CN109394982A - 一种具有清口止咳功效的组合物及其制备方法 - Google Patents
一种具有清口止咳功效的组合物及其制备方法 Download PDFInfo
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Abstract
本发明属于食品加工技术领域,具体涉及一种具有清口止咳功效的组合物及其制备方法。本发明组合物采用石斛、甘草、白茅根、蒲公英根、余甘子、罗汉果、金银花七种药食同源的植物原料科学配比,经水煮提取,将提取液进行高速离心处理,有效富聚功效活性成分。本发明提取工艺简单,充分考虑各原料间的配比,使各原料在特定的配比下相互协同、共同作用,不仅具有清咽止咳的功效,而且有显著的清新口气的作用,无毒副作用、安全性高,组成简单、成本低,适宜人群广泛。
Description
技术领域
本发明属于食品加工技术领域,具体涉及一种具有清口止咳功效的组合物及其制备方法。
背景技术
喉痹是耳鼻喉科的常见病、多发病,是以咽部的红肿疼痛,吞咽不利、咽中异物感、咽痒、咳嗽为主要症状的急慢性咽部疾病,相当于现代医学中的急、慢性咽喉炎。慢性咽炎为咽部黏膜、黏膜下及淋巴组织的慢性炎症,常为上呼吸道慢性炎症的一部分,近年该病的发病率有不断增高趋势,患者主要表现为咽腔干燥、发痒感、刺激性咳嗽等临床症状,导致患者睡眠不佳、失眠、食欲不振等后果,严重危害了人们的身心健康。从临床用药来看,西医大多采用非甾体类抗炎药缓解咽喉肿痛的症状,同时运用抗生素或激素类制剂,但抗生素的长期使用会出现耐药性,降低机体免疫力等副作用。中医药作为传统医药,对治疗慢性咽炎经验丰富,效果显著,且毒副作用小。具有独特的优势。例如,中国专利CN104491413A公开了一种清肺止咳片,有效成分包括桔梗2~6份、桑葚1~7份、栀子2~5份、紫草1~7份、橘皮1~5份、麻黄2~10份、丝瓜络3~8份、乌梅1~5份、枇杷叶1~10份、白芍3~5份、玉竹1~3份、半夏2~8份、肉桂3~6份、鱼腥草2~5份、牛蒡子3~7份、甘草1~5份,原料煎煮浓缩后加入辅料制成片剂;该清肺止咳片虽然有较好的止咳效果,但是组分复杂不利于制备过程中的质量控制,并且在制成片剂过程中一般需要加入硬脂酸镁和化学香精等辅料以保证片剂成型和可接受性,但是这种辅料不宜大量服用,长期服用易引起胃部和咽部不适。而且含片是一种需要在口腔内长期停留直至完全融化分解后,才能在局部发挥持久药效的药物,如果将含片当口服药吞入,或匆忙嚼烂,可能会失去其局部持久产生药效的意义,而且中药含片多有苦味和沙砺感,口感欠佳。
发明内容
为此,针对现有技术中的止咳含片成分复杂、功效不明显,口感欠佳等缺陷,提供一种药食同源、功效明显、成分简单、口感好的清口止咳组合物。
为此,本发明的技术方案如下:
一种具有清口止咳功效的组合物,以重量份计,其原料包括:石斛10-90份、甘草1-30份、白茅根5-60份、蒲公英根1-30份、余甘子2-70份、罗汉果5-25份和金银花3-20份。
进一步地,以重量份计,其原料包括:石斛20-50份、甘草1-15份、白茅根5-40份、蒲公英根10-30份、余甘子10-50份、罗汉果5-20份和金银花3-10份。
