CN105663899A - 用于治疗肺脓肿的中药药物 - Google Patents
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Abstract
本发明提供了一种用于治疗肺脓肿的中药药物,其原料药包括薏苡仁、浙贝母、苇茎、桃仁、冬瓜子、鱼腥草、黄精、白芨、白芷、白茅根、白蔹、大蓟、小蓟、北沙参、金银花、海蛤粉、生栀子、蒲公英、桔梗、黄芩、半枝莲、半边莲、白花蛇舌草、党参、生黄芪、生白术和生甘草。本发明中药制剂可以提高患者免疫能力,改善血液循环,以及其止咳、平喘、解热的作用,实验研究发现本发明制剂亦能明显降低患者STM水平,具有良好的抗炎兼活血化瘀、疏通微循环作用,从而有效地保护患者血管内皮系统,达到较好的临床治疗效果。
Description
技术领域
本发明涉及中医药技术领域,尤其涉及一种用于治疗肺脓肿的中药药物。
背景技术
肺脓肿是由多种病原菌引起的肺实质坏死的肺部化脓性感染,由于病程长、死亡率高以及一些诊断和治疗上的问题,肺脓肿这种疾病一直都困扰着内、外科医生,在第二次世界大战以后,随着有效抗生素对原发性肺脓肿治疗效果的不断提高,使得肺脓肿的自然病程发生了改变,而外科手术治疗的作用也有了明显降低,在抗生素尚未问世之前的年代,肺脓肿呈现出进行性加重,当时对肺脓肿病人的治疗主要是支持治疗和体位引流,在当时肺脓肿的死亡率高达30%,且存活下来的病人中30%都遗留有明显的呼吸道症状,到20世纪40年代后期,由于青霉素的临床应用,以及胸外科手术技术的进步使得肺脓肿的预后有了明显改善,死亡率也有了下降,由于青霉素和其它一些抗生素的广泛应用,大多数化脓性肺炎都能得以控制,而仅有极少数的肺化脓性病变会发展成肺脓肿,这使得肺脓肿的发病率有了明显的下降,但在后来的几十年中,由于皮质备醇类药物、化疗药物、免疫抑制剂的广泛应用,使得气管一支气管树的自然环境发生了改变,从而使得继发于机体自然抵抗力降低时的机遇性肺脓肿的发病率有所上升,再加上抗生素的耐药性和吸毒人员的增加,使得肺脓肿的发病率呈现逐年上升的趋势。
祖国医学认为肺脓肿属于肺痈的范畴,本病主要成因为感受外邪,内犯于肺,或因痰热素盛,蒸灼肺脏,以致热壅血瘀,蕴酿成痈,血败肉腐化脓,按照中医理论,肺脓肿的中医辩证属于邪热入里,热毒内盛,治疗当以清热化痰、逐瘀排脓为治法,本发明中药制剂可以提高患者免疫能力,改善血液循环,以及其止咳、平喘、解热的作用,实验研究发现本发明制剂亦能明显降低患者STM水平,具有良好的抗炎兼活血化瘀、疏通微循环作用,从而有效地保护患者血管内皮系统,达到较好的临床治疗效果。
发明内容
本发明提供了一种用于治疗用于治疗肺脓肿的中药药物,可以提高患者免疫能力,改善血液循环,以及其止咳、平喘、解热的作用,实验研究发现本发明制剂亦能明显降低患者STM水平,具有良好的抗炎兼活血化瘀、疏通微循环作用,从而有效地保护患者血管内皮系统,达到较好的临床治疗效果。
本发明提供一种用于治疗肺脓肿的中药药物,其原料药包括薏苡仁、浙贝母、苇茎、桃仁、冬瓜子、鱼腥草、黄精、白芨、白芷、白茅根、白蔹、大蓟、小蓟、北沙参、金银花、海蛤粉、生栀子、蒲公英、桔梗、黄芩、半枝莲、半边莲、白花蛇舌草、党参、生黄芪、生白术和生甘草。
其中,所述中药药物中各原料药的重量份分别为薏苡仁20重量份~30重量份、浙贝母15重量份~30重量份、苇茎10重量份~20重量份、桃仁20重量份~30重量份、冬瓜子10重量份~15重量份、鱼腥草15重量份~20重量份、黄精25重量份~40重量份、白芨10重量份~25重量份、白芷10重量份~20重量份、白茅根20重量份~30重量份、白蔹15重量份~20重量份、大蓟10重量份~20重量份、小蓟10重量份~20重量份、北沙参25重量份~40重量份、金银花30重量份~45重量份、海蛤粉5重量份~10重量份、生栀子20重量份~30重量份、蒲公英15重量份~25重量份、桔梗10重量份~20重量份、黄芩20重量份~30重量份、半枝莲10重量份~20重量份、半边莲15重量份~25重量份、白花蛇舌草20重量份~30重量份、党参20重量份~40重量份、生黄芪20重量份~30重量份、生白术10重量份~20重量份和生甘草15重量份~25重量份。
