CN105412844A - 一种预防和治疗心律不齐的药物制剂及其用途 - Google Patents
一种预防和治疗心律不齐的药物制剂及其用途 Download PDFInfo
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Abstract
本发明涉及一种预防和治疗心律不齐的药物制剂及其用途,包括:山茱萸、丹参、藏红花、黄芪、郁金、川芎、小蓟、莲子、牛蒡子、乌金草、肉桂、玉米须、五味子、甘草、萹蓄、金蚕、梨皮、金银花、栀子、淮小麦、枳实、茯苓。本发明处方经过科学选材,采用本发明保护的制备方法制备出的药物制剂具有显著的预防或治疗心律失常的作用,本发明的药物制剂能够显著延长乌头碱所致大鼠心律失常室博、室速、室颤的出现时间,并能明显减少动物死亡数。经过急性毒性试验和长期毒性试验,其毒副作用低,可以显著提高用药安全性,适合在临床中进一步推广应用。
Description
技术领域
本发明属于中医药领域,尤其是涉及一种预防和治疗心律不齐的药物制剂及其用途。
背景技术
心律失常是心血管疾病领域的常见病、多发病,其发生机制可概括为冲动形成异常、传导异常或冲动形成和传导异常同时存在。在心血管系统疾病中,心律失常是最为严重的病症之一。心律失常的危害在于它不但可加重原有心脏疾病,如加快心力衰竭的进展,而且还可导致患者突然死亡,严重威胁人类健康。缺血性心脏病是诱发室速、室颤等恶性心律失常的主要原因;心力衰竭也是恶性心律失常发生的重要原因;房颤则是最常见的慢性持续性心律失常,可引起血栓栓塞性疾病,增加患者的死亡率。
目前临床上使用的抗心律失常药物有以下类型:Ⅰ类药物——钠通道阻断剂;Ⅱ类药物——β肾上腺素受体阻断剂;Ⅲ类药物——延长动作电位时程药物;Ⅳ类药物——钙通道阻断剂。
在抗心律失常方面,药物的敏感性存在明显的个体差异,有的产生不良的副作用,单向治疗作用的药物可能会产生“致”心律失常作用。因此,有必要开发新的更有效、副作用更小的抗心律失常药物。
心律不齐属中医“臌胀”范畴,由肝、脾、肾三脏功能失调,气滞、血瘀、湿浊内蕴所致,多因饮食不节、嗜酒过度、忧郁劳损、感染湿热火毒、黄疸积聚日久不愈而致肝血疲滞,肝络阻塞,水积于腹中而成,中医在干预心律不齐方面的确有相当的疗效。
目前关于该病的治疗,没有受到足够的重视,西药治疗的副作用较大,中药治疗效果的疗程较长,服用半年或者更长时间,患者依从性较差。
发明内容
针对以上的技术缺陷,本发明提供了一种新的预防或治疗心律失常的药物。
具体而言,本发明的技术方案是这样实现的:
首先,发明人根据中药配伍经验提供了一种预防和治疗心律不齐的药物制剂,包括:山茱萸、丹参、藏红花、黄芪、郁金、川芎、小蓟、莲子、牛蒡子、乌金草、肉桂、玉米须、五味子、甘草、萹蓄、金蚕、梨皮、金银花、栀子、淮小麦、枳实、茯苓。
所述的重量份为:山茱萸10-25份、丹参15-25份、藏红花8-17份、黄芪10-36份、郁金6-18份、川芎3-8份、小蓟4-11份、莲子3-7份、牛蒡子10-25份、乌金草3-12份、肉桂4-8份、玉米须5-15份、五味子1-3份、甘草3-8份、萹蓄5-15份、金蚕1-5份、梨皮5-10份、金银花5-13份、栀子6-14份、淮小麦6-13份、枳实2-7份、茯苓9-16份。
对上述的重量份的配方进行优选,达到更好的技术效果,优选的配方为:山茱萸20份、丹参20份、藏红花11份、黄芪23份、郁金12份、川芎5.5份、小蓟7.5份、莲子5份、牛蒡子17份、乌金草7.5份、肉桂6份、玉米须10份、五味子2份、甘草5.5份、萹蓄10份、金蚕3份、梨皮7.5份、金银花9份、栀子10份、淮小麦10份、枳实5份、茯苓12份。
