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CN114984160B - 一种治疗酒精性肝病的蒙药 - Google Patents

一种治疗酒精性肝病的蒙药 Download PDF

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CN114984160B
CN114984160B CN202210630805.9A CN202210630805A CN114984160B CN 114984160 B CN114984160 B CN 114984160B CN 202210630805 A CN202210630805 A CN 202210630805A CN 114984160 B CN114984160 B CN 114984160B
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陈桂花
周慧斌
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Abstract

本发明公开了一种治疗酒精性肝病的蒙药，其包括如下组分：西红花、牛黄、熊胆粉、羚羊角、红花、丹参、诃子、葛根、五味子、紫檀香、猫爪草、水飞蓟、建莲子、川楝子、草决明、银杏叶、广木香、麦冬、栀子、白蔻仁、人参。本发明蒙药采用蒙医“清肝热、助消化、解毒、固肾”法治疗酒精性肝病，能够有效改善肝功能，改善患者生活质量；能够减少或避免酒精性肝炎发展为酒精性肝硬化；且本发明蒙药具有价格低、易普及、长期服用无毒副作用、治疗效果好、复发率低的优势；解决了当前酒精性肝炎药物治疗极其匮乏和无药可选的问题，为临床提供新的药物选择。

Description

一种治疗酒精性肝病的蒙药
技术领域：
本发明涉及药物组合物领域，特别是涉及一种治疗酒精性肝病的蒙药。
背景技术：
随着社会经济的发展，饮酒者日益增多，酒精滥用、酒精依赖和酒精中毒已成为世界各国较为普遍的公共卫生问题。肝脏是酒精代谢的主要部位，也是酒精毒性作用的主要靶器官，长期大量饮酒所致的酒精性肝病(alcoholic liver disease，ALD)在临床上发病率逐年升高，已成为继病毒性肝炎后导致肝损伤的又一大病因。酒精性肝病临床诊断上根据肝功能、影像学和组织病理学检查结果可分为如下几个分型：轻症酒精性肝病、酒精性脂肪肝、酒精性肝炎、酒精性肝纤维化和酒精性肝硬化等。
现代医学常用的治疗方法主要有戒酒、营养支持、药物治疗、肝移植等。但至今尚缺乏疗效确切且可被推荐用于ALD的治疗药物，尤其是酒精性肝炎药物治疗极其匮乏，处于无药可选的窘境，治疗总体效果不理想，毒副作用大，而且费用高，长期使用会造成肝肾损伤。
发明内容：
本发明的目的在于提供一种疗效确切、费用低且长期服用无副作用的治疗酒精性肝病的蒙药。
本发明由如下技术方案实施：一种治疗酒精性肝病的蒙药，其包括如下重量份的组分：西红花0.1-0.5份、牛黄0.5-1份、熊胆粉0.1-0.5份、羚羊角1-2份、红花3-4份、丹参3-4份、诃子3-4份、葛根3-4份、五味子3-4份、紫檀香2-4份、猫爪草2-3份、水飞蓟2-3份、建莲子2-3份、川楝子2-3份、草决明1-2份、银杏叶1-2份、广木香1-2份、麦冬1-2份、栀子1-2份、白蔻仁1-2份、人参1-2份。
优选的，所述的一种治疗酒精性肝病的蒙药，其特征在于，其包括如下重量份的组分：西红花0.36份、牛黄0.72份、熊胆粉0.45份、羚羊角1.2份、红花3.6份、丹参3.6份、诃子3.6份、葛根3.6份、五味子3.6份、紫檀香2.4份、猫爪草2.4份、水飞蓟2.4份、建莲子2.4份、川楝子2.4份、草决明1.8份、银杏叶1.8份、广木香1.8份、麦冬1.8份、栀子1.8份、白蔻仁1.8份、人参1.8份。
进一步的，所述的一种治疗酒精性肝病的蒙药，为其为散剂、水丸、蜜丸、胶囊或颗粒剂中的任意一种。
本发明蒙药以西红花、红花、牛黄、熊胆粉、羚羊角为主药，西红花与红花味甘、微苦，性凉、钝、柔、和、重、固，具有锁脉、清肝热、滋补强身、止痛的功效；牛黄微苦、微甘，性凉、重、钝、和、柔，具有清热、解毒、镇静的功效；熊胆粉味苦，性凉、钝、糙、动，具有锁脉止血、清希拉、明目、防腐、生机、止泻的功效；羚羊角味咸，性平，具有燥脓，破血痞、止泻的功效。
