CN106511838B - 一种治疗酒精性肝损伤的中药颗粒 - Google Patents
一种治疗酒精性肝损伤的中药颗粒 Download PDFInfo
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Abstract
本发明涉及治疗酒精性肝损伤的中药颗粒，有效解决在不加重肝脏负担的前提下，对酒精性肝损伤的治疗问题，由以下重量计的原料药物制成：茵陈15‑30克、栀子10‑20克、枸杞子15‑30克、五味子9‑20克、薏苡仁9‑20克、葛根15‑30克、乌梅9‑15克、甘草6‑9克和大枣9‑30克，原料药物混合，加水，煎煮2次，煎煮前，先浸泡，合并两次煎煮液，过滤，滤液减压浓缩成浸膏，真空干燥，粉碎得干浸膏粉，加入辅料，搅拌均匀，加入乙醇作为润湿剂，搅拌均匀，过筛制成湿颗粒，烘干，整粒，即得；本发明具有清热利湿，养阴柔肝之效，在防治酒精性肝损伤方面疗效肯定，是治疗酒精性肝损伤药物的创新。
Description
技术领域
本发明涉及医药领域，特别是一种治疗酒精性肝损伤的中药颗粒。
背景技术
过度饮酒及酗酒日益成为影响人类身体健康的严重问题。酗酒在世界范围内每年导致250万人死亡，占死亡率的4％，而酒精中毒引起的酒精性肝病(alcoholic liverdisease,ALD)是最多的死亡原因，随着我国人均酒精消耗量的逐渐增长，酒精性肝病已经成为某些地区的第二大肝病。肝脏是代谢酒精及药物的主要场所，临床上治疗酒精性肝损伤的药物会增加肝脏负担，因此开发安全、副作用小的药物在治疗肝损伤方面有重要指导意义。
中医药在治疗化学性肝损伤方面有其独特的优势，药食同源的中药不加重肝脏的负担，副作用小、安全有效，更能被大众接受，因此开发药食同源类中草药对酒精性肝损伤的早期治疗有不可替代的作用，但目前临床上虽有多种治疗酒精性肝损伤的中药制剂，但组份中药食同源的原料药物较少，经常服用，仍存在副作用，并且见效慢，疗效低，不能令人满意。
发明内容
针对上述情况，为克服现有技术缺陷，本发明的目的在于提供一种治疗酒精性肝损伤的中药颗粒，可有效解决在不加重肝脏负担的前提下，对酒精性肝损伤的治疗问题。
本发明解决的技术方案是，由以下重量计的原料药物制成：茵陈15-30克、栀子10-20克、枸杞子15-30克、五味子9-20克、薏苡仁9-20克、葛根15-30克、乌梅9-15克、甘草6-9克和大枣9-30克，其中，将上述原料药物混合在一起，每次加原料药物8倍重量的水，煎煮2次，每次1h，煎煮之前，先浸泡30min，再开始煎煮，合并两次煎煮液，过滤，滤液减压浓缩至60℃热测相对密度1.0-1.2的浸膏，在60℃下真空干燥，粉碎得干浸膏粉，加入辅料，干浸膏粉与辅料的重量比为1:0.8，搅拌均匀，加入质量浓度为90％的乙醇作为润湿剂，乙醇加入量为辅料和干浸膏粉总重量的30％-50％，搅拌均匀，过20目筛制成湿颗粒，在65℃下烘干，整粒，即得；所述的辅料是由淀粉和糊精以重量比1：1混均组成。
本发明具有清热利湿，养阴柔肝之效，在防治酒精性肝损伤方面疗效肯定，是治疗酒精性肝损伤药物的创新。
具体实施方式
以下结合实施例对本发明的具体实施方式作进一步说明。
实施例1
