CN116832133A - 一种用于治疗脂肪肝的中药组合物及制备方法 - Google Patents
一种用于治疗脂肪肝的中药组合物及制备方法 Download PDFInfo
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- CN116832133A CN116832133A CN202310891287.0A CN202310891287A CN116832133A CN 116832133 A CN116832133 A CN 116832133A CN 202310891287 A CN202310891287 A CN 202310891287A CN 116832133 A CN116832133 A CN 116832133A
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Abstract
本发明公开一种用于治疗脂肪肝的中药组合物及制备方法,属于药物领域。该中药组合物按重量百分比计算,包括以下组分:泽泻20%‑25%;茵陈12%‑17%;枸杞子16%‑21%;柴胡6%‑11%;姜黄6%‑11%;大黄2%‑7%;红花1%‑5%;甘草6%‑11%。经动物实验对照证明本发明的中药组合物能有效降低肝重量比大小,肝脏脂肪变性、脂肪沉积、脂肪滴明显减少等症状。本发明提供的一种用于治疗脂肪肝的中药组合物对于治疗脾虚湿盛证和湿浊内盛所致、治疗肝失疏泄、脾失健运,致痰浊盛血互结,胆汁排泄受阻所致的脂肪肝效果显著。
Description
技术领域
本发明涉及药物领域,特别涉及一种用于治疗脂肪肝的中药组合物及制备方法。
背景技术
脂肪肝(Fatty liver disease,FLD)是一类肝细胞脂肪变性和脂肪蓄积为病理特征的一类疾病,脂肪肝所引起的肝脏损伤、肝纤维化、肝硬化、甚至肝癌等危害也越来越明显,严重威胁人类健康。目前全球范围内成人脂肪肝发病率大约占25%。是仅次于病毒性肝炎的第二大肝脏疾病。FLD可分为酒精性脂肪肝(alcoholic fatty liver)和非酒精性脂肪肝(non-alcoholic fatty liver disease.,NAFLD)。非酒精性脂肪肝根据临床表现特点,目前学术界公认属于中医的“痰症”、“湿阻”“胀满”、“积证”、“肋痛”等范畴,其症状期间会呈现大量肝细胞脂肪变性和脂肪蓄积的临床综合症,其发病与遗传、环境、代谢应激等有较大相关性,病因主要与肥胖、糖尿病、高脂血症、药物等相关。至现代,国家中医药管理局于2010年在《非酒精性脂肪肝中医诊疗方案》中,统一将其中医病名定位“肝癖”。据统计,FLD随着人们生活水平的不断提高,全球有低龄化的发展趋势。
《素问·宝命全形论》言“土得木而达之”。若肝气失于疏泄,则气机郁阻,人体气血津液输布障碍,停滞为血瘀、痰浊,痰瘀即由此而成,阻滞于肝则发为本病。同时,肝失疏泄,可导致脾胃气机升降失和,影响水谷精微的运化,聚湿生痰,壅积于肝,亦可发病为本病。依据中医理论,认为FLD病病位主要在肝,肝属木,喜条达,主疏泄,能调畅全身气机,促进全身气血津液的正常输布,还可影响脾胃的运化功能。,其临床表现可归属于“胁痛”“积聚”“痰浊”“肝积”“肺气病”等范畴。当前依据组织病理学变化可分为非酒精性单纯脂肪肝、脂肪性肝炎、肝硬化三种主要类型。
