CN105726816A - 一种含有艾叶的治疗胃癌的中药组合物及其制备方法 - Google Patents
一种含有艾叶的治疗胃癌的中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明属于中药技术领域，涉及一种含有艾叶的治疗胃癌的中药组合物及其制备方法。所述的中药组合物包括以下制备原料：艾叶、白花蛇舌草、紫草、紫椿、夏枯草、佛手柑根、荔枝核、泽泻、乌梅、黄芪、党参以及甘草。本发明提供的中药组合物遵循君、臣、佐、使的制方规律，用药适宜，配伍严谨，主次分明，相互增益，可缓解病症、改善体质、补中益气以及提高生存质量。此外，本发明所述的中药组合物对治疗胃癌具有显效快，效果好，疗程短，安全性高等优点。
Description
技术领域
本发明属于中药技术领域，具体涉及一种含有艾叶的治疗胃癌的中药组合物及其制备方法。
背景技术
胃癌是严重威胁人民生命健康的恶性肿瘤之一，它的病死率高居世界各种肿瘤病死率的第2位。因此，寻找有效治疗胃癌的药物和方法是目前抗肿瘤研究的一个重要课题。中医药疗法是胃癌综合治疗中的重要手段之一，中药对于降低术后复发率、减轻放化疗不良反应、延长患者生存期以及改善患者的生存质量具有非常重要的意义。结合近年国内文献报道，目前对于胃癌中医证型的论述、分型方法、分型依据等尚不统一，大多数医家认为胃癌乃本虚标实之证，邪实为标，脾胃肾虚为本；初期以标实为主，后期以本虚为主，出现气血两亏，脏气衰弱等证。
我国是胃癌高发地区，且胃癌经常到晚期才得到诊断，而以化疗为主的综合治疗在胃癌内科治疗中占据重要地位。但目前胃癌化疗CR率低，生存期延长不显著，消化道反应、骨髓抑制等不良反应较大，加上晚期胃癌患者大多有乏力、纳差、体质下降等，免疫功能差，对化疗耐受性差，因此在中成药上寻找治疗胃癌的组方也是非常重要的。
目前中成药公开的治疗胃癌的发明专利也有，例如：中国发明专利申请201510251352.9公开了治疗胃癌的中药，该中药包括草河车、法半夏、冬凌草、苦参、黄芪、红景天、金银花、人参、灵芝、山栀子、茯苓、生白术、穿心莲、甘草、虎杖、小叶买麻滕、雷公藤、半枝莲和白花蛇草制备原料，但该组合物种类繁多、制备工艺比较粗糙，药剂形式比较单一，适用性不广，此外有些中药材如雷公藤还具有一定毒性，安全性有待更进一步评估。
发明内容
本发明的目的是克服现有药物中的不足之处，提供一种安全性高、疗程短、药剂形式灵活、适用性广的治疗胃癌的中药组合物。
本发明的目的是通过以下技术方案来实现的：
一种含有艾叶的治疗胃癌的中药组合物，其特征在于，所述的中药组合物包括以下的制备原料：艾叶、白花蛇舌草、紫草、紫椿、夏枯草、佛手柑根、荔枝核、泽泻、乌梅、黄芪、党参和甘草。
进一步地，本发明所述的治疗胃癌的中药组合物包括以下重量份数的制备原料：
艾叶20-27份白花蛇舌草18-26份紫草15-21份紫椿17-22份夏枯草16-21份佛手柑根15-20份荔枝核17-22份泽泻12-18份乌梅14-19份黄芪13-19份党参10-17份甘草6-13份。
优选地，所述的中药组合物包括以下重量份数的制备原料：
艾叶20份白花蛇舌草18份紫草15份紫椿17份夏枯草16份佛手柑根15份荔枝核17份泽泻12份乌梅14份黄芪13份党参10份甘草6份。
优选地，所述的中药组合物包括以下重量份数的制备原料：
艾叶27份白花蛇舌草26份紫草21份紫椿22份夏枯草21份佛手柑根20份荔枝核22份泽泻18份乌梅19份黄芪19份党参17份甘草13份。
优选地，所述的中药组合物包括以下重量份数的制备原料：
艾叶25份白花蛇舌草22份紫草18份紫椿20份夏枯草18份佛手柑根17份荔枝核21份泽泻15份乌梅17份黄芪17份党参13份甘草9份。
