CN106334140A - 一种中药组合物及其制备方法 - Google Patents
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Abstract
本发明属于中药技术领域,具体地说,涉及一种中药组合物及其制备方法。所述的中药组合物的组成按重量份比包括如下中药原材料:龙衣10~55重量份、土茯苓10~45重量份、龙葵15~45重量份、金线吊葫芦10~55重量份、七叶一支花5~50重量份、核桃5~45重量份、夏枯草10~45重量份、黄芪10~120重量份、松杉5~50重量份。本发明中药组合物对多种肿瘤和多种癌症均有较好的疗效。
Description
技术领域
本发明属于中药技术领域,具体地说,涉及一种中药组合物及其制备方法。
背景技术
消化系统病变引起的肿瘤及癌症、瘰疬,导致肺部疾病的肿瘤及癌症和肝脏疾病的肿瘤及癌症,如食道肿瘤及食道癌、胃溃疡肿瘤及胃癌、十二指肠溃疡和直肠肿瘤及癌症、胰腺炎症肿瘤及癌症、乳腺增生肿瘤及癌症、淋巴肿瘤及癌症、肺部肿瘤及癌症、肝硬化肿瘤及癌症、膀胱肿瘤及癌症、卵巢肿瘤及癌症。
在传统的中医学理论中阐述阴阳五行学说、藏象学、脏腑表里学说等五行的相生相克的依辅关系。肝脏的疾病会克疾脾胃的消化运化功能,而导致疾病。肺与大肠相表里,肺部的疾病会导致大肠的疾病。肺主皮毛,肺气不降、而导致脾胃运化功能失常、毒素糟粕不能正常排泄,肺气不宣、毒素堆积瘀疾皮肤、而产生面部痤疮、皮肤泡疹、湿疮痈疽、鳞屑病、白癜风等湿邪外溢的疾病。肺气不宣、湿阻经络、皮失所养,而导致湿毒内生、脾失运化、温运失调、寒湿内阻、瘀久生热、积瘤生腐。脾主造血、运化失常而导致肝气郁结、藏血功能失常、气血瘀阻、肝气犯胃、胃失所降而导致脾胃不和、化谷失常,气机上逆、噎嗝嗳气反酸、脘腹疼痛、青筋曝露、肌失所养,肺痿皮枯、面失所养、久咳阴竭、肺阻痈疡,脾湿生痰、寒积化腐、脾失统血、便血便溏,气滞血瘀、脘腹蠱胀、水湿内停、脾肿大、情志所伤,悠虑伤脾、阴精失常,悲伤损肺、气机失常,而肺气虚可导致肾不纳气,则出现心肾不交、咳喘失常,气机不降、心烦意乱、阴精耗亡、脏腑衰竭,病入膏肓。
CN102078517A公开了一种治疗肿瘤的中药,所述治疗肿瘤的中药由以下重量份的原药混合而成,白花蛇舌草20、瓜蒌30、广豆根6、半枝莲30、丹参30、赤芍30、当归30、石斛30、黄芪30、水牛角20、木香10、金银花30、连翘30、黄柏30、西洋参10、穿山甲5。该药能抑制肿瘤的生长,对于肿瘤患者发热、肿块增大、细胞变异、局部灼热、疼痛、消瘦、口渴、咽燥、便秘、舌红苔黄、少苔或无苔,脉乱或脉细等症状具有明显的改善作用。
CN103356973A公开了一种抗肿瘤的中药,所述中药由以下重量份的原料组成:黄芪15份、党参8份、丹参10份、当归8份、半枝莲20份、白花蛇舌草20份、白术15份、鸡内金10份、猪苓15份、郁金8份、蛇莓10份、猫爪草15份、炙甘草10份,三七4份、水蛭3份、蟾酥0.03份、全蝎3份、斑庄根10份、刺五加15份、姜炭10份、绢毛菊12份、败酱草15份、紫珠叶15份、鹅喉管8份。各组药相辅相成,既助药物之吸收运转,又防诸药甘滞凉寒,既能补益脾肺之气,健脾利湿,消痰软坚,破散结气,既可以单独使用治疗肿瘤,也可以与手术、放疗、化疗同时使用,其特点是见效快,疗效可靠,没有明显的毒副作用,既可以在短期内控制肿瘤的生长,消除肿瘤,同时还可以明显的增强人体体质,提高其自身抗病修复能力,是一种效果好、作用全面且没有明显毒副作用的抗肿瘤药物。
CN103385943A公开了一种治疗癌症的中药,由外敷药和内服药组成;所述外敷药包括以下重量份数的原料:食虫草、农吉利、乌骨藤、威灵仙、五味子、荷花花粉,所述内服药由重量份数为乌骨散、抗岩散和其它10种中药原料组成;所述10种中药为乌药花、倒生根、见肿消、叶下珠、海皂角、透骨消、红桂木、蚂蝗七、十大功劳和九死还阳草;或为九死还阳草、蚂蝗七、岩白菜、牛马藤、鸡血藤、矮地茶、迎春花、银杏、杜仲和川芎;或为川芎、白术、当归、生地、熟地、柴胡、茵陈、五月艾、仙鹤草和乌药等。本发明一种治疗癌症的中药及其制备方法,方法简单方便,制备得到的中药能有效的治疗癌症,防止癌症的复发,不伤害人体健康,无副作用。
