CN107137579A - 一种治疗鼻炎的药物组合物及其制备方法 - Google Patents

一种治疗鼻炎的药物组合物及其制备方法 Download PDF

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CN107137579A
CN107137579A CN201710290577.4A CN201710290577A CN107137579A CN 107137579 A CN107137579 A CN 107137579A CN 201710290577 A CN201710290577 A CN 201710290577A CN 107137579 A CN107137579 A CN 107137579A
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崔文斌
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Abstract

本发明公开一种治疗鼻炎的药物组合物。该组合物由薄荷、桑叶、冰片、荆芥、猪牙皂、牡丹皮、甘草、鸭跖草、黄芩、黄芪、麦冬、蔓荆子、黄连、鱼脑石、秦艽、豨莶草、葛根、升麻、金银花、山豆根、地塞米松和维生素等原料药组成。本发明中药组合物按照常规工艺加入常规辅料制成临床接受的胶囊剂、片剂、丸剂、颗粒剂、口服液、软膏剂、喷雾剂、擦剂、滴剂或酊剂。本发明药物组合物具有清热解毒,散风固表,宣通鼻窍之功效。对治疗鼻渊,鼻塞,流涕,前额头痛,鼻炎,鼻窦炎及过敏性鼻炎效果显著,无毒副作用。

Description

一种治疗鼻炎的药物组合物及其制备方法
技术领域
本发明涉及一种药物组合物,特别是涉及一种治疗鼻炎的药物组合物。
背景技术
鼻炎指的是鼻腔粘膜和粘膜下组织的炎症。表现为充血或者水肿,患者经常会出现鼻塞,流清水涕,鼻痒,喉部不适,咳嗽等症状。当鼻内出现炎症时,鼻腔内可以分泌大量的鼻涕,并可以因感染而变成黄色,流经咽喉时可以引起咳嗽,鼻涕量十分多时还可以经前鼻孔流出。鼻炎的病因局部病因急性鼻炎反复发作或治疗不彻底而演变成慢性鼻炎。长期间歇性或交替性鼻塞,导致头晕脑胀,严重影响睡眠、工作和学习,粘脓性鼻涕常倒流入咽腔,出现咳嗽、多痰。目前虽有一中成药治疗慢性鼻炎,但效果不是很显著。
发明内容
本发明目的在于提供一种治疗鼻炎的药物组合物。
本发明是通过如下技术方案实现的:
本发明药物组合物的原料药组成为:
本发明药物组合物的原料药组成优选为:
本发明药物组合物的原料药组成优选为:
本发明药物组合物的原料药组成优选为:
本发明中药组合物的原料药组成优选为:
本发明药物组合物的制备方法为:将牡丹皮、蔓荆子、鱼脑石、秦艽、葛根、金银花、山豆根、地塞米松和维生素B2粉碎得细粉A;将桑叶、荆芥、鸭跖草、黄芩、黄芪、豨莶草和升麻洗净,用8-24倍量的水浸泡15-45分钟后进行煎煮,第一次煎煮1-3小时,过滤,得滤液,药渣再用7-21倍量的水煎煮20-60分钟,过滤得滤液,合并两次滤液,滤过,滤液浓缩至60-100℃测相对密度为1.15-1.18,加乙醇使含醇量达65%,静置,取上清液回收乙醇,并浓缩至60-100℃测相对密度为1.25-1.30的清膏B;将余下薄荷、冰片、甘草、麦冬和黄连用清水洗净,加4-12倍量的水起进行煎煮,第一次煎煮1-3小时,过滤得滤液;药渣再用3-9倍量的水煎煮1-2小时,过滤得滤液,合并两次滤液,滤过,滤液离心分离,3000rpm离心,分离上清液,水浴蒸干浓缩至1.25-1.30的浸膏C;将清膏B和浸膏C用高速搅拌机进行搅拌均匀,再加入细粉A混合搅拌均匀,再加入交联聚维酮2-6重量份混合均匀,压制成片即可。
本发明药物组合物的制备方法优选为:将牡丹皮、蔓荆子、鱼脑石、秦艽、葛根、金银花、山豆根、地塞米松和维生素B2粉碎得细粉A;将桑叶、荆芥、鸭跖草、黄芩、黄芪、豨莶草和升麻洗净,用16倍量的水浸泡30分钟后进行煎煮,第一次煎煮2小时,过滤,得滤液,药渣再用14倍量的水煎煮40分钟,过滤得滤液,合并两次滤液,滤过,滤液浓缩至80℃测相对密度为1.15-1.18,加乙醇使含醇量达65%,静置,取上清液回收乙醇,并浓缩至80℃测相对密度为1.25-1.30的清膏B;将余下薄荷、冰片、甘草、麦冬和黄连用清水洗净,加8倍量的水起进行煎煮,第一次煎煮2小时,过滤得滤液;药渣再用6倍量的水煎煮1.5小时,过滤得滤液,合并两次滤液,滤过,滤液离心分离,3000rpm离心,分离上清液,水浴蒸干浓缩至1.25-1.30的浸膏C;将清膏B和浸膏C用高速搅拌机进行搅拌均匀,再加入细粉A混合搅拌均匀,再加入交联聚维酮4重量份混合均匀,压制成片即可。
本发明药物组合物按照常规工艺加入常规辅料制成临床接受的胶囊剂、片剂、丸剂、颗粒剂、口服液、喷雾剂、擦剂、滴剂或酊剂。
本发明药物组合物具有清热解毒,散风固表,宣通鼻窍之功效。对治疗鼻渊,鼻塞,流涕,前额头痛,鼻炎,鼻窦炎及过敏性鼻炎效果显著,无毒副作用。
本发明药物组合物中的原料药按君臣佐使进行配伍,其中猪牙皂、牡丹皮、鸭跖草、蔓荆子、鱼脑石、秦艽、豨莶草、葛根、金银花、山豆根和地塞米松为君药,在本发明治疗鼻炎中起到主要的治疗作用,另桑叶、荆芥、黄芩、黄芪、升麻和维生素B2为臣药,在本发明中辅助君药加强治疗鼻炎的辅药,其他薄荷、冰片、甘草、麦冬和黄连为为佐药和使药,在本发明组合物中起到兼证的作用。
下面实验例用于进一步说明本发明,但不限于本发明。
实验例一、临床实验
1、临床观察
治疗组选本发明片剂(按照实施例1方法制备)治疗鼻炎200例,其中男性100例,女性100例。
2、治疗方案
本发明片剂(按照实施例1方法制备),治疗二个疗程(7天一疗程),每日早、晚各服用一次,每次2片,0.25g/片。
3、诊断标准
①鼻塞:鼻塞特点为间歇性,交替性。
②多涕:常为粘液性或粘脓性,偶成脓性。脓性多于季发性感染后出现。
③嗅觉下降:多为两种原因所致,一为鼻粘膜肿胀、鼻塞,气流不能进入嗅觉区域;二为嗅区粘膜受慢性炎症长期刺激,嗅觉功能减退或消失。
④头痛、头昏:慢性鼻窦炎多表现为头沉重感。
⑤全身表现:多数人有头痛、食欲不振、易疲倦、记忆力减退及失眠等。
4、疗效标准
