CN105412281A - 一种治疗过敏性哮喘的中药组合物及其制备方法 - Google Patents
一种治疗过敏性哮喘的中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗过敏性哮喘的中药组合物,方由防风、苏叶、炙麻黄、五味子、白果、杏仁、紫苑、山萸肉、辛夷等组成。本方适应病证为过敏性哮喘,其一疏风宣降肺气,即从舒缓气道方面改善气道挛急,对气道高反应以舒缓作用;其二即是通窍降气平喘,针对鼻塞、气急、喘促,改善肺之肃降功能。
Description
技术领域
本发明属于中药技术领域,具体涉及一种治疗过敏性哮喘的中药组合物及其制备方法。
背景技术
支气管哮喘是由多种细胞和细胞组分参与的气道慢性炎症性疾病,这种慢性炎症与气道高反应性相关,通常出现广泛而多变的可逆性气流受限,导致反复发作的喘息、气促、胸闷和(或)咳嗽等症状,多在夜间和(或)清晨发作、加剧。严重的时候全身青紫,严重的患者呼吸音会突然消失。
哮喘发病的危险因素包括宿主因素(遗传因素)和环境因素两个方面。遗传因素在很多患者身上都可以体现出来,比如绝大多数患者的亲人(有血缘关系、近三代人)当中,都可以追溯到有哮喘(反复咳嗽、喘息)或其他过敏性疾病(过敏性鼻炎、特应性皮炎)病史。大多数哮喘患者属于过敏体质,本身可能伴有过敏性鼻炎和特应性皮炎,或者对常见的经空气传播的变应原(螨虫、花粉、宠物、霉菌等)、某些食物(坚果、牛奶、花生、海鲜类等)、药物过敏等。
目前,中医药在治疗过敏性哮喘领域仍属空白,本发明在总结综合治疗成功与失败经验基础上,遵循现代中医药理论,经过大量试验研究,找到一种有效治疗过敏性哮喘的中药组合物。
发明内容
本发明的目的是提供一种治疗过敏性哮喘的中药组合物。
本发明的另一目的是提供该治疗过敏性哮喘的中药组合物的制备方法。
本发明的目的是通过以下方式实现的:
一种治疗过敏性哮喘的中药组合物,该组合物由如下重量份的组分制成:
防风10-15重量份、紫苏叶10-15重量份、炙麻黄2-6重量份、五味子7-9重量份、白果7-9重量份、苦杏仁7-9重量份、紫苑7-9重量份、山萸肉7-9重量份、辛夷7-9重量份。
上述治疗过敏性哮喘的中药组合物优选由如下重量份的组分制成:
防风10-12重量份、紫苏叶10-12重量份、炙麻黄4-6重量份、五味子7-8重量份、白果7-8重量份、苦杏仁7-8重量份、紫苑7-8重量份、山萸肉7-8重量份、辛夷7-8重量份。
上述治疗过敏性哮喘的中药组合物最优选由如下重量份的组分制成:
防风10重量份、紫苏叶10重量份、炙麻黄6重量份、五味子8重量份、白果8重量份、苦杏仁8重量份、紫苑8重量份、山萸肉8重量份、辛夷8重量份。
本发明治疗过敏性哮喘的中药组合物加入药学允许的辅料制备颗粒剂、胶囊剂、片剂或丸剂。
本发明所述的中药组合物的制备方法包括如下步骤:
将紫苏叶、辛夷用水蒸气蒸馏法提取挥发性成分,采用β-环糊精包合后备用,药渣与防风、炙麻黄、苦杏仁合并,分别加水煎煮1-3次,每次1-3小时,合并提取液,浓缩成50℃条件下相对密度为1.10~1.15的清膏,醇沉至醇含量60%-70%,取上清液浓缩制成50℃条件下相对密度为1.25~1.30的清膏备用;五味子、白果、紫菀、山萸肉用60%-70%乙醇提取1-3次,每次1-3小时,合并醇提液,浓缩制成50℃条件下相对密度为1.25~1.30的清膏;将上述各清膏合并,干燥,粉碎,加入挥发油包合物,混匀,即得。
上述中药组合物的制备方法具体包括如下步骤:
将紫苏叶、辛夷用水蒸气蒸馏法提取挥发性成分,采用β-环糊精包合后备用,药渣与防风、炙麻黄、苦杏仁合并,分别加10倍量水煎煮3次,每次1.5小时,合并提取液,浓缩成50℃条件下相对密度为1.10~1.15的清膏,醇沉至醇含量70%,取上清液浓缩制成50℃条件下相对密度为1.25~1.30的清膏备用;五味子、白果、紫菀、山萸肉用60%乙醇提取三次,每次2.5小时,合并醇提液,浓缩制成50℃条件下相对密度为1.25~1.30的清膏;将上述各清膏合并,干燥,粉碎,加入挥发油包合物,混匀,即得。
