CN105617335A - 改善癌症放化疗后胆汁反流性胃炎的柴胡陷胸汤 - Google Patents
改善癌症放化疗后胆汁反流性胃炎的柴胡陷胸汤 Download PDFInfo
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Abstract
本发明提供了一种改善癌症放化疗后胆汁反流性胃炎的柴胡陷胸汤,其原料药包括柴胡、黄芩、姜半夏、川黄连、桔梗、瓜蒌仁、枳实、生姜、青蒿、竹茹、党参、黄芪、炒白术、茯苓、无柄赤芝、炙甘草、当归、白芍、丹参、仙鹤草、陈皮、延胡索、香附、白花蛇舌草、凌霄花、薏苡仁、三棱、莪术、水蛭、制鳖甲、半枝莲和半边莲。本发明柴胡陷胸汤源自《伤寒论》小柴胡汤、小陷胸汤之法,结合现代医学研究成果,自创加味柴胡陷胸汤,针对癌症放化疗后高发病胆汁反流性胃炎进行治疗,扶正祛邪,取得了满意的疗效,并且通过了安全性测评,适用于临床推广,给癌症患者带来了福音。
Description
技术领域
本发明涉及中医药技术领域,尤其涉及一种改善癌症放化疗后胆汁反流性胃炎的柴胡陷胸汤。
背景技术
在医学上,癌是指起源于上皮组织的恶性肿瘤,是恶性肿瘤中最常见的一类。相对应的,起源于间叶组织的恶性肿瘤统称为肉瘤。有少数恶性肿瘤不按上述原则命名,如肾母细胞瘤、恶性畸胎瘤等。一般人们所说的“癌症”习惯上泛指所有恶性肿瘤。肿瘤是机体在各种致瘤因素作用下,局部组织的细胞在基因水平上失去对其生长的正常调控导致异常增生与分化而形成的新生物。新生物一旦形成,不因病因消除而停止生长,他的生长不受正常机体生理调节,而是破坏正常组织与器官,这一点在恶性肿瘤尤其明显。与良性肿瘤相比,恶性肿瘤生长速度快,呈浸润性生长,易发生出血、坏死、溃疡等,并常有远处转移,造成人体消瘦、无力、贫血、食欲不振、发热以及严重的脏器功能受损等,最终造成患者死亡。
在我国,癌症是高发疾病,对于癌症的治疗,多采取放化疗,然而,采用现有的医疗手段后,往往出现一些了并发症,如发热、病灶区疼痛、呕吐、便秘,特别是术后正气大伤,脾胃虚弱,亦有正虚邪实或正邪两虚的表现,出现胆汁反流性胃炎,影响患者依从性及疗效。西药仅能进行对证治疗,往往大量的药物使用,增加了肝肾负担,进而使机体恢复受到影响,反而出现癌症迅速恶化的不良情况,近年来,对于癌症的治疗,中药的应用越来越受重视。
现代医学认为胆汁返流性胃炎的发病与手术、饮食、精神因素密切相关,认为胃十二指肠运动功能失调与胆汁反流有关,胃动力障碍进一步加重反流的胆汁酸盐对胃粘膜损伤,二者是慢性胃炎发生发展的重要原因。
现代医学对胆汁反流性胃炎的病理机制认识从胃肠排空功能障碍到反流液对胃粘液的理化影响,到对神经系统对胃幽门功能和胃内分泌的影响进行初步的研究。
内镜的诊断价值是认可的,99mTc-EHIDA胃γ闪烁照像是检查胆汁反流最客观的指标,但条件所限,不易临床普及。应结合临床症状,以内镜诊断和其他方法为辅助诊断(X线诊断,胆红素氧化酶法等等),且一致认为胆汁反流性胃炎与幽门杆菌感染无相关性。
主要应用胃肠动力药物和胃粘膜保护剂。胃肠动力药物促进胃排空,减少胆汁在胃停留时间,从而削弱本病的致病因素,常用药物有甲氧氯普胺、多潘利酮、西沙比利等。可在一定程度上缓解症状。现代医学对BRG的认识多从胃的解剖结构、神经及相关的代谢产物等角度出发进行阐述,虽未能明了其致病机理,但对中医认识BRG也不无裨益。
古代并无胆汁返流性胃炎这个病名,但是根据病因病机及疾病表现,可以追溯到汉朝《伤寒论》,仲景以小陷胸汤治痰热互结心下的小结胸证,后世医家把握住“痰热”、“结”、“合下”三点,加减不离法度。小柴胡汤疏利气机、调达上下、宣通内外。首先从病名可清楚地了解本病是由胆汁返流而造成的胃粘膜损伤,胃炎的产生,再者中西医双轨诊断已在中医界形成共识,中医四诊与西医诊断方法兼用,可最大限度地避免漏诊和误诊,同时借鉴西医病名并无损于中医辨证论治,且更有益于中西医的学术交流和大众对本病的认知。
该病分为手术创伤、情志不节、饮食劳倦三因致病,总以损伤肝胆、脾胃脏腑精气,影响气机运行、湿热内生为致病途径。
柴胡陷胸汤原方药物组成:柴胡、黄芩、姜半夏、小川连、苦桔梗、瓜蒌仁、小枳实、生姜汁。柴胡陷胸汤为是清代名医俞根初先生所制,方载《重订通俗伤寒论》中“六经方药”之“和解剂”,具有和解兼开降之功。主治少阳证具,又见胸隔痞满,按之痛者。书中有论:“陶节庵曰:少阳证具,胸隔痞满,按之痛,若用柴胡积桔汤未效,用小柴胡合小陷胸汤。一剂即廖。妙在苦与辛合,能通能降,且瓜萎之膜瓤,似人胸中之膜隔,善涤胸中垢腻,具开隔达膜之专功,故为少阳结胸之良方。现代中医临床中,柴胡陷胸汤对于胆汁返流性胃炎、返流性食管炎疗效独特,屡起沉菏。
本发明柴胡陷胸汤,在是结合临床治疗癌症的有效药物组合,并且针对影响患者预后的胆汁反流性胃炎进行组方配伍,以纯天然中草药内服,减少了临床中对症治疗的大量的西药使用,减少了肝肾负担,抑制肿瘤的发展及转移,改善了带瘤生存质量,为癌症患者带来了复印。
发明内容
本发明所要解决的技术问题是提供一种改善癌症放化疗后胆汁反流性胃炎的柴胡陷胸汤,源自《伤寒论》小柴胡汤、小陷胸汤之法,结合现代医学研究成果,自创加味柴胡陷胸汤,针对癌症放化疗后高发病胆汁反流性胃炎进行治疗,扶正祛邪,取得了满意的疗效,并且通过了安全性测评,适用于临床推广,给癌症患者带来了福音。
基于此,本发明提供一种改善癌症放化疗后胆汁反流性胃炎的柴胡陷胸汤,其原料药包括柴胡、黄芩、姜半夏、川黄连、桔梗、瓜蒌仁、枳实、生姜、青蒿、竹茹、党参、黄芪、炒白术、茯苓、无柄赤芝、炙甘草、当归、白芍、丹参、仙鹤草、陈皮、延胡索、香附、白花蛇舌草、凌霄花、薏苡仁、三棱、莪术、水蛭、制鳖甲、半枝莲和半边莲。