进一步地,以重量份计,其原料包括:石斛36份、甘草6份、白茅根33份、蒲公英根25份、余甘子30份、罗汉果15份和金银花5份。
进一步地,所述组合物的制备方法,包括粉碎、水提、有机溶剂提取中的一种或多种。
进一步地,所述组合物的制备方法,包括以下步骤:称取石斛、甘草、白茅根、蒲公英根、余甘子、罗汉果和金银花,加入10-15倍重量份的水,浸泡20-40min,煮沸20-40min,过滤;向滤渣中加入5-8倍重量份的水,煮沸40-50min,过滤;合并两次滤液并浓缩,将滤液离心、除渣、浓缩至原料药重量的1/2-3/2。
一种包括上述组合物的制剂,所述组合物加入常规辅料,按照常规工艺,制成临床上可接受的膜剂、胶囊剂、散剂、合剂、丸剂、颗粒剂、口服液、糖浆剂、膏剂、冲剂、饮料、饼干、糖果、糕点食品或方便食品。
一种上述组合物在制备具有清口和止咳功效的药品、保健食品或普通食品中的应用。
一种具有清口止咳功效的口腔膜剂,包括上述组合物和药物学上可接受的辅料。
进一步地,所述辅料包括增稠剂、缓释成膜材料、抑菌剂、保湿剂、乳化剂、食用色素或食用香精中的一种或多种。
进一步地,按重量份计,所述辅料包括增稠剂5-50份、缓释成膜材料5-80份、抑菌剂0.1-2.5份和保湿剂0.5-10份。
进一步地,按重量份计,所述辅料还包括乳化剂1-50份、食用色素0.1-1份或食用香精0.1-1份。
进一步地,所述口腔膜剂的制备方法,包括以下步骤:
1)将除矫味剂之外的辅料投入密封容器中,并加入投料1-4倍重量份的纯化水,在60-80℃的温度下真空搅拌2-4小时;
2)称取石斛、甘草、白茅根、蒲公英根、余甘子、罗汉果和金银花,加入10-15倍重量份的水,浸泡20-40min,煮沸20-40min,过滤;向滤渣中加入5-8倍重量份的水,煮沸40-50min,过滤;合并两次滤液并浓缩,将滤液离心、除渣、浓缩至原药材的1/2-3/2重量。
3)将步骤2)得到的浓缩液和矫味剂逐次加入步骤1)得到的溶液,在60-80℃的温度下真空搅拌4-6小时;
4)将步骤3)得到的溶液进行真空脱泡后静置8-18小时;
5)将步骤4)得到的溶液打入流延机的流延槽中,调整好流延槽厚度并设置流延干燥箱的温度为50-70℃,开启流延机传送装置进行流延制膜;
6)待所制膜流出干燥箱后,冷却,即得清口止咳膜。
进一步地,步骤1)、2)和3)的真空度为0.01-0.99MPa。
进一步地,步骤2)中得到的浓缩液和辅料的质量比为20-50:80-50。
进一步地,所述流延槽厚度为0.01-2mm。
进一步地,所述增稠剂为普鲁兰多糖、β-葡聚糖、明胶、胶原蛋白、果胶、黄原胶、瓜尔胶、可得然胶的一种或几种。
进一步地,所述缓释成膜材料为海藻酸钠、羧甲基纤维素钠、聚乳酸、聚乳酸-羟基乙酸共聚物中的一种或几种。
进一步地,所述保湿剂为甘油、丙二醇、亚麻籽油、蓖麻油、橄榄油、山梨醇、聚山梨酯中的一种或几种。
进一步地,所述抑菌剂为维生素C、山梨酸钾、苯甲酸钠中的一种或几种。
进一步地,所述矫味剂为阿斯巴甜、甜菊糖苷、薄荷脑中的一种或几种。
进一步地,所述食用色素为天然β胡萝卜素、花青素、姜黄、藏红花、辣椒红、辣椒橙、菊花黄浸膏、玉米黄、黑加伦红、桅子黄、桅子兰,沙棘黄、玫瑰茄红中的一种或多种。
