CN104435417A - 一种治疗乙肝的蒙药组合物 - Google Patents
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Abstract
本发明公开了一种治疗乙肝的蒙药组合物,其由炉甘石,刺梅,藏红花,石膏,牛黄,菊花,香青兰,瞿麦,五灵脂,木通,赤芍,黄连,栀子,朱砂,地丁,黄柏皮按照特定比例制成,本蒙药组合物具有疗效显著,无副作用等优点。
Description
技术领域
本发明涉及药物组合物领域,特别地,涉及治疗乙肝的蒙药组合物。
背景技术
乙型病毒性肝炎,简称乙肝,分为急性和慢性两种,是当今世界流行最广泛、危害最严重的一种传染病。急性乙肝治疗不当或转变成慢性乙肝,慢性乙肝可发展为肝硬化、肝癌。据有关资料显示,全世界约有3亿乙型肝炎病毒感染者,我国为高发病区,约有1亿乙型肝炎病毒感染者,且每年新增患者3000万以上。
目前西医治疗乙肝疾病尚无特效方法,急性乙肝以充分休息、合理饮食、适当增加营养、对症治疗为主,用药以退黄、降酶、保肝、提高机体免疫力为原则,这种姑息疗法造成了急性乙肝慢性化率较高;慢性乙肝的治疗以抗病毒为主,辅以免疫调节剂。常用的抗病毒药物如干扰素、阿糖腺苷等抑制病毒的效果并不理想、病毒清除率低、副作用也比较大,免疫调节剂如胸腺肽等价格昂贵,效果也不能令人满意。利用西医治疗乙肝达到完全清除乙肝病毒、使病毒标记(两对半)转阴有很大的难度,完全清除率大约只有10%左右。
现有技术中公开了很多治疗乙肝的中药(蒙药),中药(蒙药)制剂越来越受到患者的青睐,但却存在疗效不确切,治疗作用小,治疗效果不佳的缺点,给患者带来身体和精神上的双重伤害。
发明内容
本发明结合中医治疗相关理论,同时兼顾了中(蒙)医药原料毒附作用小微等特点,充分考虑治疗机理与药物原料疗效的辩证统一,提供了一种治疗乙肝的蒙药组合物。
具体地,该蒙药组合物为由以下重量配比的药物成分制成:
炉甘石10-12份,刺梅9-11份,藏红花7-9份,石膏9-11份,牛黄5-6.5份,菊花10-12份,香青兰10-12份,瞿麦10-12份,五灵脂12-14份,木通12-14份,赤芍10-12份,黄连5-6份,栀子7-9份,朱砂3-3.5份,地丁9-11份,黄柏皮7-9份。
优选地,炉甘石11份,刺梅10份,藏红花8份,石膏10份,牛黄6份,菊花11份,香青兰11份,瞿麦11份,五灵脂13份,木通13份,赤芍11份,黄连5.5份,栀子8份,朱砂3.2份,地丁10份,黄柏皮8份。
本发明所述的蒙药组合物可以制备成所述领域常规的剂型,例如,丸剂、散剂、汤粉剂等,优选地为丸剂。
炉甘石,性甘,平。归胃经。
刺梅,能理气活血、调经健脾。
藏红花,性甘,平。入心、肝经。
石膏,性辛甘,寒。入肺、胃经。
牛黄,性苦,凉。归心、肝经。
菊花,性甘,微苦,性温,益肺肾,退虚热。
香青兰,清胃肝热,
瞿麦,性辛,平,归肝、心经。
五灵脂,性苦甘,温。入肝、脾经。
木通,性苦,凉。入心、小肠、膀胱经。
赤芍,性酸苦,凉。入肝、脾经。
黄连,性苦,寒。入心、肝、胃、大肠经。
栀子,性苦,寒。入心、肝、肺、胃经。
朱砂,性甘,凉。入心经。
地丁,性苦,寒.。入心、肝经。
黄柏皮,性苦,寒。归肾、膀胱经。
