CN107149653A - 一种具有抗肿瘤活性的中药复方组合物及其制备方法和应用 - Google Patents
一种具有抗肿瘤活性的中药复方组合物及其制备方法和应用 Download PDFInfo
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Abstract
本发明公开了一种具有抗肿瘤活性的中药复方组合物及其制备方法和其应用,该中药复方组合物由黄芪50~150份,铁皮石斛5~25份,马兰草20~65份,皂角刺30~90份,路路通20~60份,蜂房10~40份,冬凌草15~45份,猫抓草15~45份,天葵子10~40份,五味子10~30份,地榆10~30份,水蛭3~12份,茜草10~40份,重楼15~45份,冬葵子10~30份,石见穿10~20份、漏芦10~20份、甘草20~60份和芡实30~60份制成。经抗肿瘤实验结果表明,本发明提供的中药复方组合物,配比科学合理,对多种恶性肿瘤细胞均具有强的杀灭作用,不良反应低,安全性好,应用范围广泛。
Description
技术领域
本发明涉及一种中药,具体涉及一种具有抗肿瘤活性的中药复方组合物及其制备方法和应用。
背景技术
肿瘤已成为21世纪威胁人类生存的头号杀手,中国为世界癌症高发国家之一,并且每年呈快速增长趋势。临床上目前治疗肿瘤的药物主要有化学药品,但由于化疗药物毒性大,在杀死肿瘤细胞的同时也无选择性的杀死白细胞、淋巴细胞等人体自身免疫细胞,导致病人常常由于因自身免疫能力低下并发感染,患者使用不良反应大,存活率低,且费用高。
中医药在治疗肿瘤方面具有独特的优势,以中药为代表的天然类药物具有毒副作用小、作用靶点多样、耐受性好等特点,在治疗肿瘤方面愈来愈受到重视。
因此,很有必要在现有技术的基础上,研究开发一种抗肿瘤效果好,对多种肿瘤均具有很好的治疗效果,并且不良反应低,可明显改善肿瘤患者生活质量的中药复方组合物。
发明内容
发明目的:本发明的目的是解决现有技术的不足,提供一种配比科学合理,疗效确切,临床使用安全,可多靶点发挥抗肿瘤功效,不良反应低的中药复方组合物,本发明另一个目的是提供该具有抗肿瘤活性的中药复方组合物的制备方法及其在制备治疗恶性肿瘤疾病药物中的应用。
技术方案:为了实现以上目的,本发明采取的技术方案为:
一种具有抗肿瘤活性的中药复方组合物,它包括下列重量份数的原料药:黄芪50~150份,铁皮石斛5~25份,马兰草20~65份,皂角刺30~90份,路路通20~60份,蜂房10~40份,冬凌草15~45份,猫抓草15~45份,天葵子10~40份,五味子10~30份,地榆10~30份,水蛭3~12份,茜草10~40份,重楼15~45份,冬葵子10~30份,石见穿10~20份,漏芦10~20份,甘草20~60份和芡实30~60份。
作为优选方案,以上所述的具有抗肿瘤活性的中药复方组合物,它包括下列重量份数的原料药:黄芪100~150份,铁皮石斛15~25份,马兰草30~65份,皂角刺30~60份,路路通20~40份,蜂房10~30份,冬凌草15~30份,猫抓草30~45份,天葵子20~40份,五味子20~30份,地榆20~30份,水蛭6~12份,茜草20~40份,重楼15~30份,冬葵子10~20份,石见穿10~20份、漏芦10~20份、甘草40~60份和芡实40~60份。
作为优选方案,以上所述的具有抗肿瘤活性的中药复方组合物,它包括下列重量份数的原料药:黄芪150份,铁皮石斛20份,马兰草45份,皂角刺60,路路通40份,蜂房20份,冬凌草20份,猫抓草30份,天葵子20份,五味子30份,地榆30份,水蛭8份,茜草30份,重楼30份,冬葵子20份,石见穿20份、漏芦20份、甘草40份和芡实40份。
作为优选方案,以上所述的具有抗肿瘤活性的中药复方组合物,将各原料药的提取物和药学上可接受的载体制备成口服液、颗粒剂、胶囊剂或片剂剂型的药物。
