CN105770760A - 主治胃溃疡的制剂及其制备方法 - Google Patents
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Abstract
本发明公开了一种主治胃溃疡的制剂,取下列原料制备而成,均为重量份:党参8‑10;鸡屎藤3‑6;刺五加7‑9;郁金16‑18;木蝴蝶2‑7;岩扫把4‑9;淡竹根9‑13;乌药叶5.5‑8.5;凤眼果根8‑11;黄脚鸡1.5‑3.5;短柄菝葜4‑6;鸡血李10‑12;酒饼婆11‑14;小肺筋草5‑7;代赭石1‑3。本发明的优良效果还表现在:本发明配比科学,具有保护胃黏膜,促进溃疡愈合,防止复发的功效,并且副作用较低,可以整体调节等优势。
Description
技术领域
本发明涉及中医中药领域,特别是涉及一种主治胃溃疡的制剂及其制备方法。
背景技术
胃溃疡(gastric ulcer,GU),是位于贲门至幽门之间的慢性溃疡,称为消化系统常见疾病,是消化性溃疡的一种。胃溃疡是消化性溃疡中最常见的一种,主要是指胃黏膜被胃消化液自身消化而造成的超过粘膜肌层的组织损伤。其典型表现为饥饿不适、饱胀嗳气、泛酸或餐后定时的慢性中上腹疼痛,严重时可有黑便与呕血。常见病因包括幽门螺杆菌感染、服用非甾体消炎药以及胃酸分泌过多,此外还可以由遗传因素和情绪波动、过度劳累、饮食失调、吸烟、酗酒等因素引起。
胃溃疡是现代医学名称。属临床常见病,从其临床表现来看,属于祖国医学的“胃脘痛”、“肝胃气痛”、“心痛”、“吞酸”等范畴。从病症上看,溃疡病有虚、实、寒、热之分,近年来多见寒热错杂、虚实夹杂证,以单纯某个证型出现较为少见,以虚实相兼,寒、热、湿、瘀错杂多见,由于现代人生活方式的改变、高度精神压力、生存环境的影响、营养状况的改善、饮食结构的变化、疾病谱的推移,使正虚的发病率下降,而产生湿热、气郁、淤滞、痰浊的机会增多。本病对身体危害较大,常可引起饥饿不适、饱胀、泛酸、腹痛,严重还会导致出血、穿孔、幽门梗阻和癌变等后果,应用西药治疗,病情虽能控制,但易复发,且西药对肝肾损害较大。中医药治疗胃溃疡具有保护胃黏膜,促进溃疡愈合,防止复发,并且副作用较低,可以整体调节等优势。
申请公布号CN 104888010 A(申请号 201510336142.X)的中国发明专利文献公开了一种治疗胃溃疡的中药汤剂,由下列重量配比的中药原料组成:甜叶菊3-5、灯笼草4-8、茯苓10-12、栀子花2-4、薄荷1-3、柿蒂3-5、山豆根2-4,木蝴蝶6-8、素馨花4-7、山药5-15、蜂蜜2-4、羊奶4-6、鲜芦根6-9、田七2-4。申请公布号CN 105125918 A(申请号201510575513.X)的中国发明专利文献公开了一种治疗胃溃疡的中药,由如下重量份的原料药制成:苏铁7-11、白芷7-11、紫草7-11、水毛射3-7、金匙叶草3-6、白首乌2-4、绞股蓝2-4、仙鹤草3-6、长节珠3-5、马蹄香4-7、金果榄7-10、檀香1-2、毛诃子3-5、古羊藤3-4、鬼针草2-3、半枝莲1-2、侧柏叶8-10、秦皮3-6、闹羊花2-4、棒棒草2-3、铁线蕨2-4。申请公布号CN104547497 A(申请号 201410819509.9)的中国发明专利文献公开了一种治疗胃溃疡的中药混合物,由如下重量份的原料药制成:党参15-25、白术10-15、云苓12-18、柴胡7-12、乌贼骨11-17、甘草14-20、桂枝12-17、黄芪7-12、百合2-6。