此外，本发明还提供了所述的中药组合物的制备方法，其包括以下步骤：
(1)将艾叶、白花蛇舌草、紫草、紫椿、甘草去杂质，洗净、烘干，粉碎成粗粉；
(2)将荔枝核去除表层，洗净、烘干，粉碎成粗粉；
(3)将上述步骤(1)和步骤(2)制备的粗粉混合均匀后，加入6-12倍量水浸泡1-3小时，煎煮3-5小时；过滤，滤渣加入3-6倍量水，煎煮2-4小时；过滤，滤渣再次加入1-3倍量水，煎煮1-2小时，过滤，合并三次滤液，滤液浓缩至55-60℃环境下相对密度为1.15-1.20的浓缩液，备用；
(4)称取夏枯草、佛手柑根、泽泻、乌梅、黄芪和党参用5-10倍量体积比为60-90％的乙醇提取2-3次，每次5-8小时，过滤，合并滤液，回收乙醇，浓缩滤液至60-65℃环境下相对密度为1.15-1.20的浓缩液，备用；
(5)将上述步骤(3)和步骤(4)制成的浓缩液合并，浓缩至相对密度为1.20-1.35的稠膏，减压干燥，粉碎后过80-200目筛，得到均匀的细粉，根据现代制药工艺制成成品制剂，如胶囊、片剂、颗粒剂或散剂等。
本发明中药组合物的组方中的各味药材的性味，归经和功效如下：
艾叶：本品为菊科植物艾的干燥叶。夏季花未开时采摘，除去杂质，晒干；性味苦辛，温；归肝、脾、肾经；散寒止痛，温经止血；
白花蛇舌草：本品为茜草科耳草属植物白花蛇舌草的全草。性味甘、淡，凉；归胃、大肠、小肠经；清热解毒，利尿消肿，活血止痛；
紫草：本品为紫草科植物新疆紫草、紫草或内蒙紫草的干燥根；性味甘、咸，寒；归心、肝经；凉血、活血、解毒透疹；
紫椿：本品为楝科植物紫椿的根皮、叶、果实；性味苦、甘、涩、温；归脾、肝经；燥湿、止血、杀虫；
夏枯草：本品为唇形科植物夏枯草的干燥果穗；性味辛、苦，寒；归肝、胆经；清火，明目，散结，消肿；
佛手柑根：本品为芸香科植物佛手的根；性味辛；苦；性平；归脾、胃、肾经；顺气化痰；
荔枝核：本品为无患子科植物荔枝的干燥成熟种子；性味甘、微苦，温；归肝、肾经；行气散结，祛寒止痛；
泽泻：本品为泽泻科植物泽泻的干燥块茎；性味甘，寒；归肾、膀胱经；利小便，清湿热；
乌梅：本品为蔷薇科植物梅、.的干燥近成熟果实；性味酸、涩，平；归肝、脾、肺、大肠经；敛肺，涩肠，生津，安蛔；
黄芪：本品又名绵芪；性味甘，微温；归肺、脾、肝、肾经；补气升阳、益卫固表；
党参：本品为桔梗科植物党参的根；性味甘，平；归脾、肺经；补中益气，健脾益肺；
甘草：本品为豆科植物甘草、胀果甘草或光果甘草的干燥根；性味甘、平；补脾益气，清热解毒，祛痰止咳，缓急止痛，调和诸药。
上述诸药中，艾叶为君药，散寒止痛，对胃起到主要防护作用；白花蛇舌草、紫草、紫椿、夏枯草、佛手柑根、荔枝核为臣药，其中，白花蛇舌草、佛手柑根归胃经，散结活血，紫草、紫椿、夏枯草归肝肺经，辅助君药，促进治疗胃癌对其他器官的并发症，荔枝核药性温和，归肝、肾经，行气散结，预防胃癌后续病发症；泽泻、乌梅、黄芪、党参为佐药，其中，泽泻、乌梅生津利便协助君、臣药促进胃癌患者新陈代谢，黄芪、党参补气升阳、益卫固表、增强胃癌患者体质；甘草为使药，在于调和诸药药效。组方各药相互作用，相互融通，相互促进，增强治疗胃癌的药效。
本发明和现有技术相比，具有如下技术效果：
1.本发明中药组合物发挥中药辨证治疗的效果，用药适宜，配伍严谨，主次分明，恰和病情，对胃癌的治疗针对性强。
2.本发明提供的中药组合物用药精简，低毒，药材皆为中国药典所列，来源广、成本低。
3.动物试验表明，本发明中药组合物能显著降低调节型T细胞的比例和Foxp3mRNA相对表达量，并能改善侵袭胃壁深度，对胃癌小鼠具有较好的疗效，其治疗效果与环磷酰胺比较效果更优。
4.本发明提供的中药组合物制备工艺简单易行，适合工业化生产，药剂形式灵活。
具体实施方式
