CN108704074A - 一种治疗慢性鼻炎的药物组合物及其应用 - Google Patents
一种治疗慢性鼻炎的药物组合物及其应用 Download PDFInfo
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Abstract
本发明公开了一种治疗慢性鼻炎的药物组合物及其应用,所述组合物含有下列重量份的物质:地榆总皂苷35‑200份、槲皮素200‑3000份、香茅草提取物200‑3000份。该组合物具有较好的抗慢性鼻炎效果,可用于制备治疗慢性鼻炎的药物、保健品或食品。该组合物副作用少,成本低、制备方法简单、易于工业化应用。
Description
技术领域
本发明属于制药领域,涉及一种治疗慢性鼻炎的药物组合物及其应用。
背景技术
全球约有30%的人遭受慢性鼻炎的折磨,我国的鼻炎发病率在10%-11%,我国鼻炎的发病率近年来以3-5%的速度增长。鼻炎是指鼻腔内炎症的统称,通常表现为流鼻涕、鼻塞、打喷嚏等,有60-70%的患者还会有眼部的症状,如眼部瘙痒、发红或流泪等。鼻炎主要可以分为过敏性鼻炎(变应性鼻炎)和非变应性鼻炎。少年儿童同样也是过敏性鼻炎的重灾区。中国只有一项于2005年底发起的、针对过敏性鼻炎儿童患者的全国性调查,当时调查得出的患病率是9.8%。2011年,在首都儿科研究所的调查中,重庆14岁以下儿童的过敏性鼻炎报告率达到了20.42%。
尽管鼻炎患者越来越多,但是鼻炎用药还是局限在以西医的抗组胺药、变态反应介质阻断药、皮质醇药物、减充血剂、抗胆碱能药物为主。很多病人处于使用药物的时候效果尚可,一旦不使用药物又复发的状态,同时在理论上也只是消除症状。基于上述现状,本发明人进行了大量的临床研究,发现鼻炎患者大多数免疫力低下,存在着对空气和食物的某些物质过敏反应。血液检测大多数患者IgE阳性或IgG阳性。
慢性鼻炎通常难以根治,存在彻底治愈慢性鼻炎的广泛需求。本发明人经过长期研究发现,慢性鼻炎是多个致病因素导致的一种慢性炎症反应,主要有自由基、细菌感染、致敏物质等的诸多因素参与,因此本发明人提出利用多种药物组合进行多靶点干预治疗的尝试,以实现彻底治愈慢性鼻炎。
发明内容
本发明的一个目的是提供一种通过多靶点干预有效治疗或预防慢性鼻炎的药物组合物。
本发明的另一个目的是提供上述组合物在制备治疗或预防慢性鼻炎的药物、保健品或食品中的应用。
本发明的目的是通过下列技术方案实现的:
一种用于治疗慢性鼻炎的药物组合物,包括地榆总皂苷、槲皮素和香茅草提取物。
优选地,所述药物组合物包括以下重量份的药物:地榆总皂苷35-200份、槲皮素200-3000份和香茅草提取物200-3000份。
更优选地,所述组合物包括以下重量份的药物:地榆总皂苷50-100份、槲皮素500-2500份和香茅草提取物100-2000份。
最优选地,所述组合物包括以下重量份的药物:地榆总皂苷80份、槲皮素1500份以及香茅草提取物1000份。
所述药物组合物的剂型可以是药学或保健品允许的任意剂型,优选选自片剂、胶囊剂、颗粒剂、粉剂、丸剂、口服液、注射剂和膜剂。
所述药物组合物在制备治疗或预防慢性鼻炎的药物、保健品或食品中的应用。
地榆中含有鞣质以及多酚类、三萜及其苷类、黄酮及其苷类等多种化学成分,具有抗炎消肿、抗氧化以及抗过敏等的药理作用。本发明人研究发现,鼻炎的患者大多数对空气中的某些物质过敏,而地榆能清热凉血、抗炎、抗氧化,消除鼻粘膜的炎症反应,特别是地榆总皂苷能够阻断肥大细胞的脱颗粒释放组胺的作用,而达到抗过敏的作用。此药作为君药。
槲皮素是一种植物来源的类黄酮,广泛分布于蔬菜、水果、干果以及中草药中,具有抗氧化、抗炎、扩血管、抗变态反应等多种生物活性。鼻炎是各种理化因子(致炎因子)以及某些全身性疾病引起的鼻腔黏膜的炎症,可以利用槲皮素的抗氧化、抗炎、抗变态反应的作用达到治疗鼻炎的目的。
香茅草提取物是香茅草的水或醇的提取物,属于植物次生代谢物质,主要由柠檬醛、香叶醇、香叶烯、乙酸香叶酮等成分构成,具有较强的抑菌作用,可抑制金黄色葡萄球菌生物膜的形成,具有广谱的抗菌(大肠杆菌、金黄色葡萄球菌、枯草芽孢杆菌、白色念珠菌)作用,另外还有抗氧化、抗炎、止痛的作用。
