CN108743809A - 一种清咽利喉组合物及其制备方法与应用 - Google Patents
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Abstract
本发明公开了一种清咽利喉组合物及其制备方法与应用,其由诃子、铁皮石斛、西洋参、余甘子、金银花、桔梗组成。本发明还提供了所述清咽利喉组合物的制备方法及其应用。本发明清咽利喉组合物具有显著的抗炎、止咳等生理活性和功能,能够有效清咽利喉,缓解咽喉不适症状,集食疗、预防、调理三重功效于一体,无毒副作用,可长期使用。
Description
技术领域
本发明涉及一种清咽利喉组合物,属于医药与保健食品领域。
技术背景
咽喉为人体重要的免疫器官,许多感染性疾病和免疫性疾病都与咽喉有密切关系。咽喉不适主要表现为咽部发痒、有异物感、声音沙哑、疼痛、失音、咳嗽、甚至肿胀等,这些症状又会因感冒、劳累、声带使用过度及上呼吸道感染而加重,严重者会影响到其工作效率及生活质量。据世界卫生组织调查统计,成年人“慢性咽炎”患病率已达到80%以上,尤其对于一些特殊行业的人群来说,咽部患病的比率逐年增长,主要原因可能是由于长期的工作压力、频繁的社交、应酬,饮食结构不合理,及吸烟与被动吸烟,环境污染等。目前咽部不适一般以药物治疗为主,但是药物治疗常常是以消除症状为主,并未从根本上治疗,且大部分药物都有一定的毒副作用,长期使用会对人体产生伤害,因此开发一种具有清咽利喉、生津止渴,集食疗、预防、调理三重功效于一体的产品具有重要意义。
发明内容:
本发明的目的在于克服现有技术的不足,提供一种清咽利喉组合物及其制备方法与应用。
本发明的目的之一是通过以下技术方案来实现的。
一种清咽利喉组合物,按重量计包含以下组分:诃子3-10份、铁皮石斛6-12份、西洋参3-6份、余甘子3-9份、金银花6-15份、桔梗3-10份。
优选地,所述清咽利喉组合物按重量计包含以下组分:诃子4-8份、铁皮石斛8-10份、西洋参4-5份、余甘子5-8份、金银花8-12份、桔梗5-8份。
本发明还提供了所述清咽利喉组合物的制备方法,其主要包括以下步骤:
(1)金桔混合提取物干膏粉的制备:
按配方比例称取金银花、桔梗,粉碎过筛,用50%-70%乙醇热回流提取,液料质量比为1:4-8,提取1-3次,每次提取1-3h,合并提取液、滤液过200目筛,于40-60℃减压浓缩干燥,粉碎过80目筛,制得金桔混合提取物干膏粉,其中多酚含量在5%以上,总皂苷含量在5%以上;
(2)铁皮石斛西洋参余甘子混合提取物干膏粉的制备:
按配方比例称取铁皮石斛、西洋参、余甘子,粉碎过筛,用水煎煮,液料质量比为1:6-12,提取1-3次,每次提取1-3h,合并提取液、滤液过200目筛,滤液减压浓缩干燥,粉碎过80目筛,得到铁皮石斛西洋参余甘子混合提取物干膏粉,其中总多糖含量在25%以上;
(3)诃子提取物干膏粉的制备:
按配方比例取诃子,粉碎过筛,40-60℃热水浸渍,料液质量比为1:18~25,提取液经200目筛网过滤,滤液减压浓缩干燥,粉碎过80目筛,得到诃子提取物干膏粉;
(4)组合物的制备:
将上述步骤1-3制得干膏粉,按等量递增方法混匀即得所述清咽利喉组合物。
本发明所述组合物可添加或不添加药品或食品上可接受的辅料,制成速溶粉、颗粒剂、片剂、胶囊、丸剂、溶液剂等口服制剂。
本发明所述清咽利喉组合物可应用于制备具有清咽利喉、生津止渴等功效的药品、保健食品、功能性普通食品、特殊医学配方食品、特殊膳食食品等方面。
本发明清咽利喉组合物配方简单、配伍合理、有很好的清咽利喉效果,且所用原材料均为保健品或药食同源原料,集食疗、预防、调理三重功效于一体,无毒副作用,可长期使用。(其中诃子、石斛、西洋参为国家卫计委(原卫生部)批准的保健食品(公告号:2002年第51号),余甘子、桔梗、金银花作为传统药食同源物质为国家卫计委(原卫生部)批准的药食同源物品(公告号:2002年第51号),铁皮石斛为国家卫计委(原卫生部)拟批准的即使食品又是药品的物品(公告号:2018年第278号))。