进一步地,所述食用香精为牛奶香精、水蜜桃香精、橙汁香精、黑莓香精、草莓香精、菠萝香精、苹果香精、荔枝香精、芒果香精、柠檬香精中的一种或多种。
本发明提供的具有清口止咳功效的组合物与现有技术相比,具有如下有益效果:
1、本发明提供的具有清口止咳功效的组合物以石斛、白茅根、甘草、蒲公英根、余甘子、罗汉果和金银花进行组合,将这些药物组合使得各药物功效产生协同作用,在清口止咳方面有显著功效。石斛,味辛苦温,归心、胃经,具有开窍豁痰,清肺止咳,醒神益智,化湿开胃的作用,为君药;蒲公英根具有清热解毒,消肿散结的作用。罗汉果,味甘性凉,归肺、大肠经,有润肺止咳、生津止渴的功效;白茅根,性甘寒,具有凉血止血,清肺热利尿的作用;蒲公英根、罗汉果和白茅根为臣药,调理内热,促进疗效;金银花性寒,味甘,入肺、心、胃经,具有清热解毒、抗炎、补虚疗风的功效,对肺炎球菌、脑膜炎双球菌、绿脓杆菌、结核杆菌、志贺氏痢疾杆菌、变形链球菌等有抑菌和杀菌的作用,为佐药,辅助清肺热的同时杀菌消炎;余甘子含丰富的维生素,可生津止渴,润肺化痰,治咳嗽、喉痛,协同治疗咽炎咳嗽等症;甘草,性味甘平,具有调和诸药药性的作用。
2、本发明提供的具有清口止咳功效的组合物为口腔膜剂,黏贴于口腔上颚融化,食用方便无废弃物,口腔留香持久,无副作用,避免了硬脂酸镁等辅料对胃部和咽部的刺激。
3、本发明提供的具有清口止咳功效的组合物在制备成口腔膜剂时,在负压下搅拌混合,比在常压下搅拌混合,成膜效果更好。
4、本发明提供的具有清口止咳功效的组合物原料搭配合理,成分少、制备方法简单,具有质量控制方便,成本低,效果好的优势。
具体实施方式
提供下述实施例是为了更好地进一步理解本发明,并不局限于所述最佳实施方式,不对本发明的内容和保护范围构成限制,任何人在本发明的启示下或是将本发明与其他现有技术的特征进行组合而得出的任何与本发明相同或相近似的产品,均落在本发明的保护范围之内。
实施例中未注明具体实验步骤或条件者,按照本领域内的文献所描述的常规实验步骤的操作或条件即可进行。所用试剂或仪器未注明生产厂商者,均为可以通过市购获得的常规试剂产品。
实施例1.
本实施例提供一种具有清口止咳功效的口腔膜剂;
每100g口腔膜剂,组成配比为,辅料:普鲁兰多糖25g、海藻酸钠15g、甘油2.5g、胶原蛋白5g、果胶5.5g、甜菊糖苷0.2g、维生素C 1.1g、薄荷脑0.5g和藏红花0.2g,其中矫味剂为薄荷脑;和活性成分45g。
口腔膜剂的制备方法:
1)将除矫味剂之外的辅料,按配比投入密封容器中,并加入一定量的纯化水,在70℃、0.01Mpa的条件下搅拌3小时;
2)取石斛36克、甘草9克、白茅根15克、蒲公英根20克、余甘子7克、罗汉果8克和金银花5克;加入1.5L水,浸泡30分钟,煮沸30分钟,过滤,得到滤液;再加入0.8L水,煮沸45分钟,过滤,合并两次滤液;将滤液进行离心、除渣、浓缩至45g,即得活性成分;
3)将步骤2)得到的浓缩液和矫味剂逐次加入步骤1)得到的溶液,在70℃、0.01Mpa的条件下搅拌5小时;
4)将步骤3)得到的溶液在0.01Mpa下脱泡后静置12小时;
5)将步骤4)得到的溶液打入流延机的流延槽中,调整流延槽厚度为1mm并设置流延干燥箱的温度为60℃,开启流延机传送装置进行流延制膜;待所制膜流出干燥箱后,冷却,即得清口止咳膜。
实施例2.