其中,所述柴胡陷胸汤中各原料药的重量份分别为柴胡35重量份~50重量份、黄芩20重量份~30重量份、姜半夏20重量份~30重量份、川黄连15重量份~20重量份、桔梗15重量份~20重量份、瓜蒌仁20重量份~30重量份、枳实15重量份~25重量份、生姜10重量份~20重量份、青蒿15重量份~20重量份、竹茹15重量份~30重量份、党参25重量份~40重量份、黄芪20重量份~35重量份、炒白术20重量份~30重量份、茯苓15重量份~20重量份、无柄赤芝10重量份~15重量份、炙甘草20重量份~35重量份、当归15重量份~20重量份、白芍25重量份~35重量份、丹参20重量份~30重量份、仙鹤草15重量份~20重量份、陈皮15重量份~25重量份、延胡索15重量份~25重量份、香附10重量份~25重量份、白花蛇舌草10重量份~15重量份、凌霄花10重量份~20重量份、薏苡仁15重量份~20重量份、三棱25重量份~35重量份、莪术20重量份~30重量份、水蛭10重量份~15重量份、制鳖甲10重量份~15重量份、半枝莲15重量份~20重量份和半边莲10重量份~20重量份。
其中,所述柴胡陷胸汤中各原料药的重量份分别为柴胡40重量份~45重量份、黄芩25重量份~30重量份、姜半夏20重量份~25重量份、川黄连15重量份~20重量份、桔梗15重量份~20重量份、瓜蒌仁25重量份~30重量份、枳实20重量份~25重量份、生姜10重量份~15重量份、青蒿15重量份~20重量份、竹茹20重量份~25重量份、党参30重量份~35重量份、黄芪25重量份~30重量份、炒白术25重量份~30重量份、茯苓15重量份~20重量份、无柄赤芝10重量份~15重量份、炙甘草25重量份~30重量份、当归15重量份~20重量份、白芍30重量份~35重量份、丹参25重量份~30重量份、仙鹤草15重量份~20重量份、陈皮15重量份~20重量份、延胡索20重量份~25重量份、香附15重量份~20重量份、白花蛇舌草10重量份~15重量份、凌霄花15重量份~20重量份、薏苡仁15重量份~20重量份、三棱30重量份~35重量份、莪术25重量份~30重量份、水蛭10重量份~15重量份、制鳖甲10重量份~15重量份、半枝莲15重量份~20重量份和半边莲10重量份~15重量份。
其中,所述柴胡陷胸汤中各原料药的重量份分别为柴胡45重量份、黄芩25重量份、姜半夏25重量份、川黄连20重量份、桔梗20重量份、瓜蒌仁25重量份、枳实20重量份、生姜15重量份、青蒿20重量份、竹茹20重量份、党参35重量份、黄芪30重量份、炒白术25重量份、茯苓15重量份、无柄赤芝10重量份、炙甘草30重量份、当归20重量份、白芍30重量份、丹参25重量份、仙鹤草20重量份、陈皮20重量份、延胡索20重量份、香附20重量份、白花蛇舌草10重量份、凌霄花15重量份、薏苡仁20重量份、三棱30重量份、莪术25重量份、水蛭10重量份、制鳖甲10重量份、半枝莲20重量份和半边莲15重量份。
本发明还提供上述柴胡陷胸汤的制备方法,具体为:
将各原料药分别粉碎,混合在一起,加相对于混合物质量之和5~8倍的水,浸泡6小时~12小时,以文火煎煮,煎煮3小时~5小时,将煎煮液过滤,获得第一滤液,将过滤获得的滤渣再次加入加相对于混合物质量之和3~5倍的水中,以文火煎煮2小时~4小时,过滤获得第二滤液,将第一滤液和第二滤液混合,浓缩成1g/ml的柴胡陷胸汤。
有益的技术效果
本发明提供的专用于改善癌症放化疗后胆汁反流性胃炎的柴胡陷胸汤,针对癌症放化疗后高发病胆汁反流性胃炎进行治疗,扶正祛邪,取得了满意的疗效,并且通过了安全性测评,适用于临床推广,给癌症患者带来了福音。
具体实施方式
本发明提供一种改善癌症放化疗后胆汁反流性胃炎的柴胡陷胸汤,其原料药包括柴胡、黄芩、姜半夏、川黄连、桔梗、瓜蒌仁、枳实、生姜、青蒿、竹茹、党参、黄芪、炒白术、茯苓、无柄赤芝、炙甘草、当归、白芍、丹参、仙鹤草、陈皮、延胡索、香附、白花蛇舌草、凌霄花、薏苡仁、三棱、莪术、水蛭、制鳖甲、半枝莲和半边莲。
针对癌症放化疗术后出现胆汁反流性胃炎,本发明选用古法小柴胡汤、小陷胸汤之意,临证加减,兼顾主诉胆汁反流行胃炎,因为其癌症放化疗术后,正虚邪实或者正邪两虚,本发明中药制剂加入扶正固本药物,此外加入临床治疗肿瘤的特效药物,既可以针对现有癌症进行治疗,亦可以防治癌症转移,组方思路清晰,疗效明确,其思路如下:
一、针对胆汁反流性胃炎
本发明选用柴胡陷胸汤加青蒿、竹茹进行对症治疗,柴胡,为少阳之专药,轻清升散,疏邪透发,青蒿配合柴胡,用于疏利肝胆气机。探其经旨,其意有二:其一,柴胡之能主寒热邪气者,全在于和解少阳枢机;其二,柴胡之能推陈致新者,用其能治心腹肠胃中结气和饮食积聚。半夏,味辛性温燥,质润,归脾、胃、肺经。本发明使用姜半夏,加强器燥湿化痰,降逆止呕,消痞散结的功效。黄芩、川黄连,苦、寒,苦能燥湿,寒可清泄胸腹蕴热。黄芩与柴胡相合清泄肝胆相火;川黄连同半夏、生姜配伍,有辛开苦降,泄热开结之功。瓜蒌仁,功能清热化痰,理气宽胸散结。其性寒而润,寒可下气宽畅、润可滑痰利气,黄连、姜半夏、瓜蒌仁为小陷胸汤的配伍组合,润燥相得,苦辛相合,使清热涤痰散结之功益著。生姜,辛,温,归肺、脾、胃经。功能温中止呕,化痰降逆。本发明用生姜代替生姜汁,功同生姜汁,加入竹茹,合为开痰止呕之药对,方中与姜半夏同用辛润开达,降逆散结。枳实,具有破气除痞,化痰消积功效。常用于食积证,胃肠热结气滞证,亦可治痰滞胸脱痞满,胸痹结胸。桔梗,宣肺化痰,理气开结。本品辛散苦泄,宣开肺气,化利气,无论属寒属热皆可应用。桔梗系开肺气之药,可为诸药舟揖,载之上浮,能引苦泄峻下剂。诸药合用,迅速改善胆汁反流行胃炎,恢复脾胃功能,提高患者生存质量,增加满意度。
二、清热解毒、祛邪外出
本发明柴胡陷胸汤应用于癌症患者放化疗后胆汁反流行胃炎,然而其胆汁反流性胃炎为标,毒邪内盛的癌症为本,故加入临床中治疗多种肿瘤的中药白花蛇舌草、凌霄花、薏苡仁、三棱、莪术、水蛭、制鳖甲、半枝莲、半边莲清热解毒,化瘀消癥,除治疗对应脏器癌症外,并且可以防治肿瘤的转移,其中白花蛇舌草、凌霄花、半枝莲、半边莲针对肺癌细胞具有很好的抑制作用,薏苡仁、三棱、莪术对于消化道肿瘤具有很好的治疗作用,水蛭、制鳖甲对于肝癌、胆囊恶性肿瘤具有很好的治疗作用。诸药合用,防治多种肿瘤,清热解毒、祛邪外出。
三、扶正固本