参照国家中医药管理局1994年实施的《中医病诊断疗效标准》拟定如下:
痊愈:中医临床症状、体征消失或基本消失;
显效:中医临床症状、体征明显改变;
显效:中医临床症状、体征明显改变;
有效:中医临床症状、体征均有好转;
无效:中医临床症状、体征均无明显改善;
5、治疗结果
组别 治疗人数 治愈 显效 有效 无效 总有效率
治疗组 200 183 13 3 1 99.5%
6、结论
200例患者使用本发明胶囊剂二个疗程(每个疗程7天),治疗结果显示,总有效率为99.5%。
7、讨论
本发明药物组合物中牡丹皮为毛茛科植物牡丹干燥根皮,产于安徽、四川、河南、山东等地,苦、辛,微寒,归心、肝、肾经,具有清热凉血、活血化淤、退虚热等功效;鸭跖草味甘、微苦,性寒,能清热,解毒,利尿,为消肿利尿、清热解毒之良药,此外对麦粒肿、咽炎、扁桃腺炎、宫颈糜烂、腹蛇咬伤有良好疗效;蔓荆子辛、苦、微寒,归膀胱、肝、胃经,具有疏散风热、清利头目,用于风热感冒头痛、齿龈肿痛、目赤多泪、目暗不明、头晕目眩;鱼脑石气微,味稍涩,具有化石、通淋、消炎功能,主治石淋、小便不利、中耳炎、鼻炎、脑漏;秦艽辛、苦、微寒,能够祛风湿、舒筋络、清虚热,用于风湿痹痛、筋脉拘挛、骨节酸痛、晡潮热、小儿疳积发热;豨莶草具有祛风湿、利关节、解毒之功效,主治风湿痹痛、筋骨无力、腰膝酸软、四肢麻痹、半身不遂、风疹湿疮;葛根甘、辛、凉,有解肌退热、透疹、生津止渴、升阳止泻之功效。常用于表证发热、项背强痛、麻疹不透、热病口渴、阴虚消渴、热泻热痢、脾虚泄泻。金银花是清热解毒的良药,它性甘寒气芳香,甘寒清热而不伤胃,芳香透达又可祛邪,金银花既能宣散风热,还善清解血毒,用于各种热性病,如身热、发疹、发斑、热毒疮痈、咽喉肿痛等症;山豆根具有清热解毒、消肿利咽,主治火毒蕴结,乳蛾喉痹,咽喉肿痛,齿龈肿痛,口舌生疮;地塞米松又叫德沙美松、氟甲强的松龙是抗炎、抗过敏药物,主要作为危重疾病的急救用药和各类炎症的治疗;桑叶具有清肝养肝、疏散风热、清肺、明目功效,主治风热感冒、风温初起,发热头痛,汗出恶风,咳嗽胸痛;或肺燥干咳无痰;咽干口渴;风热及肝阳上扰;目赤肿痛。荆芥味平,性温,无毒,清香气浓,荆芥为发汗,解热药,是中华常用草药之一,能镇痰、祛风、凉血,主治流行感冒,头疼寒热发汗,呕吐。黄芩具有清热燥湿、凉血安胎、解毒功效,主治温热病、上呼吸道感染、肺热咳嗽、湿热黄胆、肺炎、痢疾、咳血、目赤、胎动不安、高血压、痈肿疖疮等症。黄芪具有补气固表、利尿托毒、排脓、敛疮生肌的功效,用于气虚乏力、食少便溏、中气下陷、久泻脱肛、便血崩漏、表虚自汗、痈疽难溃、久溃不敛、血虚萎黄、内热消渴。升麻辛、微甘,微寒,归肺、脾、胃、大肠经,具有发表透疹、清热解毒、升举阳气,用于风热头痛、齿痛、口疮、咽喉肿痛、麻疹不透、阳毒发斑、脱肛、子宫脱垂。维生素B2化学式:C17H20N406,式量376.37,又叫核黄素,微溶于水,在中性或酸性溶液中加热是稳定的,为体内黄酶类辅基的组成部分,当缺乏时,就影响机体的生物氧化,使代谢发生障碍。