CN104800510A - 一种治疗胃癌的中药组合物 - Google Patents
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Abstract
本发明公开了一种治疗胃癌的中药组合物,由下列原料药制备而成,均为重量份:山药14-20;徐长卿12-18;竹林消9-13;钩藤10-15;白术11-17;金丝带10-14;珠儿参9-12;肿节风8-13;紫河车11-16;蒲黄9-14;猴头菌10-15;石榕7-14;延胡索9-16;黄药子8-12。本发明的优良效果还表现在:本发明制备方法简单,吸收效果好,安全性高,具有清热解毒、利水消肿、理气补血的药理作用,有利于患者及时减轻病状;药源易得,药材成本低廉,既能减轻患者身心上的痛苦,又能降低患者经济上的负担。
Description
技术领域
本发明涉及中医中药领域,特别是涉及一种治疗胃癌的中药组合物。
背景技术
胃癌是起源于胃上皮的恶性肿瘤,占全球癌症死亡原因的第二位。我国属胃癌高发区,据最新统计数据,每年新发现40万胃癌患者,占世界发病人数的42%,新发胃癌患者呈年轻化趋势。因此,胃癌已经并将继续成为严重危害人类健康的重大疾病。当前外科手术是胃癌首要的治疗方法,然而多数病例通常在晚期才被诊断,失去了手术根治的机会,对于无法切除的晚期胃癌以及转移性胃癌,临床多采用放疗、化疗等方法治疗。然而,胃癌对化疗敏感性差,且存在严重的副作用,从药效与安全角度考虑,开发以天然植物为主的抗癌新药迫在眉睫。
中医治疗胃癌在我国已有很久的历史,最早可追溯到《黄帝内经》。如《素问》指出:“胃脘当心而痛,上支两胁,甚则呕吐,膈咽不通。”《难经》云:“心之积名曰伏梁,起脐上,大如臂,上至心下,久不愈,令人病烦心。”中医认为:胃癌的发病机理根本在于胃阳虚,继而有气虚痰湿、血瘀等病理特征,形成肿物,阻塞通道,早期表现为厌食,食后饱胀,胃脘隐痛。痰气交阻于胃,影响脾胃运化功能,形成脾胃虚弱证;进而痰气交结,瘀血热毒内蓄不去,灼伤胃络,导致便血呕血,加上饮食不下,气血化生无源,导致气血双亏;热结津伤是胃癌发展至晚期的阶段性的病机,阳虚而致肿瘤形成,至阻水谷之道而不得通,蕴热渐生,而出现的标证。中晚期胃癌,多数为虚实夹杂。因此,中医治疗胃癌的辨证基础主要在于分清虚实关系,虚是以脾胃气虚为主,还是以胃阴不足为主,脾虚是否及肾等;实则要分清食积、气结、热蕴、痰凝、血瘀何者为患,或协同为患。
申请公布号 CN 103520653 A(申请号 201310508514.3)的中国发明专利文献公开了一种治疗胃癌的中药组合物,由下述重量的原料药组成:三棱3-20克、莪术9-20克、藤梨根3-10克、蛇葡萄根3-10克、白英3-10克、土茯苓3-20克、薏苡仁3-20克、柘木3-10克、守宫3-10克、牡蛎10-30克。申请公布号 CN 103768342 A(申请号 201410012538.4)的中国发明专利文献公开了一种治疗胃癌的中药组合物,,由以下组分按照重量分数组成:忍冬藤40-50份,地骨皮40-50份,天葵子40-50份,重楼40-50份,桂枝20-30份,羌活20-30份,吴茱萸20-30份,小茴香20-30份,荔枝核20-30份,娑罗子20-30份,刺五加5-15份,苍术5-15份,白茯苓5-15份。申请公布号CN 104435251 A(申请号 201410646162.2)的中国发明专利文献公开了一种治疗胃癌的药物,由以下原料药组成:丹参15克,黄芪15克,当归9克,厚朴15克,海螵蛸15克,木香9克,全蝎3只,桃仁12克,冬虫夏草6克,金银花12克,茵陈15克,金钱草12克,雄黄0.6克,茯苓15克,陈皮12克,蜈蚣5条,蜣螂虫15克,甘草12克。
目前西医治疗方法为手术、化疗、放疗和靶向治疗,西医治疗存在副作用大,对机体伤害大的缺点。中药能够激活和增强人体免疫细胞,免疫分子,提高机体免疫功能,增强机体抗病能力,从而发挥抗肿瘤效应,对缓解临床症状,增强体质,延长生存期都有显著疗效。
发明内容
本发明的目的是,提供一种治疗胃癌的中药组合物,通过加入几味中药原料配合制成,具有清热解毒、利水消肿、理气补血的功效。
本发明的技术方案是:
一种治疗胃癌的中药组合物,由下列原料药制备而成,均为重量份:山药14-20;徐长卿12-18;竹林消9-13;钩藤10-15;白术11-17;金丝带10-14;珠儿参9-12;肿节风8-13;紫河车11-16;蒲黄9-14;猴头菌10-15;石榕7-14;延胡索9-16;黄药子8-12。
