CN101214288B - 一种治疗肝病的中药组合物及其制备方法 - Google Patents
一种治疗肝病的中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗肝病的中药组合物及其制备方法。该中药组合物是由黄芪、葛根、柴胡、灵芝、赤芍、鳖甲、丹参、三七、鸡骨草、叶下珠按一定重量配比制备而成。它可以被制备成任何一种常用药物剂型。本发明中药组合物具有益气疏肝、活血软坚之功效。用于治疗肝炎、肝纤维化、肝硬化等肝病。
Description
技术领域
本发明涉及一种用于治疗肝病的中药组合物及其制备方法，属于中药领域。
背景技术
慢性肝炎是指病程在半年以上的肝脏慢性炎症性疾病。肝纤维化是指肝脏内纤维性***异常增生，多是持续性肝损伤或存在促纤维化刺激因子所致。肝硬化是各种原因所致的肝脏慢性、进行性的弥漫性改变，早期肝硬化系指临床上无任何特异性症状或体征，肝功能检查无明显异常，但在肝脏组织学上已有明显的病理变化。慢性乙肝是肝纤维化、肝硬化、肝癌、肝衰竭的主要危险因素；轻度的肝纤维化称为纤维肝，重者已伴有再生结节的假小叶形成时，则为肝硬化。
慢性肝炎目前尚缺乏特效的治疗方法。任何药物都不曾显示其对慢性病毒性肝炎的明确而肯定的疗效，因此目前仍在进行各种试验治疗，其治疗药物大体分三类：①抗病毒药物：包括干扰素、阿糖胞苷、磷酸阿糖胞、无环鸟苷等，其中以干扰素疗效较为肯定。②免疫调节剂：乙肝免疫球蛋白、乙肝疫苗、转移因子、免疫核糖核酸、卡介苗、免疫抑制剂、胸腺肽、猪苓多糖等，其中以免疫核糖核酸较为有效。③改善肝细胞功能的药物：如肌苷、维生素类、促肝细胞生长素等。
肝纤维化是多种病因发展为肝硬化的共同病理基础，抗纤维化的治疗旨在减轻纤维化的程度、延缓其发展，乃至逆转其病理进程。为此抗纤维化的治疗主要包括：①针对致病因子，治疗原发病。如抗肝炎病毒，治疗血吸虫病，防治酒精中毒等；②对抗肝纤维化发生发展的治疗；③如已发展至肝硬化，则需对其合并症进行防治；④对症及恢复肝功能的治疗。
肝硬化时肝组织已被增生的纤维组织改建，不易从形态结构上完全恢复正常，但是由于肝有强大代偿能力，只要及时治疗，常使疾病处于相对稳定状态，可维持相当长时期。此但如病变持续进行，发展到晚期，肝功能衰竭，患者可因肝昏迷而死亡。而目前早期肝硬化进展期的治疗药物主要有秋水仙碱、***素E(PGE)、干扰素(Interferon)、青酶胺、马洛替酯(Malotile)等，但国内外西医对其治疗尚缺乏特效的方法与药物。
目前所应用于肝病治疗的上述各药物中，多数药物在临床实践中均未得到预期的临床效果，由于西药抗肝纤维化、肝硬化、慢性肝炎的局限性，并且大多具有毒副作用。新中国建立以来，应用祖国医学治疗慢性肝病有了很大发展，中药抗肝纤维化、肝硬化、慢性肝炎的防治研究越来越受到重视，并且临床和科研研究发现中医药治疗肝病尤其是控制症状方面显示出一定优势。
我国是一个“肝病大国”，虽然在实施乙肝免疫计划后，乙肝发病得到一定控制，但目前平均每年发病约140万，居法定传染病第三位，在我国约1.2亿人携带乙肝病毒或其抗原，在乙肝患者中约20％可发展为慢性肝炎，而慢性乙肝又是肝硬化、肝癌、肝衰竭的主要危险因素，而肝纤维化则是各种慢性肝病向肝硬化发展的必经阶段。因此，开发出安全有效的药物来对肝病进行控制和治疗是非常重要的。
