CN106110068A - 用于治疗热哮型哮病的中药组合物及其制备方法 - Google Patents
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Abstract
本发明公开了一种用于治疗热哮型哮病的中药组合物及其制备方法,中药组合物由以下原料药材制成:麻黄、杏仁、石膏、冬瓜仁、薏苡仁、车前草、浙贝母、蝉蜕、射干、鱼腥草、茯苓、石苇。本发明的有益效果是:采用不同药性的中药材,科学配伍,能起到清肺渗湿,宣肺平喘的作用,能对热哮型哮病达到理想的治疗效果,且安全,无任何毒副作用,标本兼治、安全、有效,治疗费用较低,内服外敷合用能够更好的达到清肺渗湿,化痰平喘的效果,治疗效果显著。
Description
技术领域
本发明涉及含有来源于植物、动物或矿物原料的医用配制品,特别涉及一种用于治疗热哮型哮病的中药组合物及其制备方法。
背景技术
支气管哮喘是临床常见病与多发病,发病率为1%~3%,可发生于任何年龄,大多数在12岁以前起病,男性多于女性(约2~3:1),儿童比成人多,好发于秋冬季节及气候改变时,寒冷地区多于温暖地区。近10余年来,美国、英国、澳大利亚、新西兰等国家哮喘患病率有上升趋势,全世界约有1.5亿哮喘患者,每年死于哮喘病的患者达18万。我国哮喘的患病率约为1%,儿童可达3%,估计有1千万以上患者,哮喘已成为严重威胁人们健康的一种高发的公共卫生疾病。支气管哮喘相当于中医的“哮病”范畴。哮病是一种常见的反复发作的肺系疾患。它是由宿痰伏肺,复因外邪、饮食、情志、劳倦等因素,致气滞痰阻,气道挛急、狭窄而发病。以发作性喉中哮鸣有声,呼吸困难,甚则喘息不能平卧为主要表现。哮喘之名为宋·王执中在其所著的《针灸资生经》一书中首先提出的,如他说:“因与人治哮喘,只缪(刺)肺俞,不缪他穴”、“凡有喘与哮者,为按肺俞无不酸痛,皆为缪刺肺俞,令灸而愈”。至金元时期,朱丹溪在《丹溪心法》一书中始以哮喘作为独立的病名成篇,并对其治法、用药原则等做了具体的论述,哮喘的病名便从此时期正式产生。《景岳全书·杂证谟·喘促》云:“喘有夙根,遇寒即发,或遇劳即发,亦名哮喘。未发时以扶正气为主,既发时以攻邪气为主,扶正气者须辨阴阳,阴虚者补其阴,阳虚者补其阳。攻邪气者,须分微甚,或散其风,或温其寒,或清其痰火,发久者,气无不虚,故于消散中宜酌加温补,或于温补中宜量加消散。”中医学认为哮喘是因宿痰内伏于肺,并与遗传、体质、环境、外感、饮食、劳倦等因素有关。哮喘的病因以肺虚、脾虚、肾虚为本,以风、寒、热、湿、痰、瘀为标,发作期以实证表现为主,缓解期以虚证表现居多。哮喘患者素有宿痰内伏,多为肺、脾、肾三脏阳气虚损。脾主运化,若脾虚运化失职,则痰浊内生,上贮于肺;肾为人体阳气之根,主纳气,若肾精亏损,则摄纳无权,以致动则气促,呼吸困难;肺主气而司呼吸,若肺气虚,则腠理不固,外邪可由口鼻而入,六淫客于肌表而诱发肺气上逆,呼吸不利,痰随气升,气因痰阻,相互搏击,壅塞气道,肺气宣降失常,导致痰鸣气促。哮喘的中医治疗可谓丰富多彩,除了内治法外,尚有中药外敷、穴位治疗等诸多方法。中医药治疗哮喘,疗效确切,较少出现副作用,已被医学界所公认。某些有效治法和方剂,已被现代科学技术所证实。所以,中医中医药治疗哮喘有着广阔的前景。哮喘的治疗应以发作期治标,缓解期治本为原则,按照不同的临床表现和不同阶段进行。发作期应先分寒哮、热哮、寒热错杂,予以祛邪降气,除痰定喘、寒热并调为主;缓解期应着重补肺、益脾、固肾为治,以防复发。哮喘急性发作期的热哮证,是临床常见的证型。通常对热哮证的治法,多针对痰热壅肺,肺失清肃,肺气上逆的病机,而立足于清肺涤痰,降气平喘,或清热宣肺,化痰定喘。根据以上治法,常选用定喘汤、麻杏石甘汤加味等方药治疗,临床疗效仍不够理想。数年来,我们通过长期的临床实践认为:痰热壅肺虽然是热哮证的主要病机所在,但是,尚应究其痰之所由生——“湿”、“水”、“饮”这一病机环节,在治疗时应以清肺渗湿为治法,先其痰而治之,才是溯源求本之道。
西医治疗哮喘的药物可以分为控制药物和缓解药物。(1)控制药物:是指需要长期每天使用的药物。这些药物主要通过抗炎作用使哮喘维持临床控制,其中包括吸入糖皮质激素(简称激素)全身用激素、白三烯调节剂、长效β2‐受体激动剂(LABA,须与吸入激素联合应用)、缓释茶碱、色苷酸钠、抗IgE抗体及其他有助于减少全身激素剂量的药物等;(2)缓解药物:是指按需使用的药物。这些药物通过迅速解除支气管痉挛从而缓解哮喘症状,其中包括速效吸入β2‐受体激动剂、全身用激素、吸入性抗胆碱能药物、短效茶碱及短效口服β2‐受体激动剂等。上述药物尤其控制药物需长期服用,长时间使用会产生抗药性。
发明内容
本发明所要解决的技术问题在于,提供了一种配方简单、制作工艺简便、毒副作用小且药效明显的用于治疗热哮型哮病的中药组合物及其制备方法。
为了实现上述发明目的,本发明提供了一种用于治疗热哮型哮病的中药组合物,所述中药组合物由以下重量份数的原料药材制成:麻黄10~20份、杏仁10~20份、石膏10~20份、冬瓜仁10~20份、薏苡仁10~20份、车前草10~25份、浙贝母10~18份、蝉蜕10~17份、射干10~20份、鱼腥草10~20份、茯苓10~15份、石苇10~20份。
所述中药组合物由以下重量份数的原料药材制成:麻黄10~20份、杏仁10~20份、石膏10~20份、冬瓜仁10~20份、薏苡仁10~20份、车前草10~25份、浙贝母10~18份、蝉蜕10~17份、射干10~20份、鱼腥草10~20份、茯苓10~15份、石苇10~20份。