薄荷具有疏散风热、清利头目、利咽透疹、疏肝行气,主治疏风、散热、辟秽、解毒、外感风热、头痛、咽喉肿痛、食滞气胀、口疮、牙痛、疮疥、瘾疹、温病初起、风疹瘙痒、肝郁气滞、胸闷胁痛。冰片具有通诸窍、散郁火、去翳明目、消肿止痛,治中风口噤、热病神昏、惊痫痰迷、气闭耳聋、喉痹、口疮、中耳炎、痈肿、痔疮、目亦翳膜、蛲虫病。甘草味甘甜,性平和,入心、脾、肺、胃四经,生用偏凉,可泻火解毒、缓急止痛;炙用偏温,能散表寒、补中益气;此外,甘草还善于调和药性,解百药之毒。麦冬甘、微苦、凉、滋阴生津、润肺止咳、清心除烦,主治热病伤津、心烦、口渴、咽干肺热、咳嗽、肺结核。黄连具有清热燥湿、泻火解毒,用于湿热痞满、呕吐吞酸、泻痢、黄疸、高热神昏、心火亢盛、心烦不寐、血热吐衄、目赤、牙痛、消渴、痈肿疔疮,外治湿疹、湿疮、耳道流脓。本发明诸药合并具有清热解毒,散风固表,宣通鼻窍之功效。对治疗鼻渊,鼻塞,流涕,前额头痛,鼻炎,鼻窦炎及过敏性鼻炎效果显著,无毒副作用。
实验例二:典型病例
病例1:姚某某,女,48岁。患鼻窦炎多年。每因熬夜加重复发,易上火。自诉虚火大,鼻流黄涕,舌紫红略暗,苔薄白左尺脉浮数,右脉虚数,大小便正常,食欲正常。诊断:鼻窦炎,服用本发明片剂(按照实施例1方法制备;每次两次,每次2片,0.25g/片,7天一疗程)一个疗程后,头晕头痛明显减轻,黄涕减少。继续巩固服用一个疗程彻底治愈。
病例2:张某,男,52岁。自述几年前鼻子出现交替性鼻塞,导致头晕脑胀,严重影响睡眠、工作和学习,粘脓性鼻涕常倒流入咽腔,出现咳嗽、多痰的症状。诊断:慢性鼻炎,使用本发明喷雾剂(按照实施例4方法制备;7天一疗程,每日两次,)一个疗程后,鼻塞症状明显减轻,头痛减轻。后又巩固治疗一个疗程症状彻底消失,随访三年未复发。
病例3:秦某某,女,35岁。患过敏性鼻炎。春季优为严重,易上火。虚火大,鼻流黄涕,舌紫红略暗,苔薄白左尺脉浮数,右脉虚数,大小便正常,食欲正常。诊断:过敏性鼻炎,服用本发明胶囊剂(按照实施例5方法制备;每日两次,每次2粒,0.5g/粒,7天一疗程)一个疗程后,头晕头痛明显减轻,黄涕减少。继续巩固一个疗程彻底治愈。
实验例三:药效学试验
1、动物造模、分组及给药
采用0.5mgOVA(卵白蛋白)作抗原,氢氧化铝粉末30mg作佐剂,加生理盐水1ml形成混悬液,腹腔注射,隔日1次,共注射7次致敏。于致敏完成后第4天,小鼠取头低位,每侧鼻腔滴以2%OVA溶液50μl激发,隔日1次,共5次,每次激发为当日第1次滴鼻给药1h后。
ICR小鼠,体重17~23g,50只,雌雄均各半,购自中国医科院动物所。随机分成4组,其中,空白组10只,模型组10只,对照组10只,本发明组10只。于第7次致敏注射后的第2天开始给药,每日3次。本发明组0.2483g/ml(按照实施例1方法制备,用羧甲基纤维素钠配成0.5%CMC-Na混悬液),4℃冰箱保存。),对照组1.28g/ml(布地奈德鼻喷雾剂,购于阿司利康制药有限公司),均以微量加样器滴入双侧鼻孔,每侧每次滴入20μl。空白组及模型组用等容量的生理盐水滴鼻。连续给药11天。
2、观察指标及检测项目