现有的治疗胃溃疡的中药,服用时间长,显效较慢,治疗效果上难以满足患者的需求,需要进一步优化。
发明内容
针对现有技术的不足,本发明的目的是提供一种制备简单、显效快、治愈率高,安全有效的主治胃溃疡的制剂及制备方法。本发明制剂疗效显著且无任何副作用,便于临床应用。
本发明的技术方案是:
主治胃溃疡的制剂,取下列原料制备而成,均为重量份:党参8-10;鸡屎藤3-6;刺五加7-9;郁金16-18;木蝴蝶2-7;岩扫把4-9;淡竹根9-13;乌药叶5.5-8.5;凤眼果根8-11;黄脚鸡1.5-3.5;短柄菝葜4-6;鸡血李10-12;酒饼婆11-14;小肺筋草5-7;代赭石1-3。
优选的方案中,党参8.5-9.5;鸡屎藤4-5;刺五加7.5-8.5;郁金16.5-17.5;木蝴蝶3-6;岩扫把5-8;淡竹根10-12;乌药叶6-8;凤眼果根9-10;黄脚鸡2-3;短柄菝葜4.5-5.5;鸡血李10.5-11.5;酒饼婆12-13;小肺筋草5.5-6.5;代赭石1.5-2.5。
更加优选的,党参9;鸡屎藤4.5;刺五加8;郁金17;木蝴蝶4.5;岩扫把6.5;淡竹根11;乌药叶7;凤眼果根9.5;黄脚鸡2.5;短柄菝葜5;鸡血李11;酒饼婆12.5;小肺筋草6;代赭石2。
主治胃溃疡的汤剂的制备方法,步骤如下:
(1)代赭石捣碎成粗粉,加黄酒拌匀,闷12-20分钟(优选闷16分钟),文火炒干,粉碎,过筛,得细粉,备用;
(2)将鸡屎藤、酒饼婆、鸡血李、小肺筋草和黄脚鸡混合,加入2-4倍量的姜水(优选加入3倍量的姜水),浸泡2-5小时(优选浸泡3.5小时),然后取出,置于炒药锅内,文火炒干,备用;
(3)将党参、刺五加、郁金、木蝴蝶、岩扫把、淡竹根、乌药叶、凤眼果根和短柄菝葜一同置于煎锅内,加清水没过药面2-4cm,室温下浸泡3-6小时(优选室温下浸泡4.5小时),然后加入步骤(2)处理后的原料药,文火煎煮两次,每次各煎煮28-46分钟(优选每次各煎煮37分钟),合并两次煎液,过滤,滤液备用;
(4)将步骤(3)所得滤液减压浓缩至原体积的1/4,加入步骤(1)所得细粉,混匀,无菌封装,即得。
上述主治胃溃疡的汤剂的制备方法,优选的方案是,步骤(1)黄酒的量为所述原料药量的0.36-0.66倍(优选的黄酒的量为所述原料药量的0.46-0.56倍,更加优选的黄酒的量为所述原料药量的0.5倍)。
上述主治胃溃疡的汤剂的制备方法,优选的方案是,步骤(1)过125-165目筛(优选的过135-155目筛,更加优选的过145目筛)。
所述片剂的制备方法是:
(1)代赭石捣碎成粗粉,加0.5倍量的黄酒拌匀,闷16分钟,文火炒干,备用;
(2)将郁金、黄脚鸡、凤眼果根和短柄菝葜混合,置于热砂中,快速翻炒至表面略有焦斑,取出,加入0.55-0.75倍量的米醋(优选加入0.65倍量的米醋),拌匀,文火炒干为度,取出,备用;
(3)将乌药叶和酒饼婆混合,加入0.2-0.4倍量的炼蜜(优选加入0.3倍量的炼蜜),拌匀,文火炒至颜色加深,不粘手为度,取出,备用;
(4)将党参、鸡屎藤、刺五加、木蝴蝶、岩扫把、淡竹根、鸡血李和小肺筋草置于烘箱内,于92-110℃干燥1.5-2.5小时(优选于100℃干燥2小时),然后与步骤(1)-(3)处理后的原料药一同粉碎成细粉,过70-100目筛(优选过85目筛),加入其它辅料,按照片剂的加工方法制成片剂,即得。