或者:
山茱萸18份、丹参18份、藏红花8份、黄芪20份、郁金11份、川芎4.5份、小蓟6.5份、莲子4.5份、牛蒡子15份、乌金草6.5份、肉桂5份、玉米须10份、五味子1份、甘草4份、萹蓄9份、金蚕3份、梨皮6.5份、金银花8份、栀子9份、淮小麦9份、枳实4份、茯苓11份。
本发明中所用到的中药的药理作用如下:
黄芪:味甘,性温。
归经:归肺、脾经。
功能主治:补气固表,利尿排毒,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。
山茱萸:味酸,性温。
归经:归肝、肾经。
功能主治:补益肝肾,涩精固脱。用于眩晕耳鸣,腰膝酸痛,阳痿遗精,遗尿尿频,崩漏带下,大汗虚脱。内热消渴。
丹参:味苦,微寒。
归经:归心、肝经。
功能主治:活血祛瘀,通经止痛,清心除烦,凉血消痈,用于胸痹心痛,脘腹胁痛,瘕瘕积聚,热痹疼痛,心烦不眠,月经不调,痛经经闭,疮疡肿痛。
藏红花味甘,平,入心、肝经,活血化瘀通经,凉血解毒,用于经闭癥瘕,产后瘀阻,温毒发斑,忧郁痞闷,惊悸发狂。
郁金:味辛,性寒。
归经:归肝、心、肺经。
功能主治:行气化瘀,清心解郁,利胆退黄。用于经闭痛经,胸腹胀痛、刺痛,热病神昏,癫痫发狂,黄疸尿赤。
川芎:味辛,性温。
归经:归肝、胆、心包经。
功能主治:活血行气,祛风止痛。用于月经不调,经闭痛经,症瘕腹痛,胸胁刺痛,跌扑肿痛,头痛,风湿痹痛。
肉桂:味辛,性热。
归经:归肾、脾、心、肝经。
功能主治:补火助阳,引火归源,散寒止痛,活血通经。用于阳痿,宫冷,腰膝冷痛,肾虚作喘,阳虚眩晕,目赤咽痛,心腹冷痛,虚寒吐泻,寒疝,奔豚,经闭,痛经。
小蓟:味甘,性凉。
归经:归心、肝经。
功能主治:全草:凉血止血,祛瘀消肿。用于衄血,吐血,尿血,便血,崩漏下血,外伤出血,痈肿疮毒。
莲子:味甘,性平。
归经:归脾、肾、心经。
功能主治:补脾止泻,益肾涩精,养心安神。用于脾虚久泻,遗精带下,心悸失眠。
牛蒡子:味辛,性寒。
归经:归肺、胃经。
功能主治:疏散风热,宣肺透疹,解毒利咽。用于风热感冒,咳嗽痰多,麻疹,风疹,咽喉肿痛,痄腮丹毒,痈肿疮毒。
茯苓:味甘、性平。
归经:归心、肺、脾、肾经。
功能主治:利水渗湿,健脾宁心,用于水肿尿少,痰饮眩悸,脾虚食少,便溏泄泻,心神不安,惊悸失眠。
淮小麦:味甘,性平。
归经:入心经,功能养心益气。
功能主治:主治心气不足、胆怯易惊、烦扰脏躁等症。
枳实:味苦,性温。
归经:归脾、胃经。
功能主治:破气消积,化痰散痞。用于积滞内停,痞满胀痛,泻痢后重,大便不通,痰滞气阻胸痹,结胸;胃下垂,脱肛,子宫脱垂。
栀子:味苦,性寒。
归经:归心、肺、三焦经。
功能主治:泻火除烦,清热利尿,凉血解毒。用于热病心烦,黄疸尿赤,血淋涩痛,血热吐衄,目赤肿痛,火毒疮疡;外治扭挫伤痛。
五味子:味酸,性温。
归经:归肺,心、肾经。
功能主治:收敛固涩,益气生津,补肾宁心。用于久嗽虚喘,梦遗滑精,遗尿尿频,久泻不止,自汗,盗汗,津伤口渴,短气脉虚,内热消渴,心悸失眠
甘草:味甘,性平。
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。
萹蓄:味苦,性平。
归经:入肝、牌、胃、大肠经。
功能主治:利屎通淋,化湿杀虫。治恶疮疥癣,阴蚀,蛔虫病。
金银花:味甘,性寒。
