CN115554361B - 一种治疗过敏性鼻炎的中药组合物及其药剂和应用 - Google Patents
一种治疗过敏性鼻炎的中药组合物及其药剂和应用 Download PDFInfo
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Abstract
本发明公开了一种治疗过敏性鼻炎的中药组合物,其原料按重量份包括:蝉蜕5‑10份、木蝴蝶5‑10份、苍术5‑10份、石菖蒲10‑15份、黄芪10‑15份、防风10‑15份、白术10‑15份、荆芥5‑10份、紫苏叶10‑15份、辛夷花10‑15份、玉竹10‑15份、甘草5‑10份。将所述的组合物按照药学常规工艺,加入药学上的常规辅料,制成药学上可接受的剂型。本发明的中药组合物在临床症状、动物实验上均显示出对过敏性鼻炎具有明确疗效。
Description
技术领域
本发明涉及医药领域,特别涉及一种治疗过敏性鼻炎的中药组合物及其药剂和应用。
背景技术
一项在亚洲11个国家进行的调查显示,调查人群中成人过敏性鼻炎(AR)患病率达到10-30%,儿童为10-46%。据统计,全球已有4亿过敏性鼻炎患者,其中50%居住在发展中国家并且未得到有效的治疗。过敏性鼻炎是鼻喉科疾病的常见病、多发病,占全部鼻病的40%左右,其发病率近20年显著增加,发病率在10%左右。
目前用于治疗AR的药物主要有以下几类:(1)抗组胺药:抗组胺类药对鼻痒、喷嚏、流清涕有良好的效果,但对鼻塞无效果;(2)减充血剂药:停药病情反跳,久用后产生依赖性,且不良反应较多;(3)抗胆碱类药:副作用有鼻腔干涩和鼻出血,需注意用量不可太大,喷鼻次数不可太频繁;(4)糖皮质激素类药:起效快,维持疗效时间短,不良反应多;(5)肥大细胞膜稳定剂:这类药物治疗过敏性鼻炎的效果并不明显,一般仅用于预防病情的复发;(6)白三烯受体拮抗剂:治疗鼻炎的疗效不及抗组胺药物和糖皮质激素。常见的不良反应为头痛、头晕、腹痛。
目前西医学对过敏性鼻炎治疗的状况概括而言是:药物起效快,症状缓解明显,但由于过敏性鼻炎的发病是多因素作用的结果,暴露出的不足也比较明显:主要是时效短,容易复发,副作用也相对较多,患者依从性较差。
在对过敏性鼻炎的辩证认识上,国内专家的共识是:过敏性鼻炎多因体质阳气虚衰,风寒触动而发,故而应以补肺祛风,温补脾肾为要点。但目前国内常用鼻炎配方却基本以清热通窍为立方法则。
过敏性鼻炎具有病程久、复发频繁、顽固难愈的特点,符合久病入络的络病致病特点,目前国内常用鼻炎中成药均无采用络病治疗的机制。络病理论是中医学指导难治性疾病辨证治疗的独特临床应用理论,叶天士提出“疾病入络”,认为各种慢性疾病随着病程演变最终会发展至络病。AR多因肺脾肾三脏虚损,津液输布异常所致,AR患者病程较长,长久津液输布不利,可至脉络痹阻。现代西医认为,AR主要是由于机体鼻黏膜血管壁以及血容量的变化引起,与络脉的结构功能相似,因此AR与络脉理论存在密切相关性。因此在治疗中需增加祛风通络的治疗,方能取得奇效。
发明内容
针对现有技术中的缺陷,本发明提出了一种治疗过敏性鼻炎的中药组合物及其药剂和应用。
本发明提供一种治疗过敏性鼻炎的中药组合物,其原料按重量份包括:蝉蜕5-10份、木蝴蝶5-10份、苍术5-10份、石菖蒲10-15份、黄芪10-15份、防风10-15份、白术10-15份、荆芥5-10份、紫苏叶10-15份、辛夷花10-15份、玉竹10-15份、甘草5-10份。
黄芪益气健脾,固表升阳;辛夷花温肺通窍、祛风散寒,共为君药;荆芥、防风解表祛风,白术、石菖蒲健脾化湿、苍术芳香通窍共为臣药;紫苏叶解表散寒,行气和胃,木蝴蝶清肺和胃,蝉蜕祛风通络、玉竹养阴润肺共为佐药;甘草调和诸药,为使药。
本发明提供一种治疗过敏性鼻炎的中药组合物,其原料按重量份包括:蝉蜕5份、木蝴蝶5份、苍术10份、石菖蒲10份、黄芪15份、防风10份、白术10份、荆芥10份、紫苏叶10份、辛夷花15份、玉竹10份、甘草5份。