上述主治胃溃疡的片剂的制备方法,优选的方案是,步骤(4)所述辅料为质量分数为1.1%的硬脂酸镁和质量分数为3.9%的玉米淀粉。
所述丸剂的制备方法是:
(1)代赭石捣碎成粗粉,加0.5倍量的黄酒拌匀,闷16分钟,文火炒干,备用;木蝴蝶置于炒锅内,文火加热,边炒边淋入食盐水,炒至淡黄色为度,备用;
(2)将步骤(1)处理后的原料药与郁金、乌药叶、凤眼果根、短柄菝葜、鸡血李和酒饼婆一同粉碎成细粉,过65-95目筛(优选过80目筛),得混合细粉,备用;
(3)岩扫把、淡竹根、党参、黄脚鸡、鸡屎藤、小肺筋草和刺五加混合,置于中药提取器中,以浓度为50%-70%的乙醇为溶剂(优选以浓度为60%的乙醇为溶剂),溶剂的量为所述原料药量的7-10倍(优选溶剂的量为所述原料药量的8.5倍),加热回流提取两次,每次各提取34-56分钟(优选每次各提取45分钟),合并两次醇提液,回收乙醇,减压浓缩至60℃相对密度为1.26-1.28的清膏,备用;
(4)将步骤(2)所得混合细粉加入到步骤(3)所得清膏中,混匀,按照丸剂的加工方法制成梧桐子大小的丸剂,即得。
所述散剂的制备方法是:
(1)代赭石捣碎成粗粉,加0.5倍量的黄酒拌匀,闷16分钟,文火炒干,备用;木蝴蝶置于炒锅内,文火加热,边炒边淋入食盐水,炒至淡黄色为度,备用;
(2)将乌药叶和酒饼婆混合,加入0.3倍量的炼蜜,拌匀,文火炒至颜色加深,不粘手为度,取出,备用;
(3)将步骤(1)和(2)处理后的原料药与剩余原料药一同干燥,粉碎成细粉,灭菌,封装,即得。
本发明组方科学,制备方法简单,服用方便、效果显著。除此之外,本发明的优良效果还表现在:
1、本发明运用中医理论分析处方组成,根据各药味所含成分的理化性质与药理作用的研究结果,研究得到了合理、稳定的活性成分的制备方法;
2、本发明配比科学,具有保护胃黏膜,促进溃疡愈合,防止复发的功效,并且副作用较低,可以整体调节等优势;
3、本发明是在传统的中医辨证治疗的基础上结合现代最新科研成果研制而成的,诸药合用,具有疗效显著、安全方便、价格低廉的特点。
具体实施方式
下面结合实施例和实验例详细说明本发明的技术方案,但保护范围不限于此。
实施例1 主治胃溃疡的制剂,取下列原料制备而成,均为重量份(550g/份):党参8份;鸡屎藤3份;刺五加7份;郁金16份;木蝴蝶2份;岩扫把4份;淡竹根9份;乌药叶5.5份;凤眼果根8份;黄脚鸡1.5份;短柄菝葜4份;鸡血李10份;酒饼婆11份;小肺筋草5份;代赭石1份。
主治胃溃疡的制剂汤剂的制备方法是:
(1)代赭石捣碎成粗粉,加0.36倍所述原料药量的黄酒拌匀,闷12分钟,文火炒干,粉碎,过125目筛,得细粉,备用;
(2)将鸡屎藤、酒饼婆、鸡血李、小肺筋草和黄脚鸡混合,加入2倍量的姜水,浸泡2小时,然后取出,置于炒药锅内,文火炒干,备用;
(3)将党参、刺五加、郁金、木蝴蝶、岩扫把、淡竹根、乌药叶、凤眼果根和短柄菝葜一同置于煎锅内,加清水没过药面2-4cm,室温下浸泡3小时,然后加入步骤(2)处理后的原料药,文火煎煮两次,每次各煎煮28分钟,合并两次煎液,过滤,滤液备用;
(4)将步骤(3)所得滤液减压浓缩至原体积的1/4,加入步骤(1)所得细粉,混匀,无菌封装,即得。
本发明所得汤剂的服用方法是:每天三次,每次120-150mL,温热服用,7天一个疗程。
实施例2 主治胃溃疡的制剂,取下列原料制备而成,均为重量份(350g/份):党参10份;鸡屎藤6份;刺五加9份;郁金18份;木蝴蝶7份;岩扫把9份;淡竹根13份;乌药叶8.5份;凤眼果根11份;黄脚鸡3.5份;短柄菝葜6份;鸡血李12份;酒饼婆14份;小肺筋草7份;代赭石3份。
