CN104225004B - 一种含巴西人参的辅助抗肿瘤中药制剂 - Google Patents
一种含巴西人参的辅助抗肿瘤中药制剂 Download PDFInfo
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Abstract
一种含巴西人参的辅助抗肿瘤中药制剂,其特点是在中医药理论指导下,采用现代制剂技术,将巴西人参及其它中草药材制成中药复方制剂。该复方制剂的处方组成为:巴西人参、壁虎、白花蛇舌草、黄芪、陈皮,药材的重量份数之比为:5~100∶5~100∶5~100∶5~100∶2.5~50。本制剂药材提取浸膏经动物体内实验证明,可增强抗肿瘤药物环磷酰胺对小鼠S180、H22实体瘤的抑制作用,减小环磷酰胺对小鼠免疫器官影响。
Description
技术领域
本发明涉及一种含巴西人参的中药制剂,该制剂由巴西人参、壁虎、黄芪、白花蛇舌草和陈皮五味药材,经现代制剂技术制备而成,可与西药化疗技术联合使用,用于恶性肿瘤(如肝癌、胃癌)的治疗。
背景技术
恶性肿瘤是严重危害人类健康的疾病,现有的恶性肿瘤化疗药物多为细胞毒类,该类药物在杀伤肿瘤细胞的同时,对人体正常细胞也有损害,严重的破坏机体的免疫系统,使患者的生存质量水平低下、生命延长率减小。以中草药为代表的传统药物,采用多靶点、综合调节的治疗模式,为恶性肿瘤的治疗开辟了新的治疗理念和路径。本发明提供一种含巴西人参的中药制剂,该制剂可以增强西药化疗对恶性肿瘤的治疗效果,减小化疗药物对免疫系统的损害。
一种含巴西人参的辅助抗肿瘤中药制剂,该制剂的处方组成为:巴西人参、壁虎、白花蛇舌草、黄芪、陈皮,药材的重量份数之比为:5~100∶5~100∶5~100∶5~100∶2.5~50。
巴西人参为苋科(Amaranthaceae),Pfaffia属和Hebanthe属多种植物,如:Pfaffia glomerata,Hebanthe eriantha......等的根。主要分布于巴西、厄瓜多尔、巴拿马等热带雨林地区,已有300多年应用史,具有抗肿瘤、壮阳、镇静、治疗溃疡、风温性关节炎和降血糖等功效,是当地民间一种重要草药。上个世纪90年代末,成功引入我国广西、四川、浙江等地栽培,裁培地民间自发的开展了应用工作。结合民间应用的情况和国外应用资料的整理,现代中医药专家认为:巴西人参的性味,归经为:味甘、微苦,性平。归脾、肺、心、肾经。功能主治为:消肿止痛,通经利尿,补脾益肺,补肾壮阳,安神益智。主要用于治疗风湿痹痛,水肿,小便不利,痈疮肿毒,癥瘕积聚,体虚乏力,虚热消渴,失眠健忘,心悸怔忡,腰膝酸软,阳痿早泄,宫冷不孕,月经不调等。适用于西医诊为肿瘤,癌症,肾炎,尿路感染,关节炎,软组织损伤,内分泌紊乱,免疫功能低下,性功能障碍,冠心病,动脉硬化,高血压,高胆固醇,糖尿病,失眠,贫血,月经不调、痛经、经闭等。
壁虎为壁虎科(Gekkonidae)多种动物的干燥全体,如壁虎属(Gekko)无蹼壁虎(Gekko swinhonis)、多疣壁虎(Gekko japonicas)、壁虎(Gekko chinensis),蜥虎属(Hemidactylus)原尾蜥虎(Hemidactylus bowringii)、疣尾蜥虎(Hemidactylusfrenatus),等。壁虎味咸性寒,有小毒。入肾、肝二经。能软坚散结,清热解毒,并有活血散瘀,通络止痛,化湿消痰之功,是治疗有形肿块的特效中药。
