:"性凉,无毒。"③《滇南本草》:″性寒,味苦辛。″④《纲目》:"辛,微温,有小毒。"⑤《医林纂要》:″甘辛咸。"归经:①《本草经疏》:"入手太阴经。"②《本草再新》:″入肝、肺二经。"功能主治:清热解毒,利尿消肿。治肺炎,肺脓疡,热痢,疟疾,水肿,淋病,白带,痈肿,痔疮,脱肛,湿疹,秃疮,疥癣。①《别录》:″主蠼螋溺疮。"②《日华子本草》:"淡竹筒内煨,敷恶疮白秃。"③《履巉岩本草》:″大治中暑伏热闷乱,不省人事。″④《滇南本草》:"治肺痈咳嗽带脓血,痰有腥臭,大肠热毒,疗痔疮。″⑤《纲目》:″散热毒痈肿,疮痔脱肛,断痁疾,解硇毒。″⑥《医林纂要》:"行水,攻坚,去瘴,解暑。疗蛇虫毒,治脚气,溃痈疽,去瘀血。"⑦陈念祖:"生捣治呕血。″
三七:性味:甘、微苦,温。归经:归肝、胃经。功能主治:散瘀止血,消肿定痛。用于咯血,吐血,衄血,便血,崩漏,外伤出血,胸腹刺痛,跌扑肿痛。
瓜蒌:性味:甘、微苦、寒。归经:归肺、胃、大肠经。功能主治:清热涤痰,宽胸散结,润燥滑肠。用于肺热咳嗽,痰浊黄稠,胸痹心痛,结胸痞满,乳痈,肺痈,肠痈肿痛,大便秘结。
桂枝:性味:甘、微苦、寒。归经:归肺、胃、大肠经。功能主治:清热涤痰,宽胸散结,润燥滑肠。用于肺热咳嗽,痰浊黄稠,胸痹心痛,结胸痞满,乳痈,肺痈,肠痈肿痛,大便秘结。
白芍:性味:苦酸,凉。①《本经》:"味苦,平。″②《吴普本草》:"桐君:甘,无毒。岐伯:咸。李氏:小寒。雷公:酸。″③《别录》:"酸,平微寒,有小毒。"归经:入肝、脾经。①《品汇精要》:″行手太阴、足太阴经。"②《本草经疏》:"手足太阴引经药,入肝、脾血分。"功能主治:养血柔肝,缓中止痛,敛阴收汗。治胸腹胁肋疼痛,泻痢腹痛,自汗盗汗,阴虚发热,月经不调,崩漏,带下。①《本经》:″主邪气腹痛,除血痹,破坚积,治寒热疝瘕,止痛,利小便,益气。″②《别录》:″通顺血脉,缓中,散恶血,逐贼血,去水气,利膀胱、大小肠,消痈肿,(治)时行寒热,中恶腹痛,腰痛。"③《药性论》:"治肺邪气,腹中疞痛,血气积聚,通宣脏腑拥气,治邪痛败血,主时疾骨热,强五脏,补肾气,治心腹坚胀,妇人血闭不通,消瘀血,能蚀脓。"④《唐本草》:"益女子血。"
车前子:性味:甘,寒。①《本经》:"味甘,寒。"②《别录》:″咸,无毒。"③《药性论》:"甘,平。"④《药品化义》:"味淡,性平。″归经:入肾、膀胱经。①《本草蒙筌》:″入膀胱。″②《雷公炮制药性解》:"入肝、膀胱、小肠三经。"③《本草经疏》:"入肾、肝、膀胱三经。″功能主治:利水,清热,明日,祛痰。治小便不通,淋浊,带下,尿血,暑湿泻痢,咳嗽多痰,湿痹,目赤障翳。①《本经》:″主气癃、止痛,利水道小便,除湿痹。"②《本草经集注》:"主虚劳。"③《别录》:"男子伤中,女子淋沥,不欲食。养肺强阴益精。明目疗赤痛。″④《药性论》:"能去风毒,肝中风热,毒风冲眼目,赤痛障翳,脑痛泪出,去心胸烦热。"⑤《日华子本草》:″通小便淋涩,壮阳。治脱精,心烦。下气。″⑥《医学启源》:"主小便不通,导小肠中热。″⑦《滇南本草》:"消上焦火热,止水泻。"⑧《纲目》:″止暑湿泻痢。"
钩藤:性味:甘,凉。①《别录》:"微寒。″②《药性论》:"味甘,平。"③《蜀本草》:″味苦。″归经:入肝、心经。①《纲目》:″手、足厥阴。″②《本草经疏》:"手少阴、足厥阴经。″功能主治:清热平肝,熄风定惊。治小儿惊痫瘈疭,大人血压偏高,头晕、目眩,妇人子痫。①《别录》:"主小儿寒热,惊痫。"②《药性论》:″主小儿惊啼,瘈疭热壅。″③《日华子本草》:"治客忤胎风。″④《纲目》:"大人头旋目眩,平肝风,除心热,小儿内钓腹痛,发斑疹。″⑤《本草征要》:"舒筋除眩,下气宽中。"
