CN113786452A - 一种治疗过敏性结膜炎和/或过敏性鼻炎的中药组合物 - Google Patents
一种治疗过敏性结膜炎和/或过敏性鼻炎的中药组合物 Download PDFInfo
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Abstract
本发明公开了一种治疗过敏性结膜炎和/或过敏性鼻炎的中药组合物，它是由下述重量配比的原料药制备而成：川椒3～7份、川芎7～13份、地肤子7～13份、知母10～15份、防风7～13份、蝉蜕4～8份、牛蒡子7～13份。本发明组合物具有疏风清热止痒的功效，在治疗过敏性结膜炎、过敏性鼻炎方面效果显著。
Description
技术领域
本发明具体涉及一种治疗过敏性结膜炎和/或过敏性鼻炎的中药组合物。
背景技术
过敏性结膜炎属眼科常见疾病，具有易反复发作的特点，临床很多患者因过敏性鼻炎的症状，如喷嚏、流涕、鼻痒，经鼻部检查后发现结膜炎也有炎症体征，而最终确诊过敏性结膜炎。过敏性鼻炎即变应性鼻炎，是指特应性个体接触变应原后，主要由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黏膜非感染性炎性疾病。过敏性鼻炎临床发病率很高，属鼻黏膜的变态反应性疾病各年龄段均可发病，表现为每年特定时段的反复发作，迁延难愈，严重影响患者生活质量。
过敏性结膜炎合并过敏性鼻炎患者较多且较典型，发病后常需要去眼科和鼻科两个部门就诊，治疗极为不便。目前对过敏性结膜炎合并过敏性鼻炎的治疗眼科主要以局部点眼药对症治疗为主，常用药物有奥洛他定、色甘酸钠、激素眼药等，强调在早期抑制肥大细胞脱颗粒和引起过敏的炎性介质的释放，但多数治疗只是缓解却不能消除免疫反应引起的症状，激素眼药的应用容易引起激素性青光眼，尤其该病发病率高的人群是儿童及年轻人，更容易发生高眼压；鼻科治疗主要口服抗组胺等药物或结合局部喷剂，但多数治疗只是缓解症状，并且维持疗效的时间短，治疗停止后病情易复发，全身抗过敏药服用又可引起心脏疾病、困倦、嗜睡、乏力等副作用，鼻部喷剂多含有激素类药物，不宜久用。
迄今为止，没有正式上市治疗过敏性鼻结膜炎的中药制剂，更没有能同时治疗过敏性结膜炎和/或过敏性鼻炎的中药方剂。
发明内容
为解决上述问题，本发明提供了一种治疗过敏性结膜炎和/或过敏性鼻炎的中药组合物，它是由下述重量配比的原料药制备而成：
川椒3～7份、川芎7～13份、地肤子7～13份、知母10～15份、防风7～13份、蝉蜕4～8份、牛蒡子7～13份。
进一步地，它是由下述重量配比的原料药制备而成：
川椒3份、川芎10份、地肤子10份、知母12份、防风10份、蝉蜕6份、牛蒡子10份。
更进一步地，它是由原料药的药粉、或原料药的水或有机溶剂提取物为活性成分，加上药学上可接受的辅料制备而成的制剂。
更进一步地，所述制剂为口服制剂。
更进一步地，所述口服制剂为颗粒剂、散剂、丸剂或溶液剂。
本发明还提供了一种前述中药组合物的制备方法，它包括以下步骤：
(1)按照前述配比称取原料药；
(2)原料药研为粉末，或原料药的水或有机溶剂提取液，加入药学上常用的辅料或辅助性成分，即得。
本发明还提供了一种前述的中药组合物在制备过敏性结膜炎的药物中的用途。
本发明还提供了一种前述的中药组合物在制备过敏性鼻炎的药物中的用途。
本发明最后提供了一种前述的中药组合物在制备疏风清热止痒的药物中的用途。
本发明药物组合物中，牛蒡子、地肤子苦寒，为君药，疏风清热、利湿止痒，防风、蝉蜕为臣药，协助君药祛风止痒，并能明目，知母凉血养阴，祛风而不伤阴，通过凉血而止痒，川芎上行头面，兼能祛风，川椒使药，制约方中寒凉之品，并有良好的止痒作用，全方共奏疏风清热止痒之效。
