CN105998977A - 一种抗感冒药制剂 - Google Patents
一种抗感冒药制剂 Download PDFInfo
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Abstract
本发明公开了一种抗感冒药制剂。该制剂原料由以下重量份的中药组分组成:山芝麻30‑50份、一枝黄花15‑30份、枇杷叶10‑30份、百部10‑20份、芦根10‑20份、小叶榕9‑15份、甘草5‑15份。该制剂能明显改善风热感冒患者发热、恶风、咽痛、头胀痛、口渴、鼻塞、咳嗽等症状,具有清热解毒利咽、疏散风热、祛痰止咳之功效。本发明组方严谨,药少力专,对风热感冒具有良好的疗效。
Description
技术领域
本发明属于药品领域,涉及一种抗感冒药制剂。
背景技术
感冒一般指普通感冒,俗称伤风,又称上呼吸道感染,以鼻咽部卡他症状为主要表现,是最常见的呼吸道疾病。感冒由病毒和细菌所引起,但以病毒为多见,约占90%以上,目前,己发现约有12种200余型病毒可引起感冒,因为感冒病毒种类繁多、变异大、特异性免疫不巩固,目前尚没有特效的疫苗和药物,对感冒的治疗仍然处于“对症”治疗阶段,以减轻症状,缩短病程,对症处理,保护体力,注重护理,防止并发症等为主。中医学将感冒分为以下5种类型:风寒感冒、风热感冒、暑湿感冒、暑热感冒、时行感冒。中医认为,风热感冒是感受风热之邪所致的表证,其发病无年龄、性别、职业和地区差异,且全年皆有发病,尤以冬春季节高发,是风热之邪犯表、肺气失和所致,症状表现为发热、恶风、咽痛、头胀痛、口渴、鼻塞、咳嗽、痰黏或黄、鼻塞黄涕、舌尖边红、苔薄白微黄等。本发明特别针对风热感冒患者,研究出一种安全有效的中药组合物制剂,目前,尚未见相关报道。
(1)山芝麻,为梧桐科山芝麻属植物山芝麻HelictercsangustifoliaL.,以干燥根或干燥全株。《广西中药材标准》1990年版记载:【性味与归经】苦;性凉;小毒;归胃经。【功能与主治】清热解毒。主感冒发热;肺热咳嗽;咽喉肿痛;麻疹;痄腮;肠炎;痢疾;痈肿;瘰疮;毒蛇咬伤。山芝麻根含三萜类化合物山芝麻酸甲酯、山芝麻宁酸甲酯及山芝麻宁酯、新型香豆素类化合物-山芝麻内酯、葫芦素、异葫芦素,胡罗卜苷等。现代药理研究表明,山芝麻具有抗病毒、抗乙肝病毒、抗炎镇痛、抗脂质过氧化及护肝作用、抗HBV病毒、抗肝纤维化等多方面的药理作用。
(2)一枝黄花,为菊科植物一枝黄花Solidago decurrens Lour.的干燥全草。《中国药典》2010年版记载:【性味与归经】辛、苦,凉。归肺、肝经。【功能与主治】清热解毒,疏散风热。用于喉痹,乳蛾,咽喉肿痛,疮疖肿毒,风热感冒。一枝黄花化学成分:含有黄酮类芦丁、山柰酚-3-芦丁糖苷、异槲皮苷、山萘酚-葡萄糖苷;皂苷类一枝黄花酚苷;苯甲酸苄酯类2,3,6-三甲氧基苯甲酸-(2-甲氧基苄基)酯、2,6-二甲氧基苯甲酸-(2-甲氧基苄基)酯、2-羟基-6-甲氧基苯甲酸苄酯、2,6-二甲氧基苯甲酸苄酯;当归酸桂皮酯类当归酸-3,5-二甲氧基-4-乙酰氧基桂皮酯、当归酸-3-甲氧基-4-乙酰氧基桂皮酯;炔属化合物(2E-8z)-癸-二烯-4,6-二炔酸甲酯、(2z-8z)-癸-二烯-4,6-二炔酸甲酯;苯丙酸类咖啡酸(Caffeieacid)、绿原酸。现代药理研究发现,一枝黄花具有:抑菌作用、平喘祛痰、降压、胃黏膜保护等作用。
(3)枇杷叶,为蔷薇科植物枇杷Eriobotrya jaPon.ica(Thunb.)I,indl.的干燥叶。《中国药典》2010年版记载:【性味与归经】苦,微寒。归肺、胃经。【功能与主治】清肺止咳,降逆止呕;用于肺热咳嗽,气逆喘急,胃热呕逆,烦热口渴。药物化学研究表明,枇杷中主要含有挥发油、三萜类、倍半萜类、黄酮类、氨基酸、糖类、及其他有机酸类等化学成分。现代药理学研究表明枇杷叶具有抗炎、止咳、有抗肿瘤、抗病毒、降血糖、保肝利胆、清除氧自由基、增强机体免疫功能等作用,临床常用于治疗急慢性呼吸道等疾病。
