CN106344885B - 一种治疗非酒精性脂肪肝药物组合物及其制备方法和用途 - Google Patents
一种治疗非酒精性脂肪肝药物组合物及其制备方法和用途 Download PDFInfo
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Abstract
本发明公开了一种治疗非酒精性脂肪肝的药物组合物,它是由如下重量配比的原料药制备而成的制剂:生山楂20‑40份、焦山楂20‑40份、神曲10‑30份、白术10‑20份、荷叶10‑30份、泽泻5‑15份、姜黄10‑20份、决明子5‑15份、黄连3‑9份。本发明还公开了前述组合物的制备方法和用途。本发明药物组合物可有有效治疗非酒精性脂肪肝,应用前景良好。
Description
技术领域
本发明涉及一种治疗非酒精性脂肪肝的药物组合物及其制备方法和用途。
背景技术
非酒精性肝病(Non-alcoholic fatty liver disease,NAFLD)是欧美等西方发达国家肝功能酶学异常和慢性肝病最常见的原因,包括非酒精性单纯性脂肪肝(non-alcoholic simple fatty liver,NAFL)、非酒精性脂肪性肝炎(non-alcoholicsteatohepatitis,NASH)及其相关肝硬化和肝细胞癌。普通成人NAFLD患病率为20%~33%,其中NASH和肝硬化分别占10%~20%和2%~3%。肥胖症患者NAFL患病率为60%~90%(其中NASH为20%~25%,肝硬化为2%~8%),2型糖尿病和高脂血症患者NAFLD患病率分别为28%~55%和27%~92%,在体质指数>30kg/m2人群中高达80%。近年亚洲国家NAFLD增长迅速且呈低龄化发病趋势,中国的上海、广州和香港等发达地区成人NAFLD患病率在15%左右,且患病率呈快速上升趋势。NAFLD患者的病死率明显升高,NASH患者10~15年内肝硬化发生率高达15%~25%,NAFLD/NASH相关肝细胞癌占所有肝细胞癌的10%~24%,大部分NAFLD/NASH是代谢综合征的肝脏表现,增加2型糖尿病发病风险,在全身动脉粥样硬化疾病的发病过程中亦发挥重要作用,NAFLD引起的相关疾病大大提高了NAFLD患者死亡率,已成为重要的公共健康问题。目前西医尚无有效治疗NAFLD的方法。急需积极研发安全、有效的药物以防治日益增多NAFLD对人类健康的危害。
张传涛等,“加味楂曲饮对实验性非酒精性脂肪肝大鼠FFA-CYP2E1-MDA路径的影响”,时珍国医国药2014年第25卷第3期公开了加味楂曲饮可以治疗非酒精性脂肪肝,加味楂曲饮的药组成由焦山楂30g、生山楂30g、神曲20g、荷叶20g、泽泻10g、丹参15g、姜黄12g、绞股蓝15g、柴胡9g、枸杞子15g等十多味中药组成,但是其疗效有待进一步提高。
发明内容
本发明的目的在于提供了一种新的治疗非酒精性脂肪肝药物组合物。
本发明治疗脂肪肝的药物组合物,它是由如下重量配比的原料药制备而成的制剂:
生山楂20-40份 焦山楂20-40份 神曲10-30份 白术10-20份 荷叶10-30份 泽泻5-15份 姜黄10-20份 决明子5-15份 黄连3-9份。
优选地,述组合物是由如下重量配比的原料药制备而成的制剂:
生山楂30份 焦山楂30份 神曲20份 白术15份 荷叶20份 泽泻10份 姜黄15份 决明子10份 黄连6份。
优选地,所述组合物是由原料药的药粉、原料药的水或有机溶剂提取物为活性成分,加上药学上常用的辅料或辅助性成分制备而成的制剂。
优选地,所述制剂是口服制剂。其中,所述制剂为汤剂、口服液、颗粒剂、胶囊剂、散剂、丸剂、片剂。
本发明还提供了前述组合物的制备方法,
(1)按照前述配比称取原料药;
(2)制备料药的药粉、原料药的水或有机溶剂提取物,加入药学上常用的辅料或辅助性成分,即得。