所述中药组合物由以下重量份数的原料药材制成:麻黄12份、杏仁18份、石膏20份、冬瓜仁18份、薏苡仁19份、车前草20份、浙贝母15份、蝉蜕13份、射干14份、鱼腥草18份、茯苓15份和石苇16份。
为了更好的实现上述发明目的,本发明还提供了一种用于治疗热哮型哮病的中药组合物的制备方法,所述中药组合物的剂型为胶囊剂,所述制备方法包括以下步骤:
a、按照重量份数比称取上述药物,加入5‐10倍量的水浸泡1‐2小时,提取2‐5小时的挥发油,收集挥发油,药液滤过,药渣备用;
b、将步骤a得到的药渣和剩余其他原料药混合的混合物,加入醇度为60‐90%乙醇,浸泡1小时,提取3次,每次2小时,第一次加入10倍混合物质量的乙醇,第二次加入10倍混合物质量的乙醇,合并提取液,滤过;将上述两次过滤液合并再一次过滤,将再一次过滤得到的滤液减压浓缩至相对密度为80℃时1.10‐1.50,醇沉两次,调乙醇浓度60‐90%,取上清液浓缩至相对密度为80℃时1.10‐1.50,得到浸膏;
c、取步骤b得到的浸膏,加入挥发油及植物油,混合,用胶体磨研磨10分钟,不断搅拌,冷至室温得中药组合物,将所述中药组合物装入胶囊壳体中,即得胶囊剂成品。
所述步骤a中,提取上述药物所含挥发油的提取为水蒸气蒸馏法或超临界萃取法提取。
所述步骤b中,提取采用膜分离技术、超滤、醇沉、高速离心或大孔树脂方法。
为了更好的实现上述发明目的,本发明又提供了一种用于治疗热哮型哮病的中药组合物的制备方法,所述中药组合物的剂型为贴剂,所述制备方法包括以下步骤:
a、按所述重量份数比称取所有原料药材,加入10倍量的60‐90%乙醇中,加热回流提取2次,每次1~2小时,将两次提取得到的提取液合并得到提取液一,将提取液一静置,药渣备用;
b、将步骤a中的药渣,加水加热回流提取1次,每次1~2小时,提取得提取液二,静置;
c、将步骤a得到的提取液一和步骤b得到的提取液二合并,浓缩,得到药物浸膏,加热浓缩调制,得贴剂。
所述步骤c中,将步骤a得到的提取液一和步骤b得到的提取液二合并,抽入减压浓缩罐内,减压至0.03‐0.08MPa,温度保持在60‐80℃,浓缩至当温度为65℃时相对密度为1.20浸膏;用酒、醋、蜂蜜调和后即得贴剂。
为了更好的实现上述发明目的,本发明还提供了一种用于治疗热哮型哮病的中药组合物的制备方法,所述中药组合物的剂型为片剂,所述制备方法包括以下步骤:先将所有原料药材放入10倍量70‐85%乙醇中,加热回流提取2次,每次45分钟,提取活性成份,将2次提取液合并静置,得提取液一,药渣备用;将药渣加10倍量水,加热回流提取3次,每次1小时,将3次提取液合并,得提取液二;合并提取液一和提取液二,减压回收乙醇并浓缩至药液浓度为0.5g生药/mL,抽滤后,滤液相对密度约为20℃时1.06;将滤液经体积为10L的大孔吸附树脂柱洗脱两次,先用10倍树脂柱体积的去离子水或蒸馏水洗脱,再用5倍树脂柱体积的95%乙醇洗脱,收集乙醇洗脱液,去除乙醇溶剂,得到原料药液;加入淀粉压制成片剂。
所述中药组合物内服药物剂型为:片剂、糖衣片剂、薄膜衣片剂、肠溶衣片剂、胶囊剂、硬胶囊剂、软胶囊剂、口服液、***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;外用药物剂型为:熏蒸剂、乳膏剂、擦剂、酊剂、软膏剂、散剂、贴剂、凝胶剂或喷雾剂。
本发明实施例提供的技术方案带来的有益效果是:本发明采用不同药性的中药材,科学配伍,能起到寒温兼施和化痰平喘的作用,能对热哮型哮病达到理想的治疗效果,且安全,无任何毒副作用,标本兼治、安全、有效,治疗费用较低,内服外敷合用能够更好的达到寒温兼施、化痰平喘的效果,治疗效果显著。
具体实施方式
中医学认为哮喘是因宿痰内伏于肺,并与遗传、体质、环境、外感、饮食、劳倦等因素有关。哮喘的病因以肺虚、脾虚、肾虚为本,以风、寒、热、湿、痰、瘀为标,发作期以实证表现为主,缓解期以虚证表现居多。哮喘患者素有宿痰内伏,多为肺、脾、肾三脏阳气虚损。脾主运化,若脾虚运化失职,则痰浊内生,上贮于肺;肾为人体阳气之根,主纳气,若肾精亏损,则摄纳无权,以致动则气促,呼吸困难;肺主气而司呼吸,若肺气虚,则腠理不固,外邪可由口鼻而入,六淫客于肌表而诱发肺气上逆,呼吸不利,痰随气升,气因痰阻,相互搏击,壅塞气道,肺气宣降失常,导致痰鸣气促。哮喘的中医治疗可谓丰富多彩,除了内治法外,尚有中药外敷、穴位治疗等诸多方法。中医药治疗哮喘,疗效确切,较少出现副作用,已被医学界所公认。某些有效治法和方剂,已被现代科学技术所证实。所以,中医中医药治疗哮喘有着广阔的前景。哮喘的治疗应以发作期治标,缓解期治本为原则,按照不同的临床表现和不同阶段进行。发作期应先分寒哮、热哮,予以祛邪降气,除痰定喘为主;缓解期应着重补肺、益脾、固肾为治,以防复发。
中药外治疗法是临床上最常用的中医外治法之一,晋代葛洪著的《肘后方》,唐代孙思邈的《千金要方》、《千金翼方》,王涛著的《外台秘要》以及明代李时珍的《本草纲目》中所载的医疗方法都涉及到了中药外敷疗法。由于经络有内属脏腑、外络肢节、沟通表里、贯穿上下的作用,所以不但能治疗局部病变,而且还可通过外敷达到治疗全身性疾病的目的。药物通过对背部(如肺俞穴、心俞穴、膈俞穴)局部穴位的刺激作用,经过皮肤透入,激发经脉之气,促进脏腑气血运行,起到治疗作用;背部为人体最大阳经—太阳膀胱经所循行,当用适宜的药物施治于背部时,能刺激阳经,激发人体阳气,祛除体内寒邪,改善内脏及组织生理活动和病理变化,增强机体的免疫力和抗病能力。
