CN108578548A - 一种抗肿瘤的中药及其制备方法和应用 - Google Patents
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Abstract
本发明涉及一种抗肿瘤的中药及其制备方法和应用,属于中医药领域。该中药由下列重量份数的原料制成:山货榔25‑35份、蚤体15‑25份、虎掌草10‑20份、夏枯草15‑25份和蒲公英15‑25份。本发明具有很好的抑制乳腺癌肿瘤细胞生长和能促进乳腺癌肿瘤细胞凋亡的作用,疗效确切可靠,对裸鼠体内人乳腺癌(MCF‑7)细胞抑制率达75%,对人乳腺癌(MCF‑7)的抑制率达67%以上,对Lewis瘤株细胞瘤抑制率达60%。本发明可减少肿瘤患者痛苦,延长生存期,且经长期实验研究表明,本发明安全性高,毒副作用低,效果好于其他的抗肿瘤的中药组合物。可以方便和药学载体制备成多种剂型,临床上服用方便;工艺稳定,适合工业化大生产。
Description
技术领域
本发明涉及一种中药,尤其是一种抗肿瘤的中药,还涉及其制备方法和应用,属于中医药领域。
背景技术
癌症已经成为人类面临的重大医学难题,随着生活压力的增大和生活环境的恶化,患癌症的病人越来越多,肿瘤是当今社会最常见的疾病,涉及人体各个系统,严重威胁着人们的健康。
早期的癌症通常选择手术治疗,但术后仍然面临着复发与转移的问题。而中、晚期癌症的主要治疗方法目前仍是以化学治疗为主。
乳腺癌是女性最常见的恶性肿瘤之一,据资料统计,发病率占全身各种恶性肿瘤的7-10%,在妇女仅次于子宫癌,它的发病常与遗传有关,以及40-60岁之间,绝经期前后的妇女发病率较高。通常发生在乳房腺上皮组织的恶性肿瘤。是一种严重影响妇女身心健康甚至危及生命的最常见的恶性肿瘤之一。
肺癌是发病率和死亡率增长最快,对人群健康和生命威胁最大的恶性肿瘤之一。近50年来许多国家都报道肺癌的发病率和死亡率均明显增高,男性肺癌发病率和死亡率均占所有恶性肿瘤的第一位,女性发病率占第二位,死亡率占第二位。
临床上目前治疗各类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,且疗程长,费用高,在临床使用中有较大的局限性。
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。中医认为,肿瘤的形成是气血运代规律紊乱、经络受阻,气血郁结于某一部位形成,身体各个部位均会出现。但是目前报道的抗乳腺癌中药复方用药量较大,杂质成分较多,疗效不明显。
因此,研究开发一种抗肿瘤效果好,用药量少,并且不良反应低的抗肿瘤中成药具有重要意义。
发明内容
为了解决上述技术问题,本发明提供一种抗肿瘤的中药及其制备方法和应用,该中药不仅能抗癌消肿,还具有清热解毒、舒经活血的疗效。本发明的具体方案如下:
一种抗肿瘤的中药,由下列重量份数的原料制成:
山货榔25-35份、蚤体15-25份、虎掌草10-20份、夏枯草15-25份和蒲公英15-25份。
进一步地,由下列重量份数的原料制成:山货榔30份、蚤体20份、虎掌草15份、夏枯草20份和蒲公英20份。
本发明涉及的上述抗肿瘤的中药的制备方法,包括以下步骤:按重量份数称取原料,用80-100℃水煮半小时左右,即得到所述中药。
进一步地,用药量为每次150g-200g,每天2-3次。
进一步地,将所述中药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。
本发明涉及的上述中药在制备抗肿瘤药物中的应用。
本发明提供的具有抗肺癌活性的中药组合物,根据中医药理论辩证论治筛选组方,方中:
山货郎味酸,性平;入肾、膀胱经;祛风消肿,解毒消炎。
蚤体,味苦,微寒;有小毒,归肝经;清热解毒,消肿止痛,息风定惊。用于咽喉肿痛,疔毒,痈疮,外伤出血,高热,惊风抽搐,毒蛇咬伤。
虎掌草,辛、苦,寒;小毒;清热解毒,镇咳祛痰,活血舒筋。用于咽喉肿痛,咳嗽痰多,瘰疬,结核,痈疽肿毒,疟疾,风湿痛,胃痛,痢疾,跌打损伤。常用量6~10g。
