CN111569029A - 一种提高呼吸道粘膜免疫功能的中药组合物及其制备方法 - Google Patents
一种提高呼吸道粘膜免疫功能的中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种提高呼吸道粘膜免疫功能的中药组合物及其制备方法。该组合物包括包括以下重量份的组分：桔梗2～12份、生甘草1～8份、薏苡仁2～12份、玉竹2～12份、陈皮1～8份、茯苓1～8份、生黄芪2～12份、沙棘1～8份、百合2～12份、砂仁1～8份、罗汉果1～8份。本发明组合物能有效提高呼吸道粘膜及全身免疫功能，直接作用于多种呼吸道细菌、病毒，在强健肺脏的同时也能抑制呼吸道病原微生物的生长繁殖，从而有效预防呼吸道病原微生物感染，降低呼吸道疾病的发生，且安全无毒副作用。本发明制备方法简单，对生产设备无特殊要求、易操作、低成本，容易实现工业化生产。
Description
技术领域
本发明属于食品、保健食品、药品领域，涉及一种中药制剂及其制备方法，特 别涉及一种提高呼吸道粘膜免疫功能的中药组合物及其制备方法。
背景技术
呼吸系统疾病是一种常见病、多发病，多发于冬、春两季，多因病毒或细菌引起，当气 象条件发生剧烈变化时,人体因免疫力低下、生理机制不能迅速地调整，病原微生物入侵机 体也容易患上呼吸系统疾病。呼吸系统疾病主要病变在气管、支气管、肺部及胸腔，病变轻 者多咳嗽、胸痛、呼吸受影响，重者呼吸困难、缺氧，甚至呼吸衰竭而致死。其常见病主要 有急慢性支气管炎、气管炎、哮喘、慢性阻塞性肺疾病、过敏性鼻炎、肺结核等。我国呼吸系统疾病的病患虑在逐年攀升，有调查显示，呼吸系统疾病的死亡率在我国城市的死亡病因 中占第3位，成为危害健康的主要疾病之一。空气污染已被普遍认为是导致呼吸系统疾病的 重要因素，这在儿童这一人群中表现最为明显。另外，吸烟等不良生活习惯、工业经济发展 导致的理化因子、生物因子吸入以及人口年龄老化等因素，也使近年来呼吸疾病的发病率明 显增加。曾在多个国家出现的人禽流感病死率超过60％。这说明呼吸系统疾病对中国乃至世 界人民健康危害是很大的，其防治任务艰巨。
对于呼吸系统疾病的治疗，西医常用抗菌、抗病毒或激素类药物。其中抗菌药 物如：阿莫西林，其穿透细胞壁的能力强，是目前应用较为广泛的口服青霉素之一， 但其主要不良反应包括过敏反应及消化系统症状。抗病毒药物如：利巴韦林，为抗 非逆转录病毒药，但本品吸入用药可导致肺功能退化、细菌性肺炎、气胸和心血管 反应(血压下降以及心脏停搏)等。同时呼吸系统疾病常用糖皮质激素(如泼尼松、泼 尼松龙、甲泼尼龙等)进行治疗，能够起到良好的抗炎、抗毒、抗休克等效果，但 其副作用不可忽视：长期使用能造成水、盐、糖、蛋白质及脂肪代谢紊乱，减弱机 体抵抗力，阻碍组织修复，延缓组织愈合，甚至抑制儿童生长发育。综合来看，西 医治疗往往只着力于对病菌、病毒的消灭，或顾护机体肺气，虽然效果明显，但是 毒副作用大，且极易产生耐药性，长期应用会对患者健康产生不利影响。中医认为 呼吸道疾病的病因病机是人体正气不足而外感疫疠之邪所致。《诸病源候论·疫疠病 诸候》有言：“皆因岁时不和，温凉失节，人感乖戾之气而生病，则病气转相染易， 乃至灭门，延及外人，故须预服药及为法术以防之。”指出戾气的数量、毒力能直接 决定人是否患病与患病的程度，同时《瘟疫论》又云“本气充满，邪不易入，本气适 逢亏欠，呼吸之间，外邪因而乘之。”又指出素体正气亏虚也是受邪患病的基础，正 所谓“正气存内，邪不可干”。所以中医在面对呼吸道疾病时，尤如新型冠状病毒 (COVID-19)此类新发、突发呼吸道传染性疾病，其治疗的基本思路不外乎“祛邪” 兼“扶正”两个方面。