本实施例提供一种具有清口止咳功效的口腔膜剂;
每100g口腔膜剂,组成配比为,辅料:β-葡聚糖35g、海藻酸钠7g、明胶6g、亚麻籽油9g、乳酸钠5g、甜菊糖苷0.3g、维生素C 2.1g、薄荷脑0.3g和藏红花0.3g,其中矫味剂为薄荷脑;和活性成分35g。
口腔膜剂的制备方法:
1)将除矫味剂之外的辅料,按配比投入密封容器中,并加入一定量的纯化水,在70℃、0.99Mpa条件下搅拌3小时;
2)取石斛25克、甘草6克、白茅根30克、蒲公英根20克、余甘子9克、罗汉果5克和金银花5克;加入1L水,浸泡30分钟,煮沸30分钟,过滤,得到滤液;再加入0.5L水,煮沸45分钟,过滤,合并两次滤液;将滤液进行离心、除渣、浓缩至35g,即得活性成分;
3)将步骤2)得到的浓缩液和矫味剂逐次加入步骤1)得到的溶液,在70℃、0.99Mpa条件下搅拌5小时;
4)将步骤3)得到的溶液在0.99Mpa下脱泡后静置12小时;
5)将步骤4)得到的溶液打入流延机的流延槽中,调整好流延槽厚度为1mm并设置流延干燥箱的温度为60℃,开启流延机传送装置进行流延制膜;待所制膜流出干燥箱后,冷却,即得清口止咳膜。
实施例3.
本实施例提供一种具有清口止咳功效的口腔膜剂;
每100g口腔膜剂,组成配比为,辅料:β-葡聚糖30g、海藻酸钠15g、甘油8g、明胶10g、乳酸钠10g、甜菊糖苷0.1g、维生素C 1.3g、薄荷脑0.5g和藏红花0.1g,其中矫味剂为薄荷脑;和活性成分25g。
口腔膜剂的制备方法:
1)将除矫味剂之外的辅料,按配比投入密封容器中,并加入一定量的纯化水,在70℃、0.5Mpa条件下搅拌3小时;
2)取石斛36克、甘草9克、白茅根21克、蒲公英根20克、余甘子15克、罗汉果10克和金银花5克;加入1.7L水,浸泡20分钟,煮沸40分钟,过滤,得到滤液;再加入0.6L水,煮沸40分钟,过滤,合并两次滤液;将滤液进行离心、除渣、浓缩至25g,即得活性成分;
3)将步骤2)得到的浓缩液和矫味剂逐次加入步骤1)得到的溶液,在70℃、0.5Mpa条件下搅拌5小时;
4)将步骤3)得到的溶液0.5Mpa下脱泡后静置12小时;
5)将步骤4)得到的溶液打入流延机的流延槽中,调整好流延槽厚度为2mm并设置流延干燥箱的温度为60℃,开启流延机传送装置进行流延制膜;待所制膜流出干燥箱后,冷却,即得清口止咳膜。
实施例4.
本实施例提供一种具有清口止咳功效的口腔膜剂;
活性成分的组成及制备方法:
每100g口腔膜剂,组成配比为:β-葡聚糖25g、羧甲基纤维素钠15g、山梨醇8g、瓜尔胶10g、活性成分40g、阿斯巴甜0.1g、三梨酸钾1.4g、薄荷脑0.5g,矫味剂为薄荷脑。
口腔膜剂的制备方法:
1)将除矫味剂之外的辅料,按配比投入密封容器中,并加入一定量的纯化水,在60℃、0.75Mpa的条件下搅拌5小时;
2)取石斛36克、甘草6克、白茅根33克、蒲公英根25克、余甘子30克、罗汉果15克和金银花5克;加入2L水,浸泡40分钟,煮沸40分钟,过滤,得到滤液;再加入1L水,煮沸20分钟,过滤,合并两次滤液;将滤液进行离心、除渣、浓缩至40g,即得活性成分;
3)将步骤2)得到的浓缩液和矫味剂逐次加入步骤1)得到的溶液,在60℃、0.75Mpa的条件下搅拌5小时;
4)将步骤3)得到的溶液在0.75Mpa下脱泡后静置16小时;
5)将步骤4)得到的溶液打入流延机的流延槽中,调整好流延槽厚度为0.01mm并设置流延干燥箱的温度为50℃,开启流延机传送装置进行流延制膜;待所制膜流出干燥箱后,冷却,即得清口止咳膜。
实施例5.
本实施例提供一种具有清口止咳功效的组合物,该组合物原料为:
石斛36克、甘草6克、白茅根33克、蒲公英根25克、余甘子30克、罗汉果15克和金银花5克;
将上述组分混合粉碎,即得散剂。
实施例6.