目前对脂肪肝防治尚无特效药物,临床一般采用护肝、降脂、抗氧化等药物治疗,以达到降低血脂,增强肝脏抗氧化能力,从而避免肝细胞损伤目的,但由于该病发病机制复杂,西药治疗效果均不显著,且在治疗过程中常引起药物不良反应,其临床疗效受限。
因此,如何通过早期治疗,以期延缓或防止FLD的进展,保护肝功能,防止肝脏的进一步损伤,提高患者的生活和生存质量,已成为各国肝脏病学者十分关注的焦点。由此,寻找安全有效、副作用低、价格低廉的药物对防治FLD具有重要的临床科学意义。
发明内容
本发明的目的是提供一种用于治疗脂肪肝的中药组合物及制备方法,以解决上述现有技术存在的问题,本发明提供的一种中药组合物,对于治疗脾虚湿盛证和湿浊内盛所致的脂肪肝效果显著。
为实现上述目的,本发明提供了如下方案:
技术方案一:一种用于治疗脂肪肝的中药组合物,按重量百分比计算,包括以下组分:泽泻20%-25%;茵陈12%-17%;枸杞子16%-21%;柴胡6%-11%;姜黄6%-11%;大黄2%-7%;红花1%-5%;甘草6%-11%。
技术方案二:一种所述的中药组合物的制备方法,包括以下步骤:按重量份称取原料,加热提取三次得到滤液,取所述滤液浓缩即得。
进一步地,所述加热提取三次得到滤液包括:第一次加入体积比为原料10倍的饮用水,100℃下提取3小时;第二次和第三次的提取均加入体积比为原料6倍的饮用水,100℃下提取2小时;合并加热提取三次得到的提取液,100目过筛,得到滤液。
进一步地,所述浓缩包括:在75℃-92℃下减压浓缩至相对密度为1.2~1.3。优选地,在80℃下减压浓缩至相对密度为1.2。
技术方案三:一种所述的中药组合物在制备治疗脂肪肝的药物中的应用。
进一步地,所述药物还包括药学上可接受的辅料。
进一步地,所述辅料包括糊精、倍他环糊精、食用香精、甜味剂、酸味剂、填充剂、润滑剂、防腐剂、助悬剂、食用色素、稀释剂或增塑剂中的至少一种。
进一步地,所述药物的剂型包括口服剂、颗粒剂、片剂、散剂、胶囊剂、蜜丸或贴剂。
本发明公开了以下技术效果:
本发明的有效成分由泽泻,茵陈,枸杞子,柴胡,姜黄,大黄,红花,甘草八味中药制成,其中,方中泽泻、茵陈为君药,茵陈为跨、辛、微寒,归脾、胃、肝胆经,具有利水渗湿、泄热之功效;枸杞子、柴胡为臣药,枸杞子味甘性平,入肝、肾经,具有补肾健脾、养肝明目、补中益气、滋养强身的功效;柴胡性味苦凉,有疏散退热、疏肝解郁、升阳举气之功效;姜黄、大黄、红花活血行气、通经止痛,为佐药;甘草解毒,调和诸药。诸药相合,全方配伍,共奏清热利湿、行气活血之功。
本发明将有效脾虚湿盛,温阳利水之功的中药组份进行科学配伍,发挥其相互协同作用,从而获得一种具有降低体重,肝脏重量及肝/体重比值下降,肝脏脂肪变性明显减少,TC(总胆固醇),TG(甘油三酯)水平下降明显的中药组合物。现代药理研究和实验已证实本发明中药组合物作用于小鼠后,其体重有所下降(P<0.0001),肝/体重比的降低(P<0.01)在给予治疗后有逆转,病理学检测结果TG水平下降明显(P<0.01)。本发明经动物实验对照证明能有效降低肝重量比大小,肝脏脂肪变性、脂肪沉积、脂肪滴明显减少等症状。此外,制备本发明药物所用药材均为常见药材,价格适中,材料易得,且制备工艺简单,适于产业化生产。
附图说明
为了更清楚地说明本发明实施例或现有技术中的技术方案,下面将对实施例中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图仅仅是本发明的一些实施例,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其他的附图。
