CN107753664B - 一种治疗过敏性鼻炎的中药组合物及其制备方法 - Google Patents
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Abstract
本发明涉及中医药领域，尤其涉及一种治疗过敏性鼻炎的中药组合物及其制备方法。所述中药组合物由以下重量份的原料组成：麻黄10~20份、紫苏叶5~15份、苍耳子10~25份、蝉蜕10~25份、防风10~25份、蔓荆子5~15份、甘草10~15份。采用的中药成分搭配合理，药材原料容易获得，制备方法简单，成本低，疗效显著，同时能增加人体免疫力，减缓患者痛苦，能很好的治疗过敏性鼻炎引起的喷嚏、清鼻涕、鼻塞鼻痒等症状。
Description
技术领域
本发明涉及中医药领域，尤其涉及一种治疗过敏性鼻炎的中药组合物及其制备方法。
背景技术
随着工业化的发展，现代生活方式和生态环境的污染（尤其室内装修材料中苯、甲醛等有害物质严重超标等因素），过敏性鼻炎发病率有全球性增长的趋势，被视为“21世界的流行病”。每当到春天，过敏性鼻炎的发病率几率更大。所以研究治疗过敏性鼻炎对于我们来说很重要。
过敏性鼻炎是一种变态反应性鼻炎又称变应性鼻炎，是特应性个体接触致敏原后由IgE介导的介质（主要是组胺）释放、并有多种免疫活性细胞和细胞因子等参与的鼻粘膜慢性炎症反应性疾病，以鼻痒、喷嚏、鼻分泌亢进、鼻粘膜肿胀等为主要特点。过敏性鼻炎主要表现为首先是打喷嚏，喷嚏多是过敏性鼻炎的常见症状，尤其是接触到过敏原时，连打十几个喷嚏都是正常的，且每天发作的次数也比较多。
目前，治疗过敏性鼻炎的药物主要为消炎药和抗生素，治标不治本。西药多采用药物脱敏疗法，需要时间较长，会出现嗜睡，精神不济的现象，副作用比较明显。
发明内容
本发明的目的在于提供一种用于治疗过敏性鼻炎的药中药组合物，疗效显著，副作用小，标本兼治。
本发明的目的可通过如下措施来达到：
一种治疗过敏性鼻炎的中药组合物，由以下重量份的原料组成：麻黄10~20份、紫苏叶5~15份、苍耳子10~25份、蝉蜕10~25份、防风10~25份、蔓荆子5~15份、甘草10~15份。
优选地，一种治疗过敏性鼻炎的中药组合物，由以下重量份的原料组成：麻黄10～18、紫苏叶5～12份、苍耳子10～20份、蝉蜕10～20份、防风10～22份、蔓荆子5～13份、甘草10～15份。
上述治疗过敏性鼻炎的中药组合物与药学上常规辅料可制成喷剂、胶囊剂、颗粒剂。
上述治疗过敏性鼻炎的中药组合物的制备方法，包括以下步骤：按配比称取原料药材麻黄、紫苏叶、苍耳子、蝉蜕、防风、蔓荆子、甘草，加水浸泡，加水量以至少淹没原料药材为准，加热回流提取30~110分钟，提取温度为80~105℃，提取2~3次，每次提取后静置3分钟，用≤200μm滤网或筛过滤，合并提取液，将提取液浓缩至提取液重量为原料药材重量的1.1~1.4倍量，即得本发明的中药提取物。
进一步地，制备得到的中药提取物以药学上常规制备方法可制成喷剂、胶囊剂、颗粒剂。
优选地，治疗过敏性鼻炎的中药组合物的制备方法中，加水量为原料药材总重量的3~4倍。
本发明所用中药材原料成分的主要作用为：
麻黄：发汗，平喘，利水。治伤寒表实，发热恶寒无汗，头痛鼻塞，骨节疼痛，咳嗽气喘。
