CN114272349A - 一种健脾养肝的中药组合物及其制备方法和应用 - Google Patents
一种健脾养肝的中药组合物及其制备方法和应用 Download PDFInfo
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- CN114272349A CN114272349A CN202111554603.2A CN202111554603A CN114272349A CN 114272349 A CN114272349 A CN 114272349A CN 202111554603 A CN202111554603 A CN 202111554603A CN 114272349 A CN114272349 A CN 114272349A
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Abstract
本发明提供了一种健脾养肝的中药组合物及其制备方法和应用,所述组合物质量组成如下:蒲公英10‑30份,白花蛇舌草10‑30份,金银花10‑30份,柴胡1‑10份,当归5‑20份,白芍5‑20份,川芎3‑15份,炒白术5‑20份,茯苓5‑20份,制山楂5‑20份,六神曲1‑10份,炒鸡内金3‑15份,莱菔子1‑10份,制青皮2‑12份,薤白1‑8份,川连1‑10份,泡姜1‑10份和甘草1‑10份。本发明能够调补气血,健脾养肝,理气消痞,是病毒性肝炎、胃癌、肝癌前期和恢复期的基本方药。
Description
本申请是申请日为2018年11月15日、申请号为201811359557.9、发明名称为《一种健脾养肝的中药组合物及其制备方法》的分案申请。
技术领域
本发明属于中药制剂领域,具体涉及一种健脾养肝的中药组合物及其制备方法和应用。
背景技术
非酒精性脂肪性肝病已成为临床常见的肝脏疾病之一,是血清转氨酶异常的首要原因。其中非酒精性脂肪性肝炎是由非酒精性脂肪肝向非酒精性脂肪性肝硬化转化过程中一个非常重要的中间环节,是隐源性肝硬化的重要原因之一。研究表明,非酒精性脂肪性肝炎的预后不佳,约50%的非酒精性脂肪性肝炎会发展成肝纤维化,15%~30%发展成肝硬化,而3%将发展成肝功能衰竭。因此,研究非酒精性脂肪性肝炎的防治策略是目前国内外肝病界的研究热点之一。
目前现代医学尚无治疗非酒精性脂肪性肝病的特效药物,主要以祛除病因及诱因、治疗原发基础病为主,以阻止慢性肝病发展,防治脂肪性肝炎;终末期肝病则以肝移植治疗。但治疗的效果不能令人满意,尤其是非酒精性脂肪性肝炎伴有肝脏酶学改变、高脂血症。中医药对非酒精性脂肪性肝炎的防治具有独特的作用和优势,尤其在保肝降酶,改善肝功能,调节肝脏脂质代谢,降低血脂,改善患者的生活质量上具有明显优势。本研究从非酒精性脂肪性肝炎的关键病机“脾虚肝郁,痰浊瘀阻”及传统医学“见肝之病,当先实脾”的理论角度出发,从肝脾论治创立本发明药物组合物,以达健脾疏肝、活血化浊,从而防治非酒精性脂肪性肝炎。
中国专利(公开号CN102641469)公开了一种预防或治疗非酒精性脂肪肝性肝炎的药物组合物,该组合物由绞股蓝、郁金、白术、水飞蓟、泽泻、茯苓、决明子、丹参、白芥子和山楂组成。该药物组合物具有健脾疏肝,活血化浊之功效,对用于预防或治疗非酒精性脂肪性肝炎效果显著。还公开了该药物组合物的制备方法,具体为按照常规工艺加入常规辅料制成临床可接受的制剂。然而上述对该药物组合物的制备方法制备得到的药物制剂中有效的药效成分含量比较低,导致药物组合物质量差,不能最大限度地发挥该药物组合物的药效作用,影响其健脾疏肝,活血化浊的治疗功效,用于预防或治疗非酒精性脂肪性肝炎效果比较低。