图1为小鼠一般生理情况统计图;其中,A为MCD饮食诱导的日均/只小鼠粮食摄入量;B为小鼠体重变化曲线图;C为小鼠肝脏重量图;D为小鼠肝/体重比图;ND表示给予正常饮食的正常对照组小鼠、MCD表示给予4周MCD饮食的模型对照组小鼠、中药组合物-1表示给予4周MCD饮食+等倍临床剂量中药组合物低剂量小鼠、中药组合物-2表示给予4周MCD饮食+2倍临床剂量中药组合物高剂量小鼠;ns:无显著差异;*P<0.05;**P<0.01;***P<0.001;****P<0.0001;
图2为小鼠肝脏H&E染色和油红O染色结果图,其中,ND表示给予正常饮食的小鼠组、MCD表示给予4周MCD饮食的模型对照组小鼠、中药组合物-1表示给予4周MCD饮食+等倍临床剂量中药组合物低剂量小鼠、中药组合物-2表示给予4周MCD饮食+2倍临床剂量中药组合物高剂量小鼠;
图3为小鼠肝脏TC及TG含量分析结果图;其中,A为小鼠肝脏TC定量分析;B为小鼠肝脏TG定量分析;ns:无显著差异;*P<0.05;**P<0.01;***P<0.001;****P<0.0001,其中,ND表示给予正常饮食的小鼠组、MCD表示给予4周MCD饮食的模型对照组小鼠、中药组合物-1表示给予4周MCD饮食+等倍临床剂量中药组合物低剂量小鼠、中药组合物-2表示给予4周MCD饮食+2倍临床剂量中药组合物高剂量小鼠;
图4为小鼠血清TC、TG、T-Bil-V、ALT、AST、Glu-G水平检测指标结果图;ns:无显著差异;*P<0.05;**P<0.01;***P<0.001;****P<0.0001,其中ND表示给予正常饮食的小鼠组、MCD表示给予4周MCD饮食的模型对照组小鼠、中药组合物-1表示给予4周MCD饮食+等倍临床剂量中药组合物低剂量小鼠、中药组合物-2表示给予4周MCD饮食+2倍临床剂量中药组合物高剂量小鼠;
具体实施方式
现详细说明本发明的多种示例性实施方式,该详细说明不应认为是对本发明的限制,而应理解为是对本发明的某些方面、特性和实施方案的更详细的描述。
应理解本发明中所述的术语仅仅是为描述特别的实施方式,并非用于限制本发明。另外,对于本发明中的数值范围,应理解为还具体公开了该范围的上限和下限之间的每个中间值。在任何陈述值或陈述范围内的中间值,以及任何其他陈述值或在所述范围内的中间值之间的每个较小的范围也包括在本发明内。这些较小范围的上限和下限可独立地包括或排除在范围内。
除非另有说明,否则本文使用的所有技术和科学术语具有本发明所述领域的常规技术人员通常理解的相同含义。虽然本发明仅描述了优选的方法和材料,但是在本发明的实施或测试中也可以使用与本文所述相似或等同的任何方法和材料。本说明书中提到的所有文献通过引用并入,用以公开和描述与所述文献相关的方法和/或材料。在与任何并入的文献冲突时,以本说明书的内容为准。
在不背离本发明的范围或精神的情况下,可对本发明说明书的具体实施方式做多种改进和变化,这对本领域技术人员而言是显而易见的。由本发明的说明书得到的其他实施方式对技术人员而言是显而易见得的。本发明说明书和实施例仅是示例性的。
关于本文中所使用的“包含”、“包括”、“具有”、“含有”等等,均为开放性的用语,即意指包含但不限于。
实施例1
一种用于治疗脂肪肝的中药组合物(颗粒剂)的制备方法
