CN116350701A - 一种治疗咳嗽变异性哮喘的中药组合物及其制备方法 - Google Patents
一种治疗咳嗽变异性哮喘的中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明属于医药技术领域,涉及一种治疗咳嗽变异性哮喘的中药组合物及其制备方法。该中药组合物由蝉蜕、苦杏仁、木蝴蝶、玄参、法半夏、炒白芍、醋五味子及微量茄红素和β‑胡萝卜素组成。本发明以传统的中医辨证施治和现代营养学为基础,结合临床实践进行科学配伍,各味药相辅相成,且通过不断探索确定各味中药的最佳使用剂量,对咳嗽变异性哮喘疗效尤为显著。
Description
技术领域
本发明属于医药技术领域,涉及一种治疗咳嗽变异性哮喘的中药组合物及其制备方法。
背景技术
咳嗽变异性哮喘(Cough variant asthma CVA)是哮喘较为常见的一种特殊表型,咳嗽往往作为唯一或主要症状,常表现为夜间刺激性干咳,较为剧烈,无明显喘息、气促等症状或体征,但有气道高反应性,气流受限检查阳性,病理特征为非生产性咳嗽和支气管高反应性(BHR),借鉴古人“风盛则挛急”的理论将其命名为风咳,目前多被认为是经典哮喘的前兆。CVA作为支气管哮喘的一种特殊类型,可在外界诱因刺激下如遇冷空气、油烟等易诱发或加重。
咳嗽变异性哮喘为外感风邪,影响肺的宣降功能,导致津液敷布障碍,水液停聚而为痰,痰阻气机,日久成瘀而致病。CVA发病特点,基于“风盛挛急”“风盛则痒”“风胜则动”“休止无常”和“反复发病”。CVA基本病机为肺阴不足,阴虚风动,风邪扰肺,肺失清肃,气机上逆。
目前,西医治疗咳嗽变异性哮喘发作主要为支气管舒张剂、糖皮质激素、白三烯受体拮抗剂等,能取得一定的疗效,但长期治疗对身体不良反应大,并发症多,且停药后易复发,严重影响患者身体健康。因以上原因,现在不少部分CVA患者想找中医治疗CVA,市场上专门治疗CVA的中药并不多,故积极控制和治疗CVA对支气哮喘的防治有着重要意义。
发明内容
鉴于上述原因,本发明以传统的中医辨证施治和现代营养学为基础,结合临床实践进行科学配伍,提供一种治疗咳嗽变异性哮喘的中药组合物。
进一步,本发明提供一种治疗咳嗽变异性哮喘的中药组合物,所述的中药组合物含有:蝉蜕、苦杏仁、木蝴蝶、玄参、法半夏、炒白芍、醋五味子及茄红素和β-胡萝卜素。
具体地,所述的中药组合物按重量份计为:蝉蜕12-30份、苦杏仁9-25份、木蝴蝶9-25份、玄参5-25份、法半夏2-12份、炒白芍2-12份、醋五味子2-12份、茄红素1-6份和β-胡萝卜素1-6份。
具体地,所述的中药组合物按重量份计为:蝉蜕15-25份、苦杏仁10-20份、木蝴蝶10-20份、玄参10-20份、法半夏3-9份、炒白芍3-9份、醋五味子3-9份、茄红素2-4份和β-胡萝卜素3-5份。
更具体地,所述的中药组合物按重量份计为:蝉蜕20份、苦杏仁15份、木蝴蝶15份、玄参15份、法半夏9份、炒白芍6份、醋五味子6份、茄红素2份和β-胡萝卜素3份。
更具体地,上述中药组合物的剂型为常用口服制剂如丸剂、颗粒剂、胶囊、口服液等,优选为丸剂。
进一步地,一种治疗咳嗽变异性哮喘中药组合物的丸剂制备方法,其特征在于,按照以下步骤进行:
步骤1:按处方量称取蝉蜕、苦杏仁、木蝴蝶、玄参、法半夏、炒白芍、醋五味子加入药材量10-12倍的水,180-200℃煎熬至沸腾后,120-150℃煎煮1.0-2.5小时,过滤,取第一次滤液,滤渣加入8-10倍的水,180-200℃煎熬至沸腾后,120-150℃煎煮0.5-1.5小时,过滤,取第二次滤液,合并两次滤液,搅匀,备用;
步骤2:将合并滤液,在温度为50℃条件下减压浓缩,浓缩至温度为50℃时相对密度为1.02-1.16的药液;
步骤3:加入药材量5%-25%麦芽糊精,搅拌至溶解,过滤,干燥,加入处方量的茄红素和β-胡萝卜素,混匀得干药粉,按每公斤药粉配0.6公斤蜂蜜,先将蜂蜜置于锅内,用120℃熬炼,熬至蜂蜜粘稠状,再掺入药粉,充分拌匀成药膏,制成统一规格的丸剂,抛光,即得治疗咳嗽变异性哮喘蜜丸。
进一步地,一种治疗咳嗽变异性哮喘的中药组合物提取物为活性成分的药物制剂,其中药组合物提取物可以为上述丸剂制备步骤1或其他中药提取方式制备得到的粗提取或精提物即为所述中药组合物的活性成分。
进一步地,治疗咳嗽变异性哮喘的中药组合物或治疗咳嗽变异性哮喘的中药组合物的提取物在制备治疗咳嗽变异性哮喘药物中的应用
本发明所涉及重要组合物和营养素来源与功效:
蝉蜕为蝉科昆虫黑蚱CryptotympanapustulataFabricius的若虫羽化时脱落的皮壳。性味和归经:甘,寒;归肺、肝经。主治疏散风热,利咽,透疹,明目退翳,解痉。用于风热感冒,咽痛音哑,麻疹不透,风瘆瘙痒,目赤翳障,惊风抽搐,破伤风。
苦杏仁为蔷薇科植物山杏Prunus armeniaca L.var.ansu Maxim的干燥成熟种子。性味与归经:苦、微温;有小毒。归肺、大肠经。主治降气止咳平喘,润肠通便。用于咳嗽气喘,胸满痰多,肠燥便秘。
木蝴蝶为紫葳科植物木蝴蝶Oroxylum indicum(L.)Vent.的干燥成熟种子。性味与归经苦:苦、甘,凉。归肺、肝、胃经。主治清肺利咽,疏肝和胃。用于肺热咳嗽,喉痹,音哑,肝胃气痛。
玄参为玄参科植物玄参Scrophularia ningpoensis Hemsl.的干燥根。性味与归经苦:甘、苦、咸,微寒。归肺、胃、肾经。主治清热凉血,滋阴降火,解毒散结。用于热入营血,温毒发斑,热病伤阴,舌绛烦渴,津伤便秘,骨蒸劳嗽,目赤,咽痛,白喉,瘰疬,痈肿疮毒。
法半夏为天南星科植物半夏Pinellia ternata(Thunb.)Breit.的干燥块茎)的炮制加工品,具体制法为每100kg净半夏,用甘草15kg、生石灰10kg;取半夏,大小分开,用水浸泡至内无干心,取出;另取甘草适量,加水煎煮二次,合并煎液,倒入用适量水制成的石灰液中,搅匀,加入上述已浸透的半夏,浸泡,每日搅拌1~2次,并保持浸液pH值12以上,至剖面黄色均匀,口尝微有麻舌感时,取出,洗净,阴干或烘干,即得。性味与归经:辛,温。归脾、胃、肺经。主治燥湿化痰。用于痰多咳喘,痰饮眩悸,风痰眩晕,痰厥头痛。
炒白芍为白勺的清炒制品。白勺为毛茛科植物芍药Paeonia lactiflora Pall.的干燥根。夏、秋二季采挖,洗净,除去头尾和细根,置沸水中煮后除去外皮或去皮后再煮,晒干。性味与归经:苦、酸,微寒。归肝、脾经。主治养血调经,敛阴止汗,柔肝止痛,平抑肝阳。用于血虚萎黄,自汗,盗汗,胁痛,腹痛,四肢挛痛,头痛眩晕。
醋五味子为五味子炮制品。五味子为木兰科植物五味子Schisandra chinensis(Turcz.)Baill.的干燥成熟果实。习称"北五味子"。