然而上述中药在治疗上存在着一定的局限,存在对某种肿瘤或癌症治疗效果不明显的情况,大大限制了其应用。
有鉴于此特提出本发明。
发明内容
本发明要解决的技术问题在于克服现有技术的不足,提供一种中药组合物及制备方法。该中药组合物对多种肿瘤和多种癌症均有较好的疗效。
为解决上述技术问题,本发明采用如下技术方案:
一种中药组合物,其中:所述的中药组合物的组成按重量份比包括如下中药原材料:龙衣10~55重量份、土茯苓10~45重量份、龙葵15~45重量份、金线吊葫芦10~55重量份、七叶一支花5~50重量份、核桃5~45重量份、夏枯草10~45重量份、黄芪10~120重量份、松杉5~50重量份。
本发明上述中药组方能有效提高和阻断体液传播的淋巴液,导致细胞肿瘤变异及癌症细胞突变基因变异。
为大大提高治疗淋巴肿瘤及癌症和乳腺肿瘤及癌症的功效,增加对肺部肿瘤细胞及癌症细胞的变异与突变的阻断和抑制作用,所述的中药组合物还进一步包括独叶一支花5~45重量份、卷柏10~50重量份、白花蛇舌草10~50重量份、五味子10~70重量份、石橄榄10~50重量份、甘草5~40重量份。
为进一步提高对食道癌、胃癌、直肠癌等的治疗效果,所述的中药组合物还进一步包括灯笼草10~35重量份、蒲公英10~60重量份、马齿苋10~50重量份、穿破石10~50重量份。
为进一步增加对血液传播的肝脏肿瘤细胞分裂与肝癌细胞突变的阻断功效,所述的中药组合物还进一步包括人参5~50重量份、黄精10~50重量份、蝉衣10~35重量份、灵芝5~50重量份、芍药5~40重量份、草珊瑚10~40重量份、松杉5~50重量份、覆盆子5~55重量份、黄芪10~120重量份、铁包金10~45重量份、虎杖10~50重量份、夏枯草10~45重量份、紫草5~35重量份、刺五加5~50重量份。本发明组方并在脾脏胰腺及卵巢肿瘤及癌症治疗有神奇的功效,在治疗多种由体液(即血液与淋巴液)传播而导致细胞变异、肿瘤细胞分裂变异、癌细胞突变的临床症状有阻断的治疗效果和安全性,并以扶正祛邪,固本守元的治疗原则,对多种肿瘤及癌症有明显的功效。
现代医学证明:通过高效液相色谱测定方法分析,本发明的中药组合物具有临床功效的主要有效成分包括皂苷类:能抗拒肿瘤、抑制癌细胞生长。生物碱类、萜类:抗坏血酸。微量元素的锗:有机锗能使血液循环畅通、增加红血球的携氧能力,并能清除体内垃圾毒素排出体外,恶化肿瘤病变细胞组织生存环境。萘醌、黄酮类:具有淸热解毒、袪风疗癣、止痛止痢、特别是抗癌活性。含蒽醌类物质:具有抗病毒、对乙型肝炎抗原的抑制作用,对肝细胞的保护作为,抑制白细胞、促进肝细胞再生。白藜芦醇类:可抑制癌变过程中细胞和组织变异及肿瘤发生。多糖类:提高人体免疫能力、扶正固本,抑制移植肿瘤生理活性,提高肌体免疫力和耐缺氧能力,消除自由基、抑制肿瘤、抗放射,提高肝脏、骨髓、血液合成DNA、RNA和蛋白质能力、延长寿命。甙类(PD):扩血管的作为,对冠脉,脑血管、肺血管、肝血管的扩张作为。山柰酚、蒲公英萜类:具有清热解毒、袪风活血、化痰止痛、风湿痹痛、肺炎、哮喘、肝炎、肾炎、咽喉炎等活血化淤、壮筋骨。紫杉醇类:有抗癌功能、抑制肿瘤、糖尿病及心脏病的作用。酶类、超级氧化物歧化酶SOD其他混合物:含有多种维生素和微量元素及其他未明的混合物有效成分,在抑制肿瘤、癌细胞和化疗、放疗后的白细胞生成显著。
