CN110151851A - 一种以金银花甘草药对为基础的复合物及其应用 - Google Patents
一种以金银花甘草药对为基础的复合物及其应用 Download PDFInfo
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- CN110151851A CN110151851A CN201910518368.XA CN201910518368A CN110151851A CN 110151851 A CN110151851 A CN 110151851A CN 201910518368 A CN201910518368 A CN 201910518368A CN 110151851 A CN110151851 A CN 110151851A
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Abstract
本发明申请涉及一种以金银花甘草药对为基础的复合物,包括组分A:金银花、甘草的挥发油包合物,组分B:主要包括金银花、甘草以及选自桔梗、陈皮、青果、胖大海、罗汉果中一种或多种的水提取物。其中组分B的组方可根据咽炎诱因进行针对性选择,例如当设计组分B的组方:金银花、甘草、桔梗、青果、胖大海、罗汉果,则可适应针对肺部不适导致慢性咽炎的患者,起到清咽润肺的功效。本申请从抗菌消炎角度消除慢性咽炎的症状,以金银花‑甘草药对作为基础药味,再以剩余的金银花‑甘草配伍其他药味进行水提,充分利用金银花‑甘草药挥发油、水提物的抑菌消炎功效,通过配伍其他药味用于消除诱发慢性咽炎的诱因,起到标本兼治的效果。
Description
技术领域
本发明涉及一种以金银花-甘草药对为基础的复合物,尤其涉及一种服用更加安全、效果更加显著的复合物及其制剂和应用。
背景技术
当代社会科技发展迅速,环境却遭到了一定破坏。随着空气污染、公共场所吸烟或被动吸烟、以及自身的损坏,引发人们一系列呼吸道与肺部的疾病。常见症状有咽喉肿痛、瘙痒、吞咽发胀、有异物感和咳嗽等。临床报道在我国城镇居民的咽科疾病中,有10%~20%为慢性咽炎,占耳鼻喉科发生疾病的12%~14%。低于10岁儿童和超过74岁高龄的老人均可发生慢性咽炎。当咳嗽或者晨起恶心干呕等症状长期干扰患者时,患者的生活质量受到严重影响,甚至可导致患者的心理发生障碍,有焦虑或抑郁的症状表现。
诱导慢性咽炎发生的病因和影响因素很多,对应的治疗方式也会因为诱导原因而产生差异。
一、慢性咽炎的病因因素
1、鼻部及其咽喉部慢性炎症的影响
鼻部及其咽喉部的其他炎症疾病同样可导致咽部菌群微生态平衡失衡而引起慢性咽炎。扁桃体炎症、鼻窦炎等大部分的上呼吸道感染,如果治疗不彻底或者未及时得到治疗时,这些部位的炎症反应可在流涕、感冒等症状发生时通过腔隙反复刺激咽部,进而影响咽部微生物的正常健康生活环境,从而迅速发展为慢性炎症。Hatem Badran等人认为,腺样体肥大和扁桃体炎可逐渐破坏生物膜的平衡,同时炎症反应过程中产生的有机物质可作为后续邻近部位炎症反应的刺激物,从而引发慢性咽炎。
2、胃-食管反流(GERD,Gastroesophageal Reflux)
胃-食管反流(GERD),是一种由于食管的抗反流屏障、食管酸清除或者食管黏膜的防御功能等异常而引起的咽部疾病,患者长期发病可引起胃灼热、反酸,吞咽疼痛和困难,声嘶或异物感等症状。其中最为常见的是咽喉反流(LPR)。咽喉反流包括两种反映方式,即直接损害和反射,其中,直接损害表现为反流的胃酸可以直接通过食管到达咽部,引发咽部黏膜的直接损害,而反射表现为胃酸持续性刺激食管黏膜,迷走神经反射性地引起人体咳嗽、清嗓等行为,长时间作用可缓慢发展为慢性炎症。徐春来等人研究发现,所研究的20例咽喉反流的患者中,有14例咽部发生了炎症反应,并不同程度地出现了慢性咽炎的症状。
二、慢性咽炎的治疗方式
(1)个人饮食、生活习惯及个体因素的改善
饮食和生活习惯是其他治疗的基础,也是慢性咽炎患者康复的关键。通过改善患者饮食习惯,包括减少和(或)杜绝辛辣、油腻食物,戒烟限酒,减少熬夜,改正作息习惯,保证充足睡眠,加强体育锻炼,增强体质,控制体重,减少肥胖的发生。在工作环境中,可使用加湿器,对于需要长期用嗓的职业人群来说,使用正确的发声技巧,适当休息,通风通气,及时补充水分,以达到对咽部粘膜的保护。
(2)邻近器官鼻部及其咽喉部感染治疗
咽部附近器官感染,如鼻炎鼻窦炎、扁桃体炎,鼻息肉、鼻中隔偏曲、腺样体的肥大等均可刺激咽部粘膜,对于此类病因引起的慢性咽炎,去除原发性疾病是控制慢性咽炎的关键,主要手段是外科手术治疗。
(3)西医西药治疗
A.抗生素治疗抗生素可以用来治疗病原菌所致的粘膜炎症反应,但是,对于抗生素应用于慢性咽炎的治疗,大多学者持反对态度,主要是因为抗菌药物使用不合理会导致菌群失调的加重,从而更加刺激粘膜,使菌群的异常情况加重。而且,抗菌药物的使用使得耐药菌的出现,增加抗生素用药力度可增加感染几率,也进一步加重了菌群微生态失衡。