性味与归经:酸、甘,温。归肺、心、肾经。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,内热消渴,心悸失眠。
β-胡萝卜素进入人体后会变成维生素A,可以帮助呼吸道上皮组织的新陈代谢,防护呼吸道,增强呼吸系统的抵抗力,缓解支气管炎和气喘等疾病。
茄红素有非常强的抗氧化效果,能够增强免疫力,抵抗发炎反应,茄红素主要存在于番茄,也就是西红柿中,尤其以熟的番茄中含量较多,除此之外辣椒、石榴中也含有较多,建议每天摄入2-3个中等大小的番茄。
本发明构思的治疗机理根据CVA发病特点,基于“风盛挛急”“风盛则痒”“风胜则动”;CVA基本病机为肺阴不足,阴虚风动,风邪扰肺,肺失清肃,气机上逆。本发明以传统的中医辨证施治为基础,结合临床实践进行科学配伍,各味药相辅相成,其中,蝉蜕、木蝴蝶和苦杏仁皆归肺、肝经,三者合用能降气、止咳、平喘、滋肺阴、润肺燥、清肺热,合为君药;玄参味甘平咸,归肺、脾、肾经,具有清热凉血,滋阴降火功效,法半夏,味辛,性温,归脾、胃、肺经,具有燥湿化痰的功效,两者合用为臣药;炒白芍主治敛阴止汗,平抑肝阳和醋五主治收敛固涩,益气生津,补肾宁心,两者合为佐药。在传统的中医辨证施治的基础上结合现代营养学,本发明还添加β-胡萝卜素调节帮助呼吸道上皮组织的新陈代谢,防护呼吸道,增强呼吸系统的抵抗力和茄红素抵抗发炎反应,增强免疫力。通过不断探索确定各味中药的最佳使用剂量,发挥复方中药的整体调节优势,祛除病邪、缓解症状、调节免疫的有机结合,实现多靶治疗,实验证实对咳嗽变异性哮喘均有显著疗效。
与现有技术相比,本发明具有的有益效果或优点如下:
(1)本发明提供的治疗咳嗽变异性哮喘的中药组合物,其遵循咳嗽变异性哮喘患者身体系统运行特性和咳嗽变异性哮喘发病机理,在治疗咳嗽变异性哮喘有显著疗效。
(2)本发明使用中国传统中药为原料,优选蜜丸,口感好,服用方便,是通过临床试验反复验证配置而成的,符合传统中医学的理论,具有疏风解痉,镇咳平喘之功效,用于咳嗽变异性哮喘风邪恋肺证,症见刺激性干咳或呛咳,咽痒则咳,咳剧时胸闷、气急,夜间或清晨加重,无痰或少量粘液痰,口干,可伴有鼻塞流涕,恶风等症,舌淡红、苔白、脉浮。
具体实施方式
以下结合具体实施例,对本发明的具体实施方案做详细的阐述。应理解,这些实施例仅用于说明本发明,本发明的保护范围以权利要求为准。
下述各实施例中所述实验方法和检测方法,如无特殊说明,均为常规方法;所述试剂和材料,如无特殊说明,均可在市场上购买得到。
实施例1
优选组方配比实施例:提供一种治疗咳嗽变异性哮喘的中药组合物及其丸剂制备方法。
所述的中药组合物按重量份计为:蝉蜕20份、苦杏仁15份、木蝴蝶15份、玄参15份、法半夏9份、炒白芍6份、醋五味子6份、茄红素2份和β-胡萝卜素3份。
具体制备方法,包括如下步骤:
步骤1:按处方量称取蝉蜕200g、苦杏仁150g、木蝴蝶150g、玄参150g、法半夏90g、炒白芍60g和醋五味子60g,加入11000ml的水,180℃加热至沸腾后,120℃煎煮1.5小时,过滤,取第一次滤液,滤渣加入9000的水,180℃加热至沸腾后,120℃煎煮1小时,过滤,取第二次滤液,合并两次滤液,搅匀,备用;
步骤2:将合并滤液,在温度为55℃条件下减压浓缩,浓缩至温度为55℃时相对密度为1.27的药膏;