白花蛇舌草为茜草科(Rubiaceae)耳草属(Hedyotis)植物白花蛇舌草(Hedyotisdiffusa)的干燥全草。白花蛇舌草味苦、甘性寒,入胃、大肠、小肠经。有清热解毒,利尿消肿,活血止痛之功效。用于肠痈(阑尾炎),疮疖肿毒,咽喉肿痛,毒蛇咬伤,混热黄疸,肾炎,肝硬化,早期淋巴结核,小便不利等症;适用于癌症。
黄芪为豆科(Fabaceae)黄芪属(Astragalus)植物蒙古黄芪(Astragalusmembranaceus)、膜荚黄芪(Astragalus membranaceus)的干燥根。黄芪味甘性温,归肺、脾经。具有补气固表,利尿托毒,排脓,敛疮生肌之功效。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。
陈皮为芸香科(Rutaceae)柑橘属(Citrus)植物橘(Citrus reticulata)及其栽培变种的干燥成熟果皮。陈皮味苦、辛,温。归肺、脾经。具有理气健脾,燥湿化痰之功效。用于胸脘胀满,食少吐泻,咳嗽痰多。
一种含巴西人参的辅助抗肿瘤中药制剂的处方,来源于中医药专家对巴西人参等药材的药性分析和临床经验。
中医认为:癥瘕积聚,瘰疬,癌瘤之证,是因正气不足,脾肾衰败,脏腑阴阳气血功能失调,六淫、七情、饮食、起居等不良因素长期影响机体,痰湿、气血、瘀毒、郁热相搏积结,人体正不能胜邪,几种病理产物相杂而发病,属难治之病证。治宜解毒散结,活血化瘀,兼以扶正固本。方中用巴西人参为君药,巴西人参味甘性平,归脾、肺、心、肾经,既能解毒消肿止痛以冶标,又能补气健脾益肾以培本,同时通经利尿,引毒邪从下而去,可以消补兼施,标本同治,是为治癌佳品;同时,方中壁虎,味咸性寒,有小毒。入肾、肝二经。咸能软坚散结,性寒善清热解毒,并有活血散瘀,通络止痛,化湿消痰之功,是治疗有形肿块的特效药,与巴西人参合用,能起到相辅相成,相须为用的效果,同为君药。臣以白花蛇舌草,能清热解毒、活血化瘀、利水通淋,可加强君药之解毒散瘀,利湿消痰之功,亦为抗癌良药。方中黄芪补气益脾,协助君药扶正以袪邪,亦为臣药。陈皮行气散结,气行则血行,气顺则痰消,用为佐药。诸药合用,可使瘀散气行,湿去痰化,正气来复,则癥积癌瘤渐消。本方药味虽少,但药专力宏,具有攻补兼顾,祛邪不伤正,扶正不留邪之特点。
发明内容
一种含巴西人参的辅助抗肿瘤中药制剂,该制剂的处方组成为:巴西人参、壁虎、白花蛇舌草、黄芪、陈皮,药材的重量份数之比为:5~100∶5~100∶5~100∶5~100∶2.5~50。该制剂的处方药材采用以下方法提取制成制剂浸膏:
巴西人参、壁虎粉碎成粗粉,分别用40%~95%的乙醇回流提取3次,每次加醇为药材的5~15倍量,回流提取1~3小时,提取液过滤、合并滤液、回收乙醇、蒸发浓缩得巴西人参和壁虎乙醇提取混合浸膏;乙醇提取过的壁虎药材粗粉与白花蛇舌草、黄芪、陈皮药材饮片用水煎煮提取3次,每次加水为药材的5~15倍量,煮沸提取1~3小时,提取液过滤、蒸发浓缩到相对密度为1.10/80℃~1.30/80℃,得药材水提取浸膏。
将上述两种制剂浸膏与国家和行业标准及法规允许加入的辅料混合,通过适当方法可制成药品的任何剂型,这些剂型如:煎膏剂、片剂、糖衣片剂、薄膜衣片剂、肠溶衣片剂、含服片剂、泡腾片剂、硬胶囊剂、软胶囊剂、丸剂、滴丸剂、颗粒剂、茶剂、散剂、丹剂、混悬剂、溶液剂、注射剂、脂质体制剂、栓剂、硬膏剂、软膏剂、霜剂、喷雾剂、滴剂、贴剂等。本发明优先选择的剂型为口服制剂,如煎膏剂、片剂、胶囊剂、颗粒剂、合剂等。
本发明的中药制剂,能够增强化疗药物的治疗效果,减小化疗药物对机体特别是人体免疫系统的伤害。
附图说明 无。
具体实施实例
1.实施实例药材处方重量比
巴西人参10 壁虎10 白花蛇舌草10 黄芪10 陈皮5