主治胃溃疡的制剂片剂的制备方法是:
(1)代赭石捣碎成粗粉,加0.5倍量的黄酒拌匀,闷16分钟,文火炒干,备用;
(2)将郁金、黄脚鸡、凤眼果根和短柄菝葜混合,置于热砂中,快速翻炒至表面略有焦斑,取出,加入0.65倍量的米醋,拌匀,文火炒干为度,取出,备用;
(3)将乌药叶和酒饼婆混合,加入0.3倍量的炼蜜,拌匀,文火炒至颜色加深,不粘手为度,取出,备用;
(4)将党参、鸡屎藤、刺五加、木蝴蝶、岩扫把、淡竹根、鸡血李和小肺筋草置于烘箱内,于100℃干燥2小时,然后与步骤(1)-(3)处理后的原料药一同粉碎成细粉,过85目筛,加入其它辅料,辅料为质量分数为1.1%的硬脂酸镁和质量分数为3.9%的玉米淀粉,按照片剂的加工方法制成片剂,即得。
本发明所得片剂的服用方法是:每天三次,每次3-4片,温水送服,7天一个疗程。
典型病例:郭XX,女,52岁,济南人。患者于2014年7月13日来我院就诊。患者一个月前无明显诱因出现阵发性上腹胀痛,进食后胀痛加重,在小区医院检查诊断为胃炎,给予药物治疗一周后,病情未见明显改善。后来转至我院治疗。检查:患者上腹部疼痛拒按,常有嗳气,泛吐酸水,情志不舒,纳少,舌苔薄白,脉弦。胃镜检查有大量内容物,经胃肠道X线钡餐检查确诊为胃溃疡。
服用本实施例所得主治胃溃疡的制剂片剂,服用方法是:每天三次,每次3-4片,温水送服,7天一个疗程。用药一个疗程后,患者上腹胀痛明显减轻,患者精神状态好转,部分症状及体征消失,继续治疗两个疗程,患者痊愈。三个月后回访,无复发。
实施例3 主治胃溃疡的制剂,取下列原料制备而成,均为重量份(500g/份):党参8.5份;鸡屎藤4份;刺五加7.5份;郁金16.5份;木蝴蝶3份;岩扫把5份;淡竹根10份;乌药叶6份;凤眼果根9份;黄脚鸡2份;短柄菝葜4.5份;鸡血李10.5份;酒饼婆12份;小肺筋草5.5份;代赭石1.5份。
主治胃溃疡的制剂丸剂的制备方法是:
(1)代赭石捣碎成粗粉,加0.5倍量的黄酒拌匀,闷16分钟,文火炒干,备用;木蝴蝶置于炒锅内,文火加热,边炒边淋入食盐水,炒至淡黄色为度,备用;
(2)将步骤(1)处理后的原料药与郁金、乌药叶、凤眼果根、短柄菝葜、鸡血李和酒饼婆一同粉碎成细粉,过80目筛,得混合细粉,备用;
(3)岩扫把、淡竹根、党参、黄脚鸡、鸡屎藤、小肺筋草和刺五加混合,置于中药提取器中,以浓度为60%的乙醇为溶剂,溶剂的量为所述原料药量的8.5倍,加热回流提取两次,每次各提取45分钟,合并两次醇提液,回收乙醇,减压浓缩至60℃相对密度为1.26-1.28的清膏,备用;
(4)将步骤(2)所得混合细粉加入到步骤(3)所得清膏中,混匀,按照丸剂的加工方法制成梧桐子大小的丸剂,即得。
本发明所得丸剂的服用方法是:每天三次,每次6-8丸,温水送服,7天一个疗程。
实施例4 主治胃溃疡的制剂,取下列原料制备而成,均为重量份(400g/份):党参9.5份;鸡屎藤5份;刺五加8.5份;郁金17.5份;木蝴蝶6份;岩扫把8份;淡竹根12份;乌药叶8份;凤眼果根10份;黄脚鸡3份;短柄菝葜5.5份;鸡血李11.5份;酒饼婆13份;小肺筋草6.5份;代赭石2.5份。
主治胃溃疡的制剂散剂的制备方法是:
(1)代赭石捣碎成粗粉,加0.5倍量的黄酒拌匀,闷16分钟,文火炒干,备用;木蝴蝶置于炒锅内,文火加热,边炒边淋入食盐水,炒至淡黄色为度,备用;