天麻:性味:甘,平。①《本经》:"味辛,温。″②《药性论》:"无毒。味甘,平。"③《医学启源》:"气平,味苦。"归经:入肝经。①《纲目》:″入肝经气分。"②《雷公炮制药性解》:"入肝、膀胱二经。"③《本草新编》:"入脾、肾、肝、胆、心经。″功能主治:息风,定惊。治眩晕眼黑,头风头痛,肢体麻木,半身不遂,语言蹇涩,小儿惊痫动风。①《本经》:″主恶气,久服益气力,长阴肥健。″②《别录》:"消痈肿,下支满,疝,下血。″③《药性论》:"治冷气顽痹,瘫缓不遂,语多恍惚,多惊失志。″④《日华子本草》:″助阳气,补五劳七伤,通血脉,开窍。"⑤《开宝本草》:"主诸风湿痹,四肢拘挛,小儿风痫、惊气,利腰膝,强筋力。"⑥张元素:"治风虚眩晕头痛。″
玫瑰花:性味:甘微苦,温.①姚可成《食物本草》:″味甘微苦,温,无毒。″②《随息居饮食谱》:″甘辛,温。"归经:《本草再新》:"入肝、脾二经。″功能主治:理气解郁,和血散瘀。治肝胃气痛,新久风痹,吐血咯血,月经不调,赤白带下,痢疾,乳痈,肿毒。①姚可成《食物本草》:″主利肺脾,益肝胆,辟邪恶之气,食之芳香甘美,令人神爽。″②《药性考》:″行血破积,损伤瘀痛,浸酒饮。″③《纲目拾遗》:"和血,行血,理气。治风痹。"④《本草再新》:"舒肝胆之郁气,健脾降火。治腹中冷痛,胃脘积寒,兼能破血。″⑤《随息居饮食谱》:″调中活血,舒郁结,辟秽,和肝。酿酒可消乳癖。″⑥《现代实用中药》:″用于妇人月经过多,赤白带下及一般肠炎下痢等。″⑦《山东中药》:″治盱胃气痛,恶心呕吐,消化不良,泄泻,口舌糜破,吐血,噤口痢。″
柴胡:性味:苦,凉。①《本经》:"味苦,平。″②《别录》:″微寒,无毒。"③《日华子本草》:"味甘。"归经:入肝、胆经。①《珍珠囊》:"入足少阳胆、足厥阴肝、手少阳三焦、手厥阴心包络。"②《本草再新》:″入心、肝、脾三经。"功能主治:和解表里,疏肝,升阳。治寒热往来,胸满胁痛,口苦耳聋,头痛目眩,疟疾,下利脱肛,月经不调,子宫下垂。①《本经》:"主心腹肠胃中结气,饮食积聚,寒热邪气,推陈致新。"②《别录》:"除伤寒心下烦热,诸痰热结实,胸中邪逆,五藏间游气,大肠停积,水胀,及湿痹拘挛。亦可作浴汤。"③《药性论》:"治热劳骨节烦疼,热气,肩背疼痛,宣畅血气,劳乏赢瘦;主下气消食,主时疾内外热不解,单煮服。"④《千金方》:″苗汁治耳聋,灌耳中。″⑤《四声本草》:″主痰澜、胸胁中痞。″
姜黄:性味:辛苦,温。①《唐本草》:"味辛苦,大寒,无毒。″②《本草拾遗》:″味辛,温,无毒。″③李杲:"味苦甘辛,大寒,无毒。″④《东医宝鉴》:"性热,味辛苦,无毒。"归经:入脾、肝经。①《纲目》:"入心、脾。″②《雷公炮制药性解》:"入心、肺二经。"③《本草经疏》:"入足太阴、厥阴。″功能主治:破血,行气,通经,止痛。治心腹痞满胀痛,臂痛,症瘕,妇女血瘀经闭,产后瘀停腹痛,跌扑损伤,痈肿。用于气滞血瘀的胸腹痛、痛经及肢体疼痛,常配元胡、香附。①《唐本草》:″主心腹结积,疰忤,下气,破血,除风热,消痈肿。功力烈于郁金。″②《日华子本草》:"治症瘕血块,痈肿,通月经,治跌扑瘀血,消肿毒;止暴风痛冷气,下食。"③《本草图经》:"治气胀及产后败血攻心。"