优选的方案中,山药16-18;徐长卿14-16;竹林消10-12;钩藤11-14;白术13-15;金丝带11-13;珠儿参10-11;肿节风9-12;紫河车12-15;蒲黄10-13;猴头菌11-14;石榕9-12;延胡索12-13;黄药子9-11。
更加优选的,山药17;徐长卿15;竹林消11;钩藤12.5;白术14;金丝带12;珠儿参10.5;肿节风10.5;紫河车13.5;蒲黄11.5;猴头菌12.5;石榕10.5;延胡索12.5;黄药子10。
一种治疗胃癌的中药组合物,将其制成药学上可接受的汤剂,制备方法如下:
(1)取新鲜的紫河车,横直剖开血管,用水反复洗漂干净,另取花椒置布袋中加水煎汤,去渣,加入洗净的紫河车,中火煎煮3-7分钟(优选中火煎煮5分钟),及时捞出,滤净水,放入黄酒盆内拌匀,置笼屉中蒸透,取出,烘干,捣碎成细粉,备用(紫河车:花椒:黄酒=100:12:15);
(2)山药去皮,切片,与金丝带、猴头菌置于恒温干燥箱中干燥,取出,共研为粉,备用;
(3)将步骤(1)和(2)处理后的原料药粉与蒲黄混合,搅拌均匀,过筛,得混合药粉备用;
(4)将徐长卿、竹林消、钩藤、白术、珠儿参、肿节风、石榕、延胡索和黄药子一同置于中药锅中,加清水没过药面,于25℃浸泡1.6-3.0小时(优选于25℃浸泡2.3小时),然后武火加热煮沸6-10分钟(优选武火加热煮沸8分钟),转文火煎煮三次,第一次煎煮36-45分钟(优选第一次煎煮40分钟),第二次煎煮28-34分钟(优选第二次煎煮30分钟),第三次煎煮14-26分钟(优选第三次煎煮20分钟),合并三次煎液,过滤,得滤液;
(5)将步骤(3)所得混合药粉加入到上述滤液中,文火加热煎煮15-25分钟(优选文火加热煎煮20分钟),趁热过滤,滤液减压浓缩至原体积的2/3,干热灭菌,冷却,灌装,即得。
上述一种治疗胃癌的中药汤剂的制备方法,优选的方案是,步骤(2)中干燥的温度为48-62℃(优选的干燥的温度为52-58℃,更加优选的干燥的温度为55℃)。
上述一种治疗胃癌的中药汤剂的制备方法,优选的方案是,步骤(2)中干燥的时间为2.4-5.2小时(优选的干燥的时间为3.0-4.6小时,更加优选的干燥的时间为3.8小时)。
上述一种治疗胃癌的中药汤剂的制备方法,优选的方案是,步骤(3)中过60-100目筛(优选的过70-90目筛,更加优选的过80目筛)。
所述片剂的制备方法是:
(1)取新鲜的紫河车,横直剖开血管,用水反复洗漂干净,另取花椒置布袋中加水煎汤,去渣,加入洗净的紫河车,中火煎煮3-7分钟(优选中火煎煮5分钟),及时捞出,滤净水,放入黄酒盆内拌匀,置笼屉中蒸透,取出,烘干,捣碎成细粉,备用(紫河车:花椒:黄酒=100:12:15);
(2)延胡索洗净,置于药锅中,加山西陈醋共煮(延胡索:山西陈醋=5:1),煮至醋吸尽,取出,切厚片,干燥,捣碎,备用;
(3)将山药(去皮、切片)、金丝带、肿节风、猴头菌和黄药子加纯净水没过药面,室温下浸泡1-3小时(优选室温下浸泡2小时),小火煎煮两次,每次各煎煮20-40分钟(优选每次各煎煮30分钟),合并煎液,过滤,滤液减压浓缩至80℃相对密度为1.30-1.33的稠膏,真空干燥得干膏粉,备用;
(4)将徐长卿、竹林消、钩藤、白术、珠儿参和石榕分别洗净,置于中药提取器中,加入乙醇和水的混合液(原料药与乙醇和水的质量比为1:2:3),加热回流提取两次,第一次回流提取33-45分钟(优选第一次回流提取40分钟),第二次回流提取18-30分钟(优选第二次回流提取25分钟),合并两次提取液,过滤,回收乙醇,滤液减压浓缩至85℃密度为1.30g/mL的稠膏,真空干燥得干膏粉,备用;
(5)将步骤(1)-(4)所得药粉与蒲黄粉混合,加入质量分数为11%的硬脂酸镁和质量分数为12%的糊精,搅拌均匀,按照0.55-0.75g/片的计量(优选按照0.65g/片的计量),于压片机中压成片剂,即得。
所述丸剂的制备方法是:
(1)取新鲜的紫河车,横直剖开血管,用水反复洗漂干净,另取花椒置布袋中加水煎汤,去渣,加入洗净的紫河车,中火煎煮3-7分钟(优选中火煎煮5分钟),及时捞出,滤净水,放入黄酒盆内拌匀,置笼屉中蒸透,取出,烘干,捣碎成细粉,备用(紫河车:花椒:黄酒=100:12:15);
(2)延胡索洗净,加黄酒、米醋拌匀煮干(延胡索:黄酒:米醋=50:6:3),焖10-14小时(优选焖12小时),取出,切碎,微火炒至微黄色为度,切厚片,干燥,捣碎,备用;