将本发明提供的具有抗肿瘤活性的中药复方组合物的各原料的提取物制成口服液时,将各原料的提取物加蒸馏水溶解,过滤,加入糖浆,调节pH值,制成口服液。
将本发明提供的具有抗肿瘤活性的中药复方组合物的各原料的提取物制成片剂时,把各原料的提取物和乳糖或玉米淀粉,需要时加入润滑剂硬脂酸镁,混合均匀,整粒,然后压片制成片剂。
本发明提供的具有抗肿瘤活性的中药复方组合物的各原料的提取物制成胶囊剂时把各原料的提取物和载体乳糖或玉米淀粉混合均匀,整粒,然后装胶囊制成胶囊剂。
本发明提供的具有抗肿瘤活性的中药复方组合物的各原料的提取物制成颗粒剂时,把各原料的提取物和稀释剂乳糖或玉米淀粉混合均匀,整粒,干燥,制成颗粒剂。
本发明所述的具有抗肿瘤活性的中药复方组合物的制备方法,包括以下步骤:
(1)按重量份数取黄芪,铁皮石斛,马兰草,皂角刺,路路通,冬凌草,猫抓草,天葵子,五味子,地榆,茜草,重楼,冬葵子,石见穿、漏芦、甘草,加入总药材6~12倍量的乙醇提取1~3次,合并提取液,减压浓缩,得浓缩物;
(2)按重量份数取水蛭,蜂房和芡实,加入总药材6~12倍量的水提取1~3次,合并提取液,减压浓缩,得浓缩物;
(3)取步骤(1)和步骤(2)得到的浓缩物和药学上可接受的载体制备成口服液、颗粒剂、胶囊剂或片剂剂型的药物。
作为优选方案,以上所述的具有抗肿瘤活性的中药复方组合物的制备方法,步骤(1)所述的提取方法为回流、渗漉或超声提取法。
作为优选方案,以上所述的具有抗肿瘤活性的中药复方组合物的制备方法,步骤(1)所述的提取方法为回流、煎煮或超声提取法。
本发明所述的具有抗肿瘤活性的中药复方组合物在制备抗肿瘤药物中的应用。
作为优选方案,以上所述的具有抗肿瘤活性的中药复方组合物在制备抗前列腺癌、肺癌,胃癌,肝癌,结肠癌,宫颈癌,乳腺癌或脑癌药物中的应用。
本发明提供的具有抗肺癌活性的中药组合物,黄芪选用内蒙黄芪、膜荚黄芪,性味:甘;归经:脾经、肺经、肝经和肾经。具有益气固表、敛汗固脱、托疮生肌、利水消肿之功。方中重用为君药。
铁皮石斛,味甘,性微寒。具有生津养胃;滋阴清热;润肺益肾;明目强腰等功效,对于肿瘤体虚病人具有极好的固本扶正的功效。
配伍马兰草,皂角刺,路路通,冬凌草,猫抓草,天葵子,五味子,地榆,茜草,重楼,冬葵子,石见穿、漏芦、甘草,水蛭,蜂房和芡实具有很好的抗癌解毒、化痰祛瘀、益气养阴等功效,具有很好的抑制肿瘤细胞生长和能促进肿瘤细胞凋亡的作用。
有益效果:本发明提供的具有抗肿瘤活性的中药复方组合物和现有技术相比具有以下优点:
1、本发明根据中医药理论,采用辨证论治的理论进行中药组方筛选,提供的具有抗肿瘤活性的中药复方组合物配比科学合理,具有很好的抗癌解毒、化痰祛瘀、益气养阴等功效。实验结果表明,本发明提供的具有抗肿瘤活性的中药复方组合物具有很好的抑制肿瘤细胞生长和能促进肿瘤细胞凋亡的作用,并且对多种恶性肿瘤细胞均具有强的杀灭作用,应用范围广泛。
2、实验结果表明本发明提供的具有抗肿瘤活性的中药复方组合物具有扶正培本和免疫功能促进作用,且可调节体内cAMP含量和促进肿瘤坏死因子(INF)的产生,发挥多靶点,多器官治疗肿瘤的作用,可减少肿瘤患者痛苦,延长生存期,提高患者生存质量的作用,且经长期实验研究表明,本发明提供的具有抗肿瘤活性的中药复方组合物安全性高,毒副作用低。
3、本发明提供的具有抗肿瘤活性的中药复方组合物的制备方法,可操作性强,尤其是根据各味药物有效成分化学性质设计提取精制工艺,得到的提取物有效成分含量高,杂质少,且工艺稳定,适合工业化大生产。
具体实施方式
下面结合具体实施例进一步阐明本发明,应理解这些实施例仅用于说明本发明而不用于限制本发明的范围,在阅读了本发明之后,本领域技术人员对本发明的各种等价形式的修改均落于本申请所附权利要求所限定的范围。
实施列1
