CN116077594B - 一种治疗呼吸道病毒感染的中药 - Google Patents
一种治疗呼吸道病毒感染的中药 Download PDFInfo
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Abstract
本发明涉及一种治疗呼吸道病毒感染的中药,所述中药包括如下重量份配比的原料药:麻黄45~55份、太子参80~90份、柴胡63~73份、黄芩63~73份、广藿香63~73份、金银花80~90份、连翘80~90份、桔梗30~40份、牛蒡子80~90份、芦根130~150份、板蓝根63~73份、玄参63~73份、苦杏仁25~35份、白前63~73份。本发明具有散寒发表、清解热毒功效。临床上主要用来治疗风寒束表、热毒内蕴的时疫、流感、普通感冒而具有无汗、恶汗、发热、肌肉关节酸困、疼痛、头疼、咽喉疼痛、咽干咽痒、干咳少痰等。本发明中药临床上可用于四季发热性疾病和呼吸道疾病的治疗。
Description
技术领域
本发明涉及一种治疗呼吸道病毒感染的中药,属于中成药领域。
背景技术
随着气候变化和环境污染加剧等,呼吸道感染的发热类疾病越来越多,导致这些疾病的病原微生物如细菌和病毒的种类也越来越多,尤其是新病毒的产生、变异、大量的传播给全人类带来了危机。我们知道,对于细菌而言,西医的各种抗生素就发挥了重要的作用,而病毒类疾病,西医的抗病毒药物非常少,主要是由于病毒的变异远远超过新药的研发速度,过去的抗病毒药无法满足新产生病毒的治疗。
近年来随着全球气候变暖、环境污染越来越严重,大气质量明显下降,这种环境滋生的各种呼吸系统疾病上升,此外,工作压力的不断增大,生活不规律以及饮食不节和营养过剩等,导致人体体质总以阴虚内热、浮阳不潜居多,这种体质容易好发温热类疾病,而且这种体质不耐寒热,对寒热的调节功能很差,对外部六淫易感,更不用说“无问老幼、皆相染易”的疫戾。
气候的异常变化,使得细菌、病毒致病所造成的证型特点也具备了这些因素,即:风寒束表、热毒内蕴。发病之时具有不同程度的肌肉酸困,头身疼痛,恶汗、无汗、鼻塞、流清涕等风寒束表的特点,而且具有发热、咽喉干痛、干咳、声音嘶哑等热毒伤阴的表现。近多年来,内外环境所造成的阴虚内热、浮阳不潜易好发温热类疾病的人群越来越多,气候的寒热骤变以及各类空调的大量运用,也一定程度造成了热毒内蕴、风寒外束类证型的多发,这也将是今后很长一段时间,发热类疾病、呼吸道疾病,甚至是瘟疫的一种基本证型。
对于病毒所导致的呼吸道疾病,西医主要是抗病毒治疗,其次是对症支持,如果出现了咳嗽,就给予止咳药物,如果出现了咳痰,就给予祛痰药。而中医治疗的前提和基础是辨证论治,根据新的气候环境特点和人的体质特征变化,研发符合新病机的中药是解决问题的关键。
根据“风寒束表、热毒内蕴”病机,采用中药治疗呼吸道病毒性疾病,疗效确切,副作用很小。中药水煎剂量多味苦且出行携带不便,而中药合剂则量小、口感好、方便携带与服用。
发明内容
本发明涉及一种治疗呼吸道病毒的中药及其制法,本发明的中药临床应用患者依从性好,服用方便,疗效确切,副作用小。具有散寒发表、清解热毒功效。临床上主要用来治疗风寒束表、热毒内蕴的时疫、流感、普通感冒而具有无汗、恶汗 、发热、肌肉关节酸困、疼痛、头疼、咽喉疼痛、咽干咽痒、干咳少痰等。本发明中药临床上可用于四季发热性疾病和呼吸道疾病的治疗。
本发明治疗呼吸道病毒的中药方剂是在中医基础理论指导下,在传统名方“三拗汤”、“小柴胡汤”、“银翘解毒散”基础上的经典名方化裁而来,并结合本申请发明人是陕西省中医医院的丁辉主任医师,其从事临床二十余年的诊疗实践经验,依据临床疗效反馈,优化总结而成。针对时疫、流感、普通感冒等具有风寒束表、热毒内蕴证型均有较好的疗效。
本发明中药所治疾病的病因病机如下:
风寒束表、热毒内蕴在时疫、流感、普通感冒等外感热病中已经成为一个主要的证型。就其病机而言,无汗、恶汗、发热为风寒外束,肌表受邪,卫阳被遏,正邪交争;无汗,为腠理闭郁,营阴郁滞;肌肉关节酸困、身体疼痛、头疼等属于寒邪侵犯太阳经,经气运行不畅不畅所致,咽喉疼痛、咽干咽痒、干咳少痰等属于上焦热毒郁闭不宣、肺阴受伤的表现。
本发明治法治则如下:
这种病机特点恰恰具备了东汉末年和明末清初两场瘟疫的特点:内有热毒不解,外有风寒束表。这些特点就决定了其治疗原则:、“体若燔炭、汗出而散”,以辛温之药快速开太阳之表,散风寒以解被遏之卫阳,打开热毒外出之通路;/>、“辛散透达”,当外出通路打开后,以辛散清热解毒之品迅速透发在内之热毒;/>、“保胃气存津液”,给祛邪透热提供源源不断的能量。为了保证汗源充沛、津液源源不断以祛邪透热,要求患者趁热服完药后,喝热稀粥并覆被以助汗,这也是仲景发汗的必备之选。
针对这一基本病机,在传统经典理论的基础上,我们制定了银翘双解合剂,使寒热双解而散。本方根据张仲景《伤寒论》六经辨证中的太阳、少阳病的原则;《黄帝内经》中“体若燔炭、汗出而散”原则;《温病条辩》上焦病“辛散透达”的原则,并结合当前时疫以风寒束表、热毒内蕴的发病特点制定而成,本方用于时疫、流感、普通感冒具有风寒束表、热毒内蕴病机者。
