CN106822660A - 一种治疗心脑血管疾病的中药制剂 - Google Patents
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Abstract
本发明提供了一种治疗心脑血管疾病的中药制剂,治疗效果显著、口感好、取材方便、患者易于接受的使得能够增加各器官和组织供血量,活血化瘀,益气养阴,疏肝解毒调经气,提高自身免疫力功能,真正起到预防治疗心脑血管疾病的功效。其中中药原料的组分为:蒲黄、龙血竭、急性子、橙叶、大蓑衣藤根、小雪人参、三七花、柚子、山楂叶、侧柏叶、蜂花粉、月见草、芦笋、淫羊藿、紫苏梗、芹菜、佛手、月季花、金银花、玉竹、谷芽、柑桔皮、七叶胆、枸杞子、枸骨叶、野菊花、红花、了哥王、蒲公英、含羞草和山茶油。
Description
技术领域
本发明涉及中药领域,具体涉及一种治疗心脑血管疾病的中药制剂。
背景技术
心脑血管疾病是心脏血管和脑血管疾病的统称,泛指由于高脂血症、血液黏稠、动脉粥样硬化、高血压等所导致的心脏、大脑及全身组织发生的缺血性或出血性疾病。心脑血管疾病是一种严重威胁人类,特别是50岁以上中老年人健康的常见病,具有高患病率、高致残率和高死亡率的特点,即使应用目前最先进、完善的治疗手段,仍可有50%以上的脑血管意外幸存者生活不能完全自理,全世界每年死于心脑血管疾病的人数高达1500万人,居各种死因首位。
心血管疾病,又称为循环系统疾病,是一系列涉及循环系统的疾病,循环系统指人体内运送血液的器官和组织,可以细分为急性和慢性,一般都是与动脉硬化有关。
临床上,西医治疗主要有扩张血管剂、降压药和抗血小板凝聚剂等药物,这些药副作用较大,长期使用会对血管和人体器官带来不同程度的伤害。近年来,中医药防治心血管病研究获得多方面进展,如活血化瘀治疗冠心病心绞痛、益气活血或益气养阴活血治疗急性心肌梗塞或心功能不全、益气通脉温阳治疗缓慢性心律失常、益气养阳透毒治疗病毒性心肌炎、理气活血预防冠心病介入性治疗后再狭窄等,皆显示有肯定效果,中医在防治心血管系统的许多疾病方面,也显示有一定的优势。但是有些中药组合物中的往往出现取材难,制备方法难度大,应用药材贵,口感差等缺陷,因此如何充分发挥中医防治心血管病的优势,进一步提高临床疗效的基础上,提供一种取材方便,价格便宜,口感好,患者易于接受的一种中药,是现代中医临床需进一步探讨的问题。
发明内容
针对现有技术的不足,本发明经多次试验和临床应用上得到了一种治疗效果显著、口感好、取材方便、患者易于接受的一种治疗心脑血管疾病的中制剂,使得能够增加各器官和组织供血量,活血化瘀,益气养阴,疏肝解毒调经气,提高自身免疫力功能,真正起到预防治疗心脑血管疾病的功效。
为实现以上目的,本发明通过以下技术方案予以实现:
一种治疗心脑血管疾病的中制剂,原料的组分为:蒲黄、龙血竭、急性子、橙叶、大蓑衣藤根、小雪人参、三七花、柚子、山楂叶、侧柏叶、蜂花粉、月见草、芦笋、淫羊藿、紫苏梗、芹菜、佛手、月季花、金银花、玉竹、谷芽、柑桔皮、七叶胆、枸杞子、枸骨叶、野菊花、红花、了哥王、蒲公英、含羞草和山茶油。