归经:归肺、心、胃经。
功能主治:清热解毒,凉散风热,用于痈肿疔疮,喉痹,丹毒,热毒血痢,风热感冒,温病发热。
梨皮:味甘,性凉。
归经:归肺;心;肾;大肠经
功能主治:清心润肺;降火生津,解疮毒。主暑热烦渴;肺燥咳嗽;吐血;痢疾,疥癣;发背;疔疮。
金蚕:味咸,性温。
归经:归肝、脾、肾经。
功能与主治:理气止痛,温中助阳,用于,肝胃气痛,肾虚阳痿,眼干舌燥。
玉米须:味甘,性平
归经:肾;胃;肝;胆经
功能主治:利尿消肿;清肝利胆。主水肿;小便淋沥;黄疸;胆囊炎;胆结石;高血压;糖尿病;乳汁不通
莲子:味甘,性平。
归经:归脾、肾、心经。
功能主治:补脾止泻,益肾涩精,养心安神。用于脾虚久泻,遗精带下,心悸失眠。
牛蒡子:味辛,性寒。
归经:归肺、胃经。
功能主治:疏散风热,宣肺透疹,解毒利咽。用于风热感冒,咳嗽痰多,麻疹,风疹,咽喉肿痛,痄腮丹毒,痈肿疮毒。
乌金草:味甘,性平。
功能主治:平肝风,强心养血,调经,治头晕,神经衰弱,贫血,高血压症,月经不调。小蓟:味甘,性凉。
归经:归心、肝经。
功能主治:凉血止血,祛瘀消肿。用于衄血,吐血,尿血,便血,崩漏下血,外伤出血,痈肿疮毒。
肉桂:味辛,性热。
归经:归肾、脾、心、肝经。
功能主治:补火助阳,引火归源,散寒止痛,活血通经。用于阳痿,宫冷,腰膝冷痛,肾虚作喘,阳虚眩晕,目赤咽痛,心腹冷痛,虚寒吐泻,寒疝,奔豚,经闭,痛经。
川芎:味辛,性温。
归经:归肝、胆、心包经。
功能主治:活血行气,祛风止痛。用于月经不调,经闭痛经,症瘕腹痛,胸胁刺痛,跌扑肿痛,头痛,风湿痹痛。
本发明还提供了一种上述所述药物制剂的制备方法,其主要包含下述步骤:
(1)山茱萸、藏红花、郁金、乌金草、玉米须、梨皮、金银花、淮小麦、和枳实原料加12倍水浸泡,然后煎煮2次,第一次1小时,第二次2小时,合并煎煮液,减压浓缩至相对密度为1.15的浸膏,浸膏和药渣备用;
(2)牛蒡子、栀子、茯苓、五味子、金蚕和萹蓄加入4-8倍65%的乙醇,充分混匀,放置过夜,使其沉淀,24h之后取其上清液,静置24小时,备用;
(3)丹参、黄芪、川芎、莲子、肉桂、甘草和小蓟粉碎成细粉和步骤(1)中药渣混合后用加入3-6倍的75%乙醇提取2次,每次1小时,收集上清液,静置24小时,备用;
(4)取第(2)和(3)步骤中制得的上清液,减压回收乙醇,浓缩至60℃~70℃,密度为1.05的浸膏
(5)步骤(1)和步骤(4)的浸膏混合,可以加入适量的药用辅料,制备成临床上可接受的剂型。
本发明所述的药物制剂在制备预防和治疗心律不齐药物中的应用。
本发明药物可以制成片剂、胶囊剂、颗粒剂或丸剂。制备不同剂型仅所用的成型工艺和辅料不同,药物有效成分还是一样的,治疗效果也相同或近似。片剂的辅料可从淀粉、微晶纤维素、预胶化淀粉、乳糖、糖粉、羧甲淀粉钠等中进行选择;颗粒剂的辅料为蔗糖、糊精及矫味剂等中进行选择,胶囊剂的辅料可从淀粉、微晶纤维素、预胶化淀粉、乳糖、糖粉、羧甲淀粉钠、羧甲纤维素钠、羟丙甲纤维素等中进行选择;丸剂的辅料可从淀粉、微晶纤维素、预胶化淀粉等中进行选择。
本发明所述的中药组合物用于治疗心律不齐,与现有技术相比具有如下优势:
(1)本发明处方经过科学选材,采用本发明保护的制备方法制备出的药物制剂具有显著的预防或治疗心律失常的作用,本发明的药物制剂能够显著延长乌头碱所致大鼠心律失常室博、室速、室颤的出现时间,并能明显减少动物死亡数。
(2)经过急性毒性试验和长期毒性试验,其毒副作用低,可以显著提高用药安全性,适合在临床中进一步推广应用。