本发明还提供一种治疗过敏性鼻炎的水煎剂,所述水煎剂由所述的中药组合物和水制备而成。以上成分按比例混合后,水煎制备而成。800毫升水煎煮成200毫升。
本发明还提供一种治疗过敏性鼻炎的胶囊剂,所述胶囊剂由所述的中药组合物和制剂辅料制成。所述制剂辅料为硬胶囊壳或软胶囊壳。
本发明还提供一种治疗过敏性鼻炎的口服液,所述口服液由所述的中药组合物和制剂辅料制成。所述制剂辅料为溶剂、芳香剂、矫味剂、澄清剂和防腐剂中一种或多种。
本发明还提供一种治疗过敏性鼻炎的颗粒剂,所述颗粒剂由所述的中药组合物和制剂辅料制成。所述制剂辅料为填充剂、粘合剂、润湿剂、崩解剂、润滑剂和薄膜包衣材料中的一种或多种。
本发明还提供一种治疗过敏性鼻炎的凝胶,所述凝胶由所述的中药组合物和制剂辅料制成。
本发明还提供一种治疗过敏性鼻炎的洗鼻液,所述洗鼻液由所述的中药组合物和制剂辅料制成。
本发明还提供一种治疗过敏性鼻炎的散剂,所述散剂由所述的中药组合物制成。
本发明还提供所述的中药组合物在制备治疗过敏性鼻炎药物中的应用。
综上,与现有技术相比,本发明达到了以下技术效果:
(1)相对于化学药物,本本发明的中药组合物为纯中药配方,从过敏的上游机制(过敏体质)进行干预治疗,对过敏性鼻炎症状疗效显著的同时,安全性更高,并降低复发率。
(2)和国内治疗过敏性鼻炎的常用中成药比较,本发明的中药组合物遵循了过敏性鼻炎常见发病机制—阳气虚衰,风寒触发,将益气固表、健脾补肾作为组方原则。针对过敏性鼻炎体现的络病特点:病程久、复发频繁、顽固难愈,本发明的中药组合物在治疗中应用祛风通络的特色治疗。由于组方原则对应合理,加上长期大量的临床实践反复检验,本发明的中药组合物临床疗效确切,改善过敏性鼻炎效果显著。
附图说明
为了更清楚地说明本发明实施例的技术方案,下面将对实施例中所需要使用的附图作简单地介绍,应当理解,以下附图仅示出了本发明的某些实施例,因此不应被看作是对范围的限定,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其他相关的附图。
图1为本发明实施例4中小鼠体重变化结果。
图2为本发明实施例4中小鼠挠鼻次数的结果。
图3为本发明实施例4中御鼽方治疗变应性鼻炎FeNO和FnNO结果变化。
图4为本发明实施例4中小鼠tIgE结果。
图5为本发明实施例4中使用药物治疗后,造模小鼠每天挠鼻次数结果。
图6为本发明实施例4中小鼠病理结果(HE染色)。
图7为本发明实施例5中水煎剂治疗的症状评分和对生活影响评分结果;A:症状评分;B:对生活影响评分。
图8为本发明实施例5中水煎剂治疗变应性鼻炎中FeNO和FnNO的结果变化。A:FeNO(ppb)结果;B:FnNO(ppb)结果。
具体实施方式
为了使本技术领域的人员更好地理解本发明方案,下面将结合本发明实施例中的附图,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分的实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动的前提下所获得的所有其他实施例,都应当属于本发明保护的范围。
实施例1一种治疗过敏性鼻炎的水煎剂
其原料按重量份包括:蝉蜕5份、木蝴蝶5份、苍术5份、石菖蒲10份、黄芪10份、防风10份、白术10份、荆芥5份、紫苏叶10份、辛夷花10份、玉竹10份、甘草5份。以上成分按比例混合后,水煎制备而成。800毫升水煎煮成200毫升。
实施例2一种治疗过敏性鼻炎的水煎剂
其原料按重量份包括:蝉蜕10份、木蝴蝶10份、苍术10份、石菖蒲15份、黄芪15份、防风15份、白术15份、荆芥10份、紫苏叶15份、辛夷花15份、玉竹15份、甘草10份。以上成分按比例混合后,水煎制备而成。800毫升水煎煮成200毫升。
实施例3一种治疗过敏性鼻炎的水煎剂
