CN101590209B - 一种治疗肿瘤的药物及其制备方法 - Google Patents
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Abstract
本发明公开了一种治疗肿瘤的药物组合物，它是以冬凌草、石见穿、海藻、莪术、土鳖虫、半枝莲、蛇莓、拳参、黄芪、甘草、苡仁为主要原料制备而成的中药制剂。本发明处方简单、独特，价格便宜，疗效显著。具有有扶正、祛邪和增效作用。本发明还公开了以上所述药物的制备方法，根据每味中药的不同特性，分别以不同溶剂提取等预处理后，按比例配制而成。
Description
技术领域
本发明涉及一种治疗肿瘤的药物组合物。具体的说是以冬凌草、石见穿、海藻、莪术、土鳖虫、半枝莲、蛇莓、拳参、黄芪、甘草、苡仁为主要原料制备而成的中成药。本发明还涉及上述药物的制备方法。
背景技术
目前肺癌、肝癌、胃癌、食管癌、结直肠癌、乳腺癌、宫颈癌和鼻咽癌等8种癌症合计占癌症死因的80％以上，是我国今后将重点防治的主要癌症。据卫生部测算，我国2000年死于癌症的人数为140人-150万，在总死因中占第二位，在城镇居民中占第一位。据统计，近年来我国恶性肿瘤新发病人数年平均增长3.3％，发病率由177/10万增长到245/10万，20年累计上升45.35％。在不同年龄人群肿瘤发病构成中，65岁以上人群肿瘤发病率所占比重最大，约为55.36％。据专家预测，到2010年男性发病前3位肿瘤为肺癌、肝癌和大肠癌，女性发病前3位为乳腺癌、肺癌和宫颈癌。引发癌谱变化的主要原因有吸烟率高、生活压力加大、不良的生活方式及体力活动减少等。世界卫生组织认为，通过有效的预防措施，癌症的发生可减少三分之一；通过有效的早期诊治，三分之一癌症可以治愈；通过有效的治疗，其余三分之一的患者可以减少痛苦，提高生活质量。
肿瘤的治疗：恶性肿瘤的治疗需要综合治疗才能取得满意的治疗结果，任何单一的治疗方法都不能取得满意的效果.临床上常用的治疗方法有：手术切除、化学治疗、放射治疗、介入治疗、热疗、冷冻治疗、内分泌治疗、基因治疗、中医治疗等。
外科手术治疗就是将肿瘤切除，它是一种局部治疗手段，患者患肿瘤后有手术适应证的应尽量做手术治疗，切除肿瘤，再配合其他治疗方法如：化疗、放疗、生物治疗等，进行综合治疗从而达到满意的效果。
化疗就是应用化学性药物控制肿瘤细胞的生长和增殖，达到治疗肿瘤的目的，化疗可以有效的控制肿瘤的转移，但是化疗药物有一定的毒性反应和耐药性。
放射治疗就是用足够剂量的射肿瘤，将肿瘤细胞杀死，控制病变。
肿瘤生物治疗是通过提高机体的自然防御机制来杀伤或抑制肿瘤细胞的生长和增殖，以达到抗肿瘤的效应。临床上常用生物制剂有：干扰素、粒细胞集落刺激因子、促红细胞生成素、白介素II等。
介入治疗是经动脉选择性插管向肿瘤内灌注化疗药物及将肿瘤的供氧血管栓塞，从而切断肿瘤的供养，提高肿瘤局部化疗药物深度，使肿瘤缺血坏死。
高强度聚集超声治疗肿瘤是一种局部治疗手段，是无创手术治疗。它是将体外的超声波通过人体表面在肿瘤部位，使焦点区的温度在瞬间升至关重要65-100℃，使肿瘤细胞发生凝固坏死，从而达到“切除”肿瘤的目的。
冷冻治疗属于局部治疗方法，它能使肿瘤区域内的温度在短时间内降至极低(低于零下30℃)，从而破坏肿瘤组织，杀死肿瘤细胞。
另外，目前的研究热点还有新型抗肿瘤药物如生长因子抑制剂、肿瘤血管生成抑制剂、生物反应调节剂、肿瘤耐药逆转剂、端粒酶抑制剂、基因工程药物等。但由于恶性肿瘤的发病机制非常复杂，要达到真正治愈还需要有一个漫长的过程。
祖国医学在治疗肿瘤方面积累了丰富的经验，目前虽研究有一些治疗肿瘤的中成药，但仍不能满足患者的需要，且其处方组成均较复杂，药味较多，疗效不理想。故开发治疗肿瘤疗效确切的中药制剂具有广阔的前景。
发明内容
本发明的目的在于提供一种治疗肿瘤疗效确切的中药及其相应制剂。其特点有：有扶正、祛邪和增效作用。
本发明的解决方案是基于祖国医学对肿瘤的发病机理的认识，祖国医学将之归为“积聚”范畴，发病原因与痰、瘀、毒有关。根据自己多年临床经验，先从众多中药中确定一系列治疗肿瘤有效的中药，再经动物试验验证，筛选出来中药复方制剂。具有清热解毒，化痰软坚等功效。
