CN104491574B - 一种用于调治慢性乙型肝炎的中药制剂 - Google Patents
一种用于调治慢性乙型肝炎的中药制剂 Download PDFInfo
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Abstract
本发明提供了一种用于调治慢性乙型肝炎的中药制剂,属于中药及保健领域。本发明以桃仁、佛手、枳壳、鸡内金、薏米、鱼腥草、蒲公英、金银花、马齿苋、栀子、乌梅、甘草、大枣为原料进行配伍,使各药物的功效产生协同,共奏活血化瘀、健脾除湿、扶正养肝、清热解毒之功能,以实现对慢性乙型肝炎的调理和治疗作用。临床检测数据表明,本发明药物本发明的中药制剂在改善症状和体征、改善肝功能、乙肝病毒e抗原(HBeAg)转阴率、HBeAg/抗HBe血清转换率、乙肝病毒脱氧核糖核酸(HBV‑DNA)转阴率方面有明确优势。
Description
技术领域
本发明涉及一种用于调治慢性乙型肝炎的中药制剂,属于中药保健领域。
技术背景
乙型病毒性肝炎是由乙型肝炎病毒引起的一种世界性疾病,发展中国家发病率高,据统计全世界无症状携带者(HBsAg携带者)超过2.8亿,我国占1亿以上。多数无症状,其中1/3出现肝损害的临床表现。特点为起病较缓,以亚临床型及慢性型较常见,无黄疸型HBsAg持续阳性者易慢性化。本病主要通过血液及日常生活密切接触传播,另一方式为母婴传播。乙肝疫苗的应用是控制和预防乙型肝炎的根本措施。
乙型病毒性肝炎的六大症状:1、乙肝的全身症状主要表现为体力不支、疲劳、没精神,主要与肝功能受损,进食减少,食物消化吸收障碍,营养物质摄入减少造成的,另一方面,因为乙肝造成的肝脏炎症导致消耗增加而营养物质摄入不足导致肝脏代谢功能受损,加上乙肝患者精神和心理上的压力,影响乙肝患者的睡眠和休息,导致乙肝患者看起来很没有精神。2、乙肝患者的消化道症状主要表现为食欲不振、厌油、恶心、腹胀、上腹部不适等症状,主要是因为肝炎时使得胆汁的分泌减少,使得食物的消化和吸收受到影响,另外,胃肠道的充血水肿也会影响食物的吸收和消化。3、乙肝的黄疸症状主要是因为肝病病情较重时,血液中的胆红素浓度增加,胆红素从尿液中排除使得尿液颜色加深,这是黄疸最早期的表现。4、乙肝的疼痛症状主要表现为肝区疼痛,乙肝患者一般没有疼痛症状,但是当肝包膜紧张,肝包膜上的痛觉神经受刺激,就会出现右上腹,右季肋不适或隐痛。5、乙肝患者会出现肝脾肿大的症状。肝炎早期,脾脏没有明显的肿大,后期会因为门静脉高压等原因使得脾脏淤血引起脾脏肿大。6、乙肝的肝外表现,主要表现为肝硬化患者面色晦暗,出现肝病面容,还会出现蜘蛛痣或肝掌以及内分泌失调等症状。
临床诊断乙肝的主要是检测乙肝五项和肝功能指标。乙肝五项包括:乙肝表面抗原HBsAg、乙肝表面抗体HBsAb、乙肝e抗原HBeAg、乙肝e抗原体HBeAb、乙肝e抗核心体HBcAb。HBsAg、HBeAg、HBcAb呈阳性称为大三阳,HBsAg、HBeAb、HBcAb呈阳性称为小三阳。大三阳的含意是有肯定的乙肝病毒感染,病毒正在活跃复制,病毒数量较多,传染性相对较强。小三阳通常是由“大三阳”转变而来,是人体针对e抗原产生了一定程度的免疫力。一般认为小三阳的传染性较小。肝功能的指标主要是指谷丙转氨酶(ALT)、谷草转氨酶AST,总胆红素TBIL,直接胆红素DBIL、间接胆红素IBIL五项。该五肝功能指标显著增高,则断定为乙型病毒性肝炎。
目前治疗慢性乙型肝炎的药物主要a-干扰素、拉米夫定、泛昔洛韦、胸腺肽a1及其它一些抗病毒药物。这些药物价格高昂,而且有一定的副作用,在治疗的同时对机体也会造成一定伤害。
发明内容
本发明的目的是提供一种用于调治慢性乙型肝炎的中药制剂。
本发明以桃仁、佛手、枳壳、鸡内金、薏米、鱼腥草、蒲公英、金银花、马齿苋、栀子、乌梅、甘草、大枣为原料进行配伍,使各药物的功效产生协同,共奏活血化瘀、健脾除湿、扶正养肝、清热解毒之功能,以实现对慢性乙型肝炎的调理和治疗作用。