薤白:性味:辛苦,温。①《木经》:″味辛,温。″②《别录》:″苦,温,无毒。″③《千金·食治》:″味苦辛,温,滑,无毒。"④《医林纂要》:
"甘酸辛,温。"归经:①《汤液本草》:″入手阳明经。"②《本草经解》:"入足厥阴肝经、手太阴肺经、手少阴心经。"功能主治:理气,宽胸,通阳,散结。治胸痹心痛彻背,脘痞不舒,干呕,泻痢后重,疮疖。①《本经》:"主金疮疮败。″②《别录》:"归于骨。除寒热,去水气,温中散结。诸疮中风寒水肿,以涂之。″③《千金·食治》:"能生肌肉,利产妇。骨鲠在咽不下者,食之则去。"④唐本草》:″白者补而美,赤者主金疮及凤。"⑤《食疗本草》:"治妇人赤白带下。"⑥《本草拾遗》:"调中,主久利不瘥,大腹内常恶者,但多煮食之。″⑦《本草图经》:"补虚,解毒。″″主脚气;煮与蓐妇饮之,易产。″
熟地黄:性味:甘,微温。归经:归肝、肾经。功能主治:滋阴补血,益精填髓。用于肝肾阴虚,腰膝酸软,骨蒸潮热,盗汗遗精,内热消渴,血虚萎黄,心悸怔忡,月经不调,崩漏下血,眩晕,耳鸣,须发早白。
地龙:性味:甘,微温。归经:归肝、肾经。功能主治:滋阴补血,益精填髓。用于肝肾阴虚,腰膝酸软,骨蒸潮热,盗汗遗精,内热消渴,血虚萎黄,心悸怔忡,月经不调,崩漏下血,眩晕,耳鸣,须发早白。
鸡血藤:性味:苦甘,温。①《饮片新参》:"苦涩香微甘。″②《本草正义》:"温。"③江西《中草药学》:″苦温微甘。"归经:《本草再新》:"入心、脾二经。"功能主治:活血、舒筋。治腰膝酸痛,麻木瘫痪,月经不调。①《纲目拾遗》:"活血,暖腰膝,已风瘫。″②《本草再新》:"补中燥胃。"③《饮片新参》:"去瘀血,生新血,流利经脉。治暑痧,风血痹症。"④《现代实用中药》:″为强壮性之补血药,适用于贫血性之神经麻痹症,如肢体及腰膝酸痛,麻木不仁等。又用于妇女月经不调,月经闭止等,有活血镇痛之效。"
桃仁:性味:苦甘,平。①《本经》:″味苦,平。″②《别录》:″甘,无毒。″③《千金·食治》:"味苦甘辛,平,无毒。″归经:入心、肝、大肠经。①《汤液本草》:″入手、足厥阴经。"②《雷公炮制药性解》:″入肝、大肠二经。″③《本草经解》:″入手太阴肺经,手少阴心经,足太阴脾经。"功能主治:破血行瘀,润燥滑肠。治经闭,症瘕,热病蓄血,风痹,疟疾,跌打损伤,瘀血肿痛,血燥便秘。①《本经》:"主瘀血,血闭症瘕,邪气,杀小虫。"②《别录》:″止咳逆上气,消心下坚,除卒暴击血,破症瘕,通脉,止痛。″③孟诜:″杀三虫,止心痛。″④《医学启源》:″治大便血结。"
徐长卿:性味:辛,温。①《本经》:″味辛,温。″②《别录》:"无毒。"功能主治:镇痛,止咳,利水消肿,活血解毒。治胃痛,牙痛,风湿疼痛,经期腹痛,慢性气管炎,腹水,水肿,痢疾,肠炎,跌打损伤,湿疹,荨麻疹,毒蛇咬伤。1、用于风湿痹痛、腰痛、跌打损伤疼痛、脘腹痛、牙痛等各种痛症。徐长卿有较好的祛风止痛作用,广泛地用于风湿、寒凝、气滞、血瘀所致的各种痛症。近年来也用于手术后疼痛及癌肿疼痛,有一定的止痛作用。可单味应用,或随证配伍有关的药物。2、用湿疹、风疹块、顽癣等皮肤病。本品有祛风止痒作用。可单用内服或煎汤外洗,亦可配伍苦参、地肤子、白鲜皮等清利湿热的药物。此外,本品还能解蛇毒,治毒蛇咬伤。可与半边莲同用内服或外用。
红景天:性味:寒;甘;涩。归经:肺经。功能主治:补气清肺;益智养心;收涩止血;散瘀消肿。主气虚体弱;病后畏寒;气短乏力;肺热咳嗽;咯血;白带腹泻;跌打损伤;烫火伤;神经症;高原反应。
