CN114848764A - 一种防治肝损伤的中药复方组合物及其制备方法和应用 - Google Patents
一种防治肝损伤的中药复方组合物及其制备方法和应用 Download PDFInfo
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Abstract
本发明公开了一种防治肝损伤的中药复方组合物及其制备方法和应用,该复方组合物包括以下重量份数的原料药:桑椹20‑30份、珠子参10‑15份、墨旱莲6‑9份、山茱萸6‑9份、珍珠透骨草6‑9份、瓜子金6‑12份、陈皮5‑10份、大百合15‑20份、生麦芽15‑20份、生甘草5‑10份。本发明的中药组合物配比合理,经动物实验证明,其能够降低血脂水平,减轻肝脏脂肪变性,抗氧化应激,减轻脂质过氧化损伤,抑制肝脏炎症反应,减轻肝纤维化程度,对脂肪肝、酒精性肝炎、肝纤维化等肝病有较好的预防和治疗作用。且中药组合物多为药食同源之品,安全性较高。本发明中药组合物服用方便、价格低廉、疗效显著,为广大肝病患者提供了较好的选择。
Description
技术领域
本发明涉及一种防治肝损伤的中药复方组合物及其制备方法和应用,属于中药技术领域。
背景技术
肝脏是人体解毒和代谢的重要器官,各种有害因素如病毒、酒精、毒物、药物等均可以导致肝损伤。肝损伤是各种肝脏疾病的常见病理基础,长期的肝损伤往往导致肝纤维化甚至肝硬化、肝细胞癌。肝病的发病机制至今还不很明确,但目前认为主要与细胞因子、内毒素等引起的氧化应激和脂质过氧化、脂质代谢异常、炎症、免疫等多种因素有关。
随着人民生活水平的不断提高,以及酗酒、酒精依赖等不健康的饮食生活习惯增多,我国酒精性肝病的发病率明显增加。酒精性肝病的一般病程为酒精性脂肪肝,如果继续饮酒不加控制,脂肪肝(即脂肪变性)可进一步发展为脂肪性肝炎、肝纤维化。肝纤维化是多种慢性肝病,如肝炎发展至肝硬化,甚至肝癌的主要病因。研究发现,早期的肝纤维化是可以逆转的。
目前对于慢性肝损伤的治疗,西医以戒酒、营养支持为主,辅以抗炎、保肝药物,但用于慢性肝损伤的西药对肝病治疗未获得令人满意的治疗效果,因此对肝病新的治疗和预防措施已成为目前肝病研究的热点。近年来研究提示,中药复方具有多成分、多靶点和多途径的特征在防治肝损伤方面有其独特的优势。因此,有必要在中医药理论的指导下,研发一种具有较好保肝作用的中药复方组合物作为肝损伤患者的治疗手段。
发明内容
针对现有技术的不足,本发明的目的是提供一种防治肝损伤的中药复方组合物及其制备方法和应用,可有效解决治疗肝损伤的药物疗效不理想的问题。
为了实现上述目的,本发明的技术方案之一是:
一种防治肝损伤的中药复方组合物,包括以下重量份数的原料药:桑椹20-30份、珠子参10-15份、墨旱莲6-9份、山茱萸6-9份、珍珠透骨草6-9份、瓜子金6-12份、陈皮5-10份、大百合15-20份、生麦芽15-20份、生甘草5-10份。
本发明的技术方案之一是:一种防治肝损伤的中药复方组合物的制备方法,包括以下步骤:
步骤1:按重量份称取桑椹、珠子参、墨旱莲、山茱萸、珍珠透骨草、瓜子金、陈皮、大百合、生麦芽、生甘草,备用;
步骤2:将步骤1中称取的桑椹粉碎过筛,得到桑椹粗粉,往桑椹粗粉中加入乙醇溶液,回流提取2次,合并提取液,过滤,将过滤所得滤液减压浓缩,除去乙醇,得到桑椹提取液;
将桑椹提取液上大孔吸附树脂,醇洗脱2次,收集第二次醇洗脱液,减压浓缩,干燥,得到桑椹提取物;