肿瘤患者本身就是邪盛正虚或者正邪两虚,因此扶正固本,对于疾病的治疗具有十分重要的作用,本发明柴胡陷胸汤,加入党参、黄芪、炒白术、茯苓、无柄赤芝、炙甘草补脾益气,加入当归、白芍、丹参、仙鹤草养血活血,加入陈皮、延胡索、香附理气止痛,调畅三焦。诸药合用补全身气血,对预后具有十分重要的作用。
进一步优选,所述柴胡陷胸汤仅由上述原料药制备而成。
所述柴胡陷胸汤中各原料药的重量份分别为柴胡35重量份~50重量份、黄芩20重量份~30重量份、姜半夏20重量份~30重量份、川黄连15重量份~20重量份、桔梗15重量份~20重量份、瓜蒌仁20重量份~30重量份、枳实15重量份~25重量份、生姜10重量份~20重量份、青蒿15重量份~20重量份、竹茹15重量份~30重量份、党参25重量份~40重量份、黄芪20重量份~35重量份、炒白术20重量份~30重量份、茯苓15重量份~20重量份、无柄赤芝10重量份~15重量份、炙甘草20重量份~35重量份、当归15重量份~20重量份、白芍25重量份~35重量份、丹参20重量份~30重量份、仙鹤草15重量份~20重量份、陈皮15重量份~25重量份、延胡索15重量份~25重量份、香附10重量份~25重量份、白花蛇舌草10重量份~15重量份、凌霄花10重量份~20重量份、薏苡仁15重量份~20重量份、三棱25重量份~35重量份、莪术20重量份~30重量份、水蛭10重量份~15重量份、制鳖甲10重量份~15重量份、半枝莲15重量份~20重量份和半边莲10重量份~20重量份。
进一步优选,所述柴胡陷胸汤中各原料药的重量份分别为柴胡40重量份~45重量份、黄芩25重量份~30重量份、姜半夏20重量份~25重量份、川黄连15重量份~20重量份、桔梗15重量份~20重量份、瓜蒌仁25重量份~30重量份、枳实20重量份~25重量份、生姜10重量份~15重量份、青蒿15重量份~20重量份、竹茹20重量份~25重量份、党参30重量份~35重量份、黄芪25重量份~30重量份、炒白术25重量份~30重量份、茯苓15重量份~20重量份、无柄赤芝10重量份~15重量份、炙甘草25重量份~30重量份、当归15重量份~20重量份、白芍30重量份~35重量份、丹参25重量份~30重量份、仙鹤草15重量份~20重量份、陈皮15重量份~20重量份、延胡索20重量份~25重量份、香附15重量份~20重量份、白花蛇舌草10重量份~15重量份、凌霄花15重量份~20重量份、薏苡仁15重量份~20重量份、三棱30重量份~35重量份、莪术25重量份~30重量份、水蛭10重量份~15重量份、制鳖甲10重量份~15重量份、半枝莲15重量份~20重量份和半边莲10重量份~15重量份。
最优选,所述柴胡陷胸汤中各原料药的重量份分别为柴胡45重量份、黄芩25重量份、姜半夏25重量份、川黄连20重量份、桔梗20重量份、瓜蒌仁25重量份、枳实20重量份、生姜15重量份、青蒿20重量份、竹茹20重量份、党参35重量份、黄芪30重量份、炒白术25重量份、茯苓15重量份、无柄赤芝10重量份、炙甘草30重量份、当归20重量份、白芍30重量份、丹参25重量份、仙鹤草20重量份、陈皮20重量份、延胡索20重量份、香附20重量份、白花蛇舌草10重量份、凌霄花15重量份、薏苡仁20重量份、三棱30重量份、莪术25重量份、水蛭10重量份、制鳖甲10重量份、半枝莲20重量份和半边莲15重量份。
各原料药药理如下:
柴胡:拉丁名bupleuriradix,为伞形科植物柴胡或狭叶柴胡的干燥根,味苦,性微寒,归肝、胆经,具有疏散退热,升阳舒肝的功效,主治感冒发热、寒热往来、疟疾,肝郁气滞,胸肋胀痛,脱肛,子宫脱落,月经不调等证。
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。
姜半夏:味辛、性温,归脾、胃、肺经,具有降逆止呕的功效,用于呕吐反胃,胸脘痞闷,梅核气。
川黄连:味苦,性寒,入心、肺、胆、胃、大肠经,有清热燥湿,泻火解毒,凉血明目的作用,常用于治疗泻心经之火,心火旺之心烦不眠,及温热病之壮热神昏、心烦、口渴等证。
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。
瓜蒌仁:性寒,味甘,微苦,归肺、胃、大肠经,具有清热涤痰,宽胸散结,润燥滑肠的功效,主治肺热咳嗽,痰浊黄稠,胸痹心痛,结胸痞满,乳痈,肺痈,肠痈肿痛,大便秘结等证。
枳实:味苦、辛,性微寒,入脾、胃经,有破气消积,消痰除痞的作用,主要用于积滞内停、脘腹胀满、大便秘结之阳明腑实证。
生姜:味辛、性微温,入肺、脾、胃经,具有发汗解表,温中止呕,温肺止咳,解鱼蟹毒,解药毒的作用,用于脾胃虚寒,食欲减退,恶心呕吐,或痰饮呕吐,胃气不和的呕吐;风寒或寒痰咳嗽;感冒风寒,恶风发热,鼻塞头痛等证。
青蒿:拉丁名ArtemisiaeAnnuaeHerba,味苦,辛,性寒,归肝、胆经,具有清透虚热,凉血除蒸,除蒸,截疟的功效,主治暑邪发热,阴虚发热,夜热早凉,骨蒸劳热,疟疾寒热,湿热黄疸等证。
竹茹:性微寒,味甘,归肺、胃经,具有清热化痰,除烦止呕的功效,用于痰热咳嗽、胆火挟痰、烦热呕吐、惊悸失眠、中风痰迷、舌强不语、胃热呕吐、妊娠恶阻、胎动不安等证。
党参:味甘,性平,入肺、脾经,有补气益脾,养血生津的作用,主要用于脾肺气虚或气血两虚之倦怠乏力、气短,咳嗽自汗等症状,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。
黄芪:拉丁名astragaliradix,味甘,性温,入脾、肺经,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,气血不足等证。黄芪可增加细胞免疫和体液免疫功能,增加血浆中的IgM、IgA,对免疫功能有双向调节的作用。
炒白术:拉丁名Atractylodesmacrocephala,味苦,甘,性温,归脾、胃经,健脾益气,燥湿利水,止汗,安胎。用于脾虚食少,腹胀泄泻,痰饮眩悸,水肿,自汗,胎动不安。