以丹参、诃子、葛根、五味子为辅药，丹参味苦，性轻、钝、烈，具有清血热、燥恶血、止血功效；诃子味涩，性平、锐、燥，具有祛除病变、解毒、调和体素的功效；葛根味甘、辛，性凉，具有解肌退热，生津止渴之功；五味子味甘酸，性平、燥、轻、固、糙，具有止吐止泻、开胃功效。
以紫檀香、猫爪草、水飞蓟、建莲子、川楝子为佐药，紫檀香味涩、咸，性凉、钝，具有清血热、平息气血相搏、消肿等功效；猫爪草味甘、辛，性温、平，具有解毒之功效；水飞蓟味苦，性凉，具有清热利湿、疏肝利胆；建莲子味辛、涩，性温，具有益肾、祛胃肾寒、止泻、燥黄水之功效；川楝子味涩、苦，性凉、轻、淡、燥、钝，具有祛巴达干希拉、燥热性黄水、明目、止痛的功效。
使药为草决明、银杏叶、广木香、麦冬、栀子、白蔻仁、人参，草决明味胃苦、涩，性凉、糙、燥、锐，具有燥黄水、滋补之功效；银杏叶味甘、苦、涩，性平，具有活血化瘀、通络止痛、化浊降脂之功效；广木香味辛、苦，性温、腻、糙、轻，祛巴达干热、平息气血相搏、破痞、调和体素、防腐、止痛的功效；麦冬味苦，性凉，具有祛希拉、解毒、清热、消肿的功效；栀子味苦，性凉、钝、糙，具有清血热、明目、祛巴达干希拉、滋养调和体素的功效；白蔻仁味辛、苦，性温、腻、锐，轻、燥，具有祛肾寒、镇赫依、助胃火、消食开胃止呕的功效；人参味甘、微苦，性温，具有滋补、镇静的功效。
本方以西红花、红花、牛黄、熊胆粉、羚羊角为主药，清肝热、解毒、保肝、明目；辅以丹参、诃子、葛根、五味子，清血热、祛恶血、调和体素、止吐止泻、开胃的功效；佐以紫檀香、猫爪草、水飞蓟、建莲子、川楝子，清血热、解毒、平息气血相搏、清热利湿、疏肝利胆、祛胃肾寒；使药为草决明、银杏叶、广木香、麦冬、栀子、白蔻仁、人参，燥黄水、滋补、活血化瘀、通络止痛、祛巴达干热、助胃火、消食开胃止呕，本方剂组方合理，诸药合用，具有清肝热、解毒、保肝的功效，主治脂肪性肝病、酒精性肝炎等病症，且功效显著。
本发明的优点：本发明蒙药采用蒙医“清肝热、助消化、解毒、固肾”法治疗酒精性肝病，能够有效改善肝功能，改善患者生活质量；能够减少或避免酒精性肝炎发展为酒精性肝硬化；且本发明蒙药具有价格低、易普及、长期服用无毒副作用、治疗效果好的优势；解决了当前酒精性肝炎药物治疗极其匮乏和无药可选的问题，为临床提供新的药物选择。
具体实施方式：
下面将结合本发明实施例，对本发明技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
实施例1：一种治疗酒精性肝病的蒙药，按如下重量份称取原料药：西红花0.72kg、牛黄1.44kg、熊胆粉0.9kg、羚羊角2.4kg、红花7.2kg、丹参7.2kg、诃子7.2kg、葛根7.2kg、五味子7.2kg、紫檀香4.8kg、猫爪草4.8kg、水飞蓟4.8kg、建莲子4.8kg、川楝子4.8kg、草决明3.6kg、银杏叶3.6kg、广木香3.6kg、麦冬3.6kg、栀子3.6kg、白蔻仁3.6kg、人参3.6kg。将称取的上述原料药委托内蒙古国际蒙医医院国际蒙药制剂中心加工成水丸，规格为200mg/丸。
实施例2：一种治疗酒精性肝病的蒙药，按如下重量份称取原料药：西红花0.7kg、牛黄1.4kg、熊胆粉0.8kg、羚羊角3kg、红花6kg、丹参6kg、诃子6kg、葛根6kg、五味子6kg、紫檀香7kg、猫爪草5.6kg、水飞蓟5.6kg、建莲子5.6kg、川楝子5.6kg、草决明2kg、银杏叶2kg、广木香2kg、麦冬2kg、栀子2kg、白蔻仁2kg、人参2kg。将称取的上述原料药委托内蒙古国际蒙医医院国际蒙药制剂中心加工成水丸，规格为200mg/丸。
实施例1和实施例2蒙药还可采用目前常规方法制备成散剂、蜜丸、胶囊或颗粒剂。
本发明治疗酒精性肝病的蒙药(古日古木清肝丸)治疗酒精性肝炎的临床研究
本研究主要目的为通过观察蒙药古日古木清肝丸对酒精性肝炎患者的临床疗效，来探讨其有效性和安全性,为其今后临床应用提供科学依据。研究方案为随机、对照临床研究。138例受试者来源于内蒙古兴安盟科尔沁右翼中旗西哲里木镇卫生院内科门诊及住院部。
2.1研究方法
2.1.1试验用药物的名称与规格
观察组一用药：按本发明实施例1组方制备的蒙药古日古木清肝丸，剂型：水丸，(200mg/丸)由内蒙古国际蒙医医院国际蒙药制剂中心提供。
