CN111150826B - 一种治疗代偿期乙肝后肝硬化的中药 - Google Patents
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Abstract
本发明涉及治疗代偿期乙肝后肝硬化的中药，可有效解决代偿期乙肝后肝硬化的用药问题，其解决的技术方案是，该中药是由以下重量计的原料药物制成：肉桂15‑30g、红景天15‑30g、干姜15‑30g、土炒白术15‑30g、海藻10‑20g、山慈菇10‑20g、马鞭草10‑20g、水红花子10‑20g和炒吴茱萸3‑9g，本发明制备方法简单，容易生产，疗效稳定可靠，服用安全，效果好，具有温阳补气、化痰活血之功效，有效用于治疗代偿期乙肝后肝硬化，是治疗代偿期乙肝后肝硬化药物上的创新。
Description
技术领域
本发明涉及医药领域，特别是一种治疗代偿期乙肝后肝硬化的中药。
背景技术
乙肝后肝硬化为乙型肝炎发展的晚期阶段，以肝脏弥漫性纤维化、再生结节和假小叶形成为特征。代偿期乙肝后肝硬化为乙肝后肝硬化的初始阶段，症状轻微且无特异性，常见乏力、食欲不振、腹胀不适，伴肝脏肿大，质地偏硬，门静脉内径增宽，脾脏肿大，肝功能异常等。此期肝脏尚无假小叶形成，若能得到有效治疗，则有可能使病变趋于静止。若不能有效阻止病情发展，导致出现腹水或其它并发症，则进入不可逆的肝脏假小叶形成的失代偿期，预后不良。因此，代偿期乙肝后肝硬化阶段，是需要药物有效干预治疗的关键阶段。
西医目前对代偿期乙肝后肝硬化仍然没有特效的治疗方法，尚没有肯定作用的西药对抗肝脏的纤维化，主要是被动地依靠抗乙肝病毒药物抑制乙肝病毒，防止起始病因所致的肝脏炎症坏死，以求在一定程度上防止肝纤维化的发展，难以取得良好的治疗效果。因此，亟需能够有效逆转病情的治疗药物。
中医药对代偿期乙肝后肝硬化的治疗有独特的疗效，可以弥补西医治疗用药上的匮乏，如中国发明专利申请公布号CN 103494907A公开了一种治疗代偿期肝硬化的软肝丸，采用以下原料药物组成：鳖甲140-160g、穿山甲140-160g、生牡蛎430-470g、桃仁40-50g、龟甲70-80g和鸡内金140-160g，具有软坚散结、活血化瘀之功效；中国发明专利申请公布号CN11057575521A公开了一种用于治疗慢性乙型肝炎及乙型肝炎相关性代偿期肝硬化的中药组合物，其特征在于，制成该中药组合物中的有效成分的原料药，按重量配比包括：黄芪10-100份、茵陈10-200份、黄芩2-9份、黄连2-9份、黄柏2-9份、莪术5-10份、制鳖甲2-9份、焦山楂10-30份、白芍10-30份、凌霄花5-10份、麸炒白术5-20份、茯苓5-12份、柴胡5-10份、白花蛇舌草10-30份，具有健脾益气，清热利湿，解毒通络、消瘀化癥之功效。但是，以温阳补气、化痰活血为主要功效，对代偿期乙肝后肝硬化具有满意疗效的中药，尚未见报导。
发明内容
针对上述情况，为解决现有技术之缺陷，本发明之目的就是提供一种治疗代偿期乙肝后肝硬化的中药，可有效解决代偿期乙肝后肝硬化的用药问题。