夏枯草,辛、苦,寒;归肝、胆经;清热泻火,明目,散结消肿。
蒲公英,苦甘,寒;入肝、胃经;清热解毒,利尿散结。治急性乳腺炎,淋巴腺炎,瘰疬,疔毒疮肿,急性结膜炎,感冒发热,急性扁桃体炎,急性支气管炎,胃炎,肝炎,胆囊炎,尿路感染。
以上诸药合用,尤其是加大虎掌草用量后,具有很好的抗肿瘤解毒、化痰祛瘀和益气养阴等功效,具有很好的防治肝郁气滞,痰毒互结、气阴两虚导致的乳腺肿瘤等疾病以及肺部肿瘤有显著的效果。
与现有技术相比,本发明的有益效果如下:
(1)、本发明根据中医药理论和乳腺、肺部肿瘤疾病的发病特点,采用辨证论治的理论进行中药组方筛选,提供的具有抗乳腺癌活性的中药复方组合物配比科学合理,用药严谨,具有很好的抑制乳腺癌肿瘤细胞生长和能促进乳腺癌肿瘤细胞凋亡的作用,疗效确切可靠。
(2)、本发明提供的具有抗乳腺癌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,可促进肿瘤坏死因子(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,且经长期实验研究表明,本发明安全性高,无毒副作用,效果好于其他的抗肿瘤的中药组合物。
(3)、本发明提供的具有抗乳腺癌活性的中药复方组合物的提取物可以方便和药学载体制备成多种剂型,临床上服用方便;工艺稳定,适合工业化大量生产。
具体实施方式
下面将结合实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是对本发明一部分实例,而不是全部的实例。基于本发明中的实施例,本领域普通技术人员在没有付出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
实施例1
本实施例的抗肿瘤的中药,由下列重量份数的原料制成:山货榔30份、蚤体20份、虎掌草15份、夏枯草20份和蒲公英20份。按重量份数称取原料,用100℃水煮半小时左右,即得到所述中药。用药量为每次150g-200g,每天3次。
实施例2
本实施例的抗肿瘤的中药,由下列重量份数的原料制成:山货榔25份、蚤体15份、虎掌草10份、夏枯草15份和蒲公英15份。按重量份数称取原料,用100℃水煮半小时左右,即得到所述中药。将上述中药按常规方法制成口服液。
实施例3
本实施例的抗肿瘤的中药,由下列重量份数的原料制成:山货榔35份、蚤体25份、虎掌草20份、夏枯草25份和蒲公英25份。按重量份数称取原料,用90℃左右的水煮半小时左右,即得到所述中药。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。
将实施例1-3之一的药物供35岁女性乳腺癌患者服用12份,症状明显改善。供40岁男性肺癌患者服用5份,症状有所缓解。供27岁男性腰部肿瘤患者服用7份,肿瘤消除。
实施例4抗乳腺癌药理实验
(1)、对裸鼠体内人乳腺癌(MCF-7)细胞的抑制作用
实验方法:制备人乳腺癌MCF-7细胞悬液,调整细胞浓度,每鼠右前腋皮下接种人乳腺癌MCF-7细胞5×106个/0 .2ml,共接种20只,随机分成治疗组(本发明实施例1提供的具有抗乳腺癌活性的中药复方组合物,批号001.灌胃给药,2g/kg)和空白组(等容量生理盐水),每组10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1。
表1 对裸鼠体内人乳腺癌(MCF-7)细胞的抑制作用
(2)、体外抗乳腺癌活性测试
细胞株:人乳腺癌(MCF-7)细胞;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。
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)。