B.雾化吸入治疗气流将液体药物气体化,即成为气雾状,患者可经口吸入药物,使药物直接作用于呼吸道,从而进行治疗,有用药量少、局部药物浓度高等特点。如庆大霉素经雾化吸入后,可有效对抗金黄色葡萄球菌,阻止其生长和作用。地塞米松经雾化吸入后,可有效抑制咽部粘膜早期炎症反应,如充血、水肿和白细胞浸润等,使中性粒细胞增加,从而有效抑制慢性咽炎的发展。此外,对于病毒性慢性炎症,可增加抗病毒药品。近年来,中西医结合雾化治疗慢性咽炎得到了一定的效果,但是对人体也产生不同程度的副作用。
(4)中医中药治疗
陈利等人认为,慢性咽炎是由于脏腑虚损、咽喉失养、痰凝血瘀、结聚咽喉所致,属“慢喉痹”范畴,体质为虚弱质。常见的中药方有如肺肾阴虚证型喉痹,代表方有肺汤、增液汤等;痰瘀互结证型喉痹,代表方有贝母瓜蒌散、半夏厚朴汤之类,这些汤药需随证变而加减其他中药。在近几年来的专利申请当中,很多的发明公开文件使用中药进行组合配伍,经过或复杂或简单的工艺制成具有清咽效果的产品,产品类型包括糖果、中药片剂、颗粒剂、膏剂,含片等。
根据以上描述,我们发现现有的慢性咽炎治疗方法中,除了患者本身需要改善生活、饮食等习惯,其余的治疗方法主要还包括手术治疗、西医西药治疗、中医治疗法等。其中,手术治疗对早期慢性咽患者具有很好的疗效,但是治疗费用昂贵,难以为消费者接受。如今市面上有很多治疗慢性咽炎的药物,但是价格昂贵,治疗效果不佳,一旦用药量过大,不仅会导致患者具有耐药性,甚至还可能产生副作用和不良反应。中医辨证施治是现有发明专利报道较多的方法,但是使用的原料多为普通食品中无法使用的原料,组方服用安全性鲜见论述。除了以上技术难题,现在人们经常自购药材,经过煎煮、冲泡后服用,这种服用方式不仅缺乏对原料的质量控制,而且无法保证有效成分的充分溶出,起效慢,不同药材或饮片之间的比例无法精确控制,药效无法保证。
发明内容
本发明所要解决的技术问题是针对上述现有技术提供一种以金银花甘草药对为基础的复合物及其制剂,及其用于治疗或改善慢性咽炎的应用。以金银花-甘草基础药对作为抗菌消炎的基础,同时配以不同的金银花-甘草的提取成分并与不同药味进行组方配伍,用以治疗不同诱因导致的慢性咽炎,治疗针对性更强,效果更加显著。
药材全部取自药食同源的药材或饮片,提高服用安全性;合理配置各药材或饮片之间的比例,使药效提高;复合物可制成颗粒剂或片剂或粉剂,服用方便。和采用冲泡相同药剂的服用方式相比,见效更快。
本发明解决上述问题所采用的技术方案为:
一种以金银花甘草药对为基础的复合物,包括组分A:金银花、甘草的挥发油包合物,组分B:主要包括金银花、甘草以及选自桔梗、陈皮、青果、胖大海、罗汉果中一种或多种的水提取物。组分B的提取原料可以根据引起咽炎的不同病灶进行筛选,如下:
针对胃-食管反流(GERD)导致的慢性咽炎的患者,提供一种以金银花甘草药对为基础的复合物,包括组分A:金银花、甘草的挥发油包合物,组分B:主要包括金银花、甘草、桔梗、陈皮、青果的水提取物。对于胃-食管反流造成的咽部损伤,进而导致慢性咽炎的患者,可采用清咽+养胃的功效机制,来治疗慢性咽炎。以金银花-甘草药对为基础,配伍陈皮、桔梗和青果,既具有清咽效果,同时也具有理气健脾的功效。该复合物的组方及重量份数为:金银花1-10份、甘草1-10份、陈皮1-10份、桔梗1-8份、青果1-8份。
针对肺部不适导致慢性咽炎的患者,提供一种以金银花甘草药对为基础的复合物,包括组分A:金银花、甘草的挥发油包合物,组分B:主要包括金银花、甘草、桔梗、青果、胖大海、罗汉果的水提取物。该药味组合具有清热解毒、宣肺利咽的功效:金银花-甘草药对为基础,配伍胖大海、罗汉果、桔梗和青果,既具有清咽效果,同时也具有润肺的功效(清咽+润肺)。其中金银花-甘草药对清热解毒、抗菌消炎;青果归肺、胃经,具有清热解毒、利咽、生津的功效;青果、胖大海、罗汉果清热润肺,利咽开音。该组合物的组方及重量份数为:金银花1-10份、甘草1-10份、桔梗1-8份、青果1-8份、罗汉果1-6份、胖大海1-4份。
针对儿童咽喉不适的症状,提供一种适合少儿服用的具有清咽利嗓功效的以金银花甘草药对为基础的复合物,包括组分A:金银花、甘草的挥发油包合物,组分B:包括金银花、甘草、桔梗、青果的水提取物和蜂蜜,组分C:雪梨膏。该药味组合保证清咽利嗓效果的同时,加入蜂蜜、雪梨改善了口感,使之更适合少儿服用。该复合物的组方及重量份数为:金银花1-10份、甘草1-10份、桔梗1-8份、青果1-8份、雪梨1-6份、蜂蜜1-5份。本申请所述的以金银花甘草药对为基础的复合物主要制剂为颗粒剂、片剂、粉剂中任一剂型,其中颗粒剂和粉剂中的复合物含量不得少于95%,片剂中复合物的含量不得少于50%。
本申请另外提供以金银花甘草药对为基础的复合物的制备方法,包括如下步骤
(一)组分A的制备:
(1.1)炮制:甘草除去杂质,洗净,润透,切厚片,干燥;
(1.2)金银花-甘草挥发油包合物的制备:取金银花、甘草总配方量80%以上的金银花和甘草混合,投入提取罐缓慢通入蒸汽,收集经过初步油水分离的蒸馏液;冷却水进水温度≤35℃、冷却水出水温度≤60℃,挥发油提取温度90-100℃,分取挥发油;取β-环糊精置于胶体磨中,加入水,缓慢加入挥发油,挥发油与β-环糊精的比例为1:(6-16),充分研磨后,出料得挥发油β-环糊精包合液;对挥发油β-环糊精包合液进行喷干,适时收粉,过筛(例如过80目筛),得金银花-甘草挥发油包合物。
