CN111840476A - 一种治疗流行性感冒的中药组合物、制剂及其制备方法和应用 - Google Patents
一种治疗流行性感冒的中药组合物、制剂及其制备方法和应用 Download PDFInfo
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Abstract
本发明提供一种治疗流行性感冒的中药组合物、制剂及其制备方法和应用,所述中药组合物包括以下重量份药材:胆木50~200份、石膏100~260份、黄芩50~150份、青蒿50~200份、金银花50~150份、芦根50~150份、知母50~150份、桔梗30~100份、甘草20~60份。本发明中药组合物对治疗流行性感冒具有显著的效果,尤其对小儿流行性感冒具有较佳的治疗效果,且安全性高。
Description
技术领域
本发明涉及治疗感冒药物技术领域,特别涉及一种治疗流行性感冒的中药组合物、制剂及其制备方法和应用。
背景技术
流行性感冒,主要以流感病毒感染为致病因素的急性呼吸道感染疾病,可通过呼吸道飞沫在人群中传播,具有较强的传染性,临床主要表现为高热、畏寒、头痛及疲乏等。
胆木一直作为民间用药,最早收录在广州部队编《常用中草药手册》和《全国中草药汇编》等书籍中,1977年版《中国药典》一部也有收载。胆木性寒,具有清热解毒的功效,可以帮助排出湿毒热毒,使呼吸道畅通,降低体温。根据医药学研究,胆木具有消炎抑菌的作用,帮助抑制流感病毒。经现代药理学研究发现,胆木对嗜血流感杆菌、肺炎链球菌、乙型溶血性链球菌、金黄色葡萄球菌有抑制作用,并能降低内毒素致家鼠升高的体温,具有较好退热效果。
市场上的药用胆木,主要有复方中成药、胆木浸膏片、胆木浸膏胶囊和胆木注射液等,这些剂型都存在某些技术的缺陷或不足。如胆木注射液直接注入血液系统,该产品的不良反应和毒副作用更不可控,现国家医疗系统已经限制使用或建议不使用。如复方胆木中成药,胆木只是作为辅药且是复方,主要活性成分多样,毒副作用及不良反应影响因素更多,服用安全性风险高。复方清热解毒中成药,更易引起寒凉性腹泻;胆木浸膏片、胆木浸膏胶囊生产过程粉尘多,人员接触物料机会多,对生产人员健康会产生不利影响,如粉尘吸入。而且上述药物治疗效果欠佳。
发明内容
鉴于此,本发明提出一种治疗流行性感冒的中药组合物、制剂及其制备方法和应用,对治疗流行性感冒具有显著的效果,而且安全性高。
本发明的技术方案是这样实现的:
一种治疗流行性感冒的中药组合物,包括以下重量份药材:胆木50~200份、石膏100~260份、黄芩50~150份、青蒿50~200份、金银花50~150份、芦根50~150份、知母50~150份、桔梗30~100份、甘草20~60份。
进一步的,所述中药组合物还包括以下重量份辅料:填充剂100~800份、粘合剂10~60份、矫味剂2~20份。
进一步的,所述中药组合物包括以下重量份药材:胆木120~180份、石膏150~210份、黄芩45~75份、青蒿80~160份、金银花50~80份、芦根80~120份、知母70~120份、桔梗50~70份、甘草40~55份。
进一步的,所述中药组合物还包括以下重量份辅料:填充剂120~180份、粘合剂20~50份、矫味剂2~10份。
进一步的,所述中药组合物由以下重量份的药材制成:胆木150份、石膏200份、黄芩50份、青蒿150份、金银花50份、芦根100份、知母100份、桔梗60份、甘草50份。
