CN104398671A - 治疗寒痰型哮喘的中药组合物制剂及制法 - Google Patents
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Abstract
本发明公开了一种治疗寒痰型哮喘的中药组合物制剂,取下述重量配比的主要原料制备而成:焦白术5-10份;卤碱4-6份;杏仁8-12份;沉香5-10份;诃子4-8份;茯苓6-15份;积雪草8-16份;陈皮8-15份;莨菪叶5-9份;没食子6-9份。符合中医关于治疗哮喘的理论,各中药原料经辨证配伍,具有润肺化痰、疏通气管、止咳平喘的功效。全面调理肺部内环境,扶正固本,恢复机体正常活动,药效更强劲持久,且对身体无任何的伤害,安全可靠。
Description
技术领域
本发明涉及中医中药领域,特别是涉及一种治疗寒痰型哮喘的中药组合物制剂及制法。
背景技术
哮喘是由多种细胞特别是肥大细胞、嗜酸性粒细胞和T淋巴细胞参与的慢性气道炎症,在易感者中此种炎症可引起反复发作的喘息,气促、胸闷和(或)咳嗽等症状,多在夜间和(或)凌晨发生,气道对多种刺激因子反应性增高。但症状可自行或经治疗缓解。近十余年来,美国、英国、澳大利亚,新西兰等国家哮喘患病率和死亡率有上升趋势,全世界约有一亿哮喘患者,已成为严重威胁公众健康的一种主要慢性疾病,我国哮喘的患病率约为1%,儿童可达3%,据测算全国约有1千万以上哮喘患者。
典型的哮喘,发作前有先兆症状如打喷嚏,流涕,咳嗽,胸闷等,如不及时处理,可因支气管阻塞加重而出现哮喘,严重者可被迫采取坐位或呈端坐呼吸,干咳或咯大量白色泡沫痰,甚至出现紫绀等,但一般可自行或用自行或用平喘药物等治疗后缓解,某些患者在缓解数小时后可再次发作,甚至导致哮喘持续状态。此外,在临床上还存在非典型表现的哮喘,如咳嗽变异型哮喘,患者在无明显诱因咳嗽2个月以上,夜间及凌晨常发作,运动,冷空气等诱发加重,气道反应性测定存在有高反应性,抗生素或镇咳,祛痰药治疗无效,使用支气管解痉剂或皮质激素有效,但需排除引起咳嗽的其他疾病。根据有无过敏原和发病年龄的不同,临床上分为外源性哮喘和内源性哮喘,外源性哮喘常在童年,青少年时发病,多有家族过敏史,为Ⅰ型变态反应,内源性哮喘则多无已知过敏源,在成年人发病,无明显季节性,少有过敏史,可能由体内感染灶引起。
目前,治疗哮喘的药物也有很多,针对上述问题,公开号CN 102600336 A (申请号201210091449.4)的专利文献公开了一种治疗哮喘的药剂,它是由下列原料药按重量份计制成:木贼草1-10份、香附1-10份、麻黄1-5份、陈皮1-5份、鸡内金1-5份、半夏1-10份、葶苈子1-5份、远志1-5份、桔梗1-5份、桂枝1-10份、没药1-10份、五味子1-5份。公开号CN 101850079 A(申请号200910242153.6)的专利文献公开了一种治疗哮喘的中药,采用中药原料制备,配方为(按重比):橘红4-30份、灵芝2-12份、当归4-30份、苍术4-30份、三七3-20份、薏苡仁4-30份,这种治疗哮喘的中药是由下列方法制成的:(1)按上述重量比,将橘红、当归、苍术、薏苡仁经常规水提取工艺提取,制成浸膏细粉;(2)按上述重量比,将灵芝、三七分别研成细粉,与上述浸膏细粉混合,搅拌均匀;根据需要,可制成中药冲剂、颗粒剂、散剂、胶囊剂、水丸剂、片剂等剂型。公开号CN 102145144 A(申请号201110084709.0)的专利文献公开了一种治疗哮喘的中药制剂,是由以下重量配比的原料药制成:葶苈子40-60份、射干40-65份、黄岑30-45份、海蛤壳20-30份、百部20-35份、诃子20-30份、桑白皮15-25份、前胡30-45份、旋复花25-40份、款冬花10-20份、钩藤20-35份、天花粉25-35份、乌梅35-55份、紫苏子3-10份、白芥子20-30份、五味子25-35份、茯苓20-30份、紫石英20-30份、石韦15-30份、玉竹30-45份、代赭石30-45份、鳖甲20-35份、淫羊藿18-35份、枳实10-20份、熟地黄15-35份、玄参8-20份、附子12-18份、山药8-20份、泽泻10-18份、升麻20-30份、槟榔5-12份、知母15-30份。制备步骤如下:按配方比例称取各味药物,将中药材分别用水洗净,在温度115-120℃与压力0.2-0.3Mpa条件下灭菌30-35分钟,再粉碎至100目的细粉,然后制成药剂学所说的片剂、颗粒剂、丸剂或胶囊。