中国专利(申请号CN201310179566.0)公开了一种降脂护肝中药组合物及其制备方法和应用,是由中药组分和药用辅料制成的复方制剂,其特征在于:按重量份数计算,所述中药组分的配方包括:白背三七60~120份,葛根50~110份,白芍20~60份。本发明的有益效果在于,根据传统中医药理论,组成可以降脂护肝的有效方剂,并通过现代药剂学手段做成胶囊剂等现代剂型,使得本发明制剂的药效更显著,服用更加方便。本发明具有降脂、护肝的作用,可用于预防和治疗高血脂、肥胖、病毒性肝炎、化学性肝损伤、酒精性肝损伤等。其不足之处在于:治疗的效果不能令人满意,尤其是非酒精性脂肪性肝炎伴有肝脏酶学改变、高脂血症。
中国专利(申请号CN200610155717.9)公开了一种扶正益肝中药组合物及其制剂与应用,所述组合物质量组成如下:紫河车粉0.5~5份,丹参10~30份,黄芪10~30份,女贞子10~30份,虫草菌0.5~5份和三七粉1~8份。本发明所述扶正益肝中药组合物可明显提高HBV-DNA转阴率、HBeAg转换率,提高临床疗效的完全应答率,并使YMDD变异减少;尤其是与拉米夫定同时使用,可明显提高其疗效,减少其致病毒变异的副作用。其不足之处在于:单纯使用中医治疗慢性乙肝,HBV-DNA转阴率、HBeAg转换率以及综合疗效不能与拉米夫定媲美。
基于此,有必要提出一种健脾和胃的中药组合物及其制备方法,以解决现有技术中存在的问题。
发明内容
鉴于上述对现有技术的分析,本发明提供了一种健脾养肝的中药组合物及其制备方法和应用,可作为治疗肝脾不和,肝郁气滞,病毒性肝炎,胃癌,肝癌前期和恢复期的基本方药,且制备工艺简单,具有广阔的应用前景。
为了达到上述目的,本发明通过以下技术方案来实现的:
一种健脾养肝的中药组合物,由如下质量份的组分组成:蒲公英10-30份,白花蛇舌草10-30份,金银花10-30份,柴胡1-10份,当归5-20份,白芍5-20份,川芎3-15份,炒白术5-20份,茯苓5-20份,制山楂5-20份,六神曲1-10份,炒鸡内金3-15份,莱菔子1-10份,制青皮2-12份,薤白1-8份,川连1-10份,泡姜1-10份和甘草1-10份。
优选地,由如下质量份的组分组成:蒲公英30份,白花蛇舌草30份,金银花30份,柴胡10份,当归20份,白芍20份,川芎15份,炒白术20份,茯苓20份,制山楂20份,六神曲10份,炒鸡内金15份,莱菔子10份,制青皮12份,薤白8份,川连10份,泡姜10份和甘草10份;
或者由如下质量份的组分组成:蒲公英20份,白花蛇舌草20份,金银花20份,柴胡10份,当归15份,白芍15份,川芎15份,炒白术15份,茯苓15份,制山楂15份,六神曲10份,炒鸡内金10份,莱菔子10份,制青皮10份,薤白5份,川连5份,泡姜5份和甘草5份;
或者由如下质量份的组分组成:蒲公英15份,白花蛇舌草15份,金银花15份,柴胡10份,当归20份,白芍20份,川芎15份,炒白术20份,茯苓20份,制山楂20份,六神曲10份,炒鸡内金8份,莱菔子8份,制青皮8份,薤白5份,川连5份,泡姜5份和甘草5份;
或者由如下质量份的组分组成:蒲公英25份,白花蛇舌草25份,金银花25份,柴胡8份,当归8份,白芍8份,川芎8份,炒白术10份,茯苓10份,制山楂10份,六神曲5份,炒鸡内金10份,莱菔子10份,制青皮10份,薤白5份,川连5份,泡姜5份,甘草5份
本发明还提供了一种健脾养肝的中药组合物制备方法,包括如下步骤:
(1)按照所述的质量份数称取蒲公英、白花蛇舌草、金银花,加入14倍上述称取的原料药重量的质量浓度为70%的乙醇溶液进行回流提取3次,每次煎煮1.5小时,然后过滤并回收乙醇,将所得滤液浓缩后进行干燥,粉碎,过筛,得到第一干膏粉,备用;