本发明解决的技术方案是，该中药是由以下重量计的原料药物制成：肉桂15-30g、红景天15-30g、干姜15-30g、土炒白术15-30g、海藻10-20g、山慈菇10-20g、马鞭草10-20g、水红花子10-20g和炒吴茱萸3-9g，将上述原料药物混合在一起，加入原料药物10倍重量的饮用水，浸泡30分钟，用武火煎沸，再用文火煎30分钟，过滤，得第一次滤液；再将药渣加入原料药物8倍重量的饮用水，用武火煎沸，再用文火煎25分钟，过滤，得第二次滤液；将两次滤液合并，中火煎煮浓缩至400mL，即得。
本发明制备方法简单，容易生产，疗效稳定可靠，服用安全，效果好，具有温阳补气、化痰活血之功效，有效用于治疗代偿期乙肝后肝硬化，是治疗代偿期乙肝后肝硬化药物上的创新。
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详细说明。
实施例1
本发明在具体实施时，可由以下重量计的原料药物制成：肉桂20g、红景天20g、干姜20g、土炒白术20g、海藻15g、山慈菇15g、马鞭草15g、水红花子15g和炒吴茱萸6g，将上述原料药物混合在一起，加入1460mL饮用水，浸泡30分钟，用武火煎沸，再用文火煎30分钟，过滤，得第一次滤液；再将药渣加入1168mL饮用水，用武火煎沸，再用文火煎25分钟，过滤，得第二次滤液；将两次滤液合并，中火煎煮浓缩至400mL，即得。
实施例2
本发明在具体实施时，还可由以下重量计的原料药物制成：肉桂15g、红景天15g、干姜15g、土炒白术15g、海藻10g、山慈菇10g、马鞭草10g、水红花子10g和炒吴茱萸3g，将上述原料药物混合在一起，加入原料药物10倍重量的饮用水，浸泡30分钟，用武火煎沸，再用文火煎30分钟，过滤，得第一次滤液；再将药渣加入原料药物8倍重量的饮用水，用武火煎沸，再用文火煎25分钟，过滤，得第二次滤液；将两次滤液合并，中火煎煮浓缩至400mL，即得。
实施例3
本发明在具体实施中，还可由以下重量计的原料药物制成：肉桂30g、红景天30g、干姜30g、土炒白术30g、海藻20g、山慈菇20g、马鞭草20g、水红花子20g和炒吴茱萸9g，将上述原料药物混合在一起，加入原料药物10倍重量的饮用水，浸泡30分钟，用武火煎沸，再用文火煎30分钟，过滤，得第一次滤液；再将药渣加入原料药物8倍重量的饮用水，用武火煎沸，再用文火煎25分钟，过滤，得第二次滤液；将两次滤液合并，中火煎煮浓缩至400mL，即得。
本发明中药也可按照常规方法，制成丸剂、散剂、颗粒剂、片剂、胶囊剂、口服液等。本发明保护的是中药组方，而不在于剂型或制备方法。
本发明人在长期的临床实践中，基于代偿期乙肝后肝硬化“肝脏肿大，质地偏硬”的病理变化，以及病人所表现的临床症状与体征，发现其非常符合《黄帝内经》中《素问·阴阳应象大论》篇章内“阳化气，阴成形”的中医阴阳学说理论。“阳”能“化气”，将有形之质化为无形之气；“阴”能“成形”，将无形之气凝聚成有形之质。肝脏之所以“硬化”、“肿大”，根本原因就是因为“阳化气”不足，“阴成形”有余。具体而言，是因为罹患乙型肝炎日久，损伤人体阳气，肝之阳气不足，导致“阳虚生内寒”的病理格局，从而使肝脏“化气”不足，“成形”有余，肝之津血失运，凝聚为痰浊、瘀血，痰饮、瘀血等阴邪互结于肝，从而使肝脏出现“硬化”、“肿大”。因此，本病的基本病机是以阳气亏虚为本，以痰浊、瘀血为标，宜温阳补气以治其本，兼以化痰活血以治其标。通过临床反复实践验证与反复药物筛选，本发明人发现了以温阳补气为主兼以化痰活血的中药组合物，对代偿期乙肝后肝硬化具有良好效果且无毒副作用。
