CN104383244B - 一种治疗食道癌的中药组合物及其制备方法 - Google Patents

一种治疗食道癌的中药组合物及其制备方法 Download PDF

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CN104383244B
CN104383244B CN201410656861.5A CN201410656861A CN104383244B CN 104383244 B CN104383244 B CN 104383244B CN 201410656861 A CN201410656861 A CN 201410656861A CN 104383244 B CN104383244 B CN 104383244B
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CN104383244A (zh
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姚娟
王萍
王俊杰
韩淑红
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Qingdao Tumour Hospital
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Abstract

本发明属于医药领域,具体涉及一种治疗食道癌的中药组合物及其制备方法。所述中药组合物由如下重量份的原料药制备而成:半枝莲10‑40份、川芎15‑25份、一枝黄花10‑20份、王不留行10‑30份、大青叶5‑15份、当归20‑40份、川牛膝10‑25份、接骨木10‑20份、红花10‑30份、川木通5‑15份、山银花10‑30份、黑苦荞5‑15份、麦冬10‑20份、泽泻5‑15份、连翘5‑15份、芍药5‑15份。本发明提供了一种安全、有效,制备工艺简便的用于治疗食道癌的中药组合物,其治疗食道癌的效果明显,愈后不易复发,有效率可达80%。

Description

一种治疗食道癌的中药组合物及其制备方法
技术领域
本发明属于中药领域,具体涉及一种治疗食道癌的中药组合物及其制备方法。
背景技术
食道癌又称食管癌,是发生在食管上皮组织的恶性肿瘤,临床上以进行性吞咽困难为最典型的性状,占所有恶性肿瘤的2%,全世界每年约有22万人死于食道癌,我国是食道癌高发区,每年平均病死约15万人。发病年龄多在40岁以上,男性多于女性,但近年来40岁以下发病者有增长趋势。食道癌典型的症状为进行性咽下困难,先是难咽干的食物,继而是半流质食物,最后水和唾液也不能咽下。
食道癌像其他的恶性肿瘤一样虽然有基因的变化背景,涉及多因素、多阶段、多基因变异积累及相互作用的复杂过程,在分子水平上涉及众多原癌基因、抑癌基因以及蛋白质的改变。但长期不良的生活或饮食习惯可能是导致食管癌发生的元凶。目前认为,引起食管癌的相关危险因素主要有:进食含亚硝胺类较多的食物(如喜欢腌制酸菜)或霉变食品、长期喜进烫食(如潮汕人食管癌发病率高可能与长期喝功夫茶有关)、不良嗜好(如吸烟、饮酒)等。
目前,对于食道癌的治疗方法有:手术治疗、放射治疗和药物治疗。其中手术治疗对早期患者有很好的疗效,但其治疗费用昂贵,且对晚期患者治疗效果不佳,还有一些患者因身体原因不能进行手术治疗,如患者有严重心肺或肝肾功能不全。食道癌放射治疗的适应症较宽,但其会伴随严重的不良反应及出血、穿孔和放射性脊髓病等并发症。另外治疗食道癌的药物虽然种类不少,但大都价格昂贵且效果不佳,一些治疗药物,用药量大、种类多,不仅效果不好,而且还会带来许多副作用,产生不良后果。
发明内容
为了克服现有技术中存在的上述问题,一方面,本发明提供一种治疗食道癌的中药组合物,其由下述重量份的原料药制备而成:半枝莲10-40份、川芎15-25份、一枝黄花10-20份、王不留行10-30份、大青叶5-15份、当归20-40份、川牛膝10-25份、接骨木10-20份、红花10-30份、川木通5-15份、山银花10-30份、黑苦荞5-15份、麦冬10-20份、泽泻5-15份、连翘5-15份、芍药5-15份。