包括上述专利文献在内的现有技术在治疗哮喘方面还存在诸多不足,目前对哮喘的治疗多以抗炎为主,同时使用激素类的药,虽有一定疗效,但同时也产生了诸多副反应,多数只能短时间内缓解喘息、呼吸不畅等症状,但药性一过,就会出现干咳、咯大量白色泡沫痰,甚至出现紫绀等病情加速恶化的现象,导致病情愈发严重,更有患者形成激素依赖。
发明内容
针对现有技术的不足,本发明的目的之一在于提供一种治疗寒痰型哮喘的中药组合物制剂,采用地方上较为多见的中药材作为原料,各中药原料经辨证配伍。本发明的另一目的就是提供上述治疗寒痰型哮喘的中药组合物制剂的制备方法。
本发明的上述目的是通过以下技术方案来实现的:
治疗寒痰型哮喘的中药组合物制剂,取下述重量配比的主要原料制备而成:焦白术5-10份;卤碱4-6份;杏仁8-12份;沉香5-10份;诃子4-8份;茯苓6-15份;积雪草8-16份;陈皮8-15份;莨菪叶5-9份;没食子6-9份。
治疗寒痰型哮喘的中药组合物制剂,优选的方案为,取下述重量配比的主要原料制备而成:焦白术6-9份;卤碱4.5-5.5份;杏仁9-11份;沉香6-9份;诃子5-7份;茯苓9-12份;积雪草11-13份;陈皮10-13份;莨菪叶6-8份;没食子7-8份。
治疗寒痰型哮喘的中药组合物制剂,更加优选的方案为,取下述重量配比的主要原料制备而成:焦白术8份;卤碱5份;杏仁10份;沉香8份;诃子6份;茯苓11份;积雪草12份;陈皮12份;莨菪叶7份;没食子7.5份。
本发明还提供了将上述治疗寒痰型哮喘的中药组合物制剂制成药学上可接受的丸剂、喷雾剂、口服液和糖浆的制备方法。
所述治疗寒痰型哮喘的中药组合物制剂丸剂的制备方法,步骤如下:
(1)将卤碱打碎,置容器内,加等量水溶解,用多层纱布过滤至澄清,滤液置搪瓷盆内蒸发,烘干,研成粉末;
(2)将锅烧热,撒上浸湿的米,使其平贴锅上,用中火加热,至米冒烟时放入杏仁和诃子,轻轻翻动药材,中火炒20-30分钟(优选的,中火炒23-27分钟,更加优选的,中火炒25分钟),取出,筛去米,放凉,连同焦白术共研成细粉,过100-140目筛(优选的,过110-130目筛,更加优选的,过120目筛);
(3)将沉香、茯苓、陈皮和没食子置于砂锅中,加水煎煮40-60分钟(优选的,煎煮45-55分钟,更加优选的,煎煮50分钟),加入积雪草和莨菪叶,继续煎煮两次,每次煎煮20-40分钟(优选的,每次煎煮25-35分钟,更加优选的,每次煎煮30分钟),两次滤液合并,将所得滤液浓缩至原体积的1/2,加入步骤(1)-(2)所得物,混匀,浓缩(45℃)至相对密度为1.10-1.20(优选的,浓缩至相对密度为1.13-1.17,更加优选的,浓缩至相对密度为1.15),加入淀粉,混匀,制成手捏成团压之即散的软材,过80-120目筛(优选90-110目筛,更加优选100目筛),烘干,粉碎,得药粉;
(4)将蜂蜜置于锅内,用文火熬炼,等蜂蜜熬至粘稠状,掺入步骤(3)所得的药粉,充分拌匀成药膏,按中医传统制丸方法制成药丸(优选的,药丸的直径为3-5mm,更加优选的,药丸的直径为4mm),即得丸剂。
服用方法:每次6-8丸,每日3次,2天一个疗程。
根据上面所述的制备方法,优选的方案在于:步骤(4)蜂蜜的用量是药粉质量的10%-20%(优选的,蜂蜜的用量是药粉质量的15%)。
所述治疗寒痰型哮喘的中药组合物制剂喷雾剂的制备方法,步骤如下:
(1)将卤碱打碎,置容器内,加等量水溶解,用多层纱布过滤至澄清,滤液备用;