本发明是同中医的整体辩证、异病同治的学术思想，用一方解决两个部位的疾病(两个疾病同时发生，发病机制一样均1型变态反应)，为患者的治疗带来更大的治疗效益。经试验证明，在治疗过敏性鼻炎和过敏性结膜炎方面效果显著，具备临床推广应用价值。
显然，根据本发明的上述内容，按照本领域的普通技术知识和惯用手段，在不脱离本发明上述基本技术思想前提下，还可以做出其它多种形式的修改、替换或变更。
以下通过实施例形式的具体实施方式，对本发明的上述内容再作进一步的详细说明。但不应将此理解为本发明上述主题的范围仅限于以下的实例。凡基于本发明上述内容所实现的技术均属于本发明的范围。
具体实施方式
由本发明组合物制成的溶液剂、颗粒剂、散剂、丸剂的制备工艺成熟，参照现有技术常规方法即可制成。
实施例1、本发明药物的制备
配方：川椒3g、川芎10g、地肤子10g、知母12g、防风10g、蝉蜕6g、牛蒡子10g。
制备方法：
1)按配比称取上述原料药；
2)取各原料药混合，加水煎煮两次，每次加水量约为药材15倍量，煎煮时间半小时，合并煎液，滤过，浓缩，即得溶液剂。
实施例2、本发明药物的制备
配方：川椒3g、川芎7g、地肤子7g、知母10g、防风7g、蝉蜕4g、牛蒡子7g。
制备方法：
1)按配比称取上述原料药；
2)取各原料药混合，加水煎煮两次，每次加水量为药材10倍量，煎煮时间半小时，合并煎液，滤过，滤液浓缩成稠膏，混匀，减压干燥，粉碎成细粉，加入糊精，混匀，湿法制成颗粒剂。
实施例3、本发明药物的制备
配方：川椒7g、川芎13g、地肤子13g、知母15g、防风13g、蝉蜕8g、牛蒡子13g。
制备方法：
1)按配比称取上述原料药；
2)取各原料药混合，加水煎煮两次，每次加水量为药材12倍量，煎煮时间1小时，合并煎液，滤过，滤液浓缩成浸膏，制丸，得丸剂。
以下通过试验例来说明本发明的有益效果。
试验例1本发明临床疗效：
1、资料与方法
1.1一般资料
收集2021年5月10日至2021年8月23日中国中医科学院眼科医院诊断为过敏性结膜炎同时伴有过敏性鼻炎患者36例，根据随机数字表进行分为2组，治疗组20例，对照组16例，两组患者治疗前年龄、性别、病程等方面比较差异无统计学意义(P＞0.05)，具有可比性。
1.2药物和给药方法：
治疗组口服按实施例1制备的水煎剂，一日一剂，一天两次口服，对照组口服西替利嗪胶囊10mg，日一次。
2.评价指标：
1)眼鼻部症状、体征标准分4级(0无，1轻度，2中度，3重度)；
2)记录全身及眼鼻局部不良反应情况。
2.1眼部症状
眼痒：①无；②轻微，工作忙时不察觉，空闲时可感觉到，或间断眼痒，但未严重到需要手抓；③中度：有明显眼痒，尚可以忍受，有手抓骚欲望；④严重:非常明显和持续的眼痒、刺痛，不能忍受，影响正常生活。
流泪：①无流泪；②自觉结膜囊内有泪，未流出睑缘；③结膜囊内有泪，偶有泪液溢出睑缘到脸颊；④经常或连续溢泪到脸颊；
2.2眼部体征
结膜充血：①无充血，②轻：睑结膜、穹窿部充血，呈网状,③中：睑结膜、穹窿部、球结膜充血，呈网状；④严重：睑结膜充血赤红成片，血管模糊不清，穹窿部、球结膜充血明显；
结膜水肿：①无；②裂隙灯下检查可见球结膜水肿，③中度自然光线下可直接看到球结膜水肿；④严重球结膜水肿泡状隆起
分泌物：①无；②少量粘液性分泌物，呈丝状；③中度：中等量分泌物，呈线状；④严重多量分泌物，呈片状或晨醒后粘合眼睑织。
2.4鼻部症状：
鼻痒：①无；②轻微，间断；③中度：蚁行感，可以忍受；④严重:蚁行感难忍。