本发明的设计思路是不单单使用利肝养肝的药物,而要充分利用蒙药治疗的辩证、全面调理的机理,全面调理肝、脾、胃、肾、心等器官,从而最终实现对乙肝的治疗。脾胃为后天之本,气血生化之源。有胃气则生,无胃气则死。“见肝之病,知肝传脾,当先实脾”,故肝病治疗应将顾护脾胃放在首位。同时,治疗肝病还在于滋养肝肾之阴,肝藏血肾藏精,精血同源,肝血赖肾精供养,肾精依肝血补充,同源于水谷精微,有乙癸同源之说。如湿郁内盛,郁而化热,病久毒热耗损肝肾精血,致肝肾阴虚,阴虚而生内热,以致阴虚为本,热邪为标,则发为本虚标实证。基于上述设计思路,发明人通过合理确定原料药及其配比,创造性地获得了所述技术方案。
本发明的药物的服用方法为每日早晚饭后半小时服用,每次用药量基于生药量为3-5g,治疗周期为3-5个月。
具体实施方式
实施例1
按照以下重量比准备原料药:
炉甘石10份,刺梅9份,藏红花7份,石膏9份,牛黄5份,菊花10份,香青兰10份,瞿麦10份,五灵脂12份,木通12份,赤芍10份,黄连5份,栀子7份,朱砂3份,地丁9份,黄柏皮7份。按照常规方法制备成散剂。
实施例2
按照以下重量比准备原料药:
炉甘石11份,刺梅10份,藏红花8份,石膏10份,牛黄6份,菊花11份,香青兰11份,瞿麦11份,五灵脂13份,木通13份,赤芍11份,黄连5.5份,栀子8份,朱砂3.2份,地丁10份,黄柏皮8份。按照常规方法制备成丸剂。
实施例3
按照以下重量比准备原料药:
炉甘石12份,刺梅11份,藏红花9份,石膏11份,牛黄6.5份,菊花12份,香青兰12份,瞿麦12份,五灵脂14份,木通14份,赤芍12份,黄连6份,栀子9份,朱砂3.5份,地丁11份,黄柏皮9份。按照常规方法制备成汤粉剂。
实施4
试验例
一、临床资料
(一)、一般资料
全部病例为2008-2013年间慢性乙肝急性加重,经住院治疗病情恢复后,继续门诊治疗和单纯门诊就医的患者。共100例,其中男性52例,女性48;患者年龄在18-65岁之间,<20岁者13例;20-40岁者25例;40~60岁者57人;年龄>60岁者5例。
(二)、病例选择
1、西医诊断标准(1)病原学诊断:乙型肝炎病毒血清标志,选择病例HbsAg(+)阳性者80例,抗-Hbe(+)者24例.少数患者并发糖尿病。
(2)、临床诊断:
①、患者有不同程度的乏力,食欲不振,躯体不适,肝区隐痛等。其中39例有轻度黄疸,35例可触及肝和(或)脾,数例下肢轻度浮肿,无一例有腹水。
②、实验室检查:全部患者的肝酶升高且在正常上限的5倍以内。36例黄疸患者血清胆红素在34.48μmol/L左右;A/G 67例正常,31例<1∶1.5;血浆白蛋白>30g/L。食道吞钡未发现静脉曲张。
③、肝脏B超结果:轻度异常30例,肝脏表面光滑82例,表面欠光滑18例,有弥漫性病变者78例,脾大72例,P直径<=1.2cm 82例,>1.2cm者18例。
④、病理结果:判断标准为界板完整,汇管区炎症浸润者,定为慢迁肝;界板破坏,纤维结缔组织限于肝小叶周边或汇管区周围者,定为轻度慢活肝;结缔组织较多的深入小叶内者,定为中度慢活肝;纤维增生弥漫至小叶大部或偶见假小叶形成者定为重度慢活肝;在一标本中发现>=3个假小叶者定为肝硬化。96例患者进入研究前经皮刺肝等获得肝活标本,标准病例诊断:慢迁肝21例,轻度慢活肝28例,中度慢活肝33例,重度慢活肝12例,肝硬化6例。
2、病例纳入与排除标准:凡年龄在18-65岁之间,明确诊断为慢性迁延性乙型肝炎和慢性活动性乙型肝炎,肝功能不正常,符合中医疫毒热盛,痰湿中阻,气滞血瘀证。并排除乙型肝炎无症状携带者,自身免疫性肝炎,药物性肝炎,酒精性肝炎及其他非乙型病毒性肝炎患者;慢性肝炎兼有严重肾炎,糖尿病和其他原因中断治疗者;治疗期间接受其他乙肝治疗措施者;未按照规定服药而无法判定疗效或资料不全以致影响疗效判断者。