本发明中药组方经多年临床试验表明:对多种肿瘤、多种癌症、消化系统肿瘤及癌症(如肺癌、乳腺癌、淋巴癌、胃癌、食道癌、直肠癌、肝癌、胰腺癌、膀胱癌、卵巢癌)及恶性肿瘤有效率分别达73.5%、78.6%、83.4%。在治疗肿瘤效果中可直接杀死肿瘤细胞及癌症细胞,并能提高免疫力、抑制肿瘤细胞及癌症细胞的增殖,在治疗过程中攻补兼施,可抑制肿瘤细胞及癌症细胞突变、变异,对肿瘤及癌症术后的化疗、放疗的白细胞生成再生。抗基因突变、抑制肿瘤细胞生成,并直接抑制肿瘤细胞的增殖,促进肿瘤细胞凋亡,对肿瘤细胞的增长有明显的阻滞作用。从而控制肿瘤细胞从量变走向质变,阻止肿瘤细胞的爆发及恶性肿瘤的产生,及时清除变异细胞,不给变异细胞形成肿瘤细胞的机会,将肿瘤细胞扼杀在萌芽状态中。另外肿瘤细胞是基因突变形成的,基因有遗传性,突变后的基因更容易遭受致肿瘤因素的侵袭,有肿瘤体质或癌症基因人群一定要重视预防。容易恶变的乙肝患者和幽门螺旋杆菌的胃炎患者更加预防。该组方对肿瘤细胞的端粒酶基因具有抑制作用,端粒是染色体末端的一段特殊结构,随着细胞的不断分裂,端粒逐渐缩短,一旦端粒长度缩短到一个域限水平,细胞就会衰老死亡,这是正常细胞的生命周期。肿瘤细胞中含有叫做端粒酶的核糖核蛋白MYC、它能保护端粒在细胞分裂过程中不被损耗,维护端粒的长度,使肿瘤细胞继续分裂、增殖和生长,从而使肿瘤细胞获得“永生性”。该组方有效降解了肿瘤细胞中的MYC蛋白,切断了肿瘤细胞分裂的能量动力。肿瘤细胞主要是通过人体中70%的体液(即血液和淋巴液)传播的。该组方能有效提高人体双重免疫力,即细胞免疫和体液免疫。激活T、B淋巴细胞唤起机体对肿瘤的免疫识别,增强NK细胞、巨噬细胞的杀伤功能,进而清除血液和淋巴液中的肿瘤细胞,抑制肿瘤细胞增长,阻滞肿瘤细胞转移和扩散。临床显示,乳腺肿瘤容易向肺部肿瘤转移,胃部肿瘤、肠道肿瘤往往向肝脏肿瘤转移,该组方有效的抑制原发性乳腺肿瘤、胃部肿瘤、肠道肿瘤。同时能“先安未受邪之脏腑”。对肝、肺等脏器进行肿瘤细胞清除和功能养护的作为。“即病防变”着力于预在先机,筑起“防护墙”阻截肿瘤细胞转变。
本发明所述的中药组合物可制备成药学上可接受的各种剂型,优选口服液、敷抹剂、颗粒剂、片剂或膏服剂。
本发明还提供所述的中药组合物的制备方法,该方法包括如下步骤:
1)取每味中药原材料的鲜药,分别进行水提醇沉或醇提醇沉,得到提取液,然后离心过滤,收集滤液,合并每味药的滤液;
2)将合并的滤液进行提取,过滤得到所述的中药组合物。
本发明选用鲜药提取后提取,比干品药物药效相对提高3~5倍。新鲜药物提取与干品药物提取后的产品对比,鲜品药物的提取产品有害物质农药残留、重金属及炮制污染残留值为零,能有效地降低残留危害人身健康及提高用药的安全性。
上述制备方法中,所述的提取按照如下四个阶段进行:
1)第一阶段:在温度38℃、压力0.4MPa下浸渍6~8小时,然后升温至65℃,在压力0.8MPa提取1~2小时;
2)第二阶段:再将温度由65℃降温至45℃,在压力0.4MPa下提取2~4小时;
3)第三阶段:然后将温度由45℃升温至70℃,在温度70℃下提取0.5~1小时;再降温至50℃,在压力0.4MPa下提取0.5~1小时;
4)第四阶段:最后将温度由50℃降至30℃,在压力0.2MPa下提取1~3小时。
本发明采用上述四个阶段提取,对混合物成分和主要成分的提取率提高至93%以上。
优选的,本发明所述的制备方法还包括将所述的中药组合物配以药学上可接受的辅料制成药学上可接受的剂型,优选口服液、外敷剂、颗粒剂、片剂、浸膏剂或酒剂。
进一步的,本发明所述的制备方法中,当所述的剂型为口服液、外敷剂、颗粒剂、片剂或浸膏剂时,步骤1)中采用水提醇沉;
当所述的剂型为酒剂时,步骤1)中采用醇提醇沉。
具体地说,所述的水提醇沉为:加8~12倍量水进行提取,每次提取1~2小时,提取1~3次,合并提取液;向提取液中加入95%的乙醇,至含醇量达到85%,放置8~12小时,离心过滤,回收滤液。
所述的醇提醇沉为:加1~10倍量50%~70%的乙醇进行提取,每次提取60天至360天,提取1~3次,合并提取液;向提取液中加入10%~30%的乙醇,至含醇量达到11%~65%,静置7天后,离心过滤,收集滤液,再次加入1~10倍量50%~70%的乙醇按照前述的方法进行提取。
本发明中,乙醇的百分比指的是体积百分比。
与现有技术相比,本发明具有如下优点:
(1)本发明所提供的中药组合物能扶正祛邪、补益元气,调理气机、上宣下降,清热利湿、脱毒排毒,破血行气、利水行气,化瘀除湿、软坚散结,滋阴清热、活血化淤,补气养血、健脾和胃,化谷生精。
(2)本发明所提供的中药组合物对消化系统病变引起的肿瘤及癌症、瘰疬,导致肺部疾病的多种肿瘤及癌症和肝脏疾病的多种肿瘤及癌症,如食道肿瘤及食道癌、胃溃疡肿瘤及胃癌、十二指肠溃疡和直肠肿瘤及癌症、胰腺炎症肿瘤及癌症、乳腺增生肿瘤及癌症、淋巴肿瘤及癌症、肺部肿瘤及癌症、肝硬化肿瘤及癌症、膀胱肿瘤及癌症、卵巢肿瘤及癌症均有显著的疗效。
具体实施方式
为使本发明实施例的目的、技术方案和优点更加清楚,下面将结合本发明实施例,对实施例中的技术方案进行清楚、完整地描述,以下实施例用于说明本发明,但不用来限制本发明的范围。
实施例1
组成:龙衣50g、土茯苓40g、龙葵40g、金线吊葫芦50g、七叶一支花30g、核桃40g、夏枯草30g、黄芪80g、松杉30g。
制备方法:
1)取新鲜的上述中药原材料,按所述用量称取,分别加8倍量水进行提取,每次提取1小时,提取1次,合并提取液;向提取液中加入95%的乙醇,至含醇量达到85%,放置8小时,离心过滤,收集滤液,合并每味药的滤液;
2)将合并的滤液进行提取,过滤得到所述的中药组合物,其中所述的提取按照如下四个阶段进行:
a)第一阶段:在温度38℃、压力0.4MPa下浸渍6小时,然后升温至65℃,在压力0.8MPa提取1小时;
b)第二阶段:再将温度由65℃降温至45℃,在压力0.4MPa下提取2小时;
c)第三阶段:然后将温度由45℃升温至70℃,在温度70℃下提取0.5小时;再降温至50℃,在压力0.4MPa下提取0.5小时;
d)第四阶段:最后将温度由50℃降至30℃,在压力0.2MPa下提取1小时。
可进一步向将所得的中药组合物配以药学上可接受的辅料按照中药口服液的制备方法将其制备成口服液。
实施例2
组成:龙衣50g、土茯苓40g、龙葵40g、金线吊葫芦50g、七叶一支花30g、核桃40g、夏枯草30g、黄芪80g、松杉30g、独叶一支花20g、卷柏30g、白花蛇舌草25g、五味子30g、石橄榄30g、甘草25g。
制备方法:
1)取新鲜的上述中药原材料,按所述用量称取,分别加12倍量水进行提取,每次提取2小时,提取3次,合并提取液;向提取液中加入95%的乙醇,至含醇量达到85%,放置12小时,离心过滤,收集滤液,合并每味药的滤液;
2)将合并的滤液进行提取,过滤得到所述的中药组合物,其中所述的提取按照如下四个阶段进行:
a)第一阶段:在温度38℃、压力0.4MPa下浸渍8小时,然后升温至65℃,在压力0.8MPa提取2小时;
b)第二阶段:再将温度由65℃降温至45℃,在压力0.4MPa下提取4小时;
c)第三阶段:然后将温度由45℃升温至70℃,在温度70℃下提取1小时;再降温至50℃,在压力0.4MPa下提取1小时;
d)第四阶段:最后将温度由50℃降至30℃,在压力0.2MPa下提取3小时。
可进一步将所得的中药组合物配以药学上可接受的辅料按照中药颗粒剂的制备方法将其制备成中药颗粒剂。
实施例3
组成:龙衣50g、土茯苓40g、龙葵40g、金线吊葫芦50g、七叶一支花30g、核桃40g、夏枯草30g、黄芪80g、松杉30g、独叶一支花20g、卷柏30g、白花蛇舌草25g、五味子30g、石橄榄30g、甘草25g、灯笼草25g、蒲公英30g、马齿苋40g、穿破石30g。
制备方法:
1)取新鲜的上述中药原材料,按所述用量称取,分别加10倍量水进行提取,每次提取1.5小时,提取2次,合并提取液;向提取液中加入95%的乙醇,至含醇量达到85%,放置10小时离心过滤,收集滤液,合并每味药的滤液;
2)将合并的滤液进行提取,过滤得到所述的中药组合物,其中所述的提取按照如下四个阶段进行:
a)第一阶段:在温度38℃、压力0.4MPa下浸渍7小时,然后升温至65℃,在压力0.8MPa提取1.5小时;
b)第二阶段:再将温度由65℃降温至45℃,在压力0.4MPa下提取3小时;