其中,所述中药药物中各原料药的重量份分别为薏苡仁25重量份~30重量份、浙贝母20重量份~25重量份、苇茎10重量份~15重量份、桃仁20重量份~25重量份、冬瓜子10重量份~15重量份、鱼腥草15重量份~20重量份、黄精30重量份~35重量份、白芨15重量份~20重量份、白芷15重量份~20重量份、白茅根25重量份~30重量份、白蔹15重量份~20重量份、大蓟10重量份~15重量份、小蓟10重量份~15重量份、北沙参30重量份~35重量份、金银花35重量份~40重量份、海蛤粉5重量份~10重量份、生栀子25重量份~30重量份、蒲公英20重量份~25重量份、桔梗15重量份~20重量份、黄芩25重量份~30重量份、半枝莲10重量份~15重量份、半边莲20重量份~25重量份、白花蛇舌草25重量份~30重量份、党参30重量份~35重量份、生黄芪25重量份~30重量份、生白术15重量份~20重量份和生甘草15重量份~20重量份。
其中,所述中药药物中各原料药的重量份分别为薏苡仁30重量份、浙贝母25重量份、苇茎15重量份、桃仁20重量份、冬瓜子10重量份、鱼腥草20重量份、黄精30重量份、白芨20重量份、白芷20重量份、白茅根30重量份、白蔹15重量份、大蓟10重量份、小蓟10重量份、北沙参35重量份、金银花40重量份、海蛤粉5重量份、生栀子30重量份、蒲公英20重量份、桔梗20重量份、黄芩30重量份、半枝莲10重量份、半边莲20重量份、白花蛇舌草30重量份、党参35重量份、生黄芪30重量份、生白术20重量份和生甘草20重量份。
其中,所述中药药物的原料药经过提取获得浸膏后,将浸膏与药学上可接受的载体或稀释剂混合,制备成制剂,所述制剂的剂型优选为片剂、胶囊剂、颗粒剂、丸剂、口服液或注射剂,所述注射剂为注射液、注射用混悬液、冻干粉针。
其中,所述中药药物的采用煎煮的方式获得煎煮剂。
本发明还提供了上述中药药物的制备方法,具体为按上述重量份称取上述中药原料药分别粉碎,混合在一起,加2000ml水浸泡半小时,武火煎煮至沸腾后,改用文火煎煮30分钟,过滤,得滤液,滤渣加1500ml水再煎煮一次,过滤,得滤液,将两次滤液混合浓缩至生药浓度1g/ml,既得中药煎煮剂。
本发明还提供了一种用于治疗肺脓肿的中药煎煮剂,其原料药包括薏苡仁、浙贝母、苇茎、桃仁、冬瓜子、鱼腥草、黄精、白芨、白芷、白茅根、白蔹、大蓟、小蓟、北沙参、金银花、海蛤粉、生栀子、蒲公英、桔梗、黄芩、半枝莲、半边莲、白花蛇舌草、党参、生黄芪、生白术和生甘草;
所述中药煎煮剂的制备方法具体为按上述重量份称取上述中药原料药分别粉碎,混合在一起,加2000ml水浸泡半小时,武火煎煮至沸腾后,改用文火煎煮30分钟,过滤,得滤液,滤渣加1500ml水再煎煮一次,过滤,得滤液,将两次滤液混合浓缩至生药浓度1g/ml,既得中药煎煮剂。
有益的技术效果
本发明提供的用于治疗肺脓肿的中药药物,可以提高患者免疫能力,改善血液循环,以及其止咳、平喘、解热的作用,实验研究发现本发明制剂亦能明显降低患者STM水平,具有良好的抗炎兼活血化瘀、疏通微循环作用,从而有效地保护患者血管内皮系统,达到较好的临床治疗效果。
具体实施方式
发明提供一种用于治疗肺脓肿的中药药物,其原料药包括薏苡仁、浙贝母、苇茎、桃仁、冬瓜子、鱼腥草、黄精、白芨、白芷、白茅根、白蔹、大蓟、小蓟、北沙参、金银花、海蛤粉、生栀子、蒲公英、桔梗、黄芩、半枝莲、半边莲、白花蛇舌草、党参、生黄芪、生白术和生甘草。
祖国医学认为肺脓肿属于肺痈的范畴,本病主要成因为感受外邪,内犯于肺,或因痰热素盛,蒸灼肺脏,以致热壅血瘀,蕴酿成痈,血败肉腐化脓,按照中医理论,肺脓肿的中医辩证属于邪热入里,热毒内盛,治疗当以清热化痰、逐瘀排脓为治法,本发明中药制剂组方思路基于治则,分为以下几个要点:
1.托毒排脓
托毒排脓法及时清除脓痰是治疗该病最根本的方法,本发明制剂针对肺脓肿湿毒热盛的主要病机,湿解毒排脓,用透托法,使用薏苡仁、浙贝母、桃仁、苇茎、冬瓜子、鱼腥草、桔梗、白芷透毒排脓外出,脓毒脱出,病邪得祛,病去大半。
2.凉血止血
由于外邪侵袭,入里化热或嗜食辛辣肥甘,痰湿内生蕴久化热,邪热煎灼津液而致痰量增多。此时痰与热互结,急以清热凉血止血,因此加入白芨、白茅根、白蔹、大蓟、小蓟凉血止血,以防脓毒再生,加入半枝莲、半边莲、白花蛇舌草、生栀子、金银花、黄芩、蒲公英、清热泻火解毒,热邪得消,故无邪可煎灼津液,热腐成脓,病情转愈。
3.养阴润肺
肺为娇脏,本病对肺气、肺阴、肺脏损伤严重,因此在祛邪的同时,要加入养阴润肺的药物黄精、北沙参、海蛤粉,肺阴得补,肺体得养,有助于本病的迅速恢复。
4.培土生金
中医治疗疾病,十分重视脏腑配合,药物配伍,肺属金,脾属土,对于本病的后期调养,重视顾护脾胃,培土生金,以养脾脏充肺脏,子病治其母,加入党参、生黄芪、生白术、生甘草,补脾胃,助运化,养后天以补肺脏,配合养阴润肺药物,气阴双补,迅速恢复机体健康。