茯苓:味甘、淡,性平,入脾、肺、膀胱、心经,有渗湿利水、健脾宁心的作用,主要用于水湿停滞之水肿,小便不利;湿热蕴结之热淋,脾虚湿困之食少便溏、痰饮停滞、癫痫等证。
无柄赤芝:味甘淡、微苦、性平、无毒,能补肺益肾、和胃健脾、安神定志、扶正培本,除对癌症、脑溢血、心脏病有疗效之外。还对胃肠、肝脏、肾脏、白血病、神经衰弱、慢性支气管炎等有显著的疗效。
炙甘草:味甘,性平,入十二经,调和药性,祛痰止咳的作用,并能健脾和中,缓急止痛,主要用于补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。
当归:拉丁名AngelicaeSinensisRadix,味甘、辛,性温,入肝、心、脾经,具有补血活血,调经止痛,润肠通便的功效,主治心血不足之头晕目眩,倦怠乏力,心悸气短,血海空虚,冲任虚寒或淤血阻滞之月经不调,经痛,产或腹痛,及其他血瘀作痛及阴虚血少肠燥之便秘等证,其能改善子宫的血液循环、减轻盆腔充血,缓解痛经。
白芍:拉丁名PaeoniaeRadixAlba,味苦、酸,性凉,入肝、脾经,具有养血柔肝,缓中止痛,敛阴收汗的功效,主治胸腹胁肋疼痛,泻痢腹痛,自汗盗汗,阴虚发热,月经不调,崩漏,带下等证。
丹参:味苦,性微寒,归心、肝经,具有活血调经,祛瘀止痛,凉血消痈,清心除烦,养血安神的功效,主治月经不调,经闭痛经,症瘕积聚,胸腹刺痛,热痹疼痛,疮疡肿痛,心烦不眠;肝脾肿大,心绞痛等证。
仙鹤草:拉丁名AgrimoniaeHerba,味苦、涩,性平,归心、肝经,具有收敛止血,止痢杀虫的功效,主治各种出血之证,例如:吐血、尿血、便血、崩漏、咯血、衄血,赤白痢疾,劳伤脱力,痈肿,跌打,创伤出血等证。
陈皮:性温,味辛、苦;归脾、肺经,用于胸腹胀满等症。橘皮辛散通温,气味芳香,长于理气,能入脾肺,故既能行散肺气壅遏,又能行气宽中,用于肺气拥滞、胸膈痞满及脾胃气滞、脘腹胀满等症,用于湿阻中焦、脘腹痞胀、便溏泄泻,以及痰多咳嗽等证。
延胡索:味苦、辛,性温,归肝、心、胃经,具有善行走散,可升可降,具有活血散瘀,行气止痛的功效,主治胸痹心痛,胁肋、脘腹诸痛,头痛、腰痛、疝气痛、筋骨痛、痛经、经闭,产后瘀腹痛,跌打损伤等证。
香附:味辛、甘、微苦,性平,归肝、三焦经,具有理气解郁,调经止痛的功效,主治肝郁气滞,胸、胁、脘腹胀痛,消化不良,月经不调,经闭痛经,寒疝腹痛,乳房胀痛等证。
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。
凌霄花:味甘、酸,性寒,归肝、心包经,具有行血去瘀,凉血祛风的功效,用于经闭癓瘕,产后乳肿,风疹发红,皮肤瘙痒,痤疮等证。
薏苡仁:性凉,味甘、淡,归脾、胃、肺经。具有健脾渗湿、清热排脓、除痹、利水的功能,用于脾胃虚弱,便溏腹泻,或妇女带下病,脾虚湿盛水肿,小便不利,或脚气肿痛;湿热痹痛,手足拘挛,酸楚疼痛;肺痈咳唾脓痰,或肠痛拘急腹痛。
三棱:味苦、辛,性平,入肝、脾经,具有破血行气,消积止痛的功效,用于血淤闭经,痛经,产后瘀滞腹痛,腹中症瘕痞块,食积气滞,脘腹胀痛等证。
莪术:味辛、苦,性温,入肝、脾经,具有破血行气,消积止痛的功效,用于气滞血瘀所致的症瘕痞块,胸腹瘀痛,闭经,痛经,脘腹胀痛,跌打损伤,血瘀肿痛等证。
水蛭:味咸、苦,性平,入肝经,具有破血逐瘀的功效,用于血淤闭经,症瘕腹痛、蓄血、损伤瘀血作痛、痈肿丹毒等症的治疗,水蛭能消除动脉周扬硬化斑块,增加心肌营养性血流量,改善心率失常。
制鳖甲:味咸,性寒,具有滋肾潜阳,软坚散结的功效,主治阴虚发热,劳热骨蒸,热病伤阴,虚风内动,小儿惊痫,疟母,经闭,溃疡,水火烫伤等证。
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:拉丁名LobeliaeChinensisHerba,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。
本发明还提供上述柴胡陷胸汤的制备方法,具体为:
将各原料药分别粉碎,混合在一起,加相对于混合物质量之和5~8倍的水,浸泡6小时~12小时,以文火煎煮,煎煮3小时~5小时,将煎煮液过滤,获得第一滤液,将过滤获得的滤渣再次加入加相对于混合物质量之和3~5倍的水中,以文火煎煮2小时~4小时,过滤获得第二滤液,将第一滤液和第二滤液混合,浓缩成1g/ml的柴胡陷胸汤。
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柴胡陷胸汤1
将柴胡45g、黄芩25g、姜半夏25g、川黄连20g、桔梗20g、瓜蒌仁25g、枳实20g、生姜15g、青蒿20g、竹茹20g、党参35g、黄芪30g、炒白术25g、茯苓15g、无柄赤芝10g、炙甘草30g、当归20g、白芍30g、丹参25g、仙鹤草20g、陈皮20g、延胡索20g、香附20g、白花蛇舌草10g、凌霄花15g、薏苡仁20g、三棱30g、莪术25g、水蛭10g、制鳖甲10g、半枝莲20g和半边莲15g分别粉碎,混合在一起,加5kg的水,浸泡12小时,以文火煎煮,煎煮5小时,将煎煮液过滤,获得第一滤液,将过滤获得的滤渣再次加入3kg的水中,以文火煎煮4小时,过滤获得第二滤液,将第一滤液和第二滤液混合,浓缩成1g/ml的柴胡陷胸汤。
实施例2柴胡陷胸汤2
将柴胡40g、黄芩25g、姜半夏20g、川黄连15g、桔梗15g、瓜蒌仁25g、枳实20g、生姜10g、青蒿15g、竹茹20g、党参30g、黄芪25g、炒白术25g、茯苓15g、无柄赤芝10g、炙甘草25g、当归15g、白芍30g、丹参25g、仙鹤草15g、陈皮15g、延胡索20g、香附15g、白花蛇舌草10g、凌霄花15g、薏苡仁15g、三棱30g、莪术25g、水蛭10g、制鳖甲10g、半枝莲15g和半边莲10g分别粉碎,混合在一起,加5kg的水,浸泡12小时,以文火煎煮,煎煮5小时,将煎煮液过滤,获得第一滤液,将过滤获得的滤渣再次加入3kg的水中,以文火煎煮4小时,过滤获得第二滤液,将第一滤液和第二滤液混合,浓缩成1g/ml的柴胡陷胸汤。