(二)组分B的制备:
(2.1)炮制:根据组分B实际药味组合的原料,原料的炮制参照:桔梗除去杂质,洗净,润透,切厚片,干燥;甘草除去杂质,洗净,润透,切厚片,干燥;陈皮除去杂质,喷淋水,润透,切丝,干燥;青果除去杂质,冼净,干燥,用时打碎;胖大海除去杂质,粗碎;
(2.2)提取:通过水煎煮法,将剩余的金银花、甘草,炮制的桔梗、陈皮和青果按配方量领取,投入提取罐,并加入组分A制备时剩余的药渣,加入10-12倍水共煎,第一次煎煮,煮沸后微沸1-2h;第二次煎煮,将一煎液抽出过筛网,在滤渣中加入配方量的胖大海(若有)、罗汉果(若有)和10-12倍水,煮沸后微沸0.5-1h,将二煎液抽出过筛,合并两次煎液,制得提取液;
(2.3)浓缩:对步骤2.2制得的提取液进行减压浓缩,浓缩至比重为1.0-1.1的浓缩液;
(2.4)干燥:将步骤2.3制得的浓缩液进行喷干,进风温度为185-195℃,出风温度为90-95℃,制得喷干粉;
(三)混合组分A和组分B,过筛(如80目筛)并进行灭菌处理,获得所述复合物的喷干粉。
对于上述适用于儿童服用的所述复合物的制备方法包括如下步骤
(一)组分A的制备:
(1.1)炮制:甘草除去杂质,洗净,润透,切厚片,干燥;
(1.2)金银花-甘草挥发油包合物的制备:取金银花、甘草总配方量80%以上的金银花和甘草混合,投入提取罐缓慢通入蒸汽,收集经过初步油水分离的蒸馏液;冷却水进水温度≤35℃、冷却水出水温度≤60℃,挥发油提取温度90-100℃,分取挥发油;取β-环糊精置于胶体磨中,加入水,缓慢加入挥发油,挥发油与β-环糊精的比例为1:(6-16),充分研磨后,出料得挥发油β-环糊精包合液;对挥发油β-环糊精包合液进行喷干,适时收粉,过筛,得金银花-甘草挥发油包合物。
(二)组分B的制备:
(2.1)炮制:桔梗除去杂质,洗净,润透,切厚片,干燥;甘草除去杂质,洗净,润透,切厚片,干燥;青果除去杂质,冼净,干燥,用时打碎;
(2.2)提取:通过水煎煮法,将剩余的金银花、甘草,炮制的桔梗、青果按配方量领取,投入提取罐,并加入组分A制备时剩余的药渣,加入10-12倍水共煎,第一次煎煮,煮沸后微沸1-2h;第二次煎煮,将一煎液抽出过筛网,在滤渣中加入10-12倍水,煮沸后微沸0.5-1h,将二煎液抽出过筛,合并两次煎液,制得提取液;
(2.3)浓缩:对步骤2.2制得的提取液进行减压浓缩,浓缩至比重为1.0-1.1的浓缩液;
(2.4)干燥:将步骤2.3制得的浓缩液中趁热加入蜂蜜溶解后进行喷干,进风温度为185-195℃,出风温度为90-95℃,制得喷干粉;
(三)组分C的制备:
雪梨的提取:将配方量切片的雪梨加水煎煮多次,每次1.5小时,滤过,压榨残渣,压榨液与煎液合并,静置4-8小时,取上清液,滤过,滤液浓缩至比重1.0-1.1的雪梨清膏;
(四)制粒:
以雪梨清膏作为粘合剂,将组分A、组分B混匀制成软材,制粒,微波干燥,过筛得整粒的复合物。
与现有技术相比,本发明一方面以金银花-甘草药对为基础进行挥发油的提取,一方面再配伍其他药食同源的药材或饮片共同进行水提取得到喷干粉或干膏粉,最后混合制成复合物,用以治疗不同诱因导致的慢性咽炎。其中,挥发油的提取是通过下列方法制得:将金银花:甘草按照1:1进行混合投料,通入蒸汽后收集挥发油进行包合,制得金银花-甘草挥发油包合物。
本发明所使用的原料及辅料,各项指标均符合2015年版《中华人民共和国药典》记载,上述原料在缓解咽部不适中主要的有效成分和药理活性如下。
1.金银花
金银花又名忍冬花,在陶弘景的《名医别录》中有记载。其化学性成分有:(1)挥发油。挥发油是金银花有效功用成分之一,是香精和香料的重要来源之一,可通过二氧化碳萃取法、水蒸气蒸馏法提取。金银花挥发油不仅具有抗菌、解热、止咳平喘的作用,而且具有降血压、延缓衰老等作用,还具有浓烈宜人的芳香气味。金银花挥发油主要含有芳樟醇、环氧芳樟醇等,并由醇、醛、酯、酮、烷、烯等多种化学成分组成。目前为止,有70多种挥发油被提取出来,其中约有59.76%为酸类化合物。如果挥发油的种类不同,其所发挥的药理学作用也是有所差异的。(2)黄酮类、黄酮醇类。金银花中存在的黄酮类化合物主要有黄酮和双黄酮两种形式,目前被分离出有20余个。(3)有机酸。忍冬花中含有绿原酸等大量的有机酸类物质。2008年,金银花中具有抗病毒作用的双抗素也被李弟灶等学者发现,其他的成分还有三萜皂苷和忍冬皂苷等。
Xu等人发现,金银花水提取物可下调编码COX-2的mRNA的水平,从而降低炎性反应。金银花的光谱抑菌作用也很明显。张甜甜等人运用微量量热法进行了金银花中的不同化合物对大肠杆菌的作用效果的测定,发现金银花中的异绿原酸、黄酮类化合物和环烯醚萜对大肠杆菌有很好的杀伤作用。可能与金银花提取物可抑制炎性因子自由基和组胺等的释放等有关。通过抗炎抗菌活性,金银花水提取物可对咳嗽、咳痰等慢性咽炎症状有所缓解。