诸药合用,可以提高患者免疫能力,改善血液循环,以及其止咳、平喘、解热的作用,实验研究发现本发明制剂亦能明显降低患者STM水平,具有良好的抗炎兼活血化瘀、疏通微循环作用,从而有效地保护患者血管内皮系统,达到较好的临床治疗效果。
进一步优选,所述中药药物仅由上述原料药制备而成。
所述中药药物中各原料药的重量份分别为薏苡仁20重量份~30重量份、浙贝母15重量份~30重量份、苇茎10重量份~20重量份、桃仁20重量份~30重量份、冬瓜子10重量份~15重量份、鱼腥草15重量份~20重量份、黄精25重量份~40重量份、白芨10重量份~25重量份、白芷10重量份~20重量份、白茅根20重量份~30重量份、白蔹15重量份~20重量份、大蓟10重量份~20重量份、小蓟10重量份~20重量份、北沙参25重量份~40重量份、金银花30重量份~45重量份、海蛤粉5重量份~10重量份、生栀子20重量份~30重量份、蒲公英15重量份~25重量份、桔梗10重量份~20重量份、黄芩20重量份~30重量份、半枝莲10重量份~20重量份、半边莲15重量份~25重量份、白花蛇舌草20重量份~30重量份、党参20重量份~40重量份、生黄芪20重量份~30重量份、生白术10重量份~20重量份和生甘草15重量份~25重量份。
进一步优选,所述中药药物中各原料药的重量份分别为薏苡仁25重量份~30重量份、浙贝母20重量份~25重量份、苇茎10重量份~15重量份、桃仁20重量份~25重量份、冬瓜子10重量份~15重量份、鱼腥草15重量份~20重量份、黄精30重量份~35重量份、白芨15重量份~20重量份、白芷15重量份~20重量份、白茅根25重量份~30重量份、白蔹15重量份~20重量份、大蓟10重量份~15重量份、小蓟10重量份~15重量份、北沙参30重量份~35重量份、金银花35重量份~40重量份、海蛤粉5重量份~10重量份、生栀子25重量份~30重量份、蒲公英20重量份~25重量份、桔梗15重量份~20重量份、黄芩25重量份~30重量份、半枝莲10重量份~15重量份、半边莲20重量份~25重量份、白花蛇舌草25重量份~30重量份、党参30重量份~35重量份、生黄芪25重量份~30重量份、生白术15重量份~20重量份和生甘草15重量份~20重量份。
最优选,所述中药药物中各原料药的重量份分别为薏苡仁30重量份、浙贝母25重量份、苇茎15重量份、桃仁20重量份、冬瓜子10重量份、鱼腥草20重量份、黄精30重量份、白芨20重量份、白芷20重量份、白茅根30重量份、白蔹15重量份、大蓟10重量份、小蓟10重量份、北沙参35重量份、金银花40重量份、海蛤粉5重量份、生栀子30重量份、蒲公英20重量份、桔梗20重量份、黄芩30重量份、半枝莲10重量份、半边莲20重量份、白花蛇舌草30重量份、党参35重量份、生黄芪30重量份、生白术20重量份和生甘草20重量份。
各原料药药理如下:
薏苡仁:拉丁名CoicisSemen,味甘、淡,性微寒,入肺、脾、大肠经,具有健脾止泻,利水除痹,排疮脓的功效,主治湿困肺胃之泄泻;湿邪侵渍肌肤之全身水肿,小便不利;湿热阻于气血之痹通以及毒热蕴结于肺肠之肺痈、肠痈等证。
浙贝母:味苦,性寒,入肺、心经,具有清热化痰,散结解毒的功效,主治风热咳嗽,肺痈喉痹,瘰疬,疮疡肿毒等证。
苇茎:味甘、性寒,入心、肺经,具有清肺解毒,止咳排脓的功效,主治肺痈吐脓,肺热咳嗽,痈疽等证。
桃仁:味苦、甘,性平,归心、肝、大肠经,具有活血祛瘀,润肠通便,止咳平喘的作用,用于血淤闭经,痛经,产后瘀滞腹痛,气滞血瘀,络脉痹阻,关节痹痛,跌打损伤,淤血留于胁下,疼痛难忍,肺痈,肠痈,肠燥便秘等证。
冬瓜子:味甘、性微寒,归肺、大肠经,具有清肺化痰、消痈排脓、利湿的功效,主治咳嗽,肺痈,带下,水肿,淋证。
鱼腥草:拉丁名houttuyniaeherba,味辛,性微寒,入肺、膀胱经,具有清热解毒,排脓消痈,利尿通淋的功效,用于肺痈吐脓,痰热咳喘,热毒血痢,湿热淋证,热毒疮痈,蛇虫要上等证。
黄精:味甘,性平,入肺、脾、肾经,具有滋肾润肺,补脾益气的作用,用于阴虚肺燥,干咳痰少,消渴多饮,脾胃虚弱,脾气虚或脾阴不足,肾虚精亏,腰膝酸软,须发早白等证。
白芨:拉丁名BletillacRhizoma,味苦、甘、涩,性微寒,归肺、肝、胃经,具有补肺止血,消肿生肌,敛疮的功效,主治肺伤咳血,衄血,金疮出血,痈疽肿毒,溃疡疼痛,汤火灼伤,手足皲裂等证。