本发明由以下重量计的原料药物制成：茵陈30克、栀子20克、枸杞子30克、五味子20克、薏苡仁20克、葛根30克、乌梅15克、甘草9克和大枣30克，其中，将上述原料药物混合在一起，每次加原料药物8倍重量的水，煎煮2次，每次1h，煎煮之前，先浸泡30min，再开始煎煮，合并两次煎煮液，过滤，滤液减压浓缩至60℃热测相对密度1.0的浸膏，在60℃下真空干燥，粉碎得干浸膏粉，加入辅料，干浸膏粉与辅料的重量比为1:0.8，搅拌均匀，加入质量浓度为90％的乙醇作为润湿剂，乙醇加入量为辅料和干浸膏粉总重量的30％-50％，搅拌均匀，过20目筛制成湿颗粒，在65℃下烘干，整粒，即得；所述的辅料是由淀粉和糊精以重量比1：1混均组成。
实施例2
本发明由以下重量计的原料药物制成：茵陈15克、栀子10克、枸杞子15克、五味子10克、薏苡仁10克、葛根15克、乌梅9克、甘草6克和大枣12克，其中，将上述原料混合在一起，每次加原料药物8倍重量的水，煎煮2次，每次1h，煎煮之前，先浸泡30min，再开始煎煮，合并两次煎煮液，过滤，滤液减压浓缩至60℃热测相对密度1.1的浸膏，在60℃下真空干燥，粉碎得干浸膏粉，加入辅料，干浸膏粉与辅料的重量比为1:0.8，搅拌均匀，加入质量浓度为90％的乙醇作为润湿剂，乙醇加入量为辅料和干浸膏粉总重量的30％-50％，搅拌均匀，过20目筛制成湿颗粒，在65℃下烘干，整粒，即得；所述的辅料是由淀粉和糊精以重量比1：1混均组成。
实施例3
本发明由以下重量计的原料药物制成：茵陈20克、栀子10克、枸杞子15克、五味子9克、薏苡仁9克、葛根15克、乌梅9克、甘草6克和大枣9克，其中，将上述原料混合在一起，每次加原料药物8倍重量的水，煎煮2次，每次1h，煎煮之前，先浸泡30min，再开始煎煮，合并两次煎煮液，过滤，滤液减压浓缩至60℃热测相对密度1.2的浸膏，在60℃下真空干燥，粉碎得干浸膏粉，加入辅料，干浸膏粉与辅料的重量比为1:0.8，搅拌均匀，加入质量浓度为90％的乙醇作为润湿剂，乙醇加入量为辅料和干浸膏粉总重量的30％-50％，搅拌均匀，过20目筛制成湿颗粒，在65℃下烘干，整粒，即得；所述的辅料是由淀粉和糊精以重量比1：1混均组成。
实施例4
本发明由以下重量计的原料药物制成：茵陈23克、栀子15克、枸杞子22克、五味子14克、薏苡仁15克、葛根23克、乌梅12克、甘草8克和大枣21克，其中，将上述原料药物混合在一起，每次加原料药物8倍重量的水，煎煮2次，每次1h，煎煮之前，先浸泡30min，再开始煎煮，合并两次煎煮液，过滤，滤液减压浓缩至60℃热测相对密度1.1的浸膏，在60℃下真空干燥，粉碎得干浸膏粉，加入辅料，干浸膏粉与辅料的重量比为1:0.8，搅拌均匀，加入质量浓度为90％的乙醇作为润湿剂，乙醇加入量为辅料和干浸膏粉总重量的30％-50％，搅拌均匀，过20目筛制成湿颗粒，在65℃下烘干，整粒，即得；所述的辅料是由淀粉和糊精以重量比1：1混均组成。
以上所述仅为本发明的最佳实施案例，对本发明而言仅是说明性，而非限制性的，在本发明所限定的范围内对其进行一些等同或等效的替代或替换，但其本质相同，都属本发明的保护范围。
以上所述药物，其中：
茵陈：除去杂质及老茎，晒干，有利湿退黄、解毒疗疮的功效，用于黄疸及湿疮瘙痒等的治疗。
栀子：洗净，干燥，有泻火除烦、清热利湿、凉血解毒的功效，用于黄疸、血淋涩痛、热淋、热病心烦、血热吐衄、目赤肿痛、火毒疮疡等的治疗。
