CN111888452A - 一种杏茯甘草组合物及其制备方法和应用 - Google Patents
一种杏茯甘草组合物及其制备方法和应用 Download PDFInfo
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Abstract
本发明涉及一种杏茯甘草组合物及其制备方法和应用。该杏茯甘草组合物包括茯苓、杏仁、甘草、桔梗、干姜、大枣和栀子。本发明的组合物以药食同源的药材为原料,按中医理论、药性及用量,合理配比,谨守病机,辨证治疗,在大大减少药材数量的情况下,对气候多变或雾霾、抽烟、过度用嗓等引起的痰湿蕴肺证(咳嗽、痰黏色白或黄、咽痛、口干等症状)具有显著的疗效。另外,本发明的组方无毒副作用,安全可靠、服用便捷。
Description
技术领域
本发明属于医药技术领域,具体涉及一种杏茯甘草组合物及其制备方法和应用。
背景技术
肺,是人体重要的呼吸器官。通过肺的呼吸作用,不断吸进清气,排出浊气,吐故纳新,实现机体与外界环境间的气体交换,以维持人体的生命活动。而全身的血液都通过百脉流经于肺,经肺的呼吸,进行体内外清浊之气的交换,再通过肺的宣降作用,将富有清气的血液通过百脉输送至全身。此外,肺还参与调节全身的水液代谢,肺气的宣发肃降作用推动和调节全身水液的输布和排泄。由此可见,肺对于身体的正常运作起着非常大的作用,肺的健康关系全身。肺部不健康,则会影响身体其它部分的不健康。当今紧张的生活节奏下,重视肺的健康,显得尤为重要。
在气候多变季节,特别是秋燥时节,肺部容易受到侵袭,主要表现为痰湿蕴肺证:咳嗽、痰黏色白或黄、咽痛、口干等症状,目前西药虽然可以缓解症状,但是存在一定的副作用。
另外,随着特定气候条件与人类活动相互作用的结果,雾霾等灾害天气持续的时间和强度有愈发剧烈的趋势,雾霾天气易使原有呼吸系统疾病人群的病情急性发作或急性加重。此外,抽烟人群和老师等过度用嗓人群同样易遭受肺部或咽喉疾病困扰。
目前,已有众多研究关注于中药的清肺润肺效果,但其组方复杂,且疗效各异。例如专利CN108743893A(公开日20181106)公开了一种组方复杂的清肺汤方,其由十五种中药药材制成,主要用于治疗风热咳嗽;专利CN105535739A(公开日20160504)公开了一种中药制剂,其由二十七味中药药材制成,主要用于治疗痰热壅盛证型的慢性咳嗽。还未有针对气候多变、雾霾、抽烟等引起的肺部不适,组分简单且效果显著的中药组方。
因此,开发一种针对气候多变、雾霾、抽烟等引起的痰湿蕴肺证,组分简单,效果显著的新型中药组方具有重要的研究意义和推广价值。
发明内容
本发明的目的在于克服现有技术中清肺润肺组方针对性不强,组分复杂的缺陷或不足,提供一种杏茯甘草组合物。本发明提供的杏茯甘草组合物对气候多变、雾霾、抽烟等引起的痰湿蕴肺证(咳嗽、痰黏色白或黄、咽痛、口干等症状)具有明显效果,且组方简单,无毒副作用,安全可靠、服用便捷。
本发明的另一目的在于提供上述杏茯甘草组合物的制备方法。
本发明的另一目的在于提供上述杏茯甘草组合物在制备预防或治疗气候多变、抽烟或雾霾或过度用嗓引起的咽喉及肺部不适的药品或食品中的应用。
为实现上述发明目的,本发明采用如下技术方案:
一种杏茯甘草组合物,其特征在于,由如下质量份数的组分组成:
现代社会,随着经济的发展和人们生活水平的提高,人们的社会环境和饮食生活习惯也发生了改变,饮食结构不合理(喜食辛辣刺激、肥甘厚腻之品及嗜好烟酒等容易损伤脾胃,致脾胃运化失职,水湿内聚为痰)、起居失常(由于工作、娱乐及生活习惯等原因,许多现代人尤其是年轻人经常熬夜甚至通宵达旦,与古人早睡早起的生活方式相反,长期如此易导致机体阴阳失衡,内分泌紊乱)。缺乏运动(在经济飞速发展的今天,人们多选择交通工具出行,很少步行,更缺乏必要的体育锻炼,肥胖人群日渐增多)、压力过大(随着社会竞争越来越剧烈,人们在生活工作中的压力也越来越大,长期的压力容易导致情志失调),上述情况均会造成人体脏腑功能失调,气机紊乱,升降失常,若这些情况持续存在,则经络受损,脾虚运化失司,水谷精微不能濡养,滞留机体,化为湿痰。
人体易受外界侵袭(燥热之邪,或寒郁而化热,或情志过极,饥饱劳倦伤及脏腑功能失调),防御功能降低,稍不注意,或饮食起居不慎便可致抵抗力下降,又因素有痰湿积于体内,就会导致痰阻气道,肺气上逆而咳嗽,形成痰湿蕴肺的证候。
主要病因为:肺为娇脏,易受风寒暑湿热燥六淫之邪侵袭,由口鼻或皮毛而入,肺气受束,又因痰湿积于体内,湿聚为痰,湿痰上渍于肺,失其宣肃,影响气机的通畅而见咳喘,咯痰等症。病久不愈,肺气愈伤,正气不能御邪,则外邪又易复侵,以致迁延日久,缠绵难愈。
本发明提供的组方由茯苓、杏仁、甘草、桔梗、干姜、大枣和栀子组成。杏仁作用于上焦,逐胸中之水,降肺之逆气,又可开胸散结;桔梗消积聚、痰涎,主肺气气促、嗽逆,功善宣通肺气,升清祛浊,二药相伍,一升一降,升降调和,祛痰止咳平喘之效更佳,杏仁、桔梗共为君药;茯苓作用于中焦,可健脾化痰、逐中焦之水,平上冲之气,苦杏仁配茯苓可脾肺同治,肺气肃降,脾胃和畅,相辅相成,共奏开肺运脾,运中畅肺之功,甘草缓中健脾,使水饮去而肺气利,桔梗、甘草二药伍用,相得益彰,甘草泻火解毒,桔梗宣通肺气、祛痰排脓,配伍后宣通祛痰、解毒利咽、消肿排脓之功增强,茯苓、甘草共为臣药;干姜、大枣不仅可作药引之用,还可去痰下气,和荣卫,二药伍用,有养脾胃、和营卫之功,两者共为佐助药;栀子清热利湿,凉血解毒,消肿止痛,善清利三焦湿热,并且现代研究证实其具有很好的抗病毒、解热和抗炎等作用,并调和诸药药性。诸药合用,共奏健脾化痰,温润行气除湿,开提肺气,宣肺排脓,调和营卫,解毒消痈等功效。
本发明的组合物以药食同源的药材为原料,按中医理论、药性及用量,合理配比,谨守病机,辨证治疗,在大大减少药材数量的情况下,对气候多变及雾霾、抽烟、过度用嗓等原因引起的痰湿蕴肺证(咳嗽、痰黏色白或黄、咽痛、口干等症状)具有显著的疗效。另外,本发明的组方无毒副作用,安全可靠、服用便捷。
优选地,所述杏茯甘草组合物,由如下质量份数的组分组成:
更为优选地,所述杏茯甘草组合物,由如下质量份数的组分组成:
优选地,所述杏茯甘草组合物为煎剂、破壁粉体或破壁颗粒制剂或制剂。
更为优选地,所述杏茯甘草组合物为破壁粉体,所述破壁粉体的粒径≤75μm。
更为优选地,所述杏茯甘草组合物为破壁颗粒制剂,破壁颗粒的粒径为20-60目。
本发明在此也提供破壁颗粒制剂的制备方法,配方中各组分以全组分入药,具有更好的疗效。
上述杏茯甘草组合物的制备方法,包括如下步骤:
S1:将茯苓、杏仁、甘草、桔梗、干姜、栀子分别粗粉碎后混合或混合后粗粉碎,得混合细粉;所述混合细粉的粒径不小于70目;
S2:将大枣、杏仁和混合细粉混合,于不高于-10℃的温度下破壁粉碎至破壁粉体粒径不大于75μm;
S3:将S2所得的破壁粉体进行湿法制粒,即得所述杏茯甘草组合物。
杏仁中存在大量的油脂,研究发现,其单独进行破壁粉碎时,无论采用何种破壁粉碎方式均无法达到粒径D90≤75μm。
大枣易吸潮变软变粘,在常规条件下即使粉碎成60目粗粉亦不可得,进行破壁粉碎更加无法实现。