根据长期的研究,我们以为慢性乙型肝炎属于典型的慢性疾患,久病必瘀血,瘀血不祛则疾病难愈。桃仁,苦、甘,平;归心、肝、大肠经;功能:活血祛瘀,润肠通便。因此本发明以桃仁为君药,活血化瘀作为主导,为治疗乙肝明确了独特方向。
佛手,辛、苦、酸,温;归肝、脾、肺经;功能:舒肝理气,和胃止痛。枳壳,苦、辛、酸,温;归脾、胃经;功能:理气宽中,行滞消胀。鸡内金,甘,平;归脾、胃、小肠、膀胱经;功能:健胃消食,涩精止遗。薏米,甘淡、微寒;入脾、胃、肺、大肠经;功效:清热利湿,除风湿,利小便,益肺排脓,健脾胃,强筋骨。本发明以佛手、枳壳、鸡内金、薏米共为佐药,健脾、化湿、祛湿。祖国医学认为湿邪最能恋邪,湿邪不除则病毒难灭;另外佐药重在调理中焦脾胃,只因为脾胃为后天之本,脾胃不健则机体失去康复之源。
鱼腥草,味辛,性寒;入肝、肺二经;功效:清热解毒,利尿消肿。蒲公英,苦、甘,寒;归肝、胃经;功能:清热解毒,消肿散结,利尿通淋。金银花,甘,寒;归肺、心、胃经;功能:清热解毒,凉散风热。马齿苋,酸,寒;入肝、脾二经;功能:清热利湿,凉血解毒。栀子, 苦,寒;归心、肺、三焦经;功能:泻火除烦,清热利尿,凉血解毒。本发明以鱼腥草、蒲公英、金银花、马齿苋、栀子为同为佐药,直入主题,在君臣药有力的主导下清热解毒,一举杀灭病毒。
乌梅,酸、涩,平;归肝、脾、肺、大肠经;功能:敛肺,涩肠,生津,安蛔。甘草,甘,平;归心、肺、脾、胃经;功能:补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。大枣,甘,温;归脾、胃经;功能:补中益气,养血安神。本发明以乌梅、甘草、大枣为使药,扶持正气、保护肝脏,让全方的目标作用更有力量,同时还能起到调和诸药作用。
本发明全方共奏活血化瘀、健脾除湿、扶正养肝、清热解毒之功能,以实现对慢性乙型肝炎的调理和治疗作用。
本发明的中药制剂中,各原料的重量配比为:桃仁18-26份,佛手8-15份,枳壳8-15份,鸡内金8-15份,薏米8-15份,鱼腥草4-8份, 蒲公英4-8份,金银花4-8份,马齿苋4-8份,栀子4-8份,乌梅1-4份,甘草1-4份,大枣1-4份。
优选配比为:桃仁20-23份,佛手9-12份,枳壳9-12份,鸡内金9-12份,薏米9-12份,鱼腥草6-7份, 蒲公英6-7份,金银花6-7份,马齿苋6-7份,栀子6-7份,乌梅2-3份,甘草2-3份,大枣2-3份。
最佳配比为:桃仁21份,佛手10份,枳壳10份,鸡内金10份,薏米10份,鱼腥草6份,蒲公英6份,金银花6份,马齿苋6份,栀子6份,乌梅3份,甘草3份,大枣3份。
本发明的中药制剂可以按中药药剂学的常规工艺和辅料制备成各种内服制剂。如胶囊剂、片剂、颗粒剂、散剂、丸剂(包括水丸、蜜丸、糖衣丸、胶丸、肠溶丸或滴丸)或口服液。
下面是本发明中药制剂调治慢性乙型肝炎的临床试验资料。
1、临床观察对象:选择临床确诊(诊断符合2000年9月西安会议制定的“病毒肝炎的防治方案”标准;HBeAg(+)、血清HBV DNA>5.0E+02 IU/mL。)的慢性乙型肝炎患者50例,男29例、女21例,年龄在18~45岁之间,病程在2-17年之间。
2、临床指标:三系统五项检测呈“大三阳”;HBV-DNA阳性;肝功异常;无任何不适症状或乏力、纳差、腹胀、肝区疼痛;无任何体征或肝肿大、脾肿大。
3、治疗方法:服用本发明颗粒剂药物。规格:6g/袋,30袋/盒。用法:早晚各两袋,温开水直接冲服,或熔化口服。疗程:6月1周期,一般观察1-2周期。
4、疗效判定指标:HBeAg阴转,HBeAg/抗HBe血清转换,HBV-DNA阴转,肝功能恢复正常,症状和体征恢复正常。
5、治疗结果:治疗结果见表1。