一种治疗心脑血管疾病的中制剂,原料的各重量组份为:蒲黄1-5份、龙血竭1-5份、急性子1-5份、橙叶10-15份、大蓑衣藤根1-5份、小雪人参5-10份、三七花10-15份、柚子15-30份、山楂叶10-15份、侧柏叶10-15份、蜂花粉10-15份、月见草1-5份、芦笋10-20份、淫羊藿1-5份、紫苏梗5-10份、芹菜15-20份、佛手10-20份、月季花10-15份、金银花10-15份、玉竹10-15份、谷芽10-15份、柑桔皮10-15份、七叶胆5-10份、枸杞子10-15份、枸骨叶10-15份、野菊花10-15份、红花10-15份、了哥王10-15份、蒲公英10-15份、含羞草1-5份和山茶油10-15份。
制备方法:
(1)将柚子、芦笋、芹菜、佛手洗净依次放入榨汁机加一倍量的水,去渣滤液备用;
(2)将橙叶、三七花、月季花、金银花、侧柏叶、蒲公英、枸骨叶、野菊花、红花、山楂叶去除表面杂质,炒干后研碎至200-300目细粉备用;
(3)将龙血竭、急性子、大蓑衣藤根、小雪人参、月见草、淫羊藿、紫苏梗、玉竹、谷芽、柑桔皮、七叶胆、枸杞子、了哥王、含羞草原料组分于砂锅,加两倍量水,先用中火熬制1小时,边熬边加入(1)中备用滤液和(2)中备用细粉,然后改为文火1.5小时煎熬,继续加入蒲黄和蜂花粉文火煎熬1.5小时,趁热过滤残渣,滤液加入山茶油混合均匀即得汤饮剂,一日一剂分三次服用。
一种治疗心脑血管疾病的中制剂,原料的各重量组份为:蒲黄1.5-4.5份、龙血竭1.5-4.5份、急性子1.5-4.5份、橙叶10.5-14.5份、大蓑衣藤根1.5-4.5份、小雪人参5.5-9.5份、三七花10.5-14.5份、柚子15.5-25份、山楂叶10.5-14.5份、侧柏叶10.5-14.5份、蜂花粉10.5-14.5份、月见草1.5-4.5份、芦笋10.5-19.5份、淫羊藿1.5-4.5份、紫苏梗5.5-9.5份、芹菜15-20份、佛手10.5-19.5份、月季花10.5-14.5份、金银花10.5-14.5份、玉竹10.5-14.5份、谷芽10.5-14.5份、柑桔皮10.5-14.5份、七叶胆5.5-9.5份、枸杞子10.5-14.5份、枸骨叶10.5-14.5份、野菊花10.5-14.5份、红花10.5-14.5份、了哥王10.5-14.5份、蒲公英10.5-14.5份、含羞草1.5-4.5份和山茶油10.5-14.5份。
一种治疗心脑血管疾病的中制剂,原料的各重量组份为:蒲黄3.5份、龙血竭3.5份、急性子3.5份、橙叶12.5份、大蓑衣藤根3.5份、小雪人参8.5份、三七花12.5份、柚子20份、山楂叶12.5份、侧柏叶12.5份、蜂花粉12.5份、月见草3.5份、芦笋15.5份、淫羊藿3.5份、紫苏梗8.5份、芹菜18份、佛手14.5份、月季花12.5份、金银花12.5份、玉竹12.5份、谷芽12.5份、柑桔皮12.5份、七叶胆8.5份、枸杞子12.5份、枸骨叶12.5份、野菊花12.5份、红花12.5份、了哥王12.5份、蒲公英12.5份、含羞草3.5份和山茶油12.5份。
本发明所述中药药理及药性:
蒲黄:性甘,平,归肝、心包经,具有止血、化瘀,通淋的功效,主要用于治疗吐血,衄血,咯血,崩漏,外伤出血,经闭通经,胸腹刺痛,跌扑肿痛,血淋涩痛。
枸骨叶:味苦,性凉;归肝、肾经。具有清热养阴,益肾,平肝的功效,主要用于肺痨咯血,骨蒸潮热,头晕目眩。
山茶油:《中国药典》(1995年版)将茶油作为药用油收载,茶油因其富含多种营养成分,内服、外用都有很好的效用。茶油有清热化湿、杀虫解毒的作用。
经常服用,能抑制衰老,对慢性咽炎和预防人体高血压、动脉硬化、心血管系统疾病有很好的疗效。长期服用,能清胃润肠、可治痧气腹痛、急性蛔虫阴塞性肠梗阻、习惯性便秘。