方中麻黄辛温,轻扬上达,善开宣肺郁,散风寒,疏腠理,透毛窍,有“治感第一要药”之称。麻黄乃肺经专药,为宣肺平喘之要药。细辛辛香走窜,有升浮之性,外可温散风寒,有解热镇痛之功,助麻黄发汗解表,配温经通脉之生姜,促汗而解风寒之邪。射干苦寒泄降,能清肺泄热,降痰平喘,解毒利咽,为咽喉肿痛要药。紫菀苦温润肺益金,专能开泄肺郁,定咳降逆,宣通窒滞,兼疏肺家气血。款冬花味苦主降,顺肺中之气,又清肺中之血,能开郁润肺,化痰止咳,有邪可散,散而***,无邪可润,润而不寒。“病痰饮者,当以温药和之”。饮非温不化,痰非气降不消。麻黄、细辛、半夏,降逆消痰,温肺化饮于内。乌梅、五味子之酸,以补不足,令正气自敛;黄芩、石韦、火麻仁苦寒,能清热祛湿化痰;附子、干姜、桂枝、蜀椒皆温热之品,可温肾暖脾而助运;党参、当归益气补血而扶正,以补后天。白芥子、荜茇具有祛除体内各种顽痰;元胡具有活血,散瘀,理气之功。诸药相合,具有清温并用,化痰平喘的效果,对于寒热错杂、正气虚弱之哮病,效果显著。
麻黄,味辛、微苦,性温。具有发汗解表,宣肺平喘,利水消肿等功效。麻黄始载于《本经》,列为中品。麻黄中含有麻黄碱和伪麻黄碱等成分。麻黄碱有收缩血管升高血压的作用,对心脏亦有兴奋作用。其升压作用缓慢持久,收缩血管的作用温和持久。麻黄碱对中枢有兴奋作用,较大治疗量即能兴奋大脑皮层及皮质下中枢,亦能兴奋呼吸中枢和血管运动中枢,在***中毒时有苏醒作用,可用于发作性睡病。麻黄碱对支气管平滑肌有较持久的解痉作用,作用于虹膜辐状肌可使瞳孔扩大,也能使胃肠道肌肉松弛,抑制蠕动,兴奋离体子宫、膀胱扩约肌;麻黄碱对骨胳肌有抗疲劳作用,能促进被箭毒所抑制的神经肌肉间的传导,麻黄碱及总生物碱对正常及发热的猫均无发汗作用。伪麻黄碱亦有升压收缩血管、松弛支气管平滑肌的作用,并较麻黄碱有更强的利尿作用。麻黄碱的作用原理主要是其与肾上腺素能受体结合,一部分是由于促进介质释放的间接因素。麻黄碱反复应用时易产生快速耐受性,作用迅速减弱,最后可以完全消失。
杏仁,苦,温,有毒。入肺、大肠经。中药典籍《本草纲目》中列举杏仁的三大功效:润肺,清积食,散滞。清积食是说杏仁可以帮助消化、缓解便秘症状;《现代实用中药》记载:“杏仁内服具有轻泻作用,并有滋补之效。”对于年老体弱的慢性便秘者来说,服用杏仁效果更佳。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***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。甜杏仁作为食品,可作扁桃仁的代替品。美国研究人员的一项最新研究成果显示,胆固醇水平正常或稍高的人,可以用杏仁取代其膳食中的低营养密度食品,达到降低血液胆固醇并保持心脏健康的目的。研究者认为,杏仁中所富含的多种营养素,比如维生素E,单不饱和脂肪和膳食纤维共同作用能够有效降低心脏病的发病危险。样本中85位中老年志愿者(平均年龄56岁)的总胆固醇水平降低了7.6%,低密度脂蛋白胆固醇水平下降了9%。也未造成体重的增加。
石膏,辛甘,寒。入胃经、肺经。生石膏:去净杂石,洗净泥土,打碎成小块。煅石膏:取净石膏块,置坩埚内,在无烟炉火中煅至酥松状,取出,放凉,碾碎。清热泻火,除烦止渴,收敛生肌(用煅石膏)。生石膏既天然二水石膏(CaSO4·2H2O),据明朝李时珍《本草纲目》第九卷记载“生石膏亦称细理石,又名“寒水石”,主治中风寒热,有解肌发汗,除口干舌焦,头痛牙疼等功能。乃祛瘟解热之良药。”据中医理论及民间使用证明:高血压属热症,生石膏性大寒,用石膏磨制而成的,以寒克热能自然调节脑神经和人脑正常温度,使脑血管正常工作,可有效地控制血压升高,长期坚持使用能将血压逐步降低至正常水平。近代张锡纯《医学衷中参西录》第一卷
石膏之质,中含硫氧,是以凉而能散,有透表解肌之力,外感有实热者,放胆用之直胜金丹。《神农本经》谓其微寒,则性非大寒可知;且谓其宜于产乳,其性尤纯良可知。医者多误认为大寒而煅用之,则宣散之性变为收敛(点豆腐必煅用,取其能收敛也),以治外感有实热者,竟将其痰火敛住,凝结不散,用至一两即足伤人,是变金丹为鸠毒也。迨至误用石膏偾事,流俗之见,不知其咎在煅不在石膏,转谓石膏用之其猛烈犹足伤人,而不煅者更可知矣。于是一倡百和,遂视用石膏为畏途,即有放胆用者,亦不过七八钱而止。夫石膏之质甚重,七八钱不过一大撮耳。以微寒之药,欲用一大撮扑灭寒温燎原之热,又何能有大效。是以愚用生石膏以治外感实热,轻证亦必至两许;若实热炽盛,又恒重用至四五两,或七八两,或单用,或与他药同用,必煎汤三四茶杯,分四五次徐徐温饮下,热退不必尽剂。如此多煎徐服者,欲以免病家之疑惧,且欲其药力常在上焦、中焦,而寒凉不至下侵致滑泻也。盖石膏生用以治外感实热,断无伤人之理,且放胆用之,亦断无不退热之理。惟热实脉虚者,其人必实热兼有虚热,仿白虎加人参汤之义,以人参佐石膏亦必能退热。
冬瓜仁,性味甘,凉。为葫芦科植物冬瓜的种子。归肺、大肠经。具有清肺化痰;消痈排脓;利湿功效,主治痰热咳嗽;肺痈;肠痈;白浊;带下;脚气;水肿;淋证。冬瓜子含有丰富的蛋白质,脂肪,脲酶,皂苷B族维生素等。冬瓜子所含脂肪主要为不饱和脂肪酸,其中主要成分也是亚油酸,它可以降低人体血液中的胆固醇和甘油酸脂,有助于防治冠心病。冬瓜子水提取后,经透析得透析内液,为B细胞致丝裂剂,有无性系B细胞激活剂活性及佐剂活性,可使空斑形成细胞数数目显著增高,呈现免疫促进作用。从冬瓜子中分离纯化出4个组分,具有抑制胰蛋白酶活力的作用。
