CN104258037A - 一种治疗肺癌的中药组合物及其制备方法 - Google Patents
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Abstract
本发明属于中医药技术领域,公开了一种治疗肺癌的中药组合物及其制备方法,它的特殊之处在于:药效成分由如下原料制成:牛西西、鹅不食草、棉花根、延胡索、白花蛇舌草、山药、党参、石见穿、香附、黄芪、蒲公英、土鳖虫、百合、千年健、杏仁、茯苓和甘草组成。本发明治疗肺癌的药物,可以延长患者的生存期,具有抗癌活性好、疗效显著、有效率高等特点。
Description
技术领域
本发明属于中医药技术领域,具体涉及一种治疗癌症的中药组合物及其制备方法。
背景技术
目前,肺癌无论是发病率还是死亡率都是增长最快的恶性肿瘤之一。早期肺癌一般采用手术治疗是获得治愈及远程治疗的可靠手段,但能够根治者不足30%。放疗和化疗对部分肺癌患者近期有效,但毒副作用大,而复发转移率高。肺癌的总体疗效较差,5年的生产率不足10%。
中医认为,肺癌属于肺积、肺岩、肺胀、息贲、痞癖、痰饮、咳嗽、咯血、胸痛、喘证、发热、虚劳等范畴。多是由于人体正气不足,阴阳气血失调,使脏腑经络的功能发生障碍,机体抗病能力降低,邪气乘虚而入,滞留于肺,痰气瘀毒互结日久形成肿块而成肺癌。
非小细胞肺癌为最常见的肺癌病理类型,约占肺癌的85%左右。非小细胞肺癌又包括鳞状上皮细胞癌、腺癌和大细胞癌等几种类型,非小细胞癌的癌细胞生长缓慢,恶性程度相对低些,扩散转移发生的较晚。
随着中药学的发展,越来越多的临床研究表明,中药可以调整或增强机体免疫功能,改善患者临床症状,增强或巩固放化疗效果,减轻毒副反应,维持患者带瘤较长期生存,提高患者生活质量。
CN 102000263B公开了一种疗效好、不易复发、无毒副作用、能根治肺癌的中药制剂,它由下述重量份数配比的原料制成:肺筋草25-35份、斑叶兰10-25份、大蓟15-35份、隔山香15-25份、松叶蕨15-30份、八角莲10-20份、山慈菇10-20份、岩白菜20-40份、兔儿伞20-40份、榔榆20-40份。
CN 102600298A公开了一种治疗肺癌的中草药组合物,涉及中药领域。其以蟾皮、莪术、蒲公英、郁金、金银花、夏枯草、牛膝、红花、丁香、瓜蒌皮、枇杷叶、桔梗、甘草为原料按照一定的配伍要求,经加工制成的药物制剂,可增强机体免疫力,和延长肿瘤患者生命。
CN 102688385B公开了一种治疗中晚期癌症的中药。其特征在于该中药由三尖杉、喜树果、乌骨藤、白花蛇舌草、猪殃殃、墨旱莲、金钱草、败酱草、蜂房、鹅不食草、山豆根、黄灵芝、山慈菇组成。能够提高病人的免疫功能,逐渐缩小癌肿肿块,减少病人痛苦,延长癌症患者的生存期,适于各种癌症患者特别是中晚期癌症患者服用。
发明内容
本发明的第一个目的在于提供一种抗癌活性好,疗效显著,有效率高的治疗肺癌的中药组合物。
本发明是通过如下技术方案实现的:
一种治疗肺癌的中药,其特殊之处在于:药效成分由如下原料制成:牛西西、鹅不食草、棉花根、延胡索、白花蛇舌草、山药、党参、石见穿、香附、黄芪、蒲公英、土鳖虫、百合、千年健、杏仁、茯苓和甘草组成。
作为优选的技术方案,本发明治疗肺癌的中药,由如下重量份的原料制成:
牛西西12-19、鹅不食草10-19、棉花根9-18、延胡索9-18、白花蛇舌草9-18、山药6-14、党参6-14、石见穿6-14、香附4-8、黄芪4-8、蒲公英4-8、土鳖虫4-8、百合2-6、千年健2-6、杏仁1-10、茯苓1-8和甘草1-18组成。
作为最优选的技术方案之一,本发明治疗肺癌的中药,由如下重量份的原料制成:
牛西西16、鹅不食草16、棉花根16、延胡索12、白花蛇舌草12、山药8、党参8、石见穿8、香附6、黄芪8、蒲公英6、土鳖虫6、百合3、千年健3、杏仁3、茯苓2和甘草16组成。
作为最优选的技术方案之一,本发明治疗肺癌的中药,由如下重量份的原料制成:
牛西西18、鹅不食草18、棉花根16、延胡索12、白花蛇舌草16、山药12、党参12、石见穿12、香附8、黄芪6、蒲公英4、土鳖虫8、百合2、千年健4、杏仁6、茯苓2和甘草12组成。
作为最优选的技术方案之一,本发明治疗肺癌的中药,由如下重量份的原料制成:
牛西西12、鹅不食草12、棉花根9、延胡索12、白花蛇舌草18、山药14、党参14、石见穿14、香附4、黄芪4、蒲公英8、土鳖虫8、百合6、千年健2、杏仁8、茯苓8和甘草4组成。
各组分的药理作用如下:
牛西西:性味,苦、酸,寒。凉血止血,清热解毒,杀虫。用于功能性子宫出血,吐血,咯血,鼻衄,牙龈出血,尾、十二指肠出血,便血,紫癜,便秘,水肿;外用治疥癣,疮疖,脂溢性皮炎。
鹅不食草:性味,辛,温。归肺、肝经。通鼻窍,止咳,用于风寒头痛,咳嗽痰多,鼻塞不通,鼻渊流涕。
棉花根:性味,味甘;性温。归肺;脾;肝经。平喘;通经止痛。主咳嗽;气喘;有经不调;崩漏。
延胡索:性味,辛、苦,温。归肝、脾经。活血,利气,止痛。用于胸胁、脘腹疼痛,经闭痛经,产后瘀阻,跌扑肿痛。
白花蛇舌草:性味,甘、淡,凉。归经,入胃、大肠、小肠经。清热解毒,利尿消肿,活血止痛。用于肠痈(阑尾炎),疮疖肿毒,湿热黄疸,小便不利等症;外用治疮疖痈肿,毒蛇咬伤。
山药:性味,甘,平。归脾、肺、肾经。补脾养胃,生津益肺,补肾涩精。用于脾虚食少,久泻不止,肺虚喘咳,肾虚遗精,带下,尿频,虚热消渴。麸炒山药补脾健胃。用于脾虚食少,泄泻便溏,白带过多。
党参:性味,甘,平。归脾、肺经。补中益气,健脾益肺。用于脾肺虚弱,气短心悸,食少便溏,虚喘咳嗽,内热消渴。
石见穿:性味,微苦,平。清热解毒,活血镇痛。用于黄疸型肝炎,癌症,肾炎,白带,痛经,***结核,象皮病;外用治面神经麻痹,乳腺炎,疖肿。
香附:性味,辛、微苦、微甘,平。归肝、脾、三焦经。行气解郁,调经止痛。用于肝郁气滞,胸、胁、脘腹胀痛,消化不良,胸脘痞闷,寒疝腹痛,***胀痛,***,经闭痛经。
黄芪:性味,甘,温。归肺、脾经。补气固表,利尿托毒,排脓,敛疮生肌。用于气虚乏力,食少便溏,中气下陷,久泻脱肛,便血崩漏,表虚自汗,气虚水肿,痈疽难溃,久溃不敛,血虚痿黄,内热消渴;慢性肾炎蛋白尿,糖尿病。
蒲公英:性味,苦、甘,寒。归肝、胃经。清热解毒,消肿散结,利尿通淋。用于疔疮肿毒,乳痈,瘰疠,目赤,咽痛,肺痈,肠痈,湿热黄疸,热淋涩痛。
土鳖虫:性味,咸,寒;有小毒。归肝经。破瘀血,续筋骨。用于筋骨折伤,瘀血经闭,症瘕痞块。
百合:性味,甘,寒。归心、肺经。养阴润肺,清心安神。用于阴虚久咳,痰中带血,虚烦惊悸,失眠多梦,精神恍惚。
千年健:性味,苦,辛,温。归肝、肾经。祛风湿,健筋骨,活血止痛。用于风寒湿痹,腰膝冷痛,下肢拘挛麻木。
杏仁:性味,苦,温,有毒。入肺、大肠经。祛痰止咳,平喘,润肠。治外感咳嗽,喘满,喉痹,肠燥便秘。
茯苓:性味,甘、淡,平。归心、肺、脾、肾经。利水渗湿,健脾宁心。用于水肿尿少,痰饮眩悸,脾虚食少,便溏泄泻,心神不安,惊悸失眠。
甘草:性味,甘,平。归心、肺、脾、胃经。补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。用于脾胃虚弱,倦怠乏力,心悸气短,咳嗽痰多,脘腹、四肢挛急疼痛,痈肿疮毒,缓解药物毒性、烈性。