进一步的,所述填充剂为乳糖、葡萄糖、蔗糖、甘露醇、果糖、糊精、环拉酸钠中至少一种;所述粘合剂为聚乙烯吡咯烷酮、淀粉浆、甲基纤维素、聚乙二醇、乙醇水溶液中至少一种;所述矫味剂为阿斯巴坦、甜菊苷中至少一种。
一种治疗流行性感冒的中药组合物的制备方法,包括以下步骤:
(1)取上述重量份的胆木、石膏、甘草、芦根,加水提取2次,第一次加6~8倍量水,提取2~4小时;第二次加2~4倍量水,提取2~4小时,合并提取液,过滤,减压浓缩至相对密度为1.10~1.25(50℃),放凉,搅拌下缓缓加入乙醇,使含醇量达50~70%,静置20-28小时,滤取上清液,得醇沉滤液,备用;
(2)取上述重量份的青蒿、金银花、桔梗、知母、黄芩,加6~10倍量70~90v/v%乙醇溶液提取,回流1.5~3小时;提取液滤过,与上述步骤(1)醇沉滤液合并,减压浓缩成相对密度为1.25~1.35(50℃)的清膏,减压干燥,粉碎,过50-70目筛,得干浸膏粉,即得。
一种治疗流行性感冒的中药组合物制剂,其制备方法包括以下步骤:
(1)取上述重量份的胆木、石膏、甘草、芦根,加水提取2次,第一次加6~8倍量水,提取2~4小时;第二次加2~4倍量水,提取2~4小时,合并提取液,过滤,减压浓缩至相对密度为1.10~1.25(50℃),放凉,搅拌下缓缓加入乙醇,使含醇量达50~70%,静置20-28小时,滤取上清液,得醇沉滤液,备用;
(2)取上述重量份的青蒿、金银花、桔梗、知母、黄芩,加6~10倍量70~90v/v%乙醇溶液提取,回流1.5~3小时;提取液滤过,与上述步骤(1)醇沉滤液合并,减压浓缩成相对密度为1.25~1.35(50℃)的清膏,减压干燥,粉碎,过50-70目筛,得干浸膏粉;
(3)取上述干浸膏粉,加入填充剂、矫味剂,混匀,再加入粘合剂制粒,干燥,整粒,分装即得。
进一步的,步骤(3)中,所述干燥温度为50~75℃,所述干燥时间为1~3h。
本发明任一项所述的中药组合物在制备治疗流行性感冒的药物中的应用。
与现有技术相比,本发明的有益效果是:
(1)本发明方中,胆木、石膏为君药,具有大清阳明气分疫热之效;青蒿、黄芩、金银花、知母共为臣药,辅助君药起到在透散卫分表邪的同时,兼顾了温病热邪易蕴结成毒及多夹秽浊之气的特点;桔梗、芦根为共佐药;甘草为使药;全方具有表里双解,清肺止咳的功效,对治疗流行性感冒具有显著的效果,尤其对小儿流行性感冒具有较佳的治疗效果。
其中,君药:胆木、石膏,功善清解,透热出表,大清阳明气分疫热;胆木性味苦寒,功善清热燥湿解毒。石膏辛甘大寒清热泻火,兼可解肌透热,使邪热透达于外,同时石膏还能除烦,生津止渴。石膏配合胆木清热透邪,使里热之邪从外而解,内清外透,使伏热之邪有外达之机。
臣药:青蒿,苦寒清热,辛香透散,善清解暑热,既清透邪热,又辟秽化湿;黄芩味苦燥湿,清热解毒,尤善清泄中上焦湿热,两药相合透邪外出;金银花气味芳香,既能疏散风热,清热解毒,又可辟秽化浊,既可透散卫分表邪,又能兼顾温热病多兼夹秽浊之气的特点。知母苦寒质润同时配伍,一方面助君药清气分大热,一方面还能起到滋阴生津,而不恋邪的作用。以上四药均为皆为臣药。
佐药:桔梗载药上行,辛散宣畅肺气以利解表。芦根热泻火除烦、生津止渴,升散之中具有清降之性,既疏散风热,又长于宣肺祛痰,清肺止咳,共为佐药。
使药:石膏、知母寒凉容易伤胃,配伍甘草,既能益胃生津,调和药性,又能保护脾胃,防止石膏、知母寒凉伤胃。甘草调和诸药,护胃安中,为使药。