呼吸道粘膜免疫系统(respiratory passage mucosa immunesystem，RMIS)作为粘膜免疫系统的重要组成部分，是保护机体特别是呼吸道免于病原体侵犯的重要屏 障。呼吸道粘膜免疫系统作为机体防御功能第一道防线，在抵抗病原微生物入侵中 承担着重要任务。因此，呼吸道黏膜免疫的相关研究正成为临床及科研中的热点之 一。中医在提高呼吸道粘膜及全身免疫功能、抑制病原微生物等方面优势突出，并 且经过长期的实践探索，形成了一定的理论体系，且治疗手段多样，疗效确切。中 医药治疗呼吸系统疾病，减少西药用量及不良反应，且标本兼治，具有显著优势。 而“药食同源”类中药，兼有营养和治疗的双向作用，在治疗呼吸系统疾病更是具有 优势。因此，以中医理论为指导，开发一款安全、有效的“药食同源”类中药产品具 有重要意义。
(1)桔梗，为桔梗科植物桔梗Platycodon grandiflorum(Jacq.)A.DC.的干燥根。收载于《中国药典》2015年版：【性味与归经】苦、辛，平。归肺经。【功能与主 治】宣肺，利咽，祛痰，排脓。用于咳嗽痰多，胸闷不畅，咽痛音哑，肺痈吐脓。
(2)生甘草，即甘草，为豆科植物甘草Glycyrrhiza uralensis Fisch.、胀果甘草Glycyrrhiza infata Bat.或光果甘草Glycyrrhiza glabra L.的干燥根和根茎。收载于《中 国药典》2015年版：【性味与归经】甘，平。归心、肺、脾、胃经。【功能与主治】 补脾益气，清热解毒，祛痰止咳，缓急止痛，调和诸药。用于脾胃虚弱，倦怠乏力， 心悸气短，咳嗽痰多，脘腹、四肢挛急疼痛，痈肿疮毒，缓解药物毒性、烈性。
(3)薏苡仁，为禾本科植物薏苡Coix lacryma-jobi L.var.mayuen(Roman.)Stapf的干燥成熟种子。收载于《中国药典》2015年版：【性味与归经】甘、淡，凉。归 脾、胃、肺经。【功能与主治】利水渗湿，健脾止泻，除痹，排脓，解毒散结。用 于水肿，脚气，小便不利，脾虚泄泻，湿痹拘挛，肺痈，肠痈，赘疣，癌肿。
(4)玉竹，为百合科植物玉竹Polygonatum odoratum(Mill.)Druce的干燥根茎。收载于《中国药典》2015年版：【性味与归经】甘，微寒。归肺、胃经。【功能与 主治】养阴润燥，生津止渴。用于肺胃阴伤，燥热咳嗽，咽干口渴，内热消渴。
(5)陈皮，为芸香科植物橘Citrus reticulata Blanco及栽培变种的干燥成熟果皮。 收载于《中国药典》2015年版：【性味与归经】苦、辛，温。归肺、脾经。【功能 与主治】理气健脾，燥湿化痰。用于脘腹胀满，食少吐泻，咳嗽痰多。
(6)茯苓，为多孔菌科真菌茯苓Poria cocos(Schw.)Wolf的干燥菌核。收载于《中国药典》2015年版：【性味与归经】甘、淡，平。归心、肺、脾、肾经。【功能与 主治】利水渗湿，健脾，宁心。用于水肿尿少，痰饮眩悸，脾虚食少，便溏泄泻， 心神不安，惊悸失眠。
(7)生黄芪，即黄芪，为豆科植物蒙古黄芪Astragalus membranaceus(Fisch.)Bge.var.mongholicus(Bge.)Hsiao或膜荚黄芪Astragalus membranaceus(Fisch.)Bge.的干燥根。收载于《中国药典》2015年版：【性味与归经】 甘，微温。归肺、脾经。【功能与主治】补气升阳，固表止汗，利水消肿，生津养 血，行滞通痹，托毒排脓，敛疮生肌。用于气虚乏力，食少便溏，中气下陷，久泻 脱肛，便血崩漏，表虚自汗，气虚水肿，内热消渴，血虚萎黄，半身不遂，痹痛麻 木，痈疽难溃，久溃不敛。