行为学指标评分每次卵清蛋白双侧鼻腔滴鼻激发后,观察记录30min内小鼠喷嚏、搔鼻次数、流涕量,采用叠加法计算总分,总分≥5分表示造模成功。
(1)喷嚏:一次连续3-9个为1分,10-14个为2分,≥15个为3分。
(2)鼻痒:搔鼻2-3次为1分,3-5次为2分,≥5次为3分。
(3)流涕:流至鼻孔为1分,超过前鼻孔为2分,流涕满面为3分。
血液检测指标在第11天治疗结束后,禁食过夜,次日断头采集血液标本,按试剂盒说明书的要求进行测定。
(1)血清白三烯E4(LTE4)测定取血清标本,用ELISA法于波长450nm的酶标仪上检测。根据LTE4试剂盒内附的标准品血清测定的OD值结果,得出标准曲线,再通过测定各小鼠血清LTE4的OD值,算出各小鼠的血清LTE4抗体浓度。
(2)血清免疫球蛋白E(IgE)测定方法同上,用ELISA法于波长450nm的酶标仪上检测。血清IgE抗体浓度计算方法同上。
鼻黏膜组织病理形态学和免疫组化观察小鼠断头采集血处死后,取其鼻甲和中隔粘膜于10%福尔马林中固定,石蜡包埋,每标本切两片,分别作光镜观察和免疫组化检查。光镜下每张切片观察5个(10×40)视野,计嗜酸性细胞平均数。NF-kB免疫组化检查采用二步法,具体操作按试剂盒说明书进行。
3实验结果
行为学指标的改变表1结果表明,模型组动物在第1次给OVA溶液滴鼻激发后,就出现喷嚏、搔鼻和流涕的症状,随着激发次数的增加,症状逐渐加剧,第4次激发时,出现了典型的变应性鼻炎症状。而本发明组对小鼠的喷嚏、搔鼻、流涕等变应性鼻炎行为学症状均有明显的抑制作用,改善AR症状。
表1本发明药物对AR小鼠行为学指标的影响
由表1可见,空白组模型组比较,P<0.01;本发明组与模型组比较有显著差异P<0.01,本发明组与对照比较无显著差异。
表2本发明药物对AR小鼠血清中IgE、LTE4含量的影响
血清LTE4、IgE指标的变化表2结果表明,模型组血清中LTE4、IgE含量显著升高。与模型组比较,本发明组干预治疗后血清LTE4、IgE含量显著低于模型组。
空白组与模型组比较有显著差异,P<0.01;本发明组与模型组比较有显著差异,P<0.01。本发明组与对照组比较无显著差异。
表3本发明药物对AR小鼠鼻粘膜嗜酸性细胞计数的影响
组别 动物数(只) 鼻粘膜嗜酸性细胞计数(个)
空白组 10 4.22±1.68
模型组 10 6.35±2.32
对照组 10 3.32±2.24
本发明组 10 4.25±2.31
鼻粘膜病理形态学的改变表3结果表明,模型组小鼠鼻粘膜嗜酸性细胞计数显著升高,本发明组小鼠嗜酸性细胞计数显著降低。本发明组与对照组小鼠鼻粘膜组织嗜酸性细胞比较无显著差异。
表4对AR小鼠NF-kB免疫组化的影响
组别 动物数(只) NF-kB免疫组化(灰度值)
空白组 10 225.41±9.18
模型组 10 235.12±5.58
对照组 10 221.45±8.15
本发明组 10 227.43±8.95
免疫组化的改变表4结果表明,各组的小鼠NF-kB免疫组化无显著差异。
下述实施例均能实现上述实验例的效果。
具体实施方式
实施例1 片剂