本发明中药的方解如下:
方中君药为麻黄;臣药为柴胡、黄芩、广藿香、金银花、连翘、太子参;佐药为炒牛蒡子、芦根、板蓝根、玄参、白前;使药为苦杏仁、桔梗。本方以麻黄开太阳之表,散风寒解被遏之卫阳,达到通玄府、开热毒内出之道路,通过表解汗出达到退热之目的;柴胡、黄芩为少阳药,具有疏利三焦、宣通内外的作用,柴胡气质轻清,不仅协助麻黄开表,表开后黄芩可使在上焦的邪热散出,金银花、连翘、板蓝根清热解毒,在麻黄表开、柴胡升散的基础上透达热毒外出;藿香解表和中以厚肠胃;桔梗、杏仁、白前走上以宣肺,炒牛蒡子一药而独具辛散透达、解毒利咽的功效。芦根、玄参养阴生津,以护津液,太子参益气健脾、生津润肺,始终保证汗源充沛使其有汗可发。本方核心在于解除被遏之卫阳,使热邪、热毒从表而出,并充实津液之源。西药发汗药的强发其汗,由于津液产生乏源,非常容易造成热势再其而反复。为了保证汗源充沛、津液源源不断以祛邪,要求患者药喝完后,喝热稀粥并覆被以助汗。
近几年的临床运用表明,凡是符合这一病机的,其退热效果明显,能有效缓解症状,一定程度上克服了西医类退热药热势容易反复的缺点。
本发明中药组分和用量配比也是经过本申请发明人大量临床实践摸索总结从而得出来有效治疗方剂,各组分用量在下述重量份范围都有较好的临床疗效。
本专利申请的技术方案为:
一种治疗呼吸道病毒的中药,其特征在于,所述中药包括如下重量份配比的原料药:麻黄45~55份、太子参80~90份、柴胡63~73份、黄芩63~73份、广藿香63~73份、金银花80~90份、连翘80~90份、桔梗30~40份、牛蒡子80~90份、芦根130~150份、板蓝根63~73份、玄参63~73份、苦杏仁25~35份、白前63~73份。
作为本发明治疗呼吸道病毒的中药的进一步优选,所述中药包括如下重量份配比的原料药:麻黄51份、太子参86份、柴胡68份、黄芩68份、广藿香68份、金银花86份、连翘86份、桔梗34份、牛蒡子86份、芦根137份、板蓝根68份、玄参68份、苦杏仁29份、白前68份。
优选的,所述中药包括如下重量份配比的原料药:麻黄54份、太子参90份、柴胡72份、黄芩72份、广藿香72份、金银花90份、连翘90份、桔梗36份、炒牛蒡子90份、芦根144份、板蓝根72份、玄参72份、苦杏仁30份、白前72份。
所述中药的剂型为:合剂(口服液)、颗粒剂、丸剂、胶囊剂、片剂,优选为合剂。
本发明中药的制备方法包括如下步骤:
步骤:取上述麻黄、太子参、柴胡、黄芩、广藿香、金银花、连翘、桔梗、牛蒡子、芦根、板蓝根、玄参、苦杏仁、白前药材,加入药材重量8~12倍量的水,煎煮1~3次,每次煎煮时间为0.5~1.5小时,滤过,合并上述煎煮滤液;
步骤:取步骤/>合并煎煮滤液,进行减压浓缩成清膏,再加入药剂学上常用的辅料制成口服制剂。
优选的,所述步骤中加入药材重量10倍量的水,煎煮2次,每次煎煮时间为1小时。
优选的,所述步骤中所述辅料中矫味剂为:三氯蔗糖、甜菊糖、蔗糖、木糖醇。
优选的,所述步骤中所述辅料中防腐剂为羟苯乙酯、苯甲酸、苯甲酸钠、山梨酸。
本发明治疗呼吸道病毒的中药在制备治疗呼吸道感染、时疫、流感、普通感冒、新型冠状病毒感染、病毒性肺炎、咽炎、扁桃体炎药物中的应用。
本发明中药的有益效果
、本发明方药由中医经典方剂“三拗汤”、“小柴胡汤”、“银翘解散”
等诸方化裁优选,并结合本申请发明人多年来的临床实践经验,依据临床疗效反馈,不断优化、修正、总结、整理而成。该方药是由麻黄、太子参、柴胡、黄芩、藿香、金银花、连翘、桔梗、炒牛子、芦根、板蓝根、玄参、杏仁、白前、等十四味药物组成。全方君臣佐使合理配伍,共奏散寒发表、清解热毒之效。临床上用于治疗呼吸道病毒性疾病如普通感冒、流感、新冠病毒感染,对于退热、缓解各种不适安全有效。
本发明治疗呼吸道病毒感染的中药,其所对应的院内制剂产品为银翘双解合剂。主治病毒性感冒症见:恶寒、无汗、发热,咳嗽,咽喉疼痛,肌肉酸困疼痛等。本处方原以汤剂形式使用,但汤剂需现用新制,久置易霉变,不便携带,口服剂量也较大,难以满足现代制剂疗效确切、质量可控、方便生产、方便临床用药等要求,且此类患者需要服药时间较长,故而做成口服制剂比较适合。目前常用口服剂为片剂、颗粒剂、胶囊剂、合剂等。本发明中药最优选的剂型为合剂,是在汤剂基础上发展和改进的,并保持了汤剂用药特点,服用量较汤剂小,可以成批生产,省去临时配方和煎煮的麻烦,且质量相对稳定,便于服用、携带和贮藏,适合工业化生产。
、本发明制备工艺具有科学合理性,并能使得本发明中药中的所含的有效物质成分最大限度提取出来,为了达到最佳的提取效率,本发明优选最佳工艺为:分别以药材量10倍量水煎煮两次,每次1.0小时,滤过,合并滤液,浓缩至适量,加入适量三氯蔗糖(0.1g/100ml)、羟苯乙酯(0.05g/100ml)混匀,加水调整成1000ml,即得。
、本发明中药经过在临床多年反复应用验证,新冠病毒感染期间临床总有效率达95%。本发明中药治疗时疫、流感、普通感冒具有临床疗效显著,且安全方便的优势,值得临床实践中推广应用。
