CN105535714A - 肿瘤科患者术后调治胰腺癌的制剂及制法 - Google Patents
肿瘤科患者术后调治胰腺癌的制剂及制法 Download PDFInfo
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Abstract
本发明公开了一种肿瘤科患者术后调治胰腺癌的制剂,主要由下列原料药制备而成,均为质量份:虎杖7-12,佛手花9-13,山矾根6-14,酒饼婆4-10,田基黄3-7,铜锤草6-12,玫瑰花5-9,荸荠3-6,菝葜7-10,干苔4-9,蚕退纸6-10,山豆根8-12,急性子5-11,鸡爪芋3-8,全叶青兰6-9。本发明药源广,成本低,适于长期服用,患者无经济负担,本组方根据中医药原则和多年临床经验得到,具有等功效,本发明疗效稳定,抗癌消积,有效抑制癌细胞的扩散,减缓病情的进展。
Description
技术领域
本发明涉及中医中药领域,特别是涉及一种肿瘤科患者术后调治胰腺癌的制剂及制法。
背景技术
胰腺癌是一种恶性程度很高,诊断和治疗都很困难的消化道恶性肿瘤,约90%为起源于腺管上皮的导管腺癌。其发病率和死亡率近年来明显上升。5年生存率<1%,是预后最差的恶性肿瘤之一。关于胰腺癌的致病因素尚不明确,慢性胰腺炎、糖尿病的人群中发生胰腺癌的比例比正常人群高一些。烟民患胰腺癌的风险是不吸烟者的3倍以上。“三高”饮食,即高蛋白、高脂肪、高热量食品会对胰腺癌的发生起到一些不好的影响。胰腺癌可发生于胰腺的头、体、尾部或累及整个胰腺,但以胰头部最多,约占胰腺癌的60%~70%。发生于胰体者次之,尾部最少见。肉眼观肿瘤呈圆形或卵圆形。边界有的分明,有的弥漫浸润与邻近胰腺组织难以分辨。胰腺癌的早期症状有厌食,消化不良及体重下降;腹部不适或疼痛,约有半数患者以腹痛为首发症状,约有20%的病人腹痛能放射到背部、左肩部,疼痛在仰卧时加剧,坐立、弯腰、侧卧、屈膝时减轻;黄疸,表现为皮肤及巩膜发黄。
公布号CN104095225A(申请号201410257355.9)的中国专利文献公开了一种胰腺癌患者食用的微生态特殊膳食,该产品以L-谷氨酰胺为主要原料,根据胰腺癌患者的体质特征,用传统中医精髓理论,有针对性的合理配伍:石斛、薏苡仁、砂仁、蒲公英、决明子、夏枯草、牡蛎、枸杞、陈皮、茯苓、黄精、桑叶等药食两用中草药提取物,再添加多种抗炎益生菌、维生素和矿物质制成。公布号CN104082462A(申请号201410263181.7)的中国专利文献公开了一种调理胰腺癌的茶,由石斛、薏苡仁、砂仁、蒲公英、决明子、夏枯草、枣、牡蛎、枸杞、芦根、甘草、香菇、陈皮、茯苓、黄精、乌梅、菊花、栀子、桑叶等药食两用中草药提取物制成。公布号CN104082734A(申请号201410262566.1)的中国专利文献公开了一种调理胰腺癌的方便食品,由石斛、薏苡仁、砂仁、蒲公英、决明子、夏枯草、枣、牡蛎、枸杞、芦根、甘草、香菇、陈皮、茯苓、黄精、乌梅、菊花、栀子、桑叶等药食两用中草药提取物,再添加维生素和矿物质制成。
目前临床上治疗胰腺癌主要以放化疗和手术治疗为主,均会对患者造成不可逆转的伤害,且疗效均不高,同时给患者造成较大经济压力,因此可采用中西结合的综合方法对患者治疗,以减轻患者痛苦,提高生活质量。
发明内容
针对现有技术的不足,本发明的目的是提供一种疗效好、易久服的肿瘤科患者术后调治胰腺癌的制剂及制法。
本发明的技术方案是:
肿瘤科患者术后调治胰腺癌的制剂,主要由下列原料药制备而成,均为质量份:虎杖7-12,佛手花9-13,山矾根6-14,酒饼婆4-10,田基黄3-7,铜锤草6-12,玫瑰花5-9,荸荠3-6,菝葜7-10,干苔4-9,蚕退纸6-10,山豆根8-12,急性子5-11,鸡爪芋3-8,全叶青兰6-9。