(2)本发明将该中药组合物的各味药材水提取和醇提取分开先进行提取,得到的提取膏粉与合适的辅料进行搭配,得到治疗流行性感冒的中药组合物的溶解度和口感好,便于作为儿童药服用。本发明解决了中药制剂苦口问题,获得产品味微甜,改善药物口感,患者具有很高的治疗依从性,减少患者治疗中的痛苦,尤其是使儿童能够积极配合用药,对治疗小儿病毒性流感的更好发挥疗效,也更容易被市场和广大患者所接受。
(3)本发明得到的制剂颗粒在水中溶解迅速、形成澄清透明口感好的溶液,便于服用,生物利用度高,药效佳。
(4)本发明中药组合物为纯中药,在保证药效佳的情况下,避免使用西药组分,降低胃肠不良反应的发生率,提升治疗的安全性。
(5)本发明方法操作简单、生产周期短、无需特殊的设备,成本低、收率高,适于工业化生产。
具体实施方式
为了更好理解本发明技术内容,下面提供具体实施例,对本发明做进一步的说明。
本发明实施例所用的实验方法如无特殊说明,均为常规方法。
本发明实施例所用的材料、试剂等,如无特殊说明,均可从商业途径得到。
本发明所采用的原药材具体描述如下:
胆木为茜草科植物乌檀Nauclea officinalis Pierre.ex Pitard的枝、树皮。小枝纤细而光滑。叶对生,纸质;叶柄长10-15mm;托叶倒卵形,长6-10mm,先端圆,早落;叶片椭圆形,罕有倒卵形,长7-14cm,宽4-7cm,先端渐尖,略钝,基部楔形,全缘,侧脉8对,近边缘处彼此连结,两面均明显。头状花序顶生,单生,圆球形;总花梗长1-3cm,中部以上有早落的苞片;花5数;萼管连成肉质体:子房下位。小坚果合成一球状体,熟时黄褐色,直径9-15mm,表面粗糙。种子椭圆形,长约1mm,腹面平坦,背面拱起,种皮黑色有光泽,并有微小窝孔。
石膏为硫酸盐类矿物石膏族石膏,主含含水硫酸钙(CaSO4·2H2O),采挖后,除去杂石及泥沙。为纤维状的集合体,呈长块状、板块状或不规则块状。白色、灰白色或淡黄色,有的半透明。体重,质软,纵断面具绢丝样光泽。气微,味淡。
黄芩为唇形科植物黄芩Scutellaria baicalensis eori的干燥根。春、秋二季采挖,除去须根及泥沙,晒后撞去粗皮,晒干。本品呈圆锥形,扭曲,长8~25cm,直径1~3cm。表面棕黄色或深黄色,有稀疏的疣状细根痕,上部较粗糙,有扭曲的纵皱或不规则的网纹,下部有顺纹和细皱。质硬而脆,易折断,断面黄色,中间红棕色;老根中心枯朽状或中空,呈暗棕色或棕黑色。气微,味苦。
青蒿为菊科植物黄花蒿Artemisia annua L.的干燥地上部分。秋季花盛开时采割,除去老茎,阴干。茎呈圆柱形,上部多分枝,长30~80cm,直径0.2-0.6cm;表面黄绿色或棕黄色,具纵棱线;质略硬,易折断,断面中部有髓。叶互生,暗绿色或棕绿色,卷缩易碎,完整者展平后为三回羽状深裂,裂片和小裂片矩圆形或长椭圆形,两面被短毛。气香特异,味微苦。
金银花为忍冬科植物忍冬Lonicera japonica Thunb.、红腺忍冬Lonicerahypolau-ca Miq.、山银花Lonicera confusa DC.或毛花柱忍冬Lonicera dasystylaRehd.的干燥花蕾或带初开的花。夏初花开放前采收,干燥。外表黄色或黄褐色,被有短柔毛及腺毛,基部有绿色细小的花萼,5裂,裂片三角形,无毛。剖开花蕾则见5枚雄蕊及1枚雌蕊。花冠唇形,雌雄蕊呈须状伸出。忍冬呈棒状,上粗下细,略弯曲,长2~3cm,上部直径约3mm,下部直径约1.5mm。表面黄白色或绿白色(贮久色渐深),密被短柔毛。偶见叶状苞片。花萼绿色,先端5裂,裂片有毛,长约2mm。开放者花冠筒状,先端二唇形;雄蕊5个,附于筒壁,黄色;雌蕊1个,子房无毛。气清香,味淡、微苦。红腺忍冬长2.5~4.5cm,直径0.8~2mm。表面黄白至黄棕色,无毛或疏被毛。萼筒无毛,先端5裂,裂片长三角形,被毛。开放者花冠下唇反转。花柱无毛。山银花长1.6~3.5cm,直径0.5~2mm。萼筒和花冠密被灰白色毛,子房有毛。毛花柱忍冬长2.5~4cm,直径1~2.5mm。表面淡黄色微带紫色,无毛。花萼裂片短三角形。开放者花冠上唇常不整齐,花柱下部多密被长柔毛。