1.一种具有抗肿瘤活性的中药复方组合物,它由下列重量份数的原料药制成:黄芪150份,铁皮石斛20份,马兰草45份,皂角刺60,路路通40份,蜂房20份,冬凌草20份,猫抓草30份,天葵子20份,五味子30份,地榆30份,水蛭8份,茜草30份,重楼30份,冬葵子20份,石见穿20份、漏芦20份、甘草40份和芡实40份。
2.本发明所述的具有抗肿瘤活性的中药复方组合物的制备方法,包括以下步骤:
(1)按重量份数取黄芪150份,铁皮石斛20份,马兰草45份,皂角刺60,路路通40份,冬凌草20份,猫抓草30份,天葵子20份,五味子30份,地榆30份,茜草30份,重楼30份,冬葵子20份,石见穿20份、漏芦20份、甘草40份,加入总药材8倍量的乙醇回流提取3次,合并提取液,减压浓缩,得浓缩物;
(2)按重量份数取蜂房20份,水蛭8份和芡实40份,加入总药材8倍量的水回提取2次,合并提取液,减压浓缩,得浓缩物;
(3)取步骤(1)和步骤(2)得到的浓缩物加入乳糖,玉米淀粉混合均匀,加入润滑剂硬脂酸镁,混合均匀,整粒,然后压片制成片剂。
实施列2
1.一种具有抗肿瘤活性的中药复方组合物,它由下列重量份数的原料药制成:黄芪150份,铁皮石斛25份,马兰草65份,皂角刺60份,路路通40份,蜂房40份,冬凌草45份,猫抓草45份,天葵子40份,五味子30份,地榆30份,水蛭9份,茜草40份,重楼45份,冬葵子30份,石见穿20份,漏芦20份,甘草60份和芡实60份。
2.本发明所述的具有抗肿瘤活性的中药复方组合物的制备方法,包括以下步骤:
(1)按重量份数取黄芪150份,铁皮石斛25份,马兰草65份,皂角刺60份,路路通40份,冬凌草45份,猫抓草45份,天葵子40份,五味子30份,地榆30份,茜草40份,重楼45份,冬葵子30份,石见穿20份,漏芦20份,甘草60份,加入总药材6倍量的乙醇回流提取3次,合并提取液,减压浓缩,得浓缩物;
(2)按重量份数取蜂房40份,水蛭9份和芡实60份,加入总药材10倍量的水回提取3次,合并提取液,减压浓缩,得浓缩物;
(3)取步骤(1)和步骤(2)得到的浓缩物,然后加入稀释剂乳糖或玉米淀粉混合均匀,整粒,干燥,制成颗粒剂。
实施列3
1.一种具有抗肿瘤活性的中药复方组合物,它由下列重量份数的原料药制成:黄芪100份,铁皮石斛25份,马兰草30份,皂角刺30份,路路通20份,蜂房10份,冬凌草15份,猫抓草30份,天葵子20份,五味子20份,地榆20份,水蛭6份,茜草20份,重楼15份,冬葵子10份,石见穿10份、漏芦10份、甘草40份和芡实40份。
2.本发明所述的具有抗肿瘤活性的中药复方组合物的制备方法,包括以下步骤:
(1)按重量份数取黄芪100份,铁皮石斛25份,马兰草30份,皂角刺30份,路路通20份,蜂房10份,冬凌草15份,猫抓草30份,天葵子20份,五味子20份,地榆20份,水蛭6份,茜草20份,重楼15份,冬葵子10份,石见穿10份、漏芦10份、甘草40份,加入总药材10倍量的乙醇回流提取2次,合并提取液,减压浓缩,得浓缩物;
(2)按重量份数取蜂房40份,水蛭9份和芡实60份,加入总药材10倍量的水回提取3次,合并提取液,减压浓缩,得浓缩物;
(3)取步骤(1)和步骤(2)得到的浓缩物,然后加入然后和乳糖,玉米淀粉混合均与,整粒,然后装胶囊制成胶囊剂。
实施列4抗肿瘤药理实验
具有抗肿瘤活性的中药复方组合物对裸鼠体内人肿瘤抑制作用的实验研究
(1)对裸鼠体内人胃癌细胞(MGC-803)细胞的抑制作用
实验方法:将细胞培养瓶内贴壁生长的MGC-803细胞,制备成细胞悬液,调整细胞浓度,镜下计数,于每鼠右前肢腋部皮下接种5×106个MGC-803细胞,共接种30只,将其随机分成治疗组(本发明提供的具有抗肿瘤活性的中药复方组合物,实施例1,灌胃给药3g/kg),和空白组(等容量生理盐水),每组15只。接种48小时后,用药,连续30天,停药后,处死动物观察MGC-803细胞在裸鼠体内生长情况并称瘤重,抑制率=(治疗组瘤重-空白组瘤重)/空白组瘤重×100%。具体实验结果见表1。