优选的方案中,虎杖8-11,佛手花10-12,山矾根8-12,酒饼婆6-8,田基黄4-6,铜锤草8-10,玫瑰花6-8,荸荠4-5,菝葜8-9,干苔5-8,蚕退纸7-9,山豆根9-11,急性子6-10,鸡爪芋4-7,全叶青兰7-8。
更加优选的,虎杖9.5,佛手花11,山矾根10,酒饼婆7,田基黄5,铜锤草9,玫瑰花7,荸荠4.5,菝葜8.5,干苔6.5,蚕退纸8,山豆根10,急性子8,鸡爪芋5.5,全叶青兰7.5。
所述的肿瘤科患者术后调治胰腺癌的制剂的汤剂的制备方法,步骤如下:
(1)取急性子用黄酒浸30分钟,取出,焙干,将山矾根和酒饼婆去杂切片,与焙干的急性子一同置于炒锅内,喷淋米醋拌匀,放置10分钟,文火加热,炒干,取出,晾凉;
(2)将铜锤草和干苔洗净,用米泔水浸润30分钟,取出,切丝,置于炒锅内,炒至原料药表面微黄,取出,晾凉;
(3)将荸荠洗净去皮,加水打浆,浆汁加洗净的佛手花和玫瑰花煎煮,大火煮沸后小火煎20-32分钟(优选的,小火煎24-28分钟;更加优选的,小火煎26分钟),过滤,收集滤液;
(4)将虎杖、田基黄、菝葜、山豆根、鸡爪芋和全叶青兰去杂洗净,与步骤(1)(2)所制原料药一起加水煎煮,加水量为所煎煮原料药质量的7倍,大火煮沸后小火煎27分钟,过滤,收集滤液,滤渣加水再煮,加水量和煎煮时间同第一次,合并两次煎煮所得滤液;
(5)将蚕退纸置于耐火容器上,加热至表面焦黑,取出,研末后加入到步骤(4)所制滤液混匀,再加入步骤(3)所制滤液拌匀,灭菌,即得汤剂。
所述的肿瘤科患者术后调治胰腺癌的制剂汤剂的制备方法,步骤(3)加水量为荸荠质量的14-20倍(优选的,加水量为荸荠质量的16-18倍;更加优选的,加水量为荸荠质量的17倍)。
所述的肿瘤科患者术后调治胰腺癌的制剂的散剂的制备方法,步骤如下:
(1)取急性子用黄酒浸30分钟,取出,焙干,将山矾根和酒饼婆去杂切片,与焙干的急性子一同置于炒锅内,喷淋米醋拌匀,放置10分钟,文火加热,炒干,取出,晾凉;
(2)将铜锤草和干苔洗净,用米泔水浸润30分钟,取出,切丝,置于炒锅内,炒至原料药表面微黄,取出,晾凉;
(3)将荸荠洗净去皮,切片,与佛手花和玫瑰花加炼蜜水拌匀,浸润15分钟,取出,焙干,与步骤(1)(2)所制原料药一起粉碎过筛,制成药粉;
(4)将虎杖、田基黄、菝葜、山豆根、鸡爪芋和全叶青兰去杂洗净加水煎煮,加水量为所煮原料药质量的8倍,大火煮沸后小火煎27分钟,过滤,收集滤液,滤渣加水再煮,加水量和煎煮时间同第一次,合并两次煎煮所得滤液,浓缩成相对密度为1.24(60℃)的清膏;
(5)将蚕退纸置于耐火容器上,加热至表面焦黑,取出,研末后与步骤(3)(4)所制药粉和清膏拌匀,干燥,粉碎过筛,制成粉状,灭菌,即得散剂。
所述的肿瘤科患者术后调治胰腺癌的制剂散剂的制备方法,步骤(5)粉碎过120-260目筛(优选的,粉碎过160-220目筛;更加优选的,粉碎过190目筛)。
所述的肿瘤科患者术后调治胰腺癌的制剂的丸剂的制备方法,步骤如下:
(1)取急性子用黄酒浸30分钟,取出,焙干,将山矾根和酒饼婆去杂切片,与焙干的急性子一同置于炒锅内,喷淋米醋拌匀,放置10分钟,文火加热,炒干,取出,晾凉;
(2)将铜锤草和干苔洗净,用米泔水浸润30分钟,取出,切丝,置于炒锅内,炒至原料药表面微黄,取出,晾凉;
(3)将荸荠洗净去皮,切片,与佛手花和玫瑰花加炼蜜水拌匀,浸润15分钟,取出,焙干,与步骤(1)(2)所制原料药一起粉碎过筛,制成药粉;
(4)将虎杖、田基黄、菝葜、山豆根、鸡爪芋和全叶青兰去杂洗净加水煎煮,加水量为所煮原料药质量的8倍,大火煮沸后小火煎,过滤,收集滤液,滤渣加水再煮,加水量和煎煮时间同第一次,合并两次煎煮所得滤液,浓缩成相对密度为1.24(60℃)的清膏;
(5)将蚕退纸置于耐火容器上,加热至表面焦黑,取出,研末后与步骤(3)(4)所制药粉和清膏拌匀,干燥,粉碎过80目筛,制成药粉,加炼蜜和水泛制成丸,干燥,灭菌,即得丸剂。