葛根:性味:甘辛,平。①《本经》:"味甘,平。"②《别录》:"无毒。生根汁,大寒。"③《纲目》:"甘辛,平,无毒。"归经:入脾、胃经。①张元素:″通行足阳明经。"②《本草新编》:″入胃,又入肺。″③《本草求真》:″入胃,兼入脾。″④《要药分剂》:″入胃、膀胱二经,兼入脾经。″功能主治:升阳解肌,透疹止泻,除烦止温。治伤寒、温热头痛项强,烦热消渴,泄泻,痢疾,癍疹不透,高血压,心绞痛,耳聋。①《本经》:"主消渴,身太热,呕吐,诸痹,起阴气,解诸毒。"②《别录》:"疗伤寒中风头痛,解肌,发表,出汗,开腠理。疗金疮,止痛,胁风痛。″″生根汁,疗消渴,伤寒壮热。″③《本草经集注》:"杀野葛、巴豆、百药毒。"④陶弘景:"生者捣取汁饮之,解温病发热。葛根为屑,疗金疮断血,亦疗疟及疮。″⑤《药性论》:"治天行上气,呕逆,开胃下食,主解酒毒,止烦渴。熬屑治金疮,治时疾解热。"⑥《唐本草》:″末服之,主猘狗啮,并饮其汁良。"
石菖蒲:性味:辛,微温,①《本经》:″辛,温。″②《另口录》:"无毒。″③《药性论》:″味苦辛,无毒。"归经:入口、肝、脾经。①《纲目》:″手少阴、足厥阴。"②《雷公炮制药性解》:"入心、脾、膀胱三经。"③《本草经解》:"入足厥阴肝经、手太阴肺经。"功能主治:开窍,豁痰,理气,活血,散风,去湿。治癫痫,痰厥,热病神昏,健忘,气闭耳聋,心胸烦闷,胃痛,腹痛,风寒湿痹,痈疽肿毒,跌打损伤。化湿开胃,开窍豁痰,醒神益智。用于脘痞不饥、噤口下痢、神昏癫痫、健忘耳聋。①《本经》:″主风寒湿痹,咳逆上气,开心孔,补五脏,通九窍,明耳目,出音声。"②《别录》:"主耳聋,痈疮,温肠胃,止小便利,四肢湿痹,不得屈伸,小儿温疟,身积热不解,可作浴汤。聪耳目,益心智。"③《药性论》:"治风湿顽痹,耳鸣,头风,泪下,杀诸虫,治恶疮疥瘙。″
半夏:性味:辛,温;有毒。归经:归脾、胃、肺经。功能主治:燥湿化痰,降逆止呕,消痞散结。用于痰多咳喘,痰饮眩悸,风痰眩晕,痰厥头痛,呕吐反胃,胸脘痞闷,梅核气;生用外治痈肿痰核。姜半夏多用于降逆止呕。
下面结合具体实施例对本发明做进一步阐述。
实施例1
绞股蓝2份、甘草2份、茯苓3份、枸杞8份、益母草9份、丹参1份、川穹2份、酸枣仁3份、泽泻3份、决明子4份、桔梗5份、薄荷2份、五味子2份、黄连3份、黄芪2份、夏枯草2份、鱼腥草1份、三七3份、瓜蒌6份、桂枝4份、白芍7份、车前子2份、钩藤1份、天麻2份、玫瑰花3份、柴胡6份、姜黄3份、薤白4份、熟地黄5份、地龙2份、鸡血藤2份、桃仁3份、徐长卿3份、红景天2份、葛根4份、石菖蒲3份、半夏6份、金银花4份、凌霄花6份、白薇4份。
所述制剂剂型为口服液剂,其制备方法的包括:
a、取原料加入5-10倍量的乙醇中浸泡1-2小时,加热提取2次,每次1-2小时,去上清液,合并提取液,100-180目滤过,再经截流分子量为5000-10000的超滤柱超滤,超滤液减压浓缩相对密度为80℃时1.10的浸膏,加热浓缩至膏状,静置备用,成为组分1;
b、将乙醇提取过的药渣放入10倍量水中,加热回流提取2次,每次提取时间为1~2小时,100-120目滤过,再经截流分子量为5000-10000的超滤柱超滤,超滤液减压浓缩相对密度为80℃时1.10的浸膏,加热浓缩至膏状,静置备用,成为组分2;
c、将上述两种组分膏状浓缩成糊状,浓缩液用CO60灭菌,辐照剂量8k,加入糊精,然后真空罐装密封即得,使用时直接饮用。