步骤3:加入药材量10%麦芽糊精,搅拌至溶解,过滤,喷雾干燥,加入茄红素20g和β-胡萝卜素30g,混匀得干药粉,按每公斤药粉配0.6公斤蜂蜜,先将蜂蜜置于锅内,120℃熬炼,熬至蜂蜜粘稠状,再掺入药粉,充分拌匀成药膏,制成统一规格的丸剂,抛光,即得治疗咳嗽变异性哮喘蜜丸。
实施例2
最大配比实施例:提供一种治疗咳嗽变异性哮喘的中药组合物及其丸剂制备方法。
所述的中药组合物按重量份计为:蝉蜕30份、苦杏仁25份、木蝴蝶25份、玄参25份、法半夏12份、炒白芍12份、醋五味子12份、茄红素6份和β-胡萝卜素6份。
制备方法同实施例1,此处不在赘述。
实施例3
最小配比实施例:提供一种治疗咳嗽变异性哮喘的中药组合物及其丸剂制备方法。
所述的中药组合物按重量份计为:蝉蜕12份、苦杏仁9份、木蝴蝶9份、玄参5份、法半夏2份、炒白芍2份、醋五味子2份、茄红素1份和β-胡萝卜素1份。
制备方法同实施例1,此处不在赘述。
实施例4
阴性对照组1:不含君药(蝉蜕、苦杏仁、木蝴蝶)的治疗咳嗽变异性哮喘的中药组合物及其丸剂制备方法。
所述的中药组合物按重量份计为:玄参15份、法半夏9份、炒白芍6份、醋五味子6份、茄红素2份和β-胡萝卜素3份。
制备方法同实施例1,此处不在赘述。
实施例5
阴性对照组2:不含臣药(玄参、法半夏)的治疗咳嗽变异性哮喘的中药组合物及其丸剂制备方法。
所述的中药组合物按重量份计为:蝉蜕20份、苦杏仁15份、木蝴蝶15份、玄参15份、法半夏9份、炒白芍6份、醋五味子6份、茄红素2份和β-胡萝卜素3份。
制备方法同实施例1,此处不在赘述。
实施例6
阴性对照组3:不含佐药(炒白芍、醋五味子)的治疗咳嗽变异性哮喘的中药组合物及其丸剂制备方法。
所述的中药组合物按重量份计为:蝉蜕20份、苦杏仁15份、木蝴蝶15份、玄参15份、法半夏9份、茄红素2份和β-胡萝卜素3份。
制备方法同实施例1,此处不在赘述。
实施例7
阴性对照组4:不含微量元素(茄红素和β-胡萝卜素)的治疗咳嗽变异性哮喘的中药组合物及其丸剂制备方法。
所述的中药组合物按重量份计为:蝉蜕20份、苦杏仁15份、木蝴蝶15份、玄参15份、法半夏9份、炒白芍6份、醋五味子6份。
制备方法同实施例1,此处不在赘述。
实施例8
以下通过试验例来进一步阐述本发明所述组合物的有益效果,说明本发明中药组合物治疗咳嗽变异性哮喘作用研究。
一、镇咳作用
选用SPF级小鼠90只,体重20±2g,饲养条件为动物饲养室相对温度为21±5℃,相对湿度为40%-70%,光照条件为12h/12h明暗交替。将上述大鼠随机分为九组,每组10只,雌、雄各半,分别为:
1组为阳性药物优选组,选用实施例1制备的治疗咳嗽变异性哮喘中药蜜丸;
2组为阳性药物最大配比组,选用实施例2制备的治疗咳嗽变异性哮喘中药蜜丸;
3组为阳性药物最小配比组,选用实施例3制备的治疗咳嗽变异性哮喘中药蜜丸;
4组为阴性对照组1,选用实施例4制备的缺君药的治疗咳嗽变异性哮喘中药蜜丸;
5组为阴性对照组2,选用实施例5制备的缺臣药的治疗咳嗽变异性哮喘中药蜜丸;
6组为阴性对照组3,选用实施例6制备的缺佐药的治疗咳嗽变异性哮喘中药蜜丸;
7组为阴性对照组4,选用实施例7制备的缺微量元素的治疗咳嗽变异性哮喘中药蜜丸;
8组为模型对照组:选用辅料麦芽糊精制备的蜜丸。
