CN105535138A - 一种用于治疗肝纤维化的中药制剂及其制备方法 - Google Patents
一种用于治疗肝纤维化的中药制剂及其制备方法 Download PDFInfo
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Abstract
本发明属于医药技术领域,具体涉及一种用于治疗肝纤维化的中药制剂及其制备方法。该中药制剂是由擦剂和内服剂组成,所述擦剂通过以下原料制备而成:红花,厚朴皮,牡丹皮,牛膝,蜈蚣,五加皮,冰片,水杨酸,三乙醇胺;所述内服剂通过以下原料制备而成:积雪草、杜仲翅果、白首乌,矢车菊,桃仁,苦胆草,马鞭草,皂角种子。本发明科学合理的配伍各原料药,安全高效,攻补兼施,各药材在作用上相辅相成,协同作用,增强机体免疫功能,从而使肝纤维化有效逆转,达到治疗肝纤维化病变的作用。
Description
技术领域
本发明属于医药技术领域,具体涉及一种用于治疗肝纤维化的中药制剂及其制备方法。
背景技术
肝纤维化(Fibrosis)是指肝脏纤维结缔组织的过度沉积,是纤维增生和纤维分解不平衡的结果,肝纤维化是慢性肝损伤的代偿性修复反应,是慢性肝病进一步向肝硬化发展的主要中间环节,各种病因所引起的慢性肝病绝大多数都有肝纤维化,而肝纤维化是一个可逆转的病变。中医理论认为,肝纤维化多是由湿热疫毒之邪外侵,病邪残留难尽、迁延反复,加之正气不足,情志不遂,肝气郁结等导致功能失调,气血运行不畅,肝络瘀阻,是一个由实转虚、由聚至积、由气入血及络的动态病变过程,该病属于本虚标实之证,与脾肾密切相关。西药副作用大,加重肝负担;中医药在抗肝纤维化治疗方面具有突出的优势和广阔的应用前景。
发明内容
针对现有技术存在的问题,本发明提供了一种用于治疗肝纤维化的中药制剂及其制备方法。
本发明所采用的技术方案为:
本发明提供了一种用于治疗肝纤维化的中药制剂,是由擦剂和内服剂组成;
所述擦剂通过以下重量份原料制备而成:红花20-25g,厚朴皮25-30g,牡丹皮18-24g,牛膝15-18g,蜈蚣8-10g,五加皮20-25g,冰片60-80g,水杨酸2-3g,三乙醇胺0.2-0.4g;
所述内服剂通过以下重量份原料制备而成:积雪草30-35g、杜仲翅果12-15g、白首乌15-20g,矢车菊30-35g,桃仁20-25g,苦胆草15-20g,马鞭草15-20g,皂角种子20-30g。
本发明所提供的擦剂采用以下方法制备而成:
(1)将牛膝、蜈蚣研磨至60目,加入橄榄油,在温度35-38℃下浸泡6d,过滤后得浸出液备用;
(2)将红花、厚朴皮、牡丹皮、五加皮研磨至80目,然后加入甘油-乙醇-水的混合液,加入三乙醇胺,在45-55℃下保温搅拌50min,过滤后得滤液备用;
(3)合并浸出液及滤液,搅拌均匀,加入水杨酸和冰片,再次搅拌30min即可。
进一步的,步骤(1)中,所述橄榄油的加入量为牛膝及蜈蚣总重的20倍。
进一步的,步骤(2)中,所述甘油-乙醇-水的混合液为红花、厚朴皮、牡丹皮、五加皮总重的10倍。
上述混合液中甘油、乙醇、水的体积比为5:3:1。
本发明提供的内服剂采用以下方法制备而成:
(1)将皂角种子、马鞭草、积雪草、苦胆草混合后加入8倍量的黄酒和水的混合液,浸泡30min后,小火熬开后继续煎熬30min,过滤,滤渣中二次加入7倍量的米醋和水的混合液后,小火熬开后继续煎熬30min,过滤,合并两次滤液,加热至60-65℃,保温20min,冷却后得备用滤液;
(2)将杜仲翅果、白首乌,矢车菊,桃仁研磨后过100目筛,得混合细粉备用;
(3)将备用滤液加入混合细粉中,制备成丸剂即可。
进一步的,内服剂制备过程中所述黄酒和水的体积比为1:7。
上述黄酒的含醇量为12%。
进一步的,所述米醋和水的体积比为2:5。
上述米醋的醋酸含量为5%。
本发明提供的中药制剂的用法用量:每日擦剂和内服剂配合使用。内服剂:制备的水丸每10丸重1g,一日3次,每次1g;擦剂则取适量擦于中脘穴,按揉至发热后即可,一日3次。
以上药材配方是按照临床试验数据,经科学方法筛选而得到的,对不同情况病人,如症状较轻者、症状非常严重者或者不同年龄段的病人,为达到相同效果,在保证各原料配比不变的条件下,可相应增减药量,但药量变动幅度不宜过大,不应超过药量15%。