发明内容
本发明的目的在于提供一种新的中药组合物，该组合物具有益气疏肝、活血软坚之功能，用于治疗慢性肝炎、肝纤维化、早期肝硬化。
本发明的另-个目的在于提供上述中药组合物的制备方法。
本发明的第三个目的在于提供上述中药组合物在制备治疗慢性肝炎、肝纤维化、早期肝硬化的药物中的应用。
本发明是通过以下技术方案实现的：
本发明是由下述重量份的原料制成的：黄芪1-30份、葛根1-20份、柴胡1-20份、灵芝1-10份、赤芍1-20份、鳖甲1-20份、丹参1-20份、三七1-10份、鸡骨草1-20份、叶下珠1-30份。
优选的重量份为：黄芪5-15份、葛根1-10份、柴胡1-10份、灵芝1-6份、赤芍1-10份、鳖甲1-10份、丹参1-10份、三七1-6份、鸡骨草1-10份、叶下珠5-15份。
本发明中药组合物的制备方法如下：
将所述重量份的原料药分别加水或不同浓度的乙醇提取，提取液浓缩干燥得粗提物，或直接粉碎得到药材粉末，或采用精制方法，例如，水提醇沉法、有机溶剂萃取法、柱层析法、二氧化碳超临界萃取法、水蒸气蒸馏法进行精制得到精提物；将上述粗提物或药材粉末或精提物加入制备不同剂型时所需的各种常规辅料，如稀释剂、崩解剂、赋形剂、粘合剂、润滑剂、表面活性剂、填充剂、防腐剂、稳定剂、矫味剂、增稠剂、助流剂等，以常规的中药制剂方法制备成任何一种常用剂型，如片剂、分散片、泡腾片、口腔崩解片、含片、咀嚼片、胶囊剂、软胶囊剂、微囊剂、颗粒剂、丸剂、散剂、滴丸剂、缓释制剂、控释制剂、口服液体制剂、注射剂等。
本发明中药组合物的优选制备方法如下：
将鳖甲、灵芝水提取；黄芪、丹参、葛根、三七不同浓度的乙醇提取，减压回收乙醇；柴胡、鸡骨草、赤芍、叶下珠水提取；合并滤液，浓缩，干燥，粉碎成细粉，加入辅料，制成药剂学上任何一种药剂。
本发明中药组合物的最优选制备方法如下：
将鳖甲、灵芝加8倍量水提取3次，每次3小时，滤过，合并滤液，备用；黄芪、丹参、葛根、三七加入8倍量70％乙醇提取3次，每次1小时，滤过，合并滤液，60℃减压回收乙醇，备用；柴胡、鸡骨草、赤芍、叶下珠，加8倍量水提取3次，每次1小时，滤过，滤液与前述两种提取液合并，浓缩至相对密度为1.30-1.35(50℃)的稠膏，减压干燥(60℃，-0.08Mpa)，粉碎成细粉，加入适量糊精，混和均匀，加入5％PVPK30乙醇溶液为湿润剂，制粒，干燥，制得颗粒剂。
本发明中各药物作用机理如下：
黄芪：温，甘，归肺、脾经，具有补气固表、利尿托毒、排脓、敛疮生肌之功效。现代研究表明，黄芪有保护肝脏、防止肝糖原减少的作用，黄芪多糖有促进肝细胞再生的作用，临床利用粉末直接服用治疗肝脾肿大和肝病血清蛋白比例倒置等。