本发明治疗呼吸道病毒感染的中药所含原料药的来源、功效、化学成分概括如下,以便本领域技术人员更加清楚的理解。
麻黄,为麻黄科植物草麻黄Ephedra sinica Stapf中麻黄Ephedra intermediaSchrenk et C.A.Mey.或木贼麻黄Ephedraequisetina Bge.的干燥草质茎。功效为:发汗散寒,宣肺平喘,利水消肿。用于风寒感冒,胸闷喘咳,风水浮肿。麻黄化学成分复杂,含有多类化合物,其中生物碱、挥发油、多糖和黄酮类成分具有多种药理作用和主要活性成分。麻黄碱和伪麻黄碱是麻黄药材主要有效成分,麻黄中还含有包括苯丙胺类、喹啉类生物碱等成分。
太子参,为石竹科植物孩儿参Pseudostellaria heterophylla(Miq.)Pax ex Paxet Hoffm.的干燥块根。功效:益气健脾,生津润肺。用于脾虚体倦,食欲不振,病后虚弱,气阴不足,自汗口渴,肺燥干咳。太子参中主要含环肽类、苷类、糖类、氨基酸类、磷脂类、挥发油类、脂肪酸类、油脂类、甾醇类和微量元素等化学成分。
柴胡,为伞形科植物柴胡Bupleurum chinense DC.或狭叶柴胡Bupleurumscorzonerifolium Willd.的干燥根。功效:疏散退热,疏肝解郁,升举阳气。用于感冒发热,寒热往来,胸胁胀痛,月经不调,子宫脱垂,脱肛。其主要活性成分有:柴胡皂苷类、挥发油类、黄酮类、香豆素类、甾醇类、多炔类、多糖类。
黄芩,为唇形科植物黄芩Scutellaria baicalensis Georgi的干燥根。功效:清热燥湿,泻火解毒,止血,安胎。用于湿温、暑湿,胸闷呕恶,湿热痞满,泻痢,黄疸,肺热咳嗽,高热烦渴,血热吐衄,痈肿疮毒,胎动不安。黄芩的化学成分有黄酮类、萜类、酚酸类、苯乙醇、氨基酸、甾醇、挥发油、多糖和微量元素等多种成分。其中黄芩苷、黄芩素、汉黄芩苷、汉黄芩素是其主要有效成分等。
广藿香,为唇形科植物广藿香Pogostemon cablin(Blanco)Benth.的干燥地上部分。功效:芳香化浊,和中止呕,发表解暑。用于湿浊中阻,脘痞呕吐,暑湿表证,湿温初起,发热倦怠,胸闷不舒,寒湿闭暑,腹痛吐泻,鼻渊头痛。藿香中存在大量的挥发油类成分,主要为萜类(单萜、倍半萜)、酮类、酚类、醇类、醚类、酯类等化合物。从藿香中提取分离的非挥发油类成分主要包括黄酮类(黄酮类和黄酮醇等)、萜类(二萜和三萜等)、酚酸类(迷迭香酸,原儿茶酸,绿原酸,新绿原酸等)、苯丙素类、醌类、甾体等化学成分。
金银花,为忍冬科植物忍冬Lonicera japonica Thunb.的干燥花蕾或初开的花。功效:用于痈肿疔疮,喉痹,丹毒,热毒血痢,风热感冒,温病发热。金银花中的化学成分有三萜及三萜皂苷、环烯醚萜类、黄酮类、挥发油类等。
连翘,为为木犀科植物连翘Forsythia suspensa (Thunb.) Vahl的干燥果实。功效:清热解毒,消肿散结,疏散风热。用于痈疽,瘰疬,乳痈,丹毒,风热感冒,温病初起,温热入营,高热烦渴,神昏发斑,热淋涩痛。连翘属植物主要含有萜类、苯乙醇及其苷类、木脂素类、黄酮类和一些醇、酯、醚、醛、酮等类化合物。
桔梗,为桔梗科植物桔梗 Platycodon、grandiflorum (Jacq.) A.DC.的干燥根。用于咳嗽痰多,胸闷不畅,咽痛音哑,肺痈吐脓。桔梗主要化学成分有皂苷类、黄酮类、酚类、甾醇类、多糖类以及脂肪酸软脂酸、亚油酸、硬脂酸、亚麻酸、油酸、棕榈酸等多种化合物。桔梗具有止咳和化痰的功效,其中,桔梗皂苷D为主要的镇咳活性成分。
牛蒡子,为菊科植物牛蒡Arctium lappa L.的干燥成熟果实。炒牛蒡子照清炒法炒至略鼓起、微有香气。疏散风热,宣肺透疹,解毒利咽。用于风热感冒,咳嗽痰多,麻疹,风疹,咽喉肿痛,痄腮,丹毒,痈肿疮毒。牛蒡子中可提取到多种化合物成分,其中木脂素类化合物含量最为丰富,牛蒡子苷和牛蒡子苷元为主要的活性成分物质。
芦根,为禾本科植物芦苇Phragmites communis Trin.的新鲜或干燥根茎。功效:清热泻火,生津止渴,除烦,止呕,利尿。用于热病烦渴,肺热咳嗽,肺痈吐脓,胃热呕哕,热淋涩痛。芦根中含蛋白质、氨基酸、脂肪类、有机酸、糖类、维生素、无机元素、甾酮、天冬酰胺、薏苡素、生育酚以及龙胆酸、咖啡酸、阿魏酸和香草酸等酚酸类化合物。
板蓝根,为十字花科植物菘蓝Isatis indigotica Fort.的干燥根。功效:清热解毒,凉血利咽。用于温疫时毒,发热咽痛,温毒发斑,痄腮,烂喉丹痧,大头瘟疫,丹毒,痈肿。板蓝根中包括多糖类、生物碱类、苯丙素类、有机酸类及其衍生物、氨基酸类及多肽、含硫化合物芥子苷类、黄酮类、蒽醌类、甾体类、三萜类、核苷类等化合物。板蓝根生物碱类成分、木脂素、有机酸类、氨基酸类、黄酮类等成分,具有抗病毒、抗炎、解热等药理作用。
玄参,为玄参科植物玄参Scrophularia ningpoensis Hemsl.的干燥根。功效:清热凉血,滋阴降火,解毒散结。用于热入营血,温毒发斑,热病伤阴,舌绛烦渴,津伤便秘,骨蒸劳嗽,目赤,咽痛,白喉,瘰疬,痈肿疮毒。玄参化学成分包括环烯醚萜、苯丙素、萜类(三萜、二萜等)、苯酚及苯乙醇苷、甾醇、黄酮、脂肪酸、糖类等类型,其中环烯醚萜和苯丙素成分报道较多。玄参的药理作用有抗炎解热、镇痛、中枢抑制作用及抗菌作用。