(8)沙棘，为胡颓子科植物沙棘Hippophae rhamnoides L.的干燥成熟果实。收 载于《中国药典》2015年版：【性味与归经】酸、涩，温。归脾、胃、肺、心经。 【功能与主治】健脾消食，止咳祛痰，活血散瘀。用于脾虚食少，食积腹痛，咳嗽 痰多，胸痹心痛，瘀血经闭。跌扑瘀肿。
(9)百合，为百合科植物卷丹Lilium lancifolium Thumb、百合Lilium browniiF.E.Brown var.viridulum Baker或细叶百合Liliumpumilum DC.r的干燥肉质鳞叶。收 载于《中国药典》2015年版：【性味与归经】甘，寒。归心、肺经。【功能与主治】 养阴润肺，清心安神。用于阴虚燥咳，劳嗽咳血，虚烦惊悸，失眠多梦，精神恍惚。
(10)砂仁，为姜科植物阳春砂Amomum villosum Lour.、绿壳砂Amomum villosumLour.var.xanthioides T.L.Wu et Senjen或Amomum longiligulare T.L.Wu的干 燥成熟果实。收载于《中国药典》2015年版：【性味与归经】辛，温。归脾、胃、 肾经。【功能与主治】化湿开胃，温脾止泻，理气安胎。用于湿浊中阻，脘痞不饥， 脾胃虚寒，呕吐泄泻，妊娠恶阻，胎动不安。
(11)罗汉果，为葫芦科植物罗汉果Siraitia grosvenorii(Swingle)C.Jeffreyex A.M.Lu et Z.Y.Zhang的干燥果实。收载于《中国药典》2015年版：【性味与归经】 甘，凉。归肺、大肠经。【功能与主治】清热润肺，利咽开音，滑肠通便。用于肺 热燥咳，咽痛失音，肠燥便秘。
发明内容
本发明的目的是针对现有各种治疗呼吸系统疾病的药物存在的不足而提供一种提高呼吸道粘膜免疫功能的中药组合物及其制备方法，该中药组合物结合人们对天 然健康产品的追求，依据传统中医配伍原则，选用药食同源药材，可有效改善呼吸 道粘膜及全身免疫功能，且能直接作用于多种呼吸道细菌、病毒，无任何毒副作用， 且制备工艺简单。
本发明的技术方案如下：
一种提高呼吸道粘膜免疫功能的中药组合物，包括以下重量份的组分：桔梗2～12份、生甘草1～8份、薏苡仁2～12份、玉竹2～12份、陈皮1～8份、茯苓1～8 份、生黄芪2～12份、沙棘1～8份、百合2～12份、砂仁1～8份、罗汉果1～8份。
进一步的，以上所述的提高呼吸道粘膜免疫功能的中药组合物，优选包括以下 重量份的组分：桔梗5～9份、生甘草3～5份、薏苡仁5～9份、玉竹5～9份、陈 皮3～5份、茯苓3～6份、生黄芪5～9份、沙棘3～5份、百合5～9份、砂仁3～ 5份、罗汉果3～5份。
进一步的，以上所述的提高呼吸道粘膜免疫功能的中药组合物，更优选包括以 下重量份的组分：桔梗8份、生甘草4份、薏苡仁8份、玉竹7份、陈皮4份、茯 苓5份、生黄芪7份、沙棘4份、百合7份、砂仁4份、罗汉果4份。
进一步的，以上所述的提高呼吸道粘膜免疫功能的中药组合物制备成医药领域可接受的任意内服制剂，优选制备成颗粒剂。
以上所述的提高呼吸道粘膜免疫功能的中药组合物制备成颗粒剂的制备方法，包括以下步骤：
(1)分别取桔梗、生甘草、薏苡仁、玉竹、陈皮、茯苓、生黄芪、沙棘、百合、 砂仁、罗汉果，净选，干燥；