紫苏叶：辛、微温，无毒。发表，散寒，理气，和营。治感冒风寒，恶寒发热，咳嗽，头痛无汗，气喘，胸腹胀满，呕恶腹泻，咽中梗阻，妊娠恶阻，胎动不安。
苍耳子：具有发散风寒,通鼻窍,祛风湿,止痛之功效,用于风寒感冒,鼻渊,风湿痹痛,风疹痉痒等。
蝉蜕：甘，寒。入肺、肝经。散风热、退目翳，透气，解痉等功能。主治感冒分热、音哑，麻疹不透，风疹作痒，小儿惊痫。
防风：味辛、甘，温。归膀肌、肝、脾经。主治解表祛风，胜湿，止痉。具有镇痛、抗菌、解热等作用。
蔓荆子：辛苦，寒。入肝，胃，膀胱经。散风清热的功能。主治感冒风热，头痛目赤，牙龈肿痛。
甘草：味甘；性平。归心、肺、脾、胃经。具有清热解毒、止咳祛痰、补脾和胃、调和诸药的功效。
与现有技术相比，本发明有如下有益效果：肺主一身之表，开窍于鼻，鼻窍不通责之于肺。麻黄宣肺解表，紫苏叶理气解表，二药解表宣通肺气。苍耳子发散风寒善通鼻窍，为通鼻窍之要药，蝉蜕甘寒入肺经，疏散风热、利咽开音，蔓荆子疏散风热、清利头目，善治头面诸疾，三药共用散风清热，开通鼻窍。防风为风药，在此取其风药能升阳气之功效，助诸药上行头面，甘草调和诸药。方内诸药配伍共奏宣肺鼻窍之效。采用的中药成分搭配合理，药材原料容易获得，制备方法简单，成本低，疗效显著，同时能增加人体免疫力，减缓患者痛苦，能很好的治疗过敏性鼻炎引起的喷嚏、清鼻涕、鼻塞鼻痒等症状。
具体实施方式
实施例1
一种治疗过敏性鼻炎的中药组合物，按重量份有以下原料组成：麻黄10、紫苏叶8、苍耳子12、蝉蜕15、防风14、蔓荆子5、甘草12。
具体方法：称取相应中药材，用清水进行回流提取，水量以至少淹没中药材为准，把温度控制在95℃下回流提取50分钟，之后用≤200μm滤网或筛过滤得提取液，浓缩至药材与提取液之比为1：1.2，即提取液重量为药材重量的1.2倍量，即得本发明的中药提取物，将取得的药汁经过活性炭过滤即可进行杀菌灌装，制成喷剂。
实施例2
一种治疗过敏性鼻炎的中药组合物，按重量份有以下原料组成：麻黄15、紫苏叶10、苍耳子18、蝉蜕17、防风17、蔓荆子10、甘草13。
具体方法：称取相应中药材，用清水进行回流提取，水量以至少淹没中药材为准，把温度控制在95℃下回流提取50分钟，之后用≤200μm滤网或筛过滤得提取液，浓缩至药材与提取液之比为1：1.2，即提取液重量为药材重量的1.2倍量，即得本发明的中药提取物，之后进行浓缩，浓缩至浸膏状。得到的浸膏真空干燥75℃，得到干膏，粉碎，过100目筛，得到药粉；取预胶化淀粉和微粉硅胶分别过100目筛，备用。将药粉与预胶化淀粉和微粉硅胶按质量比32:63:4混合均匀，分装入空心胶囊中，制成胶囊剂。
实施例3
一种治疗过敏性鼻炎的中药组合物，按重量份有以下原料组成：麻黄18、紫苏叶12、苍耳子20、蝉蜕19、防风17、蔓荆子12、甘草14。
具体方法：称取相应中药材，用清水进行回流提取，水量以至少淹没中药材为准，把温度控制在95℃下回流提取50分钟，之后用≤200μm滤网或筛过滤得提取液，浓缩至药材与提取液之比为1：1.2，即提取液重量为药材重量的1.2倍量，即得本发明的中药提取物。将提取物减压浓缩至比重1.0的稠膏状，喷雾干燥，进口温度为130℃，出口温度为85℃。之后在提取物中加入乳糖24份、可溶性淀粉12份、糊精36份，混合均匀；取1份十二烷基硫酸镁润滑，之后用摇摆式制粒机制粒，制成颗粒剂。