所以,金银花的挥发油更具有抗菌消炎作用,其水提取成分:黄酮类、黄酮醇类、有机酸等也具有可期望的抗菌抗炎功效。本申请的目的是要充分释放金银花的抗菌抗炎作用,对其挥发油和水提取成分充分提取。
2.甘草
甘草味甘,性平。归心、肺、脾、胃经。具有补脾益气,祛痰止咳,缓急止痛,清热解毒之功效。常用于心气不足,脉结心悸,脾气虚证,咳喘,院腹、四肢挛急疼痛,热毒疮疡、咽喉肿痛及药物、食物中毒等。甘草含三萜类(三萜皂苷甘草酸的钾、钙盐为甘草甜素,是甘草的甜味成分)、黄酮类、生物碱、多糖等成分。甘草具有抗心率失常、抗溃疡、抑制胃酸分泌、缓解胃肠平滑肌痉挛及镇痛作用。张明发等研究发现甘草黄酮类化合物(异甘草素、异甘草苷、甘草素等)、甘草多糖和甘草酸是其抗炎、抗变应性炎症的活性成分,可提高吞噬细胞的吞噬功能、调节淋巴细胞数量与功能、抑制IgE抗体形成、抗炎症介质及前炎性细胞因子,具有抗炎、抗变态反应的药理活性。杨晓露等研究发现甘草黄酮类成分异甘草素可呈剂量依赖性抑制细胞上清液中亚硝酸盐含量,部分通过丝裂原活化蛋白激酶(MAPKs)中细胞外信号调节激酶(ERK)信号通路抑制iNOS、COX-2基因、蛋白的表达,从而达到抗炎效果。
3.金银花-甘草药对
金银花、甘草配伍,名曰银花甘草汤,出自《疡医大全》;又曰忍冬汤、银花甘草汤,出自《医学心语》;又曰金银花散,出自《外科精义》和《卫生宝鉴》;又曰金银花酒,出自《外科理例》卷一。金银花-甘草药对清热解毒,托里止痛,排脓,主治各种热毒疮疡、血热血证,泻痢便血、斑疹等以及风热火盛之咽喉乳蛾肿痛。金银花性味甘寒,气味芳香,功能清热解毒,为热毒疮疡之要药,性平稳而功效显著。甘草生用,甘而微凉,既能泻火解毒,又能补虚护胃。两药配伍,甘草助金银花增强清热解毒之力,同时甘缓护胃。两药相须之中又兼调和之义。
刘少印利用GC-MS联用技术对金银花甘草配伍后的挥发油成分进行检测,结果显示,通过该药对与单味药的化学组成分析,从化学成分数量及含量来看,该药对为两单味药综合作用的结果,并没有哪味药起主导作用;金银花-甘草药对与单味药金银花共有的挥发油组分为53个,与单味药甘草共有的挥发油组分为39个,金银花-甘草药对、金银花、甘草三者共有的挥发油组分为27个;即金银花-甘草药对配伍后,产生了新的成分,同时单味药中的某些成分消失了。
金银花-甘草药对表现出一定的抗菌性。王宏军采用微管-平板法测定金银花与甘草配伍对猪链球菌Ⅱ型的作用,结果显示,金银花对大肠埃希菌的MIC为500μg/mL,甘草对大肠埃希菌的MIC为1000μg/mL,金银花与甘草联用对大肠埃希菌的MIC为125μg/mL,SI为0.5。根据判定标准(SI≤0.75呈现协同作用,SI=1~2呈现无关作用;SI>2呈现拮抗作用),故金银花与甘草配伍时呈协同作用。王春华等也对金银花与甘草配伍的抗菌作用进行了研究,结果显示,金银花甘草(15:1)水提物的MIC为15.63μg/mL,也表现为协同作用。
由于金银花、甘草无论是其挥发油组分还是其水提取成分均表现出抗菌消炎的作用,同时基于学者研究表明金银花-甘草药对的挥发油和水提物均表现出协同作用,且该协同作用在抗菌效果方面表现显著。本申请从抗菌消炎角度消除慢性咽炎的症状,以金银花-甘草药对作为基础药味,发挥金银花-甘草药对挥发油的抗菌消炎作用。再以剩余的金银花-甘草配伍其他药味进行水提,一方面进一步释放金银花-甘草药对水提物的抑菌消炎功效,另一方面,配伍其他药味用于消除诱发慢性咽炎的诱因,起到标本兼治的效果,提高慢性咽炎患者的治愈率。
具体实施方式
以下结合实施例对本发明作进一步详细描述。实施例不构成本发明的任何限制,本领域的技术人员在本发明的基础上做出任何非实质性的修改,都应属于本发明的保护范围。
实施例1:金银花-甘草药对挥发油包合物制备方法
处方:金银花10kg,甘草10kg
本实施例的清咽组合物的制备方法,包括以下各步骤:
1)炮制:甘草除去杂质,洗净,润透,切厚片,干燥。
2)金银花-甘草挥发油包合物的制备:取配方量的金银花和甘草按照1:1比例混合,投入提取罐缓慢通入蒸汽,收集经过初步油水分离的蒸馏液1小时;冷却水进水温度≤35℃、冷却水出水温度≤60℃,挥发油提取温度90-100℃。分取挥发油。按挥发油与β-环糊精比例为1:10,取β-环糊精置于胶体磨中,加入适量的水,缓慢加入挥发油,充分研磨后,放料得挥发油β-环糊精包合液。对挥发油β-环糊精包合液进行喷干,进风温度为165-195℃,出风温度为80-105℃。适时收粉,过80目筛,得金银花-甘草挥发油包合物。
实施例2:一种清咽养胃的复合物及其制剂
处方:金银花5kg,甘草5kg、陈皮5kg、桔梗4kg、青果4kg。
本实施例的清咽组合物的制备方法,包括以下各步骤:
1)炮制:桔梗除去杂质,洗净,润透,切厚片,干燥;甘草除去杂质,洗净,润透,切厚片,干燥;陈皮除去杂质,喷淋水,润透,切丝,干燥;青果除去杂质,冼净,干燥,用时打碎。
2)金银花-甘草挥发油包合物的制备:将配方量20%的金银花和甘草,按实施例1的制备方法得到组分A。