白芷:性温,味辛,归肺、脾、胃经,具有解表散寒,祛风止痛,通鼻窍,燥湿止带,消肿排脓的功效,主治头痛,眉棱骨痛,齿痛,鼻渊,寒湿腹痛,肠风痔漏,赤白带下,痈疽疮疡,皮肤燥痒,疥癣等证。
白茅根:味甘,性寒,入肺、胃、膀胱经,有凉血止血、清热利尿的作用,主要用于肺胃有积热之吐血、咳血;湿热下注蕴结膀胱之尿血;热病烦渴引饮;胃热呕吐;湿热黄疸等证。
白蔹:拉丁名AmpelopsisRadix,味苦、性微寒,归心、胃经,具有清热解毒、消痈散结、敛疮生肌的功效,主治痈疽发背、疔疮、烧烫伤等证。
大蓟:拉丁名CirsiiJaponiciHerba,性凉,味甘,苦,归心、肝经,具有凉血、止血、祛瘀、消痈肿的功效,主治吐血,衄血,尿血,血淋,血崩,带下,肠风,肠痈,痈疡肿毒,疔疮等证。
小蓟:味甘、苦,性凉,归心、肝经,具有凉血止血,祛瘀消肿的功效,用于衄血,吐血,尿血,便血,崩漏下血,外伤出血,痈肿疮毒等证。
北沙参:味甘、微苦,性微寒,具有养阴清肺,益胃生津的作用,用于肺热燥咳、劳嗽痰血、热病津伤口渴等证,黄精和北沙参结合使用可用于治疗脾胃阴虚、饥不欲食、脘腹不舒、口燥咽干,舌红少津等症。
金银花:拉丁名loniceraejaponicaeflos,味甘、性寒,入心、肺、胃、大肠经,有清热解毒的作用,兼能凉血止痢。主要用于外感风热、温热病热毒较盛,或温病初起热邪尚在上焦而未下行时;热毒下痢、大便下血;暑温证。
海蛤粉:味咸、性寒,入心肾二经,具有清热,利水,化痰,软坚的功效。主治热痰喘嗽,水肿,淋病,瘿、瘤,积聚,血结胸痛,血痢,痔疮,崩漏,带下。
生栀子:拉丁名gardeniaefructus,味苦,性寒,入心、肺、三焦,有除烦泻火、疏肝解郁、清热利湿、凉血止血的作用,主要用于温热病热郁胸脘之心烦不安、烦扰不宁;肝郁不舒或肝经有热之头晕目眩,胸胁疼痛,目赤咽干;湿热黄疸;气滞血瘀之脘腹胀痛等证。
蒲公英:拉丁名TaraxaciHerba,味甘、苦,性寒,入肝、胃经,具有清热解毒、消痈散结、清肝明目、利尿通淋的作用,主要用于疮疡肿毒的治疗,对乳痈效果尤其显著,亦可用于肝火上炎之目赤肿痛等证。
桔梗:味苦、辛,性微温,入肺经,具有祛痰止咳、宣肺排脓的功效,主治咳嗽痰多、咽喉肿痛、肺痈吐脓、胸满胁痛、痢疾腹痛、口舌生疮、目赤肿痛、小便癃闭等证。
黄芩:拉丁名ScutellariaeRadix,味苦、性寒,入心、肺、胃、胆、大肠经,有清热燥湿,泻火解毒,安胎,止血的作用,主要用于湿热所致之腹泻、痢疾、黄疸、热淋;肺热咳嗽,口渴咽痛,还可用于胎热不安,热毒火邪侵淫皮肤之疮痈毒肿之证。
半枝莲:味辛、苦,性寒,入肺经、肝经、肾经,具有清热解毒、散瘀止血、利尿消肿的作用,主治:热毒痈肿;咽喉疼痛;肺痈;肠痈;瘰疬;毒蛇咬伤;跌打损伤;吐血;衄血;血淋;水肿;腹水及癌症。
半边莲:味辛,性平,归心、小肠、肺经,具有清热解毒、利尿消肿的功效,主治蛇虫咬伤、湿热黄疸、湿疹湿疮、痈肿疔疮等证。
白花蛇舌草:味苦、甘,性寒,入心,肝,脾,大肠经,具有清热解毒,利水渗湿的作用,用于肺热喘咳,咽喉肿痛,肠痈,疖肿疮疡,毒蛇咬伤,热淋涩痛,水肿,痢疾,肠炎,湿热黄疸,癌肿等证。
党参:拉丁名CodonopsisRadix,味甘,性平,入肺、脾经,有补气益脾,养血生津的功效,主治脾肺气虚或气血两虚之倦怠乏力、气短,咳嗽自汗等证,党参长于补脾养胃,调理中焦,兼有养血的作用,其性平,健脾运而不燥;滋味阴而不湿,能够改善机体的免疫状态,提高抗病能力,促进消化吸收,提高新陈代谢,促进肠道对营养物质的吸收。
生黄芪:拉丁名astragaliradix,味甘、性温,归肺、脾经,有补益脾土,升举阳气,固表止汗,托疮生肌等作用,主要用于治疗脾肺气虚所致之乏力食少便溏,心悸气短,中气下陷之脏器下垂,气不摄血之崩漏便血,久泻脱肛;表虚不固之自汗盗汗;气血不足、阳气衰微之疮疡不起、脓成不溃、溃久不敛;以及气虚失运之水肿,小便不利等证。
生白术:拉丁名atractylodismacrocephalaerhizoma,味苦、甘,性温,归脾、胃经,具有健脾益气、燥湿利水、止汗安胎的功效,用于脾虚食少、腹胀泄泻、痰饮眩悸、水肿、自汗、胎动不安等证。
生甘草:味甘,性平,入十二经,有清热解毒,调和药性,祛痰止咳的作用,并能健脾和中,缓急止痛,主要用于脾胃虚弱之腹胀纳呆,乏力;能缓解腹中拘挛性疼痛,缓和某些药物的烈性和毒性,减轻药物对机体的毒副作用或对胃肠道的刺激。