其原料按重量份包括:蝉蜕5份、木蝴蝶5份、苍术10份、石菖蒲10份、黄芪15份、防风10份、白术10份、荆芥10份、紫苏叶10份、辛夷花15份、玉竹10份、甘草5份。以上成分按比例混合后,水煎制备而成。800毫升水煎煮成200毫升。
实施例4动物实验
(1)实验目的:为了探讨本发明的中药组合物在变应性鼻炎中的作用机制,进行鼻炎小鼠造模,并使用低浓度及高浓度药物治疗,验证药物的安全性。
(2)造模和分组:
使用4周龄Balb/c雌性小鼠进行造模,进行安全性验证及药物疗效验证实验。在灌胃期间,OVA刺激后30min内,每天观察小鼠挠鼻次数;治疗结束后,收集小鼠血清及鼻黏膜,检测血清tIgE,进行鼻粘膜HE染色,观察病理变化及嗜酸粒细胞计数。分组和用药浓度:使用实施例3的配比制备而成,中药水煎剂高浓度组(16倍药物浓度,10只),中药水煎剂低浓度组(8倍药物浓度,10只),氯雷他定组(2mg/kg,10只),过敏性鼻炎造模组(10只),对照组(10只)。氯雷他定作为常用的治疗过敏性鼻炎的西药阳性对照,过敏性鼻炎造模组作为空白对照。对照组则为正常小鼠。中药水煎剂高浓度和低浓度组使用的中药水煎剂均使用实施例3的成分和比例制备而成。
(3)药物安全性验证:每天观察体重变化并记录进行分析。
(4)实验结果及分析
图1显示使用高低浓度水煎剂后,与对照组比较,小鼠体重未见明显降低;图2显示使用药物治疗后,造模小鼠每天挠鼻次数结果;图3显示小鼠使用药物七天后,与造模组比较,使用水煎剂能够显著减轻小鼠的过敏症状;图4为七天后小鼠tIgE结果,显示使用药物治疗均能降低小鼠的tIgE(p<0.05),高浓度水煎剂对降低tIgE效果比低浓度好。图5为使用药物治疗后,造模小鼠每天挠鼻次数结果,图6为药物治疗后小鼠病理结果(HE染色),结果显示炎症细胞减少,嗜酸性粒细胞数量明显降低。
以上结果表明使用本发明的中药水煎剂后,小鼠挠鼻次数明显降低,病理结果显示,炎症明显消退,血清中IgE及鼻腔中嗜酸粒均明显下降,并存在剂量依赖性。同时本发明的水煎剂抗过敏作用显著,药物安全性好,无毒性反应。
实施例5临床疗效研究
(1)研究目的
本实施例旨在评估本发明的水煎剂对变应性鼻炎临床症状的改善作用,并观察其安全性及评估其对变应性鼻炎患者生活质量的影响。
(2)研究方案
①治疗开始之前进行基线症状登记:记录患者的基础信息(年龄,性别等),现病史(首发时间及诊断时间),临床评价采用变应性鼻炎的临床症状评分,采用变应性鼻炎患者生活质量问卷(RQLQ)对主要鼻部症状打喷嚏、流涕和鼻塞的严重性进行评估。
实验室检测项目:包括血常规(治疗前),血清tIgE(治疗前),皮肤点刺实验(治疗前)、FeNO(ppb)(治疗前后)以及FnNO(ppb)(治疗前后)。
②治疗3周后:填写变应性鼻炎RQLQ评分表。
鼻结膜炎生存质量评分量表(RQLQ)内容如下:
变应性鼻炎患者生存质量调查问卷
以下是一些由于鼻/眼睛症状限制的活动列表。你在过去的7天里因为你的鼻/眼睛症状而受到限制的3个主要活动。
1、骑自行车 | 2、阅读 | 3、购物 |
4、做家庭维修 | 5、做家务活 | 6、进出空调房间 |
7、看电视 | 8、运动或锻炼 | 9、晨练 |
10、使用电脑 | 11、乒乓球 | 12、与宠物玩耍 |
13、与儿女们或孙子们玩耍 | 14、参加团体式体育运动 | 15、驾驶 |
16、唱歌 | 17、进行正常的社交活动 | 18、性生活 |
19、羽毛球 | 20、聊天 | 21、吃东西 |
22、使用吸尘器 | 23、拜访朋友或亲戚 | 24、外出散步 |
25、带孩子上下学 | 26、户外活动 | 27、工作 |
28、坐在户外 | 29、带孩子上公园 | 30、置身于吸烟环境 |
在下划线上写下你3个最主要的活动,然后在方框中用“√”标出在过去的7天里该项活动在多大程度上受你的鼻/症状所困扰。
睡眠
在过去的7天里,你在多大程度上因你的鼻/眼睛症状而被以下睡眠问题所困扰?