本发明中药组合物在制备治疗过敏性哮喘的药物中应用具有显著的效果。
本发明组合物从两个方面针对过敏性哮喘的治疗,其一疏风宣降肺气,即从舒缓气道方面改善气道挛急,对气道高反应以舒缓作用;其二即是通窍降气平喘,针对鼻塞、气急、喘促,改善肺之肃降功能。
发明人在临床上形成了对哮喘的总体分析,并根据当前哮病诊疗方面加以分析,认为“热哮、寒哮,痰为中心,伏痰为夙痰”的认识,一直受到关注,且教科书,诸多论著均已反复论证。而另一组即具有过敏因素基础,甚致具有体质禀赋,家族因素患者占有较大比例的“风哮”亦感论证不多,从风论治者更显不足,反复研究根据临床用药进行了再次筛选确定了此处方。
该方中以防风、苏叶为君,其意在于疏风、抗敏之意,二药亦在临床构成从风论治。防风,疏风祛风,对呼吸***过敏性疾病有疗效。苏叶,疏风,对气道疾患类应用较多,二者均有疏风宣肺、抗敏缓急之功;
方中炙麻黄、紫苑、杏仁为臣药,麻黄为疏风降气及宣肺平喘之大药,治疗胸闷喘哮之要药,有专家也曾善用麻黄治疗哮喘的经验;紫苑、杏仁更是宣肃肺之气,润肺下气,针对哮喘憋气喘急而用,助麻黄共应对哮喘发作,或慢性持续而治;
方中白果、五味子、山萸肉均有纳气敛肺、舒缓气道的作用,针对临床气道高反应所择取药物以助君、臣药以求降气、纳气、敛肺,定喘,三药为佐药;
辛夷,疏风通窍,亦有抗过敏之疗效,取其为使药。
全方不属过寒、过热方,方为不寒不热,即“辛平为主”以治风邪为患,用以舒缓气道,宣降肺气,调理肃降失常,平喘且兼通窍为法,以应对哮喘见风证者之治疗总意。
具体实施方式
以下通过试验例来进一步阐述本发明所述的药物的有益效果,这些试验例包括本发明药物(以下称哮喘方)的急性毒性实验和药效学试验。
一、药效实验:
1、材料
1.1受试药
哮喘方:按照实施例1方法制备得到。
1.2对照药
醋酸***片:规格0.75mg/片,批号:130125201,辰欣药业股份有限公司
1.3动物
SD大鼠50只,雄性,体重180~200g,清洁级,上海西普而-必凯实验动物有限公司,合格证号:(沪)2008-0016。
1.4试剂
卵白蛋白OVA,货号:A5503,(sigma);氢氧化铝Al(OH)3,货号239186,(sigma);IL-4、IFN-γ及TGF-β1试剂盒,批号20141120,由北京华英生物技术研究所提供。
2、实验方法
2.1大鼠过敏性哮喘模型建立
60只大鼠随机等分为正常对照组、哮喘模型组和***组16.2mg/kg、哮喘方高、中、低剂量组,给药剂量分别为14g/kg、7g/kg、3.5g/kg。按Vanacker等报道的方法,哮喘模型鼠在d0和d7每只腹腔内注射抗原混液(OVA1mg,氢氧化铝200μg,溶于1ml生理盐水配成混悬液)致敏。d14开始用1%OVA超声雾化吸入而激发,每两天1次,每次30min,共2周。正常对照组大鼠于d0和d7用1ml生理盐水腹腔内注射,d14开始用生理盐水超声雾化吸入,每两天1次,每次30min,共2周。***组和哮喘方组大鼠其d14开始灌胃给予相应药物,1ml/100g,共2周。正常对照组和哮喘模型组大鼠于d14灌胃给予等量CMC-Na溶液,共2周。
2.2指标检测
2.2.1支气管肺泡灌洗(BALF)及标本采集
各组大鼠最后一次激发1h后,每只大鼠以10%水合氯醛35mg/kg腹腔注射麻醉后,腹主动脉取血致死。消毒并打开胸腔,结扎右侧主支气管,用气管插管针***气管,固定后,行左侧肺肺泡灌洗术。缓慢注入D-hanks液5ml停留10s,缓慢回抽,重复3次;回收液约4ml。回收液立即注入EP管,4℃1500r/min离心15min。取适量沉淀作细胞涂片,瑞氏-姬姆萨法染色,按形态学标准进行细胞分类。余下沉淀用4ml生理盐水重新稀释后,加入血细胞计数板,在显微镜下作细胞计数。