实施例2
a、取原料药绞股蓝2份、甘草2份、茯苓3份、枸杞8份、益母草9份、丹参1份、川穹2份、酸枣仁3份、泽泻3份、决明子4份、桔梗5份、薄荷2份、五味子2份、黄连3份、黄芪2份、夏枯草2份、鱼腥草1份、三七3份、瓜蒌6份、桂枝4份、白芍7份、车前子2份、钩藤1份、天麻2份、玫瑰花3份、柴胡6份、姜黄3份、薤白4份、熟地黄5份、地龙2份、鸡血藤2份、桃仁3份、徐长卿3份、红景天2份、葛根4份、石菖蒲3份、半夏6份、金银花4份、凌霄花6份、白薇3份入水中浸泡,热提取2次,成浸膏状,为组分1;
b、药渣乙醇提取1次,浓缩过滤为浸膏状,为组分2;
c、将上述两种浸膏浓缩成糊状,浓缩液用CO60灭菌,辐照剂量8k,加入糊精,然后真空冷冻密封即得。
实施例3
绞股蓝1份、甘草10份、茯苓3份、枸杞10份、益母草4份、丹参1份、川穹2份、酸枣仁5份、泽泻4份、决明子5份、桔梗5份、薄荷2份、五味子3份、黄连6份、黄芪3份、夏枯草2份、鱼腥草1份、三七3份、瓜蒌7份、桂枝4份、白芍7份、车前子2份、钩藤1份、天麻2份、玫瑰花3份、柴胡6份、姜黄3份、薤白4份、熟地黄5份、地龙2份、鸡血藤2份、桃仁3份、徐长卿3份、红景天2份、葛根4份、石菖蒲3份、半夏6份、金银花4份、凌霄花2份、白薇1份。
所述制剂剂型为口服液剂,其制备方法的包括:
a、取原料加入5-10倍量的乙醇中浸泡1-2小时,加热提取2次,每次1-2小时,去上清液,合并提取液,100-180目滤过,再经截流分子量为5000-10000的超滤柱超滤,超滤液减压浓缩相对密度为80℃时1.10的浸膏,加热浓缩至膏状,静置备用,成为组分1;
b、将乙醇提取过的药渣放入10倍量水中,加热回流提取2次,每次提取时间为1~2小时,100-120目滤过,再经截流分子量为5000-10000的超滤柱超滤,超滤液减压浓缩相对密度为80℃时1.10的浸膏,加热浓缩至膏状,静置备用,成为组分2;
c、将上述两种组分膏状浓缩成糊状,浓缩液用CO60灭菌,辐照剂量8k,加入糊精,然后真空罐装密封即得,使用时直接饮用。
药理学毒性试验
1、急性毒性试验
应用小鼠进行急性毒性实验表明:小鼠口服灌胃本发明的中药制剂胶囊剂,在488.8g生药/kg剂量下,给药后小鼠出现轻微活动减少,1小时左右恢复正常,给药后连续观察7天,无一动物死亡,其全身状况、饮食、摄水、小便和体重增长均正常,实验结果表明:小鼠口服灌胃本发明的中药制剂胶囊剂的最大给药量为488.8g生药/kg/d(LD50>488.8g生药/kg)。本发明的中药制剂每日临床用药总量为0.1g生药/kg/d;按体重计,小鼠灌胃本发明的中药制剂的耐受量为临床病人的4888倍。提示该药急性毒性低,临床用药安全。
2、长期毒性试验
选用SD大鼠,给予不同浓度(18.0、6.0、2.0g生药/kg)的本发明的中药制剂胶囊剂,每天灌胃一次,连续90天,末次给药后24小时各组活杀1/2动物(雌雄各半),其余1/2动物继续观察2周后活杀。试验期间观察动物的外观、一般行为、摄食量、体重变化,给药后90天和停药2周进行血液学(RBC、HB、网织红细胞、PLT、CT、WBC及分类)和血液生化(AST、ALT、ALP、Glu、BUN、Crea、TP、T.BIL、ALB、CHOL)、尿液生化、脏器系数、病理组织学等指标检查。