步骤3:将步骤1中称取的珠子参、墨旱莲、山茱萸、珍珠透骨草、瓜子金、陈皮、大百合、生麦芽、生甘草混合在一起,加水浸泡,煎煮提取2次,过滤,合并两次滤液,浓缩,得到混合提取物;
步骤4:将步骤2中的桑椹提取物与步骤3中的混合提取物混合均匀,即得到所述中药复方组合物。
进一步,步骤2中桑椹粉碎后过30目筛,桑椹粗粉中加入的乙醇溶液为桑椹粗粉重量的6-8倍,浓度为20-60%(v/v);回流提取时间为1-2小时;两次醇洗脱中第一次醇洗脱为用2-4倍树脂体积的20-30%(v/v)乙醇溶液洗脱,第二次醇洗脱为用6-8倍树脂体积的40-60%(v/v)乙醇溶液洗脱。
进一步,步骤3中浸泡时间为30分钟,第一次煎煮提取加水量为混合原料药的4倍重量,时间为1小时,第二次煎煮提取加水量为滤渣的2倍重量,时间为0.5小时。
进一步,步骤3中浓缩至相对密度为1.2-1.4。
本发明的技术方案之一是:一种上述中药复方组合物在制备防治肝损伤药物中的应用。
进一步,所述药物为中药复方组合物加入辅料后,制成颗粒剂、片剂、胶囊剂、丸剂等。
本发明的技术方案中所述的桑椹为桑科植物桑Morus alba L.的干燥果穗。味甘、酸,性寒,归心、肝、肾经。具有滋阴补血,生津润燥的功效。主要用于肝肾阴虚,眩晕耳鸣,心悸失眠,须发早白,津伤口渴等症。桑椹是药食同源之品,含有多种活性成分,如白藜芦醇、黄酮类、多糖类及生物碱等。现代药理研究表明桑椹具有抗氧化、保肝、降血糖、降血脂、抗肿瘤、抗抑郁和保护神经等作用,用于治疗多种疾病,包括肝炎、胃病、眼病、糖尿病和高血压等。桑椹为临床常见的补阴药,可治疗肝肾阴虚病证,其具有滋阴补血的功效亦针对了肝病的主要病因病机。
本发明的技术方案中所述的珠子参为五加科植物珠子参Panax japonicusC.A.Mey.var.major(Burk.)C.Y.Wu et K.M.Feng或羽叶三七Panax japonicus C AMey.var.bipinnatifidus(Seem)C.Y.Wu et K.M.Feng的干燥根茎。珠子参的皂苷类化学成分表现出较强的抗肝损伤作用。
本发明的技术方案中所述的墨旱莲为菊科植物鳗肠Eclipta prostrata L.的干燥地上部分。
本发明的技术方案中所述的山茱萸为山茱萸科植物山茱萸Cornus officinalisSieb.et Zucc.的干燥成熟果肉。
本发明的技术方案中所述的珍珠透骨草为大戟科植物地构叶Speranskiatuberculata(Bge.)Baill.的干燥全草。
本发明的技术方案中所述的瓜子金为远志科植物瓜子金Polygala japonicaHoutt.的干燥全草。
本发明的技术方案中所述的陈皮为芸香科植物橘Citrus reticulata Blanco及其栽培变种的干燥成熟果皮。
本发明的技术方案中所述的大百合为百合目百合科大百合属植物大百合Cardiocrinum giganteum(Wall.)Makino的干燥肉质鳞叶。
本发明的技术方案中所述的生麦芽为禾本科植物大麦Hordeum vulgare L.的成熟果实经发芽干燥的炮制加工品。
本发明的技术方案中所述的生甘草为豆科植物甘草Glycyrrhiza uralensisFisch.、胀果甘草Glycyrrhiza inflata Bat.或光果甘草Glycyrrhiza glabra L.的干燥根和根茎。