(2)将焦白术、沉香和诃子置于玻璃容器中,加入2-4倍的浓度为70%-80%的乙醇,加热回流提取两次,合并提取液,滤液回收乙醇至无醇味;
(3)将沉香、茯苓、陈皮和没食子置于砂锅中,加入步骤(1)所得滤液,加水煎煮40-60分钟(优选的,煎煮45-55分钟,更加优选的,煎煮50分钟),加入积雪草和莨菪叶,继续煎煮两次,每次煎煮20-40分钟(优选的,每次煎煮25-35分钟,更加优选的,每次煎煮30分钟),两次滤液合并,将所得滤液浓缩至原体积的1/2;
(4)将步骤(2)和步骤(3)所得液体混合,加入单糖浆,灭菌4-8分钟(优选的,灭菌5-7分钟,更加优选的,灭菌6分钟),混合均匀辅以药学上可接受的载体包装。
根据上面所述的制备方法,优选的方案在于:步骤(4)单糖浆的用量是液体质量的6%-10%(优选的,单糖浆的用量是液体质量的8%)。
使用方法:使用时向口腔内喷药,每天喷药3-5次,每次喷2-3下,2天为一个疗程。
所述治疗寒痰型哮喘的中药组合物制剂口服液的制备方法,步骤如下:
(1)将卤碱打碎,置容器内,加等量水溶解,用多层纱布过滤至澄清,滤液备用;
(2)将焦白术、沉香和诃子置于玻璃容器中,加入2-4倍的浓度为70%-80%的乙醇,加热回流提取两次,合并提取液,滤液回收乙醇至无醇味;
(3)将沉香、茯苓、陈皮和没食子置于砂锅中,加入步骤(1)所得滤液,加水煎煮40-60分钟(优选的,煎煮45-55分钟,更加优选的,煎煮50分钟),加入积雪草和莨菪叶,继续煎煮两次,每次煎煮20-40分钟(优选的,每次煎煮25-35分钟,更加优选的,每次煎煮30分钟),两次滤液合并;
(4)将步骤(2)和步骤(3)所得液体混合,加入相对于液体质量的8%的单糖浆,混匀,高温杀菌10-20分钟(优选的,高温杀菌13-17分钟,更加优选的,高温杀菌15分钟),以每支6ml的规格进行无菌封装。
服用方法:每次1支,每日3次,2天一个疗程。
所述治疗寒痰型哮喘的中药组合物制剂糖浆的制备方法,步骤如下:
(1)将卤碱打碎,置容器内,加等量水溶解,用多层纱布过滤至澄清,滤液置搪瓷盆内蒸发,烘干,研成粉末;
(2)将锅烧热,撒上浸湿的米,使其平贴锅上,用中火加热,至米冒烟时放入杏仁和诃子,轻轻翻动药材,中火炒20-30分钟(优选的,中火炒23-27分钟,更加优选的,中火炒25分钟),取出,筛去米,放凉,连同焦白术共研成细粉,过100-140目筛(优选的,过110-130目筛,更加优选的,过120目筛);
(3)将沉香、茯苓、陈皮和没食子置于砂锅中,加水煎煮40-60分钟(优选的,煎煮45-55分钟,更加优选的,煎煮50分钟),加入积雪草和莨菪叶,继续煎煮两次,每次煎煮20-40分钟(优选的,每次煎煮25-35分钟,更加优选的,每次煎煮30分钟),两次滤液合并,将所得滤液浓缩至原体积的1/2,加入步骤(1)-(2)所得物,混匀,浓缩(25℃)至相对密度为1.10-1.20(优选的,浓缩至相对密度为1.13-1.17,更加优选的,浓缩至相对密度为1.15);
(4)取相对于稠膏质量的10%的冰糖,置于锅中,加水熬制(水的用量是冰糖用量的3倍),可听见冰糖在水里噼里啪啦的声音,待冰糖完全融化后停火;
(5)将步骤(3)所得稠膏与步骤(4)所得冰糖水混合,加入山梨酸,混合均匀,无菌封装。
根据上面所述的制备方法,优选的方案在于:步骤(5)山梨酸的用量是浓缩液质量的0.02%-0.04%(优选的,山梨酸的用量是浓缩液质量的0.03%)。
本发明的有益效果主要体现在:
服用方法:每次6-8g,用35-40℃的温开水冲服,每日3次,2天一个疗程。
1、本发明治疗寒痰型哮喘的中药组合物制剂,符合中医关于治疗哮喘的理论,各中药原料经辨证配伍,在作用上相铺相成,具有润肺化痰、益肺补肾、疏通气管、止咳平喘的功效。适合治疗急慢性支气管炎、支气管哮喘等,疗效显著。
2、全面调理肺部内环境,扶正固本,恢复免疫功能,机体正常活动,药效更强劲、持久,有效治愈哮喘病症。