具体实施方式
虽然本说明书按照实施方式加以描述,但并非每个实施方式仅包含一个独立的技术方案,说明书的这种叙述方式仅仅是为清楚起见,本领域技术人员应当将说明书作为一个整体,各实施例中的技术方案也可以经适当组合,形成本领域技术人员可以理解的其他实施方式。
实施例1:一种用于预防和治疗心律失常的药物制剂,包括以下重量克中药材:
山茱萸10克、丹参15克、藏红花8-克、黄芪10克、郁金6克、川芎3克、小蓟4克、莲子3克、牛蒡子10克、乌金草3克、肉桂4克、玉米须5克、五味子1克、甘草3克、萹蓄5克、金蚕1克、梨皮5克、金银花5克、栀子6克、淮小麦6克、枳实2克、茯苓9克。
制备成胶囊剂的方法为:
(1)山茱萸、藏红花、郁金、乌金草、玉米须、梨皮、金银花、淮小麦、和枳实原料加12倍水浸泡,然后煎煮2次,第一次1小时,第二次2小时,合并煎煮液,减压浓缩至相对密度为1.15的浸膏,浸膏和药渣备用;
(2)牛蒡子、栀子、茯苓、五味子、金蚕和萹蓄加入4-8倍65%的乙醇,充分混匀,放置过夜,使其沉淀,24h之后取其上清液,静置24小时,备用;
(3)丹参、黄芪、川芎、莲子、肉桂、甘草和小蓟粉碎成细粉和步骤(1)中药渣混合后用加入3-6倍的75%乙醇提取2次,每次1小时,收集上清液,静置24小时,备用;
(4)取第(2)和(3)步骤中制得的上清液,减压回收乙醇,浓缩至60℃~70℃,密度为1.05的浸膏;
(5)步骤(1)和步骤(4)的浸膏混合,称其重量,可以其重量12.5%的淀粉、微晶纤维素混合物(淀粉和微晶纤维素重量用量比为1:1),干燥装入胶囊。
实施例2:一种用于预防和治疗心律失常的药物制剂,包括以下重量克中药材:
山茱萸25克、丹参25克、藏红花17克、黄芪36克、郁金18克、川芎8克、小蓟11克、莲子7克、牛蒡子25克、乌金草12克、肉桂8克、玉米须15克、五味子3克、甘草8克、萹蓄15克、金蚕5克、梨皮10克、金银花13克、栀子14克、淮小麦13克、枳实7克、茯苓16克。
制备方法同实施例1。
实施例3:一种用于预防和治疗心律失常的药物制剂,包括以下重量克中药材:
山茱萸20克、丹参20克、藏红花11克、黄芪23克、郁金12克、川芎5.5克、小蓟7.5克、莲子5克、牛蒡子17克、乌金草7.5克、肉桂6克、玉米须10克、五味子2克、甘草5.5克、萹蓄10克、金蚕3克、梨皮7.5克、金银花9克、栀子10克、淮小麦10克、枳实5克、茯苓12克。
制备方法同实施例1。
实施例4:一种用于预防和治疗心律失常的药物制剂,包括以下重量克中药材:
山茱萸18克、丹参18克、藏红花8克、黄芪20克、郁金11克、川芎4.5克、小蓟6.5克、莲子4.5克、牛蒡子15克、乌金草6.5克、肉桂5克、玉米须10克、五味子1克、甘草4克、萹蓄9克、金蚕3克、梨皮6.5克、金银花8克、栀子9克、淮小麦9克、枳实4克、茯苓11克。
制备方法同实施例1。
实施例5:一种用于预防和治疗心律失常的药物制剂,包括以下重量克中药材:
山茱萸20克、丹参20克、藏红花11克、黄芪23克、郁金12克、川芎5.5克、小蓟7.5克、莲子5克、牛蒡子17克、乌金草7.5克、肉桂6克、玉米须10克、五味子2克、甘草5.5克、萹蓄10克、金蚕3克、梨皮7.5克、金银花9克、栀子10克、淮小麦10克、枳实5克、茯苓12克。
制备颗粒剂的方法为:
(1)山茱萸、藏红花、郁金、乌金草、玉米须、梨皮、金银花、淮小麦、和枳实原料加12倍水浸泡,然后煎煮2次,第一次1小时,第二次2小时,合并煎煮液,减压浓缩至相对密度为1.15的浸膏,浸膏和药渣备用;