(3)将除步骤(1)和步骤(2)以外的剩余原料药置于中药锅中,加4-8倍量的纯净水(优选加6倍量的纯净水),武火加热至沸,转文火煎煮三次,第一次煎煮46-58分钟(优选第一次煎煮52分钟),第二次煎煮28-40分钟(优选第二次煎煮35分钟),第三次煎煮12-24分钟(优选第三次煎煮18分钟),合并三次煎液,过滤,滤液减压浓缩至70℃相对密度为1.15-1.20的稠膏,备用;
(4)将步骤(1)和步骤(2)处理后的药粉加入到上述稠膏中,同时加入质量分数为10%的蔗糖细粉,搅拌均匀,加工成梧桐子大小的丸剂,即得。
所述胶囊剂的制备方法是:
(1)取新鲜的紫河车,横直剖开血管,用水反复洗漂干净,另取花椒置布袋中加水煎汤,去渣,加入洗净的紫河车,中火煎煮3-7分钟(优选中火煎煮5分钟),及时捞出,滤净水,放入黄酒盆内拌匀,置笼屉中蒸透,取出,烘干,捣碎成细粉,备用(紫河车:花椒:黄酒=100:12:15);猴头菌切成丝和金丝带一同置于铁锅中,炒至微黄色,趁热倒入白醋内渍淬,取出,晾干,研粉,备用;
(2)延胡索洗净,置于药锅中,加山西陈醋共煮(延胡索:山西陈醋=5:1),煮至醋吸尽,取出,切厚片,干燥,捣碎,备用;白术洗净,切厚片,置于密闭容器中,加入食盐水浸润,待浸透后,放入炒锅,调温至65℃,翻炒至药材表面变色且略带焦斑,冷却,筛去碎屑,研末,备用;
(3)将除紫河车、猴头菌、金丝带、延胡索和白术以外的原料药充分干燥,磨碎成粉,加入步骤(1)和步骤(2)处理后的原料药粉,边搅拌边加入质量分数为11%的蔗糖细粉和10%的聚山梨酯80,混匀,制粒,过六号筛,整粒,装入胶囊壳,即得。
本发明提供的一种治疗胃癌的中药组合物组方科学,制备方法简单,所得产品使用方便、便于携带。除此之外,本发明的优良效果还表现在:
1、本发明采用多味中药配制,各药相辅相成,具有抑制肿瘤细胞、诱导肿瘤细胞凋亡的作用;
2、本发明制备方法简单,吸收效果好,安全性高,具有清热解毒、利水消肿、理气补血的药理作用,有利于患者及时减轻病状;
3、本发明所用中药,搭配合理,能缓解各种类型胃癌的临床症状,减轻放、化疗的毒副反应,提高治疗率,延长生存时间;
4、药源易得,药材成本低廉,既能减轻患者身心上的痛苦,又能降低患者经济上的负担。
具体实施方式
下面结合实施例和实验例详细说明本发明的技术方案,但保护范围不限于此。
本发明所用主要中药原料的药理如下:
山药:基原:本品为薯蓣科植物薯蓣的干燥根茎。性味:甘,平。归经:归脾、肺、肾经。功效:补脾养胃,生津益肺,补肾涩精。主治: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。
徐长卿:基原:为萝藦科植物徐长卿的根及根茎或带根全草。化学成份:全草含牡丹酚约1%。又找出有与肉珊瑚甙元、去酰牛皮泊甙元、茸毛牛奶藤甙元和去酰萝藦甙元极为相似的物质以及醋酸、桂皮酸等。根含黄酮甙、糖类、氨基酸、牡丹酚。药理作用:小鼠腹腔注射徐长卿提取液,能显着减少自发活动,但并不延长巴比妥类的睡眠时间,也有镇痛作用。性味:辛,温。功能主治:镇痛,止咳,利水消肿,活血解毒。治胃痛,牙痛,风湿疼痛,经期腹痛,慢性气管炎,腹水,水肿,痢疾,肠炎,跌打损伤,湿疹,荨麻疹,毒蛇咬伤。
竹林消:基原:为百合科植物单茎算盘七的根。性味:《西藏常用中草药》:“性寒,味甘淡。”功能主治:①《西藏常用中草药》:“清肺止咳。用于肺热咳嗽,虚痨损伤。”②《陕西草药》:“滋补,健脾胃,镇痛。治虚劳脾胃不和,心慌气短,妇女血亏,筋骨疼。”
钩藤:基原:为茜草科植物钩藤或华钩藤及其同属多种植物的带钩枝条。化学成份:带钩茎枝叶含钩藤碱、异钩藤碱、柯诺辛因碱、异柯诺辛因碱、柯楠因碱、二氢柯楠因碱、硬毛帽柱木碱、硬毛帽柱木因碱。性味:甘,凉。归经:入肝、心经。药理作用:①镇静作用;②降压作用。功能主治:清热平肝,熄风定惊。治小儿惊痫瘈疭,大人血压偏高,头晕、目眩,妇人子痫。
白术:基原:本品为菊科植物白术的干燥根茎。化学成份:含挥发油1.4%,主要成分为苍术醇、苍术酮等,并含有维生素A。性味:苦、甘,温。归经:归脾、胃经。功效:健脾益气,燥湿利水,止汗,安胎。主治:用于脾虚食少,腹胀泄泻,痰饮眩悸、水肿,自汗,胎动不安。
金丝带:基原:为松萝科植物绿树发的丝状体。化学成份:含绿树发酸、狐衣酸和D-阿糖醇。性味:甘苦,平。功能主治:除风湿,止血止痛,调经活血,镇静安神,健脾胃。治劳伤腰腿痛,外伤出血,月经不调,子宫脱垂,白带,精神病,痫症,半身不遂,阳痿,头晕目眩。