含羞草:(除去根部):甘、涩,凉。宁心安神,清热解毒。用于吐泻,失眠,小儿疳积,目赤肿痛,深部脓肿,带状泡疹。与山茶油同用对心脏病水肿有疗效。
龙血竭:
【性味归经】性温、平,味甘、咸,无毒,入血分,归肺、脾、肾三经,
【功能与主治】:活血散瘀,定痛止血,敛疮生肌。用于跌打损伤,瘀血作痛,妇女气血凝滞,外伤出血,脓疮久不收口。
急性子:
【性味与归经】微苦、辛,温;有小毒。归脾、肝经。
【功能与主治】破血消积,软坚散结。用于经闭,积块,噎膈,外疡坚肿,骨鲠在喉等症。
橙叶:
【性味】辛;苦;性平
【归经】肝经
【功效】散瘀止痛
【功效分类】活血祛瘀药
【功用主治】《岭南采药录》:捣烂敷疮,能止疼散瘀。
大蓑衣藤根:
【性味】味辛,性温。
【功用主治-大蓑衣藤根的功效】行气活血,祛风湿,止痛。
治跌打损伤,瘀血疼痛,风湿性筋骨痛,肢体麻木。
小雪人参:
【性味】甘;微淡;性平
【归经】脾经
【功能主治】健脾补虚;清热利湿;活血调经。主虚劳;血虚头晕;水肿;腹水;痢疾;经闭;痛经。
三七花:
【性味】性凉,味甘、微苦。
【功用】主要用于清热、解毒、 凉血、降压、调脂、免疫调节、活血通脉、养生抗衰、消炎镇痛作用的有效成份。具有显著的平肝、祛痰、平喘、镇痛安眠、扩冠、抗过敏、排毒养颜等功效。
柚子:
柚子味甘酸、性凉,具有理气化痰、润肺清肠、补血健脾等功效,能治食少、口淡、消化不良等症,能帮助消化、除痰止渴、理气散结。
山楂叶:
【性味】酸;平;
【功能主治】有消食健胃、活血化淤、收敛止痢之功能。对肉积痰饮、痞满吞酸、泻痢肠风、腰痛疝气、产后儿枕痛、恶露不尽、小儿乳食停滞等,均有疗效。主漆疮,溃疡不敛,高血压病。
侧柏叶:
【性味】性寒,味苦涩。
【功能主治】凉血,止血,祛风湿,散肿毒。治吐血、衄血、尿血、血痢、肠风、崩漏,风湿痹痛,细菌性痢疾,高血压,咳嗽,丹毒,痄腮,烫伤。《生草药性备要》:"散血敷疮,同片糖捶敷。亦治跌打。"《医林纂要》:"泄肺逆,泻心火,平肝热,清血分之热。"《岭南采药录》:"凉血行气,祛风,利小便,散瘀。"
月季花:
【性味归经】味甘、性温,入肝经。
【功能主治】有活血调经、消肿解毒之功效。由于月季花的祛瘀、行气、止痛作用明显,故常被用于治疗月经不调、痛经等病症,妇女出现闭经或月经稀薄、色淡而量少、小腹痛,兼有精神不畅和大便燥结等,或在月经期出现上述症状,用胜春汤治疗效果好。
了哥王:
【性味归经】苦辛,寒。有毒。①《生草药性备要》:“味辛,性平,有毒。”②《南宁市药物志》:“苦,寒,有毒。”入心、肺、小肠三经。
【功能主治】清热药,清热解毒药功效主治 清热解毒,消肿散结,止痛。治瘰疬、痈肿、风湿痛、百日咳、跌打损伤。
蜂花粉:抗前列腺增生、抗炎抗缺氧、增强免疫调节、抗衰老、降血脂及美容养颜等。①增强人体综合免疫功能:蜂花粉多糖能激活巨噬细胞的吞噬活动,提高人体抗病能力。②防衰老、美容作用:蜂花粉属营养性的美容化妆品,花粉中的VE、超氧化歧化酶(SOD)、硒等成分能滋润营养肌肤,恢复皮肤的弹性和光洁。花粉中的肌醇可使白发变黑,脱发渐生,保持头发乌黑亮丽。③防治脑心血管疾病:花粉中的黄酮类化合物能有效清除血管壁上脂肪的沉积,从而起软化血管和降血脂的作用。④防治前列腺疾病:花粉是前列腺炎的克星,以油菜花粉、荞麦花粉效果最佳。我国治前列腺疾病的有效药物-前列康就是以花粉为原料的。⑤减肥:服用蜂花粉可以吸收足够的营养,造成饱食感。同时,花粉中的卵磷脂可燃烧过剩的脂肪,达到减肥的目的。⑥调节肠胃功能:花粉有许多杀菌成分,能杀灭大肠杆菌等,并能防治便秘。⑦保肝护肝:花粉中的黄酮类化合物同样可防止脂肪在肝上的沉积。⑧调节神经系统,促进睡眠。⑨辅助治疗其他疾病:花粉对贫血、糖尿病、改善记忆力、更年期障碍等有较好效果。⑩辅助治疗前列腺疾病:可调节男性内分泌,恢复膀胱尿道平滑肌功能。