表1 对裸鼠体内MGC-803细胞的抑制作用
(2)对裸鼠体内人肝癌(SMMC-7451)细胞的抑制作用
实验方法:制备SMMC-7451细胞悬液,调整细胞浓度,每鼠右前腋皮下接种SMMC-7451细胞5×106个/0.2ml,共接种30只,随机分成治疗组(本发明提供的具有抗肿瘤活性的中药复方组合物,实施例1,灌胃给药,3g/kg)和空白组(等容量生理盐水),每组15只,24小时后,开始用药,每天一次,连续30天,停药后,处死动物,观察肿瘤生长情况并剖取瘤组织称重,具体实验结果见表2。抑制率=(治疗组瘤重-空白组瘤重)/空白组瘤重×100%
表2 对裸鼠体内SMMC-7451细胞的抑制作用
(3)对裸鼠体内人肠粘液腺癌的抑制作用
取瘤源裸鼠,取出瘤组织,切成0.3-0.4mm的小块,将瘤组织接种在裸鼠的背部皮下,共接种30只,于接种后24天,随机分成治疗组(本发明提供的具有抗肿瘤活性的中药复方组合物,实施例1,灌胃给药,3g/kg)和空白组(等容量生理盐水),每组15只,连续用药30天,于末次给药后24h处死动物,剖取瘤组织称重,计算抑制率(%),具体实验结果见表3。抑制率=(治疗组瘤重-空白组瘤重)/空白组瘤重×100%
表3 对裸鼠体内人肠粘液腺癌的抑制作用
(4)对裸鼠体内肺癌(MCF-7)细胞的抑制作用
实验方法:制备肺癌(MCF-7)细胞悬液,调整细胞浓度,每鼠右前腋皮下接种MCF-7细胞5×106个/0.2ml,共接种30只,随机分成治疗组(本发明提供的具有抗肿瘤活性的中药复方组合物,实施例1,灌胃给药,3g/kg)和空白组(等容量生理盐水),每组15只,24小时后,开始用药,每天一次,连续24天,停药后,处死动物,观察肿瘤生长情况并剖取瘤组织称重,具体实验结果见表4。
表4 对裸鼠体内MCF-7细胞的抑制作用
由以上实验结果表明:本发明提供的具有抗肿瘤活性的中药复方组合物对人胃癌,肝癌,人肠粘液腺癌,肺癌裸鼠体内移植具有明显的抑制作用,表明本发明提供的具有抗肿瘤活性的中药复方组合物体内具有很强的抗人恶性肿瘤的作用,可以用于恶性肿瘤疾病的治疗。
实施例5体外抗癌实验
细胞株:人乳腺癌、脑癌和前列腺癌由南京中医药大学药理实验室提供;96孔板购自Costar公司;RMPI1640培养基购自Gibco公司;DMEM培养基购自Gibco公司;新生牛血清购自杭州四季青公司;噻唑蓝(MTT)和DMSO购自Amresco公司;
以下实施例所使用的实验仪器如下:
实验仪器:超净工作台(苏州净化型号SW-CJ-IFD),CO2培养箱(SANYO型号:XD-101),酶标仪BIO-RAD(Model NO.550Serial NO.16971)。
以下实施例所使用的实验方法如下:
实验方法:使用改良MTT法对本发明实施例1制备得到的中药复方组合物进行体外抗肿瘤细胞实验:将人乳腺癌、脑癌和前列腺癌用胰酶进行消化、计数、制成浓度为5×104个/ml的细胞悬液。将96孔板中每孔加入100μl细胞悬液(每孔5×103个细胞),然后置于37℃,5%CO2培养箱中培养24小时;用非完全培养基稀释药物至所需的不同梯度浓度,每孔加入100μL相应的含药培养基,同时设立阴性对照组,溶媒对照组和阳性对照组,再将96孔板置于37℃,5%CO2培养箱中培养72小时。然后每孔加入20μLMTT(5mg/ml),继续培养4小时,终止培养,弃去培养基,每孔加入150μLDMSO溶解,摇床10分钟轻轻混匀。在λ=4570nm、620nm两波长下用酶标仪检测每孔的吸光度即OD值,以各复孔的平均值作为该组细胞的OD值,计算各药物的抑制率。
实验结果显示本发明实施例1制备得到的中药复方组合物,对人乳腺癌、脑癌和前列腺癌均具有较强的抑制作用,各剂量组呈现了较好的量效关系。实验结果如表5所示。