以下通过具体实施方式的描述对本发明作进一步说明，但这并非是对本发明的限制，本领域技术人员根据本发明的基本思想，可以做出各种修改或改进，但是只要不脱离本发明的基本思想，均在本发明的范围之内。
实施例1
本发明实施例1中药组合物包括如下重量份数的制备原料：
艾叶20份白花蛇舌草18份紫草15份紫椿17份夏枯草16份佛手柑根15份荔枝核17份泽泻12份乌梅14份黄芪13份党参10份甘草6份。
制备方法如下：
(1)将艾叶、白花蛇舌草、紫草、紫椿、甘草去杂质，洗净、烘干，粉碎成粗粉；
(2)将荔枝核去除表层，洗净、烘干，粉碎成粗粉；
(3)将上述步骤(1)和步骤(2)制备的粗粉混合均匀后，加入8倍量水浸泡3小时，煎煮4小时；过滤，滤渣加入5倍量水，煎煮3小时；过滤，滤渣再次加入2倍量水，煎煮2小时，过滤，合并三次滤液，滤液浓缩至60℃环境下相对密度为1.15的浓缩液，备用；
(4)称取夏枯草、佛手柑根、泽泻、乌梅、黄芪和党参用10倍量体积比为75％的乙醇提取3次，每次8小时，过滤，合并滤液，回收乙醇，浓缩滤液至60℃环境下相对密度为1.15的浓缩液，备用；
(5)将上述步骤(3)和步骤(4)制成的浓缩液合并，浓缩至相对密度为1.20的稠膏，减压干燥，粉碎后过200目筛，得到均匀的细粉，根据现代制药工艺制成颗粒剂。
实施例2
本发明实施例2中药组合物包括如下重量份数的制备原料：
艾叶27份白花蛇舌草26份紫草21份紫椿22份夏枯草21份佛手柑根20份荔枝核22份泽泻18份乌梅19份黄芪19份党参17份甘草13份。
制备方法同实施例1。
实施例3
本发明实施例3中药组合物包括如下重量份数的制备原料：
艾叶25份白花蛇舌草22份紫草18份紫椿20份夏枯草18份佛手柑根17份荔枝核21份泽泻15份乌梅17份黄芪17份党参13份甘草9份。
制备方法同实施例1。
实施例4
本发明实施例4中药组合物包括如下重量份数的制备原料：
艾叶25份白花蛇舌草22份紫草18份紫椿20份夏枯草18份佛手柑根17份荔枝核21份泽泻15份乌梅17份黄芪17份党参13份甘草9份。
制备方法同实施例1。
本发明中药组合物药效学研究：
本发明中药组合物对615系小鼠胃癌模型的药效学研究
1.试验方法：将615系小鼠颈背部皮下种植小鼠前胃癌(MFC)细胞株建立胃癌小鼠模型，建模后经病理学检验，筛选成功构建模型的小鼠72只，体质量35-55g，雌雄各半，按性别体重随机分为6组，分别为空白对照组、阳性药对照组、本发明实施例1、2、3、4组，每组12只，雌雄各半。随后对各组进行不同处理，空白对照组除喂养和其他试验组相同外不做其他处理，阳性药对照组服用环磷酰胺，给药剂量为100mg/kg、本发明实施例1、2、3、4组分别服用实施例1-4制得的中药颗粒，并按150mg/kg给药，各组每天给药一次，连续七天为一个疗程，连续服用两个疗程，检测胃癌相关细胞以及mRNA表达情况，并作统计学分析。
2.试验结果：
表1各试验组小鼠的调节型T(Treg)细胞比例比较
注：与空白对照组比较，*P＜0.05，**P＜0.01；与阳性药对照组比较，#P＜0.05。
表2各试验组小鼠的Foxp3mRNA的相对表达量
注：与空白对照组比较，*P＜0.05。
表3各试验组小鼠的胃癌病理大切片分析统计
由上表1-3的结果可知，本发明中药组合物能显著降低调节型T细胞的比例和Foxp3mRNA相对表达量，并能改善侵袭胃壁深度，对胃癌小鼠具有较好的疗效，其治疗效果与环磷酰胺比较，效果更优，其中以实施例3组的效果较佳，其降低调节型T细胞比例的效果与环磷酰胺比较，具有显著性差异。
由于已经通过以上较佳实施例描述了本发明，在本发明的精神和/或范围内，任何针对本发明的替换/或组合来实施本发明，对于本领域的技术人员来说都是显而易见的，且包含在本发明之中。
Claims (7)
