CN106266807A - 一种治疗乙肝、慢性肝性引发的肝硬化的中药组合物及其制备方法 - Google Patents
一种治疗乙肝、慢性肝性引发的肝硬化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乙肝、慢性肝性引发的肝硬化的中药组合物主要由以下重量份数的中药制备而成:茵陈30‑40份、只月季25‑30份、柴胡5‑15份、丹参20‑30份、垂盆草35‑50份、当归20‑30份、沙棘子20‑30份、赤芍15‑20份、炒白术75‑90份、太子参35‑45份、款冬花10‑20份、制大黄20‑35份、山楂15‑25份、黄芩15‑25份、金银花10‑20份、麦芽15‑25份、生鸡内金25‑30份、车前子10‑20份、泽泻10‑20份、铁皮石斛15‑25份、制厚朴3‑10份、炒枳壳5‑10份、龙胆草5‑10份、制香附5‑10份。本发明的中药组合物可以显著改善肝硬化患者的身体状况,肝功能得到大部或部分恢复,患者多项血清指标正常或接近正常,治疗有效率高。同时本发明的制剂,可以工业化生产,质量可控,患者服用方便。
Description
技术领域
本发明属于中药技术领域,特别涉及一种治疗乙肝、慢性肝性引发的肝硬化的中药组合物及其制备方法。
背景技术
肝硬化是一种慢性、进行性、弥漫性肝病,由肝纤维化发展而成,是所有慢性肝脏损伤的最终病理阶段。由各种病因引起肝细胞弥漫性坏死、再生,诱发纤维结缔组织增生,导致小叶结构破坏和假小叶重建,组织修复过程中以胶原为主要成分的细胞外基质合成增多、降解相对不足,从而导致其过量沉积遂成肝硬化。
目前对于肝硬化的病因分析确定和治疗还有待进步。西医治疗肝硬化早期主要是抑制病毒,但是无法阻止肝硬化的发展。在中晚期(失代偿期)是对症治疗,以消除症状为主要目标。西医目前还没有有效逆转纤维化的药物。中医方面针对肝硬化的中药由很多,对早期的肝硬化治疗确实部分有效,对于中晚期基本都是以保健为主,且总体而言有效率低,药物还大多是汤剂、丸剂等传统手段,比如,CN105434995A公开了一种治疗肝硬化的中药汤剂及其制备方法,CN104826020A公开了一种治肝炎并发肝硬化腹水的中药丸剂及制备方法,汤剂、丸剂等制剂质量不易控制,服用不方便。张静雯等提出对于很多肝硬化患者来说,传统药物治疗是肝硬化治疗的基石,新制剂的出现及新方法、新理念的提出为肝硬化患者的治疗带来更多的选择。21世纪面临的新挑战是在其应用受限的情况下,如何快速有效的治疗肝硬化(张静雯,时永全,韩英.肝硬化的治疗进展[J].临床肝胆病杂志,2015,31(3):465-468)。
发明内容
针对上述问题,本发明提出了一种治疗乙肝、慢性肝性引发的肝硬化的中药组合物,具体如下:
一种治疗乙肝、慢性肝性引发的肝硬化的中药组合物,其特征在于,所述中药组合物主要由以下重量份数的中药制备而成:茵陈30-40份、只月季25-30份、柴胡5-15份、丹参20-30份、垂盆草35-50份、当归20-30份、沙棘子20-30份、赤芍15-20份、炒白术75-90份、太子参35-45份、款冬花10-20份、制大黄20-35份、山楂15-25份、黄芩15-25份、金银花10-20份、麦芽15-25份、生鸡内金25-30份、车前子10-20份、泽泻10-20份、铁皮石斛15-25份、制厚朴3-10份、炒枳壳5-10份、龙胆草5-10份、制香附5-10份。