3、对哮喘缓解期的治疗重视扶正固本,使哮喘发作次数明显减少,间隔时间延长,提高了患者的生活质量。
4、避免了口服西药的副作用大的缺陷,同时克服了对激素药容易形成依赖性的不足,本发明无副作用,且对身体无任何的伤害,安全可靠。
具体实施方式
下面结合实施例和实验例详细说明本发明的技术方案,但保护范围不被此限制。
各原料药的药理功效分别为:
焦白术:味苦、甘,性温。归脾、胃经。为药材白术炮制加工后的饮片。炮制方法:取白术片,置热锅内,用中火(150-180℃)炒至表面焦褐色,喷水少许,熄灭火星,取出,晾凉,过筛。而白术为菊科植物白术的根茎。具有健脾止泻的功效。用于脾虚泄泻,久痢,或妇女的淋带白浊等症。
卤碱:味苦,性寒,无毒。亦名卤盐、寒石、石碱。从碱地掘取,用作硝皮。为为矿物盐凝结的卤水块,4种的主要化学成分均为镁和氯。强心,利尿,镇静,消炎,降血压。用于克山病,大骨节病,地方性甲状腺肿,风湿性关节炎,矽肺,高血压病。
杏仁:味苦,性微温。杏仁富含蛋白质、脂肪、糖类、胡萝卜素、B族维生素、维生素C、维生素P以及钙、磷、铁等营养成分。其中胡萝卜素的含量在果品中仅次于芒果,人们将杏仁称为抗癌之果。杏仁含有丰富的脂肪油,有降低胆固醇的作用,因此,杏仁对防治心血管系统疾病有良好的作用;中医中药理论认为,杏仁具有生津止渴、润肺定喘的功效,常用于肺燥喘咳等患者的保健与治疗。
沉香:味辛、苦,性微温。归脾、胃、肾经。为瑞香料植物白木香含有树脂的木材。具有行气止痛,温中止呕,纳气平喘的功效。用于胸腹胀闷疼痛,胃寒呕吐呃逆,肾虚气逆喘急。
诃子:味苦、酸、涩,性平。归肺、大肠经。为使君子科植物河子或绒毛河子的干燥成熟果实。具有涩肠敛肺,降火利咽的功效。用于久泻久痢,便血脱肛,肺虚喘咳,久嗽不止,咽痛音哑。
茯苓:味甘、淡,性平。归心、肺、脾、肾经。俗称云苓、松苓、茯灵,为多孔菌科真菌茯苓的干燥菌核。具有利水渗湿,健脾宁心的功效。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。
积雪草:味苦、辛,性寒。归肝、脾、肾经。为伞形科植物积雪草的干燥全草。具有清热利湿,解毒消肿的功效。用于湿热黄疸,中暑腹泻,砂淋血淋,痈肿疮毒,跌扑损伤。
陈皮:味苦、辛,性温。归肺、脾经。为芸香科植物橘及其栽培变种的干燥成熟果皮。具有理气健脾,燥湿化痰的功效。用于胸脘胀满.食少吐泻,咳嗽痰多。
莨菪叶:味苦,性寒,有大毒。别名铃铛草、麻性草。为茄科植物莨菪的叶片。莨菪叶含灰分20%,总生物碱0.045-0.14%,其中主要是天仙子胺、东莨菪碱及阿托品;另含一种苦甙名天仙子苦甙。具有镇痛,解痉的功效。用于胃痛,齿痛,气管炎咳喘。
没食子:味苦,性温。归肺、脾、肾经。为没食子蜂科昆虫没食子蜂的幼虫寄生于壳斗科植物没食子树幼枝上所产生的虫瘿。具有涩肠、固精、止咳、止血、敛疮的功效。用于久泻久痢,遗精,盗汗,咳嗽,咯血,便血,创伤出血,疮疡久不收口,口疮,齿痛。
实施例1 治疗寒痰型哮喘的中药组合物制剂,取下述主要原料制备而成(每份取50g):焦白术5份;卤碱4份;杏仁8份;沉香5份;诃子4份;茯苓6份;积雪草8份;陈皮8份;莨菪叶5份;没食子6份。
上述治疗寒痰型哮喘的中药组合物制剂丸剂的制备方法,步骤如下:
(1)将卤碱打碎,置容器内,加等量水溶解,用多层纱布过滤至澄清,滤液置搪瓷盆内蒸发,烘干,研成粉末;
(2)将锅烧热,撒上浸湿的米,使其平贴锅上,用中火加热,至米冒烟时放入杏仁和诃子,轻轻翻动药材,中火炒25分钟,取出,筛去米,放凉,连同焦白术共研成细粉,过120目筛;
(3)将沉香、茯苓、陈皮和没食子置于砂锅中,加水煎煮50分钟,加入积雪草和莨菪叶,继续煎煮两次,每次煎煮30分钟,两次滤液合并,将所得滤液浓缩至原体积的1/2,加入步骤(1)-(2)所得物,混匀,浓缩(45℃)至相对密度为1.15,加入淀粉,混匀,制成手捏成团压之即散的软材,过100目筛,烘干,粉碎,得药粉;