c)第三阶段:然后将温度由45℃升温至70℃,在温度70℃下提取0.8小时;再降温至50℃,在压力0.4MPa下提取0.8小时;
d)第四阶段:最后将温度由50℃降至30℃,在压力0.2MPa下提取2小时。
可进一步将所得的中药组合物配以药学上可接受的辅料按照中药外敷剂的制备方法将其制备成中药外敷剂。
实施例4
组成:龙衣50g、土茯苓40g、龙葵40g、金线吊葫芦50g、七叶一支花30g、核桃40g、夏枯草30g、黄芪80g、松杉30g、独叶一支花20g、卷柏30g、白花蛇舌草25g、五味子30g、石橄榄30g、甘草25g、灯笼草255g、蒲公英30g、马齿苋40g、穿破石30g、人参30g、黄精35g、蝉衣25g、灵芝25g、芍药30g、草珊瑚20g、松杉10g、覆盆子30g、黄芪80g、铁包金25g、虎杖30g、夏枯草25g、紫草20g、刺五加15g。
制备方法:
1)取新鲜的上述中药原材料,按所述用量称取,加9倍量水进行提取,每次提取1.8小时,提取2次,合并提取液;向提取液中加入95%的乙醇,至含醇量达到85%,放置9小时,离心过滤,收集滤液,合并每味药的滤液;
2)将合并的滤液进行提取,过滤得到所述的中药组合物,其中所述的提取按照如下四个阶段进行:
a)第一阶段:在温度38℃、压力0.4MPa下浸渍7.5小时,然后升温至65℃,在压力0.8MPa提取1.8小时;
b)第二阶段:再将温度由65℃降温至45℃,在压力0.4MPa下提取3.5小时;
c)第三阶段:然后将温度由45℃升温至70℃,在温度70℃下提取0.8小时;再降温至50℃,在压力0.4MPa下提取0.8小时;
d)第四阶段:最后将温度由50℃降至30℃,在压力0.2MPa下提取2.5小时。
可进一步将所得的中药组合物按照中药浸膏剂的制备方法将其制备成中药浸膏剂。
实施例5
组成:龙衣50g、土茯苓40g、龙葵40g、金线吊葫芦50g、七叶一支花30g、核桃40g、夏枯草30g、黄芪80g、松杉30g、独叶一支花20g、卷柏30g、白花蛇舌草25g、五味子30g、石橄榄30g、甘草25g、灯笼草255g、蒲公英30g、马齿苋40g、穿破石30g、人参30g、黄精35g、蝉衣25g、灵芝25g、芍药30g、草珊瑚20g、松杉10g、覆盆子30g、黄芪80g、铁包金25g、虎杖30g、夏枯草25g、紫草20g、刺五加15g。
制备方法:
1)取新鲜的上述中药原材料,按所述用量称取,加11倍量水进行提取,每次提取1.6小时,提取2次,合并提取液;向提取液中加入95%的乙醇,至含醇量达到85%,放置9小时,离心过滤,收集滤液,合并每味药的滤液;
2)将合并的滤液进行提取,过滤得到所述的中药组合物,其中所述的提取按照如下四个阶段进行:
a)第一阶段:在温度38℃、压力0.4MPa下浸渍7.2小时,然后升温至65℃,在压力0.8MPa提取1.6小时;
b)第二阶段:再将温度由65℃降温至45℃,在压力0.4MPa下提取3.2小时;
c)第三阶段:然后将温度由45℃升温至70℃,在温度70℃下提取0.8小时;再降温至50℃,在压力0.4MPa下提取0.8小时;
d)第四阶段:最后将温度由50℃降至30℃,在压力0.2MPa下提取1.8小时。
可进一步将所得的中药组合物按照中药浸膏剂的制备方法将其制备成中药浸膏剂。
实施例6
组成:龙衣10g、土茯苓10g、龙葵15g、金线吊葫芦10g、七叶一支花5g、核桃5g、夏枯草10g、黄芪10g、松杉5g。
制备方法:
1)取新鲜的上述中药原材料,按所述用量称取,分别加1倍量50%的乙醇进行提取,每次提取60天,提取1次,合并提取液;向提取液中加入10%的乙醇,至含醇量达到11%,静置7天后,离心过滤,收集滤液,合并每味药的滤液;
2)将合并的滤液进行提取,过滤得到所述的中药组合物,其中所述的提取按照如下四个阶段进行:
a)第一阶段:在温度38℃、压力0.4MPa下浸渍6小时,然后升温至65℃,在压力0.8MPa提取1小时;