枸杞子：洗净，晒干，有滋补肝肾、益精明目的功效，用于治疗肝肾阴虚及早衰证。
五味子：洗净，晒干，有收敛固涩、益气生津、补肾宁心的功效，用于治疗肺虚久咳、自汗、盗汗、遗精、滑精、久泻、津伤口渴等的治疗。
薏苡仁：除去杂质，洗净，晒干，有健脾渗湿、利水消肿的功效，用于治疗水肿、腹胀、泄泻、小便不利等治疗。
葛根：洗净，切成厚片或小块，晒干，有解肌退热，透疹，生津止渴，升阳止泻之功。常用于表证发热，项背强痛，麻疹不透，热病口渴，阴虚消渴，热泻热痢，脾虚泄泻的治疗。
乌梅：洗净，低温烘干后闷至皱皮，有涩肠止泻、生津止渴的功效，用于久泻久痢，呕吐、消渴的治疗。
甘草：除去须根，晒干，切厚片，有补脾益气、缓急止痛、清热解毒、调和诸药的功效，用于脾气虚弱、脘腹及四肢挛急疼痛，热毒疮疡，咽喉肿痛，药食中毒及调节药性。
大枣：洗净，晒干，有补中益气、养血安神的功效，用于脾气虚弱、消瘦、倦怠乏力、便溏、脏躁及失眠证的治疗。
由上述药物可知，本发明诸药配伍，具有清热利湿，养阴柔肝之效，在防治酒精性肝损伤方面疗效肯定，可有效减轻酒精性肝损伤，疗效肯定，有关试验资料如下：
一、动物实验
1、材料与方法
1.1动物：KM小鼠，SPF级，雌雄各半，18～22g。
1.2药物与仪器：上述发明中药、联苯双酯，日本奥林巴斯AU400全自动生化分析仪，；Cytation3细胞成像酶标仪；UV-2000紫外可见分光光度计；GL-16G台式离心机，上海安亭科学仪器厂；电子天平；DZKW-4型电子恒温水浴锅。
1.3方法：72只小鼠随机分为6组，分别为空白对照组、模型组、本发明低、中、高剂量组(25.5g/kg、51g/kg、102g/kg)和联苯双酯组(5.625mg/kg)。每组12只，雌雄各半。本发明低、中、高剂量组及联苯双酯组按10ml/kg体积分别灌胃给予不同剂量中药和联苯双酯，空白对照组和模型组每日灌胃给予相同体积的蒸馏水，除空白对照组外的其余5组于灌药1h后，按1.4ml/kg体积灌胃给予50％无水乙醇造成酒精性肝损伤模型，连续给药及造模7d。最后一次造模后6h，摘眼球取血。4℃4000rpm离心15min，取血清，-80℃冻存，用于常规生化检测。
1.4测定指标ALT、AST
1.5统计分析
应用SPSS17.0统计软件，计量资料采用“均数±标准差”表示，多组间比较采用单因素方差法，组间两两比较方差齐性时用LSD方法分析，方差不齐时用Dunnett’s方法分析。
2结果
2.1血清生化指标的影响
与空白对照组相比较，模型组ALT、AST升高(p<0.05)，与模型组相比，本发明低、中、高剂量组和联苯双酯组ALT、AST降低(p<0.05)，其中本发明低剂量组与联苯双酯组降低ALT、AST效果相当，结果见表1。
表1保肝颗粒对急性酒精性肝损伤小鼠生化指标ALT、AST的影响(n＝12)
| 指标 | 剂量(g/kg) | ALT(IU/L) | AST(IU/L) |
| 空白对照 | 7.575±2.1231* | 28.917±4.4407* | |
| 模型 | 15.817±5.5409 | 46.167±12.7837 | |
| 联苯双酯 | 5.625×10<sup>-3</sup> | 10.008±5.474* | 31.083±9.2683* |