将牡丹皮、蔓荆子、鱼脑石、秦艽、葛根、金银花、山豆根、地塞米松和维生素B2粉碎得细粉A;将桑叶、荆芥、鸭跖草、黄芩、黄芪、豨莶草和升麻洗净,用16倍量的水浸泡30分钟后进行煎煮,第一次煎煮2小时,过滤,得滤液,药渣再用14倍量的水煎煮40分钟,过滤得滤液,合并两次滤液,滤过,滤液浓缩至80℃测相对密度为1.15-1.18,加乙醇使含醇量达65%,静置,取上清液回收乙醇,并浓缩至80℃测相对密度为1.25-1.30的清膏B;将余下薄荷、冰片、甘草、麦冬和黄连用清水洗净,加8倍量的水起进行煎煮,第一次煎煮2小时,过滤得滤液;药渣再用6倍量的水煎煮1.5小时,过滤得滤液,合并两次滤液,滤过,滤液离心分离,3000rpm离心,分离上清液,水浴蒸干浓缩至1.25-1.30的浸膏C;将清膏B和浸膏C用高速搅拌机进行搅拌均匀,再加入细粉A混合搅拌均匀,再加入交联聚维酮4g混合均匀,压制成片即可。每片0.25g,每日二次,每次2片。
实施例2 片剂
将牡丹皮、蔓荆子、鱼脑石、秦艽、葛根、金银花、山豆根、地塞米松和维生素B2粉碎得细粉A;将桑叶、荆芥、鸭跖草、黄芩、黄芪、豨莶草和升麻洗净,用16倍量的水浸泡30分钟后进行煎煮,第一次煎煮2小时,过滤,得滤液,药渣再用14倍量的水煎煮40分钟,过滤得滤液,合并两次滤液,滤过,滤液浓缩至80℃测相对密度为1.15-1.18,加乙醇使含醇量达65%,静置,取上清液回收乙醇,并浓缩至80℃测相对密度为1.25-1.30的清膏B;将余下薄荷、冰片、甘草、麦冬和黄连用清水洗净,加8倍量的水起进行煎煮,第一次煎煮2小时,过滤得滤液;药渣再用6倍量的水煎煮1.5小时,过滤得滤液,合并两次滤液,滤过,滤液离心分离,3000rpm离心,分离上清液,水浴蒸干浓缩至1.25-1.30的浸膏C;将清膏B和浸膏C用高速搅拌机进行搅拌均匀,再加入细粉A混合搅拌均匀,再加入交联聚维酮4g混合均匀,压制成片即可。每片0.25g,每日二次,每次2片。
实施例3 片剂
将牡丹皮、蔓荆子、鱼脑石、秦艽、葛根、金银花、山豆根、地塞米松和维生素B2粉碎得细粉A;将桑叶、荆芥、鸭跖草、黄芩、黄芪、豨莶草和升麻洗净,用16倍量的水浸泡30分钟后进行煎煮,第一次煎煮2小时,过滤,得滤液,药渣再用14倍量的水煎煮40分钟,过滤得滤液,合并两次滤液,滤过,滤液浓缩至80℃测相对密度为1.15-1.18,加乙醇使含醇量达65%,静置,取上清液回收乙醇,并浓缩至80℃测相对密度为1.25-1.30的清膏B;将余下薄荷、冰片、甘草、麦冬和黄连用清水洗净,加8倍量的水起进行煎煮,第一次煎煮2小时,过滤得滤液;药渣再用6倍量的水煎煮1.5小时,过滤得滤液,合并两次滤液,滤过,滤液离心分离,3000rpm离心,分离上清液,水浴蒸干浓缩至1.25-1.30的浸膏C;将清膏B和浸膏C用高速搅拌机进行搅拌均匀,再加入细粉A混合搅拌均匀,再加入交联聚维酮4g混合均匀,压制成片即可。每片0.25g,每日二次,每次2片。
实施例4 喷雾剂
上述药物按照常规工艺加入常规辅料制成喷雾剂。一日两次,喷于鼻腔内。
实施例5 胶囊剂
上述药物按照常规工艺加入常规辅料制成胶囊剂。每粒0.5g,每日2次,每次2粒.