芦根为禾本科植物芦苇Phramites communis Trin.的新鲜或干燥根茎。全年均可采挖,除去芽、须根及膜状叶,鲜用或晒干。呈扁圆柱形。节处较硬,节间有纵皱纹。鲜芦根呈长圆柱形,有的略扁,长短不一,直径1~2cm。表面黄白色,有光泽,外皮疏松可剥离,节呈环状,有残根和芽痕。体轻,质韧,不易折断。切断面黄白色,中空,壁厚1~2mm,有小孔排列成环。气微,味甘。
知母为百合科植物知母Anemarrhena asphodeloides Be.的干燥根茎。春、秋二季采挖,除去须根及泥沙,晒干,习称“毛知母”;或除去外皮,晒干。本品呈长条状,微弯曲,略扁,偶有分枝,长3~15cm,直径0.8~1.5cm,一端有浅黄色的茎叶残痕。表面黄棕色至棕色,上面有一凹沟,具紧密排列的环状节,节上密生黄棕色的残存叶基,由两侧向根茎上方生长;下面隆起而略皱缩,并有凹陷或突起的点状根痕。质硬,易折断,断面黄白色。气微,味微甜、略苦,嚼之带粘性。
桔梗为桔梗科植物桔梗Platycodon randiflorum(Jacq.)A.DC.的干燥根。春、秋二季采挖,洗净,除去须根,趁鲜剥去外皮或不去外皮,干燥。呈圆柱形或略呈纺锤形,下部渐细,有的有分枝,略扭曲,长7~20cm,直径0.7~2cm。表面淡黄白色至黄色,不去外皮者表面黄棕色至灰棕色,具纵扭皱沟,并有横长的皮孔样斑痕及支根痕,上部有横纹。有的顶端有较短的根茎或不明显,其上有数个半月形茎痕。质脆,断面不平坦,形成层环棕色,皮部黄白色,有裂隙,木部淡黄色。气微,味微甜后苦。
甘草为豆科植物甘草lycyrrhiza uralensis Fisch.、胀果甘草lycyrrhizainflata Bat.或光果甘草lycyrrhiza labra L.的干燥根及根茎。春、秋二季采挖,除去须根,晒干。根呈圆柱形,长25~100cm,直径0.6~3.5cm。外皮松紧不一。表面红棕色或灰棕色,具显著的纵皱纹、沟纹、皮孔及稀疏的细根痕。质坚实,断面略显纤维性,黄白色,粉性,形成层环明显,射线放射状,有的有裂隙。根茎呈圆柱形,表面有芽痕,断面中部有髓。气微,味甜而特殊。
实施例1
一种治疗流行性感冒的中药组合物,包括以下重量份药材和辅料制成:
胆木150份、石膏200份、黄芩50份、青蒿150份、
金银花50份、芦根100份、知母100份、桔梗60份、
甘草50份、蔗糖120份、95v/v%乙醇水溶液40份、阿斯巴坦8份。
上述中药组合物制剂的制备方法包括以下步骤:
(1)水提-醇沉:按上述重量份取胆木、石膏、甘草、芦根,加水提取2次,第一次加7倍量水,提取3小时;第二次加3倍量水,提取3小时,提取液合并,滤过,减压浓缩至相对密度为1.10~1.25(50℃),放凉,搅拌下缓缓加入乙醇,使含醇量达60%,静置24小时,滤取上清液,即得醇沉滤液,备用。
(2)醇提-浓缩:按上述重量份取青蒿、金银花、桔梗、知母、黄芩,加8倍量80v/v%乙醇溶液提取,回流2小时;提取液滤过,与上述步骤(1)醇沉滤液合并,减压浓缩成相对密度为1.25~1.35(50℃)的清膏,减压干燥,粉碎,过60目筛,得干浸膏粉。