观察组二用药：按本发明实施例2组方制备的蒙药古日古木清肝丸，剂型：水丸，(200mg/丸)由内蒙古国际蒙医医院国际蒙药制剂中心提供。
对照组用药：护肝片，剂型：片剂，(0.35g/片)由黑龙江葵花药业股份有限公司提供(国药准字Z20003336)。
2.1.2随机发药
本试验研究具体操作为：在试验研究过程中对于符合入组标准的患者根据筛选合格的顺序先后分配药物编号，药品管理员或研究者根据药物编号进行发药，剩余药物交还研究者或者药品管理员。
2.1.3用药方法与疗程
观察组一：口服，一次15丸，一日2次，早、晚餐后温开水送，每个疗程6周，治疗3个疗程；
观察组二：口服，一次15丸，一日2次，早、晚餐后温开水送，每个疗程6周，治疗3个疗程；
对照组：护肝片,一次4片，一日2次,早、晚餐后温开水送，每个疗程6周，治疗3个疗程；
2.1.4观察指标
2.1.4.1肝纤维化指标：治疗前后上午空腹采血进行肝功能、血脂、肝纤维化指标包括血清透明质酸(HA)、层黏连蛋白(LN)、Ⅲ型前胶原(PCⅣ)、Ⅳ型胶原(CⅣ)的检查。
2.1.4.2B超：治疗前后各做一次B超，并分级为正常(-)、轻度(+)、中度(++)、重度(+++)。
2.1.5疗效标准
参照国家中医药管理局2002年《中药新药临床研究指导原则(试行)》及相关文献资料判定：
治愈：临床症状完全消失，B超检查肝脏回声基本恢复正常，肝功能恢复正常，血清总胆固醇(TC)下降＞20％，甘油三酯(TG)下降＞40％；显效：临床症状基本或完全消失，B超检查肝脏回声病情分级下降1级，肝功能恢复正常，血清总胆固醇(TC)下降＞10％-20％，甘油三酯(TG)下降＞20％-40％；有效：临床症状明显好转，B超检查肝脏回声病情分级下降1级或好转，肝功能基本正常和(或)血清总胆固醇(TC)下降10％-20％，甘油三酯(TG)下降20％-40％；无效：临床症状及各项检查结果未达到上述标准。
2.1.6统计学处理
用SPSS 18.0统计软件进行统计学分析，本组肝功能疗效数据比较采用t检验，B超及总疗效数据比较时用X2检验，P<0.05，说明有显著差异，有统计学意义。
2.2结果
2.2.1蒙医辨证治疗酒精性肝炎临床总疗效
治疗3个疗程后，观察组一46例中治愈40例，显效4例，有效1例，无效1例，总有效率97.83％；观察组二46中治愈38例，显效2例，有效4例，无效2例，总有效率95.65％；对照组46例中治愈10例，显效8例，有效15例，无效13例，总有效率71.74％(P＜0.01)。提示蒙医辨证治疗酒精性肝炎能显著提高临床疗效(见表1)。
表1、三组总疗效比较
*观察组一与对照组比较，P＜0.01；#观察组二与对照组比较，P＜0.01；％观察组一与观察组二比较，P＜0.05。
2.2.2蒙医辨证治疗对酒精性肝病肝纤维化的影响
治疗3个疗程后，各组均能改善酒精性肝炎肝纤维化，但观察组一和观察组二的改善效果均显著优于对照组，与对照组比较差异有统计学意义(P＜0.01)；且观察组一的改善效果优于观察组二，差异有统计学意义(P＜0.05)。提示蒙医辨证治疗酒精性肝炎能显著改善酒精性肝炎患者肝纤维化(见表2)，表2中对照组治疗前和治疗后数据为对照组患者检查结果的均值；观察组一治疗前和治疗后数据为观察组一患者检查结果的均值；观察组二治疗前和治疗后数据为观察组二患者检查结果的均值。
表2、三组对肝纤维化的影响
治疗前后比较：*P＜0.05，**P＜0.01，***P＜0.001；观察组一与对照组比较：※P＜0.01；观察组二与对照组比较：#P＜0.01；观察组一与观察组二比较：％P＜0.05。
2.2.3蒙医辨证治疗对酒精性肝炎B超疗效的影响
治疗3个疗程后，各组均能改善酒精性肝炎影像学指标，但观察组一和观察组二的改善效果均显著优于对照组，与对照组比较差异有统计学意义(P＜0.01)；且观察组一的改善效果优于观察组二，差异有统计学意义(P＜0.05)。提示蒙医辨证治疗能显著改善酒精性肝炎患者肝脏影像学改变(见表3)。
表3、三组治疗前后对肝B超疗效的影响
治疗前后比较：*P＜0.05，**P＜0.01，***P＜0.001；观察组一与对照组比较：※P＜0.01；观察组二与对照组比较：#P＜0.01；观察组一与观察组二比较：％P＜0.05
以上所述仅为本发明的较佳实施例而已，并不用以限制本发明，凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。