(2)牛蒡子、栀子、茯苓、五味子、金蚕和萹蓄加入4-8倍65%的乙醇,充分混匀,放置过夜,使其沉淀,24h之后取其上清液,静置24小时,备用;
(3)丹参、黄芪、川芎、莲子、肉桂、甘草和小蓟粉碎成细粉和步骤(1)中药渣混合后用加入3-6倍的75%乙醇提取2次,每次1小时,收集上清液,静置24小时,备用;
(4)取第(2)和(3)步骤中制得的上清液,减压回收乙醇,浓缩至60℃~70℃,密度为1.05的浸膏;
(5)步骤(1)和步骤(4)的浸膏混合,称其重量,可以其重量10%的蔗糖、糊精混合物(蔗糖、糊精重量用量比为1:1),搅拌均匀加热至80~90℃,过100目筛,用喷雾干燥机制得提取物粉末,分装即得颗粒剂。
实施例6:动物模型试验
乌头碱它主要使迷走神经兴奋,对周围神经损害。中毒症状以神经系统和循环系统的为主,其次是消化系统症状。临床主要表现为口舌及四肢麻木,全身紧束感等,通过兴奋迷走神经而降低窦房结的自律性,引起易位起搏点的自律性增高而引起各心律失常,损害心肌。稳心颗粒的主要成分为党参、黄精、三七、琥珀、甘松。主要治疗养,定悸气脉,阴益复活血化瘀。主治气阴两虚兼心脉瘀阻所致的心悸不宁、气短乏力、头晕心悸、胸闷胸痛,适用于心律失常,室性早搏,房性早搏等属上述症候者。主要用于致命性室性心律失常,本试验选为阳性对照组。本试验采用乌头碱作为心律失常小鼠的试剂,研究本发明药物制剂对心律失常的功能影响。
6.1、动物模型以及给药
健康雄性Wistar大鼠,SPF级,60只,体重180~250g,将买来的小鼠饲养1周适应环境,将大鼠按体重随机分为6组,每组10只,分别为正常对照组、模型对照组、中药组合物低剂量组、中药组合物中剂量组、中药组合物高剂量组、胺碘酮组。各组连续灌胃7天。具体给药剂量如下
正常对照组:等体积的生理盐水
模型对照组:等体积的生理盐水
稳心颗粒组:灌胃给予15mg/kg人参皂苷
中药组合物低剂量组:灌胃给予3g/kg中药组合物
中药组合物中剂量组:灌胃给予6g/kg中药组合物
中药组合物高剂量组:灌胃给予12g/kg中药组合物
6.1.2.实验方法及数据处理
末次给药后25min后除正常对照组外,其它组用20%乌拉坦(5mg/kg)麻醉,并描述6各组的心电图。然后舌背静脉注射0.04%乌头碱(60μg/kg)。实验中观察心律失常出现的类型,室性早搏(VP):连续出现5个以下的室性异位搏动;室性心动过速(VT):连续出现5个以上的室性早搏;心室颤动(VF):QRS波及T波消失,代之一系列大小、形状不同的不规则波动。观测VP的发生时间,并统计VT、VF的发生时间以及动物死亡数。
数据以表示,采用SPSS15.0软件进行方差分析。
6.1.3.结果与讨论
表1马钱苷元对乌头碱诱发大鼠心律失常的保护作用
与模型对照组相比,#P<0.05,##P<0.01;
与阳性对照组相比,¥P<0.05,¥¥P<0.01;
从表1结果表明,正常对照组与模型对照组比较,具有显著性差异(P<0.01)药物制剂各组以及阳性对照组能明显延长VP、VT、VF的出现时间,与模型对照组相比均有显著性差异(P<0.01);并能明显减少动物死亡数,差异有显著性(P<0.01);与阳性对照组比较,药物制剂高剂量组能明显延长VP、VT、VF的出现时间,有显著性差异(P<0.05或P<0.01);并能明显减少动物死亡数,差异有显著性(P<0.01)。本发明中药组合物的心律失常效果明显优于阳性对照组。
6.2、毒性试验