(2)按以下重量份称取原材料：桔梗2～12份、生甘草1～8份、薏苡仁2～ 12份、玉竹2～12份、陈皮1～8份、茯苓1～8份、生黄芪2～12份、沙棘1～8 份、百合2～12份、砂仁1～8份、罗汉果1～8份；
(3)取步骤(2)称量好的原材料，加水煎煮，过滤，滤液浓缩，得到提取物；
(4)取步骤(3)所得的提取物，加入与提取物质量比为1:1的赋型剂，制颗 粒，干燥，即得。
进一步的，以上所述的提高呼吸道粘膜免疫功能的中药组合物制备成颗粒剂的制备方法，步骤(3)项下的所述加水煎煮为加4～10倍量的水煎煮2次，每次0.5～ 2h，煎煮温度为70～100℃；所述浓缩为70～100℃加热浓缩至滤液总体积的15％。
进一步的，以上所述的提高呼吸道粘膜免疫功能的中药组合物制备成颗粒剂的制备方法，步骤(4)项下所述赋型剂为淀粉，所述干燥温度为50～70℃。
以上所述的提高呼吸道粘膜免疫功能的中药组合物在制备用于预防健康人群呼吸道感染病原微生物的药品中的应用。
与现有技术相比，本发明具有以下有益效果：
1.本发明提高呼吸道粘膜免疫功能的中药组合物，通过现代科学理论配制而成。方中桔梗、甘草合用，排痰驱邪、清热解毒而能治标，补脾益肺而能治本；百合、 玉竹、罗汉果，养阴润肺、生津止渴；茯苓、陈皮、砂仁、薏苡仁，健运脾气、燥 化湿邪、通利水气，使养阴而不滋腻、祛湿而不伤正；生黄芪益气固表、健脾补中， 肺脾兼顾而能收到奇效；沙棘健脾消食、止咳祛痰、活血祛瘀，使诸药补而不滞。 全方标本同治，共收扶正驱邪之功效。能有效提高呼吸道粘膜及全身免疫功能，直 接作用于多种呼吸道细菌、病毒，在强健肺脏的同时也能抑制呼吸道病原微生物的 生长繁殖，从而有效预防呼吸道病原微生物感染，降低呼吸道疾病的发生。经动物 试验结果表明其可促进气道黏膜sIgA的分泌量，提高小鼠呼吸道粘膜免疫；经临床 试验结果表明，其减少上呼吸道感染发生的有效率达到85％，明显高于对照组。
2.本发明通过科学合理配方，组方严谨，药少力专，原料药均取自“药食同源” 品种，具有疗效显著，价廉，使用方便，安全、无毒副作用等特点，为天然健康食 品，可长期使用，安全有效。
3.本发明制备方法简单，对生产设备无特殊要求、易操作、低成本，容易实现 工业化生产。
具体实施方式
下面结合具体实施例对本发明作进一步描述，但不限制本发明的保护范围和应用范围：
一、一种提高呼吸道粘膜免疫功能的中药组合物的制备
实施例1
一种提高呼吸道粘膜免疫功能的中药组合物制备成颗粒剂的制备方法，包括以下步骤：
(1)分别取桔梗、生甘草、薏苡仁、玉竹、陈皮、茯苓、生黄芪、沙棘、百合、 砂仁、罗汉果，净选，干燥；
(2)按以下重量份称取原材料：桔梗1200g、生甘草800g、薏苡仁1200g、玉 竹1200g、陈皮800g、茯苓800g、生黄芪1200g、沙棘800g、百合1200g、砂仁800g、 罗汉果800g；
(3)取步骤(2)称量好的原材料，加水于70℃煎煮2次，第一次加10倍量 水煎煮2h，第二次加8倍量水煎煮1h，过滤，合并滤液，滤液于100℃加热浓缩至 滤液总体积的15％，得提取物；
(4)取步骤(3)所得的提取物，加入与提取物质量比例为1:1的淀粉作为赋 型剂，制颗粒，于干燥箱中70℃干燥，至水分完全烘干，即得。
实施例2
一种提高呼吸道粘膜免疫功能的中药组合物制备成颗粒剂的制备方法，包括以下步骤：
(1)分别取桔梗、生甘草、薏苡仁、玉竹、陈皮、茯苓、生黄芪、沙棘、百合、 砂仁、罗汉果，净选，干燥；