3)提取:通过水煎煮法,将剩余的金银花、甘草,炮制的桔梗,陈皮和青果按配方量领取,投入提取罐,并加入步骤2中剩余的药渣,加入12倍水共煎。第一次煎煮,煮沸后微沸1.5h;第二次煎煮,将一煎液抽出过200目筛网,在滤渣中加入10倍水,煮沸后微沸0.5h,将二煎液抽出过200目筛。合并两次煎液,制得提取液。
4)浓缩:通过减压浓缩法,对步骤3中制得的提取液进行减压浓缩,加热温度为75℃,浓缩至比重为1.08的浓缩液。
5)干燥:采用喷雾干燥法,对步骤4中制得的浓缩液进行喷干,进风温度为185-195℃范围间,出风温度为90-95℃,制得喷干粉。
6)混合:将步骤2中制得的金银花-甘草挥发油包合物(组分A)与步骤5中的喷干粉(组分B)混合均匀。
7)过筛和灭菌:过80目筛,并进行灭菌处理。
8)最终获得的喷干粉可以用于制作各种剂型的产品,如颗粒剂、片剂、粉剂中任一剂型,其中颗粒剂和粉剂中的复合物含量不得少于95%,片剂中复合物的含量不得少于50%。
对于胃-食管反流造成的咽部损伤,进而导致慢性咽炎的患者,可采用清咽+养胃的功效机制,来治疗慢性咽炎。本实施例中以金银花-甘草药对为基础,配伍陈皮、桔梗和青果,既具有清咽效果,同时也具有理气健脾的功效。以下对陈皮、青果和桔梗的药理作用进行论述。
陈皮
本品为芸香科植物橘Citrusreticulata Blanco及其栽培变种的干燥成熟果皮。药材分为“陈皮”和“广陈皮”。采摘成熟果实,剥取果皮,晒干或低温干燥。
陈皮又名橘皮,橘皮在《金匮要略》中共出现有三处,分别是《胸痹心痛短气病脉证治第九》:“胸痹,胸中气塞,短气,茯苓杏仁甘草汤主之;橘枳姜汤亦主之”。《呕吐哕下利病脉证治第十七》:“干呕,哕,若手足厥者,橘皮汤主之。哕逆者,橘皮竹茹汤主之”。上述三方用药精简,临床应用效果显著,橘皮在三方中作为主药,其药食两用,效果显著,价格便宜,且药材来源方便。
现代临床报道方面多见于橘皮汤和橘皮竹茹汤,主要用于治疗呕吐、反流性食管炎、胆汁反流性胃炎、呃逆等胃部疾病和心律失常等心脏疾病。金英应用加味橘皮竹茹汤治疗妊娠剧吐38例,与西药(维生素等)治疗38例对照,疗程1周,以呕吐症状缓解为疗效标准,结果中药组治愈27例,好转8例,无效3例,总有效率92.1%,平均疗程(6.71±1.06)d,与西药组比较疗效差异有统计学意义(P<0.05)。李少华等应用橘皮竹茹汤原方治疗反流性食管炎34例,与西药(甲氧氯普安、甲氰咪胍)治疗35例对照,以症状消失,胃镜下无胆汁反流为痊愈。结果:1周后,治疗组约50%症状消失,西药组仅8.6%;2周后复查胃镜,中药组稍好于西药组,差别无统计学意义(P>0.05)。姚春等以加味橘皮竹茹汤治疗胆汁反流性胃炎35例,与口服铝碳酸镁片治疗35例对照,疗程4周,以症状和胃镜积分为疗效标准,结果:在临床症状改善方面,中药组优于西药组,且有统计学意义(P<0.05);在胃镜积分方面,两组差异无统计学意义(P>0.05)。
在本实施例中,陈皮可以温和刺激胃肠道,促进消化液分泌和排除肠内积气,且陈皮水煎剂可以促进胃排空。
青果
青果是橄榄(Canarium album Raeusch)的成熟果实干燥后所得,存在于中国福建一带。性平,味甘、涩、酸,含有脂肪、胡萝卜素、维生素B1、B2、B3和维生素C等,更含有丰富的矿物质元素,包含天冬氨酸等18种氨基酸,具有清热、利咽、解毒等功效。青果具有抑菌作用,也有着利咽止咳的功效,其主要作用的化学物质为没食子酸。何颖在二甲苯所造成的小鼠耳肿胀试验,以及醋酸所诱导的小鼠腹腔毛细血管通透性改变的试验中发现,青果中总黄酮对小鼠耳肿胀程度和毛细血管通透性的增加均具有抑制作用,在剂量上表现有依赖性,可能的药理学机制是青果可有效控制TNF-α和IL-1β的mRNA的表达,减少炎症反应蛋白的形成,从而达到抗炎镇痛和利咽止咳的效果。此外,研究发现,青果具有抗氧化作用、改善糖脂代谢作用、解酒护肝作用和抗人类免疫缺陷病毒(HIV)和抗肿瘤作用。
桔梗
桔梗属桔梗科,其药用价值的描写最早出自于《神农本草经》,是一种常见的药食同源类物质。桔梗中含有大量的生物活性成分,如皂苷A、C、D等16种单体,其中含有的皂苷D最多,此外,黄酮类物质、多糖、维生素、脂肪酸等也是桔梗的重要组成成分,所含有的维生素种类有胡萝卜素、VB及VC等。桔梗具有抗炎抑菌作用。Park S J等人发现,桔梗对特异性皮炎小鼠皮肤样损害的治疗效果显著。桔梗水提取物下调IL-8的水平,抑制NOS与COX-2的表达,阻断前列腺素E(PGE2)的生成,从而抑制炎症反应。Chung等人研究桔梗皂苷D的作用时发现,桔梗皂苷D可产生C28甲酯类衍生物,抑制NF-κB通道,从而发挥抗炎作用。此外,杨晓杰等人研究得出,桔梗多糖可有效抑制对真菌的生长繁殖,但是对细菌却无抑制表现。其他的药理学作用包括保护肝脏、抗肿瘤和调节免疫能力,此外,桔梗减缓疲劳感、降低血糖、减少肥胖等方面均有作用。
实施例3:一种清热解毒、宣肺利咽的复合物及其制剂
处方:金银花5kg,甘草5kg、桔梗4kg、青果4kg、罗汉果3kg、胖大海2kg。
本实施例的清咽组合物的制备方法,包括以下各步骤:
1)炮制:桔梗除去杂质,洗净,润透,切厚片,干燥;甘草除去杂质,洗净,润透,切厚片,干燥;胖大海除去杂质,粗碎;青果除去杂质,冼净,干燥,用时打碎。