所述中药药物的原料药经过提取获得浸膏后,将浸膏与药学上可接受的载体或稀释剂混合,制备成制剂,所述制剂的剂型优选为片剂、胶囊剂、颗粒剂、丸剂、口服液或注射剂,所述注射剂为注射液、注射用混悬液、冻干粉针。
所述药学上可接受的载体或稀释剂选自填充剂、崩解剂、粘合剂、润滑剂、矫味剂、渗透压调节剂或表面活性剂中的一种或几种。
所述中药药物也可以采用煎煮的方式获得煎煮剂,在本发明中优选使用煎煮剂。
本发明还提供了上述中药药物的制备方法,具体为按上述重量份称取上述中药原料药分别粉碎,混合在一起,加2000ml水浸泡半小时,武火煎煮至沸腾后,改用文火煎煮30分钟,过滤,得滤液,滤渣加1500ml水再煎煮一次,过滤,得滤液,将两次滤液混合浓缩至生药浓度1g/ml,既得中药煎煮剂。
以下采用实施例来详细说明本发明的实施方式,借此对本发明如何应用技术手段来解决技术问题,并达成技术效果的实现过程能充分理解并据以实施。
实施例1中药煎煮剂1
将薏苡仁30g、浙贝母25g、苇茎15g、桃仁20g、冬瓜子10g、鱼腥草20g、黄精30g、白芨20g、白芷20g、白茅根30g、白蔹15g、大蓟10g、小蓟10g、北沙参35g、金银花40g、海蛤粉5g、生栀子30g、蒲公英20g、桔梗20g、黄芩30g、半枝莲10g、半边莲20g、白花蛇舌草30g、党参35g、生黄芪30g、生白术20g和生甘草20g粉碎,混合在一起,加2000ml水浸泡半小时,武火煎煮至沸腾后,改用文火煎煮30分钟,过滤,得滤液,滤渣加1500ml水再煎煮一次,过滤,得滤液,将两次滤液混合浓缩至生药浓度1g/ml,既得中药煎煮剂1。
实施例2中药煎煮剂2
将薏苡仁25g、浙贝母20g、苇茎10g、桃仁20g份、冬瓜子10g、鱼腥草15g、黄精30g、白芨15g、白芷15g、白茅根25g、白蔹15g、大蓟10g、小蓟10g、北沙参30g、金银花35g、海蛤粉5g、生栀子25g、蒲公英20g、桔梗15g、黄芩25g、半枝莲10g、半边莲20g、白花蛇舌草25g、党参30g、生黄芪25g、生白术15g和生甘草15g粉碎,混合在一起,加2000ml水浸泡半小时,武火煎煮至沸腾后,改用文火煎煮30分钟,过滤,得滤液,滤渣加1500ml水再煎煮一次,过滤,得滤液,将两次滤液混合浓缩至生药浓度1g/ml,既得中药煎煮剂2。
实施例3中药煎煮剂3
将薏苡仁30g、浙贝母25g、苇茎15g、桃仁25g、冬瓜子15g、鱼腥草20g、黄精35g、白芨20g、白芷20g、白茅根30g、白蔹20g、大蓟15g、小蓟15g、北沙参35g、金银花40g、海蛤粉10g、生栀子30g、蒲公英25g、桔梗20g、黄芩30g、半枝莲15g、半边莲25g、白花蛇舌草30g、党参35g、生黄芪30g、生白术20g和生甘草20g粉碎,混合在一起,加2000ml水浸泡半小时,武火煎煮至沸腾后,改用文火煎煮30分钟,过滤,得滤液,滤渣加1500ml水再煎煮一次,过滤,得滤液,将两次滤液混合浓缩至生药浓度1g/ml,既得中药煎煮剂3。
毒理学检测
实施例4本发明大鼠急性毒性试验
因为本发明制剂治疗肺癌所采用的药物,较为合适的给药方式为口服给药,因此本发明制剂的毒理学研究采用灌胃给药方式进行。
实验动物:清洁级Wistar大鼠,40只,雌雄各半,由山东中医药大学动物中心提供。实验前置动物于室内适应环境-周,自由摄食和摄水,室温24±2℃,相对湿度40±2%,照明昼夜明暗交替。
实验药品:本发明制剂实施例1制备的煎煮剂1灌胃,3次/日,制成生药浓度为0.85g/ml的药液,4℃保存,备用,使用时恒温至24℃。
实验方法:按照随机数字表,将大鼠分为对照组和实验组(灌胃本发明实施例1制备的煎煮液1,制备成生药浓度0.85g/ml,相当于生药量51g/kg/d)。灌胃量为20ml/kg,对照组灌胃蒸馏水20ml/kg。连续给药7天,停药观察3天。记录大鼠体重、进食、饮水情况,记录灌胃后大鼠各项反应,灌胃间期大鼠各项生理反应,以及死亡情况。
结果与结论:通过急性毒理实验研究,观察7天大鼠灌胃后情况,灌胃给药前,各组动物体重、进食、饮水情况无统计学差异,灌胃给药后,各组大鼠体重变化、进食饮水情况,无统计学差异。行为学无明显异常,未出现死亡及其他毒性反应。本实验组剂量(生药浓度51g/kg/d),是临床成人用药的122.4倍,现代药理学认为,对于药物急性毒性实验,最大耐受量相当于人临床日用剂量100倍以上而动物无死亡,无明显毒性反应情况出现时,该药是安全的。通过本急性毒性试验验证,无毒性反应,可以认定,本药品临床用药是安全的。
实施例5本发明大鼠慢性毒性试验