本实施例提供一种具有清口止咳功效的组合物,该组合物原料为:
石斛36克、甘草6克、白茅根33克、蒲公英根25克、余甘子30克、罗汉果15克和金银花5克;将上述组合粉碎,加入2L水,浸泡40分钟,煮沸40分钟,过滤,得到滤液;再加入1L水,煮沸20分钟,过滤,合并两次滤液;将滤液进行离心、除渣、浓缩至0.1-1倍体积,获得膏剂。
实施例7.
本实施例提供一种具有清口止咳功效的组合物,该组合物原料为:
石斛36克、甘草6克、白茅根33克、蒲公英根25克、余甘子30克、罗汉果15克和金银花5克;将上述组合粉碎,加入2L水,浸泡40分钟,煮沸40分钟,过滤,得到滤液;再加入1L水,煮沸20分钟,过滤,合并两次滤液;将滤液进行离心、除渣、浓缩至1.5-2倍体积,获得提取液。
对比例1
辅料组成:普鲁兰多糖25g、海藻酸钠15g、甘油2.5g、胶原蛋白5g、果胶5.5g、甜菊糖苷0.2g、维生素C 1.1g、薄荷脑0.5g和藏红花0.2g。
口腔膜剂的制备方法:
1)将除矫味剂之外的辅料,按配比投入密封容器中,并加入一定量的纯化水,在70℃、0.01Mpa的条件下搅拌3小时;
2)矫味剂加入步骤1)得到的溶液,在70℃、0.01Mpa的条件下搅拌5小时;
3)将步骤二得到的溶液在0.01Mpa下脱泡后静置12小时;
4)将步骤三得到的溶液打入流延机的流延槽中,调整好流延槽厚度为1mm并设置流延干燥箱的温度为60℃,开启流延机传送装置进行流延制膜;
5)待所制膜流出干燥箱后,冷却,即得清口止咳膜。
对比例2
本对比例提供一种具有清口止咳功效的口腔膜剂;
每100g口腔膜剂,组成配比为,辅料:普鲁兰多糖25g、海藻酸钠15g、甘油2.5g、胶原蛋白5g、果胶5.5g、甜菊糖苷0.2g、维生素C 1.1g、薄荷脑0.5g和藏红花0.2g,其中矫味剂为薄荷脑;和活性成分45g。
口腔膜剂的制备方法:
1)将除矫味剂之外的辅料,按配比投入密封容器中,并加入一定量的纯化水,在70℃、0.01Mpa的条件下搅拌3小时;
2)取石斛36克、甘草9克、余甘子7克、罗汉果8克和金银花5克;加入1.5L水,浸泡30分钟,煮沸30分钟,过滤,得到滤液;再加入0.8L水,煮沸45分钟,过滤,合并两次滤液;将滤液进行离心、除渣、浓缩至45g,即得活性成分;
3)将步骤2)得到的浓缩液和矫味剂逐次加入步骤1)得到的溶液,在70℃、0.01Mpa的条件下搅拌5小时;
4)将步骤3)得到的溶液在0.01Mpa下脱泡后静置12小时;
5)将步骤4)得到的溶液打入流延机的流延槽中,调整好流延槽厚度为1mm并设置流延干燥箱的温度为60℃,开启流延机传送装置进行流延制膜;待所制膜流出干燥箱后,冷却,即得清口止咳膜。
实验例1.