杏仁,为蔷薇科植物山杏Prunus armeniaca L.var.ansu Maxim.、西伯利亚杏Prunus sibirica L.、东北杏 Prunus mandshurica (Maxim.)Koehne或杏Prunusarmeniaca L. 的干燥成熟种子。功效:降气止咳平喘,润肠通便。用于咳嗽气喘,胸满痰多,肠燥便秘。苦杏仁中含有苦杏仁苷、脂肪油、苦杏仁酶、苦杏仁苷酶、樱叶酶、氨基酸、多种维生素及矿物质元素等。
白前,为萝藦科植物柳叶白前Cynanchum stauntonii(Decne.)Schltr.ex Lévl.或芫花叶白前Cynanchum glaucescens(Decne.)Hand.-Mazz.的干燥根茎和根。功效:降气,消痰,止咳。用于肺气壅实,咳嗽痰多,胸满喘急。从白前中已分离得到多种化合物,包括C21甾体皂苷、挥发油类、三萜类、黄酮类、苯酮及其衍生物、甾醇类、木脂素类等。
为了进一步说明本发明中药制备工艺方法的创新性,我们提供筛选部分工艺优选实验数据,以期进一步说明本发明工艺技术的科学性和合理性。
1.工艺设计
(1)取麻黄、太子参、柴胡、黄芩、广藿香、金银花、连翘、桔梗、炒牛蒡子、芦根、板蓝根、玄参、苦杏仁、白前一定量,加水煎煮,合并水煎液,浓缩;(2)加入一定比例的三氯蔗糖、羟苯乙酯,混合,调整总量。
2.工艺研究
2.1仪器、试剂
沃特斯UPLC H-CLSS型超高效液相色谱仪、PDA紫外可见检测器、Empower化学工作站、ACQUITY UPLC BEH C18柱(50mm×2.1mm,1.7µm)、超声波清洗机(H66025T)、BP211D型分析天平(德国赛多利斯)、WS70-1型红外快速干燥箱(上海市吴淞五金厂制造)、FW135型粉碎机(天津市泰斯特仪器有限公司)、101型电热鼓风干燥箱(北京市永光明医疗仪器厂)、HCTP11B10架盘药物天平(北京市宣武区天平厂)。甲醇为色谱纯,水为纯净水,其他试剂均为分析纯。黄芩苷对照品(供含量测定用,110715-202203),购自中国食品药品检定研究院。
2.2提取部分工艺筛选
从资料分析可知,麻黄、太子参、柴胡、黄芩、藿香、金银花、连翘、桔梗、炒牛蒡子、芦根、板蓝根、玄参、苦杏仁、白前十四味药进行水煎既有利于有效成分的溶出,又不增加生产成本,而且符合合剂的制备要求,因此我们将其设计为水煎,通过正交试验,以黄芩中的黄芩苷含量为考察指标,并结合干浸膏量进行综合分析,重点对提取次数,加水量和提取时间进行考察,以确定最佳水提取工艺条件。
2.2.1因素水平的确定及正交表的选择
为了确定最优的提取条件,拟采用正交试验对水提取工艺中所涉及的条件进行优选,通常情况下:提取时间、加水量、提取次数对提取结果影响较大,因此,以加水量(A)、提取时间(B)、提取次数(C)作为影响因素,各选择三个水平,以L9(34)表安排试验,筛选最佳提取工艺条件。因素水平表见表1。
2.2.2试验方法
按处方比例称取麻黄9g、太子参15g、柴胡12g、黄芩12g、广藿香12g、金银花15g、连翘15g、桔梗6g、炒牛蒡子15g、芦根24g、板蓝根12g、玄参12g、苦杏仁5g、白前12g共9份,随机编成①~⑨号,按L9(34)正交表(见表3)安排进行试验,提取液滤过,测量总体积,备用。
2.2.3干膏制备
精密量取上述各提取液50mL,分别置于已恒重的蒸发皿中,水浴蒸干,残渣于105℃干燥3小时,取出,置于干燥器中放置30分钟,称重计算,结果见表2。
2.2.4 黄芩苷的含量测定
参照《中国药典》2020年版一部黄芩项下黄芩苷含量测定法测定。
色谱条件 色谱柱:ACQUITY UPLC BEH C18柱(50mm× 2.1mm,1.7µm);流动相:甲醇-0.1%磷酸水(47:53);流速:0.3mL/min;柱温:室温;检测波长:280nm;进样量:对照品1.0μL,样品0.5μL。
对照品溶液的制备:精密称取黄芩苷对照品适量,加甲醇制成每1mL含0.268mg的溶液,即得。
供试品溶液的制备:取每个正交试验所得的水提液,离心(3500r,20min)吸取上清液,用微孔滤膜(0.22μm)滤过,即得。
样品含量测定 依据中国药典2020年版四部通则0512,分别精密吸取对照品溶液1.0μL及供试品溶液各0.5μL,注入液相色谱仪,测定,结果见表2。
综合值=(黄芩苷量/最大黄芩苷量)*70+(干膏量/最大干膏量)*30
2.2.5 方差分析
依据表2正交试验安排和数据分析中的数据,进行方差分析,结果见下表3。
表2中极差R值大小显示,各因素作用主次为C>A>B,方差分析(表3)因素C有显著影响,提取2次R值达提取3次的93%;因素A、B均无显著影响。结合上述结果,同时考虑生产成本,选择A2B1C2,即加水10倍量,煎煮2次,每次1.0小时作为最佳提取工艺。