(2)按以下重量份称取原材料：桔梗200g、生甘草100g、薏苡仁200g、玉竹 200g、陈皮100g、茯苓100g、生黄芪200g、沙棘100g、百合200g、砂仁100g、罗 汉果100g；
(3)取步骤(2)称量好的原材料，加水于100℃煎煮2次，第一次加6倍量 水煎煮1.5h，第二次加4倍量水煎煮0.5h，过滤，合并滤液，滤液于70℃加热浓缩 至滤液总体积的15％，得提取物；
(4)向步骤(3)所得的提取物中加入与提取物的质量比例为1:1的淀粉作为 赋型剂，制颗粒，于干燥箱中50℃干燥，至水分完全烘干，即得。
实施例3
一种提高呼吸道粘膜免疫功能的中药组合物制备成颗粒剂的制备方法，包括以下步骤：
(1)分别取桔梗、生甘草、薏苡仁、玉竹、陈皮、茯苓、生黄芪、沙棘、百合、 砂仁、罗汉果，净选，干燥；
(2)按以下重量份称取原材料：桔梗900g、生甘草500g、薏苡仁900g、玉竹 900g、陈皮500g、茯苓600g、生黄芪900g、沙棘500g、百合900g、砂仁500g、罗 汉果500g；
(3)取步骤(2)称量好的原材料，加水于80℃煎煮2次，第一次加9倍量水 煎煮1.5h，第二次加7倍量水煎煮1.5h，过滤，合并滤液，滤液于90℃加热浓缩至 滤液总体积的15％，得提取物；
(4)向步骤(3)所得的提取物中加入与提取物的质量比例为1:1的淀粉作为 赋型剂，制颗粒，于干燥箱中60℃干燥，至水分完全烘干，即得。
实施例4
一种提高呼吸道粘膜免疫功能的中药组合物制备成颗粒剂的制备方法，包括以下步骤：
(1)分别取桔梗、生甘草、薏苡仁、玉竹、陈皮、茯苓、生黄芪、沙棘、百合、 砂仁、罗汉果，净选，干燥；
(2)按以下重量份称取原材料：桔梗500g、生甘草300g、薏苡仁500g、玉竹 500g、陈皮300g、茯苓300g、生黄芪500g、沙棘300g、百合500g、砂仁300g、罗 汉果300g。
(3)取步骤(2)称量好的原材料，加水于90℃煎煮2次，第一次加7倍量水 煎煮2h，第二次加5倍量水煎煮0.5h，过滤，合并滤液，滤液于80℃加热浓缩至 滤液总体积的15％，得提取物；
(4)向步骤(3)所得的提取物中加入与提取物的质量比例为1:1的淀粉作为 赋型剂，制颗粒，于干燥箱中60℃干燥，至水分完全烘干，即得。
实施例5
一种提高呼吸道粘膜免疫功能的中药组合物制备成颗粒剂的制备方法，包括以下步骤：
(1)分别取桔梗、生甘草、薏苡仁、玉竹、陈皮、茯苓、生黄芪、沙棘、百合、 砂仁、罗汉果，净选，干燥；
(2)按以下重量份称取原材料：桔梗800g、生甘草400g、薏苡仁800g、玉竹 700g、陈皮400g、茯苓500g、生黄芪700g、沙棘400g、百合700g、砂仁400g、罗 汉果400g
(3)取步骤(2)称量好的原材料，加水于90℃煎煮2次，第一次加8倍量水 煎煮2h，第二次加6倍量水煎煮1h，过滤，合并滤液，滤液于90℃加热浓缩至滤 液总体积的15％，得提取物；
(4)向步骤(3)所得的提取物中加入与提取物的质量比例为1:1的淀粉作为 赋型剂，制颗粒，于干燥箱中60℃干燥，至水分完全烘干，即得。
二、动物试验
1.材料
1.1动物
昆明种小鼠(一级)40只，健康雄性，体重22.2±1.3g，由成都中医药大学实验 动物研究中心提供。适应性喂养2天后，小鼠按体重随机分为2组，分别是：空白对 照组和试验组，每组20只。
1.2样品
取本发明实施例5制备的样品，用开水溶解，待冷却至常温后配制成0.41g生药 /mL的溶液作为供试品溶液
1.3试剂
sIgA的ELISA检测试剂盒。
1.4主要仪器
全自动多功能酶标仪MK3(芬兰雷勃)。