本发明经过研究发现,利用油脂含量低的混合细粉与杏仁混合,并调控混合细粉与杏仁的质量比大于2:1,在低温(不高于-10℃)进行振磨破壁粉碎可达到D90≤75μm。同时,意外发现,在低温下进行振磨破壁粉碎可成功实现大枣的破壁粉碎。
本发明提供的方法可成功制备得到破壁粉体,配方中各组分以全组分入药,具有更好的疗效。
同时,该方法可得破壁颗粒制剂。
更为优选地,S1中混合细粉的粒径为110~130目。
优选地,S2的破壁粉碎方法为振磨破壁粉碎。
优选地,S2中大枣、杏仁和混合细粉的质量比为1:0.7~1.1:2~4。
更为优选地,S2中大枣、杏仁和混合细粉的质量比为1:0.9:2.6。
优选地,S3中湿法制粒的过程为:将破壁粉体和润湿剂混合,加入摇摆颗粒机中进行制粒,干燥即得所述杏茯甘草组合物。
更为优选地,所述润湿剂为75%乙醇,破壁粉体和75%乙醇的质量比为1:0.47。
上述杏茯甘草组合物制备预防或治疗气候多变、抽烟、雾霾或过度用嗓引起的痰湿蕴肺证的药品或食品中的应用也在本发明的保护范围内。
与现有技术相比,本发明具有如下有益效果:
本发明提供的杏茯甘草组合物对气候多变、雾霾、抽烟及用嗓过度等引起的痰湿蕴肺证(咳嗽、痰黏色白或黄、咽痛、口干等症状)具有明显效果,且组方简单,无毒副作用,安全可靠、服用便捷。
具体实施方式
下面结合实施例进一步阐述本发明。这些实施例仅用于说明本发明而不用于限制本发明的范围。下例实施例中未注明具体条件的实验方法,通常按照本领域常规条件或按照制造厂商建议的条件;所使用的原料、试剂等,如无特殊说明,均为可从常规市场等商业途径得到的原料和试剂。本领域的技术人员在本发明的基础上所做的任何非实质性的变化及替换均属于本发明所要求保护的范围。
实施例1~7
本实施例提供一系列的杏茯甘草组合物,其组分及用量如下:
具体的,实施例1~7的配方及用量如表1。
表1实施例1~7的杏茯甘草组合物的配方(份/100g)
配方 | 茯苓 | 杏仁 | 甘草 | 桔梗 | 干姜 | 大枣 | 栀子 |
实施例1 | 10 | 9 | 4 | 9 | 2 | 10 | 1 |
实施例2 | 8 | 6.4 | 3 | 8 | 1.5 | 8 | 0.8 |
实施例3 | 12 | 12 | 5 | 10 | 2.5 | 12 | 1.2 |
实施例4 | 4.5 | 3.5 | 1 | 3 | 1 | 5 | 0.5 |
实施例5 | 20 | 16.5 | 20 | 15 | 3 | 15 | 2 |
实施例6 | 5 | 8 | 4 | 8 | 2 | 9 | 1 |
。
各实施例的杏茯甘草组合物通过如下方法制备成特定的破壁颗粒制剂:
(1)粗粉碎:按处方量称取茯苓、甘草、桔梗、干姜、栀子,混合均匀后经粗粉碎机组粉碎成120目混合细粉。
(2)破壁粉碎:取(1)中的混合细粉,加入大枣和杏仁,经振磨破壁粉碎系统,预先启动强制冷使振磨过程中制冷温度在﹣10℃以下,开启振磨粉碎机振磨粉碎30min后出料,得300目左右混合振磨粉,混合振磨粉的D90≤75μm。
(3)制粒:将(2)中混合振磨粉投入高效湿法混合机中,开启混合干混1~2分钟使各物料混合均匀。以75%乙醇作为润湿剂,加入量为混合振磨粉∶75%乙醇=1:0.47,用预装24目筛的摇摆颗粒机制粒,制得湿颗粒装入立式沸腾干燥床的料斗内,设定沸腾干燥进风温度75℃,出风温度52℃,开始时先只开启进风而不开启加热运行5分钟,以使大部分的乙醇逸散后开启加热装置,待出风温度超过52℃后,关闭加热装置,继续进风10分钟左右,得干颗粒。