本发明中药在祖传秘方的基础上,结合现代医药学理论,研制而成。经临床实验验证,本发明17味中药配伍使用,可以相互协同,解毒增效,提高人体自身抗癌免疫力,重新平衡患者体内阴阳,起到益气养阴、扶正固本,活血化淤,清热解毒,软坚散结之功效,能有效控制肺癌细胞的复制、扩散和转移,可用于肺癌术后、中晚期肺癌、肺部转移癌的治疗以及延长患者的生存期。
本发明的另一目的是提供了一种治疗肺癌的中药组合物的制备方法,其制备方法包含以下步骤:
1)称取牛西西、白花蛇舌草、石见穿、土鳖虫和千年健,干燥粉碎,过80目筛备用;
2)称取鹅不食草、棉花根、山药、香附、黄芪、蒲公英、百合、杏仁和甘草,干燥粉碎过80目筛,加8-12倍量75-95%乙醇回流提取1-3h,提取液回收乙醇,浓缩至膏状,干燥,粉碎过80目筛,得醇提物;
3)称取延胡索、党参和茯苓,干燥粉碎,过80目筛;
4)取步骤2)醇提后药渣与步骤3)粉碎后的延胡索、党参和茯苓混匀,加6-8倍量水煎煮2次,每次1-3小时,合并滤液,滤液减压浓缩至膏状,干燥,粉碎过80目筛,得水提物。
5)将步骤1)所得药粉、步骤2)所得醇提物、步骤4)所得水提物混合均匀,制成药剂学上的各种剂型。
本发明的中药组合物还可以加一种或多种药学上可接受的载体,以口服或肠胃外给药的方式施用于需要这种治疗的患者。用于口服时,可将其制成常规的固体制剂,如片剂、胶囊、软胶囊、分散片、口服液、颗粒、咀嚼片、口崩片、滴丸、缓释片、缓释胶囊、控释片、控释胶囊,制成液体制剂如水或油悬浮剂或其它液体制剂如糖浆等。
本发明的中药组合物可采用现有制药领域中的常规方法生产,需要的时候可以添加各种药学上可接受的载体。所述的载体包括药学领域常规的赋形剂、填充剂、粘合剂、湿润剂、崩解剂、吸收促进剂、表面活性剂、吸附载体、润滑剂等。
本发明的中药组合物在制成口服制剂时,可选择的填充剂有:淀粉、糖粉、磷酸钙、硫酸钙二水物、糊精、微晶纤维素、乳糖、预胶化淀粉、甘露醇等;可选择的粘合剂有:羧甲基纤维素钠、PVP-K30、羟丙基纤维素、淀粉浆、甲基纤维素、乙基纤维素、羟丙甲纤维素、胶化淀粉等;可选择的崩解剂有:干淀粉、交联聚维酮、交联羧甲基纤维素钠、羧甲基淀粉钠,低取代羟丙基纤维素等;可选择的润滑剂有;硬脂酸镁、滑石粉、十二烷基硫酸钠、微粉硅胶等。
本发明中药组合物优选为口服制剂,所述的口服制剂优选为片剂、胶囊、软胶囊、分散片、口服液、颗粒、咀嚼片、口崩片、滴丸、缓释片、缓释胶囊、控释片、控释胶囊。
最优选地,本发明口服制剂为颗粒剂或胶囊剂。
本发明优点:
1.本发明治疗肺癌的药物,可以延长患者的生存期,具有抗癌活性好、疗效显著、有效率高等特点。
2.本发明治疗肺癌的药物所用中药材来源广泛。
3.本发明中药组合物制剂工艺简单。
4.本发明中药制剂,日服剂量小,服用方便。
具体实施方式
下面结合具体实施例,进一步阐述本发明。这些实施例应理解为仅用于说明本发明而不用于限制本发明的保护范围。在阅读了本发明记载的内容之后,本领域技术人员可以对本发明作各种改动或修改,这些等效变化和修饰同样落入本发明权利要求所限定的范围。
实施例1:本发明胶囊剂的制备
处方(以重量份计):
制备工艺
1)称取牛西西、白花蛇舌草、石见穿、土鳖虫和千年健,干燥粉碎,过80目筛备用;
2)称取鹅不食草、棉花根、山药、香附、黄芪、蒲公英、百合、杏仁和甘草,干燥粉碎过80目筛,加10倍量95%乙醇回流提取2h,提取液回收乙醇,浓缩至膏状,干燥,粉碎过80目筛,得醇提物;
3)称取延胡索、党参和茯苓,干燥粉碎,过80目筛;
4)取步骤2)醇提后药渣与步骤3)粉碎后的延胡索、党参和茯苓混匀,加8倍量水煎煮2次,每次2小时,合并滤液,滤液减压浓缩至膏状,干燥,粉碎过80目筛,得水提物。
5)将步骤1)所得药粉、步骤2)所得醇提物、步骤4)所得水提物混合均匀,直接灌装胶囊,每粒装药粉0.4g。
实施例2:本发明颗粒剂的制备