薏苡仁,性味甘、淡,微寒。具有利湿健脾、舒筋除痹、清热排脓等功效。主治肺痈、肠痈、小便淋沥、湿温病、泄泻带下、风湿痹痛、筋脉拘挛等。《本草正》:薏苡,味甘淡,气微凉,性微降而渗,故能去湿利水,以其志湿,故能利关节,除脚气,治痿弱拘挛湿痹,消水肿疼痛,利小便热淋,亦杀蛔虫。以其微降,故亦治咳嗽唾脓,利膈开胃。以其性凉,故能清热,止烦渴、上气。但其功力甚缓,用为佐使宜倍。《药品化义》:薏米,味甘气和,清中浊品,能健脾阴,大益肠胃。主治脾虚泻,致成水肿,风湿盘缓,致成手足无力,不能屈伸。盖因湿胜则土败,土胜则气复,肿自消而力自生。取其入肺,滋养化源,用治上焦消渴,肺痈肠痈。又取其味厚沉下,培植部,用治脚气肿痛,肠红崩漏。若咳血久而食少者,假以气和力缓,倍用无不效。《本草述》:薏苡仁,除湿而不如二术助燥,清热而不如芩、连辈损阴,益气而不如参、术辈犹滋湿热,诚为益中气要药。然其味淡,其力缓,如不合群以济,厚集以投,冀其奏的然之效也能乎哉?《本草新编》:薏仁最善利水,不至损耗真阴之气,凡湿盛在下身者,最宜用之,视病之轻重,准用药之多寡,则阴阳不伤,而湿病易去。故凡遇水湿之症,用薏仁一、二两为君,而佐之健脾去湿之味,未有不速于奏效者也,倘薄其气味之平和而轻用之,无益也。
车前草,味甘,性寒。归肝、肾、膀胱经。具有清热利尿、凉血、解毒等功效。主治结膀胱、小便不利、淋浊带下、暑湿泻痢、衄血、尿血、肝热目赤、咽喉肿痛、痈肿疮毒等。药理研究表明,车前草煎剂以高低两种剂量给猫灌胃,均可使猫的致咳电刺激阈显著上升,且随剂量增加,作图加强。小鼠灌服30g/kg车前草煎剂,可显著抑制氨水所致咳嗽。车前草煎剂2.0×10(‐2)g/L可使家兔支气管肺标本的肺流出量显著增加。车前草煎剂可显著对抗组胺、乙酰胆碱所致豚鼠离体气管的收缩,使气管平滑肌松弛,具有平喘作用。给家兔灌服车前草煎剂,可使家兔气管分泌量显著增加,有一定祛痰作用。车前草煎剂给猫灌胃,可使麻醉猫气管内分泌物增加,有明显祛痰作用,但作用不及桔梗。在给药后3‐6小时作用达高峰,可维持6‐7小时。车前黄酮甙除能促进气管及支气管粘液的分泌外,还能抑制呼吸中枢,使呼吸加深变慢,并有一定镇咳作用。《纲目》:"王旻《山居录》,有种车前剪苗食法,则昔人常以为蔬矣。今野人犹采食之。"《植物名实图考》:"车前,《本经》上品。《尔雅》:苤苢,马舄;马舄,车前。释《诗》者或以为去恶疾,或以为宜子,皆传闻师说,未可非也。《逸周书》作桴苢;《韩涛》谓是本,似李可食,其说本此。古今草木,同名异物,同物异名,何可悉数"郭注《尔雅》,多存旧说,是可师矣。《救荒本草》谓之年轮菜′雩类农臼:《尔雅》:苤苢,马舄,车前。前非难识者,《韩诗》说均以为泽舄为何耶?盖汉承秦绝学之后,书缺有间,学者力守师说,口耳相承,虽有他解,不敢辄易,谨之至也。王安石出己意为新学,不能通,辄即易一说以解之,而独于新法,以为终不可废,其视治国乃不如治经。车前之名,三尺童子知之。滇南谓之虾蟆叶、即虾蟆衣之转音也。绝域方言,其名犹占。"
浙贝母,味苦,性寒。归肺,心经。具有清热化痰、降气止咳、散结消肿等功效。主治风热或痰热咳嗽、肺痈吐脓、瘰疬瘿瘤、疮痈肿毒等。.药理研究表明,浙贝母碱和去氢浙贝母碱4mg/kg灌胃,对小鼠氨气引咳有抑制作用,4mg/kg皮下注射对电刺激麻醉猫喉上神经引咳也有镇咳作用。贝母生物碱具有阿托品样作用,对兔、猫离体肺灌流表明,低浓度可使支气管松弛,高浓度则对支气管有轻微收缩作用。《本草正义》:象贝母蓄寒泄降,而能散结。《本经》主伤寒烦热、淋沥邪气;《别录》止烦、热、渴、出汗,皆泄降除热也。疝瘕以热结而言,泄热散结,故能治之。喉痹,热之结于上者也。乳难之乳,即孳乳之乳,指产难也、贝母滑降,且能散结,故催生而治产难。甄权《药性论》谓贝母作末酒服,治产难及胞衣不出;近人保生无忧散一方,为催生保产灵药,内有贝母,程钟龄释之谓贝母滑润,久皆本此。而注《本经》者仅以为下乳汁,恐非真目。主金疮者,苫降清热之功也,不仅可以内服,亦可外作渗药。居人以象贝通治阳证痈疡,消肿退热,殊有捷效,亦本于此。主风痉者,苦寒清热,泄降定风之功也。《别录》疗腹中结实、心下满,皆指邪热窒塞之证,苦泄散结,皆能主之。洗洗恶风寒者,风寒外袭于皮毛,内合于肺,象贝清泄肺气而辛能疏散,其效可知。目眩为肝阳上乘,项直为风邪外感,舌降泄风,辛泄疏散,治之宜也。咳嗽上气,又痰热之侵肺,苦泄清金而又降逆之功用也。象贝母,味苦而性寒,然含有辛散之气。故能除热,能泄降,又能散绪。今人乃以通治风热、温热、时气热邪,则寒能胜热,辛能散邪也。主郁气痰核等证,虽辛散苦泄,开结散郁也,催生下乳,又其泄降之余义。至于治疸、治疡、清喉咽,主吐衄、疗痰嗽、通二便,种种功力,无非清热泄降四中,足以赅之,要之皆象贝之功用,而市肆通行之川贝,淡泊异常,断不足以语此。《本草正》:大治肺痈肺萎,咳喘,吐血,衄血,最降痰气,善开郁结,止疼痛,消胀满,清肝火,阴耳目,除时气烦热,黄疸淋闭,便血溺血;解热毒,杀诸虫及疗喉痹,瘰疬,乳痈发背,一切痈疡肿毒,湿热恶疮,痔漏,金疮出血,火疮疼痛,较之川贝母,清降之功,不啻数倍。《本草从新》:去时感风痰。《纲目拾遗》:解毒利痰,开宣肺气,凡肺家突风火有痰者宜此。