葛根：性凉，味甘、辛。具有解表退热，生津，透疹，升阳止泻的作用。葛根含异黄酮成分葛根素、葛根素木糖甙、大豆黄酮、大豆黄酮甙及β-谷甾醇、花生酸，又含多量淀粉(新鲜葛根中含量为19-20％)。葛根富含的黄酮类化合物能有效地清除-OH，抑制红细胞膜，肝、脾、脑组织的氧化损伤。体外实验表明，葛根异黄酮10-1000mg/g可明显抑制小鼠肝、肾组织及大白兔脑组织匀浆在振荡温度条件下引起的脂质过氧化产物(LPO)丙二醛的升高，并呈剂量效应关系。葛根可使主要吞噬碳粒的肝、脾脏的碳粒摄取功能增强，使细胞性免疫功能反应性恢复。葛根有利于肝脏有排毒解毒并有修复受损肝细胞的作用。药理实验表明，葛根对大鼠肝纤维化有预防作用。
柴胡：性味苦凉，有疏散退热、疏肝解郁、升恢复肝细胞的正常代谢和血液供应，促进损伤的修复与肝细胞阳举气之功效。临床上，除了传统的治疗肝郁气滞证之外。在现代也被用来治疗各种肝脏疾病，如肝硬化。从现代药理学角度讲，乙酰胆碱具有调节消化***和神经***功能的作用，乙酰胆碱可被胆碱酯酶水解。柴胡皂苷可以抑制胆碱酯酶，发挥拟胆碱样作用，进而对消化***和神经***发挥调节作用，从而治疗肝郁证.起到疏肝解郁的作用。肝星状细胞(HSC)又称贮脂细胞(FSC)，在某些病理状态下，FSC激活和增殖并合成胶原和细胞外基质(ECM)，使胶原和ECM过度蓄积从而形成肝纤维化。近期有实验证明：柴胡可以直接抑制HSC分泌胶原蛋白，抑制FSC激活和增殖，进而抑制FSC合成ECM的能力，而且还可以有效地稳定肝细胞膜***，中和可溶性细胞因子对肝细胞增殖的抑制效应，防止肝细胞损伤和坏死。柴胡可以抑制小鼠肝细胞的凋亡，对CCI4、D一氨基半乳糖和脂多糖与卡介苗致小鼠慢性肝损伤有显著的修复保护作用。
灵芝：平，甘。归心、肺、肝、肾经。具有补气安神、止咳平喘之功能。研究表明，灵芝及其复方制剂对实验动物具有不同程度的降血脂与肝酯作用，并有保护肝损伤作用；灵芝单味可降低血脂，减少肝指数，减轻肝脏脂肪变性；对抗由CCl4引起的肝损伤，防止其脂肪变性及炎细胞浸润。
赤芍：苦，微寒，归肝经。具有清热凉血、散瘀止痛之效。现代研究表明，赤芍对乙肝病毒DNAP有较强的直接抑制作用，可减少红细胞聚集、改善肝脏微循环、恢复肝细胞的正常代谢和血液供应，促进损伤的修复与肝细胞再生等作用。
鳖甲：有滋阴潜阳、软坚散结作用。研究表明鳖甲对大鼠实验性肝纤维化具有明显的保护作用，早期应用可以预防或延缓肝纤维化的形成和发展。
丹参：微寒，苦，归心、肝经，具有祛瘀止痛、活血通经、清心除烦之功能。研究表明丹参对肝脏缺血-再灌注损伤有明显的保护作用，对大鼠急性肝损伤有明显的保护作用，丹酚酸B-镁盐有抗大鼠D-半乳糖胺肝损伤的作用，丹参注射液对大鼠离体灌流肝及门静脉血管有一定的影响，对CCl4损伤的大鼠离体灌流肝有保护作用，能有效的推迟和减轻缺血后再灌流引起的不可逆肝损伤的作用，有促进肝再生的作用；对大鼠肝部分切除后肝脏DNA合成及细胞***增殖有明显的促进作用；对实验性肝硬变有防治作用；有促进肝纤维重吸收的作用；对慢性活动性患者肝功能有明显的改善作用；大剂量丹参有较好的抗肝纤维化的疗效；口服丹参制剂能使已经暴露于较强的肝癌危险因素的人群得到一定程度的保护等作用。
三七：味甘微苦，性温，归肝、胃经。具有散瘀止血，消肿定痛的作用。药理实验表明，三七对肝细胞损伤有一定的保护作用，并可明显抑制肝组织中成纤维细胞及胶原纤维增生，是较理想的防治肝纤维化的药物。