6.2.1、毒性试验
本品因受药液浓度、灌胃给药容积的限制无法测得半数致死量(LD50),因此以最大药液浓度(0.82g/ml)及动物最大给药容积(0.5ml/10g体重)一日内灌胃给药3次(间隔4小时),一日内最大给药剂量为123g/kg。为成年人临床用药剂量(0.33g/kg/d)的372.7倍。连续观察14天,在此剂量下,动物均未出现毒性反应。给药后全部动物体重逐渐增长,14天内动物无一死亡,未见到任何毒性反应,亦未发现毒性靶器官。
6.2.2、长期毒性实验
方法:根据本品的大鼠药效学有效剂量和临床拟用日剂量,本试验设计三个剂量组,一个对照组,为66.6g/kg、22.2g/kg和7.4g/kg组,分别为成年人临床用药剂量的180、60、20倍,对照组给予20倍的生理盐水,每组40只大鼠,雌雄各半,每日口服灌胃给药3次,给药体积2ml/100g体重,每周给药6天,连续给药26周。试验期间对大鼠的外观行为进行观察、对体重、摄食量等指标进行检测,并分别于给药13周末、26末及4周恢复期结束计算脏器系数,进行血液学、血液生化学检测和病理组织学检查。
6.2.3、结果:试验期间,各给药组动物行为活动和外观体。征无异常表现;各给药组动物摄食量、体重增长无明显影响,与对照组比较无显著性差别(P>0.05);各给药组未发现对血液学及血液生化学等指标与药物毒性相关的不良影响,与对照组比较无显著性差别(P>0.05);各给药组动物脏器组织外观形态、位置及脏器切面未见异常,给药13周末、26周末脾脏和胸腺脏器系数与对照组相比无显著差异(P>0.05或P>0.01),其它脏器系数无明显影响(与对照组比较P>0.05);本品66.6g/kg组动物脏器中未发现与药物相关的病理学改变。
6.2.4、结论:通过急性毒性实验和长期毒性试验,结果表明本发明药物制剂既没有急性毒性,也没有长期毒性,亦无延迟性毒性反应,说明本发明药物制剂临床用药安全。
实施例7:临床观察:
7.1、临床资料
本院从共收治了458例心律失常患者进行临床观察治疗。年龄为30-77岁,平均年龄为53.3岁,男228例,女230例。
7.2、治疗方法
治疗组:229例,男114例女115例,口服实施例3的胶囊剂,每次2粒,每日三次,饭后半小时后服用。疗程6周。
观察组:229例,男114例女115例,稳心颗粒次。一水冲服开1袋,一日3次。疗程6周。
7.3、疗效判定标准
疗效标准参照《中医病症判断疗效标准》中有关疗效标准。
治愈:临床症状全部消失,实验室检查正常。
显效:临床症状基本消失,试验室检查各相关指标接近正常水平。
有效:临床症状减轻,试验室检查各相关指标有所改善,体征有改善。
无效:临床症状无明显好转或加重。
7.4、临床结果
6周之后的治疗结果见表2。
表2治疗组和观察组的治疗结果
组别 | 治愈 | 显效 | 有效 | 无效 |
治疗组 | 201 | 12 | 15 | 0 |
观察组 | 165 | 27 | 30 | 7 |
治疗组中治愈201例(87.77%),显效12例,有效15例,无效0例,总有效率为100%;观察组中治愈165例(72.05%),显效27例,有效30例,无效7例。
本发明配制简单,吸收效果好,药效持续时间长,疗效显著,无副作用,安全性高,生产成本低,有利于病患及时减轻病状。
7.5、典型案例
病例1:田某,男,46岁。患者自诉时常具有心悸现象,心跳较快,未认真治疗,后来病情加重,去医院就诊,经检测心跳每分钟100-110次左右,诊断为心律不齐,服用本发明是实施例3的药物制剂治疗,服用20天后,症状明显改善,心跳减缓,继续服用40天后,心跳恢复正常,心电图检查正常,6个月后随访未复发。