实施例3柴胡陷胸汤3
将柴胡45g、黄芩30g、姜半夏25g、川黄连20g、桔梗20g、瓜蒌仁30g、枳实25g、生姜15g、青蒿20g、竹茹25g、党参35g、黄芪30g、炒白术30g、茯苓20g、无柄赤芝15g、炙甘草30g、当归20g、白芍35g、丹参30g、仙鹤草20g、陈皮20g、延胡索25g、香附20g、白花蛇舌草15g、凌霄花20g、薏苡仁20g、三棱35g、莪术30g、水蛭15g、制鳖甲15g、半枝莲20g和半边莲15g分别粉碎,混合在一起,加5kg的水,浸泡12小时,以文火煎煮,煎煮5小时,将煎煮液过滤,获得第一滤液,将过滤获得的滤渣再次加入3kg的水中,以文火煎煮4小时,过滤获得第二滤液,将第一滤液和第二滤液混合,浓缩成1g/ml的柴胡陷胸汤。
实施例4药理学急毒性试验
本发明中药使用药物柴胡、黄芩、姜半夏、川黄连、桔梗、瓜蒌仁、枳实、生姜、青蒿、竹茹、党参、黄芪、炒白术、茯苓、无柄赤芝、炙甘草、当归、白芍、丹参、仙鹤草、陈皮、延胡索、香附、白花蛇舌草、凌霄花、薏苡仁、三棱、莪术、水蛭、制鳖甲、半枝莲、半边莲,组方配伍得当,符合中华人民共和国药典规定,并通过了药物的安全性评估,具体毒理研究如下:
实验动物:SPF级,昆明小鼠,40只,20±2g,雌雄各半,由山东中医药大学动物实验中心提供,动物合格证号SCXK(鲁)2013-0140。
受试药物
实验组:采用本发明实施例1制备的柴胡陷胸汤1,浓缩成相当于含生药量1.35g/ml的溶液,4℃保存备用。
对照组:0.9%生理盐水,其余条件同本发明药物组。
实验方法:取SPF级,昆明小鼠40只,雌雄各半,适应性饲养一周。按随机数表法,将小鼠分为2组,分别是对照组20只,实验组20只,雌雄各半,分笼饲养。
实验前,各组小鼠禁食不禁水12h,对照组灌胃蒸馏水0.1ml/10g体重,3次/日,实验组,灌胃本发明的柴胡陷胸汤1,0.1ml/10g体重,3次/日,给药间隔4h。连续给药7天,停药观察3天。
观察指标
观察给药期间及停药观察期间,各组小鼠的一般情况,如发育情况(体温、体重、心率),皮毛情况,精神状态,各天然孔情况,自主活动情况。
根据实验要求,给药期间出现动物死亡,立即解剖,观察各脏器情况,剥离各脏器,称重,并计算脏器指数,心脏取血理化检测;如无死亡,则根据实验要求,在观察期后,予10%水合氯醛麻醉,打开腹腔,观察各脏器情况,腹主动脉取血处死,做理化检测,剥离各脏器,称重,并计算脏器指数。
结果
实验期间无小鼠死亡,根据实验安排进行相关检测。
给药期间及停药观察期间,各组小鼠在体重、体温等基础体征,无明显异常,两组比较,无统计学差异,外观正常,无畸形,皮毛色泽正常,精神状态良好,各天然孔干净,无异常分泌物,自主活动正常,无异常行为。
根据实验要求,在观察期后,予10%水合氯醛麻醉,腹主动脉取血处死,打开腹腔,观察各脏器情况,各组小鼠脏器排列正常,无粘连,无出血,所取血液做理化检测,各组小鼠血常规无异常,肝功、肾功检查无异常,剥离各脏器,称重,计算脏器指数,经统计学分析,无统计学差异,两组同期进行比较,统计学无差异。
通过小鼠急性毒性试验,小鼠给药量为40.5g/kg/d,换算成正常成人给药量405g/kg/d(小鼠与60kg健康成人换算系数为10.09),为正常成人每日给药量的135倍(正常60kg成人中药摄入量为3.5g/kg/d),一般认为,动物实验中,给药为人100倍以上,而无明显毒副作用,可以认为药物是安全的。通过本实验可以证实,本发明柴胡陷胸汤在急性毒性试验中,无急性毒性反应,无迟发毒性,基本可以认为是安全的,故临床使用是安全的。
实施例5药理学长期毒性试验
实验动物:同急毒性试验
受试药物
实验组:本发明实施例1制备的柴胡陷胸汤1,制备成相当于含生药量1.05g/ml、0.75g/ml、0.45g/ml的溶液,4℃保存备用。
对照组:灌胃生理盐水,其余条件同本发明药物组。
实验方法
取SPF级,昆明小鼠40只,雌雄各半,适应性饲养一周。按随机数表法,将小鼠分为2组,分别是对照组10只、高剂量组10只、中剂量组10只、低剂量组10只,雌雄各半,分笼饲养。
实验前,各组小鼠禁食不禁水12h,对照组灌胃蒸馏水0.1ml/10g体重,2次/日,高、中、低剂量组,分别灌胃本发明柴胡陷胸汤1.05g/ml、0.75g/ml、0.45g/ml,2次/日,给药间隔6h。连续给药14天,停药观察7天。
观察指标
观察给药期间及停药观察期间,各组小鼠的一般情况,如发育情况(体温、体重、心率),皮毛情况,精神状态,各天然孔情况,自主活动情况。
根据实验要求,给药期间出现动物死亡,立即解剖,观察各脏器情况,剥离各脏器,称重,并计算脏器指数,心脏取血理化检测;如无死亡,则根据实验要求,在观察期后,予10%水合氯醛麻醉,打开腹腔,观察各脏器情况,腹主动脉取血处死,做理化检测,剥离各脏器,称重,并计算脏器指数。
结果
实验期间无小鼠死亡,根据实验安排进行相关检测。
给药期间及停药观察期间,各组小鼠在体重、体温等基础体征,无明显异常,两组比较,无统计学差异,外观正常,无畸形,皮毛色泽正常,精神状态良好,各天然孔干净,无异常分泌物,自主活动正常,无异常行为。
根据实验要求,在观察期后,予10%水合氯醛麻醉,腹主动脉取血处死,打开腹腔,观察各脏器情况,各组小鼠脏器排列正常,无粘连,无出血,所取血液做理化检测,各组小鼠血常规无异常,肝功、肾功检查无异常,剥离各脏器,称重,计算脏器指数,经统计学分析,无统计学差异,两组同期进行比较,统计学无差异。
通过小鼠长期毒性试验,小鼠给药量为21g/kg/d、15g/kg/d、9g/kg/d,换算成正常成人给药量210g/kg/d、150g/kg/d、90g/kg/d,为正常成人每日给药量的60倍、42.86倍、25.71倍,通过本实验可以证实,本发明柴胡陷胸汤在长期毒性试验中,无蓄积毒性,无迟发毒性,基本可以认为是安全的,故临床使用是安全的。