| 本发明低剂量组 | 25.5 | 11.633±4.9172* | 32.250±7.9787* |
| 本发明中剂量组 | 51 | 11.717±4.5555* | 36.583±10.7995* |
| 本发明高剂量组 | 102 | 12.033±5.3668 | 38.917±8.2402 |
与模型组比较*P＜0.05
二、本发明临床试验资料如下：
1资料与方法
1.1临床资料
全部患者均根据实验室检查证实为酒精性肝损伤。纳入标准：①有近期大量饮酒史；②无症状或有轻度的右胁不适、乏力、纳差；③实验室检查ALT、AST、GGT均不同程度升高；④排除病毒感染、药物及其他非酒精引起的肝损伤。将患者随机分为治疗组和对照组，各120例。治疗组男100例，女20例，年龄27～60岁，平均年龄44岁，病程0～0.5年。对照组男92例，女28例，年龄25～58岁，平均年龄42岁，病程0～0.5年。两组患者年龄、性别、病程等一般资料比较差异无统计学意义(p>0.05),具有可比性。
1.2治疗方案
治疗组：本发明中药颗粒，每次100mg，日3次；对照组：甘草酸二胺胶囊150mg,日3次；两组均口服，均以15天为1疗程，共服用2个疗程。
1.3疗效标准
观察两组患者肝功能指标(ALT、AST、GGT)及询问患者症状治疗前后变化情况。①显效：患者症状消失，肝功能指标恢复正常。②有效：患者症状减轻，肝功能指标明显降低或基本接近正常水平。③无效：未达到临床治疗有效标准或病情加重。
1.4两组临床疗效比较
治疗组临床显效率率及总有效率高于对照组，经Ridit分析，u＝1.97，P＝0.048。差异具有统计学意义(P<0.05)，具体见表2。
表2两组临床疗效比较(n,％)
| 组别 | 例数 | 显效例数 | 有效例数 | 无效例数 | 总有效率 |
| 治疗组 | 120 | 48 | 64 | 8 | 93.3％ |
| 对照组 | 120 | 20 | 40 | 20 | 83.3％ |
1.5结论：
由上述可清楚看出，本发明中药颗粒优于对照组，并且在用药期间，未发现不良反应的情况，无毒副作用，用药安全，疗效肯定，价格实惠，易于广大患者接受，可明显降低酒精性肝损伤ALT、AST、GGT水平，改善其症状，具有实际是临床意义。且本发明中所用的原料药物均为药食同源的药物，价格低廉，无毒副作用，能在日常生活中将本发明颗粒作为保健品食用，且服用方便，易于保证疗程持续性。
Claims (5)
1.一种治疗酒精性肝损伤的中药颗粒，其特征在于，由以下重量计的原料药物制成：茵陈15-30克、栀子10-20克、枸杞子15-30克、五味子9-20克、薏苡仁9-20克、葛根15-30克、乌梅9-15克、甘草6-9克和大枣9-30克，其中，将上述原料药物混合在一起，每次加原料药物8倍重量的水，煎煮2次，每次lh，煎煮之前，先浸泡30min，再开始煎煮，合并两次煎煮液，过滤，滤液减压浓缩至60℃热测相对密度1.0-1.2的浸膏，在60℃下真空干燥，粉碎得干浸膏粉，加入辅料，干浸膏粉与辅料的重量比为l︰0.8，搅拌均匀，加入质量浓度为90％的乙醇作为润湿剂，乙醇加入量为辅料和干浸膏粉总重量的30％-50％，搅拌均匀，过20目筛制成湿颗粒，在65℃下烘干，整粒，即得；所述的辅料是由淀粉和糊精以重量比l︰l混匀组成。