用于制备本发明中药组合物的原料药中,桑椹具有滋阴补血,生津润燥之功,味甘酸能补益肝肾之阴,兼能凉血补血养肝为君药;珠子参苦甘,微寒,具有滋补养阴,祛瘀止痛之效,墨旱莲甘寒能补肝肾之阴,山茱萸酸涩微温质润,其性温而不燥,补而不峻,功善补益肝肾,既能益精,又可助阳,可平补阴阳,三者为臣药;佐以珍珠透骨草、瓜子金,珍珠透骨草辛温解毒除湿,活血止痛,瓜子金活血散瘀,解毒止痛;又佐以陈皮、大百合、生麦芽,陈皮理气健脾,大百合宽胸利气,生麦芽疏肝行气,取其扶正以祛邪之功;生甘草甘平能补脾益气,清热解毒,且可调和诸药,为使药。诸药同用,共奏滋补肝肾、疏肝理气、健脾益气、解毒除湿、活血散瘀之功。
与现有技术相比,本发明的有益效果在于:
本发明的中药复方组合物用于治疗肝损伤,可以降低血脂,增强机体免疫力。本发明根据中医脾胃肝胆病久而不解,病及于肾而致肝、脾、肾同病,正气已衰,邪气未减的特点,本虚为肝肾阴虚之证,标实为湿热血瘀之证,在用药方面相对集中于具有滋补肝肾、疏肝理气、健脾益气、解毒除湿、活血散瘀的功效,经多年临床实践,研制了此预防和治疗肝损伤的复方组合物。
本发明的中药组合物配比合理,经动物实验证明,其能够降低血脂水平,减轻肝脏脂肪变性,抗氧化应激,减轻脂质过氧化损伤,抑制肝脏炎症反应,减轻肝纤维化程度,对脂肪肝、酒精性肝炎、肝纤维化等肝病有较好的预防和治疗作用。且中药组合物多为药食同源之品,安全性较高,对于在肝损伤期间所出现的食欲不振、乏力、脘腹和胁肋胀满疼痛、消瘦等症状明显减轻,肝部脂肪堆积明显减少,肝功能和肝纤维化明显改善。本发明中药组合物服用方便、价格低廉、疗效显著,为广大肝病患者提供了较好的选择。
附图说明
图1为各组急性酒精性肝损伤小鼠肝脏组织HE染色(×200)。图中,A:正常对照组;B:模型组;C:联苯双酯组;D:中药复方组合物低剂量组;E:中药复方组合物中剂量组;F:中药复方组合物高剂量组。
图2为各组肝纤维化小鼠肝脏组织HE染色(上排)和Masson染色(下排)(×200)。图中,A:正常对照组;B:模型组;C:联苯双酯组;D:中药复方组合物低剂量组;E:中药复方组合物中剂量组;F:中药复方组合物高剂量组。
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
一种防治肝损伤的中药复方组合物,包括以下重量份数的原料药:桑椹30份、珠子参15份、墨旱莲9份、山茱萸9份、珍珠透骨草9份、瓜子金12份、陈皮10份、大百合20份、生麦芽20份、生甘草10份。
其制备方法,包括以下步骤:
步骤1:按重量份称取桑椹、珠子参、墨旱莲、山茱萸、珍珠透骨草、瓜子金、陈皮、大百合、生麦芽、生甘草,备用;
步骤2:将步骤1中称取的桑椹粉碎后过30目筛,得到桑椹粗粉,往桑椹粗粉中加入8倍量的60%(v/v)乙醇溶液回流提取,提取2次,每次提取1小时,合并提取液,过滤,将过滤所得滤液减压浓缩,除去乙醇,得到桑椹提取液;
将桑椹提取液上AB-8型大孔吸附树脂,先用2倍树脂体积的30%(v/v)乙醇溶液洗脱除杂,再用8倍树脂体积的40%(v/v)乙醇溶液洗脱,收集第二次乙醇洗脱液,减压浓缩,干燥,得到桑椹提取物;
步骤3:将步骤1中称取的珠子参、墨旱莲、山茱萸、珍珠透骨草、瓜子金、陈皮、大百合、生麦芽、生甘草混合在一起,加入混合原料药4倍重量的水浸泡30分钟,煎煮提取1小时,过滤;滤渣再加入相当于滤渣重量2倍量的水,煎煮提取0.5小时,过滤;合并两次滤液,滤液浓缩至相对密度为1.2-1.4,得到混合提取物;