1-7组给予本发明对应实施例中制备的治疗咳嗽变异性哮喘中药蜜丸,用量相当于60Kg成人临床等效剂量。
各组小鼠灌胃给药,每日2次,1g/10g体重,连续给药3天,8组模型对照组在同等条件下给麦芽糊精制备蜜丸。末次给药一小时后,将小鼠依次放入30cm×20cm×15cm的塑料盒中,用超声雾化器喷雾氨水20秒,取出放入笼中,记录小鼠自取出到出现第一声咳嗽的时间(潜伏期),并记录3分钟内咳嗽的次数,结果如表1所示。
表1各组治疗咳嗽变异性哮喘中药蜜丸对小鼠的镇咳作用
组别 | 动物数(只) | 潜伏期平均(秒) | 咳嗽平均次数(秒) |
1组 | 10 | 30.1 | 5.2 |
2组 | 10 | 27.7 | 7.4 |
3组 | 10 | 25.8 | 8.7 |
4组 | 10 | 20.1 | 12.3 |
5组 | 10 | 25.4 | 9.1 |
6组 | 10 | 23.0 | 6.2 |
7组 | 10 | 26.9 | 7.7 |
8组 | 10 | 19.0 | 13.2 |
由表1可知,1-7治疗组相比模型对照组均对氨水引起小鼠咳嗽的潜伏期有一定的延长作用,对氨水引起小鼠的咳嗽次数有一定的减少作用,与模型对照组比较均有显著性差异。
二、平喘作用
取豚鼠100只,体重220±25g,随机分为九组,每组10只,雌、雄各半,分别为:
1组为阳性药物优选组,选用实施例1制备的治疗咳嗽变异性哮喘中药蜜丸;
2组为阳性药物最大配比组,选用实施例2制备的治疗咳嗽变异性哮喘中药蜜丸;3组为阳性药物最小配比组:
3组为选用实施例3制备的治疗咳嗽变异性哮喘中药蜜丸;
4组为阴性对照组1,选用实施例4制备的缺君药的治疗咳嗽变异性哮喘中药蜜丸;
5组为阴性对照组2,选用实施例5制备的缺臣药的治疗咳嗽变异性哮喘中药蜜丸;
6组为阴性对照组3,选用实施例6制备的缺佐药的治疗咳嗽变异性哮喘中药蜜丸;
7组为阴性对照组4,选用实施例7制备的缺微量元素的治疗咳嗽变异性哮喘中药蜜丸;
8组模型对照组:选用辅料麦芽糊精制备的蜜丸。
9组为空白对照组:选用辅料麦芽糊精制备的蜜丸。
1-7组给予本发明对应实施例中制备的治疗咳嗽变异性哮喘中药蜜丸,用量相当于60Kg成人临床等效剂量。
除9组空白对照组外,其余两组豚鼠每只腹腔注射10%卵白蛋白生理盐水1ml致敏,从致敏后第3天开始灌胃给药,每日1次,1ml/100g体重,连续给药12天,模型对照组和空白对照组在同等条件下给麦芽糊精制备蜜丸。每周称一次体重,于末次给药一小时后,将豚鼠依次放入30cm×20cm×15cm的塑料盒中,用超声雾化器恒压喷雾5%卵白蛋白生理盐水30秒,停止喷雾后,观察5分钟,记录豚鼠自停止喷雾到出现喘息性抽搐的时间(潜伏期),及发生跌倒休克的动物数,结果如表2。
表2各组治疗咳嗽变异性哮喘中药蜜丸对小鼠的平喘作用
组别 | 动物数(只) | 潜伏期平均(秒) | 跌倒休克率(%) |
1组 | 10 | 81.1 | 10 |
2组 | 10 | 77.9 | 20 |
3组 | 10 | 76.6 | 20 |
4组 | 10 | 71.4 | 40 |
5组 | 10 | 77.1 | 30 |
6组 | 10 | 74.7 | 30 |
7组 | 10 | 78.3 | 30 |
8组 | 10 | 71.3 | 40 |