二、治疗方法
1、药物:本发明实施例2的丸剂,每个丸剂含生药1g。
2、方法:每三个月为1个疗程,每6个月为一个大疗程.研究开始,患者每次服本发明丸剂2个,每日3次。每1-2个月复查肝功,每3个月复查血清病毒标记和B超。2个大疗程后停药,每6个月实验室常规检查肝功能、乙型肝炎病毒血清标志和肝脏B超,至少随访4次,多者达8次。
三,治疗结果
1、疗效判定标准:参照1990年全国病毒性肝炎第六次学术的有关中医证候疗效判定标准和西医疗效标准。
慢乙肝的诊断标准:
A.有肝病症状、病史在一年以上
B.有慢肝体征
C.有乙肝病毒血清学发现
D.肝功能反复或持续异常达一年以上、肝功能全面损伤
E.B超发现肝病慢性化征象
F.肝病理检查有慢性化特征
凡符合以上任何三项条件者即可确认为慢性乙型肝炎。
(1)总疗效:100例患者中,89例(89%)在治疗1-2个月内肝功能恢复正常,症状改善。11例(11%)在3-7个月内肝功恢复,症状消失,随访稳定。
(2)研究中未发现任何明显毒副作用。
本发明其他实施例的药用效果与上述实施例无明显统计学差异。
个案辅以说明:
谢某某,男,38岁,2010年5月22日初诊。分辨免疫学化验结果:乙肝表面抗原(HbsAg)307.8ng/ml(参考范围:0-0.5)(+),乙肝表面抗体(HbsAb)3.30miv/ml(参考范围:0-10),乙肝e抗原(HBeAg)0.33ncv/ml(参考范围:0-0.03)(+),乙肝e抗体(HBeAb)0.66ncv/ml(参考范围:0-1.5),乙肝核心抗体(HBcAb)6.12ncv/ml(参考范围:0-0.1)(+)。该患者就诊后开始使用本发明药物组合物,连续服用2个疗程后,该患者的肝区疼痛明显减轻,食欲渐佳。继续服用一个疗程后自觉症状消失,2011年6月18日复查免疫学,报告单结果:乙肝表面抗原(HbsAg)0.3ng/ml,乙肝表面抗体(HbsAb)6miv/ml,乙肝e抗原(HBeAg)0.02ncv/ml,乙肝e抗体(HBeAb)0.45ncv/ml,乙肝核心抗体(HBcAb)0.06ncv/ml。
Claims (3)
1.一种治疗乙肝的蒙药组合物,其特征在于由以下重量配比的药物成分制成:
炉甘石10-12份,刺梅9-11份,藏红花7-9份,石膏9-11份,牛黄5-6.5份,菊花10-12份,香青兰10-12份,瞿麦10-12份,五灵脂12-14份,木通12-14份,赤芍10-12份,黄连5-6份,栀子7-9份,朱砂3-3.5份,地丁9-11份,黄柏皮7-9份。
2.根据权利要求1的治疗乙肝的蒙药组合物,其特征在于所述药物成分配比为:
炉甘石11份,刺梅10份,藏红花8份,石膏10份,牛黄6份,菊花11份,香青兰11份,瞿麦11份,五灵脂13份,木通13份,赤芍11份,黄连5.5份,栀子8份,朱砂3.2份,地丁10份,黄柏皮8份。
3.根据权利要求1或2的治疗乙肝的蒙药组合物,其药物剂型为丸剂、散剂或汤粉剂。
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CN1362168A (zh) * | 2001-01-02 | 2002-08-07 | 杨孟君 | 一种纳米安宫牛黄制剂药物及其制备方法 |
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