(4)将相对于药粉质量的15%的蜂蜜置于锅内,用文火熬炼,等蜂蜜熬至粘稠状,掺入步骤(3)所得的药粉,充分拌匀成药膏,按中医传统制丸方法制成直径为4mm的药丸。
服用方法:每次6-8丸,每日3次,2天一个疗程。
典型病例一:王XX,女,52岁,工人,山东省淄博市博山县人。十多年前因受凉出现咳嗽,咯痰,当时并没有太在意,自服了一些止咳的药物,咳嗽有所缓解。只是不到半个月,再次出现咳嗽,并且比第一次来的更加严重,去医院诊断为轻微哮喘,治疗后得到缓解,但接下来的日子里时好时坏,平均每年犯咳嗽2-5次,且病情逐渐加重。近年来因反复感冒,发作时哮喘伴咯浓痰,病情逐渐加重且伴有呼吸困难,胸闷,痰稠不易咳出。走路散步,爬2层楼便会出现呼吸困难。
后来听说本发明治疗寒痰型哮喘的中药组合物制剂的疗效很好,于是服用实施例1所得治疗寒痰型哮喘的中药组合物制剂丸剂,服用完2个疗程后,咳嗽的症状便有所缓解,精神、体力均得到不同程度地恢复。继续服用2个疗程后,体质增强,胸闷、咳嗽、呼吸困难明显缓解。后期的不断追访中得知犯病的频率明显减少了,一年到头来很少再犯。
实施例2 治疗寒痰型哮喘的中药组合物制剂,取下述主要原料制备而成(每份取60g):焦白术6份;卤碱4.5份;杏仁9份;沉香6份;诃子5份;茯苓9份;积雪草11份;陈皮10份;莨菪叶6份;没食子7份。
上述治疗寒痰型哮喘的中药组合物制剂喷雾剂的制备方法,步骤如下:
(1)将卤碱打碎,置容器内,加等量水溶解,用多层纱布过滤至澄清,滤液备用;
(2)将焦白术、沉香和诃子置于玻璃容器中,加入3倍的浓度为75%的乙醇,加热回流提取两次,合并提取液,滤液回收乙醇至无醇味;
(3)将沉香、茯苓、陈皮和没食子置于砂锅中,加入步骤(1)所得滤液,加水煎煮50分钟,加入积雪草和莨菪叶,继续煎煮两次,每次煎煮30分钟,两次滤液合并,将所得滤液浓缩至原体积的1/2;
(4)将步骤(2)和步骤(3)所得液体混合,加入相当于液体质量的8%的单糖浆,灭菌6分钟,混合均匀辅以药学上可接受的载体包装。
使用方法:使用时向口腔内喷药,每天喷药3-5次,每次喷2-3下,2天为一个疗程。
典型病例二:方XX,男,47岁,农民,山东省淄博市沂源县人。反复呼吸困难,伴咳嗽咯痰10余年,10多年前,方先生家附近建起了一个打石场,半年后方先生出现呼吸困难,伴咳嗽,咯大量白色泡沫痰,日轻夜重,症状反复出现。曾多次接受过治疗,也尝试了很多偏方,但治疗效果不理想。近日因呼吸困难加重:呼吸困难,咳嗽并咯白色泡沫样痰,喉中发出阵阵哮鸣音,胸闷,紫绀。诊断为慢性支气管哮喘。
服用实施例2所得治疗寒痰型哮喘的中药组合物制剂喷雾剂,服用完2个疗程后,感觉好受多了,胸痛、气喘、咳嗽都减轻了。于是继续服用2个疗程后,哮喘的症状完全得到缓解,可以过正常的生活了。
实施例3 治疗寒痰型哮喘的中药组合物制剂,取下述主要原料制备而成(每份取40g):焦白术9份;卤碱5.5份;杏仁11份;沉香9份;诃子7份;茯苓12份;积雪草13份;陈皮13份;莨菪叶8份;没食子8份。
上述治疗寒痰型哮喘的中药组合物制剂口服液的制备方法,步骤如下:
(1)将卤碱打碎,置容器内,加等量水溶解,用多层纱布过滤至澄清,滤液备用;
(2)将焦白术、沉香和诃子置于玻璃容器中,加入3倍的浓度为75%的乙醇,加热回流提取两次,合并提取液,滤液回收乙醇至无醇味;
(3)将沉香、茯苓、陈皮和没食子置于砂锅中,加入步骤(1)所得滤液,加水煎煮50分钟,加入积雪草和莨菪叶,继续煎煮两次,每次煎煮30分钟,两次滤液合并;
(4)将步骤(2)和步骤(3)所得液体混合,加入相对于液体质量的8%的单糖浆,混匀,高温杀菌15分钟,以每支6ml的规格进行无菌封装。
服用方法:每次一支,每日3次, 2天一个疗程。
典型病例三:甄XX,男,6岁,山东省烟台市蓬莱市人。出现咳嗽、流涕、喘息症状,于是去医院就诊,当时呼吸困难,胸闷,咳嗽,喉中痰鸣;伴咽干微痛,流涕,打喷嚏。家长述患儿曾反复发作喘息约5-6次,大多由感冒引起。诊断为小儿哮喘。