本发明还提供了前述药物组合物在制备治疗脂肪肝的药物组合物中的用途。其中,所述药物组合物是治疗非酒精性脂肪肝的药物组合物。
本发明生山楂是指蔷薇科(Rosaceae)落叶灌木或小乔木山楂CrataegusPinnatifida Bunge、山里红Crataegus pinnatifida Bunge var.Major N.E.Br.或野山楂Crataegus cuneata Sheb et Zucc.的干燥成熟果实;所述焦山楂是指生山楂的炒焦制品(中火炒至表面焦褐色,内部黄褐色);所述神曲是指系由面粉、赤小豆、苦杏仁、鲜青蒿、鲜苍耳、鲜辣蓼混匀后经发酵而成的曲剂,含有酵母菌、酶类、维生素B复合体、麦角固醇、挥发油、苷类等。
本发明药物组合物,配方精当,可以显著降酶、改善肝脏组织学作用:降低实验性NAFLD大鼠血清中ALT、AST、TC、TG,减少FFA生成,减轻肝脏脂肪沉积程度,使得肝细胞胞浆内红染脂肪滴数量有不同程度减少,治疗非酒精性脂肪肝,为临床治疗非酒精性脂肪肝提供一种的选择,应用前景良好。
下面通过具体实施方式对本发明做进一步详细说明,但是并不是对本发明的限制,根据本发明的上述内容,按照本领域的普通技术知识和惯用手段,在不脱离本发明上述基本技术思想前提下,还可以做出其它多种形式的修改、替换或变更。
具体实施方式
实施例1本发明药物组合物的制备
取生山楂30g、焦山楂30g、神曲20g、白术15g、荷叶20g、泽泻10g、姜黄15g、决明子10g、黄连6g。
第一步:先将药材放入砂锅内,加入2000ml的水,浸泡半个小时。第二步:以武火(大火)煮沸后,再以文火(小火)煮到剩300ml,将煮好的药液倒出于碗中。第三步:可重复第一、二步,前后两次混合服用。
实施例2本发明药物组合物的制备
取生山楂20g、焦山楂20g、建曲10g、白术10g、荷叶10g、泽泻5g、姜黄10g、决明子5g、黄连3g。
第一步:先将药材放入砂锅内,加入2000ml的水,浸泡半个小时。第二步:以武火(大火)煮沸后,再以文火(小火)煮到剩300ml,将煮好的药液倒出于碗中。第三步:可重复第一、二步,前后两次混合服用。
实施例3本发明药物组合物的制备
取生山楂40g、焦山楂40g、建曲30g、白术20g、荷叶30g、泽泻15g姜黄20g、决明子15g、黄连9g。
第一步:先将药材放入砂锅内,加入2000ml的水,浸泡半个小时。第二步:以武火(大火)煮沸后,再以文火(小火)煮到剩300ml,将煮好的药液倒出于碗中。第三步:可重复第一、二步,前后两次混合服用。
以下通过试验例具体说明本发明的有益效果。
试验例1本发明组合物治疗非酒精性脂肪肝的研究
1材料
1.1受试品与试剂 本发明组合物(实施例1制备的本发明组合物);对照组:焦山楂30g、生山楂30g、神曲20g、荷叶20g、泽泻10g、丹参15g、姜黄12g、绞股蓝15g、柴胡9g、枸杞子15g,按照实施例1方法制备的药物。阳性药物:复方蛋氨酸胆碱片。
1.2实验动物同批次健康SDF级大鼠60只(合格证号0002906,生产许可证SCXK(川)2008-24)
1.3仪器
Varioskan Flash microplate reader多功能酶标仪:Thermo公司
KRYOSTAT 1720型冰冻切片机:德国Leitz公司
日立7170a全自动生化分析仪:日立公司
2方法
2.1分组及造模
所有大鼠适应性喂养一周后,大鼠随机分为3组:正常组、模型组、阳性药物组、对照药物组、本发明药物组,每组10只。正常组饲以基础饲料,其余五组均饲以高脂饲料(组成:胆固醇2%,胆酸钠0.5%,丙硫氧嘧啶0.2%,蔗糖5%,猪油10%,基础饲料82.3%。)诱导实验模型[王倩,管小琴.大鼠非酒精性脂肪肝造模方法的改进.世界华人消化杂志.2007,15(11):1219-1224],实验动物自由饮水和进食。
2.2给药方法