(2)将乌药叶和酒饼婆混合,加入0.3倍量的炼蜜,拌匀,文火炒至颜色加深,不粘手为度,取出,备用;
(3)将步骤(1)和(2)处理后的原料药与剩余原料药一同干燥,粉碎成细粉,灭菌,封装,即得。
本发明所得散剂的服用方法是:每天三次,每次20-30g,热水煎服,7天一个疗程。
典型病例:赵XX,男,41岁,泰安人。患者于2014年9月14日来我院就诊。患者自述:两年前因不良饮食习惯导致胃炎,经治疗后康复;近两个月,时常感觉上腹部隐隐作痛,饥饿时疼痛加重,胃内灼热,伴有干呕症状;经同事介绍来我院检查治疗。检查:患者上腹部按压疼痛,口燥咽干,渴不欲饮,五心烦热,时作干呕,大便干燥,舌红少津有裂纹,苔少,脉细数。经胃镜检查确诊胃溃疡。
服用本实施例所得主治胃溃疡的制剂散剂,服用方法:每天三次,每次20-30g,热水煎服,7天一个疗程。用药一个疗程后,患者上腹疼痛基本消失,其他症状及体征部分消失,继续用药两个疗程,患者痊愈。三个月后回访,无复发。
实施例5 主治胃溃疡的制剂,取下列原料制备而成,均为重量份(450g/份):党参9份;鸡屎藤4.5份;刺五加8份;郁金17份;木蝴蝶4.5份;岩扫把6.5份;淡竹根11份;乌药叶7份;凤眼果根9.5份;黄脚鸡2.5份;短柄菝葜5份;鸡血李11份;酒饼婆12.5份;小肺筋草6份;代赭石2份。
主治胃溃疡的制剂汤剂的制备方法是:
(1)代赭石捣碎成粗粉,加0.5倍所述原料药量的黄酒拌匀,闷16分钟,文火炒干,粉碎,过145目筛,得细粉,备用;
(2)将鸡屎藤、酒饼婆、鸡血李、小肺筋草和黄脚鸡混合,加入3倍量的姜水,浸泡3.5小时,然后取出,置于炒药锅内,文火炒干,备用;
(3)将党参、刺五加、郁金、木蝴蝶、岩扫把、淡竹根、乌药叶、凤眼果根和短柄菝葜一同置于煎锅内,加清水没过药面2-4cm,室温下浸泡4.5小时,然后加入步骤(2)处理后的原料药,文火煎煮两次,每次各煎煮37分钟,合并两次煎液,过滤,滤液备用;
(4)将步骤(3)所得滤液减压浓缩至原体积的1/4,加入步骤(1)所得细粉,混匀,无菌封装,即得。
本发明所得汤剂的服用方法是:每天三次,每次120-150mL,温热服用,7天一个疗程。
党参:基源:本品为桔梗科植物党参、素花党参或川党参的干燥根。化学成份:党参根含皂甙、微量生物碱、蔗糖、葡萄糖、菊糖、淀粉、粘液及树脂等。性味:甘,平。归经:归脾、肺经。功效:补中益气,健脾益肺。主治:用于脾肺虚弱,气短心悸,食少便溏,虚喘咳嗽,内热消渴。
鸡屎藤:基源:为双子叶植物药茜草科植物鸡屎藤的全草及根。化学成份:全株含环烯醚萜甙类;鸡屎藤甙,鸡屎藤次甙,鸡屎藤甙酸,车叶草甙,去乙酰车叶草甙。还含矢车菊素糖甙,矮牵牛素糖甙,蹄纹天竺素,摁贝素及一饱和羰基混合物。叶中含熊果酚甙,挥发油,C10-表叶绿素和脱镁叶绿素。药理作用:1、镇痛:鸡屎藤注射液10-30ml/kg腹腔注射,小鼠热板法试验有镇痛作用。鸡屎藤蒸馏液100:1浓缩液10-30ml/kg腹腔注射对小鼠电刺激法有镇痛作用。2、抗惊厥:鸡屎藤蒸馏液对戊四唑引起的小鼠惊厥有抑制作用,并降低死亡鼠数。性味:甘酸;平。归经:心;肝;脾;肾经。功能主治:祛风除湿;消食化积;解毒消肿;活血止痛。主治风湿痹痛;食积腹胀;小儿疳积;腹泻;痢疾;中暑;黄疸;肝炎;肝脾肿大;咳嗽;瘰疬;肠痈;无名肿毒;脚湿肿烂;烫火伤;湿疹;皮炎;跌打损伤;蛇蛟蝎螫。