珠儿参:基原:为五加科植物大叶三七的呈串珠状的根茎。炮制:拣净杂质,打碎用或水润,切片,晒干。性味:苦甘,寒。归经:《四川中药志》:“入肝、胃二经。” 功能主治:养阴,清肺,散瘀,止血,定痛。治热病烦渴,阴虚咳嗽,痨伤吐血,鼻衄,咽痛,风湿性关节炎,小儿惊风,跌打损伤。
肿节风:基原:为金栗兰科植物草珊瑚的全株。化学成份:含挥发油、酯类、酚类、鞣质、黄酮、氰甙、香豆素、内酯。性味:性微温,味苦、辛。归经:归心、肝经。功能主治:抗菌消炎,祛风通络,活血散结。用于肺炎、阑尾炎、蜂窝组织炎、风湿痹痛、跌扑损伤、肿瘤。
紫河车:基原:为健康人的胎盘。化学成份:胎盘的成分较复杂。胎盘球蛋白制品中含有多种抗体,在临床上长期来用于被动免疫。人胎盘中还含有干扰素(商品胎盘球蛋白中多半含有),有抑制多种病毒对人细胞的作用,以及有能抑制流感病毒的巨球蛋白,称β-抑制因子。药理作用:①抗感染作用;②增强机体抵抗力;③激素样作用;④对血凝的影响;性味:甘咸,温。归经:入肺、肝、肾经。功能主治:补气,养血,益精。治虚损,羸瘦,劳热骨蒸,咳喘,咯血,盗汗,遗精,阳痿,妇女血气不足,不孕或乳少。
蒲黄:基原:为香蒲科植物长苞香蒲、狭叶香蒲、宽叶香蒲或其同属多种植物的花粉。化学成份:长苞香蒲的花粉含异鼠李素的甙、廿五烷、挥发油及脂肪油约10%。脂肪油含游离的棕榈酸和硬脂酸约30%,谷甾醇约13%,此外尚含棕榈酸、硬脂酸及油酸的甘油酯、α-香蒲甾醇。药理作用:①蒲黄煎剂、酊剂,乙醚浸液对离体及在位子宫均表现兴奋作用;②蒲黄提取物可使离体兔肠蠕动增强,但可被阿托品所阻断;③口服水浸液或5%乙醇浸液能使家兔凝血时间明显缩短;蒲黄提取物使家兔血小板数目增加、凝血酶元时间缩短;蒲黄粉外用对犬动脉出血有止血作用;④高浓度(1:100)蒲黄煎剂在试管内能抑制结核菌的生长,对豚鼠实验性结核病具有某些疗效。性味:甘辛,凉。归经:入肝、心经。功能主治:凉血止血,活血消瘀。生用治经闭腹痛,产后瘀阻作痛,跌扑血闷,疮疖肿毒;炒黑止吐血,衄血,崩漏,泻血,尿血,血痢,带下;外治重舌,口疮,聤耳流脓,耳中出血,阴下湿痒。
猴头菌:基原:真菌类担子菌纲多孔菌目齿菌科猴头菌,以子实体入药。药理作用:1、增强免疫功能;2、抑瘤作用;3、抗溃疡作用及降血糖作用;4、延缓衰老作用。性味:甘,平。功能主治:利五脏,助消化。主治消化不良,神经衰弱、身体虚弱。
石榕:基原:苦苣苔科芒毛苣苔属植物芒毛苣苔,以全株或根、茎、叶入药。性味:辛、淡,凉。功能主治:清热化痰,利水消肿,祛瘀散结。用于支气管炎,哮喘,肺结核,肾炎水肿,胃癌,食道癌,肝癌,乳腺癌,肺癌;外用治跌打损伤,烧烫伤,痈肿疮疖。
延胡索:基原:为罂粟科植物延胡索的块茎。性味:辛苦,温。归经:入肝、胃经。功能主治:活血,散瘀,理气,止痛。治心腹腰膝诸痛,月经不调,症瘕,崩中,产后血晕,恶露不尽,跌打损伤。
黄药子:基原:为薯蓣科植物黄独的块茎。性味:苦,平。归经:《本草经疏》:“入手少阴、足厥阴经。”功能主治:凉血,降火,消瘿,解毒。治吐血,衄血,喉痹,瘿气,疮痈瘰疬。
实施例1 一种治疗胃癌的中药组合物,由下列原料药制备而成,均为重量份(45g/份):山药14份;徐长卿12份;竹林消9份;钩藤10份;白术11份;金丝带10份;珠儿参9份;肿节风8份;紫河车11份;蒲黄9份;猴头菌10份;石榕7份;延胡索9份;黄药子8份。
一种治疗胃癌的中药汤剂的制备方法是:
(1)取新鲜的紫河车,横直剖开血管,用水反复洗漂干净,另取花椒置布袋中加水煎汤,去渣,加入洗净的紫河车,中火煎煮3分钟,及时捞出,滤净水,放入黄酒盆内拌匀,置笼屉中蒸透,取出,烘干,捣碎成细粉,备用(紫河车:花椒:黄酒=100:12:15);
(2)山药去皮,切片,与金丝带、猴头菌置于恒温干燥箱中于48℃干燥2.4小时,取出,共研为粉,备用;
(3)将步骤(1)和(2)处理后的原料药粉与蒲黄混合,搅拌均匀,过60目筛,得混合药粉备用;
(4)将徐长卿、竹林消、钩藤、白术、珠儿参、肿节风、石榕、延胡索和黄药子一同置于中药锅中,加清水没过药面,于25℃浸泡1.6小时,然后武火加热煮沸6分钟,转文火煎煮三次,第一次煎煮36分钟,第二次煎煮28分钟,第三次煎煮14分钟,合并三次煎液,过滤,得滤液;
(5)将步骤(3)所得混合药粉加入到上述滤液中,文火加热煎煮15分钟,趁热过滤,滤液减压浓缩至原体积的2/3,干热灭菌,冷却,灌装,即得。