处方(以重量份计):
1)称取牛西西、白花蛇舌草、石见穿、土鳖虫和千年健,干燥粉碎,过80目筛备用;
2)称取鹅不食草、棉花根、山药、香附、黄芪、蒲公英、百合、杏仁和甘草,干燥粉碎过80目筛,加10倍量90%乙醇回流提取提取3h,提取液回收乙醇,浓缩至膏状,干燥,粉碎过80目筛,得醇提物;
3)称取延胡索、党参和茯苓,干燥粉碎,过80目筛;
4)取步骤2)醇提后药渣与步骤3)粉碎后的延胡索、党参和茯苓混匀,加6倍量水煎煮2次,每次2小时,合并滤液,滤液减压浓缩至膏状,干燥,粉碎过80目筛,得水提物。
5)将步骤1)所得药粉、步骤2)所得醇提物、步骤4)所得水提物混合均匀,加入淀粉,乙醇造粒,干燥,装袋,每袋10g,含药粉2g。
实施例3:本发明胶囊剂的制备
处方(以重量份计):
制备工艺:同实施例1。
实施例4:本发明颗粒剂的制备
处方(以重量份计):
制备工艺:同实施例1。
一、试验例 本发明中药组合物对移植性小鼠Lewis肺癌抑瘤率影响
1.材料
1.1.药物:本发明中药组合物(参加本发明实施例1),金复康口服液。
1.2.动物:SPF级KM小鼠60只,4周龄,雌雄各半,体重22±4克,根据完全随机分组方法进行分组;随机分为4组模型组、对照组、本发明低剂量组和本发明高剂量组。每组15只。
1.3.瘤株:肺癌Lewis瘤株。
2、实验方法:
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备成密度为3.0×107个/ml单细胞悬液,在无菌条件下注射于小鼠腹腔内,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%乙醇的烧杯中浸泡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1.0×107个/ml,接种于小鼠右腋下,每只0.4ml。
小鼠接种肿瘤后第四天开始给药,每天上午给药一次,连续给药10天,组给药方法如下:
模型组:灌胃等量的生理盐水;
对照组:金复康口服液,5ml/kg;
本发明低剂量组:50mg/kg;
本发明高剂量组:100mg/ml;
称体重,摘瘤,称重,计算抑瘤率,计算公式如下:
3.统计学方法
数据采用SPSS19.0软件进行统计分析,计量资料以表示,治疗前后指标比较采用t检验;计数资料采用X2检验。P<0.05表示差异具有统计学意义。
4、实验结果
表1本发明中药组合物对小鼠肺癌瘤重和抑瘤率的影响()
给药各组 | 小鼠数 | 平均瘤重(g)X±SD | 肿瘤抑制率(%) |
模型组 | 15 | 4.40±0.72 | - |
对照组 | 15 | 3.18±0.89* | 27.7 |
本发明高剂量组 | 15 | 2.12±0.66*# | 51.8# |
本发明低剂量组 | 15 | 2.32±0.58*# | 47.3# |
备注:*表示与模型组比较P<0.05;#表示与对照组比较:P<0.05
讨论:与模型组相比,本发明中药组合物低剂量组和高剂量组的抑瘤率明显提高,具有显著性差异。与对照组相比,本发明中药组合物低剂量组和高剂量组的抑瘤率明显提高,具有显著性差异。以上实验结果表明,本发明中药组合物在抑制肺癌Lewis实体瘤方面具有具有很好的治疗效果。
实验例二、临床实验资料
1.病例选择及实验分组
肺癌早期可无任何症状,大多在胸部X线检查时发现,肿瘤增大后,常出现咳嗽、咳痰、痰中带血或少量咳血,继发感染可有脓性痰,并有发热、食欲减退、消瘦等。凡具有上述症状并被确诊为肺癌患者均作为选择病例,共计128例,随机分为实验组80例,对照组48例,两组症状,病程,年龄、性别等,经统计学处理P>0.05,具有可对比性。