b)第二阶段:再将温度由65℃降温至45℃,在压力0.4MPa下提取2小时;
c)第三阶段:然后将温度由45℃升温至70℃,在温度70℃下提取0.5小时;再降温至50℃,在压力0.4MPa下提取0.5小时;
d)第四阶段:最后将温度由50℃降至30℃,在压力0.2MPa下提取1小时。
可进一步向将所得的中药组合物配以药学上可接受的辅料按照中药口服液的制备方法将其制备成酒剂。
实施例7
组成:龙衣55g、土茯苓45g、龙葵45g、金线吊葫芦55g、七叶一支花50g、核桃45g、夏枯草45g、黄芪120g、松杉50g、独叶一支花45g、卷柏50g、白花蛇舌草50g、五味子70g、石橄榄50g、甘草40g。
制备方法:
1)取新鲜的上述中药原材料,按所述用量称取,分别加10倍量70%的乙醇进行提取,每次提取360天,提取3次,合并提取液;向提取液中加入30%的乙醇,至含醇量达到65%,静置7天后,离心过滤,收集滤液,合并每味药的滤液;
2)将合并的滤液进行提取,过滤得到所述的中药组合物,其中所述的提取按照如下四个阶段进行:
a)第一阶段:在温度38℃、压力0.4MPa下浸渍6小时,然后升温至65℃,在压力0.8MPa提取1小时;
b)第二阶段:再将温度由65℃降温至45℃,在压力0.4MPa下提取2小时;
c)第三阶段:然后将温度由45℃升温至70℃,在温度70℃下提取0.5小时;再降温至50℃,在压力0.4MPa下提取0.5小时;
d)第四阶段:最后将温度由50℃降至30℃,在压力0.2MPa下提取1小时。
可进一步向将所得的中药组合物配以药学上可接受的辅料按照中药口服液的制备方法将其制备成酒剂。
实施例8
组成:龙衣50g、土茯苓40g、龙葵40g、金线吊葫芦50g、七叶一支花30g、核桃40g、夏枯草30g、黄芪80g、松杉30g、独叶一支花5g、卷柏10g、白花蛇舌草10、五味子10g、石橄榄10g、甘草5g、灯笼草10g、蒲公英10g、马齿苋10g、穿破石10g。
制备方法:
1)取新鲜的上述中药原材料,按所述用量称取,分别加5倍量60%的乙醇进行提取,每次提取200天,提取2次,合并提取液;向提取液中加入20%的乙醇,至含醇量达到45%,静置7天后,离心过滤,收集滤液,合并每味药的滤液;
2)将合并的滤液进行提取,过滤得到所述的中药组合物,其中所述的提取按照如下四个阶段进行:
a)第一阶段:在温度38℃、压力0.4MPa下浸渍6小时,然后升温至65℃,在压力0.8MPa提取1小时;
b)第二阶段:再将温度由65℃降温至45℃,在压力0.4MPa下提取2小时;
c)第三阶段:然后将温度由45℃升温至70℃,在温度70℃下提取0.5小时;再降温至50℃,在压力0.4MPa下提取0.5小时;
d)第四阶段:最后将温度由50℃降至30℃,在压力0.2MPa下提取1小时。
可进一步向将所得的中药组合物配以药学上可接受的辅料按照中药口服液的制备方法将其制备成酒剂。
实施例9
组成:龙衣12g、土茯苓12g、龙葵18g、金线吊葫芦15g、七叶一支花8g、核桃8g、夏枯草12g、黄芪12g、松杉8g、独叶一支花8g、卷柏12g、白花蛇舌草12g、五味子12g、石橄榄12g、甘草8g、灯笼草10g、蒲公英30g、马齿苋40g、穿破石30g、人参5g、黄精10g、蝉衣35g、灵芝5g、芍药5g、草珊瑚10g、松杉5g、覆盆子5g、黄芪10g、铁包金10g、虎杖10g、夏枯草10g、紫草5g、刺五加5g。
1)取新鲜的上述中药原材料,按所述用量称取,加11倍量水进行提取,每次提取1.6小时,提取2次,合并提取液;向提取液中加入95%的乙醇,至含醇量达到85%,放置9小时,离心过滤,收集滤液,合并每味药的滤液;
2)将合并的滤液进行提取,过滤得到所述的中药组合物,其中所述的提取按照如下四个阶段进行:
a)第一阶段:在温度38℃、压力0.4MPa下浸渍7.2小时,然后升温至65℃,在压力0.8MPa提取1.6小时;