优选地,所述中药组合物由如下重量份的原料药制备而成:
半枝莲40份、川芎20份、一枝黄花20份、王不留行10份、大青叶15份、当归25份、川牛膝20份、接骨木10份、红花25份、川木通5份、山银花30份、黑苦荞5份、麦冬20份、泽泻5份、连翘12份、芍药5份;或者
半枝莲15份、川芎25份、一枝黄花15份、王不留行30份、大青叶5份、当归35份、川牛膝15份、接骨木20份、红花10份、川木通15份、山银花15份、黑苦荞15份、麦冬10份、泽泻15份、连翘5份、芍药12份。
进一步优选地,所述中药组合物由如下重量份的原料药制备而成:
半枝莲25份、川芎20份、一枝黄花15份、王不留行20份、大青叶10份、当归30份、川牛膝18份、接骨木15份、红花20份、川木通10份、山银花20份、黑苦荞10份、麦冬15份、泽泻10份、连翘10份、芍药10份。
另一方面,本发明提供了所述中药组合物的制备方法,其包括如下步骤:
(1)按照上述中药组合物的重量配比称取原料药半枝莲、川芎、一枝黄花、王不留行、大青叶、当归、川牛膝、接骨木、红花、川木通、山银花、黑苦荞、麦冬、泽泻、连翘和芍药,干燥、粉碎,混合均匀后得到原料药混合物,备用;
(2)向步骤(1)中得到的原料药混合物中加入5-15倍量的水,煎煮三次,每次1-3小时,合并煎液,滤过,滤液浓缩成相对密度为1.10-1.25的清膏(80℃);
(3)向步骤(2)所得的清膏中加入乙醇至含醇量60-80%(v/v),搅拌,静置12-24小时,滤过,滤液减压回收乙醇,即得所述中药组合物。
进一步优选地,本发明中药组合物的制备方法包括如下步骤:
(1)按照上述中药组合物的重量配比称取原料药半枝莲、川芎、一枝黄花、王不留行、大青叶、当归、川牛膝、接骨木、红花、川木通、山银花、黑苦荞、麦冬、泽泻、连翘和芍药,干燥、粉碎,混合均匀后得到原料药混合物,备用;
(2)向步骤(1)中得到的原料药混合物中加入12倍量的水,煎煮三次,每次2小时,合并煎液,滤过,滤液浓缩成相对密度为1.10-1.25的清膏(80℃);
(3)向步骤(2)所得的清膏中加入乙醇至含醇量80%(v/v),搅拌,静置24小时,滤过,滤液减压回收乙醇,即得所述中药组合物。
在本发明一个优选的实施方案中,可以按照本领域常规的制备方法,通过加入药物领域中常见的辅料,例如润滑剂、崩解剂、粘合剂等,按照中药制剂领域常规的制备方法将上述原料药制备成任何一种适合的中药制剂,例如片剂、散剂、颗粒剂、丸剂、胶囊剂、口服液等。
所述药物领域中常见的辅料包括药物领域在制备上述制剂过程中常规和通用的辅料。
再一方面,本发明还提供了所述中药组合物的医药用途。本发明中药组合物的服用方法:每日1剂,分早晚两次服用,连服30天为一个疗程。临床实验结果表明,本发明的中药组合物治疗食道癌的效果十分明显,且无明显毒副作用,愈后不易复发,总有效率可达80%。
本发明的有益效果:
本发明各原料药组合使用能够最大程度的发挥药效,标本兼治,虚实并治,内外通调,缓急兼收,共奏行气止痛、清热解毒、活血化瘀、散肿排毒之功,极大的提高了人体自身免疫力,且不会对人体产生毒副作用。因此,本发明克服了现有技术中存在的不足,提供了一种安全、有效,工艺简便的用于治疗食道癌的中药制剂。
具体实施方式
通过以下实施方式进一步详细说明本发明的技术方案。需要指出的是,以下说明仅仅是对本发明要求保护的技术方案的举例说明,并非对这些技术方案的任何限制。本发明的保护范围以所附权利要求书记载的内容为准。
实施例1
一种治疗食道癌的中药组合物,其由下述重量的原料药制备而成:
半枝莲40g、川芎20g、一枝黄花20g、王不留行10g、大青叶15g、当归25g、川牛膝20g、接骨木10g、红花25g、川木通5g、山银花30g、黑苦荞5g、麦冬20g、泽泻5g、连翘12g、芍药5g。
所述中药组合物的制备方法,具体步骤如下:
(1)按照上述中药组合物的配比称取原料药半枝莲、川芎、一枝黄花、王不留行、大青叶、当归、川牛膝、接骨木、红花、川木通、山银花、黑苦荞、麦冬、泽泻、连翘和芍药,干燥、粉碎,混合均匀后得到原料药混合物,备用;
(2)向步骤(1)中得到的原料药混合物中加入6倍量的水,煎煮三次,每次1.5小时,合并煎液,滤过,滤液浓缩成相对密度为1.10-1.25的清膏(80℃);
(3)向步骤(2)所得的清膏中加入乙醇至含醇量60%(v/v),搅拌,静置12小时,滤过,滤液减压回收乙醇,即得所述中药组合物。
服用方法为:取上述制备得到的中药组合物,每日一剂,早晚两次服用,30天为一个疗程。
实施例2
一种治疗食道癌的中药组合物,其由下述重量的原料药制备而成:
半枝莲15g、川芎25g、一枝黄花15g、王不留行30g、大青叶5g、当归35g、川牛膝15g、接骨木20g、红花10g、川木通15g、山银花15g、黑苦荞15g、麦冬10g、泽泻15g、连翘5g、芍药12g。
所述中药组合物的制备方法,具体步骤如下:
(1)按照上述中药组合物的配比称取原料药半枝莲、川芎、一枝黄花、王不留行、大青叶、当归、川牛膝、接骨木、红花、川木通、山银花、黑苦荞、麦冬、泽泻、连翘和芍药,干燥、粉碎,混合均匀后得到原料药混合物,备用;
(2)向步骤(1)中得到的原料药混合物中加入15倍量的水,煎煮两次,每次2.5小时,合并煎液,滤过,滤液浓缩成相对密度为1.10-1.25的清膏(80℃);
(3)向步骤(2)所得的清膏中加入乙醇至含醇量70%(v/v),搅拌,静置18小时,滤过,滤液减压回收乙醇,即得所述中药组合物。
服用方法为:取上述制备得到的中药组合物,每日一剂,早晚两次服用,30天为一个疗程。
实施例3
一种治疗食道癌的中药组合物,其由下述重量的原料药制备而成:
半枝莲25g、川芎20g、一枝黄花15g、王不留行20g、大青叶10g、当归30g、川牛膝18g、接骨木15g、红花20g、川木通10g、山银花20g、黑苦荞10g、麦冬15g、泽泻10g、连翘10g、芍药10g。
所述中药组合物的制备方法,具体步骤如下:
(1)按照上述中药组合物的配比称取原料药半枝莲、川芎、一枝黄花、王不留行、大青叶、当归、川牛膝、接骨木、红花、川木通、山银花、黑苦荞、麦冬、泽泻、连翘和芍药,干燥、粉碎,混合均匀后得到原料药混合物,备用;
(2)向步骤(1)中得到的原料药混合物中加入12倍量的水,煎煮三次,每次2小时,合并煎液,滤过,滤液浓缩成相对密度为1.10-1.25的清膏(80℃);
(3)向步骤(2)所得的清膏中加入乙醇至含醇量80%(v/v),搅拌,静置24小时,滤过,滤液减压回收乙醇,即得所述中药组合物。
服用方法为:取上述制备得到的中药组合物,每日一剂,早晚两次服用,30天为一个疗程。
实施例4 本发明中药组合物治疗食道癌的临床效果实验
(1)病例选择:
选择病例共50例,其中男35例,女15例,年龄在38-65岁之间,平均年龄为51岁。病例的症状为进行性吞咽困难伴胸骨后疼痛、消瘦,所有病例均经CT、纤维胃镜及病理活组织检查确诊,瘤体0.8-4.6cm。
(2)治疗方法:
服用本发明上述实施例3制备得到的中药组合物,每日一剂,早晚两次服用,30天为一个疗程。服用2个疗程后再进行CT、内镜或病理检查。
(3)疗效标准:
痊愈:吞咽困难症状消失能进食普通食物,CT或内镜、病理检查正常。
显效:吞咽症状好转,能进食流食或半流食,CT及内镜检查瘤体消退达到50%。
无效:症状未见明显好转,进食仍有困难,CT及内镜检查无明显改善。
(4)治疗结果:
痊愈19例,占38%。显效:21例,占42%。总有效率为80%。无效为 10 例,占 20%。
可见,本发明中药组合物治疗食道癌的疗效显著,50例患者中治愈19例,显效21例,总有效率80%,且无毒副作用,使用方法简单,适用于放、化疗无效或年老体弱者,极大的提高了患者的依从性。
实施例5 本发明中药组合物治疗食道患者的典型病例