通过急毒性试验研究,本发明制剂在临床人体给药的122.4倍无毒副作用,因此临床中肺癌患者需要服用本发明制剂至少3个月,因此需要进行长期毒理实验研究,验证其有无蓄积毒性或迟发毒性,特别是脏器的改变。
实验动物、实验药品同急毒性试验。
实验方法:按照随机数字表,将大鼠分为对照组和高剂量组(灌胃本发明实施例1制备的煎煮剂1,制备成生药浓度0.55g/ml,相当于生药量33g/kg/d)、低剂量组(灌胃本发明实施例1制备的煎煮剂1,制备成生药浓度0.35g/ml,相当于生药量21g/kg/d)。灌胃量为20ml/kg,对照组灌胃蒸馏水20ml/kg。连续给药60天,停药观察14天。记录大鼠体重、进食、饮水情况,记录灌胃后大鼠各项反应,灌胃间期大鼠各项生理反应,以及死亡情况。
结果与结论:实验中高低剂量分别为33g/kg/d,21g/kg/d,对应成人临床日拟用量的79.2倍、50.4倍,连续给药60d后,通过与对照组比较各项检测指标,如一般状态、体重、进食量、饮水量各组间无统计学差异。通过对各组大鼠进行组织病理学对比分析,未见明显的毒性敏感指标和毒性靶器官。停药观察2周后,高、低剂量组大鼠各项检测指标均属正常,未见迟发性毒性反应和蓄积性毒性反应。综合各组长期毒性试验结果,本发明灌胃煎煮剂应用对大鼠无明显毒副作用,临床成人拟用剂量和疗程处于安全范围。因此对应临床使用60d的疗程中,也是处于安全范围内。
实施例6临床研究
资料和方法
病例来源
2014年3月1日至2014年12月31日就诊于呼吸科门诊或住院的肺脓肿患者160例,随机分为两组,每组80人,治疗组(男35,女45,平均年龄43.35±9.51岁),对照组(男33,女47,平均年龄45.20±9.08岁)。经t检验,两组在性别,年龄等分布无统计学差异P>0.05。
诊断标准
西医诊断标准:急性起病之恶寒,发热,咳嗽,咯痰增多,肺部听诊可闻湿性罗音,尤其是局限性湿性罗音,外周血象白细胞总数升高,中性粒细胞比例增高,白细胞核左移或见胞浆中毒颗粒,X线胸片可见肺实质渗出性炎症阴影,除外支气管炎、间质性肺炎、肺结核、肺肿瘤。
中医诊断标准:咳嗽,咳吐脓血浊痰虽减少,但日久不净,或痰液一度清稀而复转臭浊,胸痛虽减轻但不消除,身热虽不高但缠绵不退,病情时轻时重,面色无华,形体消瘦,气短自汗,潮热,盗汗,舌质红,苔少或微黄,脉细或虚数。
排除标准
不符合诊断标准或误诊的病例;
入院时患者病情己进入溃脓期或恢复期;
在治疗过程中因形成脓胸而行胸腔闭式引流术者;
在治疗过程中因各种原因不愿或不能坚持治疗的病例。
治疗方法
对照组:诊断一旦明确后,立即给予抗生素、祛痰药、雾化吸入、营养支持等治疗。
治疗组:在对照组治疗基础上,每日口服本发明实施例1制备的煎煮剂200ml,早晚分温各一次。
观测指标
临床观测指标患者治疗前后的临床疗效、白细胞计数、中性粒细胞分类变化、血STM值。
检测方法治疗前后分别采集空腹静脉血1.8ml,以1:9的质量分数为3.8%的枸橼酸钠0.2ml抗凝,2h内以3000rmin速度离心10min留取上清,保存于80℃冰箱待标本齐全后37℃解冻,用双抗体夹心酶联免疫吸附试验测量可溶性血栓调节蛋白(Solublethrombmodulin,STM)浓度试剂盒由AmeriCanDiagnostiCa公司提供,酶标仪为BIORAD55O型。
安全性指标
不良反应临床表现、治疗前后血、尿、大便常规、肝肾功能、心电图。
疗效标准
痊愈:临床症状、体征均消失,X线胸片正常或呈纤维条索阴影;
有效:体温、血白细胞正常,咳嗽减轻,痰量渐少,X线胸片示炎症病灶明显吸收;
无效:症状稍改善,痰检仍可见细菌生长,X线胸片见炎性浸润无明显吸收。
统计方法
分组资料计量指标及治疗前后配对计量资料采用t检验,计数资料采用X2验,计量资料以均数士标准差表示。
结果
两组患者临床疗效比较
表1两组患者临床疗效比较
组别 | N | 痊愈 | 有效 | 无效 | 总有效率% |
对照组 | 80 | 22 | 49 | 9 | 88.75 |
治疗组 | 80 | 29 | 48 | 2* | 97.50* |
与对照组比较,*P<0.05
经统计学检验,在治疗效果上,治疗组痊愈与有效与对照组无统计学差异,但均数要高于对照组,说明疗效稍优于对照组,但是对无效患者的统计学分析,有统计学差异,说明治疗组无效率远低于对照组。
两组患者治疗后血浆STM比较。
表2两组患者治疗后血浆STM比较
治疗前后,#P<0.05;与对照组比较,*P<0.05