b)第二阶段:再将温度由65℃降温至45℃,在压力0.4MPa下提取3.2小时;
c)第三阶段:然后将温度由45℃升温至70℃,在温度70℃下提取0.8小时;再降温至50℃,在压力0.4MPa下提取0.8小时;
d)第四阶段:最后将温度由50℃降至30℃,在压力0.2MPa下提取1.8小时。
可进一步将所得的中药组合物按照中药浸膏剂的制备方法将其制备成中药浸膏剂。
实施例10
组成:龙衣12g、土茯苓12g、龙葵18g、金线吊葫芦15g、七叶一支花8g、核桃8g、夏枯草12g、黄芪12g、松杉8g、独叶一支花8g、卷柏12g、白花蛇舌草12g、五味子12g、石橄榄12g、甘草8g、灯笼草35g、蒲公英60g、马齿苋50g、穿破石50g、人参50g、黄精50g、蝉衣10g、灵芝50g、芍药40g、草珊瑚40g、松杉50g、覆盆子55g、黄芪120g、铁包金45g、虎杖50g、夏枯草45g、紫草35g、刺五加50g。
制备方法:同实施例9。
对比例1
组成:与实施例1相同。
制备方法:
1)取新鲜的上述中药原材料,按所述用量称取,分别加8倍量水进行提取,每次提取1小时,提取1次,合并提取液;向提取液中加入95%的乙醇,至含醇量达到85%,放置8小时,离心过滤,收集滤液,合并每味药的滤液;
2)在温度38℃、压力0.4MPa下浸渍6小时,然后升温至65℃,在压力0.8MPa提取1小时,然后过滤,得到药物组合物。
试验例1
该试验例考察了本发明和现有技术的方法所制得的中药组合物的提取率。
结果见表1所示:
表1
样品 | 提取率 |
实施例1 | 93% |
实施例2 | 93.2% |
实施例3 | 93.4% |
实施例4 | 93.5% |
实施例5 | 93.1% |
对比例1 | 78.6% |
从上述试验结果可以看出,采用本发明的方法提取率得到了明显的提高。
试验例2
下面结合临床实验数据说明本发明的治疗效果:
1、一般资料
发明人于2005年4月至2016年1月间共收集100例医院确诊为癌症的门诊患者(男67例、女33例,年龄10-78岁,40-49岁占18%,50-59岁占20%,60-69岁占36%,70岁及其以上占12%,小于40岁占14%),其中胃癌占28%、肺癌占12%、乳腺癌占10%、肝癌和食道癌占16%、直肠癌和胰腺癌占10%、卵巢癌占4%、淋巴癌及恶性肿瘤占20%。在治疗过程中观察到本发明中药对胃癌、肝癌、食道癌、淋巴癌疗效特别突出,对肺癌、卵巢癌、乳腺癌疗效次之,对其他癌症亦有不同程度的疗效。
2、试验方法
2.1治疗方法
对照组口服安慰剂糊米荞麦粉,每次3克,每日3次,温开水吞服,疗程90天。
治疗组口服本发明具体实施方式实施例1制得的中药,每次10ml,每日3次,温开水吞服,疗程90天。
2.2观察项目
治疗前后患者体重、血压、血常规、贫血、疼痛、消瘦、乏力、水肿、食欲不振、发热、呕吐、便血等症状的变化。实验室检查癌组织大小变化和恶化情况。记录停药两年后患者生存情况。
3、疗效标准与治疗结果
3.1疗效标准
痊愈:临床症状逐渐好转甚至消失,试验室检查癌组织消失或转为良性,生存两年逐渐恢复健康且未见复发。
好转:临床症状减轻,实验室检查癌组织停止扩散或生长,继续生存两年以上。
无效:临床症状无明显好转或继续加重,实验室检查癌组织继续扩散或生长,两年内死亡。
3.2治疗统计结果见表2。
表2、两组疗效比较
组别 | 病例(例) | 痊愈(例) | 好转(例) | 无效(例) | 总有效率(%) |
治疗组 | 70 | 46 | 21 | 3 | 96 |
对照组 | 30 | 0 | 1 | 29 | 3 |
可见,本发明制得的中药能够安全有效治疗多种癌症。一般病人服用一周后精神状况普遍改观,疼痛、水肿减轻,食欲逐步恢复,体温恢复正常;继续服药二周后,肿块缩小,病症日渐缓解,血压、血象改善,体重回升,体质日益增强;三周后症状基本消失;六周后能日常活动,料理家务;坚持服用3~6个疗程,一个疗程为30天,普遍病情好转,部分痊愈。