2.2.6 验证试验
按处方比例量称取药材,按优选的工艺条件进行验证试验,结果见表4。
从表4验证结果来看,黄芩苷量和干膏量均较稳定,说明优选的提取条件基本可行。
2.3成型工艺筛选
2.3.1 浓缩
本品为合剂,将提取好的溶液,经过浓缩,使体积符合要求即可。
2.3.2 防腐剂的选择
合剂属于溶液剂,我们选择常规的羟苯乙酯为本品的防腐剂,其用量参照相关规定,定为每升0.5g。
2.3.3 矫味剂的选择
常用的矫味剂有蔗糖粉、甜菊糖苷、三氯蔗糖等。其中三氯蔗糖甜度是蔗糖的600倍,是唯一一种以蔗糖为原料的甜品剂,口感纯正,稳定性高,耐酸碱,耐高温,货架期长,安全性高,ADI值15mg/kg,无热量,不参与新陈代谢,不被吸收,适合糖尿病人,肥胖病患者,心血管类疾病患者食用。因此我们选择三氯蔗糖作为矫味剂。
2.3.4矫味剂用量的选择
取浓缩液加不同比例的三氯蔗糖,尝其口感,结果见表5。
由表5结果可以看出,浓缩液:三氯蔗糖= 100:0.1的比例制备,甜味适当,口感较好。
3.1 本发明中药优化工艺制备三批样品考察
组方:麻黄510g、太子参860g、柴胡680g、黄芩680g、广藿香680g、金银花860g、连翘860g、桔梗340g、炒牛蒡子860g、芦根1370g 、板蓝根680g、玄参680g、苦杏仁290g、白前680g;
中试工艺:以上十四味,分别以10倍量水煎煮两次,每次1.0小时,滤过,合并滤液,浓缩至适量,加入适量三氯蔗糖(0.1g/100ml)、羟苯乙酯(0.05g/100ml)混匀,加水调整成10000ml,即得。
3.2中试结果见表6。
中试结果表6说明,浓缩液量和成品量基本稳定,此工艺大生产可行。
具体实施方式
为了更加充分理解本发明的实施,下面列举一个或多个实验例,下面通过典型的实施例对本发明做进一步的说明。本发明所述中药所对应的成品制剂包括不限于:银翘双解饮(本发明所对应的院内制剂)或颗粒剂,或采用本发明实施例1制备的中药水煎剂或免煎配方颗粒等不同形式的口服制剂。
实施例1 本发明中药合剂的制备
称量按照下述剂量配比:麻黄510g、太子参860g、柴胡680g、黄芩680g、广藿香680g、金银花860g、连翘860g、桔梗340g、炒牛蒡子860g、芦根1370g、板蓝根680g、玄参680g、苦杏仁290g、白前680g;以上十四味,分别以10倍量水煎煮两次,每次煎煮1.0小时,滤过,合并滤液,浓缩至适量,加入适量三氯蔗糖(0.1g/100ml)、羟苯乙酯(0.05g/100ml)混匀,加水调整成10000ml,即得。
实施例2 本发明中药合剂的制备
称量按照下述剂量配比:麻黄540g、太子参900g、柴胡720g、黄芩720g、广藿香720g、金银花900 g、连翘900 g、桔梗360 g、炒牛蒡子900 g、芦根1440 g、板蓝根720g、玄参720g、苦杏仁300g、白前720g;以上十四味,分别以10倍量水煎煮两次,每次煎煮1.0小时,滤过,合并滤液,浓缩至适量,加入适量三氯蔗糖(0.09g/100ml)、羟苯乙酯(0.06g/100ml)混匀,加水调整成10000ml,即得。
实施例3 本发明中药合剂的制备
称量按照下述剂量配比:麻黄450g、太子参900g、柴胡630g、黄芩730g、广藿香630g、金银花900g、连翘800g、桔梗400g、牛蒡子900g、芦根1500g、板蓝根730g、玄参730g、苦杏仁350g、白前630g;以上十四味,分别以12倍量水煎煮1次,每次煎煮1.5小时,滤过,合并滤液,浓缩至适量,加入适量甜菊糖(0.08g/100ml)、苯甲酸(0.04g/100ml)混匀,加水调整成10000ml,即得。
实施例4 本发明中药合剂的制备
称量按照下述剂量配比:麻黄550g、太子参800g、柴胡730g、黄芩630g、广藿香730g、金银花800g、连翘900g、桔梗300g、牛蒡子800g、芦根1300g、板蓝根630g、玄参630g、苦杏仁250g、白前730g;以上十四味,分别以8倍量水煎煮3次,每次煎煮1.0小时,滤过,合并滤液,浓缩至适量,加入适量蔗糖(0.09g/100ml)、苯甲酸钠(0.06g/100ml)混匀,加水调整成10000ml,即得。
实施例5 本发明中药颗粒剂的制备
称量按照下述剂量配比:麻黄510g、太子参860g、柴胡680g、黄芩680g、广藿香680g、金银花860g、连翘860g、桔梗340g、炒牛蒡子860g、芦根1370g、板蓝根680g、玄参680g、苦杏仁290g、白前680g;以上十四味,分别以10倍量水煎煮2次,每次1.0小时,滤过,合并滤液,减压浓缩至稠膏(相对密度为1.26~1.38),再加入淀粉,蔗糖,混合均匀,制成颗粒剂。
实施例6 本发明中药丸剂的制备
称量按照下述剂量配比:麻黄470g、太子参830g、柴胡700g、黄芩680g、广藿香710g、金银花830g、连翘860g、桔梗300g、炒牛蒡子860g、芦根1370g、板蓝根710g、玄参700g、苦杏仁300g、白前700g;以上十四味,分别以10倍量水煎煮两次,每次煎煮1.2小时,滤过,合并滤液,减压浓缩至稠膏(相对密度为1.30~1.36),加入蜂蜜,混合均匀,制丸。