(4)筛分:干颗粒经预装上层20目、下层60目筛的振荡筛分机筛分,得杏茯甘草组合物颗粒。各实施例的颗粒记为实施例1~6-破壁颗粒制剂。
另外,将实施例1的配方通过煎煮的方式制成煎煮剂(记为实施例1-煎煮剂),其煎煮过程如下:按照实施例1的处方依据临床中药煎煮方法,放入不锈钢锅内,摊平,加水约1000mL至没药物表面1~2cm,浸泡120min后,煎煮2次,每次沸腾后煎煮20min倒出药液,合并2次药液,减压浓缩为每毫升含原生药材3g的浸膏,4℃保存,备用。
同时,将实施例1的配方通过破壁粉碎的方式制成破壁粉制剂(记为实施例1-破壁粉制剂),其过程如下:
(1)按实施例1的处方量称取茯苓、甘草、桔梗、干姜、栀子,混合均匀后经粗粉碎机组粉碎成120目混合细粉。
(2)破壁粉碎:取(1)中的混合细粉,加入大枣和杏仁,经振磨破壁粉碎系统,预先启动强制冷使振磨过程中制冷温度在10℃以下,开启振磨粉碎机振磨粉碎30min后出料,得300目左右混合振磨粉,混合振磨粉的D90≤75μm,得破壁粉体制剂备用。
对比例1
本对比例提供一种杏茯甘草组合物,通过如下方法尝试将其制备成破壁粉体:按实施例1处方量称取茯苓、杏仁、甘草、桔梗、干姜、大枣和栀子,混合均匀后利用粗粉碎机组进行粉碎,发现其完全无法进行粗粉碎,粉碎开展不久即在粉碎腔内粘结卡死。
对比例2
本对比例提供一种杏茯甘草组合物,通过如下方法尝试将其制备成破壁粉体:
(1)粗粉碎:按实施例1处方量的53%称取茯苓、甘草、桔梗、干姜、栀子,混合均匀后经粗粉碎机组粉碎成120目混合细粉。
(2)取(1)中的混合细粉,加入大枣和杏仁(大枣、杏仁和混合细粉的比值为1:1.1:1.9),经振磨破壁粉碎系统,预先启动强制冷使振磨过程中制冷温度在﹣10℃以下,开启振磨粉碎机振磨粉碎30min,发现其破壁粉碎效果很差,所得粉体为油状粘稠的大颗粒。
对比例3
本对比例提供一种杏茯甘草组合物,通过如下方法尝试将其制备成破壁粉体:
(1)粗粉碎:按处方量称取茯苓、甘草、桔梗、干姜、栀子,混合均匀后经粗粉碎机组粉碎成120目混合细粉。
(2)破壁粉碎:取(1)中的混合细粉,加入大枣和杏仁,经振磨破壁粉碎系统,在室温(25℃)下开启振磨粉碎机振磨粉碎30min后,发现其完全无法进行破壁粉碎,所得粉体在破壁腔内与机器相互粘结卡死。
对比例4
本对比例提供一种杏茯甘草组合物,
通过如下方法尝试将其制备成破壁粉体:
(1)粗粉碎:按处方量称取茯苓、甘草、桔梗、干姜、栀子,混合均匀后经粗粉碎机组粉碎成120目混合细粉。
(2)破壁粉碎:取(1)中的混合细粉,加入大枣和杏仁,经气流破壁粉碎系统,预先启动强制冷使破壁过程中制冷温度在﹣10℃以下,粉碎30min后,发现其完全无法进行破壁粉碎,所得粉体在破壁腔内堆积成团。
由上述对比例可知,杏仁因其含有大量的挥发油,不利于破壁;直接破壁(对比例1)、破壁时与混合细粉的比例不合适(对比例2)、常温下破壁(对比例3)、破壁方式不合适(对比例4)均无法得到符合要求的破壁粉体。
性能测试
(1)对氨水引发咳嗽小鼠的影响
1、受试品
实施例1-6-破壁颗粒制剂、实施例1-煎煮剂、实施例1-破壁粉制剂。
2、实验动物
ICR小鼠,雌雄各半,体质量为(20±2)g。
3、实验方法
取ICR小鼠54只,随机分为9组,每组6只,随机取出6只为空包对照组,其余各组分为实施例1-6-破壁颗粒组、实施例1-煎煮剂组、实施例1-破壁粉制剂组,各组按计量灌胃给药0.2g(生药材)/l0g体重,空白对照组给予同等体积的生理盐水,每日1次,连续10d。末次给药前16h禁食不禁水,于末次给药30min后,将小鼠放入超声雾化器内,加入氨水(30wt%)雾化10s致咳,立即取出小鼠,观察小鼠咳嗽(小鼠腹肌收缩,同时张大嘴,有时可听见咳嗽声)潜伏期及其3min内咳嗽次数。