2.实施实例制剂制备方法
2.1巴西人参、壁虎的提取:取处方量巴西人参和壁虎粗粉,分别用85%乙醇回流提取3次,首次加乙醇8倍量,回流2小时,二、三次都加乙醇6倍量,回流1小时,回流提取液过滤,合并,回收乙醇到无醇味、蒸发浓缩到相对密度为1.20~1.30/80℃既得。
2.2药材的水提取:取乙醇提取过的壁虎粗粉,加入处方量白花蛇舌草、黄芪、陈皮饮片,加水煮沸提取两次,首次加水10倍量,煮沸提取2小时,二次加水8倍量,煮沸提取1小时,提取液过滤,滤液蒸发浓缩到相对密度为1.20~1.30/80℃即得。
2.4颗粒剂的制备
将上述两部分浸膏充分混合均匀,得发参天龙浸膏,向浸膏加入适量蔗糖粉,制软材、制颗粒、干燥制得干燥颗粒30g,分装既得颗粒剂,该颗粒剂称为:‘发参天龙颗粒’。
3.发参天龙颗粒增强抗肿瘤作用的动物学实验
3.1抗S180实体瘤实验
3.1.1实验材料
3.1.1.1药物
1)三种不同浓度的发参天龙浸膏灌胃液(分别为高剂量组、中剂量组、低剂量组),由发明人实验室配制。
2)环磷酰胺注射液的配制:山西普德药业股份有限公司生产,批号:04121001,规格:200mg/瓶,用0.9%生理盐水制成浓度为1mg/ml的溶液。
3.1.1.2动物 清洁级KM小鼠,6周龄,体重18~22g,雌雄各半,由广西医科大学医学实验动物中心提供(证号:SCXK桂2009-0002)。
3.1.1.3S180荷瘤小鼠:提供单位:广东省医学实验动物中心,证号:SCXK(粤)2008-2
3.1.2实验方法
3.1.2.1药物配制方法
1)高剂量发参天龙浸膏灌胃液
由发参天龙浸膏配制而成,给药量相当于成人日给药量的20倍。
2)中剂量发参天龙浸膏灌胃液
由发参天龙浸膏配制而成,给药量相当于成人日给药量的10倍。
3)低剂量发参天龙浸膏灌胃液
由发参天龙浸膏配制而成,给药量相当于成人日给药量的1.67倍。
3.1.2.2造模方法
选取饲养7天的腹部明显膨隆的S180移植瘤小鼠,腹部皮肤消毒,用一次性无菌注射器抽取腹水,放入无菌烧杯,细胞计数,生理盐水稀释细胞浓度至8×107/mL,每只小鼠右侧腋下皮下接种生理盐水稀释的癌细胞混悬液0.2mL。
3.1.2.3分组方法
将接瘤小鼠随机分为模型组;阳性组;1/2阳性组;1/2阳性组加高剂量组;1/2阳性组加中剂量组;1/2阳性组加低剂量组;每组14只,雌雄各7只,分笼喂养给药,另取同批没有接受肿瘤细胞注射的小鼠14只(雌雄各半)作为空白对照组。
3.1.2.4给药方法
先称量小鼠重量,每日固定时间段,给药具体方法及计量如下:
空白组:每日灌胃组予0.7%CMC-Na,0.2mL/10g,注射生理盐水,连续13d;
模型组:每日灌胃给予07%CMC-Na,0.2mL/10g,注射生理盐水,连椟13d;
阳性组:每日注射环磷酰胺溶液,0.2mL/10g,每日灌胃给予0.7%CMC-Na,0.2mL/10g,连续13d;
1/2阳性组:每日注射环磷酰胺溶液,0.1mL/10g,每日灌胃给予0.7%CMC-Na,0.2mL/10g,连续13d;
1/2阳性组加高剂量组:每日注射环磷酰胺溶液,0.1mL/10g,高剂量浸膏溶液0.2ml/10g小鼠灌胃,连续13d;
1/2阳性组加中剂量组:每日注射环磷酰胺溶液,0.1mL/10g,中剂量浸膏溶液0.2ml/10g小鼠灌胃,连续13d;
1/2阳性组加低剂量组:每日注射环磷酰胺溶液,0.1mL/10g,低剂量浸膏溶液0.2ml/10g小鼠灌胃,连续13d;
给药后投放饲料,称量每日的总饲料量,第二天给药前再称量剩余饲料量,计算组总进食量和只均进食量。