将泽泻525g、茵陈350g、枸杞子436g、柴胡218g、姜黄218g、大黄131g、红花90g和甘草220g混合得到原料药,加入饮用水,饮用水加水量为原料药的10倍,加热提取3小时(100℃),得到提取液1;饮用水加水量为原料药的6倍,加热提取3小时(100℃),得到提取液2;饮用水加水量为原料药的6倍,加热提取3小时(100℃),得到提取液3;合并提取液1-3,过100目筛,得到滤液,将滤液放到温度为80℃下,减压浓缩至相对密度为1.20的浸膏。将上述浸膏2份、糊精0.8份和倍他环糊精0.2份混匀,制成颗粒,干燥后整粒,即得。分装成每袋装12克。服用方法:每次12g,每日3次,温开水送服。
实施例2
一种用于治疗脂肪肝的中药组合物(片剂)的制备方法
将泽泻525g、茵陈350g、枸杞子436g、柴胡218g、姜黄218g、大黄131g、红花90g和甘草220g混合得到原料药,加入饮用水,饮用水加水量为原料药的10倍,加热提取3小时(100℃),得到提取液1;饮用水加水量为原料药的6倍,加热提取3小时(100℃),得到提取液2;饮用水加水量为原料药的6倍,加热提取3小时(100℃),得到提取液3;合并提取液1-3,过100目筛,得到滤液,将滤液放到温度为90℃下,减压浓缩至相对密度为1.2的浸膏。将上述浸膏2份、糊精0.8份和倍他环糊精0.2份混匀,制成颗粒,干燥后整粒,80℃真空干燥,粉碎过65目筛得干粉,用体积分数为95%的乙醇作湿润剂制软材,过16目筛制粒,干燥,整粒,制粒完成后分装即得。服用方法:每次1片,每日3次,温开水送服。
实施例3
一种用于治疗脂肪肝的中药组合物(散剂)的制备方法
处方:将泽泻525g、茵陈350g、枸杞子436g、柴胡218g、姜黄218g、大黄131g、红花90g和甘草220g。制备方法:按上述配方配比取原料药,将泽泻、茵陈、枸杞子、柴胡、姜黄、大黄和甘草研碎成粉末后,再加入红花,将8味中药材充分混匀,制成粉剂,分装,即得。分装成每袋装12克。服用方法:每次1包,每日3次,温开水送服。
实施例4
一种用于治疗脂肪肝的中药组合物(胶囊剂)的制备方法
处方:将泽泻525g、茵陈350g、枸杞子436g、柴胡218g、姜黄218g、大黄131g、红花90g和甘草220g。制备方法:按上述配方配比取原料药,将泽泻、茵陈、枸杞子、柴胡、姜黄、大黄和甘草研碎成粉末后,再加入红花,将8味中药材充分混匀,其中,按照中药材:糊精:环糊精=1:0.4:0.1混合,分装成每粒胶囊12克。服用方法:每次1粒,每日3次,温开水冲服。
实施例5
一种用于治疗脂肪肝的中药组合物(蜜丸)的制备方法
处方:将泽泻525g、茵陈350g、枸杞子436g、柴胡218g、姜黄218g、大黄131g、红花90g和甘草220g。制备方法:按上述配方配比取原料药,将泽泻、茵陈、枸杞子、柴胡、姜黄、大黄和甘草研碎成粉末后,再加入红花,将8味中药材充分研成细粉加入炼蜜(药粉:蜂蜜=1.5:1),拌匀,制成柔软、坚硬、适宜和可塑性好的软材,再依次制丸条、分丸粒、搓圆丸粒。即得。分装成每个蜜丸12克。服用方法:每次12g,每日3次,温开水冲服。
实施例6
一种用于治疗脂肪肝的中药组合物(贴剂)的制备方法