4、统计学处理
5、实验结果
表2为对氨水所致小鼠咳嗽的影响。
表2对氨水所致小鼠咳嗽的影响
组别 | 咳嗽次数(次/3min) | 潜伏时间(s) |
空白对照组 | 43.34±5.43 | 14.35±5.33 |
实施例1破壁颗粒组 | 22.95±4.45<sup>①</sup> | 46.69±4.57<sup>①</sup> |
实施例2破壁颗粒组 | 28.51±5.57<sup>①</sup> | 37.37±4.36<sup>①</sup> |
实施例3破壁颗粒组 | 27.46±5.31<sup>①</sup> | 39.42±4.21<sup>①</sup> |
实施例4破壁颗粒组 | 32.33±5.17<sup>①</sup> | 32.44±4.09<sup>①</sup> |
实施例5破壁颗粒组 | 34.42±5.65<sup>①</sup> | 30.43±4.23<sup>①</sup> |
实施例6破壁颗粒组 | 29.23±5.43<sup>①</sup> | 38.54±4.16<sup>①</sup> |
实施例1煎煮剂组 | 25.15±4.35<sup>①②</sup> | 41.17±4.55<sup>①②</sup> |
实施例1破壁粉制剂组 | 22.16±6.77<sup>①</sup> | 47.65±4.67<sup>①</sup> |
注:与空白对照组相比,①P<0.05;与实施例1破壁颗粒组相比,②P<0.05。
(2)对小鼠祛痰作用的影响
1、受试品
实施例1-6-破壁颗粒制剂、实施例1-煎煮剂、实施例1-破壁粉制剂。
2、实验动物
昆明种小鼠,雌雄各半,体质量为(20±2)g。
3、实验方法
3.1酚红标准曲线的制备
精密称取酚红50mg,置于500mL量瓶中,用5%碳酸氢钠溶解并定容至刻度,制成酚红储备液。取酚红储备液1000μL,750μL,500μL,250μL,100μL,50μL,25μL l分别置于10mL量瓶中,用5%碳酸氢钠溶液溶解至刻度。于分光光度计上,用0.5cm比色皿以试剂空白为参比在558nm处测量吸光度值。以浓度为横坐标,吸收度为纵坐标,绘制标准曲线,得到线性回归方程为A=0.71C+0.0086,r=0.9999。
取小鼠54只,随机分为9组,分组情况见下表,
给药各组按计量灌胃给药0.2mL/l09体重,随机取出6只为空白对照组,其余各组分为实施例1-6-破壁颗粒组、实施例1-煎煮剂组、实施例1-破壁粉制剂组,各组按计量灌胃给药0.2g(生药材)/l0g体重,空白对照组给予同等体积的生理盐水,每日1次,连续10d。末次给药前16h禁食不禁水,于末次给药30min后,腹腔注射酚红(5%)0.1mL/10g体重,30min后处死小鼠,剥离气管和周围组织,剪下自甲状软骨至气管分支处之间的一段气管,放入盛有2mL生理盐水的试管中,加1mol/ml的NaOH溶液0.1mL,摇匀。放置4h后,于分光光度计上,在558nm处测定吸收值,并从标准曲线上查出酚红浓度。
4、统计学处理
5、实验结果
表3为对呼吸道酚红分泌的影响。
表3对呼吸道酚红分泌的影响
组别 | 酚红含量(μg/ml) |
空白对照组 | 1.22±0.35 |
实施例1破壁颗粒组 | 1.92±0.47<sup>①</sup> |
实施例2破壁颗粒组 | 1.67±0.48<sup>①</sup> |