3.1.2.4记录及取材方法
动物荷瘤第14天,小鼠摘眼球取血分离血清,后处死小鼠取胸腺、脾脏、剥离瘤体,胸腺、脾脏、瘤体称重。胸腺、脾脏、瘤体用10%甲醛溶液浸泡保留。
肿瘤抑制率(%)=[1-(平均试验组瘤重/平均对照组瘤重)]×100%。胸腺指数=胸腺平均重量(mg)/平均体重(10g);脾脏指数=脾脏平均重量(mg)/平均体重(10g)。各项实验数据处理结果均以表示,采用spss19.0统计软件进行单因素方差分析及组间两两比较。P<0.05为有统计学差异。
3.1.3 实验结果
发参天龙浸膏辅助抗S180实体瘤实验结果(n=14)
与模型组比较:★P<0.05,★★P<0.01
从以上结果看出:高剂量发参天龙浸膏与低剂量环磷酰胺联合用药,可以明显增强低剂量环磷酰胺的抗S180肿瘤作用;而且联合用药后与单独使用环磷酰胺相比较可以减轻环磷酰胺对小鼠免疫器官的影响。
3.2抗H22实体瘤实验
3.2.1实验材料
3.2.1.1药物
1)三种不同浓度的发参天龙浸膏灌胃液(分别为高剂量组、中剂量组、低剂量组),由发明人实验室配制。
2)环磷酰胺注射液的配制:山西普德药业股份有限公司生产,批号:04121001,规格:200mg/瓶,用0.9%生理盐水制成浓度为1mg/ml的溶液。
3.2.1.2动物 清洁级KM小鼠,6周龄,体重18~22g,雌雄各半,由广西医科大学医学实验动物中心提供(证号:SCXK桂2009-0002)。
3.2.1.3H22荷瘤小鼠:提供单位:广东省医学实验动物中心,证号:SCXK(粤)2008-2
3.2.2实验方法
3.2.2.1 药物配制方法
1)高剂量发参天龙浸膏灌胃液
由发参天龙浸膏配制而成,给药量相当于成人日给药量的20倍。
2)中剂量发参天龙浸膏灌胃液
由发参天龙浸膏配制而成,给药量相当于成人日给药量的10倍。
3)低剂量发参天龙浸膏灌胃液
由发参天龙浸膏配制而成,给药量相当于成人日给药量的1.67倍。
3.2.2.2造模方法
选取饲养7天的腹部明显膨隆的H22移植瘤小鼠,腹部皮肤消毒,用一次性无菌注射器抽取腹水,放入无菌烧杯,细胞计数,生量盐水稀释细胞浓度至8×107/mL,每只小鼠右侧腋下皮下接种生理盐水稀释的癌细胞混悬液0.2mL。
3.2.2.3分组方法
将接瘤小鼠随机分为模型组;阳性组;1/2阳性组;1/2阳性组加高剂量组;1/2阳性组加中剂量组;1/2阳性组加低剂量组;每组14只,雌雄各7只,分笼喂养给药。
3.2.2.4药药方法
先称量小鼠重量,每日固定时间段,给药具体方法及计量如下:
模型组:每日灌胃给予0.7%CMC-Na,0.2mL/10g,注射生理盐水,连续13d;
阳性组:每日注射环磷酰胺溶液,0.2mL/10g,每日灌胃给予0.7%CMC-Na,0.2mL/10g,连续13d;
1/2阳性组:每日注射环磷酰胺溶液,0.1mL/10g,每日灌胃给予0.7%CMC-Na,0.2mL/10g,连续13d;
1/2阳性组加高剂量组:每日注射环磷酰胺溶液,0.1mL/10g,高剂量浸膏溶液0.2ml/10g小鼠灌胃,连续13d;
1/2阳性组加中剂量组:每日注射环磷酰胺溶液,0.1mL/10g,中剂量浸膏溶液0.2ml/10g小鼠灌胃,连续13d;
1/2阳性组加低剂量组:每日注射环磷酰胺溶液,0.1mL/10g,低型量浸膏溶液0.2ml/10g小鼠灌胃,连续13d;
给药后投放饲料,称量每日的总饲料量,第二天给药前再称量剩余饲料量,计算组总进食量和只均进食量。
3.2.2.4记录及取材方法