实施例7 本发明中药胶囊剂的制备
称量按照下述剂量配比:麻黄530g、太子参820g、柴胡700g、黄芩680g、广藿香680g、金银花860g、连翘860g、桔梗340g、炒牛蒡子860g、芦根1400g、板蓝根680g、玄参680g、苦杏仁300g、白前700g;以上十四味,分别以10倍量水煎煮两次,每次煎煮0.8小时,滤过,合并滤液,减压浓缩至稠膏(相对密度为1.30~1.36),加入甘露醇、微晶纤维素,混合均匀,制粒,填充装入胶囊。
实施例8 本发明中药片剂的制备
称量按照下述剂量配比:麻黄510g、太子参860g、柴胡680g、黄芩680g、广藿香680g、金银花860g、连翘860g、桔梗340g、炒牛蒡子860g、芦根1370g、板蓝根680g、玄参680g、苦杏仁290g、白前680g;以上十四味,分别以10倍量水煎煮两次,每次煎煮1.0小时,滤过,合并滤液,减压浓缩至稠膏(相对密度为1.30~1.36),加入羟丙基甲基纤维素,混合均匀,制粒,压制成中药片剂。
1.本发明中药治疗新型冠状病毒感染的临床观察
1.1一般资料
收集门诊符合临床标准要求(陕西省中医医院)风寒束表、热毒内蕴证型时疫患者296例,患者年龄、病程、病情程度等一般资料进行比较,其无统计学意义(P>0.05),具有可比性。
1.2诊断标准
1.2.1西医诊断标准
1.2.1.1新型冠状病毒感染诊疗方案(试行第九版)诊断标准:
1.疑似病例。
有下述流行病学史中的任何1条,且符合临床表现中任意2条。无明确流行病学史的,符合临床表现中的3条;或符合临床表现中任意2条,同时新型冠状病毒特异性IgM抗体阳性(近期接种过新型冠状病毒疫苗者不作为参考指标)。
(1)流行病学史
①、发病前14天内有病例报告社区的旅行史或居住史;②、发病前14天内与新型冠状病毒感染者有接触史;③、发病前14天内曾接触过来自有病例报告社区的发热或有呼吸道症状的患者;④、聚集性发病(14天内在小范围如家庭、办公室、学校班级等场所,出现2例及以上发热和/或呼吸道症状的病例)。
(2)临床表现
①、发热和(或)呼吸道症状等新型冠状病毒感染相关临床表现;②、具有新型冠状病毒感染影像学特征;③、发病早期白细胞总数正常或降低,淋巴细胞计数正常或减少。
2.确诊病例
疑似病例具备以下病原学或血清学证据之一者:
(1)新型冠状病毒核酸检测阳性;
(2)未接种新型冠状病毒疫苗者新型冠状病毒特异性IgM抗体和IgG抗体均为阳性。
1.2.1.2发热的诊断标准
人体昼夜温度波动超过1℃,口腔温度超过37.3℃。
1.2.2中医辨证标准
中医证候诊断标准(参考《中医临床诊疗术语证候部分》GB/T16751.2--1997及《中药新药临床研究指导原则》2002制定)
1.2.2.1风寒束表证
主症:恶寒重,发热轻,无汗,头痛,肢节酸疼。舌苔薄白而润,脉浮或浮紧。次症:鼻塞流涕,咽痒咳嗽,痰吐稀薄色白。
1.2.2.2热毒内蕴证
主症:发热或高热,精神萎靡,咽干、咽痒、咽痛,口舌生疮,头晕头沉,肢体困重,乏力,食欲大减或无,恶心呕吐,舌质红绛,苔黄或黄褐厚燥或焦黑起刺,脉洪大或滑数。
次症:大便秘结或粘滞不爽,小便黄赤。
结合临床实践,我们将收治患者的证型总结为“风寒束表、热毒内蕴证”。
主症:恶寒,发热,头痛,无汗,咽干、咽痛、咳嗽、鼻塞、流涕、舌质红、脉浮或脉浮数。次症:肢体酸痛、喑哑、不思饮食、舌红或不红苔薄。
1.3纳入标准
符合上述诊断标准。
1.4排除标准
1)排除有消化、泌尿、血液系统等疾病感染致发热者。2)过敏体质或对多种药物过敏者,或对本次试验用药的组成成分既往有过敏史者;3)发病后已使用过治疗本病其它药物者;4)未按规定服药,无法判定疗效者,或资料不全无法判定疗效。5)具有严重的原发性心血管病变、肝脏病变、肾脏病变、血液学病变、肺脏疾病、或影响其生存的严重疾病,如肿瘤或艾滋。
1.5 治疗方法
用法用量:采用本发明实施例1制备的中药水煎剂或免煎颗粒服用,服药后喝热稀粥,盖被发汗,微微发汗即可,若无出汗,可每4小时服药一次。孕妇可正常服药,小儿服用量减半。服药期间忌辛辣刺激饮食,宜多饮水,注意休息。
注意事项:
1.过敏体质者慎用。2.本品性状发生改变时禁止使用。3.本品适用于风寒束表、热毒内蕴的时疫、流感、普通感冒。无汗、恶寒、肌肉关节酸痛,发热或尚未出现发热者均可服用,越早应用效果越佳。4.喝药时将药温服并喝热稀粥盖被子捂汗,可以起到非常好的协同治疗效果。5.如果汗出过多,则停用,补充电解质或到医院就诊。6.体温持续超过39℃不降,请配合其他降温措施或到医院就诊。
7.有虚寒性胃肠病者,可用姜汤送服。8.请将本品放在儿童不能接触的地方。9.如正在使用其他药品,使用本品前请咨询医师或药师。
1.6 疗效评价标准
疗效指数(尼莫地平法) = (治疗前积分一治疗后积分) /治疗前积分×100%
痊愈:临床症状消失或基本消失,证候积分减少≥95%。