月见草:
【性味】性温,味甘。
【功用】有强筋壮骨、祛风除湿的功能,用于治疗风湿病,筋骨疼痛等症。其种子经过榨油、皂化、酸化可先先获得γ-亚麻酸,以此为原料,经过化学结构改造,再经过生物合成即可得到前列腺素E1,它是抗血栓、扩血管新药,广泛用于血栓性脉管炎、慢性动脉闭塞症、心肌梗塞、视网膜中央静脉血栓动脉造影、血管重建造影等。
芦笋:
【药理价值】1、有助于平抑血压降血脂;2、有助于抑制心脏血管疾病;3、有助于预防和抗癌;4、有助于防治老年便秘、利尿解乏;5、有助于抑制和抵抗病毒菌;6、有助于增强体质消除疲劳。
【营养价值】1、高维生素、高纤维素、高蛋白2、低糖、低脂肪3、含有多种人体必需的大量元素和微量元素
【保健功效】1、防癌抗癌功效,能抑制拓扑异构酶活性,直接杀灭癌细胞,破坏癌细胞端粒酶,使癌细胞不能增殖分裂而凋之,激活抗癌基因调控信号,传导细胞生长正常化。2、对心脏血管疾病的治疗作用,芦笋能抑制高血压,防止血管硬化,降低血脂及胆固醇。3、对人体免疫系统的影响,芦笋可降低循环免疫复合物CIC含量,可产生胸腺素,促进T细胞的产生,从而提高免疫功能,调节免疫机制。4、在抗衰老方面的作用能够降低人体器官的过氧化脂质,LOP的含量,提高超氧化物歧化酶SOD的活性从而延缓衰老。
淫羊藿:
【味性归经】辛、甘,温。归肝、肾经;
【主治功能】补肾阳,强筋骨,祛风湿。
淫羊藿茎叶含有淫羊藿甙和挥发油。经证实,淫羊藿有雄性激素样的作用,其功效强于蛤蚧和海马。临床显示,它通过促进精液分泌,使精囊充满精液后,反过来又能刺激感觉神经,从而激发性欲而致阴茎勃起。同时,淫羊藿还可以抑制血管运动中枢,扩张周围血管,使血压下降,并能镇咳、祛痰、平喘,对脊髓灰质炎病毒、白色葡萄球菌、金黄色葡萄球菌等也有显著的抑制作用。
紫苏梗:
【性味归经】辛,温。归肺、脾经。
【功能主治】 理气宽中,止痛,安胎。用于胸膈痞闷,胃脘疼痛,嗳气呕吐,胎动不安。
芹菜:
【性味】味甘辛,无毒
【功用】具有有平肝清热,祛风利湿,除烦消肿,凉血止血,解毒宣肺,健胃利血、清肠利便、润肺止咳、降低血压、健脑镇静的功效。常吃芹菜,尤其是吃芹菜,对预防高血压、动脉硬化等都十分有益,并有辅助治疗作用。
佛手:
【性味归经】辛、苦、酸,温,归肝、脾、肺经。
【功能主治】补肝暖胃,止呕吐,消胃寒痰,治胃气疼痛,止面寒疼,和中行气。用于肝胃气滞,白带过多,胸胁胀痛,胃脘痞满,食少呕吐。
金银花:
【性味】性甘、寒;
【功用】有清热、解毒、消炎、抗菌之作用。《本草纲目》载“金银花,善于化毒,故治痈疽、肿毒、疮癣……”。自古以来,金银花常用于清热解毒,治疗温病发热,热毒血痢,痈疡等症,亦用于风热感冒,支气管炎等病症。现代药理研究表明,金银花具有抑菌、抗病毒、抗炎、解热、调节免疫等作用。
玉竹:
【性味归经】甘,微寒,归肺、胃经。
【功能主治】养阴润燥,生津止渴,用于肺胃阴伤,燥热咳嗽,咽干口渴,内热消渴。
谷芽:
【性味归经】甘,平。归脾、胃经。