刺五加:基源:为五加科五加属植物刺五加的根、根茎或茎叶。成分:根含刺五加苷A、B、B1、C、D、E,刺五加苷A即胡萝卜苷,刺五加苷B即丁香苷;根还含芥子醛葡萄糖苷,松柏醛葡萄糖苷等。药性:《陕西中药志》:“辛,温,入肝、肾二经。”功用主治:益气,补肾,安神,活血。主治脾虚乏力,气虚浮肿,失眠多梦,健忘,腰膝酸软,小儿行迟,胸痹疼痛,久咳,风湿痹痛。
郁金:基源:为姜科植物姜黄、郁金或莪术的块根。性味:辛苦,凉。归经:入心、肺、肝经。功能主治:行气解郁,凉血破瘀。治胸腹胁肋诸痛,失心癫狂,热病神昏,吐血,衄血,尿血,血淋,妇女倒经,黄疸。
木蝴蝶:基源:为紫葳科植物木蝴蝶的干燥成熟种子。性味:苦,寒。归经:入肺、肝经。功能主治:润肺,舒肝,和胃,生肌。治咳嗽,喉痹,音哑,肝胃气痛,疮口不敛。
岩扫把:来源:为毛茛科植物盾叶唐松草的全草或根。化学成份:含海罂粟碱,去氢海罂粟碱,箭头唐松草米定碱,去氢箭头唐松草米定碱,唐松草坡芬碱。性味:苦;寒。归经:归肝;胃;大肠经。功能主治:清热解毒;燥湿。主主治湿热黄疸;湿热痢疾;小儿惊风;目赤肿痛;丹毒游风;鹅口疮;跌打损伤。
淡竹根:基源:为禾木科植物淡竹的根茎。性味:甘;淡;寒。功能主治:清热除烦;涤痰定惊。主发热心烦;惊悸;小儿惊痫。
乌药叶:基源:为樟科植物乌药的叶。性味:辛;温。归经:脾;肾经。功能主治:温中理气;消肿止痛。主脘腹冷痛;小便频数;风湿痹痛;跌打伤痛;烫伤。
凤眼果根:基源:为梧桐科植物苹婆的根。性味:甘;平。功能主治:。主胃溃疡
黄脚鸡:基源:为百合科植物深裂竹根七的根茎。性味:味甘;性平。功能主治:益气健脾;养阴润肺;活血舒筋。主产后虚弱;小儿疳积;阴虚咳嗽;多汗;口干;跌打肿痛;风湿疼痛;腰痛。
短柄菝葜:基源:为百合科植物托柄菝葜的根茎。性味:辛;苦;凉。功能主治:祛风;清热;利湿;凉血止血。主风湿热痹;足膝肿痛;血淋;崩漏。
鸡血李:基源:为蔷薇科植物杏李的根或叶。性味:苦;寒;无毒。归经:心;肝经。功能主治:清热除烦,利水通淋,止血。主消渴,心烦,白浊,水肿,吐血,崩漏,跌打损伤,瘀血作痛。
酒饼婆:基源:为番荔枝科植物紫玉盘的叶或根。性味:辛;苦;性微温。归经:肝;胃经。功能主治:祛风除湿;行气健胃;止痛;化痰止咳。主风湿痹痛;腰腿痛;跌打损伤;消化不良;腹胀腹泻;咳嗽痰多。
小肺筋草:基源:为百合科植物粉条儿菜和短柄粉条儿菜的根及全草。化学成份:粉条儿菜根含皂甙,基甙元为异娜草皂甙元及薯蓣皂甙元。性味:味甘;苦;性平。归经:肺、肝经。功能主治:清热;润肺止咳;活血调经;杀虫。主咳嗽;咯血;百日咳 ;喘息;肺痈;乳痈;肋腺炎;经闭;缺乳;小儿疳积;蛔虫病;风火牙痛。
代赭石:基源:为氧化物类矿物赤铁矿的矿石。化学成份:主含三氧化二铁,其中铁70%,氧30%,有时含杂质钛、镁、铝、硅和水分。性味:苦、甘、平。归经:归肝、胃、心胞经。功能主治:平肝镇逆,凉血止血。治噫气呕逆,噎膈反胃,哮喘,惊痫,吐血,鼻衄,肠风,痔瘘,崩漏带下。
试验例1 本发明所得主治胃溃疡的制剂(实施例5)的临床应用:
1 资料和方法
1.1 一般资料
2011年7月-2014年12月,在4所医院胃肠科门诊筛选380例胃溃疡患者,其中男性206例,女性174例,年龄最大70岁,年龄最小24岁,病程在三个月-5年。所有患者均经电子胃镜或X线钡餐检查确诊。
1.2 诊断标准
(1)临床均以不同程胃脘痛为主,伴有反酸,嗳气,灼烧感,饱胀感,恶心或呕吐等症状;
(2)胃镜或X线钡餐检检查证明有胃溃疡者。