服用实施例3所得治疗寒痰型哮喘的中药组合物制剂口服液2个疗程后,诸症状缓解,肺部哮鸣音消失,继续服用2个疗程后,呼吸顺畅,咳嗽的症状消失。后期追访中得知患儿已经痊愈。
实施例4治疗寒痰型哮喘的中药组合物制剂,取下述主要原料制备而成(每份取20g):焦白术8份;卤碱5份;杏仁10份;沉香8份;诃子6份;茯苓11份;积雪草12份;陈皮12份;莨菪叶7份;没食子7.5份。
上述治疗寒痰型哮喘的中药组合物制剂糖浆的制备方法,步骤如下:
(1)将卤碱打碎,置容器内,加等量水溶解,用多层纱布过滤至澄清,滤液置搪瓷盆内蒸发,烘干,研成粉末;
(2)将锅烧热,撒上浸湿的米,使其平贴锅上,用中火加热,至米冒烟时放入杏仁和诃子,轻轻翻动药材,中火炒25分钟,取出,筛去米,放凉,连同焦白术共研成细粉,过120目筛;
(3)将沉香、茯苓、陈皮和没食子置于砂锅中,加水煎煮50分钟,加入积雪草和莨菪叶,继续煎煮两次,每次煎煮30分钟,两次滤液合并,将所得滤液浓缩至原体积的1/2,加入步骤(1)-(2)所得物,混匀,浓缩(25℃)至相对密度为1.15;
(4)取相对于稠膏质量的10%的冰糖,置于锅中,加用量是冰糖用量的3倍的水熬制,可听见冰糖在水里噼里啪啦的声音,待冰糖完全融化后停火;
(5)将步骤(3)所得稠膏与步骤(4)所得冰糖水混合,加入相当于浓缩液质量0.03%的山梨酸,混合均匀,无菌封装。
服用方法:每次6-8g,用35-40℃的温开水冲服,每日3次,2天一个疗程。
试验例:针对实施例4所得治疗寒痰型哮喘的中药组合物制剂糖浆的疗效检测,我们做了毒性试验和临床试验,具体情况如下:
毒性试验急性毒性试验 选用SPF级昆明小鼠,饲养在方形透明鼠笼中,保证充足的饮水和食物,实验前饲养2-3天,以适应实验环境,并观察其正常生长活动和健康状况。饲养前需要对小鼠的饲养房、笼具、饮水瓶等进行消毒,给药前禁食不禁水12小时。选用正常健康的小鼠20只,雌雄各半,体重18-22g,保证雌性未产、无孕。使用灌胃针对小鼠进行灌胃:将实施例4所得治疗寒痰型哮喘的中药组合物制剂糖浆用温水稀释,将灌胃针由动物口角插入,一般进针深度2.5-3cm,每只小鼠灌胃0.3ml药液,给药后密切观察小鼠的反应,观察15天,试验动物未发现中毒表现、无死亡,解剖未明显异常,判断本发明治疗寒痰型哮喘的中药组合物制剂对小鼠急性毒性属实际无毒级。
长期毒性试验 选用SPF级昆明小鼠,饲养在方形透明鼠笼中,保证充足的饮水和食物,实验前饲养2-3天,以适应实验环境,并观察其正常生长活动和健康状况。饲养前需要对小鼠的饲养房、笼具、饮水瓶等进行消毒。给药前禁食不禁水12小时。选用正常健康的小鼠20只,雌雄各半,体重18-22g,同样保证雌性未产、无孕。服用实施例4所得治疗寒痰型哮喘的中药组合物制剂糖浆用温水稀释,每只小鼠每天控制给药量1g,连续用药7周,停药3周后观察,给药期间每周称体重一次,可观察到饮水量食量均正常,体重增加,无死亡或濒死动物,小鼠的毛发、行为、大小便、脏器重量、血象、肝肾功能、血糖、血脂等指标均无明显影响,脏器肉眼没有发现异样变化。组织学检查结果表明,用药7周及停药3周后,小鼠各脏器均无明显改变,说明本发明治疗寒痰型哮喘的中药组合物制剂对小鼠长期用药后毒性非常小,停药后也没有异样反应,应用安全。
临床试验:为了验证实施例4所得的治疗寒痰型哮喘的中药组合物制剂糖浆的疗效,我们进行了对比试验。试验筛选哮喘患者200人,筛选标准:患者肢软乏力,身上没劲;常常胸闷、喘息、咳嗽、呼吸困难;哮喘呈季节性发作,或者冷哮,或者热哮;哮喘时胸胀气粗,声高息涌,喘不得卧。在确诊观察的对象中,男性97例,女性103 例,无其它严重疾病,年龄为3岁-81 岁,平均年龄49.4 岁。随机地分为对照组和实验组,其中实验组有150人,对照组有50人。实验组:服用实施例4所得治疗寒痰型哮喘的中药组合物制剂糖浆,每次8g,用35-40℃的温开水冲服,每日3次,2天一个疗程;对照组:采用其他治疗方案,比如万托林气雾剂、哮喘胶囊等。我们每天同等时间,同等情况下用药,并同时观察、记录每小组病人的身体状况。疗效情况判定标准:痊愈:5个疗程后,体质增强,身上有劲;胸闷、咳嗽、呼吸困难明显缓解;哮喘发作次数减少,时间较短。显效:5个疗程后,体质增强,身上有劲;胸闷、喘息、咳嗽、呼吸困难有所缓解,但仍需继续治疗。无效:5个疗程后,症状未有任何改善,病情继续发展。其中有效包括痊愈和显效。对照组和实验组的疗效对比,具体情况如表1所示:
表1
疗效分析:从表1可以看出,服用本发明实施例4所得治疗寒痰型哮喘的中药组合物制剂糖浆的疗效远都比使用其他治疗方式的疗效好。其中,从有效率来看,服用实施例4所得治疗寒痰型哮喘的中药组合物制剂糖浆高达98%,而使用其他治疗方式的仅为86%;从治愈率来看,服用实施例4所得治疗寒痰型哮喘的中药组合物制剂糖浆的治愈率高达58%,而使用其他治疗方式的仅为42%。实验表明服用实施例4所得治疗寒痰型哮喘的中药组合物制剂糖浆与采用其他治疗方式相比,其疗效大幅度提高,且治愈率高,无效率低。
最后应说明的是,实施例只是本发明最优的具体实施方式而已,并不用于限制本发明,尽管参照前述实施例对本发明进行了详细的说明,对于本领域的技术人员来说,其依然可以对前述各实施例所记载的技术方案进行修改,或者对其中部分技术特征进行等同替换。凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (10)
1.治疗寒痰型哮喘的中药组合物制剂,其特征是,取下述重量配比的主要原料制备而成:焦白术5-10份;卤碱4-6份;杏仁8-12份;沉香5-10份;诃子4-8份;茯苓6-15份;积雪草8-16份;陈皮8-15份;莨菪叶5-9份;没食子6-9份。
2.根据权利要求1所述的中药组合物制剂,其特征是,取下述重量配比的主要原料制备而成:焦白术6-9份;卤碱4.5-5.5份;杏仁9-11份;沉香6-9份;诃子5-7份;茯苓9-12份;积雪草11-13份;陈皮10-13份;莨菪叶6-8份;没食子7-8份。
3.根据权利要求1所述的中药组合物制剂,其特征是,取下述重量配比的主要原料制备而成:焦白术8份;卤碱5份;杏仁10份;沉香8份;诃子6份;茯苓11份;积雪草12份;陈皮12份;莨菪叶7份;没食子7.5份。
4.根据权利要求1-3任一所述的中药组合物制剂,其特征在于,将该中药组合物制剂制成药学上可接受的丸剂,制备方法是:
(1)将卤碱打碎,置容器内,加等量水溶解,用多层纱布过滤至澄清,滤液置搪瓷盆内蒸发,烘干,研成粉末;
(2)将锅烧热,撒上浸湿的米,使其平贴锅上,用中火加热,至米冒烟时放入杏仁和诃子,轻轻翻动药材,中火炒20-30分钟(优选的,中火炒23-27分钟,更加优选的,中火炒25分钟),取出,筛去米,放凉,连同焦白术共研成细粉,过100-140目筛(优选的,过110-130目筛,更加优选的,过120目筛);
(3)将沉香、茯苓、陈皮和没食子置于砂锅中,加水煎煮40-60分钟(优选的,煎煮45-55分钟,更加优选的,煎煮50分钟),加入积雪草和莨菪叶,继续煎煮两次,每次煎煮20-40分钟(优选的,每次煎煮25-35分钟,更加优选的,每次煎煮30分钟),两次滤液合并,将所得滤液浓缩至原体积的1/2,加入步骤(1)-(2)所得物,混匀,浓缩(45℃)至相对密度为1.10-1.20(优选的,浓缩至相对密度为1.13-1.17,更加优选的,浓缩至相对密度为1.15),加入淀粉,混匀,制成手捏成团压之即散的软材,过80-120目筛(优选90-110目筛,更加优选100目筛),烘干,粉碎,得药粉;
(4)将蜂蜜置于锅内,用文火熬炼,等蜂蜜熬至粘稠状,掺入步骤(3)所得的药粉,充分拌匀成药膏,按中医传统制丸方法制成药丸(优选的,药丸的直径为3-5mm,更加优选的,药丸的直径为4mm),即得丸剂。