处方:泽泻525g、茵陈350g、枸杞子436g、柴胡218g、姜黄218g、大黄131g、红花90g和甘草220g。制备方法:按上述配方配比取原料药,将泽泻、茵陈、枸杞子、柴胡、姜黄、大黄和甘草研碎成粉末后,再加入红花,将8味中药材充分研成细粉涂在基材上,均匀地涂抹在基材表面,形成贴剂的主体,进行涂布;根据贴剂的规格和大小要求,将涂布好的基材切割成相应的形状和尺寸;将切割好的贴剂进行质量检验,包括外观、粘附力等多个方面的检查,以确保贴剂符合生产标准和质量要求。使用方法:每次1贴,贴于右下腹,每日3次,洁肤后使用。
实施例7
本实施例为效果应用试验例,下面将通过动物实验来证明本发明中药组合物具有的技术效果。
1药效学实验
为验证本发明药物在减少脂肪肝内脂肪蓄积、减轻脂肪肝内脂肪变性的药理作用,为其临床使用提供科学依据,特进行以下药效学实验。本实验采用蛋氨酸胆碱缺乏饲料(Methionine and Choline Deficient L-AminoAcid Diet,MCD)饮食诱导的小鼠脂肪肝模型,根据脂肪肝主要指标及其病理切片进行检测。
1.1实验材料
1.1.1实验对象
8周龄SPF级雄性C57 BL/6J小鼠24只,体重为20g~22g,购自斯贝福(北京)生物技术有限公司。
1.1.2实验条件
小鼠饲养于室温18-24℃,相对湿度为65%的屏障环境内,接受明暗交替12h的光照,按3只/笼进行分笼饲养,给予自由饮水,饲料给予标准饲料或MCD饲料,适应性饲养7天。
1.1.3主要实验仪器设备
深圳迈瑞全自动生化分析仪、LEICA石蜡切片机RM2245、LEICA冰冻切片机CM1950、I3x多功能酶标仪、OLYMPUS BX63全自动荧光显微镜N21773。
1.2实验方法
1.2.1实验分组
小鼠随机分为4组,6只一组,分别为:正常对照组、模型对照组、中药组合物低剂量组(等倍临床剂量)、中药组合物高剂量组(2倍临床剂量)。除正常对照组给予正常饮食外,其余3组给予MCD饮食4周诱导构建脂肪肝模型,中药组合物低剂量组及高剂量组同时给予中药组合物治疗。
1.2.2给药方法
中药组合物低剂量组及中药组合物高剂量组在给予MCD饮食喂养同时给予中药组合物灌胃治疗,灌胃时间与MCD饮食喂养同步,共4周,其中中药组合物低剂量组按5.46g/kg/d给药,中药组合物高剂量组按10.92g/kg/d给药,以灭菌去离子水为溶剂溶解后,于每日早上予小鼠灌胃治疗。而正常对照组小鼠每日给予与中药组合物低剂量组等量的灭菌去离子水灌胃,模型对照组小鼠在给予MCD饮食喂养同时给予与中药组合物低剂量组等量的灭菌去离子水灌胃,持续4周,直至实验结束。
1.2.3小鼠体重、肝脏重量及粮食摄入量
从给予MCD喂养后开始称重,每隔2天称量一次小鼠体重及饲料重量,及时补充新鲜饲料,记录小鼠体重变化曲线。实验结束时对小鼠进行称重后,予小鼠以麻醉后使用颈椎脱臼法处死小鼠取出肝脏进行称重,计算肝/体重比。
1.2.4小鼠肝脏组织病理学染色
H&E染色:实验结束取出小鼠肝脏浸泡于4%多聚甲醛中进行固定,行常规石蜡包埋后切片,厚度为3μM。切片于65℃烤箱烤片2h后,经二甲苯及梯度酒精脱蜡水化,PBS缓冲液冲洗后进行苏木素染色;再经盐酸酒精分化,水洗返蓝;0.5%伊红乙醇液染色后,置于梯度酒精及二甲苯中脱水透明;使用中性树脂封片保存,显微镜下观察及拍照。