鸡骨草：甘，苦，性凉。归肝、胃经。具有清热解毒、舒肝止痛之功能，用于治疗黄疸、胁肋不舒、胃脘胀痛、急慢性肝炎、乳腺炎。临床用于治疗急性黄疸型肝炎，对CCl4所致急性肝损伤有一定的保护作用。
叶下珠：微苦、甘，凉。具有清热利尿，明目，消积的作用。药理实验证明，叶下珠片对乙肝病毒有抑制作用，具有保护肝细胞及提高细胞免疫力功能作用。
本发明以中医理论为依据，采用上述的有效药物成分相互配合组方，在研究并汇集历代传统名方特长的同时，结合现代科学研究的成果而成的临床验方。各种试验结果显示，其在治疗肝病疾患方面效果确切，表明其有效药物组分配合有序。本发明药物具有益气疏肝、活血软坚之功效，用于治疗慢性肝炎、肝纤维化、早期肝硬化脾虚肝郁、气血瘀阻证，症见胁肋刺痛或胀痛、食欲不振、脘腹胀满、大便溏烂、神疲乏力、面色晦暗、舌暗、苔薄、脉弦。
以下通过具体实施方式，对本发明的上述内容作进一步的详细说明：
具体实施方式
实施例1：
黄芪20g、葛根15g、柴胡15g、灵芝8g、赤芍15g、鳖甲15g、丹参15g、三七8g、鸡骨草15g、叶下珠20g
将鳖甲、灵芝加8倍量水提取3次，每次3小时，滤过，合并滤液，备用；黄芪、丹参、葛根、三七加入8倍量70％乙醇提取3次，每次1小时，滤过，合并滤液，60℃减压回收乙醇，备用；柴胡、鸡骨草、赤芍、叶下珠，加8倍量水提取3次，每次1小时，滤过，滤液与前述两种提取液合并，浓缩至相对密度为1.30-1.35(50℃)的稠膏，减压干燥(60℃，-0.08Mpa)，粉碎成细粉，加入适量糊精，混和均匀，加入60％乙醇溶液为湿润剂，制粒，干燥，即得颗粒剂。
实施例2：
黄芪20g、葛根6g、柴胡6g、灵芝5g、赤芍6g、鳖甲6g、丹参10g、三七5g、鸡骨草6g、叶下珠20g
将鳖甲、灵芝加8倍量70％乙醇提取3次，每次3小时，滤过，合并滤液，备用；黄芪、丹参、葛根、三七、柴胡、鸡骨草、赤芍、叶下珠加入8倍量70％乙醇提取3次，每次1小时，滤过，合并滤液，60℃减压回收乙醇，备用；合并滤液，浓缩至相对密度为1.30-1.35(50℃)的稠膏，减压干燥(60℃，-0.08Mpa)，粉碎成细粉，加入乳糖、淀粉适量，混匀，制粒，干燥，加入硬脂酸镁，混匀，压片，包衣，即得片剂。
实施例3：
黄芪10g、葛根10g、柴胡10g、灵芝10g、赤芍10g、鳖甲10g、丹参10g、三七10g、鸡骨草10g、叶下珠10g
将鳖甲、灵芝加8倍量水提取3次，每次3小时，滤过，合并滤液，备用；黄芪、丹参、葛根、三七、柴胡、鸡骨草、赤芍、叶下珠加8倍量水提取3次，每次1小时，滤过，合并滤液，备用；合并滤液，浓缩成清膏，加乙醇使含醇量达到65％，静置冷藏过夜，取上清液，减压回收乙醇，加入适量的糖精钠、香精、苯甲酸钠、山梨醇、吐温-80，搅拌混合均匀，加水定容，分装，即得口服液。
实施例4：
黄芪30g、葛根10g、柴胡6g、灵芝3g、赤芍6g、鳖甲6g、丹参10g、三七6g、鸡骨草6g、叶下珠30g