所述的肿瘤科患者术后调治胰腺癌的制剂丸剂的制备方法,步骤(4)大火煮沸后小火煎23-31分钟(优选的,小火煎25-29分钟;更加优选的,小火煎27分钟)。
所述的肿瘤科患者术后调治胰腺癌的制剂的胶囊剂的制备方法,步骤如下:
(1)取急性子用黄酒浸30分钟,取出,焙干,将山矾根和酒饼婆去杂切片,与焙干的急性子一同置于炒锅内,喷淋米醋拌匀,放置10分钟,文火加热,炒干,取出,晾凉;
(2)将铜锤草和干苔洗净,用米泔水浸润30分钟,取出,切丝,置于炒锅内,炒至原料药表面微黄,取出,晾凉;
(3)将荸荠洗净去皮,切片,与佛手花和玫瑰花加炼蜜水拌匀,浸润15分钟,取出,焙干,与步骤(1)(2)所制原料药一起粉碎过100目筛,制成药粉;
(4)将虎杖、田基黄、菝葜、山豆根、鸡爪芋和全叶青兰去杂洗净加水煎煮,加水量为所煮原料药质量的8倍,大火煮沸后小火煎23-31分钟(优选的,小火煎25-29分钟;更加优选的,小火煎27分钟),过滤,收集滤液,滤渣加水再煮,加水量和煎煮时间同第一次,合并两次煎煮所得滤液,浓缩成清膏;
(5)将蚕退纸置于耐火容器上,加热至表面焦黑,取出,研末后与步骤(3)(4)所制药粉和清膏拌匀,加10%淀粉浆、蔗糖和干淀粉制软材,制颗粒,装入胶囊,即得胶囊剂。
所述的肿瘤科患者术后调治胰腺癌的制剂胶囊剂的制备方法,步骤(4)浓缩成相对密度为1.18-1.24(60℃)的清膏(优选的,浓缩成相对密度为1.19-1.23的清膏;更加优选的,浓缩成相对密度为1.21的清膏)。
本发明提供的肿瘤科患者术后调治胰腺癌的制剂经科学选材,严谨配伍,精心制备而成。除此之外,本发明的优良效果还表现在:
1、本发明药源广,成本低,适于长期服用,患者无经济负担;
2、本组方根据中医药原则和多年临床经验得到,具有祛瘀散结、疏肝理气等功效;
3、本发明疗效稳定,抗癌消积,有效抑制癌细胞的扩散,减缓病情的进展。
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肿瘤科患者术后调治胰腺癌的制剂,主要由下列原料药制备而成(每份10g):虎杖7份,佛手花9份,山矾根6份,酒饼婆4份,田基黄3份,铜锤草6份,玫瑰花5份,荸荠3份,菝葜7份,干苔4份,蚕退纸6份,山豆根8份,急性子5份,鸡爪芋3份,全叶青兰6份。
上述肿瘤科患者术后调治胰腺癌的制剂汤剂的制备方法是:
(1)取急性子用黄酒浸30分钟,取出,焙干,将山矾根和酒饼婆去杂切片,与焙干的急性子一同置于炒锅内,喷淋米醋拌匀,放置10分钟,文火加热,炒干,取出,晾凉;
(2)将铜锤草和干苔洗净,用米泔水浸润30分钟,取出,切丝,置于炒锅内,炒至原料药表面微黄,取出,晾凉;
(3)将荸荠洗净去皮,加水打浆,加水量为荸荠质量的17倍,浆汁加洗净的佛手花和玫瑰花煎煮,大火煮沸后小火煎26分钟,过滤,收集滤液;
(4)将虎杖、田基黄、菝葜、山豆根、鸡爪芋和全叶青兰去杂洗净,与步骤(1)(2)所制原料药一起加水煎煮,加水量为所煎煮原料药质量的7倍,大火煮沸后小火煎27分钟,过滤,收集滤液,滤渣加水再煮,加水量和煎煮时间同第一次,合并两次煎煮所得滤液;
(5)将蚕退纸置于耐火容器上,加热至表面焦黑,取出,研末后加入到步骤(4)所制滤液混匀,再加入步骤(3)所制滤液拌匀,灭菌,即得汤剂。
实施例2肿瘤科患者术后调治胰腺癌的制剂,主要由下列原料药制备而成(每份10g):虎杖12份,佛手花13份,山矾根14份,酒饼婆10份,田基黄7份,铜锤草12份,玫瑰花9份,荸荠6份,菝葜10份,干苔9份,蚕退纸10份,山豆根12份,急性子11份,鸡爪芋8份,全叶青兰9份。
肿瘤科患者术后调治胰腺癌的制剂散剂的制备方法是:
(1)取急性子用黄酒浸30分钟,取出,焙干,将山矾根和酒饼婆去杂切片,与焙干的急性子一同置于炒锅内,喷淋米醋拌匀,放置10分钟,文火加热,炒干,取出,晾凉;
(2)将铜锤草和干苔洗净,用米泔水浸润30分钟,取出,切丝,置于炒锅内,炒至原料药表面微黄,取出,晾凉;
(3)将荸荠洗净去皮,切片,与佛手花和玫瑰花加炼蜜水拌匀,浸润15分钟,取出,焙干,与步骤(1)(2)所制原料药一起粉碎过筛,制成药粉;
(4)将虎杖、田基黄、菝葜、山豆根、鸡爪芋和全叶青兰去杂洗净加水煎煮,加水量为所煮原料药质量的8倍,大火煮沸后小火煎27分钟,过滤,收集滤液,滤渣加水再煮,加水量和煎煮时间同第一次,合并两次煎煮所得滤液,浓缩成相对密度为1.24(60℃)的清膏;
(5)将蚕退纸置于耐火容器上,加热至表面焦黑,取出,研末后与步骤(3)(4)所制药粉和清膏拌匀,干燥,粉碎过190目筛,制成粉状,灭菌,即得散剂。
典型病例:xxx,女,46岁。主诉:近两个月上腹胀痛明显,伴有恶心,巩膜及全身皮肤发黄,近几日恶心呕吐难忍,医院检查,经CT检查诊断为胰头癌,入院行根治性切除术,术后进行化疗,化疗后7天出现,神疲乏力,头晕恶心,遂拒绝继续化疗。
后经人介绍服用本实施例所得肿瘤科患者术后调治胰腺癌的制剂散剂,每天2次,每次6-10g,温开水冲服,15天一个疗程。服用两个疗程后,乏力、恶心等症消失,黄疸消退,服用三个疗程后,腹痛消除,精神明显好转,服用五个疗程后,患者无不适症状,面色红润,气色佳,后坚持服药治疗,随访两年,病情稳定。
实施例3肿瘤科患者术后调治胰腺癌的制剂,主要由下列原料药制备而成(每份10g):虎杖8份,佛手花10份,山矾根8份,酒饼婆6份,田基黄4份,铜锤草8份,玫瑰花6份,荸荠4份,菝葜8份,干苔5份,蚕退纸7份,山豆根9份,急性子6份,鸡爪芋4份,全叶青兰7份。
肿瘤科患者术后调治胰腺癌的制剂丸剂的制备方法是:
(1)取急性子用黄酒浸30分钟,取出,焙干,将山矾根和酒饼婆去杂切片,与焙干的急性子一同置于炒锅内,喷淋米醋拌匀,放置10分钟,文火加热,炒干,取出,晾凉;
(2)将铜锤草和干苔洗净,用米泔水浸润30分钟,取出,切丝,置于炒锅内,炒至原料药表面微黄,取出,晾凉;
(3)将荸荠洗净去皮,切片,与佛手花和玫瑰花加炼蜜水拌匀,浸润15分钟,取出,焙干,与步骤(1)(2)所制原料药一起粉碎过筛,制成药粉;
(4)将虎杖、田基黄、菝葜、山豆根、鸡爪芋和全叶青兰去杂洗净加水煎煮,加水量为所煮原料药质量的8倍,大火煮沸后小火煎27分钟,过滤,收集滤液,滤渣加水再煮,加水量和煎煮时间同第一次,合并两次煎煮所得滤液,浓缩成相对密度为1.24(60℃)的清膏;
(5)将蚕退纸置于耐火容器上,加热至表面焦黑,取出,研末后与步骤(3)(4)所制药粉和清膏拌匀,干燥,粉碎过80目筛,制成药粉,加炼蜜和水泛制成丸,干燥,灭菌,即得丸剂。
典型病例:xxx,男,53岁。主诉:两年前因上腹胀痛、不适,入院检查,胃镜显示慢性胃炎,服药治疗,效果不显著,半年后再次检查,经CT、MRI和病理学检查,确诊为胰尾癌,行胰腺癌根治术,两周后进行化疗6次,出现肾功能损害,并伴有上腹痞胀,四肢乏力,遂停止化疗。
后经人介绍服用本实施例所得肿瘤科患者术后调治胰腺癌的制剂丸剂,采用每天2次,每次4粒,用温开水送服,15天一个疗程。服用两个疗程后,上腹不适基本消失,偶有嗳气,服用四个疗程后,上腹不适完全消失,精神好转,适量增加,后一直坚持服用,一年内随访身体状态稳定。
实施例4肿瘤科患者术后调治胰腺癌的制剂,主要由下列原料药制备而成(每份10g):虎杖11份,佛手花12份,山矾根12份,酒饼婆8份,田基黄6份,铜锤草10份,玫瑰花8份,荸荠5份,菝葜9份,干苔8份,蚕退纸9份,山豆根11份,急性子10份,鸡爪芋7份,全叶青兰8份。
肿瘤科患者术后调治胰腺癌的制剂胶囊剂的制备方法是:
(1)取急性子用黄酒浸30分钟,取出,焙干,将山矾根和酒饼婆去杂切片,与焙干的急性子一同置于炒锅内,喷淋米醋拌匀,放置10分钟,文火加热,炒干,取出,晾凉;
(2)将铜锤草和干苔洗净,用米泔水浸润30分钟,取出,切丝,置于炒锅内,炒至原料药表面微黄,取出,晾凉;
(3)将荸荠洗净去皮,切片,与佛手花和玫瑰花加炼蜜水拌匀,浸润15分钟,取出,焙干,与步骤(1)(2)所制原料药一起粉碎过100目筛,制成药粉;
(4)将虎杖、田基黄、菝葜、山豆根、鸡爪芋和全叶青兰去杂洗净加水煎煮,加水量为所煮原料药质量的8倍,大火煮沸后小火煎27分钟,过滤,收集滤液,滤渣加水再煮,加水量和煎煮时间同第一次,合并两次煎煮所得滤液,浓缩成相对密度为1.21(60℃)的清膏;
(5)将蚕退纸置于耐火容器上,加热至表面焦黑,取出,研末后与步骤(3)(4)所制药粉和清膏拌匀,加10%淀粉浆、蔗糖和干淀粉制软材,制颗粒,装入胶囊,即得胶囊剂。
典型病例:xxx,男,60岁。主诉:胃脘隐隐作痛不适3个月,左侧腹部偶有疼痛,单位体检时发现胰腺有肿物,后经CT、MRI以及病理学等检查,诊断为胰头癌,未转移,住院治疗后行胰头、十二指肠切除术,术后2周进行化疗。并服用本实施例所得肿瘤科患者术后调治胰腺癌的制剂胶囊剂,采用每天2次,每次3粒,用温开水送服,15天一个疗程。服用两个疗程后,患者腹部疼痛明显减轻,体力有所恢复,饮食规律,食欲一般,有轻微恶心反应,服用四个疗程后,患者临床症状全部消失,出院回家疗养,随访一年未复发。
实施例5肿瘤科患者术后调治胰腺癌的制剂,主要由下列原料药制备而成(每份10g):虎杖9.5份,佛手花11份,山矾根10份,酒饼婆7份,田基黄5份,铜锤草9份,玫瑰花7份,荸荠4.5份,菝葜8.5份,干苔6.5份,蚕退纸8份,山豆根10份,急性子8份,鸡爪芋5.5份,全叶青兰7.5份。
肿瘤科患者术后调治胰腺癌的制剂汤剂的制备方法是:
(1)取急性子用黄酒浸30分钟,取出,焙干,将山矾根和酒饼婆去杂切片,与焙干的急性子一同置于炒锅内,喷淋米醋拌匀,放置10分钟,文火加热,炒干,取出,晾凉;
(2)将铜锤草和干苔洗净,用米泔水浸润30分钟,取出,切丝,置于炒锅内,炒至原料药表面微黄,取出,晾凉;
(3)将荸荠洗净去皮,加水打浆,加水量为荸荠质量的17倍,浆汁加洗净的佛手花和玫瑰花煎煮,大火煮沸后小火煎26分钟,过滤,收集滤液;
(4)将虎杖、田基黄、菝葜、山豆根、鸡爪芋和全叶青兰去杂洗净,与步骤(1)(2)所制原料药一起加水煎煮,加水量为所煎煮原料药质量的7倍,大火煮沸后小火煎27分钟,过滤,收集滤液,滤渣加水再煮,加水量和煎煮时间同第一次,合并两次煎煮所得滤液;
(5)将蚕退纸置于耐火容器上,加热至表面焦黑,取出,研末后加入到步骤(4)所制滤液混匀,再加入步骤(3)所制滤液拌匀,灭菌,即得汤剂。
本发明所用主要中药原料的药理如下:
虎杖:基原:为蓼科植物虎杖的根茎。性味:微苦,微寒。归经:归肝、胆、肺经。功能主治:祛风利湿,散瘀定痛,止咳化痰。用于关节痹痛,湿热黄疸,经闭,症瘕,水火烫伤,跌扑损伤,痈肿疮毒,咳嗽痰多。
佛手花:基原:为芸香科植物佛手的花朵和花蕾。性味:微苦,微温。归经:肝,胃经。功能主治:疏肝理气,和胃快隔。主肝胃气痛,食欲不振。
山矾根:基原:山矾科植物山矾的根。性味:苦,辛,性平。归经:肝、胃经。功能主治:清热利湿,凉血止血,祛风止痛。主黄疸,泄泻,痢疾,血崩,风火牙痛,头痛,风湿痹痛。
酒饼婆:基原: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。
田基黄:基原:为藤黄科植物地耳草的全草。性味:甘,苦,凉。归经:肺,肝,胃经。功能主治:清热利湿,解毒,散瘀消肿。主湿热黄疸,泄泻,痢疾,肠痈,痈疖肿毒,乳蛾,口疮,目赤肿痛,毒蛇咬伤,跌打损伤。