非鼻/眼症状
在过去的7天里,你在多大程度上因你的鼻/眼睛症状而被以下问题所困扰?
实际问题
在过去的7天里,你在多大程度上因你的鼻/眼症状而被以下问题所困扰?
鼻部症状
在过去的7天里,你在多大程度上被下列症状所困扰?
眼部症状
在过去的7天里,你在多大程度上被下列症状所困扰?
情感
在过去的7天里,你有多少时候由于你的鼻/眼症状受到以下情感问题所困扰?
通过调查问卷的评分统计,最终形成图7的数据曲线。
实验室检测项目:FeNO(ppb)以及FnNO(ppb)。(FeNO是由检测呼出气里面的一氧化氮浓度,它的单位是ppb,指的是每次呼吸里有多少个一氧化氮的粒子)。
(3)结论
40例使用本发明的水煎剂治疗变应性鼻炎患者的临床试验结果,使用本发明的水煎剂,每天1剂,7天为1个疗程,3周后症状明显改善,反映鼻部炎症的FnNO明显下降,证明本发明的水煎剂能够降低变应性鼻炎患者鼻部炎症反应,改善过敏症状(图7-8)。图7表示经过3周中药治疗,患者症状有明显改善。图8表示经过3周中药治疗,FnNO明显下降,说明鼻部炎症减轻。
综合以上实施例,本发明遵循了过敏性鼻炎常见发病机制—阳气虚衰,风寒触发,将益气固表、健脾补肾作为组方原则,采用络病治疗的机制,加上长期大量的临床实践反复检验,本发明的中药组合物临床疗效确切,在临床症状、动物实验上均显示出对过敏性鼻炎具有明确疗效。
虽然以上实验仅进行了单纯化合物的测试,但根据中药组合物已知的理化性质,能够得出其制成的口服剂型均能达到以上药效,适用的剂型及相应辅料如下所述:
本发明可根据成分种类、成分含量、剂型等产生多个实施方式。例如:
实施方式1:以所述中药组合物为药效成分的口服液;
以口服液为例,口服液是在汤剂、注射剂基础上发展起来的新剂型,具有剂量小、吸收较快、质量稳定、携带和服用方便、易于保存的优点,其含有多种有效成分,对质量和口感有很大的影响。在不改变主要活性成分结构和功能前提下,如何能最大限度的保留有效成分、改善口感是其选用辅料的一个难点。在口服液中添加辅料可以提高口感,改善澄清度,增强稳定性,提高产品质量。
口服液常用辅料有:溶剂、芳香剂、矫味剂、澄清剂、防腐剂等,这些辅料可同时加入,也可择其一加入,其中溶剂是必加的,可以采用水。不同的辅料组合有甜味剂、芳香剂、澄清剂或防腐剂,或甜味剂和防腐剂的组合,优选甜味剂和防腐剂的组合。部分辅料兼具增甜和增香的作用,此时只需加入一种辅料即可。
针对口服液,优选地,所述甜味剂选自蛋白糖、木糖醇、阿斯巴甜和三氯蔗糖中的一种或多种。
针对口服液,优选地,所述防腐剂选自对羟基苯甲酸酯、丁基羟基茴香醚、丁基羟基甲苯和山梨酸中的一种或多种。
防腐剂可选用对羟基苯甲酸酯、丁基羟基甲苯或山梨酸,优选丁基羟基甲苯。也可以组合使用,例如羟基苯甲酸酯与丁基羟基甲苯的组合,或丁基羟基甲苯与山梨酸的组合,或对羟基苯甲酸酯与山梨酸的组合,或对羟基苯甲酸酯、丁基羟基甲苯和山梨酸的组合。
针对口服液,优选地,所述芳香剂为水果香精。
针对口服液,优选地,所述澄清剂为壳聚糖和明胶中的一种或两种混合。
实施方式2:以所述中药组合物为药效成分的片剂;
片剂具有剂量准确,质量稳定,服用、携带及运输方便等优点。
针对片剂,所述制剂辅料包括稀释剂、粘合剂、润滑剂和崩解剂中一种或多种,优选稀释剂、粘合剂、润滑剂和崩解剂的组合。
针对片剂,优选地,所述稀释剂为纤维素类和无机盐类中的一种或多种。例如微晶纤维素、硫酸钙、磷酸氢钙及药用碳酸钙、甘露醇等,以增加原料体积助其成型的。
针对片剂,优选地,所述粘合剂为水、乙醇、羧甲基纤维素钠、羟丙基纤维素、甲基纤维素、乙基纤维素、明胶和聚乙烯吡咯烷酮等中的一种或多种。