将鳖甲、灵芝加8倍量水提取3次，每次3小时，滤过，合并滤液，备用；黄芪、丹参、葛根、三七加入8倍量70％乙醇提取3次，每次1小时，滤过，合并滤液，60℃减压回收乙醇，备用；柴胡、鸡骨草、赤芍、叶下珠，加8倍量水提取3次，每次1小时，滤过，滤液与前述两种提取液合并，浓缩至相对密度为1.30-1.35(50℃)的稠膏，减压干燥(60℃，-0.08Mpa)，粉碎成细粉，加入酒石酸、碳酸氢钠、甜叶菊甙、木糖醇混匀，用无水乙醇制粒，干燥，加入硬脂酸镁，混匀，压制成片，即得泡腾片。
实施例5：
黄芪30g、葛根3g、柴胡10g、灵芝3g、赤芍10g、鳖甲3g、丹参3g、三七3g、鸡骨草10g、叶下珠20g
将鳖甲、灵芝加8倍量水提取3次，每次3小时，滤过，合并滤液，备用；黄芪、丹参、葛根、三七加入8倍量60％乙醇提取3次，每次1小时，滤过，合并滤液，60℃减压回收乙醇，备用；柴胡、鸡骨草、赤芍、叶下珠，加8倍量水提取3次，每次1小时，滤过，滤液与前述两种提取液合并，浓缩至相对密度为1.30-1.35(50℃)的稠膏，减压干燥(60℃，-0.08Mpa)，粉碎成细粉，加入乳糖，混匀，用95％乙醇制粒，干燥，装入胶囊，即得胶囊剂。
实施例6：
黄芪15g、葛根10g、柴胡10g、灵芝6g、赤芍10g、鳖甲10g、丹参10g、三七6g、鸡骨草10g、叶下珠15g
将鳖甲、灵芝加8倍量水提取3次，每次3小时，滤过，合并滤液，备用；黄芪、丹参、葛根、三七加入8倍量80％乙醇提取3次，每次1小时，滤过，合并滤液，60℃减压回收乙醇，备用；柴胡、鸡骨草、赤芍、叶下珠，加8倍量水提取3次，每次1小时，滤过，滤液与前述两种提取液合并，浓缩至相对密度为1.30-1.35(50℃)的稠膏，减压干燥(60℃，-0.08Mpa)，粉碎成细粉，加入低取代羟丙基纤维素，微晶纤维素，碳酸氢钙，以等量递增的方式混匀，用50％乙醇制粒，干燥，压制成片，即得分散片。
实施例7：
黄芪10g、葛根3g、柴胡20g、灵芝10g、赤芍20g、鳖甲2g、丹参20g、三七1g、鸡骨草20g、叶下珠5g
将鳖甲、灵芝加10倍量水提取3次，每次3小时，滤过，合并滤液，备用；黄芪、丹参、葛根加入10倍量90％乙醇提取3次，每次1小时，滤过，合并滤液，60℃减压回收乙醇，备用；柴胡、鸡骨草、赤芍、叶下珠，加8倍量水提取3次，每次1小时，滤过，合并滤液，浓缩至相对密度为1.30-1.35(50℃)的稠膏，减压干燥(60℃，-0.08Mpa)，粉碎成细粉，加入三七细粉，加入适量蜂蜜，混和均匀，制丸剂。
实施例8：
黄芪10g、葛根6g、柴胡6g、灵芝3g、赤芍6g、鳖甲6g、丹参6g、三七3g、鸡骨草6g、叶下珠10g
将鳖甲、灵芝加8倍量水提取3次，每次3小时，滤过，合并滤液，备用；黄芪、丹参、葛根、三七加入8倍量70％乙醇提取3次，每次1小时，滤过，合并滤液，60℃减压回收乙醇，备用；柴胡、鸡骨草、赤芍、叶下珠，加8倍量水提取3次，每次1小时，滤过，滤液与前述两种提取液合并，浓缩至相对密度为1.30-1.35(50℃)的稠膏，减压干燥(60℃，-0.08Mpa)，粉碎成细粉，加入适量糊精，混和均匀，加入5％PVPK30乙醇溶液为湿润剂，制粒，干燥，即得颗粒剂。
实施例9：
黄芪30g、葛根20g、柴胡20g、灵芝10g、赤芍20g、鳖甲20g、丹参20g、三七10g、鸡骨草20g、叶下珠30g