蝉蜕,味甘、咸,性凉。归肺、肝经。具有疏散风热,利咽开音,透疹,明目退翳,息风止痉功效。用于风热感冒,温病初起,咽痛音哑,麻疹不透,风疹瘙痒,目赤翳障,急慢惊风,破伤风证,小儿夜啼不安。1、风热感冒,温病初起,咽痛音哑。本品甘寒清热,质轻上浮,长于疏散肺经风热以宣肺利咽、开音疗哑,故风热感冒,温病初起,症见声音嘶哑或咽喉肿痛者,尤为适宜。用治风热感冒或温病初起,发热恶风,头痛口渴者。治疗风热火毒上攻之咽喉红肿疼痛、声音嘶哑。2、麻疹不透,风疹瘙痒。本品宣散透发,疏散风热,透疹止痒,用治风热外束,麻疹不透;用治风湿浸淫肌肤血脉,皮肤瘙痒。
射干,射干味苦,性寒,归肺经。具泻火解毒,消痰,利咽等功效。主治热毒痰多郁结、咽喉肿痛、痰涎壅盛、咳嗽气喘等。射干始载于《神农本草经》,列为下品。《本草纲目》载:“射干,能降火,故古方治喉痹咽痛为要药。孙真人《千金方》治喉痹有乌翣膏。张仲景《金匮玉函》方治咳而上气,喉中作水鸡声,有射干麻黄汤。又治疟母鳖甲煎丸,亦用乌扇烧过,皆取其降厥阴相火也。火降则血散肿消,而痰结自解,癥瘕自除矣。”射干为治咽喉肿痛常用的药品,能清热毒、消肿痛。
鱼腥草,性味辛、寒。归肝、肺经。具有清热解毒、排脓消痈、利尿通淋等功效。主治肺痈吐脓、痰热喘咳、热痢、痈肿疮毒、热淋等。鱼腥草毒性很低。鱼腥草素给小鼠口服之半数致死量为1.6±0.081g/kg;对犬静脉滴注,38‐47mg/kg不致引起死亡,如增至61‐64mg/kg则可引起死亡,解剖可见肺脏有严重出血和血栓。给犬灌胃,每日80‐160mg/kg,连续1个月,可见有大量流涎现象,早期常出现呕吐,此外则未见异常。鱼腥草毒性很低,小鼠皮下注射的LD50是1.6±0.081g/kg,给体重17‐20g的小鼠静脉注射1.5mg的鱼腥草素(相当于人体注射剂量的200倍左右),观察1周无死亡现象,且90%体重增加,经解剖亦未见病变发生。对犬静脉滴注38‐47mg/kg不致引起死亡,剂量增至61‐64mg/kg则可引起死亡,解剖可见肺部有严重出血和血栓。给犬皮下注射每日80‐160mg/kg,连续1mo,可见有大量的流涎,早期常出现呕吐,对食欲、血象及肝肾功能等均无明显的影响。《本草纲目》:散热毒痈肿,疮痔脱肛,断店疾,解硇毒。《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。.陈念祖:生捣治呕血。.《分类草药性》:治五淋,消水肿,去食积,补虚弱,消膨胀。《岭南采药录》:叶:敷恶毒大疮,能消毒;煎服能去湿热,治痢疾。《现代实用中药》:生叶:烘热外贴,为发泡药,可治疮癣。凡疥癣肿胀,湿疹,腰痛等可作浴汤料。生嚼其根,防止冠心病的心绞痛发作。
茯苓,利水渗湿,健脾化痰,宁心安神,败毒抗癌。药性平和,利湿而不伤正气。适量服食可作为春夏潮湿季节的调养佳品。可治小便不利、水肿胀满、痰饮咳逆、呕逆、恶阻、泄泻、遗精、淋浊、惊悸、健忘等症。所含茯苓酸具有增强免疫力、抗肿瘤以及镇静、降血糖等的作用。可松弛消化道平滑肌,抑制胃酸分泌,防止肝细胞坏死,抗菌等功效。茯苓中的主要成分为茯苓聚糖,含量很高。对多种细菌有抑制作用;能降胃酸,对消化道溃疡有预防效果;对肝损伤有明显的保护作用;有抗肿瘤的作用;能多方面对免疫功能进行调节;能使化疗所致白细胞减少加速回升;并有镇静的作用。
石韦,甘、苦,微寒。归肺、膀胱经。功能主治:利尿通淋,清热止血。用于热淋,血淋,石淋,小便不通,淋沥涩痛,吐血,衄血,尿血,崩漏,肺热喘咳。
以下采用实施例来详细说明本发明的实施方式,借此对本发明如何应用技术手段来解决技术问题,并达成技术效果的实现过程能充分理解并据以实施。
实施例1胶囊剂
本发明实施例提供了一种用于治疗热哮型哮病的中药组合物,中药组合物由以下原料药材制成:麻黄1500g、杏仁1200g、石膏2500g、冬瓜仁1500g、薏苡仁1800g、车前草1400g、浙贝母1200g、蝉蜕1200g、射干1500g、鱼腥草1900g、茯苓1800g、石韦1200g。
本发明实施例还提供了一种用于治疗热哮型哮病的中药组合物的制备方法,中药组合物的剂型为胶囊剂,其制备方法包括以下步骤:
a、按照上述重量称取制半夏、橘红、桃仁和炒扁豆,加入7倍量的水浸泡1.5小时,提取4小时的挥发油,收集挥发油,药液滤过,药渣备用;其中,提取采用超临界萃取法提取;
b、将步骤a得到的药渣和剩余其他原料药材混合的混合物,加入醇度为75%乙醇,浸泡1小时,提取3次,每次2小时,第一次加入10倍混合物质量的乙醇,第二次加入10倍混合物质量的乙醇,合并提取液,滤过;将上述两次过滤液合并再进行过滤,将再进行过滤得到的滤液减压浓缩至相对密度为80℃时1.30,醇沉两次,调乙醇浓度75%,取上清液浓缩至相对密度为80℃时1.40,得到浸膏;其中,提取采用膜分离技术;
c、取步骤b得到的浸膏,加入挥发油及植物油,混合,用胶体磨研磨10分钟,不断搅拌,冷至室温,得中药组合物,将中药组合物装入胶囊壳体中,即得胶囊剂成品。
实施例2贴剂
本发明实施例提供了一种用于治疗热哮型哮病的中药组合物,中药组合物由以下原料药材制成:麻黄1200g、杏仁1200g、石膏2400g、冬瓜仁1500g、薏苡仁1800g、车前草1400g、浙贝母1200g、蝉蜕1200g、射干1500g、鱼腥草1900g、茯苓1800g、石韦1200g。
本发明实施例还提供了一种用于治疗热哮型哮病的中药组合物的制备方法,中药组合物的剂型为贴剂,其制备方法包括以下步骤:
a、按所述重量份数比称取所有原料药材,加入10倍量的75%乙醇中,加热回流提取2次,每次1.5小时,将两次提取得到的提取液合并得到提取液一,将提取液一静置,药渣备用;
b、将步骤a中的药渣,加水加热回流提取1次,每次1~2小时,提取得提取液二,静置;
c、将步骤a得到的提取液一和步骤b得到的提取液二合并,抽入减压浓缩罐内,减压至0.05MPa,温度保持在70℃,浓缩至当温度为65℃时相对密度为1.20浸膏;用酒、醋、蜂蜜调和后即得贴剂。
肚脐,穴名神阙,为任脉重要穴位,古有“神阙,主治百病,及老人、虚人泄泻如神”之说,脐所在部位又为冲脉经行之处,任督二脉互为表里,统领人体诸经百脉,故脐部通过以上经络与全身诸脏腑器官密切联系。人体腹壁单薄,局部用药易于吸收,且无痛苦,本发明实施例的贴剂外敷神阙可达散寒通阳、理气止痛,调理脾胃。
实施例3片剂
本发明实施例提供了一种用于治疗热哮型哮病的中药组合物,中药组合物由以下原料药材制成:麻黄1200g、杏仁1200g、石膏2400g、冬瓜仁1500g、薏苡仁1800g、车前草1400g、浙贝母1200g、蝉蜕1200g、射干1500g、鱼腥草1900g、茯苓1800g、石韦1200g。
本发明实施例还提供了一种用于治疗热哮型哮病的中药组合物的制备方法,制备方法包括以下步骤:先将所有原料药材放入10倍量82%乙醇中,加热回流提取两次,每次45分钟,提取活性成份,将两次提取液合并静置,得提取液一,药渣备用;将药渣加10倍量水,加热回流提取三次,每次1小时,将三次提取液合并,得提取液二;合并提取液一和提取液二,减压回收乙醇并浓缩至药液浓度为0.5g生药/mL,抽滤后,滤液相对密度约为20℃时1.06;将滤液经体积为10L的大孔吸附树脂柱洗脱两次,先用10倍树脂柱体积的去离子水或蒸馏水洗脱,再用5倍树脂柱体积的95%乙醇洗脱,收集乙醇洗脱液,去除乙醇溶剂,得到原料药液;加入淀粉压制成片剂。
药理药效学实验:
1、蓄积毒性试验报告
试验方法:将本发明实施例3的片剂对大鼠按7.81、18.34和40.11g生药/kg连续用药12周(1.0ml/100g体重,每天2次)及停药4周后,结果表明:本发明中药组合物对大鼠的毛发、行为、大小便、体重、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和组织学检查结果表明,用药12周及停药4周后,大鼠各脏器均无明显改变。说明本发明中药组合物对大鼠长期用药后毒性小,停药后也没有异样反应,应用安全。
2、急性毒性试验:应用NIH小鼠40只,SPF级,雌雄各半,体重16~20g,进行急性毒性试验。小鼠随机分为两组,每组20只,即对照组和给药组,实验前禁食12小时;将本发明的实施例1制备的胶囊剂溶解在水中,(浓度为6.58g生药/ml,最高浓度)灌胃,灌胃容积为5ml/kg(即单次给药剂量为32.9生药/kg),对照组给予等量生理盐水,一天给药2次,给药间隔时间6小时,给药后连续观察14天,并记录小鼠的毒性反应及死亡数。实验结果表明:与对照组比较,给药后小鼠未见明显差异,实验连续观察14天,小鼠全身状况、饮食、饮水、体重增长均正常。小鼠口服灌胃本发明的胶囊剂LD50>32.9生药/kg,每日最大给药量为65.8生药/kg/日。本发明的中药临床用药量为5.0g生药/日/人,成人体重以60KG计,平均用药剂量为0.083g生药/kg/日。按体重计:小鼠(平均体重以20g计)口服灌胃本发明的中药的耐受量为临床用量的793倍。因此本发明的中药组合物急性毒性低,临床用药安全
3、急性皮肤刺激试验
本发明实施例2中药组合物贴剂依据***《化妆品卫生规范》(2002)第二部分“皮肤刺激性/腐蚀性试验”中6.3节进行进行皮肤刺激试验,选取日本大耳白兔雄性4只,体重2kg~3kg,按照“急性经皮毒性试验”的方法,制备涂料,然后取0.5g直接涂抹在动物左侧皮肤上(另一侧作为对照),采用封闭试验,敷用时间4小时,试验结束后用温水冲洗残留受试物,于除去受试物后1h、24h、48h和72h分别观察动物受试区和对照区的皮肤反应,最高积分均值为“0”。因此,本发明的中药组合物对动物皮肤无刺激性。
4、过敏试验:
取健康白色豚鼠18只,体重250‐300g,雌雄兼用,试验前剔除两侧背毛,每侧3×3cm,随机分为试验组、空白对照组(基质)和阳性对照组。阳性对照组用2,4‐二硝基氯苯,致敏用1%浓度,激发用0.1%浓度。取本发明实施例2的贴剂0.1g涂于背部去毛区,隔日1次,共3次。于末次接触后14天,在背部同一区域涂抹本品0.1g,6h后去除药品后即刻观察,并于24、48、72h观察有无过敏反应。空白对照组和阳性对照组用同法激发接触和观察。试验结果:阳性对照组动物皮肤在致敏1小时后即出现局限性红斑和轻微水肿,24小时过敏反应症状加重,并有硬结形成,致敏率为100%,试验组和空白对照组动物皮肤均未出现任何过敏反应症状,致敏率为0%。
临床资料
1、资料与方法
1.1一般资料:选择2011年4月‐2012年12月期间,某医院治疗的热哮型哮病的患者共386例,其中,男246例,女140,年龄30‐70岁。随机分为两组,治疗组193例,对照组193例。两组患者在年龄、性别、病情轻重方面比较差异无统计学意义,具有可比性,并根据病情的轻重门诊治疗。
1.2诊断标准:西医诊断标准:参考《支气管哮喘防治指南》(中华医学会呼吸病学分会哮喘学组修订,2008年)。
