CN105770520A - 一种用于治疗冠心病的药物制剂及其用途 - Google Patents
一种用于治疗冠心病的药物制剂及其用途 Download PDFInfo
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Abstract
本发明涉及一种用于治疗冠心病的药物制剂及其用途,药物制剂含有:石菖蒲、冰片、熟三七、党参、黄芪、牛蒡子、土鳖虫、车前子、丹参、香附、淫羊藿、白蒺藜、洪连、佩兰、山药、浮小麦、红背马蓝、卷柏、茭白、甘草。本发明采用不同药性的中药材,进行了科学配伍,诸药联合具固本去标、复正除邪之功效,君臣佐使俱全,阴阳均衡,同时注重肾、心、肝、脾等脏腑的机能协调,降脂抗凝、降低血液粘稠度,溶解血栓,诸药相互搭配达到改善血液循环,解除血管痉挛,抗动脉硬化,可有效地治疗心血管***疾病,使药效和功能更为全面而标本兼治。
Description
技术领域
本发明涉及用于治疗冠心病的药物及其用途,特别涉及一种用于治疗冠心病的药物制剂及其用途,属于医药领域。
背景技术
众所周知,冠状动脉性心脏病简称冠心病,是一种最常见的心脏病,是指因冠状动脉狭窄、供血不足而引起的心肌机能障碍和(或)器质性病变,故又称缺血性心脏病,是心脑血管疾病的一种。随着现代生活节奏的加快,心脑血管疾病逐年增加,且呈现出“发病率高、致残率高、死亡率高、复发率高、并发症多”,即“四高一多”的特点。
冠心病是指因冠状动脉狭窄、供血不足而引起的心肌机能障碍和(或)器质性病变,故又称缺血性心肌病。冠心病是一种由冠状动脉器质性(动脉粥样硬化或动力性血管痉挛)狭窄或阻塞引起的心肌缺血缺氧(心绞痛)或心肌坏死(心肌梗塞)的心脏病,亦称缺血性心脏病。冠心病的发生与冠状动脉粥样硬化狭窄的程度和支数有密切关系,同时患有高血压、糖尿病等疾病,以及过度肥胖、不良生活习惯等是诱发该病的主要因素。冠心病是全球死亡率最高的疾病之一,根据世界卫生组织2011年的报告,中国的冠心病死亡人数已列世界第二位。据不完全统计,目前我国心脑血管疾病患者已接近3亿,每年因心脑血管疾病死亡的人数达300多万,而以冠心病最为常见,它成为危害人们健康的重要因素之一。冠心病是动脉粥样硬化导致器官病变的最常见类型,是危害中老年人健康的常见病,并呈现年轻化倾向。冠脉变窄的原因在于:血液中的血脂长期过高、胆固醇日积月累地沉淀在冠状动脉管腔的内膜上,形成地图样斑块,使本来光滑的内膜变的粗糙,柔软的管壁变得僵硬,在此基础上,破裂的血小板也凝聚粘附上去,于是就像河道被淤泥堵塞一样,使冠脉管腔变窄,甚至完全闭塞。冠脉的不畅甚至完全闭塞,造成心肌供血不好,心肌得不到血液的营养而坏死称为心肌梗死,这是冠心病最严重的表现。一旦心肌大面积梗死,又不能快速消除的话,那么人的生命也就结束了。
目前,对于冠心病的治疗,化学药物能很快地缓解症痛,然而普遍具有较大副作用。市场上治疗心脏病的药物种类很多,中药治疗效果优于西药,常规药物对治疗冠心病有一定的疗效,能缓解一定的症状,但效果不确定。
发明内容
针对现有技术的缺陷,本发明是针对目前治疗之现状,提供一种用于治疗冠心病的药物制剂,无毒副作用,效果好。
具体而言,本发明的具体方案是这样实现的:
首先,发明人根据中药配伍经验提供了一种用于治疗冠心病的药物制剂,处方中含有的中药成分为:石菖蒲、冰片、熟三七、党参、黄芪、牛蒡子、土鳖虫、车前子、丹参、香附、淫羊藿、白蒺藜、洪连、佩兰、山药、浮小麦、红背马蓝、卷柏、茭白、甘草。
进一步,发明人根据中药配伍经验提供了一种用于治疗冠心病的药物制剂,处方的各原料用量在本发明的重量份范围都具有较好的疗效,所述的配方以及重量份为:石菖蒲5-13份、冰片4-10份、熟三七13-26份、党参10-20份、黄芪12-23份、牛蒡子10-24份、土鳖虫3-6份、车前子3-8份、丹参8-14份、香附5-10份、淫羊藿6-11份、白蒺藜3-7份、洪连5-9份、佩兰4-9份、山药10-20份、浮小麦11-17份、红背马蓝5-11份、卷柏5-10份、茭白4-11份、甘草6-10份。