(2)按照所述的质量份数称取柴胡、当归、白芍、川芎、炒白术、茯苓、制山楂、六神曲、炒鸡内金、莱菔子、制青皮、薤白、川连、泡姜、甘草混合均匀,加入8倍上述称取的原料药重量的水进行煎煮3次,每次煎煮1小时,过滤,将所得滤液浓缩成相对密度为1.11-1.15的浸膏,冷却,然后向所述浸膏中加入乙醇或乙醇溶液至所述浸膏中醇的质量浓度为60%,冷藏静置,过滤并回收乙醇,将得到的浓缩液干燥,粉碎,过筛,得到第二干膏粉,备用;
(3)将步骤(1)中获得的所述第一干膏粉和步骤(2)中获得的所述第二干膏粉混匀,加入辅料,采用常规工艺制成临床上可接受的剂型。
进一步地,所述步骤(1)中的浓缩为低温浓缩,浓缩温度为20-60℃。
进一步地,所述步骤(2)中的浓缩为减压浓缩,浓缩温度为60-80℃。
进一步地,所述步骤(1)和步骤(2)中的过筛为过20-200目筛。
进一步地,步骤(3)中所述辅料为糊精。
进一步地,所述辅料的加入量为所述第一干膏粉和所述第二干膏粉的混合物重量的40-60%。
本发明还提供了上述中药组合物在制备预防肝损伤药物中的应用。
本发明还提供了上述中药组合物在制备升高SOD活性和/或降低MDA含量的药物中的应用。
本发明与现有技术相比,具有如下的有益效果:
(1)对四氯化碳诱导的小鼠急性肝损伤,本发明可明显降低小鼠血清中ALT、AST含量,能降低CCl4对肝细胞膜的溶解作用,对肝细胞膜具有一定的保护作用,肝组织病理切片镜检结果也证实了本发明提供的受试样能减轻干细胞变性、坏死、出血,促进肝细胞再生,对肝脏起到较好的保护作用。
(2)本发明可降低BCG+LPS诱导免疫肝损伤小鼠的脏器系数和血清转氨酶,升高肝匀浆SOD活性,降低MDA含量,对免疫性肝损伤有保护作用。
(3)本发明中药组合物具有调补气血,健脾和胃,理气消痞的功能,能够恢复肝脾功能,保护肝损伤;且生产成本低、工艺简单,是病毒性肝炎、胃癌、肝癌前期和恢复期的基本方药。
具体实施方式
以下通过实施例形式,对本发明的上述内容再作进一步的详细说明,但不应将此理解为本发明上述主题的范围仅限于以下实施例,凡基于本发明上述内容所属实现的技术均属于本发明的范围。
实施例1
一种健脾养肝的中药组合物,所述组合物质量组成如下:蒲公英30份,白花蛇舌草30份,金银花30份,柴胡10份,当归20份,白芍20份,川芎15份,炒白术20份,茯苓20份,制山楂20份,六神曲10份,炒鸡内金15份,莱菔子10份,制青皮12份,薤白8份,川连10份,泡姜10份,甘草10份。
一种健脾养肝的中药组合物制备方法,包括如下步骤:
(1)按照所述的质量份数称取蒲公英、白花蛇舌草、金银花,加入14倍上述称取的原料药重量的质量浓度为70%的乙醇溶液进行回流提取3次,每次煎煮1.5小时,然后过滤并回收乙醇,将所得滤液在温度为60℃下低温浓缩后进行干燥,粉碎,过100目筛,得到第一干膏粉,备用;
(2)按照所述的质量份数称取柴胡、当归、白芍、川芎、炒白术、茯苓、制山楂、六神曲、炒鸡内金、莱菔子、制青皮、薤白、川连、泡姜、甘草混合均匀,加入8倍上述称取的原料药重量的水进行煎煮3次,每次煎煮1小时,过滤,将所得滤液在温度为60℃下减压浓缩成相对密度为1.11-1.15的浸膏,冷却,然后向所述浸膏中加入乙醇或乙醇溶液至所述浸膏中醇的质量浓度为60%,冷藏静置,过滤并回收乙醇,将得到的浓缩液干燥,粉碎,过100目筛,得到第二干膏粉,备用;
(3)将步骤(1)中获得的所述第一干膏粉和步骤(2)中获得的所述第二干膏粉混匀,加入第一干膏粉和所述第二干膏粉的混合物重量的40%的糊精,采用常规工艺制成临床上可接受的剂型,即得。
实施例2
一种健脾养肝的中药组合物,所述组合物质量组成如下:蒲公英20份,白花蛇舌草20份,金银花20份,柴胡10份,当归15份,白芍15份,川芎15份,炒白术15份,茯苓15份,制山楂15份,六神曲10份,炒鸡内金10份,莱菔子10份,制青皮10份,薤白5份,川连5份,泡姜5份,甘草5份。