(4)百部,为百部科植物直立百部Stemona sessilifolia(Miq.)Miq.、蔓生百部Stemonaja Ponica(Bl.)Miq.或对叶百部Stemona tuberosa Lour.的干燥块根。【性味与归经】甘、苦,微温。归肺经。【功能与主治】润肺下气止咳,杀虫灭虱;用于新久咳嗽,肺痨咳嗽,顿咳;外用于头虱,体虱,蛲虫病,阴痒;蜜百部润肺止咳。用于阴虚劳嗽。百部化学成分主要为百部碱类,目前其根部分离得到了六十多个结构各异的百部生物碱。现代药理研究表明,百部对多种致病性细菌、真菌以及多种寄生虫、昆虫有较好的杀灭作用,还具有中枢镇静、镇痛等功效。
(5)芦根,为禾本科植物芦苇Phragmites communis Trin.的新鲜或干燥根茎。《中国药典》2010年版记载:【性味与归经】甘,寒。归肺、胃经。【功能与主治】清热泻火,生津止渴,除烦,止呕,利尿。用于热病烦渴,肺热咳嗽,肺痈吐脓,胃热呕哕,热淋涩痛。
(6)小叶榕,为桑科植物榕树Ficus Microcarpa L.f.的干燥叶。【性味与归经】味淡,性凉。【功能与主治】清热发表,解毒消肿,祛湿止痛。主治感冒,慢性气管炎,百日咳,扁桃体炎,目赤,牙痛,肠炎,乳痈,跌打损伤。
(7)甘草,为豆科植物甘草Glycyrrhiza uralensis Fisch.、胀果甘草Glycyrrhizainflata Bat.或光果甘草Glycyrrhiza glabra L.的干燥根及根茎。【性味与归经】甘,平。归心、肺、脾、胃经。【功能与主治】补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。用于脾胃虚弱,倦怠乏力,心悸气短,咳嗽痰多,脘腹、四肢挛急疼痛,痈肿疮毒,缓解药物毒性、烈性。
发明内容
本发明的目的是提供一种抗感冒药制剂,该制剂具有清热解毒利咽、疏散风热、祛痰止咳功效,能有效治疗风热感冒。
本发明所采用的技术方案如下:
一种抗感冒药制剂,原料由以下重量份的中药组分组成:山芝麻30-50份、一枝黄花15-30份、枇杷叶10-30份、百部10-20份、芦根10-20份、小叶榕9-15份、甘草5-15份;
其制备方法为:
(1)分别取上述中药组分,净选,干燥;
(2)按上述重量份分别称取中药组分;
(3)将称量好的中药组分置提取罐中,加8倍量水,加热提取3次,每次1.5小时,滤过,合并滤液,滤液浓缩成60℃时相对密度为1.20-1.30稠膏,加入适量淀粉,干燥,粉碎,得干膏粉;
(4)再加入1%的硬脂酸镁,混匀,装入胶囊,即得。
以上抗感冒药制剂,原料优选由以下重量份的中药组分组成:山芝麻40份、一枝黄花20份、枇杷叶20份、百部15份、芦根15份、小叶榕12份、甘草8份。
以上所述抗感冒药制剂,可制备成药学上可接受的任意剂型,如:散剂、颗粒剂(冲剂)、丸剂、片剂、胶囊、汤剂、合剂(包括口服液)、糖浆剂等。作为优选,所述剂型为胶囊剂。
以上所述制剂的制备方法科学,生产工艺简单,服用量少,方便服用,疗效好。
本发明是在中医药传统理论的基础上,结合民间用药经验,运用现代科学理论配制而成,诸药合用共奏清热解毒利咽、疏散风热、祛痰止咳之功,能明显改善患者发热、恶风、咽痛、头胀痛、口渴、鼻塞、咳嗽等症状。本发明组方严谨,药少力专,对风热感冒具有良好的疗效。
具体实施方式
下面结合具体实施例对本发明作进一步描述,但不限制本发明的保护范围和应用范围:
一、治疗风热感冒中药组合物制剂的制备方法
1.试验设计:
本试验用3个实施例分别制备成胶囊剂,具体参数详见表1。
表1实施例制备参数表
2.操作步骤:
(1)分别取山芝麻、一枝黄花、枇杷叶、百部、芦根、小叶榕、甘草,净选,干燥;