优选的,所述中药组合物主要由以下重量份数的中药制备而成:茵陈35份、只月季28份、柴胡10份、丹参25份、垂盆草45份、当归25份、沙棘子25份、赤芍18份、炒白术80份、太子参40份、款冬花15份、制大黄25份、山楂20份、黄芩20份、金银花15份、麦芽20份、生鸡内金27份、车前子15份、泽泻15份、铁皮石斛20份、制厚朴5份、炒枳壳7份、龙胆草7份、制香附7份。
优选的,制备所述中药组合物的中药还包含1-10份重量份数的增强剂,所述增强剂主要由冬虫夏草、南沙参、蟾蜍、百合、麝香、牛黄、珍珠、北沙参、鬼臼、薄荷制备而成。
优选的,所述增强剂的冬虫夏草、南沙参、蟾蜍、百合、麝香、牛黄、珍珠、北沙参、鬼臼、薄荷的重量比为1-10:1-5:1-5:1-10:1-5:1-5:1-10:1-5:1-5:1-10。
优选的,所述增强剂的冬虫夏草、南沙参、蟾蜍、百合、麝香、牛黄、珍珠、北沙参、鬼臼、薄荷的重量比为10:5:5:10:1:1:10:1:5:5。
本发明中,只月季为蔷薇科植物月季Rosa chinensis Jacq.的未开放花苞,蟾蜍为蟾蜍科动物中华大蟾蜍Bufo bufo gargarizans Cantor或黑眶蟾蜍Bufomelanostictus Schneider的胴体,鬼臼为为小檗科植物八角莲Dysosma versipellis(Hance)M.Cheng的根茎,其余药材均出自《中国药典》(2015版)第一部。
本发明还公开了一种治疗乙肝、慢性肝性引发的肝硬化的中药组合物的制备方法,主要包含以下步骤:
A取垂盆草、龙胆草和茵陈加工成段,与茵陈、只月季、款冬花、金银花混合,加10倍体积水,60℃提取1小时,重复2次,合并提取液得到提取液Ⅰ;
B取柴胡、丹参、当归、沙棘子、赤芍、炒白术、太子参、制大黄、山楂、黄芩、麦芽、生鸡内金、车前子、泽泻、铁皮石斛、制厚朴、炒枳壳、制香附,混合均匀,加10倍体积水,80℃提取2小时,重复3次,合并提取液得到提取液Ⅱ;
C A步骤所得的提取液Ⅰ和B步骤所得的提取液Ⅱ,合并,滤过,滤液可浓缩至相对密度为1.15-1.20(50℃)的清膏;滤液也可减压干燥得到干燥提取物。
本发明还公开了另一种治疗乙肝、慢性肝性引发的肝硬化的中药组合物的制备方法,主要包含以下步骤:
A取垂盆草、龙胆草和茵陈加工成段,与茵陈、只月季、款冬花、金银花、百合、薄荷混合,加10倍体积水,60℃提取1小时,重复2次,合并提取液得到提取液Ⅰ;
B取柴胡、丹参、当归、沙棘子、赤芍、炒白术、太子参、制大黄、山楂、黄芩、麦芽、生鸡内金、车前子、泽泻、铁皮石斛、制厚朴、炒枳壳、制香附、南沙参、蟾蜍、北沙参、鬼臼,混合均匀,加10倍体积水,80℃提取2小时,重复3次,合并提取液得到提取液Ⅱ;
C取冬虫夏草、麝香、牛黄、珍珠,研磨成粉,加10倍体积水,60℃提取1小时,重复3次,合并提取液得到提取液Ⅲ;
D A步骤所得的提取液Ⅰ、B步骤所得的提取液Ⅱ和C步骤所得的提取液Ⅲ,合并,滤过,滤液可浓缩至相对密度为1.15-1.20(50℃)的清膏;滤液也可减压干燥得到干燥提取物。
本发明还公开了一种治疗乙肝、慢性肝性引发的药物制剂,包含前述中药组合物和一种或多种药学上可接受的辅料。
优选的,所述药物为口服制剂,所述口服制剂为颗粒剂、口服液、片剂或硬胶囊剂。
本发明还公开了一种中药组合物在制备治疗乙肝、慢性肝性引发的肝硬化药物中的应用。