1.一种含有艾叶的治疗胃癌的中药组合物，其特征在于，所述的中药组合物包括以下制备原料：艾叶、白花蛇舌草、紫草、紫椿、夏枯草、佛手柑根、荔枝核、泽泻、乌梅、黄芪、党参以及甘草。
2.根据权利要求1所述的含有艾叶的治疗胃癌的中药组合物，其特征在于，所述的中药组合物包括以下重量份数的制备原料：
艾叶20-27份白花蛇舌草18-26份紫草15-21份紫椿17-22份夏枯草16-21份
佛手柑根15-20份荔枝核17-22份泽泻12-18份乌梅14-19份黄芪13-19份
党参10-17份甘草6-13份。
3.根据权利要求2所述的含有艾叶的治疗胃癌的中药组合物，其特征在于，所述的中药组合物包括以下重量份数的制备原料：
艾叶20份白花蛇舌草18份紫草15份紫椿17份夏枯草16份佛手柑根15份
荔枝核17份泽泻12份乌梅14份黄芪13份党参10份甘草6份。
4.根据权利要求2所述的含有艾叶的治疗胃癌的中药组合物，其特征在于，所述的中药组合物包括以下重量份数的制备原料：
艾叶27份白花蛇舌草26份紫草21份紫椿22份夏枯草21份佛手柑根20份
荔枝核22份泽泻18份乌梅19份黄芪19份党参17份甘草13份。
5.根据权利要求2所述的含有艾叶的治疗胃癌的中药组合物，其特征在于，所述的中药组合物包括以下重量份数的制备原料：
艾叶25份白花蛇舌草22份紫草18份紫椿20份夏枯草18份佛手柑根17份
荔枝核21份泽泻15份乌梅17份黄芪17份党参13份甘草9份。
6.根据权利要求1-5任一所述的含有艾叶的治疗胃癌的中药组合物，其特征在于，所述中药组合物的制备方法包括以下步骤：
(1)将艾叶、白花蛇舌草、紫草、紫椿、甘草去杂质，洗净、烘干，粉碎成粗粉；
(2)将荔枝核去除表层，洗净、烘干，粉碎成粗粉；
(3)将上述步骤(1)和步骤(2)制备的粗粉混合均匀后，加入6-12倍量水浸泡1-3小时，煎煮3-5小时；过滤，滤渣加入3-6倍量水，煎煮2-4小时；过滤，滤渣再次加入1-3倍量水，煎煮1-2小时，过滤，合并三次滤液，滤液浓缩至55-60℃环境下相对密度为1.15-1.20的浓缩液，备用；
(4)称取夏枯草、佛手柑根、泽泻、乌梅、黄芪和党参用5-10倍量体积比为60-90％的乙醇提取2-3次，每次5-8小时，过滤，合并滤液，回收乙醇，浓缩滤液至60-65℃环境下相对密度为1.15-1.20的浓缩液，备用；
(5)将上述步骤(3)和步骤(4)制成的浓缩液合并，浓缩至相对密度为1.20-1.35的稠膏，减压干燥，粉碎后过80-200目筛，得到均匀的细粉，根据现代制药工艺制成成品制剂。
7.一种制备如权利要求1-6任一所述的含有艾叶的治疗胃癌的中药组合物的方法，其特征在于，包括以下步骤：
(1)将艾叶、白花蛇舌草、紫草、紫椿、甘草去杂质，洗净、烘干，粉碎成粗粉；
(2)将荔枝核去除表层，洗净、烘干，粉碎成粗粉；
(3)将上述步骤(1)和步骤(2)制备的粗粉混合均匀后，加入6-12倍量水浸泡1-3小时，煎煮3-5小时；过滤，滤渣加入3-6倍量水，煎煮2-4小时；过滤，滤渣再次加入1-3倍量水，煎煮1-2小时，过滤，合并三次滤液，滤液浓缩至55-60℃环境下相对密度为1.15-1.20的浓缩液，备用；
(4)称取夏枯草、佛手柑根、泽泻、乌梅、黄芪用5-10倍量体积比为60-90％的乙醇提取2-3次，每次5-8小时，过滤，合并滤液，回收乙醇，浓缩滤液至60-65℃环境下相对密度为1.15-1.20的浓缩液，备用；
(5)将上述步骤(3)和步骤(4)制成的浓缩液合并，浓缩至相对密度为1.20-1.35的稠膏，减压干燥，粉碎后过80-200目筛，得到均匀的细粉，根据现代制药工艺制成成品制剂。
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