试验结果表明:本发明的中药制剂在高、中、低剂量组动物一般状态良好,外观体征、行为活动、进食量和体重增长均无异常变化;三个剂量组及对照组血液学检查、血液生化学、尿液生化检查均在正常范围,组间无显著差异;各组主要脏器组织病理学检查未见明显异常。上述指标停药2周后也未见改变。本试验用药剂量分别为临床用药剂量的180、60、20倍,根据试验结果本发明的中药制剂在高、中、低三个剂量(18.0、6.0、2.0g生药/kg)连续90天给药对大鼠无明显影响,无明确的毒性靶器官和敏感指标,恢复期观察也未见延迟性毒性反应,提示本发明的中药制剂临床应用的剂量安全性较高。
临床试验
一般资料
为了验证本发明中药组合物的效果,在青岛市多名血管外科专家的共同研究和指导下,自2008年3月至2015年11月,收治早期闭塞性周围动脉粥样硬化患者237例。全部病例均经体检,检查足背动脉搏动的强度、指压甲床试验、测踝动脉收缩压与肱动脉收缩压比值及实验室辅助检查等多项检查确诊,且无严重心、肝、肾功能不良。随机分为治疗组121例,其中年龄20~65岁,平均年龄54岁。对照组116例,其中年龄30~71岁,平均年龄55岁。两组在性别、年龄、病情等方面均无显著差异(P>0.05),具有可比性,详见表1。
注:两组比较:P>0.05
诊断标准:
本发明参照王吉耀主编的供8年制及7年制临床医学等专业用的内科学367页之诊断标准制定。①年龄多在50岁以上;②有高脂血症、糖尿病或高血压病史;③间歇性跛行,肢痛伴下肢动脉搏动减弱、消失、不对称,踝/肱动脉收缩压指数<1.0;④多普勒检查阳性。
治疗方法:
对照组:采用西药常规治疗:控制血脂用辛伐他汀或非诺贝特,控制血糖用格列吡嗪或胰岛素,控制血压用依那普利、硝苯地平缓释片,改善患者血液循环用低分子右旋糖酐,其它采取对症治疗。
治疗组:服用本发明实施例3药物,每天分三次饭后口服,10天为一疗程。两组分别治疗10周后,观察临床症状与各项辅助检查等改善情况。
疗效评价:
显效:临床症状消失,指压甲床毛细血管充盈时间缩短,测踝/肱指数接近或等于1;足背动脉搏动接近正常或正常;血脂血压血糖控制正常。
有效:临床症状基本消失,指压甲床毛细血管充盈时间稍延长或接近正常,测踝/肱指数大于0.7以上;足背动脉搏动接近正常;血脂血压血糖均控制在接近正常。
无效:临床症状与指压甲床毛细血管充盈时间均无明显改善,测踝/肱指数在0.5以下;足背动脉搏动减弱或消失。
统计学方法:数据用率表示,采用X2检验,以P<0.05为差异有统计学意义。
结果:
治疗前后两组症状改善情况比较
治疗组服用本发明实施例3中药组合物,临床症状改善率(92.6%)显著优于对照组单纯用西药常规治疗后临床症状改善率(43.8%),详见表2。
治疗前后两组辅助检查结果改善比较:详见表3
注:两组比较:P>0.05
不良反应:对照组有13例出现干咳,有4例出现低血糖眩晕。治疗组未见明显不良反应。
以上数据显著说明了本发明各原料有效成份相互影响、协同作用,对动脉粥样硬化患者有很好的治疗效果。以上所述,仅是本发明的最佳实施例而已,并非对本发明作任何形式上的限制,任何熟悉本领域的技术人员,在不脱离本发明技术方案范围情况下,利用上述揭示的方法内容对本发明技术方案做出许多可能的变动和修饰,均属于权利要求书保护的范围。

Claims (10)

1.一种治疗动脉粥样硬化的中药制剂,其特征在于:由以下各组分组成:
绞股蓝1-30份、甘草1-30份、茯苓1-30份、枸杞1-30份、益母草1-30份、丹参1-30份、川穹1-30份、酸枣仁1-30份、泽泻1-30份、决明子1-30份、桔梗1-30份、薄荷1-30份、五味子1-30份、黄连1-30份、黄芪1-30份、夏枯草1-30份、鱼腥草1-30份、三七1-30份、瓜蒌1-30份、桂枝1-30份、白芍1-30份、车前子1-30份、钩藤1-30份、天麻1-30份、玫瑰花1-30份、柴胡1-30份、姜黄1-30份、薤白1-30份、熟地黄1-30份、地龙1-30份、鸡血藤1-30份、桃仁1-30份、徐长卿1-30份、红景天1-30份、葛根1-30份、石菖蒲1-30份、半夏1-30份、金银花1-30份、凌霄花1-30份、白薇1-30份。
2.根据权利要求1所述的一种治疗动脉粥样硬化的中药制剂,其特征在于:由以下重量份数的各组分组成:
绞股蓝1-20份、甘草1-20份、茯苓1-20份、枸杞1-20份、益母草1-20份、丹参1-20份、川穹1-20份、酸枣仁1-20份、泽泻1-20份、决明子1-20份、桔梗1-20份、薄荷1-20份、五味子1-20份、黄连1-20份、黄芪1-20份、夏枯草1-20份、鱼腥草1-20份、三七1-20份、瓜蒌1-20份、桂枝1-20份、白芍1-20份、车前子1-20份、钩藤1-20份、天麻1-20份、玫瑰花1-20份、柴胡1-20份、姜黄1-20份、薤白1-20份、熟地黄1-20份、地龙1-20份、鸡血藤1-20份、桃仁1-20份、徐长卿1-20份、红景天1-20份、葛根1-20份、石菖蒲1-20份、半夏1-20份、金银花1-20份、凌霄花1-20份、白薇1-20份。
3.根据权利要求1至2所述的一种治疗动脉粥样硬化的中药制剂,其特征在于:由以下重量份数的各组分组成:
绞股蓝1-10份、甘草1-10份、茯苓1-10份、枸杞1-10份、益母草1-10份、丹参1-10份、川穹1-10份、酸枣仁1-10份、泽泻1-10份、决明子1-10份、桔梗1-10份、薄荷1-10份、五味子1-10份、黄连1-10份、黄芪1-10份、夏枯草1-10份、鱼腥草1-10份、三七1-10份、瓜蒌1-10份、桂枝1-10份、白芍1-10份、车前子1-10份、钩藤1-10份、天麻1-10份、玫瑰花1-10份、柴胡1-10份、姜黄1-10份、薤白1-10份、熟地黄1-10份、地龙1-10份、鸡血藤1-10份、桃仁1-10份、徐长卿1-10份、红景天1-10份、葛根1-10份、石菖蒲1-10份、半夏1-10份、金银花1-10份、凌霄花1-10份、白薇1-10份。
4.根据权利要求1至3所述的一种治疗动脉粥样硬化的中药制剂,其特征在于:所述中药制剂的剂型为:片剂、糖衣片剂、薄膜衣片剂、肠溶衣片剂、硬胶囊剂、软胶囊剂、口服液、口含剂、颗粒剂、冲剂、蜜丸剂、散剂、丹剂、溶液剂、注射剂、栓剂、硬膏剂或糖浆剂。
5.根据权利要求1至4所述的一种治疗动脉粥样硬化的中药制剂的制备方法,其特征在于:所述制剂剂型为口服液剂,其制备方法的包括:
a、取原料放入乙醇中浸泡,热提取2次,成膏状,为组分1;
b、药渣水提取2次,浓缩过滤为膏状,为组分2;
c、将上述两种膏状浓缩成糊状,灭菌,加入糊精,然后真空冷冻密封。
6.根据权利要求5所述的一种治疗动脉粥样硬化的中药制剂的制备方法,其特征在于:所述步骤a中,取原料加入5-10倍量的乙醇中浸泡1-2小时,加热提取2次,每次1-2小时,去上清液,合并提取液,100-180目滤过,再经截流分子量为5000-10000的超滤柱超滤,超滤液减压浓缩相对密度为80℃时1.10的浸膏,加热浓缩至膏状,静置备用,成为组分1。。