本发明的中药组合物可以显著改善肝硬化患者的身体状况,肝功能得到大部或部分恢复,患者多项血清指标正常或接近正常,治疗有效率高。同时本发明的制剂,可以工业化生产,质量可控,患者服用方便。
具体实施方式
实施例1
一种治疗乙肝、慢性肝性引发的肝硬化的中药组合物,所述中药组合物主要由以下重量份数的中药制备而成:茵陈30g、只月季25g、柴胡5g、丹参20g、垂盆草35g、当归20g、沙棘子20g、赤芍15g、炒白术75g、太子参35g、款冬花10g、制大黄20g、山楂15g、黄芩15g、金银花10g、麦芽15g、生鸡内金25g、车前子10g、泽泻10g、铁皮石斛15g、制厚朴3g、炒枳壳5g、龙胆草5g、制香附5g。
实施例2
一种治疗乙肝、慢性肝性引发的肝硬化的中药组合物,所述中药组合物主要由以下重量份数的中药制备而成:茵陈40g、只月季30g、柴胡15g、丹参30g、垂盆草50g、当归30g、沙棘子30g、赤芍20g、炒白术90g、太子参45g、款冬花20g、制大黄35g、山楂25g、黄芩25g、金银花20g、麦芽25g、生鸡内金30g、车前子20g、泽泻20g、铁皮石斛25g、制厚朴10g、炒枳壳10g、龙胆草10g、制香附10g。
实施例3
一种治疗乙肝、慢性肝性引发的肝硬化的中药组合物,所述中药组合物主要由以下重量份数的中药制备而成:茵陈35g、只月季28g、柴胡10g、丹参25g、垂盆草45g、当归25g、沙棘子25g、赤芍18g、炒白术80g、太子参40g、款冬花15g、制大黄25g、山楂20g、黄芩20g、金银花15g、麦芽20g、生鸡内金27g、车前子15g、泽泻15g、铁皮石斛20g、制厚朴5g、炒枳壳7g、龙胆草7g、制香附7g。
实施例4
实施例1-3治疗乙肝、慢性肝性引发的肝硬化的中药组合物的制备方法,主要包含以下步骤:
A取垂盆草、龙胆草和茵陈加工成段,与茵陈、只月季、款冬花、金银花混合,加10倍体积水,60℃提取1小时,重复2次,合并提取液得到提取液Ⅰ;
B取柴胡、丹参、当归、沙棘子、赤芍、炒白术、太子参、制大黄、山楂、黄芩、麦芽、生鸡内金、车前子、泽泻、铁皮石斛、制厚朴、炒枳壳、制香附,混合均匀,加10倍体积水,80℃提取2小时,重复3次,合并提取液得到提取液Ⅱ;
C A步骤所得的提取液Ⅰ和B步骤所得的提取液Ⅱ,合并,滤过,滤液可浓缩至相对密度为1.15-1.20(50℃)的清膏;滤液也可减压干燥得到干燥提取物。
实施例5
一种治疗乙肝、慢性肝性引发的肝硬化的中药组合物,所述中药组合物主要由以下重量份数的原料药制备而成:茵陈35g、只月季28g、柴胡10g、丹参25g、垂盆草45g、当归25g、沙棘子25g、赤芍18g、炒白术80g、太子参40g、款冬花15g、制大黄25g、山楂20g、黄芩20g、金银花15g、麦芽20g、生鸡内金27g、车前子15g、泽泻15g、铁皮石斛20g、制厚朴5g、炒枳壳7g、龙胆草7g、制香附7g、增强剂1g,所述增强剂主要包含冬虫夏草、南沙参、蟾蜍、百合、麝香、牛黄、珍珠、北沙参、鬼臼、薄荷,所述增强剂的冬虫夏草、南沙参、蟾蜍、百合、麝香、牛黄、珍珠、北沙参、鬼臼、薄荷的重量比为10:5:5:10:5:1:1:1:1:1。
实施例6