实施例6临床研究
原发性肝癌是我国常见的恶性肿瘤,发病率仅次于胃癌、食道癌,且发病率称上升趋势,预后较差,原发性肝癌经放化疗后,胆汁反流性胃炎发病率极高,其中肝动脉介入治疗是近年来治疗原发性肝癌的非手术治疗,其疗效肯定,但是并发症也十分明显,因此,本发明柴胡陷胸汤选取该病进行临床研究进行描述。
原发性肝癌西医诊断标准
符合《中国常见恶性肿瘤诊治规范》原发性肝癌诊断标准。
1.如无其他肝癌证据,AFP对流法阳性或放免法>400μg/ml,持续四周以上,并能排除妊娠、活动性肝病、生殖腺胚胎源性肿瘤及转移性肝癌者。
2.影像学检查有明确肝内实质性占位病变,能排除肝血管瘤和转移性肝癌,并具有下列条件之一者:①AFP>200mg/mI。②典型的原发性肝癌影像学表现。②无黄疸而AKP或r-GT明显增高。④远处有明确的转移性病灶或有血性腹水,或在腹水中找到癌细胞。⑤明确的乙型肝炎标志物阳性的肝硬化。
胆汁反流性胃炎西医诊断标准
胆汁反流性胃炎患者胃部饱胀感或不适,往往饭后加重,或有胃痛,或胃部发凉,可伴腹胀、嗳气、反酸、烧心、恶心、呕吐、胃振水音、肠鸣、排便不畅、食欲减退和消瘦等;严重的还可有胃出血,表现为呕血或排黑便(柏油样便)以及大便潜血试验呈阳性等。
1)胃镜检查:可直接看到胃液较多,呈草绿色,胃粘膜充血、水肿、或呈糜烂;幽门口开放,胆汁从十二指肠通过幽门反流至胃病理活组织检查提示胃炎。
2)胃吸出物测定:插胃管抽吸空腹和餐后胃液,测定其中胆酸含量,如空腹基础胃酸分泌量(BAO)<3.5mmol/h,胆酸超过30μg/ml,则可确诊胆汁返流性胃炎。
3)同位素测定:静脉注射2mCI99mTc-丁亚胺双醋酸,每隔5分钟观察肝及胆道共1小时。1小时病人员饮100ml水,内含0.3mCI99mTc,以准确测定胃的位置。随后在2小时内,每15分钟检查肝、胆囊及胃区,决定肠胃返流指数。正常值为8.6±6.0。也可用99mTc标记的溶液注入十二指肠或空肠上段,然后描记胃内同位素的含量,用以了解肠胃返流的程度。
中医诊断标准
中医辨证分型标准
符合《中医内科学》肝癌诊断标准。
肝癌是以脏腑气血亏虚为本,气、血、湿、热、瘀、毒互结为标,蕴结于肝,渐成症积,肝失疏泄为基本病机,以右胁肿硬疼痛,消瘦,食欲不振,乏力,或有黄疸或昏迷等为主要表现的一种恶性疾病。
1.不明原因的右胁不适或疼痛,原有肝病症状加重伴全身不适、胃纳减退、乏力、体重减轻等均应纳人检查范围。
2.右胁部肝脏进行性肿大,质地坚硬而拒按,表面有结节隆起,为有诊断价值的体征,但已属中晚期。
3.结合肝区B超、Cr扫描、Mm、肝穿刺、血清学检查(如甲胎球蛋白等)等,有助于明确诊断。
病例来源和分组
所观察的159例病例全部来自2013年9月-2014年12月的门诊及住院病人。采用随机对照临床试验方法,将所观察病例分为治疗组和对照组。治疗组82例,男40例,女42例;年龄22-61岁,平均年龄为42.15±4.45岁;病程4月-15年。对照组77例,男47例,女40例;年龄23-60岁,平均年龄41.01±4.32岁;病程3月-14年。两组在性别、年龄、病程等方面经统计学分析无显著性差异(P>0.05),具有可比性。
纳入标准
年龄在18~70岁,符合中西医诊断标准,并且进行肝动脉介入治疗,出现胆汁反流行胃炎的症状,卡氏评分≥60分。
排除标准
有严重的循环、呼吸、血液、内分泌和肾脏等系统疾病者;对本发明中药部分成分或者全方煎煮液过目者。
治疗方法
治疗组
本发明实施例1制备的柴胡陷胸汤1,50ml/次,2次/日,分早、晚两次温服,2周为一疗程。
对照组
给与消炎利胆片,江西瑞金三九药业有限公司,国药准字Z20134268,6片/次,2次/日,口服,温水送服。
以上服药疗程为2周,嘱两组患者在治疗期间注意饮食,尽量避免情绪刺激。
疗效标准
治愈:临床症状、体征完全消失,影像学检查结果正常
显效:临床症状、体征基本消失,影像学检查结果明显改善
有效:临床症状、体征大部分消失,影像学检查结果有所改善
无效:临床症状、体征及影像学检查结果均较治疗前无改善
统计方法
采用SPSS15.0统计分析软件进行统计学处理,计量资料用表示,采用t检验;计数资料用X2检验;等级资料用Ridit分析或秩和检验。
治疗结果
两组临床综合疗效比较,见表1。
表1两组临床疗效综合评价
组别 | N | 治愈 | 显效 | 有效 | 无效 | 总有效率 |
治疗组 | 82 | 21 | 24 | 32 | 3 | 96.34% |
对照组 | 77 | 15 | 15 | 36 | 11 | 85.71% |
治疗前后组内比较P<0.05有显著差异,说明治疗前后有统计学差异;治疗组与对照组比较,经ridit分析,得P<0.05,说明两组直接疗效有统计学差异,治疗组疗效优于对照组。
两组治疗后中医临床症状改善比较,见表2。
表2症状积分改善比较
治疗前后组内比较P<0.05有显著差异,说明治疗前后有统计学差异;治疗组与对照组比较,经ridit分析,得P<0.05,说明两组直接疗效有统计学差异,治疗组疗效优于对照组。
通过实验研究证实,本发明柴胡陷胸汤对于原发性肝癌介入治疗后出现的胆汁反流性胃炎具有很好的治疗作用,优于传统药物治疗,适用于临床推广。
实施例7实验研究
实验一本发明柴胡陷胸汤对于胆汁反流性胃炎小鼠的影响
1材料与方法
实验动物:SD大鼠。
实验用药
对照组:达喜,国药准字:H20013410,产品批号:130128;吗丁啉(西安杨森制药有限公司),国药准字:H10910003,产品批号130208,制备成达喜-吗丁啉混合液,即(2.5mg达喜+0.4mg吗丁啉)/ml,灌胃量按10ml/kg体重。
实验组:本发明实施例1制备的柴胡陷胸汤,制备成0.87g/ml,灌胃量按10ml/kg体重,4℃保存备用。
空白组:给与生理盐水灌胃,10ml/kg体重。
模型对照组:给与生理盐水灌胃,10ml/kg体重。