在上述药物中，其中：肉桂，味辛、甘，性大热，归肝、肾、脾、心经，补火助阳，引火归元，散寒止痛，温通经脉；红景天，味甘、苦，性平，归肺、心经，益气活血，通脉平喘；干姜，味辛，性热，归脾、胃、肾、心、肺经，温中散寒，回阳通脉，温肺化饮；土炒白术，味苦、甘，性温，归脾、胃经，健脾益气，燥湿利水，止汗，安胎。海藻，味苦、咸，性寒，归肝、胃、肾经，消痰软坚散结，利水消肿；山慈菇，味甘、辛，性凉，归肝、脾经，化痰散结，清热解毒；马鞭草，味苦，性凉，归肝、脾经，活血散瘀，解毒，利水，退黄，截疟；水红花子，味咸，性微寒，归肝、胃经，散血消癥，消积止痛，利水消肿；炒吴茱萸，味辛、苦，性热，归肝、脾、胃、肾经，散寒止痛，降逆止呕，助阳止泻。
根据中药君臣佐使的配伍原则和治疗代偿期乙肝后肝硬化的实际，肉桂补火助阳，红景天益气活血，共为君药；干姜温阳散寒，土炒白术益气燥湿，共为臣药；海藻消痰软坚散结，山慈菇化瘀散结，马鞭草活血散瘀，水红花子散血消癥，共为佐药；炒吴茱萸暖肝散寒，引药归于足厥阴肝经，为使药。组分间配伍严谨，层次分明，环环相扣，互相支持，共奏温阳补气、化痰活血之效，并经临床试验得到了充分证明，相关实验资料如下：
1资料与方法
1.1一般资料
74例代偿期乙肝后肝硬化患者，均符合《慢性乙型肝炎防治指南》中的诊断标准，根据就诊时间的先后，按简单随机化方法，随机分为观察组37例和对照组37例。观察组37例中，男22例，女15例；年龄31～68岁，平均(42.17±4.84)岁；乙型肝炎病程8～17年，平均(10.92±2.31)年。对照组37例中，男23例，女14例；年龄30～69岁，平均(42.78±5.13)岁；乙型肝炎病程7～18年，平均(11.13±2.89)年。两组一般资料比较，无统计学差异(P＞0.05)，具有可比性。
1.2治疗方案
对照组口服恩替卡韦分散片，1日1次，1次1片(0.5mg)；观察组在对照组用药的基础上，加服本发明实施例1制得的中药汤剂治疗，每日1剂，水煎为400mL，早晚饭后各服200mL。两组均8周为1个疗程，共2个疗程。
1.3观察指标和统计方法
测定两组治疗前后丙氨酸氨基转移酶(ALT)、天冬氨酸氨基转移酶(AST)等肝功能指标水平，Ⅲ型前胶原(PCⅢ)、IV型胶原(IV-C)、透明质酸酶(HA)、层连粘蛋白(LN)等血清肝纤维化指标水平，脾脏厚度和门静脉内径，药物不良反应等，采用SPSS 20.0统计学软件进行统计学比较，记数资料采用x2检验，记量资料采用t检验。
2结果
2.1两组治疗前后肝功能、肝纤维化指标水平比较
结果见表1。观察组治疗后各项指标水平，与观察组治疗前和对照组治疗后比较，均有显著性统计学差异(P＜0.05)，提示观察组具有较好的改善肝功能和减轻肝脏硬化的治疗作用，其疗效明显优于对照组。
表1两组治疗前后肝功能和肝纤维化指标水平比较
注：与本组治疗前相比，△P＜0.05；与对照组治疗后相比，*P＜0.05。
2.2两组治疗前后脾脏厚度、门静脉内径比较
结果见表2。观察组治疗后脾脏厚度、门静脉内径，与观察组治疗前和对照组治疗后比较，均有显著性统计学差异(P＜0.05)，提示观察组具有较好的降低脾脏厚度和门静脉内径的治疗作用，其疗效明显优于对照组。
表2两组治疗前后脾脏厚度和门静脉内径比较
注：与观察组治疗前和对照组治疗后相比，△P＜0.05。