一种健脾养肝的中药组合物制备方法,包括如下步骤:
(1)按照所述的质量份数称取蒲公英、白花蛇舌草、金银花,加入14倍上述称取的原料药重量的质量浓度为70%的乙醇溶液进行回流提取3次,每次煎煮1.5小时,然后过滤并回收乙醇,将所得滤液在温度为50℃下低温浓缩后进行干燥,粉碎,过150目筛,得到第一干膏粉,备用;
(2)按照所述的质量份数称取柴胡、当归、白芍、川芎、炒白术、茯苓、制山楂、六神曲、炒鸡内金、莱菔子、制青皮、薤白、川连、泡姜、甘草混合均匀,加入8倍上述称取的原料药重量的水进行煎煮3次,每次煎煮1小时,过滤,将所得滤液在温度为70℃下减压浓缩成相对密度为1.11-1.15的浸膏,冷却,然后向所述浸膏中加入乙醇或乙醇溶液至所述浸膏中醇的质量浓度为60%,冷藏静置,过滤并回收乙醇,将得到的浓缩液干燥,粉碎,过150目筛,得到第二干膏粉,备用;
(3)将步骤(1)中获得的所述第一干膏粉和步骤(2)中获得的所述第二干膏粉混匀,加入第一干膏粉和所述第二干膏粉的混合物重量的50%的糊精,采用常规工艺制成临床上可接受的剂型,即得。
实施例3
一种健脾养肝的中药组合物,所述组合物质量组成如下:蒲公英15份,白花蛇舌草15份,金银花15份,柴胡10份,当归20份,白芍20份,川芎15份,炒白术20份,茯苓20份,制山楂20份,六神曲10份,炒鸡内金8份,莱菔子8份,制青皮8份,薤白5份,川连5份,泡姜5份,甘草5份。
一种健脾养肝的中药组合物制备方法,包括如下步骤:
(1)按照所述的质量份数称取蒲公英、白花蛇舌草、金银花,加入14倍上述称取的原料药重量的质量浓度为70%的乙醇溶液进行回流提取3次,每次煎煮1.5小时,然后过滤并回收乙醇,将所得滤液在温度为40℃下低温浓缩后进行干燥,粉碎,过80目筛,得到第一干膏粉,备用;
(2)按照所述的质量份数称取柴胡、当归、白芍、川芎、炒白术、茯苓、制山楂、六神曲、炒鸡内金、莱菔子、制青皮、薤白、川连、泡姜、甘草混合均匀,加入8倍上述称取的原料药重量的水进行煎煮3次,每次煎煮1小时,过滤,将所得滤液在温度为80℃下减压浓缩成相对密度为1.11-1.15的浸膏,冷却,然后向所述浸膏中加入乙醇或乙醇溶液至所述浸膏中醇的质量浓度为60%,冷藏静置,过滤并回收乙醇,将得到的浓缩液干燥,粉碎,过80目筛,得到第二干膏粉,备用;
(3)将步骤(1)中获得的所述第一干膏粉和步骤(2)中获得的所述第二干膏粉混匀,加入第一干膏粉和所述第二干膏粉的混合物重量的40%的糊精,采用常规工艺制成临床上可接受的剂型,即得。
实施例4
一种健脾养肝的中药组合物,所述组合物质量组成如下:蒲公英25份,白花蛇舌草25份,金银花25份,柴胡8份,当归8份,白芍8份,川芎8份,炒白术10份,茯苓10份,制山楂10份,六神曲5份,炒鸡内金10份,莱菔子10份,制青皮10份,薤白5份,川连5份,泡姜5份,甘草5份。
一种健脾养肝的中药组合物制备方法,包括如下步骤:
(1)按照所述的质量份数称取蒲公英、白花蛇舌草、金银花,加入14倍上述称取的原料药重量的质量浓度为70%的乙醇溶液进行回流提取3次,每次煎煮1.5小时,然后过滤并回收乙醇,将所得滤液在温度为60℃下低温浓缩后进行干燥,粉碎,过200目筛,得到第一干膏粉,备用;
(2)按照所述的质量份数称取柴胡、当归、白芍、川芎、炒白术、茯苓、制山楂、六神曲、炒鸡内金、莱菔子、制青皮、薤白、川连、泡姜、甘草混合均匀,加入8倍上述称取的原料药重量的水进行煎煮3次,每次煎煮1小时,过滤,将所得滤液在温度为60℃下减压浓缩成相对密度为1.11-1.15的浸膏,冷却,然后向所述浸膏中加入乙醇或乙醇溶液至所述浸膏中醇的质量浓度为60%,冷藏静置,过滤并回收乙醇,将得到的浓缩液干燥,粉碎,过200目筛,得到第二干膏粉,备用;