显效:临床症状明显改善,证候积分减少≥70%。
有效:临床症状部分改善,证候积分减少≥30%。
无效:临床症状无明显改善甚或加重,证候积分减少不足30%。
1.7 治疗结果
所有病例均有流行病接触史,发热和(或)上呼吸道症状者,本研究重点关注了体温和患者临床不适,对296例呼吸道病毒感染患者的发热、恶寒、无汗、头痛、咳嗽、流涕这六种症状在治疗后24h、48h的临床疗效进行观察,结果如下:
由表7的临床观察结果可知,本发明中药治疗呼吸道病毒感染发热症状的总有效率为93%,且绝大多数患者的发热症状可在24h内得到缓解。
由表8的临床观察结果可知,患者服用本发明中药后,本发明治疗呼吸道病毒感染恶寒、无汗、头痛、咳嗽痛流涕等症状均有较高的治疗效果,患者临床症状有明显的改善,有效率均为80%以上。对咳嗽的改善率为69.7%。
1.8 不良反应
且本发明中药在临床治疗观察过程中并未发现不良反应,上述临床统计结果表明,本发明中药在治疗呼吸道病毒感染所致的时疫、流感、普通感冒方面有着显著的临床疗效,且服用安全方便,值得在临床实践中积极推广应用。
为了说明本发明中药在临床使用过程中的治疗效果,我们收集选取部分病例用药记录,以期本领域技术人员更能清楚的理解和实施本发明。
典型性病例:
病例1:秦某某,男,25岁,主诉:发热伴后枕头疼1天。现病史:患者诉本周三单位同事出现新冠病毒感染后,本周六出现发热,体温37.5℃,伴后枕紧痛,头晕,无口干及口苦,纳眠可,二便调。中医症状:舌淡胖苔薄白边稍红, 脉浮紧。
处方:麻黄9g、太子参15g、柴胡12g、黄芩12g、藿香12g、金银花15g、连翘15g、桔梗6g、炒牛蒡子15g、芦根24g、板蓝根12g、玄参12g、杏仁6g、白前12g。3付,免煎颗粒剂,日一剂,服用方法:取颗粒麻黄一格(已单独包好)、和其他颗粒各一格,用开水100~120ml冲服,服药后喝热稀粥,盖被发汗,微微发汗即可,若无出汗,可每4小时服药一次,直到微汗出后,停用麻黄,继续服用它药,一天2次即可。
服药当晚即卧床休息,身微汗出,翌日头疼除,测体温36℃,后即上班,劳累2日后家人相继发热,体温39.6℃,服用上方结合酒精擦拭额头、手足心、温水擦浴降温后热退。
病例2:邵某某,女,25岁, 主诉:发热伴头疼1天。现病史:患者诉因本单位同事出现新冠病毒感染,2022年12月13日晚出现左侧偏头痛,恶寒,身酸困疼痛,翌日测体温38.4℃,口稍干,无口苦,纳眠可,二便调。中医症状:舌淡胖苔薄白边稍红,脉浮紧。
处方:麻黄9g、太子参15g、柴胡12g、黄芩12g、藿香12g、金银花15g、连翘15g、桔梗6g、炒牛蒡子15g、芦根24g、板蓝根12g、玄参12g、杏仁6g、白前 12g。3付,水煎服,日一剂,早晚服药。
诉服药2剂后,身汗出,后退热,测体温37.3℃,休息2天后痊愈,无咳嗽,无咽痛。
病例3: 王某某, 女, 36岁,主诉:发热3天。现病史:患者诉上周六移植后头微胀痛。2天前出现低热,今日测体温38.2℃,无恶寒,身酸困,以腰臀及大腿为主。身热,无汗,无口干,咽干、伴异物感、少痰,纳可,眠一般,午休佳,大便1次/日,成型,今日大便偏干,尿利。
处方:麻黄9g、太子参15g、柴胡12g、黄芩12g、藿香12g、金银花15g、连翘15g、桔梗6g、炒牛蒡子15g、芦根24g、板蓝根12g、玄参12g、杏仁6g、白前12 g。共计3付,免煎颗粒剂,日一剂,服用方法:取颗粒麻黄一格(已单独包好)、和其他颗粒各一格,用开水100~120ml冲服,服药后喝热稀粥,盖被发汗,微微发汗即可,若无出汗,可每4小时服药一次,直到微汗出后,停用麻黄,继续服用它药,一天2次即可。再服上方1剂后汗出,呕吐2次,后热退身凉。
病例4:呼延某某,男,25岁, 主诉:发热1天。现病史:患者诉因家人出现发热,随后一日出现发热,体温39.7℃,伴咽痛、身热无汗、口干,不喜饮,伴乏力、腰痛,厌食,睡眠差,二便调。
处方:麻黄9g、太子参15g、柴胡12g、黄芩12g、藿香12g、金银花15g、连翘15g、桔梗6g、炒牛蒡子15g、芦根24g、板蓝根12g、玄参12g、杏仁6g、白前12 g。共计5付,水煎服,日一剂,早晚服药。诉服药2剂后,后退热,测体温36.5℃,伴盗汗,停药后盗汗消,后咽痛、乏力、腰痛均消,纳可,眠一般,二便调。
病例5:呼某某,男,52岁,主诉:发热1天。现病史:患者诉2022年12月19日、20日因家人相继出现发热,后又在12月22日晚出现发热,体温37.7℃,翌日38.2℃,伴体倦乏力、厌食、无口干口苦,眠可,二便调。
处方:麻黄9g、太子参15g、柴胡12g、黄芩12g、藿香12g、金银花15g、连翘15g、桔梗6g、炒牛蒡子15g、芦根24g、板蓝根12g、玄参12g、杏仁6g、白前12。5付,水煎服,日一剂,早晚服药。诉服药1剂后,后退热,测体温36.7℃,伴少汗,纳可,眠佳,二便调。