上述临床检测数据表明,本发明的中药制剂在改善症状和体征、改善肝功能、乙肝病毒e抗原(HBeAg)转阴率、HBeAg/抗HBe血清转换率、乙肝病毒脱氧核糖核酸(HBV-DNA)转阴率方面有明确优势。另外,本发明中药制剂全方均采用药食同源的原料,无毒无副作用,避免了现有技术治疗与伤害同在的现状,为广大的慢性乙型肝炎患者提供了一种安全无伤害的治疗药物。
具体实施方式
下面通过具体实施例对本发明药物的原料配比、制备及用法作进一步说明。
实施例1、颗粒剂药物的制备
原料配方:桃仁21份,佛手10份,枳壳10份,鸡内金10份,薏米10份,鱼腥草6份, 蒲公英6份,金银花6份,马齿苋6份,栀子6份,乌梅3份,甘草3份,大枣3份;
制备工艺:按药剂学制备颗粒剂的常规工艺和辅料制备而成.规格:6g/袋;
用法用量:早晚各12g,温开水冲服或熔化口服;6个月1个周期,一般观察1-2周期。
实施例2、胶囊剂药物的制备
原料配方:桃仁23份,佛手12份,枳壳12份,鸡内金12份,薏米12份,鱼腥草7份,蒲公英7份,金银花7份,马齿苋7份,栀子7份,乌梅3份,甘草3份,大枣3份;
制备工艺:按药剂学制备胶囊剂的常规工艺和辅料制备而成。规格:每粒0.3g;
用法用量:早晚各1.5g,温开水直接冲服;6个月1个周期,一般观察1-2周期。
实施例3、片剂药物的制备
原料配方:桃仁20份,佛手9份,枳壳9份,鸡内金9份,薏米9份,鱼腥草6份,蒲公英6份,金银花6份,马齿苋6份,栀子6份,乌梅2份,甘草2份,大枣2份;
制备工艺:按药剂学制备片剂的常规工艺和辅料制备而成。规格:每片1.0g;
用法用量:早晚各5.0g,温开水直接冲服;6个月1个周期,一般观察1-2周期。
实施例4、丸剂药物的制备
原料配方:桃仁18份,佛手8份,枳壳8份,鸡内金8份,薏米8份,鱼腥草4份,蒲公英4份,金银花4份,马齿苋4份,栀子4份,乌梅1份,甘草1份,大枣1份;
制备工艺:按药剂学制备丸剂的常规工艺和辅料制备而成。规格:每粒0.05g;
用法用量:早晚各5.0g,温开水直接冲服;6个月1个周期,一般观察1-2周期。
实施例5、口服液的制备
原料配方:桃仁26份,佛手15份,枳壳15份,鸡内金15份,薏米15份,鱼腥草8份,蒲公英8份,金银花8份,马齿苋8份,栀子8份,乌梅4份,甘草4份,大枣4份;
制备工艺:按药剂学制备口服液的常规工艺和辅料制备而成。规格:每瓶10ml;
用法用量:早晚各30ml,温开水直接冲服;6个月1个周期,一般观察1-2周期。
上述各实施例中,各原料配比均以重量份计。
Claims (4)
1.一种用于调治慢性乙型肝炎的中药制剂,是以桃仁、佛手、枳壳、鸡内金、薏米、鱼腥草、蒲公英、金银花、马齿苋、栀子、乌梅、甘草、大枣为原料,按中药药剂学的常规工艺和辅料制备成各种内服制剂;所述各原料按以下重量份进行配比:桃仁18-26份,佛手8-15份,枳壳8-15份,鸡内金8-15份,薏米8-15份,鱼腥草4-8份,蒲公英4-8份,金银花4-8份,马齿苋4-8份,栀子4-8份,乌梅1-4份,甘草1-4份,大枣1-4份。
2.如权利要求1所述用于调治慢性乙型肝炎的中药制剂,其特征在于:所述各原料按以下重量份进行配比:桃仁20-23份,佛手9-12份,枳壳9-12份,鸡内金9-12份,薏米9-12份,鱼腥草6-7份,蒲公英6-7份,金银花6-7份,马齿苋6-7份,栀子6-7份,乌梅2-3份,甘草2-3份,大枣2-3份。
3.如权利要求1所述用于调治慢性乙型肝炎的中药制剂,其特征在于:所述各原料按以下重量份进行配比:桃仁21份,佛手10份,枳壳10份,鸡内金10份,薏米10份,鱼腥草6份,蒲公英6份,金银花6份,马齿苋6份,栀子6份,乌梅3份,甘草3份,大枣3份。
4.如权利要求1所述用于调治慢性乙型肝炎的中药制剂,其特征在于:所述内服制剂为胶囊剂、片剂、颗粒剂、茶剂、丸剂或口服液。
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