2)金银花-甘草挥发油包合物的制备:将配方量20%的金银花和甘草,按实施例1制备得到。
3)提取:通过水煎煮法,将剩余的金银花、甘草,炮制的桔梗和青果按配方量领取,投入提取罐,并加入步骤2中剩余的药渣,加入12倍水共煎。第一次煎煮,煮沸后微沸1.5h;第二次煎煮,将一煎液抽出过200目筛网,在滤渣中加入配方量的胖大海、罗汉果以及12倍水,煮沸后微沸0.5h,将二煎液抽出过200目筛。合并两次煎液,制得提取液。
4)浓缩:通过减压浓缩法,对步骤3中制得的提取液进行减压浓缩,加热温度为75℃,浓缩至比重为1.06的浓缩液。
5)干燥:将步骤4中制得的浓缩液进行喷干,进风温度为185-195℃范围间,出风温度为90-95℃,制得喷干粉。
6)混合:将步骤2中制得的金银花-甘草挥发油包合物与步骤5中的喷干粉混合均匀。
7)过筛和灭菌:过80目筛,并进行灭菌处理。
8)最终获得的喷干粉可以用于制作各种剂型的产品,如颗粒剂、片剂、粉剂中任一剂型,其中颗粒剂和粉剂中的复合物含量不得少于95%,片剂中复合物的含量不得少于50%。
本实施例既具有清咽效果,同时也具有润肺的功效。以金银花-甘草药对为基础,清热解毒、抗菌消炎;青果归肺、胃经,具有清热解毒、利咽、生津的功效;青果、胖大海、罗汉果清热润肺,利咽开音。
桔梗、青果药理作用参见实施例2,胖大海及罗汉果药理作用如下。
胖大海:
本品为梧桐科植物胖大海Sterculia lychnophora Hance的干燥成熟种子,是传统的清咽利喉的药食两用药材。胖大海入药史载于《本草拾遗》,称“安南子”。中医学认为,胖大海味甘,性凉,入肺、大肠经,具清热、润肺、利咽、解毒的功能,主治干咳无痰、喉痛、音哑、目赤、牙痛、痔疮瘘管等。据报道,胖大海有抗病毒、镇痛、抑菌、抗炎作用,这些药理作用为其治疗咽喉疾病的药理学基础。胖大海含丰富的水溶性多糖;其种皮含有半乳糖、戊糖,还有活性成分胖大海素及钙、镁等微量元素;胚乳含西黄蓍胶黏素;种仁含脂肪类物质。现代研究表明,胖大海中的多糖类为其功能性成分,具有抗炎、治疗细菌性痢疾和抑制草酸钙结晶形成的功能。由胖大海、卤地菊与甘草组成的复方对呼吸道常见菌(如金黄色葡萄球菌)的抑制作用较强,对痢疾杆菌引起的结肠粘膜充血、水肿等急性弥漫性纤维蛋白渗出性炎症有缓解作用。
罗汉果:
本品为葫芦科植物罗汉果Siraitia grosvenorii(Swingle)C.Jeffrey exA.M.Lu et Z.Y.Zhang的干燥果实。具有清热润肺、利咽开音、润肠通便功效。现代研究表明,罗汉果具有多种与咽喉疾病相关的药理作用。罗汉果的果实和叶中均含有罗汉果三萜皂苷,还有大量的果糖、十多种人体必需氨基酸、脂肪酸、黄酮类化合物、微量元素等。罗汉果皂苷作为罗汉果甜味剂的主要成分,是一种具有甜味的三萜烯葡糖苷,其配糖苷元是三萜烯醇,具有祛痰、镇咳等药理作用。许多学者对罗汉果的化学成分进行了研究,从中分离得到甾体、黄酮、罗汉果甜苷和四环三萜酸等化合物。廖日权等对罗汉果的化学成分进行了研究,共分离得到8个化合物,分别为罗汉果醇苯甲酸酯、厚朴酚、双(5-甲酰基糠基)醚、5-羟甲基糠酸、山柰酚-7-O-A-L-鼠李糖苷、山柰酚-3,7-O-A-L-二鼠李糖苷、山柰酚、琥珀酸。赵二芳等研究和总结了罗汉果的保健功能为止咳祛痰、泻下和保肝、调节消化道运动、增强免疫等。李坚等研究了罗汉果水提取物的止咳作用,发现其水提取物能明显减少枸橼酸或辣椒素引起的豚鼠咳嗽次数和延长咳嗽潜伏期,抑制机械刺激所致豚鼠咳嗽次数。唐慧勤等考察了不同因素对罗汉果止咳作用的影响,结果均有止咳作用,果实生长期和商品规格对罗汉果的止咳作用有影响。林吴研究了不同采收期、不同品种、不同规格、不同商品学等级和不同产地的罗汉果提取物祛痰实验,均具有祛痰作用。
实施例4:一种适宜少儿服用的具有清咽利嗓功效的复合物及其制剂
处方:金银花5kg,甘草5kg、桔梗4kg、青果4kg、雪梨3kg、蜂蜜1kg。
本实施例的清咽组合物的制备方法,包括以下各步骤:
1)炮制:桔梗除去杂质,洗净,润透,切厚片,干燥;甘草除去杂质,洗净,润透,切厚片,干燥;青果除去杂质,冼净,干燥,用时打碎;新鲜雪梨,挑除其中发生腐烂并产生变质的次品后,洗干净,切片。
2)金银花-甘草挥发油包合物的制备:将配方量20%的金银花和甘草,参照实施例1的制备方法得到组分A。
3)提取:通过水煎煮法,将剩余的金银花、甘草,炮制的桔梗、和青果按配方量领取,投入提取罐,并加入步骤2中剩余的药渣,加入12倍水共煎。第一次煎煮,煮沸后微沸1.5h;第二次煎煮,将一煎液抽出过200目筛网,在滤渣中加入10倍水,煮沸后微沸0.5h,将二煎液抽出过200目筛。合并两次煎液,制得提取液。
4)浓缩:通过减压浓缩法,对步骤3中制得的提取液进行减压浓缩,加热温度为75℃,浓缩至比重为1.08的浓缩液。
5)干燥:采用喷雾干燥法,在步骤4中制得的浓缩液中趁热加入蜂蜜溶解后进行喷干,进风温度为185-195℃范围间,出风温度为90-95℃,制得喷干粉,得到组分B。