更进一步地,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:石菖蒲9份、冰片7份、熟三七20份、党参15份、黄芪16份、牛蒡子17份、土鳖虫4.5份、车前子6份、丹参11份、香附7.5份、淫羊藿8份、白蒺藜5份、洪连7份、佩兰6.5份、山药15份、浮小麦14份、红背马蓝8份、卷柏7.5份、茭白7.5份、甘草8份。或者石菖蒲8份、冰片6份、熟三七22份、党参16份、黄芪17份、牛蒡子18份、土鳖虫5份、车前子6.5份、丹参12份、香附7.5份、淫羊藿9份、白蒺藜5份、洪连7份、佩兰7份、山药15份、浮小麦15份、红背马蓝7份、卷柏8份、茭白7.5份、甘草7份。
上述所述的药物制剂中,所使用的中药均使用其常用入药部位入药,所使用的中药剂量合理,诸药合用后对于治疗冠心病具有较好的治疗的效果,尤其是治疗气虚血瘀型冠心病冠心病。
本发明的治疗冠心病的药物制剂中所使用的各味中药材的功用如下:
冰片:味辛,性寒。
归经:归心、脾、肺经。
功能主治:开窍醒神,清热止痛。用于热病神昏、痉厥,中风痰厥,气郁暴厥,中恶昏迷,目赤,口疮,咽喉肿痛,耳道流脓。
熟三七:味甘、性温。
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,胸腹剌痛,跌扑肿痛。
石菖蒲:味辛而苦,气温,无毒。
功能主治:能开心窍,善通气,止遗尿,安胎除烦闷,能治善忘。
党参:味甘,性平。
归经:归脾、肺经。
功能主治:补中益气,健脾益肺。用于脾肺虚弱,气短心悸,食少便溏,虚喘咳嗽,内热消渴。
牛蒡子:味辛、苦,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。
土鳖虫:味咸,性寒。
归经:归肝经。
功能主治:破瘀血,续筋骨,用于筋骨折伤,瘀血经闭,症瘕痞块
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,***,痛经经闭,疮疡肿痛。
淫羊藿味辛、甘,温,归肝、肾经,补肾阳,强筋骨,祛风湿,用于阳痿遗精,筋骨痿软,风湿痹痛,麻木拘挛,更年期高血压。
白蒺藜:味辛,性温。
功能与主治:平肝解郁,活血祛风,明目止痒用于头痛眩晕,胸胁胀痛,乳闭乳痈,目赤翳障,风疹瘙痒。
洪连:味苦,性寒。
功能主治:清热解毒,降血压,调经。主急慢性肝炎;肾炎;肺脓疡;高血压;月经常不调;乳腺癌。
佩兰:味辛,性平。
归经:归脾、胃、肺经。
功能主治:芳香化湿,醒脾开胃,发表解暑。用于湿浊中阻,脘痞呕恶,口中甜腻,口臭,多涎,暑湿表症,头胀胸闷。
山药:味甘,性平。
归经:归脾、肺、肾经。
功能主治:补脾养胃,生津益肺,补肾涩精。用于脾虚食少,久泻不止,肺虚喘咳,肾虚遗精,带下,尿频,虚热消渴。麸炒山药补脾健胃。用于脾虚食少,泄泻便溏,白带过多。
车前子:味甘,性寒。
归经:归肝、肾、肺、小肠经。
功能主治:清热利尿,渗湿通淋,明目,祛痰。用于水肿胀满,热淋涩痛,暑湿泄泻,目赤肿痛,痰热咳嗽。
浮小麦:味甘,性凉。
归经:归心经。
功效:祛除虚热,养阴生津,提高免疫***抵抗力,提高低抗肿瘤尤其是胃癌的能力。
红背马蓝:味苦,性平
功能主治:活血散瘀;清热解毒。主***;产后恶露不尽;湿热痢疾;疔疮痈肿;跌打损伤;骨折
卷柏:味辛,性平。
归经:归肝、心经。
功能主治:活血通经。用于经闭痛经。癓瘕痞块,跌扑损伤。卷柏炭化瘀止血。用于吐血,崩漏,便血,脱肛。
甘草:味甘,性平。
归经:入脾、胃、心、肺经。
功能主治:补中益气,清热解毒,祛痰止咳,缓急止痛。
香附:味苦,性平。
归经:归肝、脾、三焦经。