铜锤草:基原:为酢浆草科植物铜锤草的全株或根。性味:酸,寒。功能主治:散瘀消肿,清热解毒。治跌打损伤,咽喉肿痛,肾盂肾炎,淋浊,白带,水泻,痢疾,痈疮,烫伤。
玫瑰花:基原:为蔷范科植物玫瑰初放的花。性味:甘、微苦,温。归经:归肝、脾经。功能主治:行气解郁,和血,止痛。用于肝胃气痛,食少呕恶,月经不调,跌扑伤痛。
荸荠:基原:为莎草科植物荸荠的球茎。性味:甘,寒。归经:入肺、胃经。功能主治:清热,化痰,消积。治愠病消渴,黄疸,热淋,痞积,目赤,嚼喉肿痛,赘疣。
菝葜:基原:为百合科植物菝葜的根茎。性味:甘,温。功能主治:祛风湿,利小便,消肿毒。治关节疼痛,肌肉麻木,泄泻,痢疾,水肿,淋病,疔疮,肿毒,瘰疬,痔疮。
干苔:基原:为石莼科植物条浒苔的藻体。性味:咸,寒。功能主治:软坚,消结,化痰。治瘿瘤、瘰疬,烦热鼻衄。
蚕退纸:基原:为蚕蛾科昆虫家蚕蛾卵子孵化后的卵壳。性味:味甘,性平。归经:肝,心经。功能主治:止血,止痢,解毒消肿。主吐血,衄血,崩漏,肠痔下血,赤白痢疾,咽喉肿痹,牙疳,口疮,聤耳,疮疡,疔肿。
山豆根:基原:主要为豆科植物广豆根的根。性味:苦,寒。归经:入心,肺、大肠经。功能主治:清火,解毒,消肿,止痛。治喉痈,喉风,喉痹,牙龈肿痛,喘满热咳,黄疸,下痢,痔疾,热肿,秃疮,疥癣,蛇、虫、犬咬伤。
急性子:基原:为凤仙花科植物凤仙的种子。性味:微苦、辛,温,有小毒。归经:归肺、肝经。功能主治:破血软坚,消积。用于症瘕痞块,经闭,噎膈。
鸡爪芋:基原:为天南星科植物疣柄磨芋的块茎。性味:味辛,甘,性微温。功能主治:疏肝健脾,解毒散结。主慢性迁延性肝炎。
全叶青兰:基原:为唇形科植物全叶青兰的全草。性味:味苦,辛,性微湿。功能主治:祛痰,止咳,平喘。主急慢性支气管炎,支气管哮喘。
试验例1本发明所得肿瘤科患者术后调治胰腺癌的制剂(实施例5)的临床应用:
2012年6月-2014年5月,在5所医院普外科救治的胰腺癌患者中筛选出270例作为研究对象,其中女性123例,男性147例,年龄50-74岁,平均年龄(60.2±6.4)岁。全部患者均经病理学和CT、MRI等影像学证据,确诊为胰腺癌患者,其中Ⅱ期162例,Ⅲ期108例,肿瘤位于胰头部107例,胰体部84例,胰尾部79例。所有患者均为根治性切除术后的患者,未接受过任何放、化疗以及激素治疗;Karnofsky评分≥60,白细胞计数不低于3×109个/L,血小板计数不低于80×109个/L,血红蛋白水平不低于90g/L;且对本研究知情同意者。
将患者随机分为两组,实验组150例和对照组120例,两组在性别、年龄、病程、病情等方面无显著差异(P>0.05),具有可比性。术后两周对照组患者开始采用吉西他滨进行化疗,实验组在对照组的基础上服用本发明所得产品,每天服用两次(温热),每次350m1-400m1(视具体情况有所调整),15天一个疗程。治疗期间对两组患者进行连续观察,记录症状变化及不良反应的情况。
临床受益反应(clinicalbenefitresponse,CBR)采用1997年Burris等制定的CBR标准。CBR定义为:(1)镇痛药用量减少≥50%;(2)疼痛程度减轻≥50%,每天评定,疼痛缓解沿用国际通用的数字分级法(NRS)评估:将疼痛分为0~10代表不同程度的疼痛,0为无痛,10为极度疼痛。并将疼痛大致分为三级:1~3为轻度疼痛,4~6为中度疼痛,7~10为重度疼痛;(3)体力状况改善≥20%,每周测定,采用卡氏评分法评定;(4)上述3个指标稳定,加上非体液滞留的体重比入组时增加≥7%。具有以上1项指标改善,且持续4周以上,无其它指标恶化者,评价为临床受益病例。计算临床受益率。
中位生存期(Mediansurvivaltime,MST)为治疗开始至死亡或末次随访时间的中位数;生存期计算为治疗日至死亡或末次随访日,以失访、死于其他疾病和到达研究终止期为截尾数据。