6)雪梨的提取:将配方量已经切片的雪梨加水煎煮2次,每次1.5小时,滤过,压榨残渣,压榨液与煎液合并,静置4-8小时,取上清液,滤过,滤液浓缩至比重为1.07的雪梨清膏。研究表明雪梨膏在治疗慢性咽炎上具有90%的有效率。
7)制粒:以雪梨清膏作为粘合剂,将步骤2中制得的组分A、步骤5中的组分B混匀制成软材,制粒,过16目筛,于60℃微波干燥,过筛整粒,过16目筛,制得的颗粒密闭保存。
8)最终获得的颗粒可以用于制作各种剂型的产品,如片剂,片剂中复合物的含量不得少于50%。
本实施例在保证清咽利嗓效果的同时,加入蜂蜜、雪梨改善了口感、清肺化痰,使之更适合少儿服用。
梨因为味道甘甜可口,营养成分丰富,被誉为“百果之宗”,梨性凉,味甘、微酸,入肺、胃经。具有清肺化痰、生津止渴的功效,主治肺燥咳嗽、热病烦躁、津少口干、消渴、目赤、疮疡、烫火伤等症。梨中的有效成分主要为:多酚类、三萜及甾醇类化合物、酚酸酯类化合物、羽扇豆醇脂类、多糖类等。
蜂蜜性味甘平,归肺、脾、大肠经,有补中益气、缓急止痛,润燥止咳,滑肠通便及解毒之功能。用于脾胃虚弱、倦怠少食、脘腹作痛;肺虚干咳、久咳;体虚津亏便秘。
试验例1:快速缓解咽炎患者的试验
1、患者一般资料
选择50例慢性咽炎患者,其中男性28例、女性22例,年龄22-46岁,平均年龄30.86岁;病程1~10年、平均病程2.68年。
2、诊断标准
参照《耳鼻喉科学》中慢性咽炎诊断要点进行诊断,主要根据咽部症状、咽部望诊检查而做出诊断。慢性咽炎中以单纯性咽炎较为常见,表现为咽部黏膜明显充血红肿,肥厚性咽炎咽部有明显淋巴滤泡增生,融合成块;萎缩性咽炎咽部干燥,分泌物减少,颜色苍白。
3、排除标准
(1)有其他咽喉部疾病;(2)对本发明中药物过敏者;(3)患有久病、体弱、消瘦或有严重的心、肝、肾功能障碍者;(4)妊娠期和哺乳期以及有怀孕意向的患者。
4、治疗方法
颗粒(5g/包,将实施例3具有清热解毒、宣肺利咽的复合物进行湿法制粒,以水为粘合剂,加入量为混合喷干粉重量的30%;并加入润滑剂例如二氧化硅,最终制得的颗粒中复合物的含量为98%),对上述患者进行治疗。每日2次,每次1包,每天服用的颗粒剂中复合物为9.8g,持续使用15天。
5、疗效标准
显效:临床症状、体征基本消失,喉镜检测显示咽部黏膜光滑、平坦,炎性分泌物消失;有效:临床症状、体征大部分消失,喉镜检查小试咽部黏膜轻度慢性充血,黏膜红肿减轻,炎性分泌物减少;无效:临床症状、体征未见改善,甚至有所恶化,喉镜检查显示咽黏膜中度慢性充血,较干燥。
总有效率=显效率+有效率。
6、治疗结果
统计显效患者40例,占80.0%;有效患者8例,占16.0%;无效患者2例,占4%(因身体原因退出);总有效率96.0%。
实施例3产品对慢性咽炎患者能够在15天内产生有效的治疗效果,用量少,起效快。
试验例2:缓解老年胃食管反流性咽炎的试验
1、患者一般资料
选取确诊为轻度胃食管反流病(GERD)的30名老年患者,他们的主要症状是胃食管反流性咽炎,其中男性19例、女性11例,年龄59-76岁,平均年龄65岁;病程4个月~5年、平均病程1.5年。
2、排除标准
(1)有其他咽喉部疾病;(2)对本发明中药物过敏者;(3)患有久病、体弱、消瘦或有严重的心、肝、肾功能障碍者;(4)参与过本申请其他实施例制剂的效果试验。
3、临床表现
本组30名患者均有不同程度的咽部不适感,表现为咽部异物感者10例,干燥感者3例,咽部疼痒感者17例;伴有反酸、反食和嗳气症状者15例;本组患者伴有咳嗽、气喘者8例,伴有口腔溃疡者4例,伴有副鼻窦炎者2例。
4、治疗方法
粉剂(10g/袋,将实施例2的复合物加入混合喷干粉重量的1%的润滑剂例如二氧化硅,再加入混合喷干粉重量的1%的脱模剂例如硬脂酸镁或者硬脂酸,最终制得的粉剂中复合物的含量为98%),对上述患者进行治疗。每日3次,每次2袋,餐前半小时直接倒入嘴中,再用少量温水冲服,每天服用的粉剂中复合物为58.8g,持续使用30天。
5、疗效判断
显效:咽喉部症状消失,镜下见咽喉部溃疡愈合或黏膜充血、水肿消失;有效:咽喉部症状明显改善,镜下见咽喉部病变好转;无效:咽喉部症状及镜下咽喉部病变未见改善。
6、治疗结果
服用15天统计显效患者6例,占20.0%;有效患者21例,占70.0%;无效患者3例,占10%;无不良反应;总有效率90.0%。。
服用30天统计显效患者10例,占33.0%;有效患者20例,占67.0%;无效患者0例,无不良反应;总有效率100.0%。
实施例2产品对胃食管反流性咽炎老年患者能够在30天内产生有效的治疗效果,明显改善咽喉部症状,改善生活水平。
除上述实施例外,本发明还包括有其他实施方式,凡采用等同变换或者等效替换方式形成的技术方案,均应落入本发明权利要求的保护范围之内。
Claims (10)
1.一种以金银花甘草药对为基础的复合物,其特征在于:包括组分A:金银花、甘草的挥发油包合物,组分B:主要包括金银花、甘草以及选自桔梗、陈皮、青果、胖大海、罗汉果中一种或多种的水提取物。
2.一种以金银花甘草药对为基础的复合物,其特征在于:包括组分A:金银花、甘草的挥发油包合物,组分B:主要包括金银花、甘草、桔梗、陈皮、青果的水提取物;该复合物的组方为:金银花1-10份,甘草1-10份、陈皮1-10份、桔梗1-8份、青果1-8份。