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制备得到的中药组合物进行体外抗人乳腺癌细胞实验:将人乳腺癌(MCF-7)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20μL MTT(5mg/ml),继续培养4小时,终止培养,弃去培养基,每孔加入150μL DMSO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制备得到的中药组合物,对人乳腺癌(MCF-7)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2所示。
表2对人乳腺癌(MCF-7)的抑制作用结果
由以上实验结果表明:相对于常规的药物组合物(抑制率在50%-60%),本发明提供的具有抗人乳腺癌活性的中药组合物对人乳腺癌裸鼠体内移植具有明显的抑制作用,体外也具有明显抑制人乳腺癌细胞生长的作用。表明本发明提供的具有抗人乳腺癌活性的中药组合物具有显著的抗人乳腺癌的作用,可以用于乳腺癌疾病的治疗。
实施例4对抗Lewis肺癌实体肿瘤实验
1、受试动物和药物
昆明种小鼠(SPF级)18~25g,雌雄各半。Lewis肺癌实体肿瘤,替加氟为阳性对照药(规格:50mg)、本发明中药组合物(实施例1)。
2、小鼠移植瘤模型的建立
接种前一日称重,选体重相近且健康的小鼠,随机分组,设4个实验组、阳性对照组和模型组,每组10只,雌雄各半,每只称重记录。
小鼠肺癌Lewis瘤株细胞培养于1640培养液中,37℃,5%CO2下常规培养,平均每两天传代一次,至对数生长期时用生理盐水制成密度为3×107/ml单细胞悬浮液,于无菌条件下注入小鼠腹腔内,接种后7天见小鼠腹腔明显肿大,此时,脱颈处死,放入盛有75%乙醇烧杯中浸泡2~3分钟,将消毒后的小鼠放入超净工作台中,暴露腹部,用无菌注射器抽取腹水放入无菌试剂瓶内备用。将上述腹水用台盼蓝计数,用生理盐水稀释,调整细胞数至1×107/ml,接种于小鼠右腋下,每只小鼠接种0 .4ml。
动物接种肿瘤后第4天开始给药,每天按表3给药方案灌胃给药1次(每天早晨9:00给药),模型组灌胃等量的生理盐水;连续给药15天。
表3各组给药方案
3、测定指标
末次给药后空腹24h,脱颈处死小鼠,称重,剥取瘤块并称重。计算抑瘤率(%)=(模型组平均瘤重—实验组平均瘤重)/模型组平均瘤重×100%,取瘤进行病理学检查,结果见表4所示:
表4检测结果
4、结果
经病理切片实验观察,所切除的组织为肿瘤组织,组织异型性较小。实验结果表明,实施例1-3对Lewis瘤株细胞瘤都有显著的药物疗效,这表明,相对于常规的抗肿瘤药物(抑制率在40%-50%之间),本发明中药组合物对抗Lewis瘤株细胞瘤的疗效更显著。
以上所述仅为本发明的较佳实施例而已,并不用以限制本发明,凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (6)
1.一种抗肿瘤的中药,其特征在于:由下列重量份数的原料制成:
山货榔25-35份、蚤体15-25份、虎掌草10-20份、夏枯草15-25份和蒲公英15-25份。
2.根据权利要求1所述的中药,其特征在于:由下列重量份数的原料制成:山货榔30份、蚤体20份、虎掌草15份、夏枯草20份和蒲公英20份。
3.权利要求1或2所述一种抗肿瘤的中药的制备方法,其特征在于:包括以下步骤:按重量份数称取原料,用80-100℃水煮半小时,即得到所述中药。
4.根据权利要求3所述的抗肿瘤的中药的制备方法,其特征在于:用药量为每次150g-200g,每天2-3次。
5.权利要求3所述的抗肿瘤的中药的制备方法,其特征在于:将所述中药与药学上可接受的载体组合制备成口服液、颗粒剂、胶囊剂或片剂剂型的药物。
6.权利要求1-3之一所述的中药在制备抗肿瘤药物中的应用。
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