将鳖甲、灵芝加10倍量水提取3次，每次3小时，滤过，合并滤液，备用；黄芪、丹参、葛根加入15倍量50％乙醇提取3次，每次1小时，滤过，合并滤液，60℃减压回收乙醇，备用；柴胡、鸡骨草、赤芍、叶下珠，加15倍量水提取3次，每次1小时，滤过，合并滤液，浓缩至相对密度为1.30-1.35(50℃)的稠膏，减压干燥(60℃，-0.08Mpa)，粉碎成细粉，加入三七细粉，加入适量糊精，混和均匀，加入95％乙醇溶液为湿润剂，制粒，干燥，即得颗粒剂。
实施例10：
黄芪6g、葛根6g、柴胡6g、灵芝3g、赤芍6g、鳖甲6g、丹参6g、三七3g、鸡骨草6g、叶下珠6g
将鳖甲、灵芝加15倍量水提取3次，每次3小时，滤过，合并滤液，备用；黄芪、丹参、葛根、柴胡、鸡骨草、赤芍、叶下珠，加5倍量水提取3次，每次1小时，滤过，合并滤液，备用；合并两次滤液，浓缩至相对密度为1.30-1.35(50℃)的稠膏，减压干燥(60℃，-0.08Mpa)，粉碎成细粉，加入三七细粉，加入适量糊精，混和均匀，加入80％乙醇溶液为湿润剂，制粒，干燥，即得颗粒剂。
实施例11：
黄芪12g、葛根6g、柴胡6g、灵芝3g、赤芍8g、鳖甲6g、丹参8g、三七2g、鸡骨草6g、叶下珠12g
将鳖甲、灵芝加8倍量水提取3次，每次3小时，滤过，合并滤液，备用；黄芪、丹参、葛根、三七加入8倍量70％乙醇提取3次，每次1小时，滤过，合并滤液，60℃减压回收乙醇，备用；柴胡、鸡骨草、赤芍、叶下珠，加8倍量水提取3次，每次1小时，滤过，滤液与前述两种提取液合并，浓缩至相对密度为1.30-1.35(50℃)的稠膏，减压干燥(60℃，-0.08Mpa)，粉碎成细粉，加入适量糊精，混和均匀，加入5％PVPK30乙醇溶液为湿润剂，制粒，干燥，即得颗粒剂。
实施例12：
黄芪12g、葛根8g、柴胡6g、灵芝4g、赤芍10g、鳖甲3g、丹参6g、三七4g、鸡骨草10g、叶下珠10g
将鳖甲加水10倍量，高温高压提取，滤过，备用；将柴胡用水蒸汽蒸馏法提取挥发油，挥发油用beta-环糊精包合得beta-环糊精包合物，备用；将柴胡药渣、灵芝、黄芪、丹参、葛根、鸡骨草、赤芍、叶下珠加入10倍量70％乙醇提取3次，每次1小时，滤过，合并滤液，加入柴胡蒸馏后的水溶液，60℃减压回收乙醇，浓缩至相对密度为1.30-1.35(50℃)的稠膏，减压干燥(60℃，-0.08Mpa)，粉碎成细粉，加入三七细粉，加入挥发油beta-环糊精包合物，加入适量糊精，混和均匀，加入90％乙醇溶液为湿润剂，制粒，干燥，即得颗粒剂。
实施例13：
黄芪14g、葛根9g、柴胡9g、灵芝5g、赤芍9g、鳖甲9g、丹参9g、三七5g、鸡骨草9g、叶下珠14g
将鳖甲、灵芝加15倍量水提取3次，每次3小时，滤过，合并滤液，备用；黄芪、丹参、葛根、三七加入15倍量70％乙醇提取3次，每次1小时，滤过，合并滤液，60℃减压回收乙醇，备用；柴胡、鸡骨草、赤芍、叶下珠，加15倍量水提取3次，每次1小时，滤过，滤液与前述两种提取液合并，浓缩至相对密度为1.30-1.35(50℃)的稠膏，减压干燥(60℃，-0.08Mpa)，粉碎成细粉；取聚乙二醇4000加热熔融，加入微晶纤维素搅拌使溶解，加入上述细粉，混匀，滴入5-10℃的液体石蜡中，待滴丸冷却后取出，沥尽并擦除液体石蜡，即得滴丸剂。