(3)将步骤(1)中获得的所述第一干膏粉和步骤(2)中获得的所述第二干膏粉混匀,加入第一干膏粉和所述第二干膏粉的混合物重量的60%的糊精,采用常规工艺制成临床上可接受的剂型,即得。
对比例1
参照中国专利(公开号CN102641469)实施例制备得到的药物组合物。
对比例2
参照中国专利(申请号CN201310179566.0)实施例制备得到的中药组合物。
对比例3
参照中国专利(申请号CN200610155717.9)实施例制备得到的中药组合物。
实验例1
药效学试验:保肝作用检验方法
一、对四氯化碳诱导小鼠急性肝损伤的影响
1实验材料
1.1动物:昆明种小鼠,体质量18~22g,购买自广西医科大学实验动物中心(生产许可证号:SCXK桂2009-0002)。
1.2受试样品与试剂:实施例1-4、对比例1-3、四氯化碳(CC14,分析纯);ALT、AST测定试剂盒;甲醛;苏木精-伊红溶液。
2实验分组
取小鼠80只,雌雄兼用,18-22g,随机分成8组:空白对照组、对比例1-3组、实施例1-4组,每组10只。
3实验方法
实施例1-4各组给予受试样均按药材生药量4.5g/kg计,每天灌胃1次;正常组给予0.9%氯化钠溶液,对比例1-3组给予按各实施例的药材生药量4.5g/kg计,每天灌胃1次,连续30d。将动物每周称重两次,以调整受试样品剂量。于实验第30天将各组动物隔夜禁食16小时,除正常组外,各组小鼠均灌胃给1%CC14花生油溶液,灌胃量5mL/kgBW(折合CC14的剂量为80mg/kgBW),空白组给予等量的植物油,继续给予受试样至实验结束(与CC14灌胃间隔4小时以上)。给予后根据实际情况与24h或48h处死动物,取血分离血清,检测血清ALT、AST活性。并取肝脏进行病理组织学检测。
4实验结果
4.1对CC14诱导的肝损伤小鼠血清ALT与AST的活性的影响
组别 | 剂量(g/kg) | ALT(U/L) | AST(U/L) |
空白对照组 | - | 30.06±5.38 | 129.84±17.73 |
实施例1 | 4.5 | 55.26±7.83 | 145.24±8.38 |
实施例2 | 4.5 | 50.23±7.82 | 146.87±8.99 |
实施例3 | 4.5 | 53.67±7.23 | 150.42±9.26 |
实施例4 | 4.5 | 50.59±7.66 | 151.12±9.76 |
对比例1 | 4.5 | 65.46±8.83 | 161.23±11.38 |
对比例2 | 4.5 | 62.32±8.45 | 162.06±10.56 |
对比例3 | 4.5 | 63.67±8.12 | 160.87±11.45 |
实施例1-4组与对比例1-3组存在显著性差异,说明它们能降低CCl4对肝细胞膜的溶解作用,对肝细胞膜具有一定的保护作用。
病理学检测
将小鼠处死后,剖腹取肝,观察肝脏颜色,发现空白组小鼠肝脏颜色为红褐色,湿润有光泽,富有弹性,实施例1-4各组及对比例组1-3小鼠肝脏颜色比较红润。镜检小鼠肝组织切片,可观察到空白对照组肝细胞索排列整齐,肝细胞无水肿、无脂肪变性。对比例组有明显的脂肪变性,肝细胞呈弥散性脂肪变性,肝细胞内有大量小脂滴形成,未见明显气球样变和核固缩。实施例1-4组仅在中央静脉周围有小范围的脂肪变性,肝细胞水肿,胞浆疏松,未见明显气球样变和脂滴沉积。所以,对急性肝损伤有一定程度的保护作用。
肝组织病理切片镜检结果也证实了本发明提供的受试样能减轻干细胞变性、坏死、出血,促进肝细胞再生,对肝脏起到较好的保护作用。
实验例2
1实验材料
1.1动物:昆明种小鼠,体质量18~22g,购买自广西医科大学实验动物中心(生产许可证号:SCXK桂2009-0002)。