步骤4:将步骤2中的桑椹提取物与步骤3中的混合提取物混合均匀,即得到所述中药复方组合物。
上述中药复方组合物可进一步制成颗粒剂,即粉碎后加适量辅料,混匀,制粒,过筛,干燥,即制得颗粒型的防治肝损伤的中药复方组合物。
实施例2
一种防治肝损伤的中药复方组合物,包括以下重量份数的原料药:桑椹20份、珠子参10份、墨旱莲6份、山茱萸6份、珍珠透骨草6份、瓜子金6份、陈皮5份、大百合15份、生麦芽15份、生甘草5份。
其制备方法同实施例1。
实施例2制备出的中药复方组合物可进一步制成胶囊,即粉碎后加适量辅料,混匀,制粒,过筛,干燥,将制得的颗粒物装入胶囊壳,制成胶囊,即制得胶囊剂型的防治肝损伤的中药复方组合物。
实施例3
一种防治肝损伤的中药复方组合物,包括以下重量份数的原料药:桑椹25份、珠子参12份、墨旱莲8份、山茱萸8份、珍珠透骨草8份、瓜子金10份、陈皮8份、大百合18份、生麦芽18份、生甘草8份。
其制备方法同实施例1。
实施例3制备出的中药复方组合物可进一步制成丸剂,即粉碎后加适量辅料,混匀,过筛,造粒,干燥,即制得丸剂型的防治肝损伤的中药复方组合物。
实施例1-3均制备出了疗效较好的用于防治肝损伤的中药复方组合物,由于实施例1-3制备出的用于防治肝损伤的中药复方组合物疗效基本平行,故仅采用实施例1制备出的中药组合物来对本发明的效果进行说明。
实验数据
一、对小鼠急性酒精性肝损伤模型的影响
1实验方法
1.1小鼠急性酒精性肝损伤模型的制备与给药
将60只SPF级雄性KM小鼠随机均匀分为6组,分别为正常对照组、模型组、中药复方组合物低、中、高剂量组(18、36、72生药g/kg)及联苯双酯组(5.625mg/kg),每组10只。中药复方组合物给药组及联苯双酯组分别灌胃不同剂量中药复方组合物和联苯双酯,正常对照组和模型组每天给予相同体积的蒸馏水。每天给药1次,连续给药7d。于最后一次给药后1h,除正常对照组外,其余各组灌胃给予50%(v/v)乙醇(14ml/kg)建立急性酒精性肝损伤模型。
1.2标本采集
于乙醇灌胃后禁食不禁水,12h后摘眼球取血,分离血清,摘取肝脏。取肝右叶按质量体积比1:9加生理盐水制成10%的肝匀浆,离心取上清液备用。
1.3指标检测
微板法检测血清肝功能指标丙氨酸氨基转移酶(ALT)、天冬氨酸氨基转移酶(AST)水平。采用酶标仪微板法检测肝组织匀浆中超氧化物歧化酶(SOD)活性,比色法检测丙二醛(MDA)含量。收集完血清后,摘取肝脏,取肝左叶固定于10%甲醛溶液中,常规石蜡包埋切片后,HE染色,光镜下观察病理组织学改变。
1.4统计学方法
2实验结果
2.1中药复方组合物对急性酒精性肝损伤小鼠肝功能的影响见表1。
注:与模型组比较*P<0.05,**P<0.01。
由表1可见,与正常对照组相比,模型组小鼠血清中ALT、AST值显著升高(P<0.01),说明小鼠酒精性肝损伤模型造模成功。与模型组相比,中药复方组合物低、中、高剂量组和联苯双酯组ALT、AST值均明显降低(P<0.01或P<0.05),提示中药复方组合物对酒精性肝损伤小鼠肝功能具有明显的改善作用,其中高剂量组效果更佳。
2.2中药复方组合物对急性酒精性肝损伤小鼠肝组织氧化指标的影响见表2。
注:与模型组比较*P<0.05,**P<0.01。