表5 对人乳腺癌、脑癌和前列腺癌细胞的抑制作用结果
本发明根据中医药理论,采用辨证论治的理论进行配比组方,通过以上实验结果表明,本发明提供的具有抗肿瘤活性的中药复方组合物具有抗癌解毒、化痰祛瘀、益气养阴功效,具有抑制肿瘤的生长和转移作用,且能逆转肿瘤细胞的耐药性,促使肿瘤细胞的凋亡,且无明显毒副作用,说明本发明提供的具有抗肿瘤活性的中药复方组合物可以用于制备抗肿瘤新药物。
以上所述仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以做出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。
Claims (9)
1.一种具有抗肿瘤活性的中药复方组合物,其特征在于,它包括下列重量份数的原料药:黄芪50~150份,铁皮石斛5~25份,马兰草20~65份,皂角刺30~90份,路路通20~60份,蜂房10~40份,冬凌草15~45份,猫抓草15~45份,天葵子10~40份,五味子10~30份,地榆10~30份,水蛭3~12份,茜草10~40份,重楼15~45份,冬葵子10~30份,石见穿10~20份、漏芦10~20份、甘草20~60份和芡实30~60份。
2.根据权利要求1所述的具有抗肿瘤活性的中药复方组合物,其特征在于,它包括下列重量份数的原料药:黄芪100~150份,铁皮石斛15~25份,马兰草30~65份,皂角刺30~60份,路路通20~40份,蜂房10~30份,冬凌草15~30份,猫抓草30~45份,天葵子20~40份,五味子20~30份,地榆20~30份,水蛭6~12份,茜草20~40份,重楼15~30份,冬葵子10~20份,石见穿10~20份、漏芦10~20份、甘草40~60份和芡实40~60份。
3.根据权利要求2所述的具有抗肿瘤活性的中药复方组合物,其特征在于,它包括下列重量份数的原料药:黄芪150份,铁皮石斛20份,马兰草45份,皂角刺60,路路通40份,蜂房20份,冬凌草20份,猫抓草30份,天葵子20份,五味子30份,地榆30份,水蛭8份,茜草30份,重楼30份,冬葵子20份,石见穿20份、漏芦20份、甘草40份和芡实40份。
4.根据权利要求1至3任一项所述的具有抗肿瘤活性的中药复方组合物,其特征在于,将各原料药的提取物和药学上可接受的载体制备成口服液、颗粒剂、胶囊剂或片剂剂型的药物。
5.权利要求1至3任一项所述的具有抗肿瘤活性的中药复方组合物的制备方法,其特征在于包括以下步骤:
(1)按权利要求1至3任一项所述的重量份数取黄芪,铁皮石斛,马兰草,皂角刺,路路通,冬凌草,猫抓草,天葵子,五味子,地榆,茜草,重楼,冬葵子,石见穿、漏芦、甘草,加入总药材6~12倍量的乙醇提取1~3次,合并提取液,减压浓缩,得浓缩物;
(2)按权利要求1至3任一项所述的重量份数取水蛭,蜂房和芡实,加入总药材6~12倍量的水提取1~3次,合并提取液,减压浓缩,得浓缩物;
(3)取步骤(1)和步骤(2)得到的浓缩物和药学上可接受的载体制备成口服液、颗粒剂、胶囊剂或片剂剂型的药物。
6.权利要求5所述的具有抗肿瘤活性的中药复方组合物的制备方法,其特征在于,步骤(1)所述的提取方法为回流、渗漉或超声提取法。
7.权利要求5所述的具有抗肿瘤活性的中药复方组合物的制备方法,其特征在于,步骤(1)所述的提取方法为回流、煎煮或超声提取法。
8.权利要求1至3任一项所述的具有抗肿瘤活性的中药复方组合物在制备抗肿瘤药物中的应用。
9.权利要求1至3任一项所述的具有抗肿瘤活性的中药复方组合物在制备抗前列腺癌、肺癌,胃癌,肝癌,结肠癌,宫颈癌,乳腺癌或脑癌药物中的应用。
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