2.根据权利要求l所述的治疗酒精性肝损伤的中药颗粒，其特征在于，由以下重量计的原料药物制成：茵陈30克、栀子20克、枸杞子30克、五味子20克、薏苡仁20克、葛根30克、乌梅15克、甘草9克、大枣30克，其中，将上述原料药物混合在一起，每次加原料药物8倍重量的水，煎煮2次，每次lh，煎煮之前，先浸泡30min，再开始煎煮，合并两次煎煮液，过滤，滤液减压浓缩至60℃热测相对密度1.0的浸膏，在60℃下真空干燥，粉碎得干浸膏粉，加入辅料，干浸膏粉与辅料的重量比为l︰0.8，搅拌均匀，加入质量浓度为90％的乙醇作为润湿剂，乙醇加入量为辅料和干浸膏粉总重量的30％-50％，搅拌均匀，过20目筛制成湿颗粒，在65℃下烘干，整粒，即得；所述的辅料是由淀粉和糊精以重量比l︰l混匀组成。
3.根据权利要求l所述的治疗酒精性肝损伤的中药颗粒，其特征在于，由以下重量计的原料药物制成：茵陈15克、栀子10克、枸杞子15克、五味子10克、薏苡仁10克、葛根15克、乌梅9克、甘草6克、大枣12克，其中，将上述原料混合在一起，每次加原料药物8倍重量的水，煎煮2次，每次lh，煎煮之前，先浸泡30min，再开始煎煮，合并两次煎煮液，过滤，滤液减压浓缩至60℃热测相对密度1.1的浸膏，在60℃下真空干燥，粉碎得干浸膏粉，加入辅料，干浸膏粉与辅料的重量比为l︰0.8，搅拌均匀，加入质量浓度为90％的乙醇作为润湿剂，乙醇加入量为辅料和干浸膏粉总重量的30％-50％，搅拌均匀，过20目筛制成湿颗粒，在65℃下烘干，整粒，即得；所述的辅料是由淀粉和糊精以重量比l︰l混匀组成。
4.根据权利要求l所述的治疗酒精性肝损伤的中药颗粒，其特征在于，由以下重量计的原料药物制成：茵陈20克、栀子10克、枸杞子15克、五味子9克、薏苡仁9克、葛根15克、乌梅9克、甘草6克、大枣9克，其中，将上述原料混合在一起，每次加原料药物8倍重量的水，煎煮2次，每次lh，煎煮之前，先浸泡30min，再开始煎煮，合并两次煎煮液，过滤，滤液减压浓缩至60℃热测相对密度1.2的浸膏，在60℃下真空干燥，粉碎得干浸膏粉，加入辅料，干浸膏粉与辅料的重量比为l︰0.8，搅拌均匀，加入质量浓度为90％的乙醇作为润湿剂，乙醇加入量为辅料和干浸膏粉总重量的30％-50％，搅拌均匀，过20目筛制成湿颗粒，在65℃下烘干，整粒，即得；所述的辅料是由淀粉和糊精以重量比l︰l混匀组成。
5.根据权利要求l所述的治疗酒精性肝损伤的中药颗粒，其特征在于，由以下重量计的原料药物制成：茵陈23克、栀子15克、枸杞子22克、五味子14克、薏苡仁15克、葛根23克、乌梅12克、甘草8克和大枣2l克，其中，将上述原料药物混合在一起，每次加原料药物8倍重量的水，煎煮2次，每次lh，煎煮之前，先浸泡30min，再开始煎煮，合并两次煎煮液，过滤，滤液减压浓缩至60℃热测相对密度1.1的浸膏，在60℃下真空干燥，粉碎得干浸膏粉，加入辅料，干浸膏粉与辅料的重量比为l︰0.8，搅拌均匀，加入质量浓度为90％的乙醇作为润湿剂，乙醇加入量为辅料和干浸膏粉总重量的30％-50％，搅拌均匀，过20目筛制成湿颗粒，在65℃下烘干，整粒，即得；所述的辅料是由淀粉和糊精以重量比l︰l混匀组成。
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