据徐叔云教授《药理实验方法学》公式计算,计算出大鼠与人等效剂量。自造模第1d起,阳性药物组灌服0.38g/(kg·d)剂量的复方蛋氨酸胆碱片混悬液,对照药物组以20g/(kg·d)剂量对照组合物灌胃;本发明药物组以20g/(kg·d)剂量本发明组合物灌胃。正常组与模型组灌服等体积生理盐水。每天灌药1次,共8周。
3结果
3.1大鼠肝脏病理结果
普通光镜下观察发现:与模型组比较,对照药物组、本发明药物组、阳性药物组大鼠肝细胞脂肪变性不同程度减轻,肝细胞胞浆内红染脂肪滴数量有不同程度减少,上述变化以本发明药物组最为明显,本发明药物疗效优于对照药物,如表1所示。
表1大鼠肝脂肪变性程度分级评价情况
注:与模型组比较,*P<0.05;与本发明药物组比较,#P<0.05;“+”代表疾病严重程度,“+”越多表示越严重。
3.2大鼠血清学指标:
与模型组比较,对照组合物组、本发明组合物组、阳性药物组大鼠血清TC、TG、ALT、AST明显降低;与阳性药物组比较,对照组合物组、本发明组合物组血中TC、TG、ALT、AST明显降低;与对照组合物组,本发明组合物组大鼠血清TC、TG、ALT、AST明显降低,具体见表2:
表2药物实验大鼠生化指标变化的影响
注:与模型组比较,*P<0.05;与阳性对照组比较,※P<0.05,与本发明组合物比较,*※P<0.05。
由表1和表2可知,与模型组比较,本发明药物组合物均可以显著降低大鼠肝脏病理变化的状态,同时可以有效降低血清中TC、TG、ALT、AST,说明本发明药物组合物可以有效治疗脂肪肝,特别是非酒精性脂肪肝;
与对照组合物相比,本发明药物组合物的作用明显提高,说明本发明药物组合物的治疗脂肪肝的作用显著由于对照组合物,也优于阳性药物。
综上,本发明药物组合物可有效治疗非酒精性脂肪肝,为临床提供了一种新的选择,应用前景良好。
Claims (9)
1.一种治疗脂肪肝的药物组合物,其特征在于:它是由如下重量配比的原料药制备而成的制剂:
生山楂20-40份 焦山楂20-40份 神曲10-30份 白术10-20份 荷叶10-30份 泽泻5-15份 姜黄10-20份 决明子5-15份 黄连3-9份。
2.根据权利要求1所述的药物组合物,其特征在于:它是由如下重量配比的原料药制备而成的制剂:
生山楂30份 焦山楂30份 神曲20份 白术15份 荷叶20份 泽泻10份 姜黄15份决明子10份 黄连6份。
3.根据权利要求1所述的药物组合物,其特征在于:所述生山楂是指蔷薇科Rosaceae落叶灌木或小乔木山楂Crataegus Pinnatifida Bunge、山里红Crataegus pinnatifidaBunge var. Major N.E.Br. 或野山楂Crataegus cuneata Sieb et Zucc. 的干燥成熟果实;所述焦山楂是指生山楂的炒焦制品;所述神曲是指系由面粉、赤小豆、苦杏仁、鲜青蒿、鲜苍耳、鲜辣蓼混匀后经发酵而成的曲剂。
4.根据权利要求1~3任意一项所述的药物组合物,其特征在于:它是由原料药的药粉、原料药的水或有机溶剂提取物为活性成分,加上药学上常用的辅料或辅助性成分制备而成的制剂。
5.根据权利要求1~3任意一项所述的药物组合物,其特征在于:所述制剂是口服制剂。
6.根据权利要求1-3任意一项所述的药物组合物,其特征在于:所述制剂为汤剂、口服液、颗粒剂、胶囊剂、散剂、丸剂、片剂。
7.权利要求1-6任意一项所述药物组合物的制备方法,其特征在于:步骤如下:
(1)按照权利要求1或2所述配比称取原料药;
(2)制备原料药的药粉、原料药的水或有机溶剂提取物,加入药学上常用的辅料或辅助性成分,即得。
8.权利要求1-6任意一项所述药物组合物在制备治疗脂肪肝的药物组合物中的用途。
9.根据权利要求8所述的用途,其特征在于:所述药物组合物是治疗非酒精性脂肪肝的药物组合物。
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