本发明将药物通过不同的给药方式,补元气,扶正气,健脾燥湿、化瘀通络,行气活血,通过外擦及内服两种方式,对人体的肝负担小,疗效好。
本发明的有益效果为:
(1)本发明提供的擦剂在制备过程中,能够最大程度的促进有效成分的溶出,同时,加入适量水杨酸,能够同三乙醇胺等协同作用,增加擦剂的粘稠度及保湿性能,促进药物的渗入,增强药效;
(2)本发明科学合理的配伍各原料药,安全高效,攻补兼施,各药材在作用上相辅相成,协同作用,增强机体免疫功能,从而使肝纤维化有效逆转,达到治疗肝纤维化病变的作用。
具体实施方式
为了更好地理解本发明的实质,下面通过具体实施例和临床试验数据对本发明的技术方案进行进一步的阐述。
实施例1
一种用于治疗肝纤维化的中药制剂,是由擦剂和内服剂组成;
所述擦剂通过以下重量份原料制备而成:红花20g,厚朴皮28g,牡丹皮22g,牛膝18g,蜈蚣9g,五加皮25g,冰片70g,水杨酸2g,三乙醇胺0.3g;
擦剂的制备方法如下:
(1)将牛膝、蜈蚣研磨至60目,加入占牛膝和蜈蚣总重20倍的橄榄油,在温度35-38℃下浸泡6d,过滤后得浸出液备用;
(2)将红花、厚朴皮、牡丹皮、五加皮研磨至80目,然后加入占四者总重10倍的甘油-乙醇-水的混合液(甘油、乙醇、水的体积比为5:3:1),加入三乙醇胺,在45-55℃下保温搅拌50min,过滤后得滤液备用;
(3)合并浸出液及滤液,搅拌均匀,加入水杨酸及冰片,再次搅拌30min即可。
所述内服剂通过以下重量份原料制备而成:积雪草33g、杜仲翅果15g、白首乌18g,矢车菊30g,桃仁25g,苦胆草18g,马鞭草15g,皂角种子26g。
内服剂的制备方法如下:
(1)将皂角种子、马鞭草、积雪草、苦胆草混合后加入占四种原料总重8倍量的黄酒和水的混合液(黄酒和水的体积比为1:7),浸泡30min后,小火熬开后继续煎熬30min,过滤,滤渣中二次加入占四种原料总重7倍量的米醋和水的混合液(米醋和水的体积比为2:5)后,小火熬开后继续煎熬30min,过滤,合并两次滤液,加热至60-65℃,保温20min,冷却后得备用滤液;
所使用的黄酒的含醇量为12%,米醋的含醋酸量为5%;
(2)将杜仲翅果、白首乌,矢车菊,桃仁研磨后过100目筛,得混合细粉备用;
(3)将备用滤液加入混合细粉中,制备成丸剂即可,每10丸重1g。
实施例2
一种用于治疗肝纤维化的中药制剂,是由擦剂和内服剂组成;
所述擦剂通过以下重量份原料制备而成:红花22g,厚朴皮25g,牡丹皮24g,牛膝15g,蜈蚣10g,五加皮23g,冰片60g,水杨酸3g,三乙醇胺0.2g;
所述内服剂通过以下重量份原料制备而成:积雪草30g、杜仲翅果12g、白首乌20g,矢车菊33g,桃仁23g,苦胆草15g,马鞭草18g,皂角种子20g;
擦剂和内服剂的制备方法均同实施例1。
实施例3
一种用于治疗肝纤维化的中药制剂,是由擦剂和内服剂组成;
所述擦剂通过以下重量份原料制备而成:红花25g,厚朴皮30g,牡丹皮18g,牛膝16g,蜈蚣8g,五加皮20g,冰片80g,水杨酸3g,三乙醇胺0.4g;
所述内服剂通过以下重量份原料制备而成:积雪草35g、杜仲翅果14g、白首乌15g,矢车菊35g,桃仁20g,苦胆草20g,马鞭草20g,皂角种子30g;
擦剂和内服剂的制备方法均同实施例1。
1.临床实验数据
病例:明确诊断为肝纤维化的患者100名。
中医证候:
痊愈:症状全部消失,检测指标HA、PCⅢ、Ⅳ-C正常
显著:全部症状消除或主要症状消除,体征有明显改善,功能基本恢复,功能恢复;
有效:主要症状基本消失;
无效:和治疗前比较,各方面均无进步。
本发明对100例患者进行临床跟踪治疗,其中男性65例,女性35例,年龄为30-50岁患者。
治疗方法:根据患者病情,在保证各原料配比不变的条件下,可相应增减药量,但药量变动幅度不宜过大,不应超过药量15%。每日内服剂同擦剂配合使用。内服剂,每日三次,每次1g,病龄较长者可增加至3g,25天为一个疗程。擦剂:使用时,取适量涂抹于中脘穴即可,每日三次,涂抹按揉至发热即可,或用热毛巾热敷一段时间,待毛巾凉后取走即可,25天为一个疗程,服药期间,患者需控制情绪,戒烟酒,合理安排饮食,停用其他药物。
