CN104274582B - 一种用于护肝的药物组合物及其制备方法 - Google Patents

一种用于护肝的药物组合物及其制备方法 Download PDF

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CN104274582B
CN104274582B CN201410541622.5A CN201410541622A CN104274582B CN 104274582 B CN104274582 B CN 104274582B CN 201410541622 A CN201410541622 A CN 201410541622A CN 104274582 B CN104274582 B CN 104274582B
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魏凤环
沈群
贺松其
陈达理
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Guangdong Nanfang Medical Technology Development Co Ltd
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Southern Medical University
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Abstract

本发明涉及一种用于护肝的药物组合物，该药物组合物由有效成分和药学上可接受的辅料组成，其特征在于，所述的有效成分由以下重量份的原料药制成：女贞子1.5～2.5份，五味子0.5～1.5份，淫羊藿1～1.5份，虎杖2～3份，紫河车1～1.5份，刺五加1～2份，黄芪1～1.5份，丹皮1～2份，板蓝根1～2份，黄芩0.5～1.5份，桑寄生0.5～1.5份，柴胡0.5～1.5份。本发明所述药物组合物的功能在于滋养肝肾，清热解毒，调和气血，同时药物对乙肝病毒有抑制作用，降低转氨酶，增强机体免疫功能，该处方毒副作用极小，治疗作用明显，为肝损伤患者提供了一种理想的药物。

Description

一种用于护肝的药物组合物及其制备方法
技术领域
本发明涉及一种医用配制品，具体涉及以中药为原料制备的中成药。
背景技术
慢性乙型肝炎是我国常见病、多发病，危害各年龄层人群的健康，肝病时肝功能有不同程度的损害，肝脏解毒、排泄功能及贮备和再生能力降低，肝血流量减少，各种进入肝脏的药物使代谢负荷加重，从而发生内环境紊乱，进而造成肝损伤，长期的肝损伤可以导致肝硬化甚至肝癌。
目前，临床上普遍采用干扰素治疗慢性乙肝，虽然使用范围广，但疗效却越来越令人失望，同时干扰素治疗乙肝有适应症，有明显不良反应，与我国的肝病特点不符；另外一个常用药拉米夫定在其应用初期，以抑制病毒迅速，乙肝病毒DNA转阴率高，不良反应较轻、较少，价格相对低廉等优点，得到医生和患者的青睐，随着治疗时间的延长，问题慢慢浮现出来；如诱导乙肝病毒的变异，先喜后忧的现实，较窄的适应证，有限的治疗效果，遥遥无期的疗程，停药后的“反弹”，并且可能使病情明显加重，甚至恶化。
我国是肝炎高发大国，现有各类型肝病患者已超过2亿，大多需要具有肝脏保护作用的药物，代医学对肝损伤的研究比较深入，已从多方面探讨了肝损伤的发生机制，并研制开发出多种保肝药物，但疗效尚难尽人意；中药有着多靶点、多环节综合作用的特点，在治疗肝损伤方面有独特的优势。
发明内容
本发明目的就是按照中医药理论科学组方，采用现代提取、制剂工艺研制出一种具有改善肝功能、降低转氨酶的药物。
本发明实现上述目的的技术方案为：
一种用于护肝的药物组合物，该药物组合物由有效成分和药学上可接受的辅料组成，其特征在于，所述的有效成分由以下重量份的原料药制成：女贞子1.5～2.5份，五味子0.5～1.5份，淫羊藿1～1.5份，虎杖2～3份，紫河车1～1.5份，刺五加1～2份，黄芪1～1.5份，丹皮1～2份，板蓝根1～2份，黄芩0.5～1.5份，桑寄生0.5～1.5份，柴胡0.5～1.5份。
上述药物组合物中有效成分由以下重量份的原料药制成：女贞子2份、五味子1份、淫羊藿1.3份、虎杖2.5份、紫河车1.3份、刺五加1.5份、黄芪1.3份、丹皮1.5份、板蓝根1.5份、黄芩1.1份、桑寄生1.1份、柴胡1份。
上述药物组合物由以下方法制成：取女贞子、五味子、虎杖和黄芩采用乙醇提取，回收乙醇后得浸膏A；取淫羊藿、刺五加、黄芪、板蓝根、桑寄生、柴胡、紫河车采用水煎煮提取，提取液浓缩成浸膏后，加入乙醇至醇浓度大于50％，滤除沉淀，上清液浓缩得浸膏B；丹皮采用水蒸汽蒸馏提取得到丹皮酚；将浸膏A和B混匀，加入药用淀粉和/或糊精干燥后与丹皮酚混匀粉碎，再采用常规工艺制成片剂或胶囊剂。
本发明所述的药物组合物，方中以桑寄生、淫羊藿为君，滋肾养肝；再以黄芪益气固本，女贞子、紫河车滋阴养血，五味子、刺五加养肝降酶，共为臣药；佐以虎杖、板蓝根、丹皮清热凉血解毒；醋柴胡疏肝解郁、引药入肝为使药。现代药理研究表明：板蓝根、虎杖、黄芩、柴胡对乙肝病毒有抑制作用；五味子、刺五加具有降低转氨酶作用；黄芪、女贞子、淫羊藿可以增强机体免疫功能。因此，不但中医传统理论与临床实践，抑或现代药理研究均表明本处方组方法度严谨，依据充分。
具体实施方式
药物制剂的制备：取女贞子20千克、五味子10千克、淫羊藿13千克、虎杖25千克、紫河车13千克、刺五加15千克、黄芪13千克、丹皮15千克、板蓝根15千克、黄芩11千克、桑寄生11千克、柴胡10千克。按照如下工艺，女贞子、五味子、虎杖、黄芩四味中药混合后采用乙醇提取两次，每次加70％乙醇6倍量回流提取1小时，回收乙醇后得浸膏A；淫羊藿、刺五加、黄芪、板蓝根、桑寄生、柴胡、紫河车7味中药，采用水煎煮提取两次，每次加水10倍量提取两次，提取液浓缩成相对密度约在1.20的浸膏后，加入乙醇至醇浓度为60％，滤除沉淀，上清液浓缩得浸膏B；丹皮采用水蒸汽蒸馏的方法提取得到丹皮酚；将浸膏A和B混匀，加入药用淀粉和/或糊精干燥后与丹皮酚混匀粉碎，装入胶囊，即得。
临床应用研究：慢性乙型肝炎诊断按1990年第6次全国肝病会议制定的慢性乙型肝炎诊断标准。120例分为治疗组80例，对照组40例。治疗组80例中男52例，女28例；年龄最小18岁，最大62岁，平均31.71±8.12岁；病程1-8年，平均3.31±2.53年。对照组40例中男25例，女15例；年龄最小19岁，最大63岁，平均3.25±7.93岁。病程1-9年，平均3.35±2.71年。根据卫生部1993年10月制定的《中药新药治疗病毒性肝炎的临床研究指导原则》作辨证分型。湿热薰蒸证：治疗组19例，对照组9例；瘀毒内结证：治疗组25例，对照组13例；气滞血瘀证：治疗组36例，对照组18例。以上两组资料经统计学处理无显著性差异(P＞0.05)。
治疗方法治疗组用该方制剂口服，每次3粒，1日3次。对照组采用联苯双酯滴丸15mg，维生素C200mg，肝泰乐0.2g，每日3次口服。4周为一个疗程，可连续治疗2-3个疗程，治疗结束后作疗效评定。
疗效标准根据卫生部1993年10月制定《中药新药治疗病毒性肝炎(慢性肝炎)的临床研究指导原则》中的标准作疗效评定。
基本治愈：自觉症状消失；肝脾肿大稳定不变或缩小，无压痛及叩痛；肝功能检查正常；以上各项指标稳定1年以上者。
有效：主要症状消失，或基本消失；肝脾肿大稳定不变，且无明显压痛及叩痛；肝功能检查正常或原值下降50％以上，并持续3个月者。
无效：疗程结束后，SGPT不下降者。
治疗结果治疗组80例，基本治愈26例，显效28例，有效20例，无效6例，总有效率为92.5％。对照组40例，其中治愈7例，显效9例，有效9例，无效15例，总有效率为62.5％，两组临床疗效比较，有显著性意义(卡方检验P＜0.01)。
不良反应：治疗前后对血常规、肝、肾功能检测未发现损害现象。