以牛磺胆酸钠、胰酶、卵磷脂溶于水中配制成模拟胆汁反流液(胆汁反流液的制备:牛磺胆酸钠2.5g,胰酶1.5g,卵磷脂0.25g,溶于100ml蒸馏水中),反流液①可改变胃粘液特性、破坏胃粘膜屏障、刺激肥大细胞释放组胺、炎性渗出物增多、血流量减少;②使胃窦分泌胃泌素增加、胆汁激活卵磷脂酶A、胰酶引起粘膜损伤、导致炎症的存在。
动物分组及给药方法
取健康大鼠40只,雌雄各半,体重120~160g,根据体重均衡原则随机分为空白组、模型组、阳性组、实验组4组,每组10只。
①空白组灌胃蒸馏水,体积10ml/kg,每日1次。
②模型组灌胃反流剂,体积10ml/kg,每日1次。
③阳性组灌胃达喜吗丁啉混合液,达喜浓度为2%,吗丁啉浓度为0.04%,体积10ml/kg,1h后灌胃反流剂,体积10ml/kg,每日1次。
④实验组,本发明提供的柴胡陷胸汤,体积10ml/kg,1h后灌胃反流剂,体积10ml/kg,每日1次。
以上4组均给药30d。
样本处理
甲基橙胃残留率检测:于末次给药后禁食12h后,灌胃0.1%甲基橙溶液2mL/只,30min后①用10%的乌拉坦麻醉,备皮,开腹,迅速结扎贲门和幽门。②切除胃囊,清洗收集胃残留液,定容至10ml。③以2000转/分离心,取上清液于分光光度计在420nm处测定吸光度值,以0.1%甲基橙2mL加入10mL蒸馏水摇匀后测量其吸光度值,作为基数甲基橙光密度,按下列公式计算甲基橙胃残留率:
甲基橙胃残留率(%)=胃甲基橙吸光度值/基数甲基橙光密度×100%
甲基橙胃残留率的高低可反映胃排空的快慢(实验过程中模型、阳性、实验组均死亡2只)胃黏膜病理形态变化检测:于末次给药后禁食12h后,在实验1基础上测定完甲基橙残留率后将胃部延大弯剪开胃壁,并使胃黏膜面外翻,生理盐水漂洗3遍后浸泡于4%甲醛溶液固定,石蜡包埋,做厚4μm切片用于HE染色,观察胃黏膜病理形态变化。根据评分标准评分后用T检验进统计结果(实验过程中模型、阳性、实验组均死亡2只)。
评分标准:①炎细胞浸润轻度:炎细胞浸及黏膜表层,数量较少,计1分;中度:炎细胞浸入黏膜上2/3层,数量较多,计2分;重度:大量炎细胞浸入黏膜全层或肌层,计3分。②肠上皮化生轻度:占切片腺体1/3以下,计1分;中度:占切片腺体1/3~2/3,计2分;重度:几乎整个腺体被肠化上皮所代替,计3分。③腺体增生:根据腺管组织结构的异型性、上皮细胞的异型性及分化不成熟性,也相应分为轻、中、重3级,分别计1、2、3分。无症状者计0分。
数据统计
统计学处理采用SPSS15.0统计软件分析实验结果,计量资料的数据以均数±标准差表示,用配对资料均数的t检验来检验其统计学意义,用P值来表示其差异性。
结果
对胃排空的影响,见表3。
表3本发明柴胡陷胸汤对大鼠胆汁反流性胃炎模型胃排空的影响
组别 | N | 甲基橙胃残留率% |
空白组 | 10 | 31.8±4.2 |
模型组 | 10 | 49.5±4.8 |
对照组 | 10 | 28.3±3.7* |
实验组 | 10 | 29.1±4.0* |
与模型组比较,*P<0.05
由表3可见,模型组甲基橙胃残留率明显高于空白组(P<0.05)。与模型组比较,实验组及阳性组,可使大鼠甲基橙胃残留率明显低于模型组(P<0.05)。以上表明,本发明柴胡陷胸汤明显降低甲基橙胃残留率,促进大鼠胃排空。
对胃黏膜病理改变的影响,见表4。
表4本发明柴胡陷胸汤对胆汁反流性胃炎模型大鼠胃黏膜病理改变的影响
组别 | N | 评分结果腺体增生 | 炎细胞浸润 | 肠上皮化生 |
与模型组比较,*P<0.05
从表4可见,与空白对照组比较,模型组胃黏腺体增生、膜炎细胞浸润、肠上皮化生评分明显提高(P<0.05),说明反流性胃炎模型成立。
以上表明,本发明柴胡陷胸汤可减轻胃黏膜腺体增生、炎细胞浸润、肠上皮化生。
本发明柴胡陷胸汤可以减轻胃黏膜腺体增生、肠上皮化生、炎细胞浸润,提高胃排空率来达到于胆汁反流性胃炎具有很好的治疗作用。
实验二本发明柴胡陷胸汤体外抗肿瘤实验研究
材料
人胃癌细胞(Sgc)、人卵巢癌细胞(A2780)、肝癌细胞(HepG2)山东中医药大学中药学院惠赠。
本发明中药材购自同仁堂(济南)药店,并经山东中医药大学中药学院鉴定,符合2010年版药典相关要求。
其他所需化学试剂均由山东中医药大学中药学院提供。
主要仪器
HH-4型恒温水浴锅(江苏金坛市宏华仪器厂)
DZF-6021型真空干燥箱(上海精密实验设备有限公司)
LGJ冷冻干燥机(北京四环科学仪器厂)
AUW220D电子天平(日本岛津公司)
CO2恒温培养箱(MCO-15AC,日本SANYO公司)
生物倒置显微镜(XDS-18,重庆水电仪器总公司)
倒置荧光显微镜(TE2000,日本Nikon公司)
酶标检测仪(Rt2100c,美国Rayto)
方法
实验组:实施例1制备的柴胡陷胸汤,制备成浓度为200μg/ml。
肿瘤细胞培养
Sgc采用1640培养基,A2780和HepG2采用DMEM高糖培养基,在5%CO2、37℃细胞培养箱培养,细胞呈贴壁生长,用0.25%的胰酶消化传代,用于实验的细胞均处于对数生长期。
本发明柴胡陷胸汤对肿瘤细胞的抑制作用
将对数生长期的肿瘤细胞用胰蛋白酶消化后配制成密度为104个/mL的细胞悬液,按10000细胞/孔接种于96孔板,每孔加200μl。然后将平板置37℃、5%CO2湿度培养箱中24h后,于24、48、72h分别加入各个细胞样品对应的本发明柴胡陷胸汤(50、100、200、400μg/mL)的培养基,每个样本质量浓度设定平行的3个孔,对照组加不含本发明柴胡陷胸汤的培养液200μl,再放入培养箱中孵育。每孔加入用按5mg/mL新鲜配制的MTT溶液50μl,孵育4h,使MTT还原为甲瓒,当在倒置显微镜下看到孔板内的细胞周围出现丝状紫色结晶体时去除上清液,每孔加二甲基亚砜200μl,当平板摇床摇匀后,再使用酶标仪测定光密度值(检测波长570nm),以溶剂对照处理细胞为对照组,按公式计算本发明柴胡陷胸汤对细胞的抑制率。抑制率=(1-实验组/空白组)×100%。
数据处理
采用SPSS15.0统计软件进行分析,计量资料用表示,组间比较用t检验,P<0.05表明差异有统计学意义。