结果显示,服用四个疗程后,对照组中镇痛药用量减少≥50%的患者36例,疼痛减轻程度≥50%的患者49例,体力状况改善≥20%的患者35例,体重增加≥7%的患者17例,综合评价临床受益者为68例,临床受益率为56.7%。实验组组中镇痛药用量减少≥50%的患者65例,疼痛减轻程度≥50%的患者98例,体力状况改善≥20%的患者76例,体重增加≥7%的患者42例,综合评价临床受益者为138例,临床受益率为92.0%。治疗过程中,实验组出现Ⅲ~Ⅳ度中性粒细胞减少14例(9.3%),Ⅲ~Ⅳ度贫血10例(6.7%),Ⅲ~Ⅳ度血小板减少20例(13.3%),恶心、呕吐、肝肾功能损害均反应较轻,多为Ⅰ~Ⅱ度。对照组出现的上述不良反应发生率均较实验组的高,且还出现Ⅲ~Ⅳ度腹泻12例(10.0%)。随访两年,实验组中位生存时间为17.4年,对照组的为14.5年。
本发明选择中药有散瘀定痛的虎杖,疏肝理气的佛手花,清热利湿的山矾根,祛风除湿的酒饼婆,散瘀消肿的田基黄,清热解毒的铜锤草,行气解郁的玫瑰花,清热化痰的荸荠,利小便的菝葜,消结化痰的干苔,解毒消肿的蚕退纸,消肿止痛的山豆根,破血软坚的急性子,疏肝健脾的鸡爪芋,祛痰止咳的全叶青兰,诸药合用,可奏祛瘀散结、疏肝理气等功效。
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.肿瘤科患者术后调治胰腺癌的制剂,其特征在于,主要由下列原料药制备而成,均为质量份:虎杖7-12,佛手花9-13,山矾根6-14,酒饼婆4-10,田基黄3-7,铜锤草6-12,玫瑰花5-9,荸荠3-6,菝葜7-10,干苔4-9,蚕退纸6-10,山豆根8-12,急性子5-11,鸡爪芋3-8,全叶青兰6-9。
2.如权利要求1所述的肿瘤科患者术后调治胰腺癌的制剂,其特征在于,虎杖8-11,佛手花10-12,山矾根8-12,酒饼婆6-8,田基黄4-6,铜锤草8-10,玫瑰花6-8,荸荠4-5,菝葜8-9,干苔5-8,蚕退纸7-9,山豆根9-11,急性子6-10,鸡爪芋4-7,全叶青兰7-8(优选的,虎杖9.5,佛手花11,山矾根10,酒饼婆7,田基黄5,铜锤草9,玫瑰花7,荸荠4.5,菝葜8.5,干苔6.5,蚕退纸8,山豆根10,急性子8,鸡爪芋5.5,全叶青兰7.5)。
3.如权利要求1-2任一所述的肿瘤科患者术后调治胰腺癌的制剂的汤剂的制备方法,其特征在于,步骤如下:
(1)取急性子用黄酒浸30分钟,取出,焙干,将山矾根和酒饼婆去杂切片,与焙干的急性子一同置于炒锅内,喷淋米醋拌匀,放置10分钟,文火加热,炒干,取出,晾凉;
(2)将铜锤草和干苔洗净,用米泔水浸润30分钟,取出,切丝,置于炒锅内,炒至原料药表面微黄,取出,晾凉;
(3)将荸荠洗净去皮,加水打浆,浆汁加洗净的佛手花和玫瑰花煎煮,大火煮沸后小火煎20-32分钟(优选的,小火煎24-28分钟;更加优选的,小火煎26分钟),过滤,收集滤液;
(4)将虎杖、田基黄、菝葜、山豆根、鸡爪芋和全叶青兰去杂洗净,与步骤(1)(2)所制原料药一起加水煎煮,加水量为所煎煮原料药质量的7倍,大火煮沸后小火煎27分钟,过滤,收集滤液,滤渣加水再煮,加水量和煎煮时间同第一次,合并两次煎煮所得滤液;
(5)将蚕退纸置于耐火容器上,加热至表面焦黑,取出,研末后加入到步骤(4)所制滤液混匀,再加入步骤(3)所制滤液拌匀,灭菌,即得汤剂。
4.如权利要求3所述的肿瘤科患者术后调治胰腺癌的制剂汤剂的制备方法,其特征在于,步骤(3)加水量为荸荠质量的14-20倍(优选的,加水量为荸荠质量的16-18倍;更加优选的,加水量为荸荠质量的17倍)。
5.如权利要求1-2任一所述的肿瘤科患者术后调治胰腺癌的制剂的散剂的制备方法,其特征在于,步骤如下:
(1)取急性子用黄酒浸30分钟,取出,焙干,将山矾根和酒饼婆去杂切片,与焙干的急性子一同置于炒锅内,喷淋米醋拌匀,放置10分钟,文火加热,炒干,取出,晾凉;