由表2可见,与正常对照组相比,模型组小鼠肝组织中SOD活性显著下降(P<0.01),MDA含量显著升高(P<0.01)。与模型组相比,中药复方组合物各剂量组和联苯双酯组小鼠肝组织中SOD活性显著升高,MDA含量明显下降(P<0.01),提示中药复方组合物对肝组织具有抗氧化应激,减轻脂质过氧化损伤作用,其中高剂量组效果更佳。
2.3中药复方组合物对小鼠肝组织病理学的影响见图1。
光镜下观察可见正常对照组小鼠肝小叶结构清晰,肝索呈放射状排列,肝细胞无水肿、变性及坏死,汇管区无炎症细胞浸润。模型组小鼠肝索排列紊乱,胞质疏松,肝细胞出现水肿增大,有明显的脂肪变性,肝细胞内出现脂滴的异常病理改变,可见肝细胞坏死和炎症细胞浸润。与模型组比较,中药复方组合物各剂量组小鼠肝细胞病变程度明显减轻,胞浆内脂滴减少,脂肪变性明显减轻,肝细胞水肿及坏死均不明显。结果表明,中药复方组合物各剂量组可不同程度抑制肝细胞坏死和脂肪变性形成,其中以高剂量组较为明显。
二、对小鼠肝纤维化模型的影响
1实验方法
1.1小鼠肝纤维化模型的制备与给药
将60只SPF级雄性KM小鼠随机分为正常组、模型组和中药复方组合物低、中、高剂量组(18,36,72生药g/kg)及联苯双酯组(5.625mg/kg),每组10只。除正常组外,其余组小鼠均采用腹腔注射四氯化碳法复制肝纤维化模型。每周两次造模,第一周造模采用40%(v/v)四氯化碳橄榄油按2.5ml/kg腹腔注射造模。第二周采用20%(v/v)四氯化碳橄榄油按2.5ml/kg腹腔注射造模。第三周造模采用20%(v/v)四氯化碳橄榄油按1.5ml/kg腹腔注射造模。造模期间各给药组小鼠灌胃相应药物,每天1次,连续给药3周。
1.2标本采集
造模12h后处理动物,摘眼球取血,离心取血清,摘取肝脏。取肝右叶按质量体积比1:9加生理盐水制成10%的肝匀浆,离心取上清液备用。
1.3指标检测
微板法检测肝功能指标ALT、AST水平。酶联免疫分析(ELISA)法检测肝组织炎症因子肿瘤坏死因子-α(TNF-α)、白介素-6(IL-6)含量。取肝组织固定于10%甲醛溶液中,常规石蜡包埋切片后,HE和Masson染色观察和评价小鼠肝脏组织病变程度。
1.4统计学方法
2实验结果
2.1中药复方组合物对肝纤维化小鼠肝功能的影响见表3。
注:与模型组比较*P<0.05,**P<0.01。
由表3可见,与正常对照组相比,模型组小鼠血清中ALT、AST值显著升高(P<0.01),说明小鼠肝纤维化模型造模成功。与模型组相比,中药复方组合物低、中、高剂量组和联苯双酯组ALT、AST值均明显降低(P<0.01或P<0.05),提示中药复方组合物对肝纤维化小鼠肝功能具有明显的改善作用,其中高剂量组效果更佳。
2.2中药复方组合物对肝纤维化小鼠肝组织炎症指标的影响见表4。
注:与模型组比较*P<0.05,**P<0.01。
由表4可见,与正常对照组比较,模型组小鼠肝组织中TNF-α、IL-6含量显著升高(P<0.01)。与模型组比较,中药复方组合物各剂量组和联苯双酯组小鼠肝脏组织中TNF-α、IL-6含量显著降低(P<0.05或P<0.01),说明中药复方组合物可减轻肝纤维化小鼠肝细胞的炎症损伤,其中高剂量组效果更佳。
2.3中药复方组合物对小鼠肝组织病理学的影响见图2。
HE染色和Masson染色显示,正常对照组小鼠肝小叶结构清晰,肝索呈放射状排列,肝细胞无水肿、变性及坏死,汇管区无炎症细胞浸润,无纤维组织增生。模型组小鼠肝索排列紊乱,肝细胞肿胀,胞质疏松,出现大量的肝细胞脂肪变性、坏死和炎症细胞浸润,有明显的纤维组织增生和胶原沉积。与模型组比较,中药复方组合物各剂量组小鼠肝细胞病变程度明显减轻,脂肪变性明显减轻,炎症细胞浸润和肝纤维化程度明显改善,其中以高剂量组较为明显。