2.方法
2.1样品干预
试验组于第3天开始予供试品溶液，每只每天0.2mL灌胃，空白对照组以同样方 法予等量0.9％氯化钠溶液灌胃，共4周。
2.2支气管肺泡灌洗液(bronchoalveolar lavagefluid,BALF)收集和sIgA检测
常规麻醉行气管插管，以0.9％氯化钠溶液0.5mL行支气管肺泡灌洗，注入液体后，胸外按摩10s，反复抽吸3次，共行2次灌洗后回收灌洗液，保证回收率80％左右， 经4℃，2000r/min，离心5min，取上清液，按ELISA试剂盒操作步骤说明进行BALF 中sIgA分泌量的检测。
2.3统计学方法
采用SPSS 15.0统计软件，计量资料用以
表示，组间差异采用独立样本t检验，P＜0.05表示差异有统计学意义。
3.结果：
3.1一般情况
空白对照组、试验组小鼠均无死亡，毛发光泽，呼吸均匀，活动正常。
3.2 BALF中sIgA检测结果
见表1。
表1各组BALF中sIgA含量比较(
pg/mL)
注：与空白对照组比较，*P＜0.05
BALF中sIgA的含量检测可反应小鼠气道炎症状态，由表1结果可以看出试验 组较空白对照组显著性升高(P＜0.05)，表明试验可促进气道黏膜sIgA的分泌量， 提高小鼠呼吸道粘膜免疫。
三、临床试验
1.临床资料
40例研究对象均来自2018年6月至2018年7月来前进中医门诊的健康志愿者， 且符合以往有多次呼吸道感染病史者。由SAS6.12统计软件的PROCPLAN程序步 骤产生随机数及相应的供试品及病例分配方案。志愿者随机分配至试验组和对照组 各20例，其中试验组男性9例，女性11例；年龄14～65岁，平均(32.60±14.05) 岁；对照组男性7例，女性13例，年龄16～69岁，平均(33.45±14.76)岁，脱落 1例。各组志愿者一般资料比较差异无统计学意义(P＞0.05)。
2.试验对象选择
2.1西医诊断标准与中医辨证标准
既往有多次呼吸道感染病史者的诊断标准：西医诊断标准参照《内科疾病诊断 标准》制定。中医辨证标准参照《中医内科学》相关章节制定。
2.2纳入标准
符合上述诊断标准者；年龄14～80岁；以往有多次呼吸道感染病史者：既往 曾多次检查白细胞总数＞3.5×109/L且＜12.00×109/L，中性粒细胞比例＜80％；体 温≥37.5℃，并签署知情同意书。
2.3排除标准
妊娠或哺乳期妇女；合并有心、肝、肾功能和造血系统严重原发病者；精神病 志愿者；过敏体质或对多种药物过敏者。
3.试验方法
3.1供试品及其安慰剂
供试品：本发明实施例5样品。
安慰剂：由淀粉和食用色素等组成，内服颗粒外观和治疗药一致。
3.2服用方法
试验组：口服本发明实施例5样品，1袋/次，1次/天，睡前1小时服用。
对照组：口服安慰剂，1袋/次，1次/天，睡前1小时服用。
3.3服用时间
于初伏——2018年7月17日至2018年7月26日，共10天，服用第一疗程。 中伏——2018年7月27日至2018年8月15日，共20天，服用第二疗程。末伏 ——2018年8月16日——2018年8月25日，共10天，服用第三疗程，共三个疗 程。
4.观察方法
对所有实验对象进行基本信息采集，包括电话等联系方式。在疗程日期结束时，电话随访，确认疗程完整结束。第二年4-5月再次随访，了解上个冬季发病情况。
5.疗效评定标准
整个冬季，无或显著减少上呼吸道感染发生为有效，无明显改善为无效。
6.统计学处理