1.2受试样品与试剂:实施例1-4、对比例1-3、四氯化碳(CC14,分析纯);ALT、AST测定试剂盒;甲醛;苏木精-伊红溶液。
2实验分组
取小鼠80只,雌雄兼用,18-22g,随机分成8组:空白对照组、对比例1-3组、实施例1-4组,每组10只。
3实验方法
实施例1-4各组给予受试样均按药材生药量4.5g/kg计,每天灌胃1次;正常组给予0.9%氯化钠溶液,对比例1-3组给予按各实施例的药材生药量4.5g/kg计,每天灌胃1次,连续30d。将动物每周称重两次,以调整受试样品剂量。第20天小鼠尾静脉注射BCG0.2ml/只,10天后,尾静脉注射LPS0.2ml/只(7.5μg)诱导肝损伤,正常组小鼠尾静脉注射同等剂量的生理盐水。实验结束后小鼠禁食16h左右,称重,摘眼球采血3500rpm/min离心10min,分离血清,测定ALT、AST活性。小鼠脱椎处死,立即取肝脏称重,肝脏系数=肝重/体重;分光光度计测定肝匀浆组织中MDA、SOD含量。
4实验结果
组别 | 剂量(g/kg) | ALT(U/L) | AST(U/L) | 肝脏指数 |
空白对照组 | - | 60.06±5.38 | 179.84±17.73 | 4.3±0.3 |
实施例1 | 4.5 | 65.26±7.83 | 195.24±8.38 | 4.4±0.4 |
实施例2 | 4.5 | 60.23±7.82 | 196.87±8.99 | 4.5±0.3 |
实施例3 | 4.5 | 63.67±7.23 | 200.42±9.26 | 4.5±0.2 |
实施例4 | 4.5 | 60.59±7.66 | 201.12±9.76 | 4.6±0.3 |
对比例1 | 4.5 | 75.46±8.83 | 221.23±11.38 | 4.8±0.3 |
对比例2 | 4.5 | 72.32±8.45 | 222.06±10.56 | 4.7±0.4 |
对比例3 | 4.5 | 73.67±8.12 | 220.87±11.45 | 4.6±0.4 |
表3 BGG+LPS诱导的肝损伤小鼠血清MOA、SOD活性
组别 | 剂量(g/kg) | MDA(nmol/mL) | SOD(U/mgprot) |
空白对照组 | - | 9.91±4.38 | 24.84±7.73 |
实施例1 | 4.5 | 15.26±7.83 | 20.24±4.38 |
实施例2 | 4.5 | 14.23±7.82 | 20.87±5.99 |
实施例3 | 4.5 | 14.67±7.23 | 20.42±3.26 |
实施例4 | 4.5 | 13.59±7.66 | 20.12±3.76 |
对比例1 | 4.5 | 19.46±8.83 | 15.23±4.38 |
对比例2 | 4.5 | 19.32±8.45 | 15.06±4.56 |
对比例3 | 4.5 | 19.67±8.12 | 15.87±4.45 |
使用实施例1-4及对比例1-3可使免疫性肝损伤小鼠的脏器系数和血清转氨酶降低,而升高肝匀浆SOD活性,降低MDA含量。故本实验研究证明实施例1-4对BCG和LPS诱导的小鼠免疫性肝损伤具有良好的保护作用。
以上所述仅为本发明的优选实施例而已,并不用于限制本发明,尽管参照前述实施例对本发明进行了详细的说明,对于本领域的技术人员来说,其依然可以对前述各实施例所记载的技术方案进行修改,或者对其中部分技术特征进行等同替换。凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (10)