【功效主治】消食化积;健脾开胃。用于食积停滞;胀满泄泻;脾虚少食;脚气浮肿。消食和中,健脾开胃。用于食积不消,腹胀口臭,脾胃虚弱,不饥食少。炒谷芽偏于消食,用于不饥食少。焦谷芽善化积滞,用于积滞不消。
柑桔皮:
散发出金黄澄亮的果皮,除了香香的酸甜味之外,还有一股淡雅的花香味,可促进食欲、养颜美容、减少疲劳感。
可以利用桔皮宽中理气、消痰止咳的功效,桔皮泡绿茶,可去热解痰、抗菌消炎,故咳嗽多痰者饮之有益。
七叶胆:
【性味】:味苦;微甘;性凉。
【功效】:益气健脾,化痰止咳,清热解毒。
绞股蓝皂苷又名七叶胆、甘茶蔓、小苦药、公罗锅底,含有的活性成分,具有降血脂、降血糖、抗肿瘤、抗衰老、保护肝脏及增强肌体免疫功能等作用。
绞股蓝活性成份具有降血脂、降血糖、抗肿瘤、抗衰老、保护肝脏及增强肌体免疫功能等作用。
枸杞子:
【性味】甘,平,入肝、胃二经,兼入肺经;
【功能主治】补肾益精,养肝明目,补血安神,生津止渴,润肺止咳。主治:治中风眩晕,虚劳,诸见血证,咳嗽血,痿、厥、挛,消瘴,伤燥,遗精,赤白浊,脚气,鹤膝风。
野菊花:贵在野生,美在天然;其性微寒、味苦而辛;功用:具有清热解毒之功效。
红花:
【性味】性温,味辛。
【功能主治】活血通径、散瘀止痛。用于经闭、痛经、恶露不行、症瘕痞块、跌打损伤,适用各种静脉曲张,末梢神经炎,血液循环 ,腿脚麻木或青紫等淤血症。
蒲公英:
【性味】甘,微苦,寒。
【主治】清热解毒,消肿散结,上呼吸道感染,眼结膜炎,流行性腮腺炎,乳痈肿痛,胃炎,痢疾,肝炎,胆襄炎,急性阑尾炎,泌尿系感染,盆腔炎,痈疖疔疮, 咽炎,治急性乳腺炎,淋巴腺炎,瘰疠,疔毒疮肿,急性结膜炎,感冒发热,急性扁桃体炎,急性支气管炎、尿路感染。
与现有技术相比:本发明提供了一种治疗心脑血管疾病的中制剂,所采用的枸杞子、小雪人参、三七花、柚子、山楂叶、芦笋、芹菜、佛手、月季花、金银花、玉竹、谷芽、野菊花、红花、蒲公英、紫苏梗、七叶胆均可以起到活血通脉、降压降血脂的功效,还具有滋阴补阳、宽中理气调节人体神经衰弱及抗疲劳,提升人体免疫能力,同时以上中药材具有调和药物口味的功能;其中的枸骨叶、佛手、红花均具有清肝、补肝、平肝火的功能,采用的龙血竭、急性子、大蓑衣藤根、紫苏梗具有活血通络解毒的功能,采用的七叶胆自身还具有降脂降糖、护肝补脑安神,养心保脉的功能,蜂花粉又是一种较名贵的中药材具有极好的益气养血的作用,还具有增强人体综合免疫功能,防治脑心血管疾病,调节肠胃功能,保肝护肝的功效;将蒲黄、龙血竭、急性子、橙叶、大蓑衣藤根、小雪人参、三七花、柚子、山楂叶、侧柏叶、蜂花粉、月见草、芦笋、淫羊藿、紫苏梗、芹菜、佛手、月季花、金银花、玉竹、谷芽、柑桔皮、七叶胆、枸杞子、枸骨叶、野菊花、红花、了哥王、蒲公英、含羞草和山茶油多种药物经过科学的配比进行熬制,充分发挥了各个药物的治疗功能,能够增强心脑血管患者自身的免疫功能,多方面、全方位保护身体健康,具临床用药观察防治心脑血管疾病有显著的效果。
具体实施方式
为使本发明实施例的目的和优点更加清楚,下面将结合实施例对本发明作进一步描述,显然,所描述的实施例是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
实施例1
本实施例的一种优选配方按如下重量配比取料:
蒲黄1g、龙血竭1g、急性子1g、橙叶10g、大蓑衣藤根1g、小雪人参5g、三七花10g、柚子15g、山楂叶10g、侧柏叶10g、蜂花粉10g、月见草1g、芦笋10g、淫羊藿1g、紫苏梗5g、芹菜15g、佛手10g、月季花10g、金银花10g、玉竹10g、谷芽10g、柑桔皮10g、七叶胆5g、枸杞子10g、枸骨叶10g、野菊花10g、红花10g、了哥王10g、蒲公英10g、含羞草1g和山茶油10g。
制备方法:
(1)将柚子、芦笋、芹菜、佛手洗净依次放入榨汁机加一倍量的水,去渣滤液备用;
(2)将橙叶、三七花、月季花、金银花、侧柏叶、蒲公英、枸骨叶、野菊花、红花、山楂叶去除表面杂质,炒干后研碎至200-300目细粉备用;
(3)将龙血竭、急性子、大蓑衣藤根、小雪人参、月见草、淫羊藿、紫苏梗、玉竹、谷芽、柑桔皮、七叶胆、枸杞子、了哥王、含羞草原料组分于砂锅,加两倍量水,先用中火熬制1小时,边熬边加入(1)中备用滤液和(2)中备用细粉,然后改为文火1.5小时煎熬,继续加入蒲黄和蜂花粉文火煎熬1.5小时,趁热过滤残渣,滤液加入山茶油混合均匀即得汤饮剂,一日一剂分三次服用。
实施例2
本实施例的一种最佳配方按如下重量配比取料:
蒲黄3.5g、龙血竭3.5g、急性子3.5g、橙叶12.5g、大蓑衣藤根3.5g、小雪人参8.5g、三七花12.5g、柚子20g、山楂叶12.5g、侧柏叶12.5g、蜂花粉12.5g、月见草3.5g、芦笋15.5g、淫羊藿3.5g、紫苏梗8.5g、芹菜18g、佛手14.5g、月季花12.5g、金银花12.5g、玉竹12.5g、谷芽12.5g、柑桔皮12.5g、七叶胆8.5g、枸杞子12.5g、枸骨叶12.5g、野菊花12.5g、红花12.5g、了哥王12.5g、蒲公英12.5g、含羞草3.5g和山茶油12.5g。
制备方法与实施例相同。
实施例3
本实施例还有一种配方按如下重量配比取料:
蒲黄4.5g、龙血竭4.5g、急性子4.5g、橙叶14.5g、大蓑衣藤根4.5g、小雪人参9.5g、三七花14.5g、柚子25g、山楂叶14.5g、侧柏叶14.5g、蜂花粉14.5g、月见草4.5g、芦笋19.5g、淫羊藿4.5g、紫苏梗9.5g、芹菜20g、佛手19.5g、月季花14.5g、金银花14.5g、玉竹14.5g、谷芽14.5g、柑桔皮14.5g、七叶胆9.5g、枸杞子14.5g、枸骨叶14.5g、野菊花14.5g、红花14.5g、了哥王14.5g、蒲公英14.5g、含羞草4.5g和山茶油14.5g。
制备方法与实施例1相同。
实施例4
本实施例还有一种配方按如下重量配比取料:
蒲黄5g、龙血竭5g、急性子5g、橙叶15g、大蓑衣藤根5g、小雪人参10g、三七花15g、柚子30g、山楂叶15g、侧柏叶15g、蜂花粉15g、月见草5g、芦笋20g、淫羊藿5g、紫苏梗10g、芹菜20g、佛手20g、月季花15g、金银花15g、玉竹15g、谷芽15g、柑桔皮15g、七叶胆10g、枸杞子15g、枸骨叶15g、野菊花15g、红花15g、了哥王15g、蒲公英15g、含羞草5g和山茶油15g。
制备方法与实施例1相同。
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,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的最大给药量为488.8g生药/kg/d(LD 50 >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。