祖国医学认为肺脓肿属于肺痈的范畴,本病主要成因为感受外邪,内犯于肺,或因痰热素盛,蒸灼肺脏,以致热壅血瘀,蕴酿成痈,血败肉腐化脓,按照中医理论,肺脓肿的中医辩证属于邪热入里,热毒内盛,治疗当以清热化痰、逐瘀排脓为治法,本发明中药制剂可以提高患者免疫能力,改善血液循环,以及其止咳、平喘、解热的作用,实验研究发现本发明制剂亦能明显降低患者STM水平,具有良好的抗炎兼活血化瘀、疏通微循环作用,从而有效地保护患者血管内皮系统,达到较好的临床治疗效果,
实施例7实验研究
实验动物
ICR小鼠,25±3g,雄性,由山东中医药大学动物中心提供,合格证号:SCXK(鲁)2014-0315。
实验用菌株和病毒株
病毒株:甲型流感病毒A/PR8/34,由中国预防医学科学院病毒所提供。
实验用仪器
FA1004电子天平:上海天平厂;净化工作台,苏州净化设备厂;孵箱,上海分析仪器厂;CO2培养箱,德国贺利氏公司;PYX-DHS隔水势电热恒温培养箱上海跃进医疗器械厂,YXQ-280电热式压力蒸汽消毒器,上海医疗器械厂;SB2000超声波清洗器,上海中能超声有限公司。
实验条件
给药前后,实验小鼠分笼饲养全价颗粒饲料,山东天久生物技术有限公司提供,自由饮水,室温(20±2℃),湿度55%~65%。
统计方法
分组资料计量指标及治疗前后配对计量资料采用t检验,计数资料采用X2验,计量资料以均数士标准差表示。
结果
对甲型流感病毒感染小鼠的保护作用
血凝试验
根据本实验前期实验基础,确定血凝滴度为640以上,可用于甲型流感病毒感染小鼠半数致死量(LD50)滴定。
甲型流感病毒感染小鼠半数致死量(LD50)滴定
取ICR小鼠56只,体质量25±3g,随机分7组,每组8只,取增毒3次的病毒尿囊液,稀释10倍,每组滴1个病毒浓度,各组小鼠在乙醚浅麻醉下以血凝滴度为640病毒尿囊液30μL滴鼻感染小鼠,观察14d内死亡数,按Reed-Muench法计算,结果LD50为10-2.50。
本发明制剂对甲型流感病毒感染小鼠的保护作用
取ICR小鼠100只,体质量25±3g,随机分5组,每组20只:
正常对照组:等量生理盐水;模型对照组:等量生理盐水;利巴韦林组:0.1g/kg;本发明实施例1制备的煎煮剂1低剂量组:0.5mg/ml;本发明制剂高剂量组:1.0mg/ml;以上各组小鼠均灌胃给药,给药容量10ml/kg,1次/d,连续给药5d,于给药d1各组小鼠(除正常对照组外),在乙醚浅麻醉下,以血凝滴度640以上的尿囊液,给小鼠滴鼻感染,每鼠50μL(20个LD50致死量),观察动物感染后发病及死亡情况,记录14d内死亡数,结果见表3。
表3本发明制剂对甲型流感病毒感染小鼠死亡的保护作用
与模型组比较,*P<0.05
本发明制剂对甲型流感病毒感染小鼠肺指数的影响
取ICR小鼠60只,体质量25±3g。随机分6组,每组10只。分组及给药剂量,低剂量组:0.5mg/ml;本发明制剂高剂量组:1.0mg/ml;以上各组小鼠均灌胃给药,给药容量10ml/kg,1次/d,连续给药5d,于给药d1各组小鼠(除正常对照组外),各小鼠在乙醚浅麻醉下以病毒尿囊液滴鼻感染,每鼠30μL(15个LD50致死量)。实验前禁食不禁水,实验当日各组小鼠称重,脱颈处死,解剖,观察肺部病变,取全肺称重,计算各鼠肺指数值,肺指数抑制率,比较各组间差异,并取鼠肺用10%甲醛固定,作病理组织学检查。
表4本发明制剂对甲型流感病毒感染小鼠肺指数的影响
与模型组比较,*P<0.05
本发明制剂可明显延长甲型流感病毒感染小鼠存活天数,可减少感染小鼠死亡率,与病毒对照组比较具有显著性差异(P<0.05)。提示:本发明制剂对甲型流感病毒感染小鼠具有一定的保护作用。
本发明制剂能明显降低甲型流感病毒感染小鼠的肺指数值提示:本发明制剂可明显减轻甲型流感病毒所致肺部感染疾病的作用。
肺病理学检查所示:甲型流感病毒感染复制小鼠肺部感染性疾病,可造形成各种程度的化脓性支气管炎,小叶性肺炎、肺泡炎及间质性肺炎,严重者可有肺脓肿和灶性肺出血。本发明制剂具有抗甲型流感病毒所致肺部感染疾病的作用。
所有上述的首要实施这一知识产权,并没有设定限制其他形式的实施这种新产品和/或新方法。本领域技术人员将利用这一重要信息,上述内容修改,以实现类似的执行情况。但是,所有修改或改造基于本发明新产品属于保留的权利。
以上所述,仅是本发明的较佳实施例而已,并非是对本发明作其它形式的限制,任何熟悉本专业的技术人员可能利用上述揭示的技术内容加以变更或改型为等同变化的等效实施例。但是凡是未脱离本发明技术方案内容,依据本发明的技术实质对以上实施例所作的任何简单修改、等同变化与改型,仍属于本发明技术方案的保护范围。