油红O染色:取新鲜肝脏组织标本于OCT中包埋,置于-20℃进行速冻保存,行冰冻切片获得15μM厚度的切片。待冰冻切片回温后,用洗涤液洗涤20s,吸除洗涤液,加入适量改良油红O染色液(上海碧云天,货号:C0158),染色30min;去除改良油红O染色液,将适量染色洗涤液滴加于切片上,静置30s后去除染色洗涤液,浸入蒸馏水中置摇床洗涤20s;用苏木素染色液进行细胞核的复染;染色完成后使用甘油明胶封片保存,显微镜下观察及拍照。
1.2.5小鼠肝脏组织总胆固醇(TC)及甘油三酯(TG)含量测定
实验结束后取适量小鼠肝脏组织加入无水乙醇,经组织研磨仪研磨后于4℃,2500rpm条件下离心10min,取上清液;依据试剂盒(南京建成,货号:A110-1-1、A111-1-1)说明书加入标准品、蒸馏水、样品各2.5μL、工作液250μL,混匀后于37℃孵育10min,于酶标仪500nm或510nm波长下检测吸光度,而后根据公式计算其相应的含量。
1.2.6小鼠血清学指标检测
实验结束后,采用眼球取血法采集小鼠血液到5ml EP管中,以常温4000rpm离心10min,取上层血清转移至1.5ml EP管中,使用全自动生化分析仪检测血清的丙氨酸转氨酶(ALT)、天冬氨酸转氨酶(AST)、总胆红素(TBIL)、总胆固醇(TC)、甘油三酯(TG)、葡萄糖(Glu-G)。若不能马上检测,则应置于-80℃保存。
1.2.7数据分析
使用GraphPad Prism 8.0.2进行数据统计分析,结果以均数±标准差(mean±SD)表示,用one-wayANOVA进行显著性分析,ns代表无显著差异,*P<0.05,**P<0.01,***P<0.001,****P<0.0001。
1.3结果
1.3.1小鼠一般生理情况
从图1可看出,A为MCD饮食诱导的日均/只小鼠粮食摄入量;B为小鼠体重变化曲线图;C为小鼠肝脏重量图;D为小鼠肝/体重比图;ns:无显著差异;*P<0.05;**P<0.01;***P<0.001;****P<0.0001给予MCD饮食的各组小鼠饲料摄入量无显著差异;模型对照组、中药组合物低剂量组及中药组合物高剂量组小鼠的体重、肝脏重量较正常对照组有所下降(P<0.0001),但肝/体重比的降低(P<0.01)在给予中药组合物治疗后有逆转趋势。
1.3.2小鼠肝脏病理学及TC、TG含量变化
从图2的H&E及油红O染色可看出,模型对照组、中药组合物低剂量组及中药组合物高剂量组小鼠出现肝脏脂肪变性,且中药组合物低剂量组的肝脏脂肪变性较模型对照组稍有减轻,中药组合物高剂量组的肝脏脂肪变性较中药组合物低剂量组进一步减轻。
从图3(A为小鼠肝脏TC定量分析;B为小鼠肝脏TG定量分析;ns:无显著差异;*P<0.05;**P<0.01;***P<0.001;****P<0.0001;)可看出,正常对照组、模型对照组、中药组合物低剂量、中药组合物高剂量组的小鼠肝内TC检测无显著差异;模型对照组小鼠肝脏TG含量较正常对照组明显增加,中药组合物低剂量组TG水平较模型对照组有下降趋势,而中药组合物高剂量组TG水平较模型对照组下降明显(P<0.01)。
1.3.3小鼠血清学指标变化
从图4可看出,模型对照组、中药组合物低剂量组及中药组合物高剂量组较正常对照组小鼠的血清TC及Glu-G水平均下降(P<0.0001)。模型对照组小鼠血清TG水平较正常对照组下降(P<0.01),给予中药组合物治疗后有逆转MCD饮食导致的血清TG水平降低的趋势。模型对照组小鼠血清ALT、AST水平较正常对照组升高,但给予中药组合物治疗未能降低这两者的水平。模型对照组小鼠血清T-Bil-V水平较正常对照组上升(P<0.0001),中药组合物低剂量组、中药组合物高剂量组的小鼠血清T-Bil-V水平较模型对照组下降(P<0.05)。