上述采用乙醇致小鼠急性酒精性肝损伤模型、四氯化碳致小鼠肝纤维化模型均证实了本发明中药复方组合物能够减轻肝脏脂肪变性,抗氧化应激,抑制肝脏炎症反应,减轻肝纤维化程度,对脂肪肝、酒精性肝炎、肝纤维化等肝病具有确切的预防和治疗作用,故可用于制备防治肝损伤的药物。
Claims (10)
1.一种防治肝损伤的中药复方组合物,其特征在于,包括以下重量份数的原料药:桑椹20-30份、珠子参10-15份、墨旱莲6-9份、山茱萸6-9份、珍珠透骨草6-9份、瓜子金6-12份、陈皮5-10份、大百合15-20份、生麦芽15-20份、生甘草5-10份。
2.根据权利要求1所述的中药复方组合物,其特征在于,包括以下重量份数的原料药:桑椹30份、珠子参15份、墨旱莲9份、山茱萸9份、珍珠透骨草9份、瓜子金12份、陈皮10份、大百合20份、生麦芽20份、生甘草10份。
3.根据权利要求1所述的中药复方组合物,其特征在于,包括以下重量份数的原料药:桑椹20份、珠子参10份、墨旱莲6份、山茱萸6份、珍珠透骨草6份、瓜子金6份、陈皮5份、大百合15份、生麦芽15份、生甘草5份。
4.根据权利要求1所述的中药复方组合物,其特征在于,包括以下重量份数的原料药:桑椹25份、珠子参12份、墨旱莲8份、山茱萸8份、珍珠透骨草8份、瓜子金10份、陈皮8份、大百合18份、生麦芽18份、生甘草8份。
5.一种如权利要求1-4任一项所述的中药复方组合物的制备方法,其特征在于,包括以下步骤:
步骤1:按重量份称取桑椹、珠子参、墨旱莲、山茱萸、珍珠透骨草、瓜子金、陈皮、大百合、生麦芽、生甘草,备用;
步骤2:将步骤1中称取的桑椹粉碎过筛,得到桑椹粗粉,往桑椹粗粉中加入乙醇溶液,回流提取2次,合并提取液,过滤,将过滤所得滤液减压浓缩,除去乙醇,得到桑椹提取液;
将桑椹提取液上大孔吸附树脂,醇洗脱2次,收集第二次醇洗脱液,减压浓缩,干燥,得到桑椹提取物;
步骤3:将步骤1中称取的珠子参、墨旱莲、山茱萸、珍珠透骨草、瓜子金、陈皮、大百合、生麦芽、生甘草混合在一起,加水浸泡,煎煮提取2次,过滤,合并两次滤液,浓缩,得到混合提取物;
步骤4:将步骤2中的桑椹提取物与步骤3中的混合提取物混合均匀,即得到所述中药复方组合物。
6.根据权利要求5所述的制备方法,其特征在于,步骤2中桑椹粉碎后过30目筛,桑椹粗粉中加入的乙醇溶液为桑椹粗粉重量的6-8倍,浓度为20-60%(v/v);回流提取时间为1-2小时;两次醇洗脱中第一次醇洗脱为用2-4倍树脂体积的20-30%(v/v)乙醇溶液洗脱,第二次醇洗脱为用6-8倍树脂体积的40-60%(v/v)乙醇溶液洗脱。
7.根据权利要求5所述的制备方法,其特征在于,步骤3中浸泡时间为30分钟,第一次煎煮提取加水量为混合原料药的4倍重量,时间为1小时,第二次煎煮提取加水量为滤渣的2倍重量,时间为0.5小时。
8.根据权利要求5所述的制备方法,其特征在于,步骤3中浓缩至相对密度为1.2-1.4。
9.一种如权利要求1-4任一项所述中药复方组合物在制备防治肝损伤药物中的应用。
10.根据权利要求9的应用,其特征在于,所述药物为中药复方组合物加入辅料后,制成颗粒剂、片剂、胶囊剂、丸剂。
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