统计学处理采用SPSS15.0统计分析软件。所有的统计检验均采用双侧检验。计 数资料用频数和构成比进行统计描述。两组间疗效的比较采用卡方检验。P＜0.05 为差异有统计学意义。
7.结果
7.1不良反应和安全性评价
治疗过程中，两组志愿者均未出现不良反应。
7.2临床疗效比较
两组志愿者疗效比较见表2。
表2两组志愿者疗效比较[n(％)]
与对照组比较，*P＜0.05
表2结果表明：治疗后与对照组比较，试验组的有效率(85.00％)明显高于对 照组(10.53％)，差异有统计学意义(P＜0.05)。
8.结论
以上临床试验结果表明，本发明一种提高呼吸道免疫功能的中药组合物能够有效提高呼吸道粘膜及全身免疫功能，从而有效预防呼吸道病原微生物感染，降低呼 吸道疾病的发生，而且使用安全，无毒副作用，可长期使用。
Claims (10)
1.一种提高呼吸道粘膜免疫功能的中药组合物，其特征在于，包括以下重量份的组分：桔梗2～12份、生甘草1～8份、薏苡仁2～12份、玉竹2～12份、陈皮1～8份、茯苓1～8份、生黄芪2～12份、沙棘1～8份、百合2～12份、砂仁1～8份、罗汉果1～8份。
2.根据权利要求1所述的提高呼吸道粘膜免疫功能的中药组合物，其特征在于，包括以下重量份的组分：桔梗5～9份、生甘草3～5份、薏苡仁5～9份、玉竹5～9份、陈皮3～5份、茯苓3～6份、生黄芪5～9份、沙棘3～5份、百合5～9份、砂仁3～5份、罗汉果3～5份。
3.根据权利要求1所述的提高呼吸道粘膜免疫功能的中药组合物，其特征在于，包括以下重量份的组分：桔梗8份、生甘草4份、薏苡仁8份、玉竹7份、陈皮4份、茯苓5份、生黄芪7份、沙棘4份、百合7份、砂仁4份、罗汉果4份。
4.根据权利要求1～3任一所述的提高呼吸道粘膜免疫功能的中药组合物，其特征在于，所述中药组合物制备成医药领域可接受的任意内服制剂。
5.根据权利要求1～3任一所述的提高呼吸道粘膜免疫功能的中药组合物，其特征在于，所述中药组合物制备成颗粒剂。
6.一种如权利要求5所述的提高呼吸道粘膜免疫功能的中药组合物制备成颗粒剂的制备方法，其特征在于，包括以下步骤：
(1)分别取桔梗、生甘草、薏苡仁、玉竹、陈皮、茯苓、生黄芪、沙棘、百合、砂仁、罗汉果，净选，干燥；
(2)按以下重量份称取原材料：桔梗2～12份、生甘草1～8份、薏苡仁2～12份、玉竹2～12份、陈皮1～8份、茯苓1～8份、生黄芪2～12份、沙棘1～8份、百合2～12份、砂仁1～8份、罗汉果1～8份；
(3)取步骤(2)称量好的原材料，加水煎煮，过滤，滤液浓缩，得到提取物；
(4)取步骤(3)所得的提取物，加入与提取物质量比为1:1的赋型剂，制颗粒，干燥，即得。
7.根据权利要求6所述的提高呼吸道粘膜免疫功能的中药组合物制备成颗粒剂的制备方法，其特征在于，步骤(3)项下的所述加水煎煮为加4～10倍量的水煎煮2次，每次0.5～2h，煎煮温度为70～100℃。
8.根据权利要求6所述的提高呼吸道粘膜免疫功能的中药组合物制备成颗粒剂的制备方法，其特征在于，步骤(3)项下的所述浓缩为70～100℃加热浓缩至滤液总体积的15％。
9.根据权利要求6所述的提高呼吸道粘膜免疫功能的中药组合物制备成颗粒剂的制备方法，其特征在于，步骤(4)项下所述赋型剂为淀粉，所述干燥温度为50～70℃。
10.根据权利要求1～9中任一所述的提高呼吸道粘膜免疫功能的中药组合物，其特征在于，所述中药组合物在制备用于预防健康人群呼吸道感染病原微生物的食品、保健食品、药品中的应用。
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