针对片剂,优选地,所述润滑剂为硬脂酸镁、微粉硅胶、滑石粉、氢化植物油、聚乙二醇和月桂醇硫酸镁中的一种或多种。
针对片剂,优选地,所述崩解剂为低取代羟丙基、交联聚乙烯吡咯烷酮和交联羧甲基纤维素钠等中的一种或多种。
实施方式3:以所述中药组合物为药效成分的胶囊;
在本发明中,胶囊主要提高药物的稳定性和生物利用度。所述制剂辅料为胶囊壳,所述胶囊壳为硬胶囊壳或软胶囊壳。
实施方式4:以所述中药组合物为药效成分的颗粒剂;
颗粒剂可以直接吞服,也可以用温水冲入水中饮入,应用和携带比较方便,溶出和吸收速度较快。颗粒剂所用的制剂辅料与片剂相似,涉及填充剂、粘合剂、润湿剂、崩解剂、润滑剂和薄膜包衣材料中的一种或多种。
针对颗粒剂,优选地,所述填充剂为纤维素类和无机盐类中的一种或多种。例如微晶纤维素、硫酸钙、磷酸氢钙及药用碳酸钙、甘露醇等,以增加原料体积助其成型的。
针对颗粒剂,优选地,所述粘合剂为水、乙醇、羧甲基纤维素钠、羟丙基纤维素、甲基纤维素、乙基纤维素、明胶和聚乙烯吡咯烷酮等中的一种或多种。
针对颗粒剂,优选地,所述润湿剂为水或乙醇或两者的混合。例如为硬脂酸镁、微粉硅胶、滑石粉、氢化植物油、聚乙二醇和月桂醇硫酸镁中的一种或多种。
针对颗粒剂,优选地,所述崩解剂为低取代羟丙基、交联聚乙烯吡咯烷酮和交联羧甲基纤维素钠等中的一种或多种。
针对颗粒剂,优选地,所述薄膜包衣材料羟丙基甲基纤维素、聚乙二醇、醋酸纤维素酞酸酯和聚乙烯缩乙醛二乙胺醋酸酯中的一种或多种。
实施方式5:以所述中药组合物为药效成分的散剂。
本发明也可制成散剂,散剂便于分剂量和服用。
以饮料为例,将本发明的组合物制成不同风味的饮料,作为日常饮品将深受欢迎。
饮料所用的制剂辅料为澄清剂、防腐剂和香味剂中的至少一种。
本发明的组合物也可制成其它散剂。
实施方式6:以所述中药组合物为药效成分的凝胶。
实施方式7:以所述中药组合物为药效成分的洗鼻液。
以上多个实施方式可调整单位产品中的药剂量大小,以适应不同的用途,如药品、保健品、食品等。
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 (9)
1.一种治疗过敏性鼻炎的中药组合物,其特征在于,该中药组合物由以下重量份原料药制成:蝉蜕5份、木蝴蝶5份、苍术10份、石菖蒲10份、黄芪15份、防风10份、白术10份、荆芥10份、紫苏叶10份、辛夷花15份、玉竹10份、甘草5份。
2.一种治疗过敏性鼻炎的水煎剂,其特征在于,所述水煎剂由权利要求1所述的中药组合物和水制备而成。
3.一种治疗过敏性鼻炎的胶囊剂,其特征在于,所述胶囊剂由权利要求1所述的中药组合物和制剂辅料制成。
4.一种治疗过敏性鼻炎的口服液,其特征在于,所述口服液由权利要求1所述的中药组合物和制剂辅料制成。
5.一种治疗过敏性鼻炎的颗粒剂,其特征在于,所述颗粒剂由权利要求1所述的中药组合物和制剂辅料制成。
6.一种治疗过敏性鼻炎的凝胶,其特征在于,所述凝胶由权利要求1所述的中药组合物和制剂辅料制成。
7.一种治疗过敏性鼻炎的洗鼻液,其特征在于,所述洗鼻液由权利要求1所述的中药组合物和制剂辅料制成。
8.一种治疗过敏性鼻炎的散剂,其特征在于,所述散剂由权利要求1所述的中药组合物制成。
9.权利要求1所述的中药组合物在制备治疗过敏性鼻炎药物中的应用。
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左咏军 ; 宋卫中 ; 刘蔚 ; .玉屏风散在五官科的临床新用.中国中医药现代远程教育.2010,-(18),全文. * |
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