病例6:李某某,女,44岁,主诉:全身疼痛,疼痛最厉害时哭出了眼泪,同时关节僵硬,肌肉酸痛,无法正常行走,体温37.8℃。下午四点,吃银翘双解饮袋煎剂第一包后饮热稀粥卧床覆被发汗,约半个小时出汗,疼痛减半。隔三个小时,第二包,疼痛再次减少,主要头疼眼疼,局部腰疼。体温仍然37℃多,隔三个小时,服用第三包,睡觉。凌晨一点醒来,体温37℃,疼痛感基本消失。第二天,呈现感冒状态,痛感消失,体温37.5以下徘徊,早中晚三次服药。下午体温正常。晚上出去了三次,没有穿好,导致受凉,体温又开始37.8℃,吃药后卧床。凌晨体温正常。第三天至第五天,鉴于体温正常,停止服药,改吃其他中药。期间味觉嗅觉基本消失,耳鸣,喷嚏,喉痛,剧烈咳嗽。第六天、七天,又把剩下的药喝了,半夜咳嗽消失,痰也少了,嗅觉味觉听力恢复。
病例7:前途某某,女,32岁,主诉:2022年12月24日,早晨,患者出现畏寒发热、 肌肉酸痛、 最高体温39.2℃,口服布洛芬胶囊0.2g后,体温降至约38℃后,再服口服藿香正气滴丸1次,下午,出现呕吐食入即吐,补液后症状缓解。晚上及12月25日下午,服小柴胡颗粒总共3次,最高体温38.6℃,最低37.8 ℃。
由于上述诸药效果不佳,随后又服用银翘双解饮颗粒剂,按说明,间隔2小时,共口服本发明中药方剂2次,体温降至正常,后体温稍有升高,最高未超过37.5 ℃,再次服药后,体温即可降至正常。
病例8,王某某,女,34岁,主诉:2022年12月16日,早上浑身发冷,下午14点测体温39.4℃,服用银翘双解饮一袋 + 热粥一小碗,盖厚被至下午18点出汗后,体温降至38.6℃,20点左右又服用银翘双解饮一袋 + 热粥,盖厚被至晚上24点左右出汗后,体温降至37.4℃;次日上午9点左右再次服用,约2小时又出汗,汗后体温降至36.5℃;第三日下午18点左右体温又升至38.6℃,又服用了一次,晚上烧退; 此外,发烧期间严重头痛、浑身痛,腰痛到不想坐起来,烧退后痛感消失,喉咙先发痒,第三、第四天、第五天咳嗽频繁,第六天后咳嗽减少,截止目前依然觉得喉咙有痰。另外,前五天食欲严重减退,时常恶心,大概十天左右食欲恢复。
病例9,徐某,62岁,演员,2022年12月24日,开始出现全身发冷,浑身酸痛,发烧,监测体温38.2℃,患者服用一些银翘双解饮颗粒,刚好此次用上。按说明服用上述颗粒,约一小时不到,体温就降至正常。烧退后,仅有轻微的咳嗽。
病例10,王某,男,35岁,2022年12月16日,中午突发高热39.6℃,肢体酸痛,随即按说明服用银翘双解饮,汗出热退。晚上患者高热又起,在自己迷糊中一夜服用银翘双解饮8袋,晨醒后喝热水后汗出热退,测体温正常。周身疼痛几乎消失,仅余咽部稍有不适。后继服银翘双解饮2袋,善后,诸症基本消失。
Claims (8)
1.一种治疗新型冠状病毒感染的中药组合物,其特征在于,所述中药组合物由以下重量份配比的原料药组成:麻黄45~55份、太子参80~90份、柴胡63~73份、黄芩63~73份、广藿香63~73份、金银花80~90份、连翘80~90份、桔梗30~40份、牛蒡子80~90份、芦根130~150份、板蓝根63~73份、玄参63~73份、苦杏仁25~35份、白前63~73份。
2.如权利要求1所述的一种治疗新型冠状病毒感染的中药组合物,其特征在于,所述中药组合物由以下重量份配比的原料药组成:麻黄51份、太子参86份、柴胡68份、黄芩68份、广藿香68份、金银花86份、连翘86份、桔梗34份、牛蒡子86份、芦根137份、板蓝根68份、玄参68份、苦杏仁29份、白前68份。
3.如权利要求1所述的一种治疗新型冠状病毒感染的中药组合物,其特征在于,所述中药组合物由以下重量份配比的原料药组成:麻黄54份、太子参90份、柴胡72份、黄芩72份、广藿香72份、金银花90份、连翘90份、桔梗36份、炒牛蒡子90份、芦根144份、板蓝根72份、玄参72份、苦杏仁30份、白前72份。
4.如权利要求1或2所述的一种治疗新型冠状病毒感染的中药组合物,其特征在于,所述中药组合物的剂型为:合剂、颗粒剂、丸剂、胶囊剂或片剂。
5.如权利要求1或2所述的一种治疗新型冠状病毒感染的中药组合物制备方法,其特征在于,所述制备方法包括如下步骤:
步骤⑴:取上述麻黄、太子参、柴胡、黄芩、广藿香、金银花、连翘、桔梗、牛蒡子、芦根、板蓝根、玄参、苦杏仁、白前药材,加入药材重量8~12倍量的水,煎煮1~3次,每次煎煮时间为0.5~1.5小时,滤过,合并上述煎煮滤液;
步骤⑵:取步骤⑴合并煎煮滤液,进行减压浓缩成清膏,再加入药剂学上常用的辅料制成口服制剂。
6.如权利要求5所述的一种治疗新型冠状病毒感染的中药组合物制备方法,其特征在于,所述步骤⑴中加入药材重量10倍量的水,煎煮2次,每次煎煮时间为1小时。
7.如权利要求5所述的一种治疗新型冠状病毒感染的中药组合物制备方法,其特征在于,所述步骤⑵中辅料包含矫味剂,所述矫味剂选自:三氯蔗糖、甜菊糖、蔗糖、木糖醇。
8.如权利要求5所述的一种治疗新型冠状病毒感染的中药组合物制备方法,其特征在于,所述步骤⑵中辅料包含防腐剂,所述防腐剂选自:羟苯乙酯、苯甲酸、苯甲酸钠、山梨酸。
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