实施例14：
黄芪5g、葛根1g、柴胡1g、灵芝1g、赤芍1g、鳖甲1g、丹参1g、三七1g、鸡骨草1g、叶下珠5g
将鳖甲、灵芝、黄芪、丹参、葛根、三七、柴胡、鸡骨草、赤芍、叶下珠粉碎成细粉，加入适量蜂蜜，制蜜丸。
通过以下实验来进一步阐述本发明所述中药组合物的有益效果：
1、选用四氯化碳引起的大鼠肝纤维化模型，测试本发明中药组合物对肝纤维化的治疗作用：
受试药物：本发明中药组合物(实施例11)
阳性对照药：***磷酸钠
其它：四氯化碳(分析纯)；配制方法：将四氯化碳配制成40％浓度的精制植物油溶液
动物：品系：SD大鼠；体重：230-250g；性别：雄性；每组动物数：20只
实验方法：本发明中药组合物高剂量组(36g/kg)、中剂量组(24g/kg)、低剂量组(12g/kg)，造模组，***磷酸钠组(0.6mg/g)，另设正常对照组。将四氯化碳配成40％浓度的精制植物油溶液，除正常对照组动物外，其他动物每周2次皮下注射，1ml/g，连续12周，同时，喂以高脂饲料和含5％酒精的水。治疗组同时给予受试药物或阳性对照药。给药4、12周每组随机取8只大鼠取血，称体重，测定血清ALT、AST、ALP、TP、ALB、T-BIL。取肝脏称重，每个动物取同一叶肝脏部位大致相同的一块肝组织固定于10％***做病理切片检查。
实验结果：模型组动物的ALT、AST、ALP、T-BIL明显高于正常大鼠，肝脏萎缩，体积变小，发黄，造模成功。给药4周时病理组织学检查发现模型组动物肝细胞呈重度弥漫性脂肪变性，中度水样变性，尤以小叶中央病变较为严重。肝脏轻度纤维化，主要表现在汇管区纤维母细胞增加较为明显，肝小叶周边胶元纤维略有增加，肝细胞再生不明显；***组动物肝细胞轻度脂肪变性，小叶中央病变较重，未见肝纤维化形成；本发明中药组合物三个剂量组动物肝细胞呈中度至重度弥漫性脂肪变性，中度水样变性，未见肝纤维化形成。给药12周病理组织学检查发现模型组动物肝细胞水样变性明显，有明显的肝细胞坏死和肝脂肪变性，有明显的肝纤维化，属肝硬化(+-++)；***组动物肝细胞有较明显的脂肪变性和水样变性，仅有轻度的肝纤维化：本发明中药组合物三个剂量组动物肝细胞仍有较明显的脂肪变性和水样变性，仅有轻度的肝纤维化，高、中剂量组纤维化程度与***组相似或略轻，低剂量组纤维化程度也较模型组轻。肝功能检查各项指标本发明中药组合物三个剂量组也较模型组低。
实验结论：本发明中药组合物对肝纤维化模型大鼠具有确切的抗肝纤维化作用，减少肝细胞脂肪变性坏死，促进肝细胞的增生、修复。
2、对D-氨基半乳糖所致急性肝损伤的保护作用：
昆明种小鼠雌雄兼用，18～22g，随机分为以下各组，即：正常对照组，D-氨基半乳糖盐酸盐模型组，本发明药物(实施例11)高剂量组(36g/kg)、中剂量组(24g/kg)、低剂量组(12g/kg)；正常对照及模型组给予生理盐水，各给药组给予相应药物，每日1次，持续10天。于第9天给药后1小时，腹腔注射D-Gal800mg/kg，正常对照组给予等量生理盐水。造模后24小时，末次给药后1h，眶后静脉取血，进行肝功能指标(ALT、AST)检测。结果见表1。