(3)制剂:取上述干浸膏粉,并按上述重量份称取辅料,加入蔗糖,阿斯巴坦,混匀,再加入95v/v%乙醇水溶液制粒,干燥,整粒,分装即得颗粒剂。
实施例2
一种治疗流行性感冒的中药组合物,包括以下重量份药材和辅料制成:
胆木100份、石膏150份、黄芩75份、青蒿100份、
金银花75份、芦根80份、知母75份、桔梗30份、
甘草30份、蔗糖100份、聚乙烯比咯烷酮30份、甜菊素6份。
上述中药组合物制剂的制备方法包括以下步骤:
(1)水提-醇沉:按上述重量份取胆木、石膏、甘草、芦根,加水提取2次,第一次加6倍量水,提取2小时;第二次加4倍量水,提取4小时,提取液合并,滤过,减压浓缩至相对密度为1.10~1.25(50℃),放凉,搅拌下缓缓加入乙醇,使含醇量达50%,静置24小时,滤取上清液,即得醇沉滤液,备用。
(2)醇提-浓缩:按上述重量份取青蒿、金银花、桔梗、知母、黄芩,加6倍量90v/v%乙醇溶液提取,回流1.5小时;提取液滤过,与上述步骤(1)醇沉滤液合并,减压浓缩成相对密度为1.25~1.35(50℃)的清膏,减压干燥,粉碎,过60目筛,得干浸膏粉。
(3)制剂:取上述干浸膏粉,并按上述重量份称取辅料,加入蔗糖,甜菊素,混匀,再加入聚乙烯比咯烷酮制粒,干燥,整粒,分装即得颗粒剂。
实施例3
一种治疗流行性感冒的中药组合物,包括以下重量份药材和辅料制成:
胆木50份、石膏100份、黄芩100份、青蒿80份、
金银花80份、芦根80份、知母50份、桔梗30份、
甘草20份、乳糖20份、乙醇15份、阿斯巴坦2份。
上述中药组合物制剂的制备方法包括以下步骤:
(1)水提-醇沉:按上述重量份取胆木、石膏、甘草、芦根,加水提取2次,第一次加8倍量水,提取4小时;第二次加2倍量水,提取2小时,提取液合并,滤过,减压浓缩至相对密度为1.10~1.25(50℃),放凉,搅拌下缓缓加入乙醇,使含醇量达70%,静置24小时,滤取上清液,即得醇沉滤液,备用。
(2)醇提-浓缩:按上述重量份取青蒿、金银花、桔梗、知母、黄芩,加10倍量70v/v%乙醇溶液提取,回流3小时;提取液滤过,与上述步骤(1)醇沉滤液合并,减压浓缩成相对密度为1.25~1.35(50℃)的清膏,减压干燥,粉碎,过60目筛,得干浸膏粉。
(3)制剂:取上述干浸膏粉,并按上述重量份称取辅料,加入乳糖,阿斯巴坦,混匀,再加入乙醇制粒,干燥,整粒,分装即得颗粒剂。
实施例4
一种治疗流行性感冒的中药组合物,包括以下重量份药材和辅料制成:
胆木150份、石膏140份、黄芩50份、青蒿50份、
金银花50份、芦根50份、知母80份、桔梗50份、
甘草50份、蔗糖180份、95v/v%乙醇水溶液35份、甜菊素15份。
上述中药组合物制剂的制备方法包括以下步骤:
按上述重量份取药材,按照实施例1提取工艺获得干浸膏粉。
制剂:取上述干浸膏粉,并按上述重量份称取辅料,加入蔗糖、甜菊素,混匀,再加入95v/v%乙醇水溶液制粒,于65℃干燥2h,整粒,分装即得颗粒剂。
实施例5
一种治疗流行性感冒的中药组合物,包括以下重量份药材和辅料制成:
胆木200份、石膏260份、黄芩150份、青蒿200份、
金银花150份、芦根150份、知母150份、桔梗100份、
甘草60份、蔗糖800份、95v/v%乙醇水溶液60份、阿斯巴坦20份。
上述中药组合物制剂的制备方法与实施例1一致。
对比例1