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剂型,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。
动物局部刺激试验:
本发明中药制剂的豚鼠皮肤过敏试验。结果表明:皮肤过敏试验,高剂量组0.8g(药粉)/kg、低剂量组0.1g(药粉) /kg,分别相当于拟临床人用量[0.04g(药粉)/kg]的20倍、2.5倍,经皮肤给药,均未见动物产生变态反应;直肠用药刺激性试验高剂量组5.0g(药粉)/kg,低剂量组3.2g(药粉)/kg,分别相当于拟临床人用量的125、80倍,在规定的时间内观察直肠粘膜均无充血、水肿等现象,病理组织学检查与空白对照组比较无明显差异,未见出现明显的刺激性反应,每组留存的部分动物其全身状况,体重、呼吸、循环、中枢神经系统及四肢活动等,均无明显异常反应。
本发明试验研究:
1 对象与方法 1.1 对象 2015年4月至2017年3月在接诊的心脑血管疾病患者200例,其中男性105 例,女性95 例,随机分成5组,每组40人。
入选标准:以卫生部《中药新药治疗胸痹( 冠心病心绞痛) 临床研究指导原
则》为参考。
1.2本研究实施例组使用本发明中药组合物配方,不采用西医基础疗法,通过与患者协商,征得患者同意后,签署知情同意书并密切合作。1.2.1对照组采用西药降压药,中成药活血化瘀,实施例组服用本发明中药,每服药分3剂,3剂/日,一个月为一个疗程,服用1月后复查。1.3 观察指标 五组患者分别于服用药前、服用药1月后,
1.4 统计学分析 采用SPSS13.0统计学软件,进行数据分析。2 评定/治疗结果 2.1疗效评定标准
治愈:临床症状体征基本消失,心电图缺血性有明显改变,功能活动恢复正常;
好转:临床症状体征大部份消失,心电图缺血性有改变,功能活动基本恢复正常;
无效:临床症状体征没有消失,心电图缺血性无明显改变。
2.2服药组治疗结果统计:
组别 | 治愈 | 好转 | 无效 |
对照组 | 28 | 8 | 4 |
实施例1 | 36 | 4 | - |
实施例2 | 40 | - | - |
实施例3 | 39 | 1 | - |
实施例4 | 39 | 1 | - |
故本发明一种治疗心脑血管疾病的中药制剂有显著效。
本发明的抗衰老保健品进过了诸多临床试验,取得了不同程度的良好表现。现有案例1:患者:胡某某;性别:女;年龄:59岁;表现症状:常年患有高血压、高血糖,胸闷等症状,记忆力衰退易失眠,脸部皱纹较深,通过服用本发明的中药制剂4个月,前2个月每日一剂,之后两个月每2-3天服用一剂,明显改善了患者睡眠质量,脸部红晕有光泽,血压,血糖的到了有效控制,也使得胸闷等症状较少出现。
案例2:患者:张某;性别:男;年龄:63岁;表现症状:患有高血脂、高血压,易挑食,体质差,易生病,排便困难,通过服用本发明的中药制剂3个月,每2-3天服用一次,也使得了血压得到了有效降低,饮食习惯也得到了有效改善,身体体质得到了提高,排便顺畅了很多,无出现任何不良状况出现。
Claims (4)
1.一种治疗心脑血管疾病的中制剂,其特征在于:原料的组分为:蒲黄、龙血竭、急性子、橙叶、大蓑衣藤根、小雪人参、三七花、柚子、山楂叶、侧柏叶、蜂花粉、月见草、芦笋、淫羊藿、紫苏梗、芹菜、佛手、月季花、金银花、玉竹、谷芽、柑桔皮、七叶胆、枸杞子、枸骨叶、野菊花、红花、了哥王、蒲公英、含羞草和山茶油。