7.根据权利要求5所述的一种治疗动脉粥样硬化的中药制剂的制备方法,其特征在于:所述步骤b中,将乙醇提取过的药渣放入10倍量水中,加热回流提取2次,每次提取时间为1~2小时,100-120目滤过,再经截流分子量为5000-10000的超滤柱超滤,超滤液减压浓缩相对密度为80℃时1.10的浸膏,加热浓缩至膏状,静置备用,成为组分2。
8.根据权利要求5所述的一种治疗动脉粥样硬化的中药制剂的制备方法,其特征在于:所述步骤c中,将上述两种组分膏状浓缩成糊状,浓缩液用CO60灭菌,辐照剂量8k,加入糊精,然后真空罐装密封即得,使用时直接饮用。
9.一种如权利要求1至8所述的治疗动脉粥样硬化的中药制剂的制备方法,其特征在于,所述制剂剂型为胶囊剂,其制备方法的包括:
a.将所述原料放入粉碎机粉碎后过筛;
b.将过筛后剩下的颗粒物放入乙醇中加热回流提取2次;
c.再取上述乙醇提取后的药渣,加水加热回流提取1次;
d.将上述两种提取液合并,减压回收乙醇并喷雾干燥,得药粉;混合过筛得到的药粉装入胶囊制为胶囊剂。
10.一种如权利要求1至9所述的治疗动脉粥样硬化的中药制剂的制备方法,其特征在于,所述内服药物的剂型为丸剂,其制备步骤包括:
a.将所述原料药混合,切碎,过120目筛,得细药粉备用;
b.将未过筛的粗粉浸泡乙醇中提取2次;
c.再取上述步骤提取后的药渣,加水加热回流提取2次;
d.将上述两种提取液合并,减压回收乙醇成浸膏,与a步骤得到细药粉合并加入蜂蜜搓成丸剂。
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CN113694136A (zh) * 2021-09-01 2021-11-26 马万凯 一种治疗心脑血管病的中药及制备方法
CN116650606A (zh) * 2023-07-06 2023-08-29 湖南中医药大学 一种用于防治动脉粥样硬化的药物组合物

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Publication number Priority date Publication date Assignee Title
CN106166251A (zh) * 2016-08-08 2016-11-30 青岛友诚高新技术有限公司 一种用于治疗哮喘的中药制剂及其制备方法
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CN113694136A (zh) * 2021-09-01 2021-11-26 马万凯 一种治疗心脑血管病的中药及制备方法
CN113694136B (zh) * 2021-09-01 2022-04-15 马万凯 一种治疗心脑血管病的中药及制备方法
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CN116650606B (zh) * 2023-07-06 2024-05-03 湖南中医药大学 一种用于防治动脉粥样硬化的药物组合物

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Application publication date: 20160420