本对比例与实施例1的区别在于,全部药材一起采用水提,其制备方法包括以下步骤:
(1)按上述重量份取胆木、石膏、甘草、芦根、青蒿、金银花、桔梗、知母、黄芩,加水提取2次,第一次加7倍量水,提取6小时;第二次加3倍量水,提取6小时,提取液合并,滤过,减压浓缩至相对密度为1.10~1.25(50℃),放凉,搅拌下缓缓加入乙醇,使含醇量达60%,静置24小时,滤取上清液,即得醇沉滤液,减压浓缩成相对密度为1.25~1.35(50℃)的清膏,减压干燥,粉碎,过60目筛,得干浸膏粉。
(2)制剂:取上述干浸膏粉,并按上述重量份称取辅料,加入蔗糖、阿斯巴坦,混匀,再加入95v/v%乙醇水溶液制粒,干燥,整粒,分装即得颗粒剂。
对比例2
本对比例与实施例1的区别在于,全部药材一起采用乙醇提取,其制备方法包括以下步骤:
(1)按上述重量份取胆木、石膏、甘草、芦根、青蒿、金银花、桔梗、知母、黄芩,加8倍量80v/v%乙醇溶液提取,回流提取4小时,提取液滤过,减压浓缩成相对密度为1.25~1.35(50℃)的清膏,减压干燥,粉碎,过60目筛,得干浸膏粉。
(2)制剂:取上述干浸膏粉,并按上述重量份称取辅料,加入蔗糖、阿斯巴坦,混匀,再加95v/v%乙醇水溶液制粒,干燥,整粒,分装即得颗粒剂。
一、将实施例1~5及对比例1~2分别制得的治疗流行性感冒的中药组合物制剂按中国药典2015年版一部,药典2015年版四部制剂通则进行质量检验,具体检验结果如表1;
表1
由以上的检验结果可知,本发明治疗流行性感冒的中药组合物制剂各项指标符合颗粒剂项下有关的各项规定(中国药典2010年版二部附I制剂通则IN),如流动性、口感、溶化性均符合规定,故说明本发明方法的可靠性及可控性,操作简单,适合于工业化生产。其中,实施例1~4制成颗粒,口感好,而对比例1~2,口感微辣,表明采用本发明的制备工艺,制得产品口感更佳。
二、临床试验
1.基本资料:120例小儿流行性感冒患儿,年龄为3~6岁,将其分为对照组和试验组,其中对照组患儿60例;试验组患儿60例。所有患儿在入院后均伴有发热、流涕、鼻塞、咳嗽、呕吐等症状,两组患儿性别、年龄、临床症状等一般资料比较差异无统计学意义(P>0.05),具有可比性。
2.方法:给予对照组患儿口服胆木浸膏糖浆,10ml/次,3次/d,连续服用4d。给予试验组患儿采用本发明中药组合物颗粒剂治疗,1.5g/次,3次/d,连续服用4d。观察并记录两组患儿的发热、咳嗽及鼻涕的消退时间。
3.按照病毒性感冒的临床疗效评价标准对患儿的疗效进行评价。
(1)治愈:经过治疗后,患儿的发热、流涕、咳嗽等临床症状全部消失,患儿的精神状态明显改善;
(2)有效:患儿的发热、流涕、咳嗽等临床症状基本缓解,精神状态和饮食部分恢复正常;
(3)无效:患儿的临床症状均未发生明显的改善。
总有效率=(治愈+有效)例数/总例数×100%。
4.治疗结果
两组患儿临床疗效比较(n%)
经过治疗,试验组患儿的治疗总有效率为98.33%,明显高于对照组的93.33%,差异有统计学意义(P<0.05)。其中,试验组的治愈率86.67%显著高于对照组51.67%,差异有统计学意义(P<0.05)。而且试验组无不良反应例,安全性高。
以上所述仅为本发明的较佳实施例而已,并不用以限制本发明,凡在本发明的精神和原则之内,所做的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (10)