①反复发作喘息、气急、胸闷或咳嗽,多与接触变应原、冷空气、物理、化学性刺激以及病毒性上呼吸道感染、运动等有关。
②发作时在双肺可闻及散在或弥漫性、以呼气相为主的哮鸣音,呼气相延长。
③上述症状和体征可经治疗缓解或自行缓解。
④除外其他疾病所引起的喘息、气急、胸闷和咳嗽。
⑤临床表现不典型者(如无明显喘息或体征),应至少具备以下1项试验阳性:a.支气管激发试验或运动激发试验阳性;b.支气管舒张试验阳性FEV1增加≥12%,且FEV1增加绝对值≥200ml;c.呼气流量峰值(PEF)日内(或2周)变异率≥20%。
符合①‐④条或④、⑤条者,可以诊断为哮喘。
中医证候诊断参照中华中医药学会发布《中医内科常见病诊疗指南》(ZYYXH/T5‐2008):①发作时喉中哮鸣有声,呼吸困难,甚则张口抬肩,不能平卧,或***指甲紫绀。②呈反复发作性。常因气候突变、饮食不当、情志失调、劳累等因素诱发。发作前多有鼻痒、喷嚏、咳嗽、胸闷等先兆。③有过敏史或家族史。④两肺可闻及哮鸣音,或伴有湿罗音。⑤血嗜酸性粒细胞可增高。⑥痰液涂片可见嗜酸细胞。⑦胸部X线检查一般无特殊改变,久病可见肺气肿征。
1.3疗效标准:
观察患者治疗前、治疗后第3天、治疗后第6天、治疗后第9天的主症(喘息、咳嗽、咯痰、胸闷)疗效、次症(发热、心烦、口渴喜饮)消失时间、哮鸣音疗效、嗜酸粒细胞计数及复常率、肺功能等指标,上述内容均统一填写入观察表。主症及哮鸣音疗效评价标准参照《哮喘病学》及2002年颁布的《中药新药的临床研究指导原则·哮病》中介绍的方法,结合哮喘发病规律及相关情况拟定评分体系:由低到高4个层次量化,0分为最低,3分为最高。具体标准见下表1。
表1 哮病疗效指标分级量化表
通过对比研究治疗前后的上述观察内容进行评价,填入观察表后进行积分统计,据积分结果进行病情分级及观察指标分级评价,具体分级标准:观察指标分级:Ⅰ级(0分),Ⅱ级(1分),Ⅲ级(2分),Ⅳ级(3分);再据观察前后的分级结果变化情况进行疗效评价,具体疗效评价标准:无效(分级由低级别到高级别或分级未变),有效(分级降低1个级别,但未降至Ⅰ级),显效(分级降低2个或2个以上级别,但未降至Ⅰ级),临床控制(分级降至Ⅰ级)。
1.4治疗方法和治疗效果
1.4.1治疗组随机为三个治疗组1‐3,分别使用本发明实施例1‐3的不同制剂的中药组合物进行治疗:
(1)治疗组1:81例患者使用实施例1的胶囊剂,一日两次,一次服用0.3‐0.5g,十天为一疗程,连续使用2‐4个疗程后,停药一周再复诊,统计发现31位患者治疗得到临床控制,28位患者治疗显效,22位患者治疗有效,。治疗期间,没有发现药物带来的副作用,随访半年,31位临床控制和27位显效患者均没有任何复发的症状。
(2)治疗组2:81例患者使用实施例2的贴剂,一日3次,将贴剂涂贴于肚脐。十天为一疗程,连续使用3‐5个疗程后,停药一周再来复诊,统计发现29位患者得到临床控制,27位患者治疗显效,22例患者治疗有效,3例患者治疗无效。81例患者治疗期间没有发现药物带来的其他副作用,随访半年,29位临床控制和治疗显效的27例患者均没有发现任何复发的症状。
(3)治疗组3:81例患者使用实施例3的片剂,一日3次,1次服用0.3‐0.5g,十天为一疗程,连续使用2‐4个疗程后,停药一周再复诊,统计发现30位患者得到临床控制,28例患者治疗显效,22例患者治疗有效,1例患者治疗无效。81例患者治疗期间没有发现药物带来的其他副作用,随访半年,30位得到临床控制和28例治疗显效的患者均没有发现任何复发的症状。
1.3.2对照组随机分成三个对照组1‐3,分别使用不同的药物进行治疗:
(1)对照组1:81例患者使用射干麻黄汤,患者服用的中药汤剂为青岛海慈医疗集团药剂科制备,每剂煎为150ml×2袋,每次1袋,每日2次,早晚温服,连续使用2个月后,停药1周再复诊,统计发现8例患者得到临床控制,22例患者治疗显效,11例患者治疗有效,40例患者治疗无效,随访半年,统计发现8例临床控制患者中有3例停药后复发病症,治疗显效的22例患者其中有3例停药后复发。此外,患者在服用药物时存在腹泻或头痛的症状。
(2)对照组2:81例患者服用茶碱缓释胶囊剂,一次200mg,一日2次,连续服用2个月后,停药1周再复诊,统计发现7例患者得到临床控制,31例患者治疗显效,18例患者治疗有效,25例患者治疗无效,随访半年,统计发现其中7例临床控制患者中有2例停药后复发病症,显效的8例患者停药后复发;7例在服用时出现头痛、恶心、腹泻等副作用。
(3)对照组3:81例患者服用强的松,始服量为每天10mg,晚间顿服。连续服用1个月后,停药1周再复诊,统计发现8例患者得到临床控制,33例患者治疗显效,11例患者治疗有效,29例患者治疗无效,随访半年,统计发现8例临床控制患者中有4例停药后复发病症,33例显效患者中有11例停药后有复发病症;另外5例在服用时出现头痛、胃肠胀气等副作用。
通过上述临床试验可知:与对照组相比,本发明实施例1‐3的中药组合物具有治愈时间短、治愈后不易复发和无毒副作用的优点。
2、具体病例
病例1:赵某,男,41岁,根据诊断标准确定为热哮型哮病,使用本发明实施例1的胶囊剂,一日两次,一次服用0.4g,十天为一疗程,连续使用3个疗程后,停药一周再复诊,肺功能检测结果:FVC上升14%,FEV1/FVC上升10%。随访半年,无复发症状。