功能主治:行气解郁,调经止痛。用于肝郁气滞,胸、胁、脘腹胀痛,消化不良,胸脘痞闷,寒疝腹痛,***胀痛,***,经闭痛经。
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。
党参:味甘,性平。
归经:归脾、肺经。
功能主治:补中益气,健脾益肺。用于脾肺虚弱,气短心悸,食少便溏,虚喘咳嗽,内热消渴。
茭白:味甘;性寒
归经:肝;脾;肺经
功能主治:解热毒;除烦渴;利二便。主烦热;消渴;二便不通;黄疸;痢疾;热淋;目赤;乳汗不下;疮疡
本发明所述的药物剂型选自颗粒剂、胶囊剂、片剂、注射剂、酊剂、栓剂、丸剂、糖浆剂、合剂、散剂、洗剂、膜剂、滴丸中的一种。进一步优选为胶囊剂。
本发明对以上的处方经过认真的研究,根据中医用药的合理性,发明人提出了具体的一种治疗冠心病的药物制剂的制备方法,具体步骤为:
(1)取车前子、石菖蒲、冰片、白蒺藜、洪连、佩兰、山药、浮小麦、红背马蓝、卷柏和茭白加水浸泡1.5小时,武火烧开10min,文火30-60min,煎煮两次,减压浓缩至90℃,密度为1.10的浸膏,备用;
(2)取土鳖虫、香附、淫羊藿、甘草研磨成粗粉加70%乙醇提取2次,每次2小时,合并药液,静置24小时,备用;
(3)取党参、黄芪、牛蒡子和丹参粉碎成细粉用适量70%乙醇提取2次,每次1.5小时,收集提取液,合并药液,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70℃,密度为1.03的浸膏,备用;
(5)将步骤(1)和(4)的浸膏混合均匀加入熟三七得混合物,与药学上可接受的辅料制备成药物制剂。
步骤(1)所述的水和药材的比例为3:1;
上述制备方法中的药物制剂,所述药物制剂制备成颗粒剂,散剂,胶囊剂,丸剂,片剂以及临床上可接受的剂型。其中胶囊剂的制备为加入步骤(5)混合物重量10%的乳糖和糊精的混合物,乳糖和糊精的混合物中乳糖和和糊精的重量比为1:1;搅拌均匀加热至75℃,制粒,干燥并装入胶囊,即得胶囊剂,胶囊重200mg;颗粒剂的辅料可为蔗糖粉、羟甲基纤维素钠、糊精及矫味剂等中进行选择;散剂可从淀粉、白陶土、磷酸钙、沉降碳酸钙等中选择;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;片剂的辅料可从淀粉、糊精、微晶纤维素、预胶化淀粉、硬脂酸镁、乳糖、糖粉、羧甲淀粉钠等中进行选择。
与现有技术相比,本发明治疗冠心病的胶囊剂具有以下优点:
本发明药物的制剂与现有技术相比,注重中医理论,诸药联合具固本去标、复正除邪之功效,君臣佐使俱全,阴阳均衡,同时注重肾、心、肝、脾等脏腑的机能协调,降脂抗凝、降低血液粘稠度,溶解血栓,诸药相互搭配达到改善血液循环,解除血管痉挛,抗动脉硬化,可有效地治疗心血管***疾病,使药效和功能更为全面而标本兼治。
具体实施例
对于本领域技术人员而言,显然本发明实施例的细节,而且在不背离本发明的精神或基本特征的情况下,能够以其他的具体形式实现本发明。均应将实施例看作是示范性的,而且是非限制性的,因此旨在将落在权利要求的等同要件的含义和范围内的所有变化囊括在本发明内。
实施例1:一种治疗冠心病的胶囊剂,包括以下重量份中药材:
石菖蒲5-13克、冰片4-10克、熟三七13-26克、党参10-20克、黄芪12-23克、牛蒡子10-24克、土鳖虫3-6克、车前子3-8克、丹参8-14克、香附5-10克、淫羊藿6-11克、白蒺藜3-7克、洪连5-9克、佩兰4-9克、山药10-20克、浮小麦11-17克、红背马蓝5-11克、卷柏5-10克、茭白4-11克、甘草6-10克。
具体的制备方法为:
(1)取车前子、石菖蒲、冰片、白蒺藜、洪连、佩兰、山药、浮小麦、红背马蓝、卷柏和茭白加水(水和药材的比例为3:1)浸泡1.5小时,武火烧开10min,文火30-60min,煎煮两次,减压浓缩至90℃,密度为1.10的浸膏,备用;