具体实施方式:
下面通过具体实施例对本发明作进一步说明,但不以任何方式对本发明加以限制,基于本发明教导所作的任何变化或替换,均属本发明保护范围。
实施例1
处方:诃子60g、铁皮石斛90g、西洋参45g、余甘子60g、金银花105g、桔梗65g。
制备方法:
(1)金桔混合提取物干膏粉的制备:
按配方比例称取金银花、桔梗,粉碎过筛,用70%乙醇热回流提取,液料质量比为1:4,提取3次,每次提取1h,合并提取液、滤液过200目筛,于60℃减压浓缩干燥,粉碎过80目筛,制得金桔混合提取物干膏粉;
(2)铁皮石斛西洋参余甘子混合提取物干膏粉的制备:
按配方比例称取铁皮石斛、西洋参、余甘子,粉碎过筛,用水煎煮,液料质量比为1:12,提取1次,提取时间3h滤液过200目筛,滤液减压浓缩干燥,粉碎过80目筛,得到铁皮石斛西洋参余甘子混合提取物干膏粉;
(3)诃子提取物干膏粉的制备:
按配方比例取诃子,粉碎过20目筛,50℃热水浸渍,料液质量比为1:18,提取液经200目筛网过滤,滤液减压浓缩干燥,粉碎过80目筛,得到诃子提取物干膏粉;
(4)组合物的制备:
将上述步骤1-3制得干膏粉,按等量递增方法混匀即得所述清咽利喉组合物。
所述组合物可按常规片剂工艺制成片剂。
实施例2
处方:诃子100g、铁皮石斛80g、西洋参30g、余甘子50g、金银花150g、桔梗30g。
制备方法:
(1)金桔混合提取物干膏粉的制备:
按配方比例称取金银花、桔梗,粉碎过筛,用70%乙醇热回流提取,液料质量比为1:8,提取1次,每次3h,合并提取液、滤液过200目筛,于60℃减压浓缩干燥,粉碎过80目筛,制得金桔混合提取物干膏粉;
(2)铁皮石斛西洋参余甘子混合提取物干膏粉的制备:
按配方比例称取铁皮石斛、西洋参、余甘子,粉碎过筛,用水煎煮,液料质量比为1:6,提取3次,每次提取2h,合并提取液、滤液过200目筛,滤液减压浓缩干燥,粉碎过80目筛,得到铁皮石斛西洋参余甘子混合提取物干膏粉;
(3)诃子提取物干膏粉的制备:
按配方比例取诃子,粉碎过20目筛,40℃热水浸渍,料液质量比为1:25,提取液经200目筛网过滤,滤液减压浓缩干燥,粉碎过80目筛,得到诃子提取物干膏粉;
(4)组合物的制备:
将上述步骤1-3制得干膏粉,按等量递增方法混匀即得所述清咽利喉组合物。
所述组合物可按常规胶囊剂制剂工艺制成胶囊。
实施例3
处方:诃子30g、铁皮石斛60g份、西洋参60g、余甘子90g、金银花60g、桔梗100g。
制备方法:
(1)金桔混合提取物干膏粉的制备:
按配方比例称取金银花、桔梗,粉碎过筛,用50%乙醇热回流提取,液料质量比为1:7,提取2次,每次提取1h,合并提取液、滤液过200目筛,于60℃减压浓缩干燥,粉碎过80目筛,制得金桔混合提取物干膏粉;
(2)铁皮石斛西洋参余甘子混合提取物干膏粉的制备:
按配方比例称取铁皮石斛、西洋参、余甘子,粉碎过筛,用水煎煮,液料质量比为1:10,提取3次,每次提取1.5h,合并提取液、滤液过200目筛,滤液减压浓缩干燥,粉碎过80目筛,得到铁皮石斛西洋参余甘子混合提取物干膏粉;
(3)诃子提取物干膏粉的制备:
按配方比例取诃子,粉碎过20目筛,50℃热水浸渍,料液质量比为1:18,提取液经200目筛网过滤,滤液减压浓缩干燥,粉碎过80目筛,得到诃子提取物干膏粉;
(4)组合物的制备:
将上述步骤1-3制得干膏粉,按等量递增方法混匀即得所述清咽利喉组合物。
所述组合物可按常规颗粒剂制剂工艺制成颗粒剂。
实施例4
处方:诃子80g、铁皮石斛100g、西洋参50g、余甘子80g、金银花120g、桔梗50g。
制备方法:
(1)金桔混合提取物干膏粉的制备:
按配方比例称取金银花、桔梗,粉碎过筛,用50%乙醇热回流提取,液料质量比为1:8,提取2次,每次提取2h,合并提取液、滤液过200目筛,于60℃减压浓缩干燥,粉碎过80目筛,制得金桔混合提取物干膏粉;
(2)铁皮石斛西洋参余甘子混合提取物干膏粉的制备:
按配方比例称取铁皮石斛、西洋参、余甘子,粉碎过筛,用水煎煮,液料质量比为1:8,提取2次,每次提取3h,合并提取液、滤液过200目筛,滤液减压浓缩干燥,粉碎过80目筛,得到铁皮石斛西洋参余甘子混合提取物干膏粉;
(3)诃子提取物干膏粉的制备:
按配方比例取诃子,粉碎过筛,50℃热水浸渍,料液质量比为1:20,提取液经200目筛网过滤,滤液减压浓缩干燥,粉碎过80目筛,得到诃子提取物干膏粉;
(4)组合物的制备:
将上述步骤1-3制得干膏粉,按等量递增方法混匀即得所述清咽利喉组合物。
所述组合物可按常规液体剂制剂工艺制成液体剂。
实施例5
处方:诃子40g、铁皮石斛120g、西洋参40g、余甘子30g、金银花80g、桔梗80g。
制备方法:
(1)金桔混合提取物干膏粉的制备:
按配方比例称取金银花、桔梗,粉碎过筛,用60%乙醇热回流提取,液料质量比为1:6,提取2次,每次提取3h,合并提取液、滤液过200目筛,于60℃减压浓缩干燥,粉碎过80目筛,制得金桔混合提取物干膏粉;
(2)铁皮石斛西洋参余甘子混合提取物干膏粉的制备:
按配方比例称取铁皮石斛、西洋参、余甘子,粉碎过筛,用水煎煮,液料质量比为1:10,提取3次,每次提取1h,合并提取液、滤液过200目筛,滤液减压浓缩干燥,粉碎过80目筛,得到铁皮石斛西洋参余甘子混合提取物干膏粉;
(3)诃子提取物干膏粉的制备
按配方比例取诃子,粉碎过筛,60℃热水浸渍,料液质量比为1:22,提取液经200目筛网过滤,滤液减压浓缩干燥,粉碎过80目筛,得到诃子提取物干膏粉;
(4)组合物的制备:
将上述步骤1-3制得干膏粉,按等量递增方法混匀即得所述清咽利喉组合物。
所述组合物可按常规制剂工艺制成丸剂。
为表明本发明之清咽利喉作用,下述通过动物试验加以证明。
实验例1大鼠足跖肿胀实验
1.试验材料
1.1样品:实施例3的清咽利喉颗粒冲剂,规格:4g/袋,室温保存。
1.2试验动物:清洁级(Ⅱ级)Wistar种雄性大白鼠40只,体重180~220g。由河北省实验动物中心提供(合格证号码为1006160,在自由摄食、饮水环境中适应3~4d后用于试验)
1.3剂量选择:人体每日推荐剂量为12g,即0.2g/kg BW(每人体重按60Kg计),以此5、15、30倍设低、中、高三个组,以此分别为1.0g,3.0g和6.0g/kg BW。另设蒸馏水为阴性对照组。
1.4仪器与试剂
仪器:游标卡尺(精密度0.02mm),微量注射器等。
致炎剂:角叉菜胶由河北省药品检验所中药室提供。
2.试验方法:大鼠足跖肿胀实验法(依据卫生部卫生监督司颁布的《保健食品功能学评价程序和检验方法》(2003年版)清咽功能检测方法)。
2.1按体重将大鼠随机分成4个组,即3个剂量组和一个阴性对照组,每组10只。用蒸馏水配至所需浓度,灌胃量为10ml/Kg体重,每日一次,连续30天,每10天称重一次,试验期间动物单笼喂养,自由饮食,实验结束当天给予受试物1小时后,于大鼠右后足跖皮下注射致炎剂1%角叉菜胶(0.1mL/只),然后分别在注射后1h、3h、6h,用游标卡尺测量大鼠的足跖厚度,以致炎剂注射前后大鼠的足跖厚度均值之差变化来表示炎症反应的程度。试验组与阴性对照组比较,任一时间点刺激前后足跖厚度的差值明显减少,差异有显著性,可判定实验结果阳性,即该受试样品具有减轻炎症肿胀的作用。
2.2试验数据用方差分析进行统计处理。但如试验数据方差不齐,则先将数据转换为对数,若转换后的数据方差齐,再进行方差分析;若经转换后数据方差仍不齐,则改用秩和检验统计分析。
3.试验结果
3.1样品对大鼠体重的影响
见表1,各剂量组大鼠在试验前、试验过程各阶段的体重及增重量与阴性对照组比较,差异均没有显著性意义(P>0.05),表明该样品对受试大鼠的体重增长没有不良影响作用。
表1实验前后大鼠体重变化
注:表中各组间比较差异均无显著性差异(P>0.05)
3.2样品对致炎剂注射前后大鼠足肿胀的影响
表2样品对致炎剂注射前后大鼠足肿胀的影响
由表2可见,在注射致炎剂后1h、3h和6h,样品各剂量组大鼠的足跖厚度差值则明显小于阴性对照组,除1h低剂量组外,与阴性对照组的差异均具有显著性(P<0.05),表明该样品能显著减小大鼠在注射致炎剂前后的足跖厚度差值,即具有减轻大鼠的足跖炎症肿胀的作用。