喷嚏(一次连续个数)：①无；②轻微3-9个；③中度：10－14个；④严重:≧15
流涕(每日擤鼻次数)：①无；②轻微，≦4；③中度：5-9次；④严重:≧10
2.5鼻部体征
鼻窥镜下观察鼻粘膜、下鼻甲、鼻底、鼻中隔情况，分为以下四级。
①下鼻甲无肿胀；②轻微：下鼻甲轻度肿胀，中鼻甲、鼻中隔尚可见到；③中度：下鼻甲与鼻中隔(鼻底)紧靠，下鼻甲与鼻底(鼻中隔)尚有小缝；④严重:下鼻甲、鼻底鼻中隔紧靠，看不到中鼻甲。
3.评价方法
有效率评价方法参照：欧洲药品管理局(European Medicines Agency)发布《治疗过敏性鼻结膜炎医药产品临床开发指南》、《我国过敏性结膜炎诊断和治疗专家共识》中华眼科杂志,2018、《变应性鼻炎诊断和治疗指南》(中华耳鼻咽喉头颈外科杂志2016,51卷)制定的标准，分4级(0无，1轻度，2中度，3重度)，两个症状(或体征)改善一级及以上，或者同一症状(或体征)改善两级及以上为有效。(由②到①，③到②，④到③，这为改善一级，由③到①为改善两级。)
4、疗效评价结果
具体见表1和表2
表1.两组眼部疗效比较
表2.两组鼻部疗效比较
从表1～2可见：本发明组合药物治疗过敏性结膜炎、过敏性鼻炎有效率达到85％以上，相对西药西替利嗪，有效率提高了13％～19％，且未发现任何不良反应。
试验例2典型病案
陈某，女，50岁，主诉双眼痒难忍、红赤、流泪一周，伴有喷嚏、流涕、鼻痒。每年到秋天发病，于中国中医科学院眼科医院就诊，经检查：睑结膜充血成片，穹窿部、球结膜充血，呈网状，诊断为过敏性结膜炎合并过敏性鼻炎。口服实施例1制备的水煎剂，每日一剂，一天分两次口服，服用两付药后，症状明显减轻，眼痒、鼻痒大减，两周后，喷嚏、鼻子痒消失，轻度眼痒，球结膜充血消失，睑结膜充血减轻，继续服7剂眼、鼻部症状完全消失。
综上，本发明组合物，用一方剂解决两个部位的疾病，即发病机制均为1型变态反应引起的过敏性结膜炎、过敏性鼻炎，且效果显著，这为患者的治疗带来更大的治疗效，同时避免化学药物可能引起的不良反应，具备临床推广应用价值。
Claims (9)
1.一种治疗过敏性结膜炎和/或过敏性鼻炎的中药组合物，其特征在于：它是由下述重量配比的原料药制备而成：
川椒3～7份、川芎7～13份、地肤子7～13份、知母10～15份、防风7～13份、蝉蜕4～8份、牛蒡子7～13份。
2.根据权利要求1所述的中药组合物，其特征在于：它是由下述重量配比的原料药制备而成：
川椒3份、川芎10份、地肤子10份、知母12份、防风10份、蝉蜕6份、牛蒡子10份。
3.根据权利要求1或2所述的中药组合物，其特征在于：它是由原料药的药粉、或原料药的水或有机溶剂提取物为活性成分，加上药学上可接受的辅料制备而成的制剂。
4.根据权利要求1～3任一项所述的中药组合物，其特征在于：所述制剂为口服制剂。
5.根据权利要求4所述的中药组合物，其特征在于：所述口服制剂为颗粒剂、散剂、丸剂或溶液剂。
6.权利要求1～5任一项所述中药组合物的制备方法，其特征在于：它包括以下步骤：
(1)按照权利要求1所述配比称取原料药；
(2)原料药研为粉末，或原料药的水或有机溶剂提取液，加入药学上常用的辅料或辅助性成分，即得。
7.权利要求1～5任一项所述的中药组合物在制备过敏性结膜炎的药物中的用途。
8.权利要求1～5任一项所述的中药组合物在制备过敏性鼻炎的药物中的用途。
9.权利要求1～5任一项所述的中药组合物在制备疏风清热止痒的药物中的用途。
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