一种治疗乙肝、慢性肝性引发的肝硬化的中药组合物,所述中药组合物主要由以下重量份数的原料药制备而成:茵陈35g、只月季28g、柴胡10g、丹参25g、垂盆草45g、当归25g、沙棘子25g、赤芍18g、炒白术80g、太子参40g、款冬花15g、制大黄25g、山楂20g、黄芩20g、金银花15g、麦芽20g、生鸡内金27g、车前子15g、泽泻15g、铁皮石斛20g、制厚朴5g、炒枳壳7g、龙胆草7g、制香附7g、增强剂10g,所述增强剂主要包含冬虫夏草、南沙参、蟾蜍、百合、麝香、牛黄、珍珠、北沙参、鬼臼、薄荷,所述增强剂的冬虫夏草、南沙参、蟾蜍、百合、麝香、牛黄、珍珠、北沙参、鬼臼、薄荷的重量比为1:1:1:1:5:5:10:5:5:10。
实施例7
一种治疗乙肝、慢性肝性引发的肝硬化的中药组合物,所述中药组合物主要由以下重量份数的原料药制备而成:茵陈35g、只月季28g、柴胡10g、丹参25g、垂盆草45g、当归25g、沙棘子25g、赤芍18g、炒白术80g、太子参40g、款冬花15g、制大黄25g、山楂20g、黄芩20g、金银花15g、麦芽20g、生鸡内金27g、车前子15g、泽泻15g、铁皮石斛20g、制厚朴5g、炒枳壳7g、龙胆草7g、制香附7g、增强剂7g,所述增强剂主要包含冬虫夏草、南沙参、蟾蜍、百合、麝香、牛黄、珍珠、北沙参、鬼臼、薄荷,所述增强剂的冬虫夏草、南沙参、蟾蜍、百合、麝香、牛黄、珍珠、北沙参、鬼臼、薄荷的重量比为5:1:1:5:1:5:5:1:1:5。
实施例8
一种治疗乙肝、慢性肝性引发的肝硬化的中药组合物,所述中药组合物主要由以下重量份数的原料药制备而成:茵陈35g、只月季28g、柴胡10g、丹参25g、垂盆草45g、当归25g、沙棘子25g、赤芍18g、炒白术80g、太子参40g、款冬花15g、制大黄25g、山楂20g、黄芩20g、金银花15g、麦芽20g、生鸡内金27g、车前子15g、泽泻15g、铁皮石斛20g、制厚朴5g、炒枳壳7g、龙胆草7g、制香附7g、增强剂5g,所述增强剂主要包含冬虫夏草、南沙参、蟾蜍、百合、麝香、牛黄、珍珠、北沙参、鬼臼、薄荷,所述增强剂的冬虫夏草、南沙参、蟾蜍、百合、麝香、牛黄、珍珠、北沙参、鬼臼、薄荷的重量比为10:5:5:10:1:1:10:1:5:5。
实施例9
实施例5-8治疗乙肝、慢性肝性引发的肝硬化的中药组合物的制备方法,主要包含以下步骤:
A取垂盆草、龙胆草和茵陈加工成段,与茵陈、只月季、款冬花、金银花、百合、薄荷混合,加10倍体积水,60℃提取1小时,重复2次,合并提取液得到提取液Ⅰ;
B取柴胡、丹参、当归、沙棘子、赤芍、炒白术、太子参、制大黄、山楂、黄芩、麦芽、生鸡内金、车前子、泽泻、铁皮石斛、制厚朴、炒枳壳、制香附、南沙参、蟾蜍、北沙参、鬼臼,混合均匀,加10倍体积水,80℃提取2小时,重复3次,合并提取液得到提取液Ⅱ;
C取冬虫夏草、麝香、牛黄、珍珠,研磨成粉,加10倍体积水,60℃提取1小时,重复3次,合并提取液得到提取液Ⅲ;
D A步骤所得的提取液Ⅰ、B步骤所得的提取液Ⅱ和C步骤所得的提取液Ⅲ,合并,滤过,滤液可浓缩至相对密度为1.15-1.20(50℃)的清膏;滤液也可减压干燥得到干燥提取物。
实施例10颗粒剂
实施例4和9所得的清膏,加糊精及甜菊素,混匀,制成颗粒,干燥,即得。
实施例11口服液
实施例4和9所得的清膏,加入乙醇使含醇量达50%,静置24小时,滤过,滤液回收乙醇至无醇味,加入单糖浆、山梨酸钾适量,加水,搅匀,滤过,灌装,灭菌,即得。
实施例12片剂
实施例4和9所得的清膏,加入淀粉,混匀干燥,粉碎成细粉,制颗粒,干燥,压片。