实施例3破壁颗粒组 | 1.72±0.58<sup>①</sup> |
实施例4破壁颗粒组 | 1.59±0.58<sup>①</sup> |
实施例5破壁颗粒组 | 1.58±0.62<sup>①</sup> |
实施例6破壁颗粒组 | 1.66±0.52<sup>①</sup> |
实施例1煎煮剂制剂组 | 1.70±0.55<sup>①②</sup> |
实施例1破壁粉组 | 1.93±0.42<sup>①</sup> |
注:与空白对照组相比,①P<0.05;与实施例1破壁颗粒组相比,②P<0.05
止咳实验常用的动物有小鼠,因为他们对于化学刺激敏感,可产生明显的咳嗽反应。引起小鼠咳嗽的方法常用的有:氨水引咳法、二氧化硫引咳法和辣椒素吸入引咳法,而氨水引咳法,较其他两种方法简便、经济。实验结果证明实施例1-6破壁颗粒制剂组、实施例1-煎煮剂组、实施例-破壁粉制剂组均较空白对照组的咳嗽次数减少,咳嗽潜伏期延长(P<0.05),说明实施例1-6破壁颗粒制剂组、实施例1-煎煮剂组、实施例-破壁粉制剂组均可改善由于氨水刺激引起的咳嗽。同时本发明发现实施例1-破壁颗粒组的抑制咳嗽和提高潜伏期方面显著好于实施例1-煎煮剂组(P<0.05),说明全成分给药的破壁制剂组效果更佳。实施例1-破壁颗粒组和实施例1-破壁粉体制剂组在抑制咳嗽次数和提高潜伏期方面比较差异无统计学意义(P>0.05),但是本发明发现实施例1-破壁粉体制剂组容易吸潮和结块。
本发明通过酚红实验对各组的祛痰结果进行研究,结果发现实施例1-6破壁颗粒制剂组、实施例1-煎煮剂组、实施例-破壁粉制剂组均较空白对照组的酚红含量高(P<0.05),说明实施例1-6破壁颗粒制剂组、实施例1-煎煮剂组、实施例-破壁粉制剂组均有祛痰的效果。同时本发明发现实施例1-破壁颗粒组的酚红含量显著高于实施例1-煎煮剂组(P<0.05),说明全成分给药的破壁制剂组效果更佳。实施例1-破壁颗粒组和实施例1-破壁粉体制剂组在酚红含量方面比较差异无统计学意义(P>0.05),但是本发明发现实施例1-破壁粉体制剂组容易吸潮和结块。
(3)对痰湿模型大鼠的影响
1、受试品
实施例1-6-破壁颗粒制剂、实施例1-煎煮剂、实施例1-破壁粉制剂。
2、实验动物
SD大鼠,雌雄各半,体质量为(220±10)g。
3、实验方法
取SD大鼠60只,随机取出6只为空白对照组,其余54只进行造模,具体造模方法为:分别于第1天用3.5%的水合氯醛进行腹腔注射麻醉,注射量为10ml/kg。注射完成约1-2min后,检查麻醉情况,如有麻醉效果不好的,稍加少量3.5%的水合氯醛从另一侧腹腔注射,直到完全麻醉再开始进行实验。将完成麻醉的实验大鼠仰卧位固定于固定板上,暴露声门,通过拔除针芯的16号静脉套管针将200μg(1μg/μl)脂多糖溶液快速注入气管,然后将大鼠固定板垂直旋转,使脂多糖能够均匀分布于两肺,最后拔出套管,在造模后6小时,大鼠自由饮水,但禁食饲料,以免进食饲料时,造模大鼠气道被饲料阻塞而引起窒息造模开始第2天至第30天,将大鼠置于烟熏箱内,每天给进行两次烟熏,上下午各一次,每次熏半小时,每次烟熏量为10支香烟,两次烟熏之间间隔4小时。30天后将54只大鼠随机分为9组,分别为模型组、实施例1-6-破壁颗粒组、实施例1-煎煮剂组、实施例1-破壁粉制剂组,各组按计量灌胃给药4g(生药材)/l0 g体重,空白对照组和模型组给予同等体积的生理盐水,每日1次,连续14d。观察大鼠造模后和给药后的3min内咳嗽次数;采集标本前停药,大鼠禁食不禁水12小时,称重后根据大鼠的体重用3.5%水合氧醛进行麻醉,然后用一次性真空采血管股动脉取血,然后采用酶联免疫吸附法测定白细胞介素IL-2和IL-4水平。