病例2:李某,女,57岁,根据诊断标准确定为热哮型哮病,使用本发明实施例2的贴剂,一日一贴,将贴剂涂贴于肚脐。十天为一疗程,连续使用4个疗程后,停药一周再来复诊,肺功能检测结果:FVC上升10%,FEV1/FVC上升8%。随访半年,无复发症状。
病例3:孙某,男,69岁,根据诊断标准确定为热哮型哮病,使用本发明实施例3的片剂,一日3次,1次服用0.4g,十天为一疗程,连续使用3个疗程后,停药一周再来复诊,肺功能检测结果:FVC上升18%,FEV1/FVC上升13%。随访半年,无复发症状。
以上所述仅为本发明的较佳实施例,并不用以限制本发明,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.用于治疗热哮型哮病的中药组合物,其特征在于,所述中药组合物由以下重量份数的原料药材制成:麻黄10~20份、杏仁10~20份、石膏10~20份、冬瓜仁10~20份、薏苡仁10~20份、车前草10~25份、浙贝母10~18份、蝉蜕10~17份、射干10~20份、鱼腥草10~20份、茯苓10~15份、石苇10~20份。
2.根据权利要求1所述的用于治疗热哮型哮病的中药组合物,其特征在于,所述中药组合物由以下重量份数的原料药材制成:麻黄10~20份、杏仁10~20份、石膏10~20份、冬瓜仁10~20份、薏苡仁10~20份、车前草10~25份、浙贝母10~18份、蝉蜕10~17份、射干10~20份、鱼腥草10~20份、茯苓10~15份、石苇10~20份。
3.根据权利要求1或2所述的用于治疗热哮型哮病的中药组合物,其特征在于,所述中药组合物由以下重量份数的原料药材制成:麻黄12份、杏仁18份、石膏20份、冬瓜仁18份、薏苡仁19份、车前草20份、浙贝母15份、蝉蜕13份、射干14份、鱼腥草18份、茯苓15份和石苇16份。
4.一种如权利要求1‐3任意一项所述的用于治疗热哮型哮病的中药组合物的制备方法,其特征在于,所述中药组合物的剂型为胶囊剂,所述制备方法包括以下步骤:
a、按照重量份数称取上述原料药材,加入5‐10倍量的水浸泡1‐2小时,提取2‐5小时的挥发油,收集挥发油,药液滤过,药渣备用;
b、将步骤a得到的药渣和剩余其他原料药混合的混合物,加入醇度为60‐90%乙醇,浸泡1小时,提取3次,每次2小时,第一次加入10倍混合物质量的乙醇,第二次加入10倍混合物质量的乙醇,合并提取液,滤过;将上述两次过滤液合并再一次过滤,将再一次过滤得到的滤液减压浓缩至相对密度为80℃时1.10‐1.50,醇沉两次,调乙醇浓度60‐90%,取上清液浓缩至相对密度为80℃时1.10‐1.50,得到浸膏;
c、取步骤b得到的浸膏,加入步骤a得到的挥发油及植物油,植物油的添加量为浸膏重量的10%,混合,用胶体磨研磨10分钟,不断搅拌,冷至室温得中药组合物,将所述中药组合物装入胶囊壳体中,即得胶囊剂成品。
5.根据权利要求4所述的用于治疗热哮型哮病的中药组合物的制备方法,其特征在于,所述步骤a中,提取上述药物所含挥发油,采用水蒸气蒸馏法或超临界萃取法提取。
6.根据权利要求4所述的用于治疗热哮型哮病的中药组合物的制备方法,其特征在于,所述步骤b中,提取采用膜分离技术、超滤、醇沉、高速离心或大孔树脂方法。
7.一种如权利要求1‐3任意一项所述的用于治疗热哮型哮病的中药组合物的制备方法,其特征在于,所述中药组合物的剂型为贴剂,所述制备方法包括以下步骤:
a、按所述重量份数称取所有原料药材,加入10倍量的60‐90%乙醇中,加热回流提取2次,每次1~2小时,将两次提取得到的提取液合并得到提取液一,将提取液一静置,药渣备用;
b、将步骤a中的药渣,加水加热回流提取1次,每次1~2小时,提取得提取液二,静置;
c、将步骤a得到的提取液一和步骤b得到的提取液二合并,浓缩,得到药物浸膏,加热浓缩调制,得贴剂。
8.根据权利要求7所述的所述用于治疗热哮型哮病的中药组合物的制备方法,其特征在于,所述步骤c中,将步骤a得到的提取液一和步骤b得到的提取液二合并,抽入减压浓缩罐内,减压至0.03‐0.08MPa,温度保持在60‐80℃,浓缩至当温度为65℃时相对密度为1.20浸膏;用酒、醋、蜂蜜调和后即得贴剂。
9.一种如权利要求1‐3任意一项所述的用于治疗热哮型哮病的中药组合物的制备方法,其特征在于,所述中药组合物的剂型为片剂,所述制备方法包括以下步骤:先将所有原料药材放入10倍量70‐85%乙醇中,加热回流提取2次,每次45分钟,提取活性成份,将2次提取液合并静置,得提取液一,药渣备用;将药渣加10倍量水,加热回流提取3次,每次1小时,将3次提取液合并,得提取液二;合并提取液一和提取液二,减压回收乙醇并浓缩至药液浓度为0.5g生药/mL,抽滤后,滤液相对密度约为20℃时1.06;将滤液经体积为10L的大孔吸附树脂柱洗脱两次,先用10倍树脂柱体积的去离子水或蒸馏水洗脱,再用5倍树脂柱体积的95%乙醇洗脱,收集乙醇洗脱液,去除乙醇溶剂,得到原料药液;加入淀粉压制成片剂。
10.一种如权利要求1‐9任意一项所述的用于治疗热哮型哮病的中药组合物,其特征在于,所述中药组合物内服药物剂型为:片剂、糖衣片剂、薄膜衣片剂、肠溶衣片剂、胶囊剂、硬胶囊剂、软胶囊剂、口服液、***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;外用药物剂型为:熏蒸剂、乳膏剂、擦剂、酊剂、软膏剂、散剂、贴剂、凝胶剂或喷雾剂。
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