实施例13硬胶囊
实施例4和9所得的清膏,加入淀粉,混匀干燥,粉碎成细粉,85%乙醇溶液制成颗粒,干燥,加入硬脂酸镁1%,装入胶囊,即得。
对照例1小柴胡颗粒
取柴胡150g、黄芩56g、姜半夏56g、党参56g、生姜56g、甘草56g、大枣56g,按药典方法制成颗粒剂。
对照例2
一种治疗乙肝、慢性肝性引发的肝硬化的中药组合物,所述中药组合物主要包含以下重量g数的成分:柴胡10g、丹参25g、垂盆草45g、当归25g、沙棘子25g、赤芍18g、炒白术80g、太子参40g、款冬花15g、制大黄25g、山楂20g、黄芩20g、金银花15g、麦芽20g、生鸡内金27g、车前子15g、泽泻15g、铁皮石斛20g、制厚朴5g、炒枳壳7g、龙胆草7g、制香附7g。
对照例3
一种治疗乙肝、慢性肝性引发的肝硬化的中药组合物,所述中药组合物主要包含以下重量g数的成分:茵陈35g、只月季28g、垂盆草45g、当归25g、沙棘子25g、赤芍18g、炒白术80g、太子参40g、款冬花15g、制大黄25g、山楂20g、黄芩20g、金银花15g、麦芽20g、生鸡内金27g、车前子15g、泽泻15g、铁皮石斛20g、制厚朴5g、炒枳壳7g、龙胆草7g、制香附7g。
对照例4
一种治疗乙肝、慢性肝性引发的肝硬化的中药组合物,所述中药组合物主要由以下重量g数的中药制备而成:茵陈35g、只月季28g、柴胡10g、丹参25g、垂盆草45g、当归25g、沙棘子25g、赤芍18g、炒白术80g、太子参40g、款冬花15g、制大黄25g、山楂20g、黄芩20g、金银花15g、麦芽20g、生鸡内金27g、车前子15g、泽泻15g。
对照例5
一种治疗乙肝、慢性肝性引发的肝硬化的中药组合物,所述中药组合物主要由以下重量g数的原料药制备而成:茵陈35g、只月季28g、柴胡10g、丹参25g、垂盆草45g、当归25g、沙棘子25g、赤芍18g、炒白术80g、太子参40g、款冬花15g、制大黄25g、山楂20g、黄芩20g、金银花15g、麦芽20g、生鸡内金27g、车前子15g、泽泻15g、铁皮石斛20g、制厚朴5g、炒枳壳7g、龙胆草7g、制香附7g、增强剂5g,所述增强剂主要包含麝香、牛黄、珍珠、北沙参、鬼臼、薄荷,所述增强剂的麝香、牛黄、珍珠、北沙参、鬼臼、薄荷的重量比为1:1:10:1:5:5。
对照例6
一种治疗乙肝、慢性肝性引发的肝硬化的中药组合物,所述中药组合物主要由以下重量g数的原料药制备而成:茵陈35g、只月季28g、柴胡10g、丹参25g、垂盆草45g、当归25g、沙棘子25g、赤芍18g、炒白术80g、太子参40g、款冬花15g、制大黄25g、山楂20g、黄芩20g、金银花15g、麦芽20g、生鸡内金27g、车前子15g、泽泻15g、铁皮石斛20g、制厚朴5g、炒枳壳7g、龙胆草7g、制香附7g、增强剂5g,所述增强剂主要包含冬虫夏草、南沙参、蟾蜍,所述增强剂的冬虫夏草、南沙参、蟾蜍、百合的重量比为10:5:5:10。
实验例1中药组合物对肝硬化大鼠的影响
实验对象:Wistar大鼠,体重160-200g,雌雄各半。
大鼠肝硬化模型建立:应用四氯化碳制备肝硬化动物模型。
建模8周后,用对照例1(小柴胡颗粒)和实施例1-3、5-8按实施例10的方法制成的颗粒剂灌胃4周,灌胃1ml/kg体重,用药相当于生药5g/kg,空白对照组用蒸馏水。每组10只大鼠。