1.3 治疗方法
所有患者随机分为实验组和对照组,两组患者在性别、年龄、病程等方面,经统计学处理差异无显著性意义(P>0.05),具有可比性。其中实验组服用本发明所得药物,服用方法:每天三次,每次120-150mL,温热服用,7天一个疗程。共观察治疗三个疗程。对照组服用其他药物(如养胃舒、香砂养胃丸、猴头菌片等常规药物)。
1.4 疗效判定标准
参照国家中医药管理局颁布的《中医病症诊断疗效标准》:
治愈:溃疡症状、周围炎性症状以及临床症状全部消失;
显效:临床症状和溃疡症状基本消失,尚有周围炎症存在;
有效:患者的溃疡面积缩小一半以上,临床症状明显减轻;
无效:临床症状无变化甚至加重。
总有效率=(治愈例数+显效例数+有效例数)/总观察病例数×100%。
1.5 治疗结果
表1:实验组和对照组患者的治疗结果
治疗效果:实验组治愈138例(69%), 显效50例(25%),有效7例(3.5%),无效5例(2.5%),总有效率97.5%。实验组治疗效果明显优于对照组。
本发明选择党参、鸡屎藤、刺五加、郁金、木蝴蝶和岩扫把等共15味原料药配制而成。方中,党参补中益气,健脾益肺;鸡屎藤消食化积,活血止痛;刺五加益气,补肾,安神,活血;木蝴蝶润肺,舒肝,和胃;岩扫把清热解毒;乌药叶温中理气;酒饼婆健胃,止痛;代赭石平肝镇逆。实验组治疗三个疗程后,总有效率为97.5%,而对照组仅为80%。
应当指出的是,具体实施方式只是本发明比较有代表性的例子,显然本发明的技术方案不限于上述实施例,还可以有很多变形。本领域的普通技术人员,以本发明所明确公开的或根据文件的书面描述毫无异议的得到的,均应认为是本专利所要保护的范围。
Claims (10)
1.主治胃溃疡的制剂,其特征是,取下列原料制备而成,均为重量份:党参8-10;鸡屎藤3-6;刺五加7-9;郁金16-18;木蝴蝶2-7;岩扫把4-9;淡竹根9-13;乌药叶5.5-8.5;凤眼果根8-11;黄脚鸡1.5-3.5;短柄菝葜4-6;鸡血李10-12;酒饼婆11-14;小肺筋草5-7;代赭石1-3。
2.如权利要求1所述的主治胃溃疡的制剂,其特征是,取下列原料制备而成,均为重量份:党参8.5-9.5;鸡屎藤4-5;刺五加7.5-8.5;郁金16.5-17.5;木蝴蝶3-6;岩扫把5-8;淡竹根10-12;乌药叶6-8;凤眼果根9-10;黄脚鸡2-3;短柄菝葜4.5-5.5;鸡血李10.5-11.5;酒饼婆12-13;小肺筋草5.5-6.5;代赭石1.5-2.5。
3.如权利要求1所述的主治胃溃疡的制剂,其特征是,取下列原料制备而成,均为重量份:党参9;鸡屎藤4.5;刺五加8;郁金17;木蝴蝶4.5;岩扫把6.5;淡竹根11;乌药叶7;凤眼果根9.5;黄脚鸡2.5;短柄菝葜5;鸡血李11;酒饼婆12.5;小肺筋草6;代赭石2。
4.如权利要求1-3任一所述的主治胃溃疡的汤剂的制备方法,其特征是,步骤如下:
(1)代赭石捣碎成粗粉,加黄酒拌匀,闷12-20分钟(优选闷16分钟),文火炒干,粉碎,过筛,得细粉,备用;
(2)将鸡屎藤、酒饼婆、鸡血李、小肺筋草和黄脚鸡混合,加入2-4倍量的姜水(优选加入3倍量的姜水),浸泡2-5小时(优选浸泡3.5小时),然后取出,置于炒药锅内,文火炒干,备用;
(3)将党参、刺五加、郁金、木蝴蝶、岩扫把、淡竹根、乌药叶、凤眼果根和短柄菝葜一同置于煎锅内,加清水没过药面2-4cm,室温下浸泡3-6小时(优选室温下浸泡4.5小时),然后加入步骤(2)处理后的原料药,文火煎煮两次,每次各煎煮28-46分钟(优选每次各煎煮37分钟),合并两次煎液,过滤,滤液备用;