本发明所得中药汤剂的服用方法是:每天两次,每次150-180mL,温热服用,20天一个疗程。
实施例2 一种治疗胃癌的中药组合物,由下列原料药制备而成,均为重量份(25g/份):山药20份;徐长卿18份;竹林消13份;钩藤15份;白术17份;金丝带14份;珠儿参12份;肿节风13份;紫河车16份;蒲黄14份;猴头菌15份;石榕14份;延胡索16份;黄药子12份。
一种治疗胃癌的中药片剂的制备方法是:
(1)取新鲜的紫河车,横直剖开血管,用水反复洗漂干净,另取花椒置布袋中加水煎汤,去渣,加入洗净的紫河车,中火煎煮5分钟),及时捞出,滤净水,放入黄酒盆内拌匀,置笼屉中蒸透,取出,烘干,捣碎成细粉,备用(紫河车:花椒:黄酒=100:12:15);
(2)延胡索洗净,置于药锅中,加山西陈醋共煮(延胡索:山西陈醋=5:1),煮至醋吸尽,取出,切厚片,干燥,捣碎,备用;
(3)将山药(去皮、切片)、金丝带、肿节风、猴头菌和黄药子加纯净水没过药面,室温下浸泡2小时,小火煎煮两次,每次各煎煮30分钟,合并煎液,过滤,滤液减压浓缩至80℃相对密度为1.30-1.33的稠膏,真空干燥得干膏粉,备用;
(4)将徐长卿、竹林消、钩藤、白术、珠儿参和石榕分别洗净,置于中药提取器中,加入乙醇和水的混合液(原料药与乙醇和水的质量比为1:2:3),加热回流提取两次,第一次回流提取40分钟,第二次回流提取25分钟,合并两次提取液,过滤,回收乙醇,滤液减压浓缩至85℃密度为1.30g/mL的稠膏,真空干燥得干膏粉,备用;
(5)将步骤(1)-(4)所得药粉与蒲黄粉混合,加入质量分数为11%的硬脂酸镁和质量分数为12%的糊精,搅拌均匀,按照0.65g/片的计量,于压片机中压成片剂,即得。
本发明所得中药片剂的服用方法是:每天三次,每次3-5片,温水冲服,20天一个疗程。
典型病例:孙XX,男,61岁,患者于2009年6月29日来我院就诊。患者自述:三个月前无明显诱因出现反酸、烧心症状,尤其是在进食后症状加重,在家人陪同下来我院就诊。检查:患者进食不畅或反胃夹有多量粘液,食欲不振,口淡无味,胸脘胀闷或隐痛。舌质淡,苔白腻或黄腻,脉弦滑。胃镜提示:患者小弯侧可见2-3cm大小类圆形溃疡,地平,周边黏膜粗糙;后经X线及CT检查确诊为胃腺癌。
服用本实施例所得一种治疗胃癌的中药片剂,服用方法:每天三次,每次3-5片,温水冲服,20天一个疗程。服用两个疗程后,患者胸脘痛基本消失,可正常进食,病灶部位明显缓解;继续服用两个疗程后,患者不适症状基本消失,病灶部位基本恢复正常,继续服用两个疗程以巩固疗效,停药半年后回访,患者基本痊愈,无复发。
实施例3 一种治疗胃癌的中药组合物,由下列原料药制备而成,均为重量份(40g/份):山药16份;徐长卿14份;竹林消10份;钩藤11份;白术13份;金丝带11份;珠儿参10份;肿节风9份;紫河车12份;蒲黄10份;猴头菌11份;石榕9份;延胡索12份;黄药子9份。
一种治疗胃癌的中药丸剂的制备方法是:
(1)取新鲜的紫河车,横直剖开血管,用水反复洗漂干净,另取花椒置布袋中加水煎汤,去渣,加入洗净的紫河车,中火煎煮5分钟,及时捞出,滤净水,放入黄酒盆内拌匀,置笼屉中蒸透,取出,烘干,捣碎成细粉,备用(紫河车:花椒:黄酒=100:12:15);
(2)延胡索洗净,加黄酒、米醋拌匀煮干(延胡索:黄酒:米醋=50:6:3),焖12小时,取出,切碎,微火炒至微黄色为度,切厚片,干燥,捣碎,备用;
(3)将除步骤(1)和步骤(2)以外的剩余原料药置于中药锅中,加6倍量的纯净水,武火加热至沸,转文火煎煮三次,第一次煎煮52分钟,第二次煎煮35分钟,第三次煎煮18分钟,合并三次煎液,过滤,滤液减压浓缩至70℃相对密度为1.15-1.20的稠膏,备用;
(4)将步骤(1)和步骤(2)处理后的药粉加入到上述稠膏中,同时加入质量分数为10%的蔗糖细粉,搅拌均匀,加工成梧桐子大小的丸剂,即得。
本发明所得中药丸剂的服用方法是:每天三次,每次10-14丸,温水送服,20天一个疗程。
实施例4 一种治疗胃癌的中药组合物,由下列原料药制备而成,均为重量份(30g/份):山药18份;徐长卿16份;竹林消12份;钩藤14份;白术15份;金丝带13份;珠儿参11份;肿节风12份;紫河车15份;蒲黄13份;猴头菌14份;石榕12份;延胡索13份;黄药子11份。
一种治疗胃癌的中药胶囊剂的制备方法是:
(1)取新鲜的紫河车,横直剖开血管,用水反复洗漂干净,另取花椒置布袋中加水煎汤,去渣,加入洗净的紫河车,中火煎煮5分钟,及时捞出,滤净水,放入黄酒盆内拌匀,置笼屉中蒸透,取出,烘干,捣碎成细粉,备用(紫河车:花椒:黄酒=100:12:15);猴头菌切成丝和金丝带一同置于铁锅中,炒至微黄色,趁热倒入白醋内渍淬,取出,晾干,研粉,备用;
(2)延胡索洗净,置于药锅中,加山西陈醋共煮(延胡索:山西陈醋=5:1),煮至醋吸尽,取出,切厚片,干燥,捣碎,备用;白术洗净,切厚片,置于密闭容器中,加入食盐水浸润,待浸透后,放入炒锅,调温至65℃,翻炒至药材表面变色且略带焦斑,冷却,筛去碎屑,研末,备用;
(3)将除紫河车、猴头菌、金丝带、延胡索和白术以外的原料药充分干燥,磨碎成粉,加入步骤(1)和步骤(2)处理后的原料药粉,边搅拌边加入质量分数为11%的蔗糖细粉和10%的聚山梨酯80,混匀,制粒,过六号筛,整粒,装入胶囊壳,即得。
本发明所得中药胶囊剂的服用方法是:每天三次,每次4-6例,温水送服,20天一个疗程。
典型病例:赵XX,女,56岁,患者于2009年12月19日来我院就诊。患者自述:患者4个月前无明显诱因出现胃脘部不适,隐隐作痛,曾服用吗丁啉等药物治疗,未见好转,兵逐渐加重,后在某医院行胃镜检查提示为胃癌累积贲门,未采取手术治疗。转至我院检查就诊。检查:患者腹平软,上腹按压不适,无压痛、反跳痛及肌紧张,胃内灼热,乏力消瘦,五心烦热,大便干燥,大便潜血阳性,舌质红,苔微黄,脉细。胃镜、及CT检查提示为食管下段黏膜不规则,贲门管壁变硬,诊断为贲门胃腺癌。
服用本实施例所得一种治疗胃癌的中药胶囊剂,服用方法:每天三次,每次4-6例,温水送服,20天一个疗程。服用两个疗程后,患者胃脘痛明显缓解,食欲增强,大便正常,病灶部位明显缓解;继续服用两个疗程后,患者不适症状基本消失,病灶部位基本恢复正常,继续服用两个疗程以巩固疗效,停药半年后回访,患者基本痊愈,无复发。
实施例5 一种治疗胃癌的中药组合物,由下列原料药制备而成,均为重量份(35g/份):山药17份;徐长卿15份;竹林消11份;钩藤12.5份;白术14份;金丝带12份;珠儿参10.5份;肿节风10.5份;紫河车13.5份;蒲黄11.5份;猴头菌12.5份;石榕10.5份;延胡索12.5份;黄药子10份。
一种治疗胃癌的中药汤剂的制备方法是:
(1)取新鲜的紫河车,横直剖开血管,用水反复洗漂干净,另取花椒置布袋中加水煎汤,去渣,加入洗净的紫河车,中火煎煮5分钟,及时捞出,滤净水,放入黄酒盆内拌匀,置笼屉中蒸透,取出,烘干,捣碎成细粉,备用(紫河车:花椒:黄酒=100:12:15);
(2)山药去皮,切片,与金丝带、猴头菌置于恒温干燥箱中于55℃干燥3.8小时,取出,共研为粉,备用;
(3)将步骤(1)和(2)处理后的原料药粉与蒲黄混合,搅拌均匀,过80目筛,得混合药粉备用;
(4)将徐长卿、竹林消、钩藤、白术、珠儿参、肿节风、石榕、延胡索和黄药子一同置于中药锅中,加清水没过药面,于25℃浸泡2.3小时,然后武火加热煮沸8分钟,转文火煎煮三次,第一次煎煮40分钟,第二次煎煮30分钟,第三次煎煮20分钟,合并三次煎液,过滤,得滤液;
(5)将步骤(3)所得混合药粉加入到上述滤液中,文火加热煎煮20分钟,趁热过滤,滤液减压浓缩至原体积的2/3,干热灭菌,冷却,灌装,即得。
本发明所得中药汤剂的服用方法是:每天两次,每次150-180mL,温热服用,20天一个疗程。
试验例1 本发明所得一种治疗胃癌的中药组合物(实施例5)的应用研究。
1、资料和方法
1.1 一般资料
选取2009年3月-2013年4月我院收治的胃癌患者共328例,其中男性患者共193例,女性患者共135例,年龄在45-67岁,平均年龄为54.5±1.5岁。所有患者经病理组织学证实为胃腺癌患者;所有患者随机分为治疗组和对照组,两组患者在性别、年龄、病情等方面,经统计学处理差异无显著性意义(P>0.05),具有可比性。
1.2 病例筛选标准
(1)1个月内未用其它化疗及放疗;(2)KPS评分≥60分;(3)预计生存期在半年以上;(4)骨髓检查造血功能、化验肝肾功能均正常。
1.3 治疗方法
治疗组服用本发明所得药物,服用方法:每天两次,每次150-180mL,温热服用,20天一个疗程。共观察治疗四个疗程。对照组服用其他药物(如抗癌平丸、希罗达、司莫司汀等常规药物)。
1.4 疗效评判标准
根据WHO的实体瘤客观疗效评价标准分为:
完全缓解(CR):所有可见病变完全消失并至少维持4周以上;