2.2.2血清中IL-4、IFN-γ及TGF-β1水平
各组大鼠最后一次激发24h后,每只大鼠以10%水合氯醛35mg/kg腹腔注射麻醉后,腹主动脉取血,4℃3000r/min离心10min,分离血清。
2.3统计学处理方法数据以,表示,运用SPSS17.0统计软件采用单因素方差分析进行统计学处理。
3、实验结果
3.1BALF中白细胞总数、中性粒细胞百分比测定
表1哮喘方对BALF中白细胞总数、中性粒细胞百分比的影响(n=10)
注:与正常对照组比较,△P<0.05,△△P<0.01;与模型组比较,#P<0.05,##P<0.01。
与正常组相比,模型组大鼠BALF中白细胞总数和中性粒细胞百分比明显升高(P<0.01),与模型组比较,哮喘方高、中、低剂量组可降低白细胞总数和中性粒细胞百分比,差异显著(P<0.05)。
3.2血清中IL-4、IFN-γ及TGF-β1水平
表2哮喘方对血清中IL-4、IFN-γ及TGF-β1水平的影响(n=10)
注:与正常对照组比较,△P<0.05,△△P<0.01;与模型组比较,#P<0.05,##P<0.01。
与正常组相比,模型组大鼠血清中IL-4、IFN-γ及TGF-β1水平显著升高(P<0.01),与模型组比较,哮喘方高、中、低剂量组可降低IL-4、IFN-γ及TGF-β1水平(P<0.01,P<0.05)。
本试验结果表明,哮喘方对大鼠哮喘动物模型的气道炎症反应有明显的抑制作用,可降低BALF中白细胞总数和中性粒细胞百分比,降低血清IL-4、IFN-γ及TGF-β1水平。
二、急性毒性实验:
ICR小鼠40只,雌、雄动物分别按体重均衡分成2组,每组雌雄各10只,分别为对照组和给药组;给药组小鼠口服哮喘方400g生药/kg,对照组口服等容积试验用水,给药容积40mL/kg,分上下午2次给药,两次给药间隔在4~5h内。给药组及对照组均无动物濒死或死亡,小鼠单次口服哮喘颗粒最大耐受量(MTD)为400g生药/kg,约为临床拟用剂量的325倍。
实施例1本发明药物颗粒剂的制备
以上九味,紫苏叶、辛夷用水蒸气蒸馏法提取挥发性成分,采用β-环糊精包合后备用,药渣与防风、炙麻黄、苦杏仁合并,分别加10倍量水煎煮三次,每次1.5小时,合并提取液,浓缩成清膏(d=1.10~1.15,50℃),醇沉至醇含量70%,取上清液浓缩制成相对密度为1.25~1.30(50℃)的清膏备用;五味子、白果、紫菀、山萸肉用60%乙醇提取三次,每次2.5小时,合并醇提液,浓缩制成相对密度为1.25~1.30(50℃)的清膏;将上述各清膏合并,干燥,粉碎,加入挥发油包合物混合,再与适量常规辅料,混匀,制粒,制成1000g,即得。人日服用量:15g-30g。
实施例2本发明药物汤剂的制备
防风10g、紫苏叶10g、炙麻黄6g、五味子8g、白果8g、苦杏仁8g、紫苑8g、山萸肉8g、辛夷8g,加10倍量水煎煮三次,每次2.0小时,合并水煎液,浓缩成清膏(d=1.10~1.15,50℃)制成汤剂,日服用一剂。
实施例3本发明药物片剂的制备
防风150g紫苏叶150g炙麻黄60g五味子70g白果70g苦杏仁70g紫苑70g山萸肉70g辛夷70g。
以上九味,紫苏叶、辛夷用水蒸气蒸馏法提取挥发性成分,采用β-环糊精包合后备用,药渣与防风、炙麻黄、苦杏仁合并,分别加10倍量水煎煮三次,每次1.5小时,合并提取液,浓缩成清膏(d=1.10~1.15,50℃),醇沉至醇含量70%,取上清液浓缩制成相对密度为1.25~1.30(50℃)的清膏备用;五味子、白果、紫菀、山萸肉用60%乙醇提取三次,每次2.5小时,合并醇提液,浓缩制成相对密度为1.25~1.30(50℃)的清膏;将上述各清膏合并,干燥,粉碎,加入挥发油包合物混合,再与适量常规辅料,混匀,制粒,压片,制成1000片。
实施例4本发明药物胶囊剂的制备