灌胃4周后大鼠尾部取血样,用试剂盒测定肝功能相关酶,即血清丙氨酸氨基转移酶(alanineaminotransferase,ALT)、天冬氨酸氨基转移酶(aspartateaminotransferase,AST)的酶活力和总胆红素(total bilirubin,TBil)及血清白蛋白(albumin,ALB)的含量。各试剂盒的方法分别为,ALB用溴甲酚绿法,TBil用重氮法,ALT和AST用赖氏法。
表1中药组合物对肝硬化大鼠的影响
*、#、△、§为显著性差异标注,同样个数的符号表示没有差异,不同个数的符号表示有显著性差异,P<0.05。
从表1可以看出,与空白对照组相比,对照例和实施例均显著降低血清ALT、AST和GGT活性及TBil含量(P<0.05)。实施例1-3显著优于对照例1经方小柴胡颗粒以及对照例2-4,说明本发明的茵陈、只月季、柴胡、丹参、垂盆草、当归、沙棘子、赤芍、炒白术、太子参、款冬花、制大黄、山楂、黄芩、金银花、麦芽、生鸡内金、车前子、泽泻、铁皮石斛、制厚朴、炒枳壳、龙胆草、制香附能够恢复肝功能。实施例1-3中,实施例3最优,在实施例1-3组内具有显著性差异(P<0.05)。实施例7-10显著优于对照例5和6,说明本发明的冬虫夏草、南沙参、蟾蜍、百合、麝香、牛黄、珍珠、北沙参、鬼臼、薄荷能够进一步恢复肝功能。实施例7-10中,实施例10效果最优,在实施例7-10组内具有显著性差异(P<0.05)。
实验例2实施例3中药组合物颗粒剂的临床应用
2012-2014年诊断为肝硬化的患者121名,男性76名,女性45名,年龄分布为27-73岁。连续服用本实施例3的颗粒剂6个月,每天用药相当于生药5g/kg,以自我感觉改善和血清丙氨酸氨基转移酶及天冬氨酸氨基转移酶正常和接近正常为有效治疗。有效率为有效治疗患者所占百分比。
统计结果表明,服用本实施例3中药组合物颗粒剂的总有效率为91.7%,其中男性患者有效率为93.4%,女性患者有效率为88.9%。
实验例3典型病例
李某,男,40岁,患乙肝9年,精神不振,食欲欠佳,肝功能异常,诊断为肝硬化。连续服用本实施例10的颗粒剂3个月,每天用药相当于生药5g/kg,精神大为好转,多项血清指标正常或接近正常。
张某,女,57岁,诊断出患丙肝13年,面色焦黄,不思饮食,感觉腹部肿胀,人消瘦,浑身无力,诊断为肝硬化。连续服用本实施例10的颗粒剂3个月,每天用药相当于生药5g/kg,精神好转,饮食改善,日常活动逐渐活跃,多项血清指标正常或接近正常。
Claims (10)
1.一种治疗乙肝、慢性肝性引发的肝硬化的中药组合物,其特征在于,所述中药组合物主要由以下重量份数的中药制备而成:茵陈30-40份、只月季25-30份、柴胡5-15份、丹参20-30份、垂盆草35-50份、当归20-30份、沙棘子20-30份、赤芍15-20份、炒白术75-90份、太子参35-45份、款冬花10-20份、制大黄20-35份、山楂15-25份、黄芩15-25份、金银花10-20份、麦芽15-25份、生鸡内金25-30份、车前子10-20份、泽泻10-20份、铁皮石斛15-25份、制厚朴3-10份、炒枳壳5-10份、龙胆草5-10份、制香附5-10份。