4、统计学处理
5、实验结果
表4对痰湿模型大鼠炎症因子的影响
组别 | IL-2(pg/ml) | IL-4(pg/ml) |
空白对照组 | 154.23±11.09<sup>①</sup> | 5.55±1.02<sup>①</sup> |
模型对照组 | 256.88±10.25 | 14.52±2.22 |
实施例1破壁颗粒组 | 156.52±12.36<sup>①</sup> | 5.65±1.08<sup>①</sup> |
实施例2破壁颗粒组 | 172.57±10.58<sup>①</sup> | 6.21±1.11<sup>①</sup> |
实施例3破壁颗粒组 | 173.48±11.22<sup>①</sup> | 6.23±1.07<sup>①</sup> |
实施例4破壁颗粒组 | 185.44±10.52<sup>①</sup> | 7.58±1.08<sup>①</sup> |
实施例5破壁颗粒组 | 188.67±12.35<sup>①</sup> | 7.88±1.19<sup>①</sup> |
实施例6破壁颗粒组 | 175.58±10.89<sup>①</sup> | 7.05±1.05<sup>①</sup> |
实施例1煎煮剂组 | 170.25±12.86<sup>①②</sup> | 6.89±1.06<sup>①②</sup> |
实施例1破壁粉组 | 158.52±10.56<sup>①</sup> | 5.85±1.00<sup>①</sup> |
注:与模型对照组相比,①P<0.05;与实施例1破壁颗粒组相比,②P<0.05
表5对痰湿模型大鼠咳嗽次数的影响
注:与模型对照组相比,①P<0.05;与实施例1破壁颗粒组相比,②P<0.05
造模后,各个大鼠均出现呼吸节律快慢不一,活动明显降低,出现咳嗽、喷嚏现象,可闻及痰鸣音,大部分大鼠的鼻部出现有少许白色或黄色黏性分泌物。造模后大鼠咳嗽次数明显增加,IL-2、IL-4水平明显增加,本发明结果发现给药后实施例1-6破壁颗粒制剂组、实施例1-煎煮剂组、实施例-破壁粉制剂组咳嗽次数均较模型对照组减少(P<0.05),说明实施例1-6破壁颗粒制剂组、实施例1-煎煮剂组、实施例-破壁粉制剂组均有抑制咳嗽的效果。同时本发明发现实施例1-破壁颗粒组咳嗽次数显著低于实施例1-煎煮剂组(P<0.05),说明全成分给药的破壁制剂组效果更佳。实施例1-破壁颗粒组和实施例1-破壁粉体制剂组在咳嗽次数方面比较差异无统计学意义(P>0.05),但是本发明发现实施例1-破壁粉体制剂组容易吸潮和结块。同时本发明研究结果显示,实施例1-6破壁颗粒制剂组、实施例1-煎煮剂组、实施例-破壁粉制剂组抑制咳嗽可能与降低血清炎症因子水平IL-2、IL-4水平有关。
(4)志愿者实验
1、实验方法
根据《中医病证诊断疗效标准》选取秋、冬季因气候变化引起的咳嗽且中医辨证分型为痰湿蕴肺证患者60例,纳入标准:①符合中医咳嗽痰湿蕴肺证候诊断标准;②符合西医急性支气管炎或慢性支气管炎急性发作诊断标准;③年龄在18~65周岁者;④初发病例及复发病例,咳嗽发作3天以内。排除标准:①经检查证实,由支气管肺炎、肺结核、肺癌、肺部真菌感染、矽肺、刺激性气体、过敏等因素引起的急性咳嗽喘息患者;②合并心、肺、血管、肝、肾、造血系统等严重原发性疾病及精神病患者;③并发严重心肺功能不全者;④妊娠期或哺乳期患者;⑤过敏体质或对本方中各种药物过敏者;⑥咳嗽其它证型者;⑦不能配合相关检查及评分者。将60例志愿者随机均分为试验组和对照组1和对照组2,每组20例,对照组1仅给予急支糖浆(30ml/次,3次/天),试验组给予实施例1破壁颗粒制剂(3g/次,3次/天)。对照组2给予实施例1的传统中药饮片(每日3次,每次3g,加水煎煮至200mL,趁热服用,由中智大药房统一煎药)。三组均服用2周。观察三组临床症状和体征的改善情况。