(2)取土鳖虫、香附、淫羊藿、甘草研磨成粗粉加70%乙醇提取2次,每次2小时,合并药液,静置24小时,备用;
(3)取党参、黄芪、牛蒡子和丹参粉碎成细粉用适量70%乙醇提取2次,每次1.5小时,收集提取液,合并药液,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70℃,密度为1.03的浸膏,备用;
(5)将步骤(1)和(4)的浸膏混合均匀加入熟三七得混合物,加入混合物重量10%的乳糖和糊精的混合物,乳糖和糊精的混合物中乳糖和和糊精的重量比为1:1;搅拌均匀加热至75℃,制粒,干燥并装入胶囊,即得胶囊剂,胶囊重200mg。
实施例2:一种治疗冠心病的胶囊剂,包括以下重量份中药材:
石菖蒲5-13克、冰片4-10克、熟三七13-26克、党参10-20克、黄芪12-23克、牛蒡子10-24克、土鳖虫3-6克、车前子3-8克、丹参8-14克、香附5-10克、淫羊藿6-11克、白蒺藜3-7克、洪连5-9克、佩兰4-9克、山药10-20克、浮小麦11-17克、红背马蓝5-11克、卷柏5-10克、茭白4-11克、甘草6-10克。
制备方法同实施例1。
实施例3:一种治疗冠心病的胶囊剂,包括以下重量份中药材:
石菖蒲9克、冰片7克、熟三七20克、党参15克、黄芪16克、牛蒡子17克、土鳖虫4.5克、车前子6克、丹参11克、香附7.5克、淫羊藿8克、白蒺藜5克、洪连7克、佩兰6.5克、山药15克、浮小麦14克、红背马蓝8克、卷柏7.5克、茭白7.5克、甘草8克。
制备方法同实施例1。
实施例4:一种治疗冠心病的胶囊剂,包括以下重量份中药材:
石菖蒲8克、冰片6克、熟三七22克、党参16克、黄芪17克、牛蒡子18克、土鳖虫5克、车前子6.5克、丹参12克、香附7.5克、淫羊藿9克、白蒺藜5克、洪连7克、佩兰7克、山药15克、浮小麦15克、红背马蓝7克、卷柏8克、茭白7.5克、甘草7克。
制备方法同实施例1。
实施例5:动物模型试验
通心络胶囊主要成分为主要成分为人参、水蛭、全蝎、檀香、土鳖虫、蜈蚣、蝉蜕等药味经加工制成的胶囊。主要治疗冠心病,心绞痛等,中风冠止心用络于心绞痛属心气虚乏、血瘀络阻症,症见胸部憋闷、刺痛、绞痛、固定不移、心悸自汗、气短乏力、舌质紫暗或有瘀斑、脉细涩或结代。本发明用来做阳性对照试验。
5.1、气虚血瘀证造模以及给药
选用健康Wistar大鼠,雌雄不拘,月龄(18±3)月,体重280~340g,采用饥饿、疲劳、寒湿、惊恐及高脂饮食多因素造模10d。结果表明:模型鼠出现倦怠嗜睡、不思饮食、毛发稀疏易脱等气虚及舌质绛紫暗淡、皮下瘀紫或青斑等血瘀症状且体重减轻,饮水进食量减少气虚血瘀小鼠建模成功。
空白对照组给予正常饮食,模型对照组和4个治疗组给予饥饿喂养,食量为正常小鼠每日摄食量的55%,饲料为高脂饲料,造模周期为4周。给药量按成人常规剂量折算后的剂量。通心络胶囊灌胃3g/kg,本发明胶囊剂低、中、高剂量组依次灌胃1.5,3,6g/kg,分别为A、B、C组,空白对照组和模型对照组给予等量生理盐水,均1天1次,连续给药4周。
5.2、心肌缺血模型的建立
气虚血瘀证造模周期结束后,进行心肌缺血模型的复制。6组按30单位/kg剂量注射垂体后叶素,记录注射时间,15min后,乌拉坦1μg/g麻醉小鼠,心电图机记录小鼠注射垂体后叶素后一定时间的Ⅱ导联心电图,通过软件记录数据,观察心率和T波高度变化来判断心肌缺血造模是否成功。如表1
5.3、检测指标
血栓素B2(TXB2)和6酮***素F1α(6-keto-PGF1α)是一对反映血小板聚集功能与血管收缩舒张的常用指标。心电图检测完成后,立即摘小鼠眼球取血,血液不经任何处理,于室温放置。低温下3500r/min离心15min,取上层血清检测TXB2、6-keto-PGF1α含量,操作严格按照试剂盒说明书进行。酶标仪测定吸光度值,进行数据统计。如表2.