5.根据权利要求4所述的中药组合物制剂的制备方法,其特征是:步骤(4)蜂蜜的用量是药粉质量的10%-20%(优选的,蜂蜜的用量是药粉质量的15%)。
6.根据权利要求1-3任一所述的中药组合物制剂,其特征在于,将该中药组合物制剂制成药学上可接受的喷雾剂,制备方法是:
(1)将卤碱打碎,置容器内,加等量水溶解,用多层纱布过滤至澄清,滤液备用;
(2)将焦白术、沉香和诃子置于玻璃容器中,加入2-4倍的浓度为70%-80%的乙醇,加热回流提取两次,合并提取液,滤液回收乙醇至无醇味;
(3)将沉香、茯苓、陈皮和没食子置于砂锅中,加入步骤(1)所得滤液,加水煎煮40-60分钟(优选的,煎煮45-55分钟,更加优选的,煎煮50分钟),加入积雪草和莨菪叶,继续煎煮两次,每次煎煮20-40分钟(优选的,每次煎煮25-35分钟,更加优选的,每次煎煮30分钟),两次滤液合并,将所得滤液浓缩至原体积的1/2;
(4)将步骤(2)和步骤(3)所得液体混合,加入单糖浆,灭菌4-8分钟(优选的,灭菌5-7分钟,更加优选的,灭菌6分钟),混合均匀辅以药学上可接受的载体包装。
7.根据权利要求6所述的中药组合物制剂的制备方法,其特征是:步骤(4)单糖浆的用量是液体质量的6%-10%(优选的,单糖浆的用量是液体质量的8%)。
8.根据权利要求1-3任一所述的中药组合物制剂,其特征在于,将该中药组合物制剂制成药学上可接受的口服液,制备方法是:
(1)将卤碱打碎,置容器内,加等量水溶解,用多层纱布过滤至澄清,滤液备用;
(2)将焦白术、沉香和诃子置于玻璃容器中,加入2-4倍的浓度为70%-80%的乙醇,加热回流提取两次,合并提取液,滤液回收乙醇至无醇味;
(3)将沉香、茯苓、陈皮和没食子置于砂锅中,加入步骤(1)所得滤液,加水煎煮40-60分钟(优选的,煎煮45-55分钟,更加优选的,煎煮50分钟),加入积雪草和莨菪叶,继续煎煮两次,每次煎煮20-40分钟(优选的,每次煎煮25-35分钟,更加优选的,每次煎煮30分钟),两次滤液合并;
(4)将步骤(2)和步骤(3)所得液体混合,加入相对于液体质量的8%的单糖浆,混匀,高温杀菌10-20分钟(优选的,高温杀菌13-17分钟,更加优选的,高温杀菌15分钟),以每支6ml的规格进行无菌封装。
9.根据权利要求1-3任一所述的中药组合物制剂,其特征在于,将该中药组合物制剂制成药学上可接受的糖浆,制备方法是:
(1)将卤碱打碎,置容器内,加等量水溶解,用多层纱布过滤至澄清,滤液置搪瓷盆内蒸发,烘干,研成粉末;
(2)将锅烧热,撒上浸湿的米,使其平贴锅上,用中火加热,至米冒烟时放入杏仁和诃子,轻轻翻动药材,中火炒20-30分钟(优选的,中火炒23-27分钟,更加优选的,中火炒25分钟),取出,筛去米,放凉,连同焦白术共研成细粉,过100-140目筛(优选的,过110-130目筛,更加优选的,过120目筛);
(3)将沉香、茯苓、陈皮和没食子置于砂锅中,加水煎煮40-60分钟(优选的,煎煮45-55分钟,更加优选的,煎煮50分钟),加入积雪草和莨菪叶,继续煎煮两次,每次煎煮20-40分钟(优选的,每次煎煮25-35分钟,更加优选的,每次煎煮30分钟),两次滤液合并,将所得滤液浓缩至原体积的1/2,加入步骤(1)-(2)所得物,混匀,浓缩(25℃)至相对密度为1.10-1.20(优选的,浓缩至相对密度为1.13-1.17,更加优选的,浓缩至相对密度为1.15);
(4)取相对于稠膏质量的10%的冰糖,置于锅中,加水熬制(水的用量是冰糖用量的3倍),可听见冰糖在水里噼里啪啦的声音,待冰糖完全融化后停火;
(5)将步骤(3)所得稠膏与步骤(4)所得冰糖水混合,加入山梨酸,混合均匀,无菌封装。
10.根据权利要求9所述的中药组合物制剂的制备方法,其特征是:步骤(5)山梨酸的用量是浓缩液质量的0.02%-0.04%(优选的,山梨酸的用量是浓缩液质量的0.03%)。
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