2.如权利要求1所述的治疗乙肝、慢性肝性引发的肝硬化的中药组合物,其特征在于,所述中药组合物主要由以下重量份数的中药制备而成:茵陈35份、只月季28份、柴胡10份、丹参25份、垂盆草45份、当归25份、沙棘子25份、赤芍18份、炒白术80份、太子参40份、款冬花15份、制大黄25份、山楂20份、黄芩20份、金银花15份、麦芽20份、生鸡内金27份、车前子15份、泽泻15份、铁皮石斛20份、制厚朴5份、炒枳壳7份、龙胆草7份、制香附7份。
3.如权利要求1所述的治疗乙肝、慢性肝性引发的肝硬化的中药组合物,其特征在于,制备所述中药组合物的中药还包含1-10份重量份数的增强剂,所述增强剂主要由冬虫夏草、南沙参、蟾蜍、百合、麝香、牛黄、珍珠、北沙参、鬼臼、薄荷制备而成。
4.如权利要求3所述的治疗乙肝、慢性肝性引发的肝硬化的中药组合物,其特征在于,所述增强剂的冬虫夏草、南沙参、蟾蜍、百合、麝香、牛黄、珍珠、北沙参、鬼臼、薄荷的重量比为1-10:1-5:1-5:1-10:1-5:1-5:1-10:1-5:1-5:1-10。
5.如权利要求4所述的治疗乙肝、慢性肝性引发的肝硬化的中药组合物,其特征在于,所述增强剂的冬虫夏草、南沙参、蟾蜍、百合、麝香、牛黄、珍珠、北沙参、鬼臼、薄荷的重量比为10:5:5:10:1:1:10:1:5:5。
6.一种如权利要求1、2任一所述的治疗乙肝、慢性肝性引发的肝硬化的中药组合物的制备方法,其特征在于,主要包含以下步骤:
A取垂盆草、龙胆草和茵陈加工成段,与茵陈、只月季、款冬花、金银花混合,加10倍体积水,60℃提取1小时,重复2次,合并提取液得到提取液Ⅰ;
B取柴胡、丹参、当归、沙棘子、赤芍、炒白术、太子参、制大黄、山楂、黄芩、麦芽、生鸡内金、车前子、泽泻、铁皮石斛、制厚朴、炒枳壳、制香附,混合均匀,加10倍体积水,80℃提取2小时,重复3次,合并提取液得到提取液Ⅱ;
C A步骤所得的提取液Ⅰ和B步骤所得的提取液Ⅱ,合并,滤过,滤液可浓缩至相对密度为1.15-1.20(50℃)的清膏;滤液也可减压干燥得到干燥提取物。
7.一种如权利要求3-5任一所述的治疗乙肝、慢性肝性引发的肝硬化的中药组合物的制备方法,其特征在于,主要包含以下步骤:
A取垂盆草、龙胆草和茵陈加工成段,与茵陈、只月季、款冬花、金银花、百合、薄荷混合,加10倍体积水,60℃提取1小时,重复2次,合并提取液得到提取液Ⅰ;
B取柴胡、丹参、当归、沙棘子、赤芍、炒白术、太子参、制大黄、山楂、黄芩、麦芽、生鸡内金、车前子、泽泻、铁皮石斛、制厚朴、炒枳壳、制香附、南沙参、蟾蜍、北沙参、鬼臼,混合均匀,加10倍体积水,80℃提取2小时,重复3次,合并提取液得到提取液Ⅱ;
C取冬虫夏草、麝香、牛黄、珍珠,研磨成粉,加10倍体积水,60℃提取1小时,重复3次,合并提取液得到提取液Ⅲ;
D A步骤所得的提取液Ⅰ、B步骤所得的提取液Ⅱ和C步骤所得的提取液Ⅲ,合并,滤过,滤液可浓缩至相对密度为1.15-1.20(50℃)的清膏;滤液也可减压干燥得到干燥提取物。
8.一种治疗乙肝、慢性肝性引发的肝硬化的药物制剂,其特征在于,所述药物制剂包含如权利要求1-5任一所述中药组合物和一种或多种药学上可接受的辅料。
9.如权利要求8所述的治疗乙肝、慢性肝性引发的肝硬化的药物制剂,其特征在于,所述药物制剂为口服制剂,所述口服制剂为颗粒剂、口服液、片剂或硬胶囊剂。
10.一种如权利要求1-5任一项所述的治疗乙肝、慢性肝性引发的肝硬化的中药组合物在制备治疗乙肝、慢性肝性引发的肝硬化药物中的应用。
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