5.4、统计学方法
采用SPASS22.0统计分析软件处理。
表1各组小鼠的心率和T波高度
心率/(次/min) | T波幅度/mV | |
空白对照组 | 363.39±25.36 | 0.269±0.059 |
模型对照组 | 401.27±22.36## | 0.209±0.077## |
阳性对照组 | 397.69±21.54## | 0.127±0.063## |
C组 | 390.27±18.65## | 0.125±0.071## |
B组 | 395.38±19.36## | 0.128±0.054## |
A组 | 392.22±22.10## | 0.130±0.049## |
注:
与空白对照组相比,#P<0.05,##P<0.01;
从表1可以看出,空白对照组与模型对照组、阳性对照组以及A、B、C组相比,具有显著性差异(P<0.01),说明气虚血瘀模型小鼠造模成功。
表2各组TXB2和6-keto-PGF1α
注:
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。
从表2可以看出,TXB2和6-keto-PGF1α空白对照组与模型对照组相比,具有显著性差异(P<0.01),阳性对照组以及A、B、C组与模型对照组相比,均具有显著性差异(P<0.05或P<0.01),其中C组与阳性对照组相比具有显著性差异(P<0.05),进一步证实本发明的胶囊剂适合进一步临床试验。
实施例6:动物模型试验和体外实验
将实施例1、2、4制备的胶囊剂替代实施例6中使用的实施例3的胶囊剂,重复实施例5,结果发现实施例1、2、4制备的胶囊剂在治疗气虚血瘀证冠心病的治疗效果仍具有同等效力,进一步证实了本发明重量份中药材在治疗组的作用。
实施例7:临床试验
7.1、一般资料
从2009年1月~2015年1月入住医院,心内科213例心血管神经症患者为入选对象,年龄25~60岁,平均41.5岁,其中男109例,女104例;病程2月~13年,平均病程2.47年。平均分成两组,分别为治疗组和观察组,两组之间性别、病情、饮食等因素无显著性差异(P>0.05)。
7.2、诊断标准
均主诉心悸、呼吸困难、心前区疼痛或心自主神经功能紊乱症状(多汗、手足发冷、双手震颤、尿频等),伴随多梦、失眠、心烦、头晕、耳鸣等;通过详细的体格检查和必要的辅助检查,排除各种器质性心脏病;且参照《中药新药治疗心悸的临床试验指导原则》、《中医心病诊断疗效标准与用药规范》制定。中医以心悸、气短、胸闷、胸痛四大症状为着眼点排除标准:有脑、肺、肝、肾等重要脏器疾患;患者及其家属不同意入选为研究对象。
7.3、试验方法
]治疗前两周停用其它抗失眠药物。
治疗组:107例,男55例,女52例,采用本发明药物实施例3的胶囊剂治疗。每日2次,每次3粒,10天一个疗程,连续3个疗程,随访6个月。
对照组:106例,男54例,女52例,复心胶囊口服.一次2-4粒.一日3次.、欣康缓释片一天一次,一次1片,10天一个疗程,连续3个疗程,随访6个月。
7.3、疗效的评定
治愈:自觉症状全部消失,不影响工作和生活;
好转:自觉症状部分消失,轻度影响工作和生活;
无效:自觉症状无改善或加重;
复发率:(治愈+好转)又复发的个体/(治愈+好转)。
7.4、统计学方法
所有数据录入SPSS22.0统计软件,以P<0.05为差异有统计学意义。
7.5、结果
两组患者疗效的比较见下表3所示。
表3两组患者疗效的比较表
组别 | 治愈 | 有效 | 无效 | 有效率(%) | 复发率(%) |
治疗组 | 71 | 33 | 3 | 97.2 | 1.9 |
观察组 | 35 | 37 | 34 | 67.9 | 13.9 |