以上所述仅是本发明的较佳实施例而已,并非对本发明作任何形式上的限制,虽然本发明已以较佳实施例揭露如上,然而并非用以限定本发明,任何熟悉本发明的技术人员在不脱离本发明技术方案范围内,当可利用上述提示的技术内容作出些许更动或修饰为等同变化的等效实施例,但凡是未脱离本发明技术方案的内容,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、等同变化与修饰,均仍属于本发明方案的范围内。
Claims (10)
1.一种中药组合物,其特征在于:所述的中药组合物的组成按重量份比包括如下中药原材料:龙衣10~55重量份、土茯苓10~45重量份、龙葵15~45重量份、金线吊葫芦10~55重量份、七叶一支花5~50重量份、核桃5~45重量份、夏枯草10~45重量份、黄芪10~120重量份、松杉5~50重量份。
2.根据权利要求1所述的中药组合物,其特征在于:所述的中药组合物还包括独叶一支花5~45重量份、卷柏10~50重量份、白花蛇舌草10~50重量份、五味子10~70重量份、石橄榄10~50重量份、甘草5~40重量份。
3.根据权利要求2所述的中药组合物,其特征在于:所述的中药组合物还包括灯笼草10~35重量份、蒲公英10~60重量份、马齿苋10~50重量份、穿破石10~50重量份。
4.根据权利要求3所述的中药组合物,其特征在于:所述的中药组合物还包括人参5~50重量份、黄精10~50重量份、蝉衣10~35重量份、灵芝5~50重量份、芍药5~40重量份、草珊瑚10~40重量份、松杉5~50重量份、覆盆子5~55重量份、黄芪10~120重量份、铁包金10~45重量份、虎杖10~50重量份、夏枯草10~45重量份、紫草5~35重量份、刺五加5~50重量份。
5.根据权利要求1-4任意一项所述的中药组合物,其特征在于,所述的中药组合物可制备成药学上可接受的剂型,优选口服液、外敷剂、颗粒剂、片剂、浸膏剂或酒剂。
6.一种权利要求1-5任意一项所述的中药组合物的制备方法,其特征在于,所述的制备方法包括如下步骤:
1)取每味中药原材料的鲜药,分别进行水提醇沉或醇提醇沉,得到提取液,然后离心过滤,收集滤液,合并每味药的滤液;
2)将合并的滤液进行提取,过滤得到所述的中药组合物。
7.根据权利要求6所述的制备方法,其特征在于,步骤2)中所述的提取按照如下四个阶段进行:
1)第一阶段:在温度38℃、压力0.4MPa下浸渍6~8小时,然后升温至65℃,在压力0.8MPa提取1~2小时;
2)第二阶段:再将温度由65℃降温至45℃,在压力0.4MPa下提取2~4小时;
3)第三阶段:然后将温度由45℃升温至70℃,在温度70℃下提取0.5~1小时;再降温至50℃,在压力0.4MPa下提取0.5~1小时;
4)第四阶段:最后将温度由50℃降至30℃,在压力0.2MPa下提取1~3小时。
8.根据权利要求7所述的制备方法,其特征在于,所述的制备方法还包括将所述的中药组合物配以药学上可接受的辅料制成药学上可接受的剂型,优选口服液、外敷剂、颗粒剂、片剂、浸膏剂或酒剂。
9.根据权利要求7所述的制备方法,其特征在于,当所述的剂型为口服液、外敷剂、颗粒剂、片剂或浸膏剂时,步骤1)中采用水提醇沉;
当所述的剂型为酒剂时,步骤1)中采用醇提醇沉。
10.根据权利要求8所述的制备方法,其特征在于,所述的水提醇沉为:加8~12倍量水进行提取,每次提取1~2小时,提取1~3次,合并提取液;向提取液中加入95%的乙醇,至含醇量达到85%,放置8~12小时,离心过滤,回收滤液;
所述的醇提醇沉为:加1~10倍量50%~70%的乙醇进行提取,每次提取60天至360天,提取1~3次,合并提取液;向提取液中加入10%~30%的乙醇,至含醇量达到11%~65%,静置7天后,离心过滤,收集滤液,再次加入1~10倍量50%~70%的乙醇按照前述的方法进行提取。
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