表1：对D-Gal所致急性肝损伤小鼠肝功能影响
| 组别 | 剂量(g/kg) | 小鼠数量(n) | ALT/U·L-1 | AST/U·L-1 |
| 正常对照组模型组低剂量组中剂量组高剂量组 | --122436 | 1010101010 | 35.21±4.55235.57±102.01**122.01±38.35△78.58±23.49△△63.41±19.85△△ | 92.12±15.23300.17±120.39**218.25±96.35164.12±47.28△98.53±23.42△△ |
注：与对照组相比，**P＜0.01；与模型组相比，△P＜0.05，△△P＜0.01。
实验结果表明：腹腔注射D-Gal后，模型组小鼠血清ALT、AST较正常组明显升高，本发明药物预先给药10天的3个剂量组，血清ALT、AST均较模型组明显降低。表明本发明药物对肝损伤模型具有保肝降酶作用，可用于治疗肝硬化、急慢性肝炎。
Claims (6)
1.一种治疗肝病的中药组合物，其特征在于，它是由下列重量份的原料药制成：黄芪1-30份、葛根1-20份、柴胡1-20份、灵芝1-10份、赤芍1-20份、鳖甲1-20份、丹参1-20份、三七1-10份、鸡骨草1-20份、叶下珠1-30份。
2.根据权利要求1的中药组合物，其特征在于，它是由下列重量份的原料药制成：黄芪5-15份、葛根1-10份、柴胡1-10份、灵芝1-6份、赤芍1-10份、鳖甲1-10份、丹参1-10份、三七1-6份、鸡骨草1-10份、叶下珠5-15份。
3.权利要求1或2所述的中药组合物的制备方法，其特征在于，该方法为：将所述重量配比的原料药直接粉碎得到药材粉末；或分别加水或不同浓度的乙醇提取，提取液浓缩干燥得粗提物；或采用水提醇沉法、水蒸气蒸馏法进行精制得到精提物；将上述药材粉末或粗提物或精提物与辅料混合，制成药剂学上任何一种药剂。
4.根据权利要求3所述的中药组合物的制备方法，其特征在于，该方法为：将鳖甲、灵芝水提取；黄芪、丹参、葛根、三七用不同浓度的乙醇提取，减压回收乙醇；柴胡、鸡骨草、赤芍、叶下珠水提取；合并滤液，浓缩，干燥，粉碎成细粉，加入辅料，制成药剂学上任何一种药剂。
5.根据权利要求4所述的中药组合物的制备方法，其特征在于，该方法为：将鳖甲、灵芝加8倍量水提取3次，每次3小时，滤过，合并滤液，备用；黄芪、丹参、葛根、三七加入8倍量70％乙醇提取3次，每次1小时，滤过，合并滤液，60℃减压回收乙醇，备用；柴胡、鸡骨草、赤芍、叶下珠，加8倍量水提取3次，每次1小时，滤过，滤液与前述两种提取液合并，浓缩至50℃时相对密度为1.30-1.35的稠膏，在60℃，负压0.08MPa下减压干燥，粉碎成细粉，加入适量糊精，混合均匀，加入5％PVPK30乙醇溶液为湿润剂，制粒，干燥，得颗粒剂。
6.权利要求1或2所述的中药组合物用于制备治疗肝炎、肝纤维化、肝硬化的药物的应用。
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