2.根据权利要求1所述的一种治疗心脑血管疾病的中制剂,其特征在于:原料的各重量组份为:蒲黄1-5份、龙血竭1-5份、急性子1-5份、橙叶10-15份、大蓑衣藤根1-5份、小雪人参5-10份、三七花10-15份、柚子15-30份、山楂叶10-15份、侧柏叶10-15份、蜂花粉10-15份、月见草1-5份、芦笋10-20份、淫羊藿1-5份、紫苏梗5-10份、芹菜15-20份、佛手10-20份、月季花10-15份、金银花10-15份、玉竹10-15份、谷芽10-15份、柑桔皮10-15份、七叶胆5-10份、枸杞子10-15份、枸骨叶10-15份、野菊花10-15份、红花10-15份、了哥王10-15份、蒲公英10-15份、含羞草1-5份和山茶油10-15份;
制备方法:
(1)将柚子、芦笋、芹菜、佛手洗净依次放入榨汁机加一倍量的水,去渣滤液备用;
(2)将橙叶、三七花、月季花、金银花、侧柏叶、蒲公英、枸骨叶、野菊花、红花、山楂叶去除表面杂质,炒干后研碎至200-300目细粉备用;
(3)将龙血竭、急性子、大蓑衣藤根、小雪人参、月见草、淫羊藿、紫苏梗、玉竹、谷芽、柑桔皮、七叶胆、枸杞子、了哥王、含羞草原料组分于砂锅,加两倍量水,先用中火熬制1小时,边熬边加入(1)中备用滤液和(2)中备用细粉,然后改为文火1.5小时煎熬,继续加入蒲黄和蜂花粉文火煎熬1.5小时,趁热过滤残渣,滤液加入山茶油混合均匀即得汤饮剂,一日一剂分三次服用。
3.根据权利要求1所述的一种治疗心脑血管疾病的中制剂,其特征在于:原料的各重量组份为:蒲黄1.5-4.5份、龙血竭1.5-4.5份、急性子1.5-4.5份、橙叶10.5-14.5份、大蓑衣藤根1.5-4.5份、小雪人参5.5-9.5份、三七花10.5-14.5份、柚子15.5-25份、山楂叶10.5-14.5份、侧柏叶10.5-14.5份、蜂花粉10.5-14.5份、月见草1.5-4.5份、芦笋10.5-19.5份、淫羊藿1.5-4.5份、紫苏梗5.5-9.5份、芹菜15-20份、佛手10.5-19.5份、月季花10.5-14.5份、金银花10.5-14.5份、玉竹10.5-14.5份、谷芽10.5-14.5份、柑桔皮10.5-14.5份、七叶胆5.5-9.5份、枸杞子10.5-14.5份、枸骨叶10.5-14.5份、野菊花10.5-14.5份、红花10.5-14.5份、了哥王10.5-14.5份、蒲公英10.5-14.5份、含羞草1.5-4.5份和山茶油10.5-14.5份。
4.根据权利要求1所述的一种治疗心脑血管疾病的中制剂,其特征在于:原料的各重量组份为:蒲黄3.5份、龙血竭3.5份、急性子3.5份、橙叶12.5份、大蓑衣藤根3.5份、小雪人参8.5份、三七花12.5份、柚子20份、山楂叶12.5份、侧柏叶12.5份、蜂花粉12.5份、月见草3.5份、芦笋15.5份、淫羊藿3.5份、紫苏梗8.5份、芹菜18份、佛手14.5份、月季花12.5份、金银花12.5份、玉竹12.5份、谷芽12.5份、柑桔皮12.5份、七叶胆8.5份、枸杞子12.5份、枸骨叶12.5份、野菊花12.5份、红花12.5份、了哥王12.5份、蒲公英12.5份、含羞草3.5份和山茶油12.5份。
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