本发明清口止咳膜对于咽干、咽痒、咳嗽的治疗效果
1、一般性资料
本发明组合物应用于试服志愿者250例,其中男114例,女136例,年龄20~60岁。病程最短者1个月,最长者达3年,平均1年。
2、诊断标准
2.1受试者的纳入标准
1.病史:慢性咽炎人群,主观症状有咽痛、咽痒、咽干、干咳、异物感、多言加重等。
2.检查:咽部粘膜水肿、粘膜充血、咽后壁淋巴滤泡增生、分泌物附着。
具有上述症状及至少一项检查所见即可纳入观察。
2.2排除标准
1.慢性咽炎急性发作期或急性咽炎、声带结节、感冒或吸烟因素所至者。
2.鼻咽、咽、喉、鼻、喉、食管、颈部及结核、转移性肺癌病变所至者。年龄在65岁以下或18岁以上者,妊娠或哺乳期妇女及对本品过敏者。
3.合并有心、脑血管、肝、肾和造血系统等严重疾病及精神病患者。
4.短期内服用与受试功能有关的物品,影响到对结果的判断者。
5.不符合纳入标准、未按规定服用受试样品的受试者,资料不全影响功效或安全性判断者。
2.3试验设计及分组要求
采用自身和组间两种对照设计。按受试者的咽部症状、体征随机分为4组,尽可能考虑影响结果的主要因素如病程、年龄、性别等,进行均衡性检验,以保证组间的可比性。
2.4受试样品的剂量和使用方法
受试样品切割成1cm×2cm的长方形膜片,一次3片,一日三次,共15天。
2.5观察指标
各项指标于试验开始及结束时各测试一次,并检查咽部,询问症状,记录变化情况。
安全性指标
一般状况包括精神、睡眠、饮食、大小便、血压、心率等功效性指标。
症状观察
详细询问病史,主要咽部症状:咽痛、咽痒、咽干、干咳、异物感多言加重等,按症状轻重(1度、1分,2度、2分,3度、3分)计算积分,统计积分变化、症状改善率。
体征观察
咽部检查:咽部粘膜充血、粘膜水肿、咽后壁淋巴滤泡增生、分泌物等体征。按检查结果轻、中、重分为Ⅰ、Ⅱ、Ⅲ级,分别记录试食前后体征变化,计算体征积分和改善率。
观察指标功效判定:
显效:症状痊愈,咽部不适感消失,体征检查结果正常
有效:症状减轻1度,咽部体征检查结果减轻1级
无效:症状、体征均无明显改变
3、实验结果
3.1清口止咳膜对于咽干、咽痒、咳嗽的改善效果
表1对于咽干、咽痒、咳嗽的改善效果
受试样品 | 例数 | 显效例数 | 有效例数 | 无效例数 |
实施例1 | 50 | 38 | 11 | 1 |
实施例2 | 50 | 35 | 10 | 5 |
实施例3 | 50 | 32 | 14 | 4 |
对比例1 | 50 | 0 | 4 | 46 |
对比例2 | 50 | 29 | 6 | 15 |
本发明实施例1-3制得的清口止咳膜,具有显著改善嗓子干、痒和咳嗽的功效,根据所添加功效提取物的比例变化稍有差异;未添加功效提取物的对比例1,几乎没有清咽止咳效果;对比例2的清咽止咳效果明显低于实施例。
3.2清口止咳膜的口感
清新口气主要以志愿者自述感受、打分为依据,满分100分。具体结果参见表2。
表2清口止咳膜的口感分数
结果:本发明实施例1-3制得的清口止咳膜,具有显著清新口气的功效,志愿者对添加了功效成分膜片的体验感更佳,评分更高;未添加功效提取物的对比例1、对比例2,清新口气方面的体验感稍差。
4、实验结论
本发明的清口止咳膜,(1)止咳效果:该试验例中,实施例1的清口止咳膜有效率为98%,无效率为2%;实施例2的清口止咳膜有效率为90%,无效率为10%;实施例3的有效率为92%,无效率为8%;对比例1的有效率为8%,无效率为92%;对比例2的有效率为70%,无效率为30%。(2)清新口气:志愿者自述清口作用显著,留香持久者占80%以上,对添加了功效成分的口膜片打分更高。(3)食用期间未发生毒副作用。
实验例2.