(4)将步骤(3)所得滤液减压浓缩至原体积的1/4,加入步骤(1)所得细粉,混匀,无菌封装,即得。
5.根据权利要求4所述的主治胃溃疡的汤剂的制备方法,其特征是,步骤(1)黄酒的量为所述原料药量的0.36-0.66倍(优选的黄酒的量为所述原料药量的0.46-0.56倍,更加优选的黄酒的量为所述原料药量的0.5倍)。
6.根据权利要求4所述的主治胃溃疡的汤剂的制备方法,其特征是,步骤(1)过125-165目筛(优选的过135-155目筛,更加优选的过145目筛)。
7.如权利要求1-3任一所述的主治胃溃疡的片剂的制备方法,其特征是,步骤如下:
(1)代赭石捣碎成粗粉,加0.5倍量的黄酒拌匀,闷16分钟,文火炒干,备用;
(2)将郁金、黄脚鸡、凤眼果根和短柄菝葜混合,置于热砂中,快速翻炒至表面略有焦斑,取出,加入0.55-0.75倍量的米醋(优选加入0.65倍量的米醋),拌匀,文火炒干为度,取出,备用;
(3)将乌药叶和酒饼婆混合,加入0.2-0.4倍量的炼蜜(优选加入0.3倍量的炼蜜),拌匀,文火炒至颜色加深,不粘手为度,取出,备用;
(4)将党参、鸡屎藤、刺五加、木蝴蝶、岩扫把、淡竹根、鸡血李和小肺筋草置于烘箱内,于92-110℃干燥1.5-2.5小时(优选于100℃干燥2小时),然后与步骤(1)-(3)处理后的原料药一同粉碎成细粉,过70-100目筛(优选过85目筛),加入其它辅料,按照片剂的加工方法制成片剂,即得。
8.根据权利要求7所述的主治胃溃疡的片剂的制备方法,其特征是,步骤(4)所述辅料为质量分数为1.1%的硬脂酸镁和质量分数为3.9%的玉米淀粉。
9.如权利要求1-3任一所述的主治胃溃疡的丸剂的制备方法,其特征是,步骤如下:
(1)代赭石捣碎成粗粉,加0.5倍量的黄酒拌匀,闷16分钟,文火炒干,备用;木蝴蝶置于炒锅内,文火加热,边炒边淋入食盐水,炒至淡黄色为度,备用;
(2)将步骤(1)处理后的原料药与郁金、乌药叶、凤眼果根、短柄菝葜、鸡血李和酒饼婆一同粉碎成细粉,过65-95目筛(优选过80目筛),得混合细粉,备用;
(3)岩扫把、淡竹根、党参、黄脚鸡、鸡屎藤、小肺筋草和刺五加混合,置于中药提取器中,以浓度为50%-70%的乙醇为溶剂(优选以浓度为60%的乙醇为溶剂),溶剂的量为所述原料药量的7-10倍(优选溶剂的量为所述原料药量的8.5倍),加热回流提取两次,每次各提取34-56分钟(优选每次各提取45分钟),合并两次醇提液,回收乙醇,减压浓缩至60℃相对密度为1.26-1.28的清膏,备用;
(4)将步骤(2)所得混合细粉加入到步骤(3)所得清膏中,混匀,按照丸剂的加工方法制成梧桐子大小的丸剂,即得。
10.如权利要求1-3任一所述的主治胃溃疡的散剂的制备方法,其特征是,步骤如下:
(1)代赭石捣碎成粗粉,加0.5倍量的黄酒拌匀,闷16分钟,文火炒干,备用;木蝴蝶置于炒锅内,文火加热,边炒边淋入食盐水,炒至淡黄色为度,备用;
(2)将乌药叶和酒饼婆混合,加入0.3倍量的炼蜜,拌匀,文火炒至颜色加深,不粘手为度,取出,备用;
(3)将步骤(1)和(2)处理后的原料药与剩余原料药一同干燥,粉碎成细粉,灭菌,封装,即得。
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