1、李某,男,49岁,山东临沂人,2009年3月因吞咽困难在医院经食管镜及病理检查确诊为食道癌,不愿接受手术和化疗,服用本发明实施例3制备的中药组合物,每日一剂,早晚两次服用,30天为一个疗程。服用完1个疗程后即可进食稀饭等流食,继续服用1个疗程后能够服用正常饮食。随访2年未复发。
2、单某,男,57岁,河南信阳人,2010年7月因吞咽困难去医院进行CT检查确诊为食管中下段有0.8-1.6cm肿瘤,服用本发明实施例3制备的中药组合物,每日一剂,早晚两次服用,30天为一个疗程。服用1个疗程后可进食稀饭等流食,继续服用1个疗程后,食道瘤体被溶化,能够服用正常饮食,继而又服用1个疗程后,经CT检查发现瘤体消失,随访至今仍未复发。
3、高某,女,51岁,山东泰安人,于2010年1月因进行性吞咽困难在医院经CT检查确诊为食道癌,经人介绍开始服用本发明实施例1制备的中药组合物,每日一剂,早晚两次服用,30天为一个疗程。服用1个疗程后瘤体被部分减退,能进食豆浆、稀饭等流食,继续服用1个疗程后能够正常进食,经CT 检查未发现癌瘤。随访3年未复发。
4、张某,女,62岁,河北保定人,2009年12月因进食困难在医院做内镜及病理检查确诊为食管下段有1.0-1.6cm肿瘤,因化疗副作用太大改服本发明实施例1制备的中药组合物,每日一剂,早晚两次服用,30天为一个疗程。服用1个疗程后吐出红色粘稠液体,能进食稀饭等流食,继续服用1个疗程后癌瘤被溶化、能够正常进食,继而又服用1个疗程后,经CT检查未发现癌瘤。随访2年未复发。
5、李某,女,51岁,河北香河人,2008年3月因吞咽困难在医院经CT检查确诊为食管中下1/3处瘤体,经3个疗程化疗,无明显变化。经人介绍开始服用本发明实施例3制备的中药组合物,每日一剂,早晚两次服用,30天为一个疗程。服用1个疗程后吐出血性粘稠分泌物,能进食稀饭等流食,继续服用1个疗程后能够正常进食,继而又服用1个疗程后,经CT 检查未发现癌瘤。随访3年未复发。
6、王某,男,65岁,山东济南人,2009年2月经医院病理检查确诊食管癌,服用本发明实施例2制备的中药组合物,每日一剂,早晚两次服用,30天为一个疗程。服用1个疗程后即能进食稀饭等流食,继续服用1个疗程后能够正常进食,经CT 检查未发现癌瘤。至今仍健康生活。
7、田某,男,63岁,河南新乡人,2010年5月进行性吞咽困难在医院经内镜及病理检查确诊为食道癌,开始服用本发明实施例2制备的中药组合物,每日一剂,早晚两次服用,30天为一个疗程。服用1个疗程后即能进食稀饭等流食,继续服用1个疗程后能够正常进食,经CT 检查未发现癌瘤。至今仍健在。
本发明内容仅仅举例说明了要求保护的一些具体实施方案,其中一个或更多个技术方案中所记载的技术特征可以与任意的一个或多个技术方案相组合,这些经组合而得到的技术方案也在本申请保护范围内,就像这些经组合而得到的技术方案已经在本发明公开内容中具体记载一样。

Claims (2)

1.一种治疗食道癌的中药组合物,其由下述重量的原料药制备而成:
半枝莲25g、川芎20g、一枝黄花15g、王不留行20g、大青叶10g、当归30g、川牛膝18g、接骨木15g、红花20g、川木通10g、山银花20g、黑苦荞10g、麦冬15g、泽泻10g、连翘10g、芍药10g;
所述中药组合物的制备方法如下:
(1)按照上述中药组合物的配比称取原料药半枝莲、川芎、一枝黄花、王不留行、大青叶、当归、川牛膝、接骨木、红花、川木通、山银花、黑苦荞、麦冬、泽泻、连翘和芍药,干燥、粉碎,混合均匀后得到原料药混合物,备用;
(2)向步骤(1)中得到的原料药混合物中加入12倍量的水,煎煮三次,每次2小时,合并煎液,滤过,滤液浓缩成相对密度为80℃下1.10-1.25的清膏;
(3)向步骤(2)所得的清膏中加入乙醇至含醇量为80%,搅拌,静置24小时,滤过,滤液减压回收乙醇,即得所述中药组合物。
2.权利要求1所述的中药组合物在制备用于治疗食道癌的药物中的用途。
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