典型病例
病例1:王某,女,37岁。自述近几个月喉咙经常不适,嗓子干、痒、微痛;早上刷牙,恶心干呕。食用本发明实施例1的清口膜片1个疗程后,嗓子不适感消失,刷牙不再干呕;续服用1个疗程,各种不适症状消失;服用方式:一次3片,一日三次,7天为1疗程。
病例2:杨某,男,42岁,教师,咽部干、痒、微痛,言多时咳嗽,吞咽唾液时咽痛比进食时更为明显。食用本发明实施例4的清口膜片1个疗程,咽痛缓解;续服2个疗程后各种不适症状消失;服用方式:一次3片,一日三次,7天为1疗程。
病例3:薛某,男,52岁,自述慢性咽炎多年,每当换季或气候干燥时,嗓子干痒、咳嗽或吞咽时伴有轻微疼痛。食用本发明实施例5的粉剂1个疗程,咽痛缓解,咳嗽频率下降;续服2个疗程后各种不适症状消失;服用方式:取1g粉剂,加入200mL左右热水冲调后饮用,一日三次,7天为1疗程。
本发明的组合物经人体试服验证,具有清新口气、润喉止咳的功效,其对气候干燥、空气污染、上火咳嗽引起的咽喉不适效果显著,本品适宜人群广泛,无任何毒副作用。
显然,上述实施例仅仅是为清楚地说明所作的举例,而并非对实施方式的限定。对于所属领域的普通技术人员来说,在上述说明的基础上还可以做出其它不同形式的变化或变动。这里无需也无法对所有的实施方式予以穷举。而由此所引伸出的显而易见的变化或变动仍处于本发明创造的保护范围之中。
Claims (10)
1.一种具有清口止咳功效的组合物,其特征在于,以重量份计,其原料包括:石斛10-90份、甘草1-30份、白茅根5-60份、蒲公英根1-30份、余甘子2-70份、罗汉果5-25份和金银花3-20份。
2.根据权利要求1所述的组合物,其特征在于,以重量份计,其原料包括:石斛20-50份、甘草1-15份、白茅根5-40份、蒲公英根10-30份、余甘子10-50份、罗汉果5-20份和金银花3-10份。
3.一种权利要求1或2所述组合物的制备方法,其特征在于,该制备方法包括粉碎、水提、有机溶剂提取中的一种或多种。
4.根据权利要求3所述的准备方法,其特征在于,包括以下步骤:称取石斛、甘草、白茅根、蒲公英根、余甘子、罗汉果和金银花,加入10-15倍重量份的水,浸泡20-40min,煮沸20-40min,过滤;向滤渣中加入5-8倍重量份的水,煮沸40-50min,过滤;合并两次滤液并浓缩,将滤液离心、除渣、浓缩至原料药重量的1/2-3/2。
5.包括权利要求1或2所述的组合物的制剂,其特征在于,所述组合物加入常规辅料,按照常规工艺,制成临床上可接受的膜剂、胶囊剂、散剂、合剂、丸剂、颗粒剂、口服液、糖浆剂、膏剂、冲剂、饮料、饼干、糖果、糕点食品或方便食品。
6.根据权利要求1-2任一项所述的组合物在制备具有清口和止咳功效的药品、保健食品或普通食品中的应用。
7.一种具有清口止咳功效的口腔膜剂,其特征在于,包括权利要求1或2所述的组合物和药物学上可接受的辅料。
8.根据权利要求7所述的口腔膜剂,其特征在于,所述辅料包括增稠剂、缓释成膜材料、抑菌剂、保湿剂、乳化剂、食用色素或食用香精中的一种或多种。
9.一种根据权利要求7所述的口腔膜剂的制备方法,其特征在于,包括以下步骤:
1)将除矫味剂之外的辅料投入密封容器中,并加入投料1-4倍重量份的纯化水,在60-80℃的温度下真空搅拌2-4小时;
2)称取石斛、甘草、白茅根、蒲公英根、余甘子、罗汉果和金银花,加入10-15倍重量份的水,浸泡20-40min,煮沸20-40min,过滤;向滤渣中加入5-8倍重量份的水,煮沸40-50min,过滤;合并两次滤液并浓缩,将滤液离心、除渣、浓缩至原药材的1/2-3/2重量。
3)将步骤2)得到的浓缩液和矫味剂逐次加入步骤1)得到的溶液,在60-80℃的温度下真空搅拌4-6小时;
4)将步骤3)得到的溶液进行真空脱泡后静置8-18小时;
5)将步骤4)得到的溶液打入流延机的流延槽中,调整好流延槽厚度并设置流延干燥箱的温度为50-70℃,开启流延机传送装置进行流延制膜,即得清口止咳膜。
10.根据权利要求9所述的口腔膜剂的制备方法,其特征在于,步骤2)中得到的浓缩液和辅料的质量比为20-50:80-50。
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