本发明是一种治疗肿瘤的药物组合物，其特征在于它包括冬凌草、石见穿、海藻、莪术、土鳖虫、半枝莲、蛇莓、拳参、黄芪、甘草、苡仁十一味药物。
重量配比组成如下：冬凌草5-20份、石见穿5-15份、海藻5-20份、莪术5-20份、土鳖虫3-10份、半枝莲5-15份、蛇莓5-15份、拳参5-15份、黄芪5-15份、甘草2-5份、苡仁5-20份。
优选重量配比是：冬凌草10-15份、石见穿5-10份、海藻10-15份、莪术10-15份、土鳖虫4-7份、半枝莲5-10份、蛇莓5-10份、拳参5-10份、黄芪5-10份、甘草2-4份、苡仁5-10份。
本发明药物组成还可以含有白花蛇舌草、山慈姑等中药中的一种或一种以上。
本发明药物可以是任何一种药剂学上所说剂型的药物。
该药物的制备可以按多种药剂学上的常规方法制备，如：
冬凌草、石见穿、海藻、莪术、土鳖虫、半枝莲、蛇莓、拳参、黄芪、甘草、苡仁用乙醇或水等按常规方法提取，浓缩，干燥，得提取物，制成所需剂型的药物。
以上制备过程中，如有必要，可加入适量药剂学中常用的辅料，如淀粉、糊精、微晶纤维、可压性淀粉、硬脂酸镁、微粉硅胶、蔗糖、羧甲基淀粉钠等。
为进一步验证本发明治疗肿瘤的功效，开展了以下药效学试验
1材料
1.1试验动物 昆明种小鼠和NIH小鼠，日龄40～50d(体重18～22g)，雌雄兼用。
1.2试验瘤株 小鼠肝癌腹水型(H22)和小鼠s肉瘤(S180)均由中科院北京药物研究所提供，以腹水型传代保种，临用时抽取H22和S180腹水，以灭菌生理盐水稀释备用。
2实验方法与结果
2.1对动物移植性肿瘤的抑制作用
2.1.1对小鼠S180肉瘤和肝癌H22实体瘤的影响：
在灭菌条件下，分别取传代小鼠S180肉瘤和肝癌H22实体瘤瘤液以生理盐水1∶4稀释，每只0.2ml注入小鼠右腋皮下，24h分组给药，按8g/kg、4g/kg和2g/kg剂量给小鼠灌胃(ig)复方本发明组混悬液，每天1次，连续10d；阳性对照组腹腔注射(ip)环磷酰胺15mg/kg，同时ig蒸馏水；对照组ig蒸馏水。末次给药后次日处死小鼠，剥离瘤块称重，计算平均抑瘤率，用t值法分析，结果见表1。
表1 对荷瘤(S180、H22)小鼠瘤体生长的影响
注：与对照组比较，*P＜0.05，**P＜0.01，下同。(n＝10)
2.1.2对腹水型小鼠H22和S180肉瘤生存时间的影响：
取小鼠H22和S180瘤液，同上法稀释后给小鼠ip0.2ml，次日分组给药，连续10d，分组和给药方案同2.1.1。停药后每天观察小鼠一次，记录死亡时间，以各鼠生存天数计算每组平均生存时间，给药组与水对照组比较。结果见表2。
表2 对腹水型肿瘸小鼠生存时间的影响(n＝7)
2.2对荷瘤小鼠网状内皮系统吞噬功能的影响
取小鼠H22瘤液，接种瘤液和分组给药方法同2.1.1。连续给药10d，末次给药后1h，每鼠尾静脉注射10％印度墨汁，于注射后2和10min分别从眼眶取血测定血液碳粒廓清速率指数(K)。用t值法分析。结果：本发明中剂量组(K值为0.0254±0.0070)能增强荷瘤小鼠网状内皮系统吞噬功能，碳粒清除速率明显高于对照组(0.0123±0.0017)，差异有显著性意义(P＜0.05)；高(0.0133±0.0060)、低(0.0145±0.0045)剂量组小鼠无明显作用，差异无显著性意义，环磷酰胺组(0.00876±0.00312)显著抑制小鼠内皮系统吞噬功能，差异有显著性意义(P＜0.01)。
2.3增效作用取18～23g昆明种小鼠50只，雌雄各半，按1∶4稀释H腹水瘤液，每只小鼠右腋下注入0.2ml，次日按体重分为5组，第1～4组ip环磷酰胺10ml/kg，第2～4组同时ig三个剂量本发明组混悬液，第5组ig蒸馏水为荷瘤对照组，均每天一次，各连续给药7d，末次给药后称体重，以给药前后体重算体重增长率，并剥取瘤块，计算平均瘤重，各组与环磷酰胺比较，t值法分析，结果见表3。
表3 对荷瘸小鼠增效作用(x±s；n＝10)