(2)将铜锤草和干苔洗净,用米泔水浸润30分钟,取出,切丝,置于炒锅内,炒至原料药表面微黄,取出,晾凉;
(3)将荸荠洗净去皮,切片,与佛手花和玫瑰花加炼蜜水拌匀,浸润15分钟,取出,焙干,与步骤(1)(2)所制原料药一起粉碎过筛,制成药粉;
(4)将虎杖、田基黄、菝葜、山豆根、鸡爪芋和全叶青兰去杂洗净加水煎煮,加水量为所煮原料药质量的8倍,大火煮沸后小火煎27分钟,过滤,收集滤液,滤渣加水再煮,加水量和煎煮时间同第一次,合并两次煎煮所得滤液,浓缩成相对密度为1.24的清膏;
(5)将蚕退纸置于耐火容器上,加热至表面焦黑,取出,研末后与步骤(3)(4)所制药粉和清膏拌匀,干燥,粉碎过筛,制成粉状,灭菌,即得散剂。
6.如权利要求5所述的肿瘤科患者术后调治胰腺癌的制剂散剂的制备方法,其特征在于,步骤(5)粉碎过120-260目筛(优选的,粉碎过160-220目筛;更加优选的,粉碎过190目筛)。
7.如权利要求1-2任一所述的肿瘤科患者术后调治胰腺癌的制剂的丸剂的制备方法,其特征在于,步骤如下:
(1)取急性子用黄酒浸30分钟,取出,焙干,将山矾根和酒饼婆去杂切片,与焙干的急性子一同置于炒锅内,喷淋米醋拌匀,放置10分钟,文火加热,炒干,取出,晾凉;
(2)将铜锤草和干苔洗净,用米泔水浸润30分钟,取出,切丝,置于炒锅内,炒至原料药表面微黄,取出,晾凉;
(3)将荸荠洗净去皮,切片,与佛手花和玫瑰花加炼蜜水拌匀,浸润15分钟,取出,焙干,与步骤(1)(2)所制原料药一起粉碎过筛,制成药粉;
(4)将虎杖、田基黄、菝葜、山豆根、鸡爪芋和全叶青兰去杂洗净加水煎煮,加水量为所煮原料药质量的8倍,大火煮沸后小火煎,过滤,收集滤液,滤渣加水再煮,加水量和煎煮时间同第一次,合并两次煎煮所得滤液,浓缩成相对密度为1.24的清膏;
(5)将蚕退纸置于耐火容器上,加热至表面焦黑,取出,研末后与步骤(3)(4)所制药粉和清膏拌匀,干燥,粉碎过80目筛,制成药粉,加炼蜜和水泛制成丸,干燥,灭菌,即得丸剂。
8.如权利要求7所述的肿瘤科患者术后调治胰腺癌的制剂丸剂的制备方法,其特征在于,步骤(4)大火煮沸后小火煎23-31分钟(优选的,小火煎25-29分钟;更加优选的,小火煎27分钟)。
9.如权利要求1-2任一所述的肿瘤科患者术后调治胰腺癌的制剂的胶囊剂的制备方法,其特征在于,步骤如下:
(1)取急性子用黄酒浸30分钟,取出,焙干,将山矾根和酒饼婆去杂切片,与焙干的急性子一同置于炒锅内,喷淋米醋拌匀,放置10分钟,文火加热,炒干,取出,晾凉;
(2)将铜锤草和干苔洗净,用米泔水浸润30分钟,取出,切丝,置于炒锅内,炒至原料药表面微黄,取出,晾凉;
(3)将荸荠洗净去皮,切片,与佛手花和玫瑰花加炼蜜水拌匀,浸润15分钟,取出,焙干,与步骤(1)(2)所制原料药一起粉碎过100目筛,制成药粉;
(4)将虎杖、田基黄、菝葜、山豆根、鸡爪芋和全叶青兰去杂洗净加水煎煮,加水量为所煮原料药质量的8倍,大火煮沸后小火煎23-31分钟(优选的,小火煎25-29分钟;更加优选的,小火煎27分钟),过滤,收集滤液,滤渣加水再煮,加水量和煎煮时间同第一次,合并两次煎煮所得滤液,浓缩成清膏;
(5)将蚕退纸置于耐火容器上,加热至表面焦黑,取出,研末后与步骤(3)(4)所制药粉和清膏拌匀,加10%淀粉浆、蔗糖和干淀粉制软材,制颗粒,装入胶囊,即得胶囊剂。
10.如权利要求9所述的肿瘤科患者术后调治胰腺癌的制剂胶囊剂的制备方法,其特征在于,步骤(4)浓缩成相对密度为1.18-1.24的清膏(优选的,浓缩成相对密度为1.19-1.23的清膏;更加优选的,浓缩成相对密度为1.21的清膏)。
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