2、治疗方法
实验组给予本发明实施例1方法制备的中药进行治疗,每天3次,每次4-6粒,30天为一疗程,连续治疗3个疗程。
对照组给予西医治疗,服用氟尿嘧啶、长春新碱和环磷酰胺。
3、疗效标准
显效:症状完全缓解或消失,生存期达5年以上。
有效:症状部分缓解,生存期1年以上。
无效:症状无任何改善,有恶化之趋势,甚而短时间即死亡。
4、实验结果
表2治疗后生存期
组别 | 病例数 | 0.5年 | 1年 | 2年 | 3年 | 4年 | 5年 | 平均生存期 |
实验组 | 80 | 0 | 6 | 10 | 15 | 17 | 32 | 3.7 |
对照组 | 48 | 2 | 8 | 10 | 13 | 8 | 7 | 2.8 |
由上述结果可以看出,经治疗,服用本发明中药的患者5年生存率约为40%,而对照组仅为14.6%。服用本发明中药的患者平均生存期3.7年,而对照组仅为2.8年,二者有显著性差异,可见本发明中药组合物可以延长患者生存时间。
Claims (7)
1.一种治疗肺癌的中药,其特殊之处在于:药效成分由如下原料制成:牛西西、鹅不食草、棉花根、延胡索、白花蛇舌草、山药、党参、石见穿、香附、黄芪、蒲公英、土鳖虫、百合、千年健、杏仁、茯苓和甘草组成。
2.如权利要求1所述的治疗肺癌的中药,其特征在于,由如下重量份的原料制成:
牛西西12-19、鹅不食草10-19、棉花根9-18、延胡索9-18、白花蛇舌草9-18、山药6-14、党参6-14、石见穿6-14、香附4-8、黄芪4-8、蒲公英4-8、土鳖虫4-8、百合2-6、千年健2-6、杏仁1-10、茯苓1-8和甘草1-18。
3.如权利要求1所述的治疗肺癌的中药,其特征在于,由如下重量份的原料制成:
牛西西16、鹅不食草16、棉花根16、延胡索12、白花蛇舌草12、山药8、党参8、石见穿8、香附6、黄芪8、蒲公英6、土鳖虫6、百合3、千年健3、杏仁3、茯苓2、甘草16。
4.如权利要求1所述的治疗肺癌的中药,其特征在于,由如下重量份的原料制成:
牛西西18、鹅不食草18、棉花根16、延胡索12、白花蛇舌草16、山药12、党参12、石见穿12、香附8、黄芪6、蒲公英4、土鳖虫8、百合2、千年健4、杏仁6、茯苓2和甘草12组成。
5.如权利要求1所述的治疗肺癌的中药,其特征在于,由如下重量份的原料制成:
牛西西12、鹅不食草12、棉花根9、延胡索12、白花蛇舌草18、山药14、党参14、石见穿14、香附4、黄芪4、蒲公英8、土鳖虫8、百合6、千年健2、杏仁8、茯苓8和甘草4组成。
6.一种如权利要求1-5任一所述的治疗肺癌中药的制备方法,包含以下步骤:
1)称取牛西西、白花蛇舌草、石见穿、土鳖虫和千年健,干燥粉碎,过80目筛备用;
2)称取鹅不食草、棉花根、山药、香附、黄芪、蒲公英、百合、杏仁和甘草,干燥粉碎过80目筛,加8-12倍量75-95%乙醇回流提取1-3h,提取液回收乙醇,浓缩至膏状,干燥,粉碎过80目筛,得醇提物;
3)称取延胡索、党参和茯苓,干燥粉碎,过80目筛;
4)取步骤2)醇提后药渣与步骤3)粉碎后的延胡索、党参和茯苓混匀,加6-8倍量水煎煮2次,每次1-3小时,合并滤液,滤液减压浓缩至膏状,干燥,粉碎过80目筛,得水提物;
5)将步骤1)所得药粉、步骤2)所得醇提物、步骤4)所得水提物混合均匀,制成药剂学上的各种剂型。
7.如权利要求1-5任一所述的治疗肺癌中药,其特征在于,所述中药为片剂、胶囊、软胶囊、分散片、口服液、颗粒、咀嚼片、口崩片、滴丸、缓释片、缓释胶囊、控释片或控释胶囊,优选为颗粒剂或胶囊剂。
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