经过上述动物实验研究，结果表明本发明组具有显著祛邪作用，能明显抑制小鼠S180和肝癌H22实体瘤的生长，能协同环磷酰胺的抗瘤作用，本品三个剂量组小鼠平均瘤重下降，并能对抗环磷酰胺引起的小鼠体重下降，本发明各组小鼠体重增长率明显增加，研究表明有扶正、祛邪和增效作用。
具体实施方式
下面结合实施例对本发明作进一步的描述。
本发明按重量配比组成如下：
冬凌草5-20份、石见穿5-15份、海藻5-20份、莪术5-20份、土鳖虫3-10份、半枝莲5-15份、蛇莓5-15份、拳参5-15份、黄芪5-15份、甘草2-5份、苡仁5-20份。
本发明的优选重量配比是：
冬凌草10-15份、石见穿5-10份、海藻10-15份、莪术10-15份、土鳖虫4-7份、半枝莲5-10份、蛇莓5-10份、拳参5-10份、黄芪5-10份、甘草2-4份、苡仁5-10份。
本发明药物的制备方法，以冬凌草13份、石见穿8份、海藻13份、莪术13份、土鳖虫8份、半枝莲8份、蛇莓7份、拳参7份、黄芪7份、甘草3份、苡仁13份为例，可参照如下方法：
(1)将冬凌草、石见穿、海藻、莪术、土鳖虫、半枝莲、蛇莓、拳参、黄芪、甘草、苡仁用水按煎煮方法提取，浓缩，干燥，加适量淀粉或糊精，制粒，加工成颗粒剂或片剂或胶囊剂。
(2)将海藻、薏苡仁用乙醇渗漉法提取，回收溶剂，得醇提取物；冬凌草、石见穿、莪术、土鳖虫、半枝莲、蛇莓、拳参、黄芪、甘草用水按煎煮方法提取，浓缩，干燥，得水提取物，然后与醇提取物混合均匀，加适量淀粉或糊精，制粒，加工成颗粒剂或片剂或胶囊剂。
又如，用量组成为：冬凌草12份、石见穿7份、山慈姑4份、海藻12份、莪术12份、土鳖虫4份、半枝莲7份、白花蛇舌草7份、蛇莓7份、拳参7份、黄芪7份、甘草2份、苡仁12份的制剂。其制备方法为：
将海藻、薏苡仁用乙醇渗漉法提取，回收溶剂，得醇提取物；冬凌草、石见穿、山慈姑、莪术、土鳖虫、半枝莲、白花蛇舌草、蛇莓、拳参、黄芪、甘草用水按煎煮方法提取，浓缩，干燥，得水提取物，然后与醇提取物混合均匀，加适量淀粉或糊精，制粒，加工成颗粒剂或片剂或胶囊剂。
Claims (7)
1.一种治疗肉瘤和肝癌的药物，其特征在于它是由以下重量配比的原料药制成：冬凌草5-20份、石见穿5-15份、海藻5-20份、莪术5-20份、土鳖虫3-10份、半枝莲5-15份、蛇莓5-15份、拳参5-15份、黄芪5-15份、甘草2-5份、苡仁5-20份。
2.根据权利要求1所述的药物，其特征在于原料药中各药物优选重量配比范围是：冬凌草10-15份、石见穿5-10份、海藻10-15份、莪术10-15份、土鳖虫4-7份、半枝莲5-10份、蛇莓5-10份、拳参5-10份、黄芪5-10份、甘草2-4份、苡仁5-10份。
3.根据权利要求1所述的药物，其特征在于原料药中各药物重量配比范围是：冬凌草13份、石见穿8份、海藻13份、莪术13份、土鳖虫8份、半枝莲8份、蛇莓7份、拳参7份、黄芪7份、甘草3份、苡仁13份。
4.一种治疗肉瘤和肝癌的药物，其特征在于它是由以下重量配比的原料药制成：冬凌草12份、石见穿7份、山慈姑4份、海藻12份、莪术12份、土鳖虫4份、半枝莲7份、白花蛇舌草7份、蛇莓7份、拳参7份、黄芪7份、甘草2份、苡仁12份。
5.根据权利要求1至4中任一项所述的药物，其特征在于所说的药物的剂型选自颗粒剂或片剂或胶囊剂。
6.制备权利要求1至3中任一项所述的药物的方法，其特征在于：将冬凌草、石见穿、海藻、莪术、土鳖虫、半枝莲、蛇莓、拳参、黄芪、甘草、苡仁用水或不同浓度的乙醇溶液按常规方法提取，然后将各提取物混合均匀，制成所需剂型的药物。
7.制备权利要求4中所述的药物的方法，其特征在于：将冬凌草、石见穿、海藻、山慈姑、莪术、土鳖虫、半枝莲、白花蛇舌草、蛇莓、拳参、黄芪、甘草、苡仁用水或不同浓度的乙醇溶液按常规方法提取，然后将各提取物混合均匀，制成所需剂型的药物。
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| 吴继萍.中医药防治肝癌的现状与展望.《安徽中医临床杂志》.2003,第15卷(第2期),第163－165页. * |
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