实施例6 滴剂
上述药物按照常规工艺加入常规辅料制成滴剂。
实施例7 酊剂
上述药物按照常规工艺加入常规辅料制成酊剂。

Claims (9)

1.一种治疗鼻炎的药物组合物,其特征在于,该组合物的原料药组成为:
2.如权利要求1所述的药物组合物,其特征在于该组合物的原料药组成为:
3.如权利要求1所述的药物组合物,其特征在于该组合物的原料药组成为:
4.如权利要求1所述的药物组合物,其特征在于该组合物的原料药组成为:
5.如权利要求1所述的药物组合物,其特征在于该组合物的原料药组成为:
6.如权利要求1-5之所述的药物组合物,其特征在于该组合物的制备方法为:将牡丹皮、蔓荆子、鱼脑石、秦艽、葛根、金银花、山豆根、地塞米松和维生素B2粉碎得细粉A;将桑叶、荆芥、鸭跖草、黄芩、黄芪、豨莶草和升麻洗净,用8-24倍量的水浸泡15-45分钟后进行煎煮,第一次煎煮1-3小时,过滤,得滤液,药渣再用7-21倍量的水煎煮20-60分钟,过滤得滤液,合并两次滤液,滤过,滤液浓缩至60-100℃测相对密度为1.15-1.18,加乙醇使含醇量达65%,静置,取上清液回收乙醇,并浓缩至60-100℃测相对密度为1.25-1.30的清膏B;将余下薄荷、冰片、甘草、麦冬和黄连用清水洗净,加4-12倍量的水起进行煎煮,第一次煎煮1-3小时,过滤得滤液;药渣再用3-9倍量的水煎煮1-2小时,过滤得滤液,合并两次滤液,滤过,滤液离心分离,3000rpm离心,分离上清液,水浴蒸干浓缩至1.25-1.30的浸膏C;将清膏B和浸膏C用高速搅拌机进行搅拌均匀,再加入细粉A混合搅拌均匀,再加入交联聚维酮2-6重量份混合均匀,压制成片即可。
7.如权利要求6所述的药物组合物,其特征在于该组合物的制备方法为:将牡丹皮、蔓荆子、鱼脑石、秦艽、葛根、金银花、山豆根、地塞米松和维生素B2粉碎得细粉A;将桑叶、荆芥、鸭跖草、黄芩、黄芪、豨莶草和升麻洗净,用16倍量的水浸泡30分钟后进行煎煮,第一次煎煮2小时,过滤,得滤液,药渣再用14倍量的水煎煮40分钟,过滤得滤液,合并两次滤液,滤过,滤液浓缩至80℃测相对密度为1.15-1.18,加乙醇使含醇量达65%,静置,取上清液回收乙醇,并浓缩至80℃测相对密度为1.25-1.30的清膏B;将余下薄荷、冰片、甘草、麦冬和黄连用清水洗净,加8倍量的水起进行煎煮,第一次煎煮2小时,过滤得滤液;药渣再用6倍量的水煎煮1.5小时,过滤得滤液,合并两次滤液,滤过,滤液离心分离,3000rpm离心,分离上清液,水浴蒸干浓缩至1.25-1.30的浸膏C;将清膏B和浸膏C用高速搅拌机进行搅拌均匀,再加入细粉A混合搅拌均匀,再加入交联聚维酮4重量份混合均匀,压制成片即可。
8.如权利要求1-5之所述的药物组合物,其特征在于该组合物按照常规工艺加入常规辅料制成临床接受的胶囊剂、片剂、丸剂、颗粒剂、口服液、喷雾剂、擦剂、滴剂或酊剂。
9.如权利要求1-5之一所述的药物组合物在制备治疗鼻炎的药物中的应用。
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