地榆、槲皮素与香茅草在传统上并不是用于治疗鼻炎的中药,更不存在将这三种中药进行组合,共同应用于治疗慢性鼻炎。
本发明首次将地榆与槲皮素和香茅草进行组合,形成一类新的具有治疗慢性鼻炎作用的复方药物组合物。尽管这三种药物单独使用对于治疗鼻炎基本不具明显疗效,但是本发明人出乎意料地发现,这三种具有不同作用靶点的成分之间具有相互协同的抗慢性鼻炎的效果。本发明的药物组合物在临床试验中表现出了优异的治疗慢性鼻炎的作用,且安全可靠、成本低、原料易得,易于推广应用。
制备该组合物的原料均可用于保健品或食品,因此、副作用少,原料来源广泛,制备方法简单易行,便于工业化生产。
具体实施方案
下面结合具体实施例来描述本发明,应该指出的是,这些实施例仅用于说明本发明,而不应理解为对本发明的限制。
任何不采取组合物的形式但分别取各原料依据本发明记载的用量共同作用于治疗慢性鼻炎的情形也属于本发明保护的内容。
以下实施例中以1mg为一份,各种剂型的制备工艺及辅料选择均为现有技术,其中产品原料地榆总皂苷、槲皮素和香茅草提取物均购自陕西森弗集团公司。
实施例1
地榆总皂苷35份、槲皮素200份和香茅草提取物200份的比例取各组分,加入2.5份硬脂酸镁,5份淀粉,适量的水混合均匀,压片、得到片剂。
实施例2
地榆总皂苷80份.槲皮素1500份、香茅草提取物1000份的比例取各组分,加入12份羧甲基淀粉钠(CNS-Na),适量的水混合均匀,压片、得到片剂。
实施例3
地榆总皂苷200份、槲皮素3000份、香茅草提取物3000份的比例取各组分,加入25份微晶纤维素、35份糊精,适量的水混合均匀,制软材,挤出滚圆发制粒,得到颗粒剂。
实施例4
地榆总皂苷80份.槲皮素1500份,香茅草提取物1500份的比例取各组分,加水溶解,加甜叶菊苷调味,加水至500ml过滤,灌装(5ml/支),封口,105℃流动蒸汽灭菌,得口服液。
临床治疗效果
本发明的药物组合物已经用于治疗鼻炎病例千余例,随机选取其中的200例进行疗效统计,分别统计痊愈比例及痊愈1年后的复发情况调查。
使用药物:实施例1的片剂。
用药方法:所述片剂采用口服的方式,每日三次,每次2片,3个月为一个疗程。
疗效标准:
显效:鼻塞流涕、耳鸣、头疼的症状完全消失。
有效:鼻塞流涕、耳鸣、头疼症状明显减轻。
无效:鼻塞流涕、耳鸣、头疼症状未得到明显减轻。
统计结果如下表1所示:
由表1可知,本发明治疗各种鼻炎效果显著,治愈率达67.5%,有效率达99%,且复发率极低,表明本发明的药物组合物具有根治慢性鼻炎的显著技术效果。
所属领域的普通技术人员应当理解:以上任何实施例的讨论仅为示例性的,并非旨在暗示本公开的范围限于这些实施例。本发明的实施例旨在涵盖落入所附权利要求的宽泛范围之内的所有这样的替换、修改和变型。因此,凡在本发明的精神和原则之内,所做的任何省略、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)
1.一种治疗慢性鼻炎的药物组合物,其特征在于,所述药物组合物包括以下药物:地榆总皂苷、槲皮素和香茅草提取物。
2.如权利要求1所述的药物组合物,其特征在于,所述药物组合物包括下列重量份的药物:地榆总皂苷35-200份、槲皮素200-3000份、香茅草提取物200-3000份。
3.如权利要求1所述的药物组合物,其特征在于,所述药物组合物包括下列重量份的药物:地榆总皂苷50-100份、槲皮素500-2500份和香茅草提取物100-2000份。
4.如权利要求1所述的药物组合物,其特征在于,所述药物组合物包括下列重量份的药物:地榆总皂苷80份、槲皮素1500份以及香茅草提取物1000份。
5.如权利要求1所述的药物组合物,其特征在于,所述药物组合物的剂型为药学上允许的任意剂型。
6.如权利要求5所述的药物组合物,其特征在于,所述剂型选自片剂、胶囊剂、颗粒剂、粉剂、丸剂、口服液、注射剂和膜剂中的任意一种。
7.如权利要求1-6中任一项所述的药物组合物在制备治疗慢性鼻炎的药物、保健品或食品中的应用。
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