动物荷瘤第14天,小鼠摘眼球取血分离血清,后处死小鼠取胸腺、脾脏、剥离瘤体,胸腺、脾脏、瘤体称重。胸腺、脾脏、瘤体用10%甲醛溶液浸泡保留。
肿瘤抑制率(%)=[1-(平均试验组瘤重/平均对照组瘤重)]×100%。胸腺指数=胸腺平均重量(mg)/平均体重(10g);脾脏指数=脾脏平均重量(mg)/平均体重(10g)。各项实验数据数据处理结果均以表示,采用spss19.0统计软件进行单因素方差分析及组间两两比较。P<0.05为有统计学差异。
3.2.3实验结果
表2发参天龙浸膏辅助抗H22实体瘤实验结果(n=14)
与模型组比较:★P<0.05,★★P<0.01;与阳性组比较:☆P<0.05,☆☆P<0.01;与1/2阳性组比较:★★P<0.01
从以上结果看出:发参天龙浸膏与低剂量环磷酰胺联合用药可以增强环磷酰胺的抗H22肿瘤作用,这种增强作用呈现剂量依赖性;且联合用药与单独使用环磷酰胺相比较,可以使环磷酰胺对小鼠免疫器官的影响减小。
Claims (4)
1.一种含巴西人参的辅助环磷酰胺抗肿瘤的中药制剂,其特点是在中医药理论指导下,采用现代制剂技术,将巴西人参及其它中草药材制成中药复方制剂,该复方制剂的原料组成为:巴西人参、壁虎、白花蛇舌草、黄芪、陈皮,药材的重量份数之比为:5~100:5~100:5~100:5~100:2.5~50。
2.如权利要求1所述的含巴西人参的辅助环磷酰胺抗肿瘤的中药制剂,其特征在于,所述中药制剂的制备方法如下:
2.1巴西人参、壁虎粗粉分别用40%~95%的乙醇回流提取3次,每次加醇为药材的5~15倍量,回流提取1~3小时,提取液过滤、合并、回收乙醇、蒸发浓缩得巴西人参和壁虎乙醇提取混合浸膏;
2.2乙醇提取过的壁虎粗粉与白花蛇舌草、黄芪、陈皮药材饮片用水煎煮提取3次,每次加水为药材的5~15倍量,煮沸提取1~3小时,提取液过滤、蒸发浓缩到相对密度为:1.10/80℃~1.30/80℃,得药材水提取浸膏;
2.3 2.1、2.2制备的浸膏加入国家和行业标准及法规允许加入的辅料,通过适当方法制成药品的任何剂型,这些剂型包括煎膏剂、片剂、硬胶囊剂、软胶囊剂、丸剂、滴丸剂、颗粒剂、茶剂、散剂、丹剂、混悬剂、溶液剂、注射剂、脂质体制剂;所述片剂包括:糖衣片剂、薄膜衣片剂、肠溶衣片剂、含服片剂、泡腾片剂。
3.如权利要求2所述的含巴西人参的辅助环磷酰胺抗肿瘤的中药制剂,其特征在于,通过适当方法制成药品的剂型为煎膏剂、片剂、胶囊剂、颗粒剂、合剂。
4.如权利要求1所述的中药制剂在制备辅助环磷酰胺抗肿瘤药物中的应用。
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Application publication date: 20141224 Assignee: GUANGXI HENGDERUN BIOLOGICAL SCIENCE & TECHNOLOGY Co.,Ltd. Assignor: GUANGXI BOTANICAL GARDEN OF MEDICINAL PLANTS Contract record no.: X2023980045685 Denomination of invention: An auxiliary anti-tumor traditional Chinese medicine preparation containing Brazilian ginseng Granted publication date: 20171121 License type: Common License Record date: 20231106 |