防风120g紫苏叶120g炙麻黄60g五味子80g白果80g苦杏仁80g紫苑80g山萸肉80g辛夷80g。
以上九味,紫苏叶、辛夷用水蒸气蒸馏法提取挥发性成分,采用β-环糊精包合后备用,药渣与防风、炙麻黄、苦杏仁合并,分别加10倍量水煎煮三次,每次1.5小时,合并提取液,浓缩成清膏(d=1.10~1.15,50℃),醇沉至醇含量70%,取上清液浓缩制成相对密度为1.25~1.30(50℃)的清膏备用;五味子、白果、紫菀、山萸肉用60%乙醇提取三次,每次2.5小时,合并醇提液,浓缩制成相对密度为1.25~1.30(50℃)的清膏;将上述各清膏合并,干燥,粉碎,加入挥发油包合物混合,再与适量常规辅料,混匀,制粒,灌胶囊,制成1000粒。
Claims (7)
1.一种治疗过敏性哮喘的中药组合物,其特征在于该组合物由如下重量份的组分制成:
防风10-15重量份、紫苏叶10-15重量份、炙麻黄2-6重量份、五味子7-9重量份、白果7-9重量份、苦杏仁7-9重量份、紫苑7-9重量份、山萸肉7-9重量份、辛夷7-9重量份。
2.根据权利要求1所述的治疗过敏性哮喘的中药组合物,其特征在于该组合物由如下重量份的组分制成:
防风10-12重量份、紫苏叶10-12重量份、炙麻黄4-6重量份、五味子7-8重量份、白果7-8重量份、苦杏仁7-8重量份、紫苑7-8重量份、山萸肉7-8重量份、辛夷7-8重量份。
3.根据权利要求1所述的治疗过敏性哮喘的中药组合物,其特征在于该组合物由如下重量份的组分制成:
防风10重量份、紫苏叶10重量份、炙麻黄6重量份、五味子8重量份、白果8重量份、苦杏仁8重量份、紫苑8重量份、山萸肉8重量份、辛夷8重量份。
4.根据权利要求1、2或3所述的治疗过敏性哮喘的中药组合物,其特征在于该组合物加入药学允许的辅料制备汤剂、颗粒剂、胶囊剂、片剂或丸剂。
5.一种权利要求1、2或3所述的中药组合物的制备方法,其特征在于它包括如下步骤:
将紫苏叶、辛夷用水蒸气蒸馏法提取挥发性成分,采用β-环糊精包合后备用,药渣与防风、炙麻黄、苦杏仁合并,分别加水煎煮2-3次,每次1-3小时,合并提取液,浓缩成50℃条件下相对密度为1.10~1.15的清膏,醇沉至醇含量60%-70%,取上清液浓缩制成50℃条件下相对密度为1.25~1.30的清膏备用;五味子、白果、紫菀、山萸肉用60%-70%乙醇提取2-3次,每次1-3小时,合并醇提液,浓缩制成50℃条件下相对密度为1.25~1.30的清膏;将上述各清膏合并,干燥,粉碎,加入挥发油包合物,混匀,即得。
6.一种权利要求5所述的中药组合物的制备方法,其特征在于它包括如下步骤:
将紫苏叶、辛夷用水蒸气蒸馏法提取挥发性成分,采用β-环糊精包合后备用,药渣与防风、炙麻黄、苦杏仁合并,分别加10倍量水煎煮3次,每次1.5小时,合并提取液,浓缩成50℃条件下相对密度为1.10~1.15的清膏,醇沉至醇含量70%,取上清液浓缩制成50℃条件下相对密度为1.25~1.30的清膏备用;五味子、白果、紫菀、山萸肉用60%乙醇提取3次,每次2.5小时,合并醇提液,浓缩制成50℃条件下相对密度为1.25~1.30的清膏;将上述各清膏合并,干燥,粉碎,加入挥发油包合物,混匀,即得。
7.权利要求1、2或3所述的中药组合物在制备治疗过敏性哮喘的药物中的应用。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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CN111317787A (zh) * | 2020-03-25 | 2020-06-23 | 漳州片仔癀药业股份有限公司 | 中药组合物及其制剂在制备治疗支气管哮喘的药物中的用途 |
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