1.一种健脾养肝的中药组合物,其特征在于,由如下质量份的组分组成:蒲公英10-30份,白花蛇舌草10-30份,金银花10-30份,柴胡1-10份,当归5-20份,白芍5-20份,川芎3-15份,炒白术5-20份,茯苓5-20份,制山楂5-20份,六神曲1-10份,炒鸡内金3-15份,莱菔子1-10份,制青皮2-12份,薤白1-8份,川连1-10份,泡姜1-10份和甘草1-10份。
2.根据权利要求1所述的中药组合物,其特征在于,由如下质量份的组分组成:蒲公英30份,白花蛇舌草30份,金银花30份,柴胡10份,当归20份,白芍20份,川芎15份,炒白术20份,茯苓20份,制山楂20份,六神曲10份,炒鸡内金15份,莱菔子10份,制青皮12份,薤白8份,川连10份,泡姜10份和甘草10份;
或者由如下质量份的组分组成:蒲公英20份,白花蛇舌草20份,金银花20份,柴胡10份,当归15份,白芍15份,川芎15份,炒白术15份,茯苓15份,制山楂15份,六神曲10份,炒鸡内金10份,莱菔子10份,制青皮10份,薤白5份,川连5份,泡姜5份和甘草5份;
或者由如下质量份的组分组成:蒲公英15份,白花蛇舌草15份,金银花15份,柴胡10份,当归20份,白芍20份,川芎15份,炒白术20份,茯苓20份,制山楂20份,六神曲10份,炒鸡内金8份,莱菔子8份,制青皮8份,薤白5份,川连5份,泡姜5份和甘草5份;
或者由如下质量份的组分组成:蒲公英25份,白花蛇舌草25份,金银花25份,柴胡8份,当归8份,白芍8份,川芎8份,炒白术10份,茯苓10份,制山楂10份,六神曲5份,炒鸡内金10份,莱菔子10份,制青皮10份,薤白5份,川连5份,泡姜5份,甘草5份。
3.权利要求1或2所述的中药组合物制备方法,其特征在于,包括如下步骤:
混合蒲公英、白花蛇舌草和金银花,利用质量浓度为70%的乙醇溶液回流提取3次,每次煎煮1.5小时,然后过滤并回收乙醇,将所得滤液浓缩后进行干燥,粉碎,过筛,得到第一干膏粉,备用;所述质量浓度为70%的乙醇溶液的质量为蒲公英、白花蛇舌草和金银花原料药重量的14倍;
混合柴胡、当归、白芍、川芎、炒白术、茯苓、制山楂、六神曲、炒鸡内金、莱菔子、制青皮、薤白、川连、泡姜和甘草,利用水煎煮3次,每次煎煮1小时,过滤,将所得滤液浓缩成相对密度为1.11-1.15的浸膏,冷却,然后向所述浸膏中加入乙醇或乙醇溶液至所述浸膏中醇的质量浓度为60%,冷藏静置,过滤并回收乙醇,将得到的浓缩液干燥,粉碎,过筛,得到第二干膏粉,备用;所述水的质量为柴胡、当归、白芍、川芎、炒白术、茯苓、制山楂、六神曲、炒鸡内金、莱菔子、制青皮、薤白、川连、泡姜和甘草原料药重量的8倍;
混合所述第一干膏粉和所述第二干膏粉,加入辅料,采用常规工艺制成临床上可接受的剂型。
4.根据权利要求3所述的制备方法,其特征在于,在制备第一干膏粉的过程中,所述浓缩为低温浓缩,浓缩温度为20-60℃。
5.根据权利要求3所述的制备方法,其特征在于,在制备第二干膏粉的过程中,所述浓缩为减压浓缩,浓缩温度为60-80℃。
6.根据权利要求3所述的制备方法,其特征在于,在制备第一干膏粉和第二干膏粉的过程中,所述过筛均为过20-200目筛。
7.根据权利要求3所述的制备方法,其特征在于,所述辅料为糊精。
8.根据权利要求3所述的制备方法,其特征在于,所述辅料的加入量为所述第一干膏粉和所述第二干膏粉的混合物重量的40-60%。
9.权利要求1或2所述的中药组合物或权利要求3~8任一项所述制备方法得到的中药组合物在制备预防肝损伤药物中的应用。
10.权利要求1或2所述的中药组合物或权利要求3~8任一项所述制备方法得到的中药组合物在制备升高SOD活性和/或降低MDA含量的药物中的应用。
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