2、临床症状评分量表
按表6的临床症状评分量表对改善结果进行评估。
表6临床症状评分量表
3、实验结果
表7为实验结果。
表7实验结果
注:与对照组1相比,①P<0.05,与对照组2相比,②P<0.05。
由以上结果可知,试验组可以显著改善痰湿蕴肺证咳嗽志愿者的临床主要症状和体征,其效果优于传统中药饮片煎煮剂组,优于常用中药急支糖浆组,说明本发明的破壁颗粒制剂组合物用于痰湿蕴肺证咳嗽患者有良好的效果。
本发明提供的杏茯甘草组合物对气候多变、雾霾、抽烟及用嗓过度等引起的痰湿蕴肺证(咳嗽、痰黏色白或黄、咽痛、口干等症状)具有明显效果,且组方简单,无毒副作用,安全可靠、服用便捷。
上述实施例为本发明较佳的实施方式,但本发明的实施方式并不受上述实施例的限制,其他的任何未背离本发明的精神实质与原理下所作的改变、修饰、替代、组合、简化,均应为等效的置换方式,都包含在本发明的保护范围之内。
Claims (10)
1.一种杏茯甘草组合物,其特征在于,由如下质量份数的组分组成:
茯苓4.5~20份,
杏仁3.5~16.5份,
甘草1~20份,
桔梗3~15份,
干姜1~3份,
大枣5~15份,
栀子0.5~2份。
2.根据权利要求1所述杏茯甘草组合物,其特征在于,由如下质量份数的组分组成:
茯苓8~12份,
杏仁6.4~12份,
甘草3~5份,
桔梗8~10份,
干姜 1.5~2.5份,
大枣8~12份,
栀子 0.8~1.2份。
3.根据权利要求1所述杏茯甘草组合物,其特征在于,由如下质量份数的组分组成:
茯苓10份,
杏仁9份,
甘草4份,
桔梗9份,
干姜2份,
大枣10份,
栀子1份。
4.根据权利要求1所述杏茯甘草组合物,其特征在于,所述杏茯甘草组合物为煎剂、破壁粉体或破壁颗粒制剂。
5.根据权利要求4所述杏茯甘草组合物,其特征在于,所述杏茯甘草组合物为破壁颗粒制剂,颗粒粒径为20-60目。
6.权利要求1~5任一所述杏茯甘草组合物的制备方法,其特征在于,
S1:将茯苓、甘草、桔梗、干姜、栀子分别粗粉碎后混合或混合后粗粉碎,得混合细粉;所述混合细粉的粒径不小于70目;
S2:将大枣、杏仁和混合细粉混合,于不高于-10℃的温度下破壁粉碎至破壁粉体粒径不大于75μm;
S3:将S2所得的破壁粉体进行湿法制粒,即得破壁颗粒制剂状态的杏茯甘草组合物。
7.根据权利要求6所述制备方法,其特征在于,S2破壁粉碎方法为振磨粉碎,粉碎时间为20~40min,S2中大枣、杏仁和混合细粉的质量比为1:0.7~1.1:2~4。
8.根据权利要求7所述制备方法,其特征在于,S2中大枣、杏仁和混合细粉的质量比为1:0.9:2.6。
9.根据权利要求6所述制备方法,其特征在于,S3中湿法制粒的过程为:将破壁粉体和润湿剂混合,加入摇摆颗粒机中进行制粒,干燥即得所述杏茯甘草组合物。
10.权利要求1~5任一所述杏茯甘草组合物在制备预防或治疗气候多变、抽烟、雾霾或过度用嗓引起的痰湿蕴肺证的药品或食品中的应用。
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