结论:
由表3可以看出,治疗组治愈71例,有效33例,无效3例,复发2例,总有效率97.2%,复发率1.9%;观察组治愈35例,有效37例,无效34例,复发10例,总有效率67.9%,复发率13.9%。上述分析统计结果可见试验组的疗效明显优于对照组,总有效率试验组也明显优于对照组,可见本发明药物可有效治疗气虚血瘀型冠心病。
7.6、典型病例
病例1:牛某,男,63岁,山东临沂人,退休教师,2013年来我院检查,患者自诉有高血脂并发冠心病已有3年,喘息平稳,但轻微劳动平喘息便加重、胸闷、潮热、盗汗,无意识障碍及运动障碍,近来经常出现上述情况,患者心累现象明显,呼吸困难,服用多种西药效果不佳,到我院治疗,服用本发明实施例3的胶囊剂,30天之后,冠心病症状明显好转,继续服用60天停药,患者喘息平稳,心累好转,基本治愈,随访1年没有复发。
病例2:马某,女56岁,江苏盐城人,20142年来我院检查,患者自诉出现胸闷气短及头晕,时伴有心悸,疲劳时加剧,经休息可缓解,曾多次求诊门诊测血压发现血压高,最高可达190/110mmHg。查心电图提示“心肌供血不足”,诊断为冠心病,二型糖尿病,原发性高血压,经朋友介绍,到我院治疗,服用本发明实施例3的胶囊剂,30天之后,冠心病症状明显好转,继续服用60天停药,患者喘息平稳,心累好转,基本治愈,随访1年没有复发。
实施例8:毒性验证
8.1、急性毒性试验
受试中药制剂:本发明实施例1-4所制造的胶囊剂,按1:2加纯化水,制成溶液,备用。试验动物:普通级昆明小鼠,体重20g±5g,雌雄各半,雌性小鼠均无孕。
小鼠灌胃本发明中药胶囊剂配制的溶液,当灌胃剂量达到735.5g生药/kg剂量时,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。
8.1.1、试验结果表明
小鼠灌胃实施例1-4所制造的胶囊剂的最大给药量为735.5g生药/kg/d(LD50>735.5g生药/kg)。本发明的中药粉每日临床用药总量最大为0.15g生药/kg/d;按体重计,小鼠灌胃胶囊剂的耐受量为临床病人的4903.3倍。提示该药急性毒性极低,临床用药安全。
8.2、动物长期毒性试验
受试中药制剂:本发明实施例2-4所得中药胶囊剂,按1:2加纯化水,制成溶液,备用。试验动物:普通级SD大鼠,体重210g±14g,雌雄各半,雌性大鼠均无孕。
8.2.2、方法与结果:
3种中药胶囊剂:均分为高、中、低三个剂量组,单位体重给药量分别为患者服用量的180、60、20倍;将实验鼠随机分成10组,其中9组分别灌胃3种三个剂量的胶囊剂溶液,剩余1组灌胃生理盐水(患者服用量的40倍);所有10组均连续灌胃180天,观察动物全身毒性反应及严重程度,处死后按操作规程检查各部位,并进行血液学,ALT、BUN及心、肝、脾、肺、肾、胃等主要脏器的病理学检查;经过长期喂食,10组大鼠均未出现毒性反应。发育良好。肉眼外观及主要脏器未见异常。外周血象及血清ALT、BUN与对照组比较无病理性改变。病理报告心、肝、脾、肺、肾、胃等均未有意义的改变,因此,认为经病理证实,3种中药胶囊剂对动物无慢性毒性表现。
通过以上两个毒性实验,证明本发明按实施例1-4制作的中药胶囊剂是安全的,无毒副作用的,可以被患者服用。
8.3、人体毒性试验
随机抽取就诊的(疾病患者)患者100例,年龄25~60岁,平均41.5岁,其中男109例,女104例;病程2月~13年,平均病程2.47年,进行毒性评价。
8.3.2、毒性评价
用药前和服用药物持续一个月之后各作一次体检,体检项目:
(1)一般体检项目:体温、脉搏、呼吸;
(2)血、尿、大便常规检查,治疗前后各作一次;