部分缓解(PR):肿瘤病灶的最大径及其最大垂直径的乘积减少50%以上,维持4周以上;
好转(MR):肿瘤病灶的两径乘积缩小25%以上,但<50%,无新病灶出现;
稳定(SD):肿瘤病灶两径乘积缩小<25%,或增大<25%,无新病灶出现;
进展(PD):肿瘤病灶两径乘积增大>25%,或出现新病灶。
总有效率=完全缓解率+部分缓解率+好转率。稳定率=完全缓解率+部分缓解率+好转率+稳定率。
1.5 治疗结果
表1:治疗组和对照组胃癌患者的治疗结果
治疗效果:完全缓解126例(57.8%),部分缓解52例(23.9%),好转34例(15.5%),稳定6例(2.8%),进展0例,总有效率为97.2%,稳定率为100%。
本发明选择山药、徐长卿、竹林消、钩藤、白术、金丝带、珠儿参、肿节风、紫河车、蒲黄、猴头菌、石榕、延胡索和黄药子共14味主要原料药制备而成。方中,山药具有补脾养胃,生津益肺的功效;徐长卿利水消肿,活血解毒;竹林消健脾胃,镇痛;钩藤清热平肝,熄风定惊;金丝带镇静安神,健脾胃;珠儿参:养阴,清肺,散瘀,止血,定痛;肿节风抗菌消炎,祛风通络,活血散结;紫河车补气,养血,增强机体抵抗力;蒲黄凉血止血,活血消瘀;猴头菌具有增强免疫功能和抑瘤作用;石榕清热化痰,利水消肿,祛瘀散结;延胡索活血,散瘀,理气,止痛。诸药合用具有增强机体免疫及造血功能,调节胃肠运动,镇痛消炎,抗肿瘤的功效。治疗四个疗程,治疗组总有效率为97.2%,明显优于对照组。
应当指出的是,具体实施方式只是本发明比较有代表性的例子,显然本发明的技术方案不限于上述实施例,还可以有很多变形。本领域的普通技术人员,以本发明所明确公开的或根据文件的书面描述毫无异议的得到的,均应认为是本专利所要保护的范围。
Claims (10)
1.一种治疗胃癌的中药组合物,其特征在于,由下列原料药制备而成,均为重量份:山药14-20;徐长卿12-18;竹林消9-13;钩藤10-15;白术11-17;金丝带10-14;珠儿参9-12;肿节风8-13;紫河车11-16;蒲黄9-14;猴头菌10-15;石榕7-14;延胡索9-16;黄药子8-12。
2.如权利要求1所述的一种治疗胃癌的中药组合物,其特征在于,由下列原料药制备而成,均为重量份:山药16-18;徐长卿14-16;竹林消10-12;钩藤11-14;白术13-15;金丝带11-13;珠儿参10-11;肿节风9-12;紫河车12-15;蒲黄10-13;猴头菌11-14;石榕9-12;延胡索12-13;黄药子9-11。
3.如权利要求1所述的一种治疗胃癌的中药组合物,其特征在于,由下列原料药制备而成,均为重量份:山药17;徐长卿15;竹林消11;钩藤12.5;白术14;金丝带12;珠儿参10.5;肿节风10.5;紫河车13.5;蒲黄11.5;猴头菌12.5;石榕10.5;延胡索12.5;黄药子10。
4.如权利要求1-3所述的一种治疗胃癌的中药组合物,其特征在于,将其制成药学上可接受的汤剂,制备方法如下:
(1)取新鲜的紫河车,横直剖开血管,用水反复洗漂干净,另取花椒置布袋中加水煎汤,去渣,加入洗净的紫河车,中火煎煮3-7分钟(优选中火煎煮5分钟),及时捞出,滤净水,放入黄酒盆内拌匀,置笼屉中蒸透,取出,烘干,捣碎成细粉,备用(紫河车:花椒:黄酒=100:12:15);
(2)山药去皮,切片,与金丝带、猴头菌置于恒温干燥箱中干燥,取出,共研为粉,备用;
(3)将步骤(1)和(2)处理后的原料药粉与蒲黄混合,搅拌均匀,过筛,得混合药粉备用;
(4)将徐长卿、竹林消、钩藤、白术、珠儿参、肿节风、石榕、延胡索和黄药子一同置于中药锅中,加清水没过药面,于25℃浸泡1.6-3.0小时(优选于25℃浸泡2.3小时),然后武火加热煮沸6-10分钟(优选武火加热煮沸8分钟),转文火煎煮三次,第一次煎煮36-45分钟(优选第一次煎煮40分钟),第二次煎煮28-34分钟(优选第二次煎煮30分钟),第三次煎煮14-26分钟(优选第三次煎煮20分钟),合并三次煎液,过滤,得滤液;
(5)将步骤(3)所得混合药粉加入到上述滤液中,文火加热煎煮15-25分钟(优选文火加热煎煮20分钟),趁热过滤,滤液减压浓缩至原体积的2/3,干热灭菌,冷却,灌装,即得。
5.根据权利要求4所述的一种治疗胃癌的中药汤剂的制备方法,其特征在于,步骤(2)中干燥的温度为48-62℃(优选的干燥的温度为52-58℃,更加优选的干燥的温度为55℃)。