9组 | 10 | - | - |
由表2可知,1-7治疗组相比空白对照组对卵白蛋白引起豚鼠哮喘的潜伏期有一定的延长作用,对卵白蛋白引起豚鼠的跌倒休克有一定的减少作用,与模型对照组比较均有显著性差异。
综合表1和表2可知,阳性药物组的治疗效果不论是潜伏期、咳嗽次数和跌倒休克率明显优于模型对照组,即本申请治疗咳嗽变异性哮喘的中药组合物可以有效减少咳嗽,延长潜伏期,减少跌倒休克,起到镇咳、平喘的作用。
最大配比2组和最小配比3组及4-7组4个阴性对照组的潜伏期、咳嗽次数、跌倒休克率虽存在一定差异,但均优于空白对照组,而低于阳性药物组,故本申请的药物组合物中的天然中药和微量元素各组分缺一不可,共同配合治疗咳嗽变异性哮喘,起到镇咳平喘的功效。
以上仅为本发明的较佳实施方案,并非用于限定本发明的保护范围。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 (7)
1.一种治疗咳嗽变异性哮喘的中药组合物,其特征在于,所述的中药组合物含有:蝉蜕、苦杏仁、木蝴蝶、玄参、法半夏、炒白芍、醋五味子及茄红素和β-胡萝卜素。
2.根据权利要求1所述的中药组合物,其特征在于,所述的中药组合物按重量份计为:蝉蜕12-30份、苦杏仁9-25份、木蝴蝶9-25份、玄参5-25份、法半夏2-12份、炒白芍2-12份、醋五味子2-12份、茄红素1-6份和β-胡萝卜素1-6份。
3.根据权利要求1所述的中药组合物,其特征在于,所述的中药组合物按重量份计为:蝉蜕15-25份、苦杏仁10-20份、木蝴蝶10-20份、玄参10-20份、法半夏3-9份、炒白芍3-9份、醋五味子3-9份、茄红素2-4份和β-胡萝卜素3-5份。
4.根据权利要求1所述的中药组合物,其特征在于,所述的中药组合物按重量份计为:蝉蜕20份、苦杏仁15份、木蝴蝶15份、玄参15份、法半夏9份、炒白芍6份、醋五味子6份、茄红素2份和β-胡萝卜素3份。
5.一种如权利要求1-4所述的治疗咳嗽变异性哮喘中药组合物的丸剂制备方法,其特征在于,按照以下步骤进行:
步骤1:按处方量称取蝉蜕、苦杏仁、木蝴蝶、玄参、法半夏、炒白芍、醋五味子加入药材量10-12倍的水,180-200℃煎熬至沸腾后,120-150℃煎煮1.0-2.5小时,过滤,取第一次滤液,滤渣加入8-10倍的水,180-200℃煎熬至沸腾后,120-150℃煎煮0.5-1.5小时,过滤,取第二次滤液,合并两次滤液,搅匀,备用;
步骤2:将合并滤液,在温度为50℃条件下减压浓缩,浓缩至温度为50℃时相对密度为1.02-1.16的药液;
步骤3:加入药材量5%-25%麦芽糊精,搅拌至溶解,过滤,干燥,加入处方量的茄红素和β-胡萝卜素,混匀得干药粉,按每公斤药粉配0.6公斤蜂蜜,先将蜂蜜置于锅内,用120℃熬炼,熬至蜂蜜粘稠状,再掺入药粉,充分拌匀成药膏,制成统一规格的丸剂,抛光,即得治疗咳嗽变异性哮喘蜜丸。
6.以权利要求1-4任一项所述的一种治疗咳嗽变异性哮喘的中药组合物提取物为活性成分的药物制剂。
7.以权利要求1-4任一项所述的一种治疗咳嗽变异性哮喘的中药组合物或权利要求6任一项所述的一种治疗咳嗽变异性哮喘的中药组合物的提取物在制备治疗咳嗽变异性哮喘药物中的应用。
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