(3)肝功能AST、ALT;肾功能BUN、CR及血糖;心功能CPK、LDH、EKG;凝血功能及血小板。
8.3.3、对毒性评价分级,标准如下:
0级:无毒性症状表现;
l级:轻度毒性症状表现;
2级:中度毒性症状表现;
3级:严重毒性症状表现;
4级:危及生命毒性症状表现;
根据体检结果分析得出,100例(疾病患者)患者中,0级89人,1级11人,3级0人,4级0人。
从疗效及毒性评价上可以看出,本发明药物制剂可以有效地控制(疾病患者)的病变进程,而且毒副作用较小。
观察的100例患者中,服用本发明中药后仅有1例轻度腹泻,出现副反应的几率小。
Claims (9)
1.一种用于治疗冠心病的药物制剂,其特征在于,所述的药物制剂包括以下中药材:石菖蒲、冰片、熟三七、党参、黄芪、牛蒡子、土鳖虫、车前子、丹参、香附、淫羊藿、白蒺藜、洪连、佩兰、山药、浮小麦、红背马蓝、卷柏、茭白、甘草。
2.根据权利要求1所述的药物制剂,其特征在于,所述的药物制剂包括以下重量份中药材:石菖蒲5-13份、冰片4-10份、熟三七13-26份、党参10-20份、黄芪12-23份、牛蒡子10-24份、土鳖虫3-6份、车前子3-8份、丹参8-14份、香附5-10份、淫羊藿6-11份、白蒺藜3-7份、洪连5-9份、佩兰4-9份、山药10-20份、浮小麦11-17份、红背马蓝5-11份、卷柏5-10份、茭白4-11份、甘草6-10份。
3.根据权利要求1所述的药物制剂,其特征在于,所述的药物制剂包括以下重量份中药材:石菖蒲9份、冰片7份、熟三七20份、党参15份、黄芪16份、牛蒡子17份、土鳖虫4.5份、车前子6份、丹参11份、香附7.5份、淫羊藿8份、白蒺藜5份、洪连7份、佩兰6.5份、山药15份、浮小麦14份、红背马蓝8份、卷柏7.5份、茭白7.5份、甘草8份。
4.根据权利要求1所述的药物制剂,其特征在于,所述的药物制剂包括以下重量份中药材:石菖蒲8份、冰片6份、熟三七22份、党参16份、黄芪17份、牛蒡子18份、土鳖虫5份、车前子6.5份、丹参12份、香附7.5份、淫羊藿9份、白蒺藜5份、洪连7份、佩兰7份、山药15份、浮小麦15份、红背马蓝7份、卷柏8份、茭白7.5份、甘草7份。
5.根据权利要求1所述的药物制剂,其特征在于:所述的药物剂型选自颗粒剂、胶囊剂、片剂、注射剂、酊剂、栓剂、丸剂、糖浆剂、合剂、散剂、洗剂、膜剂、滴丸中的一种。
6.根据权利要求5所述的药物制剂,其特征在于,所述的药物剂型选自胶囊剂,胶囊的重量为200mg。
7.一种权利要求1所述的药物制剂的制备方法,其特征在于,具体的步骤为:
(1)取车前子、石菖蒲、冰片、白蒺藜、洪连、佩兰、山药、浮小麦、红背马蓝、卷柏和茭白加水浸泡1.5小时,武火烧开10min,文火30-60min,煎煮两次,减压浓缩至90℃,密度为1.10的浸膏,备用;
(2)取土鳖虫、香附、淫羊藿和甘草研磨成粗粉加70%乙醇提取2次,每次2小时,合并药液,静置24小时,备用;
(3)取党参、黄芪、牛蒡子和丹参粉碎成细粉用适量70%乙醇提取2次,每次1.5小时,收集提取液,合并药液,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70℃,密度为1.03的浸膏,备用;
(5)将步骤(1)和(4)的浸膏混合均匀加入熟三七得混合物,与药学上可接受的辅料制备成药物制剂。
8.根据权利要求1所述的药物制剂,其特征在于,所述的药物制剂在在制备治疗冠心病的药物中的用途。
9.根据权利要求1所述的药物制剂,其特征在于,所述的药物制剂在在制备治疗气虚血瘀型冠心病的药物中的用途。
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