1.一种治疗流行性感冒的中药组合物,其特征在于,包括以下重量份药材:胆木50~200份、石膏100~260份、黄芩50~150份、青蒿50~200份、金银花50~150份、芦根50~150份、知母50~150份、桔梗30~100份、甘草20~60份。
2.根据权利要求1所述的治疗流行性感冒的中药组合物,其特征在于,还包括以下重量份辅料:填充剂100~800份、粘合剂10~60份、矫味剂2~20份。
3.根据权利要求1所述的治疗流行性感冒的中药组合物,其特征在于,包括以下重量份药材:胆木120~180份、石膏150~210份、黄芩45~75份、青蒿80~160份、金银花50~80份、芦根80~120份、知母70~120份、桔梗50~70份、甘草40~55份。
4.根据权利要求3所述的治疗流行性感冒的中药组合物,其特征在于,还包括以下重量份辅料:填充剂120~180份、粘合剂20~50份、矫味剂2~10份。
5.根据权利要求1所述的治疗流行性感冒的中药组合物,其特征在于,由以下重量份的药材制成:胆木150份、石膏200份、黄芩50份、青蒿150份、金银花50份、芦根100份、知母100份、桔梗60份、甘草50份。
6.根据权利要求2或4所述的治疗流行性感冒的中药组合物,其特征在于,所述填充剂为乳糖、葡萄糖、蔗糖、甘露醇、果糖、糊精、环拉酸钠中至少一种;所述粘合剂为聚乙烯吡咯烷酮、淀粉浆、甲基纤维素、聚乙二醇、乙醇水溶液中至少一种;所述矫味剂为阿斯巴坦、甜菊苷中至少一种。
7.根据权利要求1、3、5任一项所述的治疗流行性感冒的中药组合物的制备方法,其特征在于,包括以下步骤:
(1)取上述重量份的胆木、石膏、甘草、芦根,加水提取2次,第一次加6~8倍量水,提取2~4小时;第二次加2~4倍量水,提取2~4小时,合并提取液,过滤,减压浓缩至相对密度为1.10~1.25(50℃),放凉,搅拌下缓缓加入乙醇,使含醇量达50~70%,静置20-28小时,滤取上清液,得醇沉滤液,备用;
(2)取上述重量份的青蒿、金银花、桔梗、知母、黄芩,加6~10倍量70~90v/v%乙醇溶液提取,回流1.5~3小时;提取液滤过,与上述步骤(1)醇沉滤液合并,减压浓缩成相对密度为1.25~1.35(50℃)的清膏,减压干燥,粉碎,过50-70目筛,得干浸膏粉,即得。
8.一种治疗流行性感冒的中药组合物制剂,其特征在于,由权利要求2或4所述的治疗流行性感冒的中药组合物制得,其制备方法包括以下步骤:
(1)取上述重量份的胆木、石膏、甘草、芦根,加水提取2次,第一次加6~8倍量水,提取2~4小时;第二次加2~4倍量水,提取2~4小时,合并提取液,过滤,减压浓缩至相对密度为1.10~1.25(50℃),放凉,搅拌下缓缓加入乙醇,使含醇量达50~70%,静置20-28小时,滤取上清液,得醇沉滤液,备用;
(2)取上述重量份的青蒿、金银花、桔梗、知母、黄芩,加6~10倍量70~90v/v%乙醇溶液提取,回流1.5~3小时;提取液滤过,与上述步骤(1)醇沉滤液合并,减压浓缩成相对密度为1.25~1.35(50℃)的清膏,减压干燥,粉碎,过50-70目筛,得干浸膏粉;
(3)取上述干浸膏粉,加入填充剂、矫味剂,混匀,再加入粘合剂制粒,干燥,整粒,分装即得。
9.根据权利要求8所述的治疗流行性感冒的中药组合物制剂,其特征在于,步骤(3)中,所述干燥温度为50~75℃,所述干燥时间为1~3h。
10.根据权利要求1-6任一项所述的中药组合物在制备治疗流行性感冒的药物中的应用。
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