服用方法：每日3次，饭前空腹服用，1个月为一个疗程，服用期间忌辛辣生冷刺激性食物。
动物毒性试验：
1.取实验小鼠20只，雌雄各半，体重120~140g，小鼠体征良好，体重等生理表现无异常，具有可比性。
2.给这组小鼠使用本发明实施例制备的抗过敏性鼻炎的中药方剂，灌胃给药，每天3次，连续服用一个月，在实验期间观察并记录所有小鼠的体征情况。
3.实验过程中所有小鼠的体征表现无异常，实验结束后未出现小鼠死亡情况，对每组小鼠中随机抽取5只进行解剖检查，主要器官均未发现异常，由实验结果可知，本发明的抗过敏性哮喘的中药方剂无明显毒性，可安全服药。
下面是本发明药物对于过敏性鼻炎的调理改善临床观察统计资料：
1.病例选取：临床上选取确诊的过敏性鼻炎患者36例，年龄20~65岁，男性24例，女性12例，分为三组实验组1~3，每组12例。
2.实验方法：给实验组1~3分别使用本发明实施例1~3制备的剂型，每日三次，实施例1每次5ml，实施例2和实施例3每次10g，连续服药一个月，观察并记录患者的恢复情况。
3.疗效判定标准：
显效：过敏性鼻炎症状消失，各项体征恢复正常，半年内未见复发；
有效：过敏性鼻炎临床症状改善，患者相较服药之前各体征表现明显好转；
无效：病情无任何改善或加重。
4.实验数据统计：
5.实验结果：由以上实验数据可以看出，本发明制备的过敏性鼻炎的中药组合物对于过敏性鼻炎的治疗的平均总有效率为88.9%，且36例患者未见任何不良反应，因此说明，本发明的中药组合物是治疗过敏性鼻炎的安全有效药物，具有很好的临床推广意义。
Claims (6)
1.一种治疗过敏性鼻炎的中药组合物，其特征在于，由以下重量份的原料组成：麻黄10~20份、紫苏叶5~15份、苍耳子10~25份、蝉蜕10~25份、防风10~25份、蔓荆子5~15份、甘草10~15份。
2.如权利要求1所述的一种治疗过敏性鼻炎的中药组合物，其特征在于，由以下重量份的原料组成：麻黄10～18、紫苏叶5～12份、苍耳子10～20份、蝉蜕10～20份、防风10～22份、蔓荆子5～13份、甘草10～15份。
3.如权利要求1所述的一种治疗过敏性鼻炎的中药组合物，其特征在于，所述中药组合物与药学上常规辅料可制成喷剂、胶囊剂、颗粒剂。
4.如权利要求1或2所述的治疗过敏性鼻炎的中药组合物的制备方法，其特征在于，包括以下步骤：
按配比称取原料药材麻黄、紫苏叶、苍耳子、蝉蜕、防风、蔓荆子、甘草，加水浸泡，加水量以至少淹没原料药材为准，加热回流提取30~110分钟，提取温度为80~105℃，提取2~3次，每次提取后静置3分钟，用≤200μm滤网或筛过滤，合并提取液，将提取液浓缩至提取液重量为原料药材重量的1.1~1.4倍量，即得权利要求 1 或 2 所述 的中药提取物。
5.如权利要求4所述的治疗过敏性鼻炎的中药组合物的制备方法，其特征在于，制备得到的中药提取物以药学上常规制备方法可制成喷剂、胶囊剂、颗粒剂。
6.如权利要求4所述的治疗过敏性鼻炎的中药组合物的制备方法，其特征在于，加水量为原料药材总重量的3~4倍。
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