(2)按表1重量份称取:山芝麻、一枝黄花、枇杷叶、百部、芦根、小叶榕、甘草;
(3)将称量好的中药组分置提取罐中,加8倍量水,加热提取3次,每次1.5小时,滤过,合并滤液,滤液浓缩成60℃时相对密度为1.20-1.30稠膏,加入适量淀粉,干燥,粉碎,得干膏粉;
(4)再加入1%的硬脂酸镁,混匀,装入胶囊,即得。
二、临床应用
1.病例选择标准
所有病例均符合2002年《中药新药临床研究指导原则》的诊断标准。
(1)临床主要症状为:发热、恶风、咽痛咽红、口渴欲饮,鼻塞、流黄涕,咳嗽,舌边尖红,苔白、微黄或黄腻,脉浮数。
(2)体温在38℃以上,病程在48小时之内。
(3)年龄10-70岁。
2.排出标准:
(1)辨证不明确或有过多兼挟症者。
(2)妊娠或乳期妇女。
(3)合并有心血管、肝、肾和造血系统等严重原发性疾病及精神病患者。
(4)未按规定服用药物者。
3.治疗方案
(1)实施例组:将上述制备好的实施例2样品,用于临床试验。口服,一次4粒,一日3次。疗程:用药3天。
(2)对照组:银翘解毒口服液(市售)。口服,一次10ml,一日3次。疗程:用药3天。
3.疗效评定标准
根据病例选择标准,参照《中医病症诊断治疗标准》及《中药新药临床研究指导原则)},将疗效分为痊愈、有效、无效。
(1)痊愈:治疗3天以内体温恢复正常,感冒的症状基本消失。
(2)有效:治疗3天以内体温较以前降低,感冒的主要症状部分消失。
(3)无效:治疗3天以内体温未降或升高,感冒的主要症状无改善。
4.试验结果:用于治疗和观察72例门诊病人。将上述制备好的实施例2样品和银翘解毒口服液,分别用于病人:治疗组:42例(男22例,女20例,平均年龄38.2岁),对照组30例(男13例,女17例,平均年龄41.8岁),结果详见表2。
表2临床试验效果表
结果表明:采用本发明实施例2治疗,治愈率为64%,有效率达98%,总体效果与对照组相当,没有不良反应发生,使用安全、有效,能明显改善患者能明显改善患者发热、恶风、咽痛、头胀痛、口渴、鼻塞、咳嗽等症状,具有清热解毒利咽、疏散风热、祛痰止咳之功效,愈后良好。以下为几个典型病例:
病例1:赵××,女,41岁,体温38.7℃,病程在48小时之内。主要症状为咽喉肿痛、咳嗽、痰黄粘稠,舌尖边红、苔薄白微黄。服用本发明实施例2,一次4粒,每日3次,连服3日,以上感冒症状消除,痊愈。
病例2:宋××,男,22岁,体温39.3℃,病程在24小时之内。主要症状为打喷嚏、恶风、头胀痛、有汗、咽喉红肿疼痛、咳嗽、痰黄。服用本发明实施例2,一次4粒,每日3次,连服3日,上述感冒症状消失,痊愈。
病例3:陈××,女,15岁,体温38.3℃,病程在24小时之内。主要症状为发热、微恶风、咽痛、口渴、鼻塞,尿少、黄,喜冷饮。服用本发明实施例2,一次4粒,每日3次。服1日,体温下降到37.2℃,咽痛缓解,服3日,体温37.0℃,发热、恶风、咽痛、口渴、鼻塞症状消除,小便正常,痊愈。
Claims (2)
1.一种抗感冒药制剂,其特征在于,原料由以下重量份的中药组分组成:山芝麻30-50份、一枝黄花15-30份、枇杷叶10-30份、百部10-20份、芦根10-20份、小叶榕9-15份、甘草5-15份;
其制备方法为:
(1)分别取上述中药组分,净选,干燥;
(2)按上述重量份分别称取中药组分;
(3)将称量好的中药组分置提取罐中,加8倍量水,加热提取3次,每次1.5小时,滤过,合并滤液,滤液浓缩成60℃时相对密度为1.20-1.30稠膏,加入适量淀粉,干燥,粉碎,得干膏粉;
(4)再加入1%的硬脂酸镁,混匀,装入胶囊,即得。
2.根据权利要求1所述抗感冒药制剂,其特征在于,原料由以下重量份的中药组分组成:山芝麻40份、一枝黄花20份、枇杷叶20份、百部15份、芦根15份、小叶榕12份、甘草8份。
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