实验例2氨水引咳实验
1.试验材料
1.1样品与试剂
实施例3的清咽利喉颗粒冲剂,规格:4g/袋,室温保存,阳性炎见宁片(广州梧州制药股份有限公司,批号:140502),规格:0.25g/片)
1.2实验动物
KM小鼠80只,SPF级,♀♂各半,体重18~22g,购自昆明医科大学实验动物中心(生产许可证号:SCXK(昆)2016-0004)。
1.3剂量选择
人体每日推荐剂量为12g,即0.2g/kg BW(每人体重按60Kg计),以此5、15、30倍设低、中、高三个组,以此分别为1.0g,3.0g和6.0g/kg BW。另设蒸馏水为空白对照组,炎见宁片为阳性对照组(按0.29g/kg计算)。
2实验方法
随机取小鼠80只(♀♂兼有)进行预实验。分别将小鼠放入500ml烧杯中,用超声波雾化器通入13%浓氨水雾化气,5s后停止。取出小鼠,从通入浓氨水雾化气开始计时,3min内不发生咳嗽的小鼠(对氨水不敏感者)及咳嗽次数超过50次者(过于敏感)弃之不用。剩余小鼠随机取50只,休息3d后,将小鼠随机分成5组,每组10只,即3个剂量组、1个空白对照组和1个阳性对照组。灌胃给药,每天1次,连续给药7d。于末次给药30min后,同法再次进行氨水引咳实验,记录小鼠从通入氨气开始至3min内初次咳嗽的时间(即咳嗽潜伏期)及咳嗽次数。
3.实验结果
实验数据采用SPSS 22.0软件进行数据分析。计量资料以x±s表示,组间比较采用单因素方差分析,方差齐性行Dunnett-t检验,方差不齐性Dunnett-T3检验。P<0.05表示差异有统计学意义。实验分析结果见表3。
表3各组大鼠咳嗽潜伏期、咳嗽次数测定结果
注:与空白组比较,P*<0.05,P**<0.01
与空白对照组比较,各给药组小鼠的咳嗽潜伏期均有所延长、咳嗽次数均有所减少。其中,高剂量组小鼠的咳嗽潜伏期较模型组显著延长(P<0.05),阳性对照组、中剂量和高剂量组小鼠咳嗽次数较空白组均显著减少(P<0.01)。
Claims (5)
1.一种清咽利喉组合物,其特征在于,所述组合物按重量计包含以下组分:诃子3-10份、铁皮石斛6-12份、西洋参3-6份、余甘子3-9份、金银花6-15份、桔梗3-10份。
2.如权利要求1所述清咽利喉组合物,其特征在于,所述组合物按重量计包含以下组分:诃子4-8份、铁皮石斛8-10份、西洋参4-5份、余甘子5-8份、金银花8-12份、桔梗5-8份。
3.如权利要求1-2任一项所述清咽利喉组合物,其特征在于,其制备方法为:
(1)金桔混合提取物干膏粉的制备:
按配方比例称取金银花、桔梗,粉碎过筛,用50%-70%乙醇热回流提取,液料质量比为1:4-8,提取1-3次,每次提取1-3h,合并提取液、滤液过200目筛,滤液减压浓缩干燥,粉碎过80目筛,制得金桔混合提取物干膏粉;
(2)铁皮石斛西洋参余甘子混合提取物干膏粉的制备:
按配方比例称取铁皮石斛、西洋参、余甘子,粉碎过筛,用水煎煮,液料质量比为1:6-12,提取1-3次,每次提取1-3h,合并提取液、滤液过200目筛,滤液减压浓缩干燥,粉碎过80目筛,得到铁皮石斛西洋参余甘子混合提取物干膏粉;
(3)诃子提取物干膏粉的制备:
按配方比例取诃子,粉碎过筛,40-60℃热水浸渍,料液质量比为1:18~25,提取液经200目筛网过滤,滤液减压浓缩干燥,粉碎过80目筛,得到诃子提取物干膏粉;
(4)组合物的制备:
将上述步骤1-3制得干膏粉,按等量递增方法混匀即得所述清咽利喉组合物。
4.根据权利要求1-3任一项所述清咽利喉组合物,其特征在于,所述组合物可添加或不添加药品或食品上可接受的辅料,制成速溶粉、颗粒剂、片剂、胶囊、丸剂、溶液剂等口服制剂。
5.权利要求1-4所述清咽利喉组合物在制备具有清咽利喉、生津止渴等功效的药品、保健食品、功能性普通食品、特殊医学配方食品、特殊膳食食品等方面的应用。
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