Claims (8)
1.一种用于治疗肺脓肿的中药药物,其特征在于:原料药包括薏苡仁、浙贝母、苇茎、桃仁、冬瓜子、鱼腥草、黄精、白芨、白芷、白茅根、白蔹、大蓟、小蓟、北沙参、金银花、海蛤粉、生栀子、蒲公英、桔梗、黄芩、半枝莲、半边莲、白花蛇舌草、党参、生黄芪、生白术和生甘草。
2.如权利要求1所述的用于治疗肺脓肿的中药药物,其特征在于:各原料药的重量份分别为薏苡仁20重量份~30重量份、浙贝母15重量份~30重量份、苇茎10重量份~20重量份、桃仁20重量份~30重量份、冬瓜子10重量份~15重量份、鱼腥草15重量份~20重量份、黄精25重量份~40重量份、白芨10重量份~25重量份、白芷10重量份~20重量份、白茅根20重量份~30重量份、白蔹15重量份~20重量份、大蓟10重量份~20重量份、小蓟10重量份~20重量份、北沙参25重量份~40重量份、金银花30重量份~45重量份、海蛤粉5重量份~10重量份、生栀子20重量份~30重量份、蒲公英15重量份~25重量份、桔梗10重量份~20重量份、黄芩20重量份~30重量份、半枝莲10重量份~20重量份、半边莲15重量份~25重量份、白花蛇舌草20重量份~30重量份、党参20重量份~40重量份、生黄芪20重量份~30重量份、生白术10重量份~20重量份和生甘草15重量份~25重量份。
3.如权利要求1或2所述的用于治疗肺脓肿的中药药物,其特征在于:各原料药的重量份分别为薏苡仁25重量份~30重量份、浙贝母20重量份~25重量份、苇茎10重量份~15重量份、桃仁20重量份~25重量份、冬瓜子10重量份~15重量份、鱼腥草15重量份~20重量份、黄精30重量份~35重量份、白芨15重量份~20重量份、白芷15重量份~20重量份、白茅根25重量份~30重量份、白蔹15重量份~20重量份、大蓟10重量份~15重量份、小蓟10重量份~15重量份、北沙参30重量份~35重量份、金银花35重量份~40重量份、海蛤粉5重量份~10重量份、生栀子25重量份~30重量份、蒲公英20重量份~25重量份、桔梗15重量份~20重量份、黄芩25重量份~30重量份、半枝莲10重量份~15重量份、半边莲20重量份~25重量份、白花蛇舌草25重量份~30重量份、党参30重量份~35重量份、生黄芪25重量份~30重量份、生白术15重量份~20重量份和生甘草15重量份~20重量份。
4.如权利要求1至3所述的用于治疗肺脓肿的中药药物,其特征在于:各原料药的重量份分别为薏苡仁30重量份、浙贝母25重量份、苇茎15重量份、桃仁20重量份、冬瓜子10重量份、鱼腥草20重量份、黄精30重量份、白芨20重量份、白芷20重量份、白茅根30重量份、白蔹15重量份、大蓟10重量份、小蓟10重量份、北沙参35重量份、金银花40重量份、海蛤粉5重量份、生栀子30重量份、蒲公英20重量份、桔梗20重量份、黄芩30重量份、半枝莲10重量份、半边莲20重量份、白花蛇舌草30重量份、党参35重量份、生黄芪30重量份、生白术20重量份和生甘草20重量份。
5.如权利要求1至4所述的用于治疗肺脓肿的中药药物,其特征在于:所述中药药物的原料药经过提取获得浸膏后,将浸膏与药学上可接受的载体或稀释剂混合,制备成制剂。
6.如权利要求1至5所述的用于治疗肺脓肿的中药药物,其特征在于:所述中药药物的采用煎煮的方式获得煎煮剂。
7.权利要求1至6所述中药药物的制备方法,其特征在于:按上述重量份称取上述中药原料药分别粉碎,混合在一起,加2000ml水浸泡半小时,武火煎煮至沸腾后,改用文火煎煮30分钟,过滤,得滤液,滤渣加1500ml水再煎煮一次,过滤,得滤液,将两次滤液混合浓缩至生药浓度1g/ml,既得中药煎煮剂。
8.一种用于治疗肺脓肿的中药煎煮剂,其特征在于:原料药包括薏苡仁、浙贝母、苇茎、桃仁、冬瓜子、鱼腥草、黄精、白芨、白芷、白茅根、白蔹、大蓟、小蓟、北沙参、金银花、海蛤粉、生栀子、蒲公英、桔梗、黄芩、半枝莲、半边莲、白花蛇舌草、党参、生黄芪、生白术和生甘草;
所述中药煎煮剂的制备方法具体为按上述重量份称取上述中药原料药分别粉碎,混合在一起,加2000ml水浸泡半小时,武火煎煮至沸腾后,改用文火煎煮30分钟,过滤,得滤液,滤渣加1500ml水再煎煮一次,过滤,得滤液,将两次滤液混合浓缩至生药浓度1g/ml,既得中药煎煮剂。
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