病例2:杨某,男,31岁。患者上大学时就检测出心跳加快的现象、近期出现心慌伴有胸闷、胸痛,服过一些中西药物治疗以及针灸治疗,效果欠佳,经家人介绍,来我院就诊,服用本发明是实施例4的药物制剂治疗,服用20天后,症状有所好转,继续服用20天后,症状消失,心电图检查无异常,6个月后随访未复发。
Claims (7)
1.一种预防和治疗心律不齐的药物制剂,其特征在于:其包括以下成分:山茱萸、丹参、藏红花、黄芪、郁金、川芎、小蓟、莲子、牛蒡子、乌金草、肉桂、玉米须、五味子、甘草、萹蓄、金蚕、梨皮、金银花、栀子、淮小麦、枳实、茯苓。
2.根据权利要求1所述的一种预防和治疗心律不齐的药物制剂,其特征在于:所述的药物制剂包括以下重量份成分:山茱萸10-25份、丹参15-25份、藏红花8-17份、黄芪10-36份、郁金6-18份、川芎3-8份、小蓟4-11份、莲子3-7份、牛蒡子10-25份、乌金草3-12份、肉桂4-8份、玉米须5-15份、五味子1-3份、甘草3-8份、萹蓄5-15份、金蚕1-5份、梨皮5-10份、金银花5-13份、栀子6-14份、淮小麦6-13份、枳实2-7份、茯苓9-16份。
3.根据权利要求1所述的一种预防和治疗心律不齐的药物制剂,其特征在于:所述的药物制剂包括以下重量份成分:山茱萸20份、丹参20份、藏红花11份、黄芪23份、郁金12份、川芎5.5份、小蓟7.5份、莲子5份、牛蒡子17份、乌金草7.5份、肉桂6份、玉米须10份、五味子2份、甘草5.5份、萹蓄10份、金蚕3份、梨皮7.5份、金银花9份、栀子10份、淮小麦10份、枳实5份、茯苓12份。
4.根据权利要求1所述的一种预防和治疗心律不齐的药物制剂,其特征在于:所述的药物制剂包括以下重量份成分:山茱萸18份、丹参18份、藏红花8份、黄芪20份、郁金11份、川芎4.5份、小蓟6.5份、莲子4.5份、牛蒡子15份、乌金草6.5份、肉桂5份、玉米须10份、五味子1份、甘草4份、萹蓄9份、金蚕3份、梨皮6.5份、金银花8份、栀子9份、淮小麦9份、枳实4份、茯苓11份。
5.一种制备权利要求1-4任一项所述的药物制剂的方法,其特征在于,具体的步骤为:
(1)山茱萸、藏红花、郁金、乌金草、玉米须、梨皮、金银花、淮小麦和枳实原料加12倍水浸泡,然后煎煮2次,第一次1小时,第二次2小时,合并煎煮液,减压浓缩至相对密度为1.15的浸膏,浸膏和药渣备用;
(2)牛蒡子、栀子、茯苓、五味子、金蚕和萹蓄加入4-8倍65%的乙醇,充分混匀,放置过夜,使其沉淀,24h之后取其上清液,静置24小时,备用;
(3)丹参、黄芪、川芎、莲子、肉桂、甘草和小蓟粉碎成细粉和步骤(1)中药渣混合后用加入3-6倍的75%乙醇提取2次,每次1小时,收集上清液,静置24小时,备用;
(4)取第(2)和(3)步骤中制得的上清液,减压回收乙醇,浓缩至60℃~70℃,密度为1.05的浸膏
(5)步骤(1)和步骤(4)的浸膏混合,可以加入适量的药用辅料,制备成临床上可接受的剂型。
6.根据权利要求5所述的药物制剂的方法,其特征在于,步骤(5)所诉的剂型可以是片剂、胶囊剂、颗粒剂、丸剂。
7.根据权利要求1所述的药物制剂,其特征在于,所述药物制剂在预防和治疗心律不齐中的应用。
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