Claims (3)

1.一种用于护肝的药物组合物，该药物组合物由有效成分和药学上可接受的辅料组成，其特征在于，所述的有效成分由以下重量份的原料药制成：女贞子1.5～2.5份，五味子0.5～1.5份，淫羊藿1～1.5份，虎杖2～3份，紫河车1～1.5份，刺五加1～2份，黄芪1～1.5份，丹皮1～2份，板蓝根1～2份，黄芩0.5～1.5份，桑寄生0.5～1.5份，柴胡0.5～1.5份。
2.根据权利要求1所述的一种用于护肝的药物组合物，其特征在于，所述的有效成分由以下重量份的原料药制成：由女贞子2份，五味子1份，淫羊藿1.3份，虎杖2.5份，紫河车1.3份，刺五加1.5份，黄芪1.3份，丹皮1.5份，板蓝根1.5份，黄芩1.1份，桑寄生1.1份，柴胡1份。
3.一种制备权利要求1或2所述的用于护肝的药物组合物的方法，该方法由以下步骤组成：取女贞子、五味子、虎杖和黄芩采用乙醇提取，回收乙醇后得浸膏A；取淫羊藿、刺五加、黄芪、板蓝根、桑寄生、柴胡、紫河车采用水煎煮提取，提取液浓缩成浸膏后，加入乙醇至醇浓度大于50％，滤除沉淀，上清液浓缩得浸膏B；丹皮采用水蒸气蒸馏提取得到丹皮酚；将浸膏A和B混匀，加入药用淀粉和/或糊精干燥后与丹皮酚混匀粉碎，再采用常规工艺制成片剂或胶囊剂。
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