6.根据权利要求4所述的一种治疗胃癌的中药汤剂的制备方法,其特征在于,步骤(2)中干燥的时间为2.4-5.2小时(优选的干燥的时间为3.0-4.6小时,更加优选的干燥的时间为3.8小时)。
7.根据权利要求4所述的一种治疗胃癌的中药汤剂的制备方法,其特征在于,步骤(3)中过60-100目筛(优选的过70-90目筛,更加优选的过80目筛)。
8.如权利要求1-3所述的一种治疗胃癌的中药组合物,其特征在于,将其制成药学上可接受的片剂,制备方法如下:
(1)取新鲜的紫河车,横直剖开血管,用水反复洗漂干净,另取花椒置布袋中加水煎汤,去渣,加入洗净的紫河车,中火煎煮3-7分钟(优选中火煎煮5分钟),及时捞出,滤净水,放入黄酒盆内拌匀,置笼屉中蒸透,取出,烘干,捣碎成细粉,备用(紫河车:花椒:黄酒=100:12:15);
(2)延胡索洗净,置于药锅中,加山西陈醋共煮(延胡索:山西陈醋=5:1),煮至醋吸尽,取出,切厚片,干燥,捣碎,备用;
(3)将山药(去皮、切片)、金丝带、肿节风、猴头菌和黄药子加纯净水没过药面,室温下浸泡1-3小时(优选室温下浸泡2小时),小火煎煮两次,每次各煎煮20-40分钟(优选每次各煎煮30分钟),合并煎液,过滤,滤液减压浓缩至80℃相对密度为1.30-1.33的稠膏,真空干燥得干膏粉,备用;
(4)将徐长卿、竹林消、钩藤、白术、珠儿参和石榕分别洗净,置于中药提取器中,加入乙醇和水的混合液(原料药与乙醇和水的质量比为1:2:3),加热回流提取两次,第一次回流提取33-45分钟(优选第一次回流提取40分钟),第二次回流提取18-30分钟(优选第二次回流提取25分钟),合并两次提取液,过滤,回收乙醇,滤液减压浓缩至85℃密度为1.30g/mL的稠膏,真空干燥得干膏粉,备用;
(5)将步骤(1)-(4)所得药粉与蒲黄粉混合,加入质量分数为11%的硬脂酸镁和质量分数为12%的糊精,搅拌均匀,按照0.55-0.75g/片的计量(优选按照0.65g/片的计量),于压片机中压成片剂,即得。
9.如权利要求1-3所述的一种治疗胃癌的中药组合物,其特征在于,将其制成药学上可接受的丸剂,制备方法如下:
(1)取新鲜的紫河车,横直剖开血管,用水反复洗漂干净,另取花椒置布袋中加水煎汤,去渣,加入洗净的紫河车,中火煎煮3-7分钟(优选中火煎煮5分钟),及时捞出,滤净水,放入黄酒盆内拌匀,置笼屉中蒸透,取出,烘干,捣碎成细粉,备用(紫河车:花椒:黄酒=100:12:15);
(2)延胡索洗净,加黄酒、米醋拌匀煮干(延胡索:黄酒:米醋=50:6:3),焖10-14小时(优选焖12小时),取出,切碎,微火炒至微黄色为度,切厚片,干燥,捣碎,备用;
(3)将除步骤(1)和步骤(2)以外的剩余原料药置于中药锅中,加4-8倍量的纯净水(优选加6倍量的纯净水),武火加热至沸,转文火煎煮三次,第一次煎煮46-58分钟(优选第一次煎煮52分钟),第二次煎煮28-40分钟(优选第二次煎煮35分钟),第三次煎煮12-24分钟(优选第三次煎煮18分钟),合并三次煎液,过滤,滤液减压浓缩至70℃相对密度为1.15-1.20的稠膏,备用;
(4)将步骤(1)和步骤(2)处理后的药粉加入到上述稠膏中,同时加入质量分数为10%的蔗糖细粉,搅拌均匀,加工成梧桐子大小的丸剂,即得。
10.如权利要求1-3所述的一种治疗胃癌的中药组合物,其特征在于,将其制成药学上可接受的胶囊剂,制备方法如下:
(1)取新鲜的紫河车,横直剖开血管,用水反复洗漂干净,另取花椒置布袋中加水煎汤,去渣,加入洗净的紫河车,中火煎煮3-7分钟(优选中火煎煮5分钟),及时捞出,滤净水,放入黄酒盆内拌匀,置笼屉中蒸透,取出,烘干,捣碎成细粉,备用(紫河车:花椒:黄酒=100:12:15);猴头菌切成丝和金丝带一同置于铁锅中,炒至微黄色,趁热倒入白醋内渍淬,取出,晾干,研粉,备用;
(2)延胡索洗净,置于药锅中,加山西陈醋共煮(延胡索:山西陈醋=5:1),煮至醋吸尽,取出,切厚片,干燥,捣碎,备用;白术洗净,切厚片,置于密闭容器中,加入食盐水浸润,待浸透后,放入炒锅,调温至65℃,翻炒至药材表面变色且略带焦斑,冷却,筛去碎屑,研末,备用;
(3)将除紫河车、猴头菌、金丝带、延胡索和白术以外的原料药充分干燥,磨碎成粉,加入步骤(1)和步骤(2)处理后的原料药粉,边搅拌边加入质量分数为11%的蔗糖细粉和10%的聚山梨酯80,混匀,制粒,过六号筛,整粒,装入胶囊壳,即得。
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