2.3两组药物不良反应比较
结果见表3。观察组药物不良反应明显小于对照组(P＜0.05)，提示本发明药物不良反应较小，并能减轻恩替卡韦的副作用。
表3两组药物不良反应比较[n,n(％)]
注：与对照组相比，△P＜0.05。
经反复试验，本发明其他实施例制备的中药均与实施例1取得了相同或相似的治疗效果，不再一一详述，防止累述。
3结论
本发明中药对代偿期乙肝后肝硬化具有较好的治疗效果，能够明显降低患者肝功能指标水平、血清肝纤维化指标水平和脾脏厚度、门静脉内径，其疗效明显优于目前西医疗法，且本发明原料丰富，制备方法简单，容易生产，疗效稳定可靠，服用安全，效果好，具有温阳补气、化痰活血之功效，有效用于治疗代偿期乙肝后肝硬化，是治疗代偿期乙肝后肝硬化药物上的创新，具有实际的临床意义和推广应用价值。
Claims (4)
1.一种治疗代偿期乙肝后肝硬化的中药，其特征在于，该中药是由以下重量计的原料药物制成：肉桂15-30g、红景天15-30g、干姜15-30g、土炒白术15-30g、海藻10-20g、山慈菇10-20g、马鞭草10-20g、水红花子10-20g和炒吴茱萸3-9g，将上述原料药物混合在一起，加入原料药物 10 倍重量的饮用水，浸泡 30 分钟，用武火煎沸，再用文火煎30分钟，过滤，得第一次滤液；再将药渣加入原料药物8倍重量的饮用水，用武火煎沸，再用文火煎25分钟，过滤，得第二次滤液；将两次滤液合并，中火煎煮浓缩至400mL，即得。
2.根据权利要求1所述的治疗代偿期乙肝后肝硬化的中药，其特征在于，由以下重量计的原料药物制成：肉桂20g、红景天20g、干姜20g、土炒白术20g、海藻15g、山慈菇15g、马鞭草15g、水红花子15g和炒吴茱萸6g，将上述原料药物混合在一起，加入1460mL饮用水，浸泡 30分钟，用武火煎沸，再用文火煎30分钟，过滤，得第一次滤液；再将药渣加入1168mL饮用水，用武火煎沸，再用文火煎25分钟，过滤，得第二次滤液；将两次滤液合并，中火煎煮浓缩至400mL，即得。
3.根据权利要求1所述的治疗代偿期乙肝后肝硬化的中药，其特征在于，由以下重量计的原料药物制成：肉桂15g、红景天15g、干姜15g、土炒白术15g、海藻10g、山慈菇10g、马鞭草10g、水红花子10g和炒吴茱萸3g，将上述原料药物混合在一起，加入原料药物 10 倍重量的饮用水，浸泡 30 分钟，用武火煎沸，再用文火煎30分钟，过滤，得第一次滤液；再将药渣加入原料药物8倍重量的饮用水，用武火煎沸，再用文火煎25分钟，过滤，得第二次滤液；将两次滤液合并，中火煎煮浓缩至400mL，即得。
4.根据权利要求1所述的治疗代偿期乙肝后肝硬化的中药，其特征在于，由以下重量计的原料药物制成：肉桂30g、红景天30g、干姜30g、土炒白术30g、海藻20g、山慈菇20g、马鞭草20g、水红花子20g和炒吴茱萸9g，将上述原料药物混合在一起，加入原料药物 10 倍重量的饮用水，浸泡 30 分钟，用武火煎沸，再用文火煎30分钟，过滤，得第一次滤液；再将药渣加入原料药物8倍重量的饮用水，用武火煎沸，再用文火煎25分钟，过滤，得第二次滤液；将两次滤液合并，中火煎煮浓缩至400mL，即得。
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