治疗效果:经临床观察,坚持使用本发明提供的中药制剂,治愈率达82%,显著率为8%,有效率为2%,总有效率为92%,无效率为8%。
2.动物实验
小鼠模型:DMN诱导的肝纤维化模型;将小鼠用1%DMNA按1ml/kg生理盐水稀释液腹腔注射,每周前3天给药,每天1次,持续3周,在第四周仅在周一给药1次,4周后小鼠肝纤维化形成。
给药方法:设置正常小鼠作为空白对照组,将小鼠模型分为4组,每组20只,其中一组作为模型对照组,另外三组分别使用本发明实施例1-3制备的内服剂,按照50mg/kg.d体重进行灌胃,模型对照组仅喂食等体积的水即可,给药20d后,断颈处死,取肝脏进行检测,检测血清中HA、PCⅢ、LN含量及肝组织中Hyp含量,具体检测结果见表1。
表1
从表1中可以看出,使用本发明制备的药物制剂,对小鼠肝纤维化的各项指标具有明显的降低作用,说明本发明的疗效好。
3.典型病例
病例1:刘某,女,42岁,经检测为肝纤维化,临床表现为疲乏无力、食欲减退,肝区隐痛,使用本发明提供的中药制剂后,内服剂同擦剂联合使用,25天为1个疗程,1个疗程后,患者医院检测,发现各项指标明显好转,继续使用1个疗程后,各项指标恢复正常,治愈,1年后随访,无复发。
病例2:薛某,男,50岁,经检测为肝纤维化,临床表现为腹胀气,伴有恶心、呕吐,便秘,使用本发明提供的中药制剂后,内服剂同擦剂联合使用,25天为1个疗程,2个疗程后,患者医院检测,发现各项指标明显好转,继续使用1个疗程后,各项指标恢复正常,治愈,1年后随访,无复发。
Claims (10)
1.一种用于治疗肝纤维化的中药制剂,其特征在于,是由擦剂和内服剂组成;
所述擦剂通过以下重量份原料制备而成:红花20-25g,厚朴皮25-30g,牡丹皮18-24g,牛膝15-18g,蜈蚣8-10g,五加皮20-25g,冰片60-80g,水杨酸2-3g,三乙醇胺0.2-0.4g;
所述内服剂通过以下重量份原料制备而成:积雪草30-35g、杜仲翅果12-15g、白首乌15-20g,矢车菊30-35g,桃仁20-25g,苦胆草15-20g,马鞭草15-20g,皂角种子20-30g。
2.根据权利要求1所述的中药制剂,其特征在于,所述擦剂采用以下方法制备而成:
(1)将牛膝、蜈蚣研磨至60目,加入橄榄油,在温度35-38℃下浸泡6d,过滤后得浸出液备用;
(2)将红花、厚朴皮、牡丹皮、五加皮研磨至80目,然后加入甘油-乙醇-水的混合液,加入三乙醇胺,在45-55℃下保温搅拌50min,过滤后得滤液备用;
(3)合并浸出液及滤液,搅拌均匀,加入水杨酸、冰片,再次搅拌30min即可。
3.根据权利要求2所述的中药制剂,其特征在于,所述橄榄油的加入量为牛膝及蜈蚣总重的20倍。
4.根据权利要求2所述的中药制剂,其特征在于,所述甘油-乙醇-水的混合液为红花、厚朴皮、牡丹皮、五加皮总重的10倍。
5.根据权利要求4所述的中药制剂,其特征在于,所述混合液中甘油、乙醇、水的体积比为5:3:1。
6.根据权利要求1所述的中药制剂,其特征在于,所述内服剂采用以下方法制备而成:
(1)将皂角种子、马鞭草、积雪草、苦胆草混合后加入8倍量的黄酒和水的混合液,浸泡30min后,小火熬开后继续煎熬30min,过滤,滤渣中二次加入7倍量的米醋和水的混合液后,小火熬开后继续煎熬30min,过滤,合并两次滤液,加热至60-65℃,保温20min,冷却后得备用滤液;
(2)将杜仲翅果、白首乌,矢车菊,桃仁研磨后过100目筛,得混合细粉备用;
(3)将备用滤液加入混合细粉中,制备成丸剂即可。
7.根据权利要求6所述的中药制剂,其特征在于,步骤(1)中,所述黄酒和水的体积比为1:7。
8.根据权利要求7所述的中药制剂,其特征在于,所述黄酒的含醇量为12%。
9.根据权利要求6所述的中药制剂,其特征在于,步骤(1)中,所述米醋和水的体积比为2:5。
10.根据权利要求9所述的中药制剂,其特征在于,所述米醋的醋酸含量为5%。
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