1.4结论
小鼠一般生理情况统计图详见图1;小鼠肝脏H&E染色和油红O染色结果图详见图2;小鼠肝脏TC及TG含量分析结果图详见图3;小鼠血清TC、TG、T-Bil-V、ALT、AST、Glu-G水平检测指标结果图详见图4。本实验采用蛋氨酸胆碱缺乏(Methionine and CholineDeficient L-AminoAcid Diet,MCD)饮食诱导的小鼠脂肪肝模型,验证了本发明的中药组合物对肝重量有所下降,给予HE及油红O染色可见,2倍临床剂量组的肝脏脂肪变性明显减少,脂肪沉积、脂肪滴明显减少,定量分析小鼠肝脏脂肪变性结果表明:2倍临床剂量组TG水平下降明显。脂肪变性定性及定量结果表明:中药组合物能减轻MCD饮食诱导脂肪肝的肝脏脂肪变性。小鼠的血清学结果说明中药组合物可能减轻肝脏脂肪变性,能够降低T-Bil-V水平;可能适用于总胆红素水平(T-Bil-V)高的脂肪肝治疗。上述结果证明,本发明提供的一种用于治疗脂肪肝的中药组合物对于治疗脾虚湿盛证和湿浊内盛所致、治疗肝失疏泄、脾失健运,致痰浊盛血互结,胆汁排泄受阻所致的脂肪肝效果显著,值得临床推广应用。
综上所述,本发明的中药组合物是根据脂肪肝的中医病机及现代医学的发病机理,按照中医的辨证及理法组方,用现代制药工艺制成有效延缓和治疗脂肪肝的药物,经动物实验对照证明能有效降低肝重量比大小,肝脏脂肪变性、脂肪沉积、脂肪滴明显减少等症状。此外,制备本发明药物所用药材均为常见药材,价格适中,材料易得,且制备工艺简单,适于产业化生产。
以上所述的实施例仅是对本发明的优选方式进行描述,并非对本发明的范围进行限定,在不脱离本发明设计精神的前提下,本领域普通技术人员对本发明的技术方案做出的各种变形和改进,均应落入本发明权利要求书确定的保护范围内。
Claims (8)
1.一种用于治疗脂肪肝的中药组合物,其特征在于,按重量百分比计算,包括以下组分:泽泻20%-25%;茵陈12%-17%;枸杞子16%-21%;柴胡6%-11%;姜黄6%-11%;大黄2%-7%;红花1%-5%;甘草6%-11%。
2.一种权利要求1所述的中药组合物的制备方法,其特征在于,包括以下步骤:按重量份称取原料,加热提取得到滤液,取所述滤液浓缩即得。
3.如权利要求2所述的制备方法,其特征在于,所述加热提取得到滤液包括:第一次加入体积比为原料10倍的饮用水,100℃下提取3小时;第二次和第三次提取均加入体积比为原料6倍的饮用水,100℃下提取2小时;合并加热提取三次得到的提取液,100目过筛,得到滤液。
4.如权利要求2所述的制备方法,其特征在于,所述浓缩包括:在75℃-92℃下减压浓缩至相对密度为1.2~1.3。
5.一种如权利要求1所述的中药组合物在制备治疗脂肪肝的药物中的应用。
6.根据权利要求5所述的应用,其特征在于,所述药物还包括药学上可接受的辅料。
7.如权利要求5所述的应用,其特征在于,所述辅料包括糊精、倍他环糊精、食用香精、甜味剂、酸味剂、填充剂、润滑剂、防腐剂、助悬剂、食用色素、稀释剂或增塑剂中的至少一种。
8.根据权利要求5所述的应用,其特征在于,所述药物的剂型包括口服剂、颗粒剂、片剂、散剂、胶囊剂、蜜丸或贴剂。
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