3.一种以金银花甘草药对为基础的复合物,其特征在于:包括组分A:金银花、甘草的挥发油包合物,组分B:主要包括金银花、甘草、桔梗、青果、胖大海、罗汉果的水提取物;该复合物的组方为:金银花1-10份,甘草1-10份、桔梗1-8份、青果1-8份、罗汉果1-6份、胖大海1-4份。
4.一种以金银花甘草药对为基础的复合物,其特征在于:包括组分A:金银花、甘草的挥发油包合物,组分B:包括金银花、甘草、桔梗、青果的水提取物和蜂蜜,组分C:雪梨膏;该复合物的组方为:金银花1-10份,甘草1-10份、桔梗1-8份、青果1-8份、雪梨1-6份、蜂蜜1-5份。
5.根据权利要求2所述的以金银花甘草药对为基础的复合物,其特征在于:应用于制备清咽养胃制剂。
6.根据权利要求3所述的以金银花甘草药对为基础的复合物,其特征在于:应用于制备清热解毒、宣肺利咽制剂。
7.根据权利要求3所述的以金银花甘草药对为基础的复合物,其特征在于:应用于制备适宜少儿服用的具有清咽利嗓功效的制剂。
8.根据权利要求1或2或3所述的以金银花甘草药对为基础的复合物,其特征在于:该复合物的制备方法包括如下步骤
(一)组分A的制备:
(1.1)炮制:甘草除去杂质,洗净,润透,切厚片,干燥;
(2.1)金银花-甘草挥发油包合物的制备:取金银花、甘草总配方量80%以上的金银花和甘草混合,投入提取罐缓慢通入蒸汽,收集经过初步油水分离的蒸馏液;冷却水进水温度≤35℃、冷却水出水温度≤60℃,挥发油提取温度90-100℃,分取挥发油;取β-环糊精置于胶体磨中,加入水,缓慢加入挥发油,挥发油与β-环糊精的比例为1:(6-16),充分研磨后,出料得挥发油β-环糊精包合液;对挥发油β-环糊精包合液进行喷干,适时收粉,过筛,得金银花-甘草挥发油包合物;
(二)组分B的制备:
(2.1)炮制:桔梗除去杂质,洗净,润透,切厚片,干燥;甘草除去杂质,洗净,润透,切厚片,干燥;陈皮除去杂质,喷淋水,润透,切丝,干燥;青果除去杂质,冼净,干燥,用时打碎;胖大海除去杂质,粗碎;
(2.2)提取:通过水煎煮法,将剩余的金银花、甘草,炮制的桔梗、陈皮和青果按配方量领取,投入提取罐,并加入组分A制备时剩余的药渣,加入10-12倍水共煎,第一次煎煮,煮沸后微沸1-2h;第二次煎煮,将一煎液抽出过筛网,在滤渣中加入配方量的胖大海、罗汉果和10-12倍水,煮沸后微沸0.5-1h,将二煎液抽出过筛,合并两次煎液,制得提取液;
(2.3)浓缩:对步骤2.2制得的提取液进行减压浓缩,浓缩至比重为1.0-1.1的浓缩液;
(2.4)干燥:将步骤2.3制得的浓缩液进行喷干,进风温度为185-195℃,出风温度为90-95℃,制得喷干粉;
(三)混合组分A和组分B,过筛并进行灭菌处理,获得所述复合物的喷干粉。
9.根据权利要求根据权利要求4所述的以金银花甘草药对为基础的复合物,其特征在于:该复合物的制备方法包括如下步骤
(一)组分A的制备:
(1.1)炮制:甘草除去杂质,洗净,润透,切厚片,干燥;
(2.1)金银花-甘草挥发油包合物的制备:取金银花、甘草总配方量80%以上的金银花和甘草混合,投入提取罐缓慢通入蒸汽,收集经过初步油水分离的蒸馏液;冷却水进水温度≤35℃、冷却水出水温度≤60℃,挥发油提取温度90-100℃,分取挥发油;取β-环糊精置于胶体磨中,加入水,缓慢加入挥发油,挥发油与β-环糊精的比例为1:(6-16),充分研磨后,出料得挥发油β-环糊精包合液;对挥发油β-环糊精包合液进行喷干,适时收粉,过筛,得金银花-甘草挥发油包合物;
(二)组分B的制备:
(2.1)炮制:桔梗除去杂质,洗净,润透,切厚片,干燥;甘草除去杂质,洗净,润透,切厚片,干燥;青果除去杂质,冼净,干燥,用时打碎;
(2.2)提取:通过水煎煮法,将剩余的金银花、甘草,炮制的桔梗、青果按配方量领取,投入提取罐,并加入组分A制备时剩余的药渣,加入10-12倍水共煎,第一次煎煮,煮沸后微沸1-2h;第二次煎煮,将一煎液抽出过筛网,在滤渣中加入10-12倍水,煮沸后微沸0.5-1h,将二煎液抽出过筛,合并两次煎液,制得提取液;
(2.3)浓缩:对步骤2.2制得的提取液进行减压浓缩,浓缩至比重为1.0-1.1的浓缩液;
(2.4)干燥:将步骤2.3制得的浓缩液中趁热加入蜂蜜溶解后进行喷干,进风温度为185-195℃,出风温度为90-95℃,制得喷干粉;
(三)组分C的制备:
雪梨的提取:将配方量切片的雪梨加水煎煮多次,每次1.5小时,滤过,压榨残渣,压榨液与煎液合并,静置4-8小时,取上清液,滤过,滤液浓缩至比重1.0-1.1的雪梨清膏;
(四)制粒:
以雪梨清膏作为粘合剂,将组分A、组分B混匀制成软材,制粒,微波干燥,过筛得整粒的复合物。
10.根据权利要求5或6或7所述的以金银花甘草药对为基础的复合物的应用,其特征在于:所述制剂为颗粒剂、片剂、粉剂中任一剂型,其中颗粒剂和粉剂中的复合物含量不得少于95%,片剂中复合物的含量不得少于50%。
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