Claims (3)

1.一种治疗酒精性肝病的蒙药，其特征在于，其原料药及重量份为：西红花0.1-0.5份、牛黄0.5-1份、熊胆粉0.1-0.5份、羚羊角1-2份、红花3-4份、丹参3-4份、诃子3-4份、葛根3-4份、五味子3-4份、紫檀香2-4份、猫爪草2-3份、水飞蓟2-3份、建莲子2-3份、川楝子2-3份、草决明1-2份、银杏叶1-2份、广木香1-2份、麦冬1-2份、栀子1-2份、白蔻仁1-2份、人参1-2份。
2.根据权利要求1所述的一种治疗酒精性肝病的蒙药，其特征在于，其原料药及重量份为：西红花0.36份、牛黄0.72份、熊胆粉0.45份、羚羊角1.2份、红花3.6份、丹参3.6份、诃子3.6份、葛根3.6份、五味子3.6份、紫檀香2.4份、猫爪草2.4份、水飞蓟2.4份、建莲子2.4份、川楝子2.4份、草决明1.8份、银杏叶1.8份、广木香1.8份、麦冬1.8份、栀子1.8份、白蔻仁1.8份、人参1.8份。
3.根据权利要求1或2所述的一种治疗酒精性肝病的蒙药，其特征在于，其为散剂、水丸、蜜丸、胶囊或颗粒剂中的任意一种。
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