结果
本发明柴胡陷胸汤对3种肿瘤细胞增殖抑制作用
本发明柴胡陷胸汤对3种肿瘤细胞的增殖抑制率具有时间及剂量依赖性,不同质量浓度的本发明柴胡陷胸汤与肿瘤细胞一起培养后,柴胡陷胸汤对3种肿瘤细胞的生长均有抑制。随着与柴胡陷胸汤培养时间的延长,柴胡陷胸汤浓度的增高,对肿瘤细胞的抑制率越高,但浓度过高时,抑制率并不能继续增高。经计算,72h后柴胡陷胸汤对sgc、A2780、HepG2的IC50分别为:26.5μg/mL、65.7μg/mL、3.7×1012μg/mL,由此可知,在3种肿瘤细胞中,柴胡陷胸汤对sgc的抑制作用最强,对HepG2的抑制作用较小。
柴胡陷胸汤对3种肿瘤细胞周期分布的影响
流式细胞检测显示柴胡陷胸汤培养sgc后,G0/G1期细胞增多,S期细胞无明显变化,G2/M期细胞减少;柴胡陷胸汤培养A2780后,S期细胞增多,G2/M期细胞减少,G0/G1期细胞无明显变化;柴胡陷胸汤培养HepG2后,G0/G1期细胞增多,S期细胞无明显变化,G2/M期细胞减少(见表1)。由此可知,柴胡陷胸汤将sgc细胞和HepG2细胞阻滞在G0/G1期,将A2780细胞阻滞在S期。
表5本发明柴胡陷胸汤对3中肿瘤细胞周期分布的影响
本发明柴胡陷胸汤具有很好的抑制多种肿瘤细胞的作用,影响肿瘤细胞的生长周期,对于临床应用柴胡陷胸汤改善肿瘤具有很好的作用。
Claims (5)
1.一种改善癌症放化疗后胆汁反流性胃炎的柴胡陷胸汤,其特征在于:原料药包括柴胡、黄芩、姜半夏、川黄连、桔梗、瓜蒌仁、枳实、生姜、青蒿、竹茹、党参、黄芪、炒白术、茯苓、无柄赤芝、炙甘草、当归、白芍、丹参、仙鹤草、陈皮、延胡索、香附、白花蛇舌草、凌霄花、薏苡仁、三棱、莪术、水蛭、制鳖甲、半枝莲和半边莲。
2.如权利要求1所述的改善癌症放化疗后胆汁反流性胃炎的柴胡陷胸汤,其特征在于:各原料药的重量份分别为柴胡35重量份~50重量份、黄芩20重量份~30重量份、姜半夏20重量份~30重量份、川黄连15重量份~20重量份、桔梗15重量份~20重量份、瓜蒌仁20重量份~30重量份、枳实15重量份~25重量份、生姜10重量份~20重量份、青蒿15重量份~20重量份、竹茹15重量份~30重量份、党参25重量份~40重量份、黄芪20重量份~35重量份、炒白术20重量份~30重量份、茯苓15重量份~20重量份、无柄赤芝10重量份~15重量份、炙甘草20重量份~35重量份、当归15重量份~20重量份、白芍25重量份~35重量份、丹参20重量份~30重量份、仙鹤草15重量份~20重量份、陈皮15重量份~25重量份、延胡索15重量份~25重量份、香附10重量份~25重量份、白花蛇舌草10重量份~15重量份、凌霄花10重量份~20重量份、薏苡仁15重量份~20重量份、三棱25重量份~35重量份、莪术20重量份~30重量份、水蛭10重量份~15重量份、制鳖甲10重量份~15重量份、半枝莲15重量份~20重量份和半边莲10重量份~20重量份。
3.如权利要求1或2所述的改善癌症放化疗后胆汁反流性胃炎的柴胡陷胸汤,其特征在于:各原料药的重量份分别为柴胡40重量份~45重量份、黄芩25重量份~30重量份、姜半夏20重量份~25重量份、川黄连15重量份~20重量份、桔梗15重量份~20重量份、瓜蒌仁25重量份~30重量份、枳实20重量份~25重量份、生姜10重量份~15重量份、青蒿15重量份~20重量份、竹茹20重量份~25重量份、党参30重量份~35重量份、黄芪25重量份~30重量份、炒白术25重量份~30重量份、茯苓15重量份~20重量份、无柄赤芝10重量份~15重量份、炙甘草25重量份~30重量份、当归15重量份~20重量份、白芍30重量份~35重量份、丹参25重量份~30重量份、仙鹤草15重量份~20重量份、陈皮15重量份~20重量份、延胡索20重量份~25重量份、香附15重量份~20重量份、白花蛇舌草10重量份~15重量份、凌霄花15重量份~20重量份、薏苡仁15重量份~20重量份、三棱30重量份~35重量份、莪术25重量份~30重量份、水蛭10重量份~15重量份、制鳖甲10重量份~15重量份、半枝莲15重量份~20重量份和半边莲10重量份~15重量份。
4.如权利要求1至3所述的改善癌症放化疗后胆汁反流性胃炎的柴胡陷胸汤,其特征在于:各原料药的重量份分别为柴胡45重量份、黄芩25重量份、姜半夏25重量份、川黄连20重量份、桔梗20重量份、瓜蒌仁25重量份、枳实20重量份、生姜15重量份、青蒿20重量份、竹茹20重量份、党参35重量份、黄芪30重量份、炒白术25重量份、茯苓15重量份、无柄赤芝10重量份、炙甘草30重量份、当归20重量份、白芍30重量份、丹参25重量份、仙鹤草20重量份、陈皮20重量份、延胡索20重量份、香附20重量份、白花蛇舌草10重量份、凌霄花15重量份、薏苡仁20重量份、三棱30重量份、莪术25重量份、水蛭10重量份、制鳖甲10重量份、半枝莲20重量份和半边莲15重量份。
5.权利要求1至4所述柴胡陷胸汤的制备方法,其特征在于:
将各原料药分别粉碎,混合在一起,加相对于混合物质量之和5~8倍的水,浸泡6小时~12小时,以文火煎煮,煎煮3小时~5小时,将煎煮液过滤,获得第一滤液,将过滤获得的滤渣再次加入加相对于混合物质量之和3~5倍的水中,以文火煎煮2小时~4小时,过滤获得第二滤液,将第一滤液和第二滤液混合,浓缩成1g/ml的柴胡陷胸汤。
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CN107184926A (zh) * | 2017-05-08 | 2017-09-22 | 黄河科技学院 | 一种辅助治疗妇科恶性肿瘤的中药组合物 |
CN109045267A (zh) * | 2018-10-30 | 2018-12-21 | 冯光成 | 一种用于治疗食道癌的中药组方 |
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