CN114558074B - 一种具有治疗代谢相关脂肪性肝病的中药组合物及其制备方法与应用 - Google Patents
一种具有治疗代谢相关脂肪性肝病的中药组合物及其制备方法与应用 Download PDFInfo
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- CN114558074B CN114558074B CN202210250245.4A CN202210250245A CN114558074B CN 114558074 B CN114558074 B CN 114558074B CN 202210250245 A CN202210250245 A CN 202210250245A CN 114558074 B CN114558074 B CN 114558074B
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Abstract
本发明公开了一种具有治疗代谢相关脂肪性肝病的中药组合物,所述的中药组合物包括:麸炒枳壳10~20g、酒黄芩10~20g、垂盆草30~60g、党参10~20g、黄芪15~30g、麸炒白术10~20g、茯苓10~20g、醋柴胡6~12g、炒白芍10~20g、醋香附10~20g、陈皮10~20g、醋青皮10~20g、法半夏10~20g、荷叶(大)10~20g、泽泻10~20g、焦山楂10~20g、路路通10~20g、炙甘草3~6g。本发明采用辨证论治的方法,通过大量实验筛选出最佳的组方,从脾论治,以化痰祛湿为大法,发挥减重的功效,以减轻MAFLD,经临床证实对代谢相关脂肪性肝病具有显著的治疗作用。
Description
技术领域
本发明涉及一种中药组合物,具体涉及一种具有治疗代谢相关脂肪性肝病的中药组合物及其制备方法,属于医药技术领域。
背景技术
代谢相关脂肪性肝病(MAFLD),是一种临床常见病、多发病,中医学将其对应于“肝癖”、“肝瘅”,近年来在我国的发病率逐年升高,全球患病率高达25%,严重危害人类健康并对社会造成巨大经济负担。至今在我国、美国和欧盟尚无药物获批用于治疗MAFLD,故而寻找有效的治疗方法迫在眉睫。
近来关于MAFLD治疗的共识目标为减肥、减少肝脏脂肪沉积,改善胰岛素抵抗,并减轻因“附加打击”而导致炎症和肝纤维化。目前临床上用于减肥的药物有限,同时往往伴有较强的胃肠道反应等副作用,而中医药在漫长的临床中,有不少关于减肥的认识和治疗方法,现代研究对其也有很多佐证,证实其具有很大潜力。
因此,有必要在现有技术的基础上,在中医药理论的指导下,结合现代研究进展筛选确定组方,研发出一种具有中医药特色,能够有效通过减肥来治疗MAFLD的中药复方组合物。
发明内容
发明目的:本发明的目的是为了克服现有技术的不足,通过大量实验筛选,根据临床经验,采用辨证论治的理论筛选出具有治疗代谢相关脂肪性肝病的中药组合物及其制备方法。
技术方案:为了实现以上目的,本发明采取的技术方案为:
一种具有治疗代谢相关脂肪性肝病的中药组合物,所述的中药组合物包括:麸炒枳壳10份、酒黄芩10份、垂盆草30份、党参10份、黄芪15份、麸炒白术10份、茯苓10份、醋柴胡6份、炒白芍10份、醋香附10份、陈皮10份、醋青皮10份、法半夏10份、荷叶(大)10份、泽泻10份、焦山楂10份、路路通10份、炙甘草3份。
一种具有治疗代谢相关脂肪性肝病的中药组合物,所述的中药组合物包括:麸炒枳壳15份、酒黄芩15份、垂盆草45份、党参10份、黄芪20份、麸炒白术15份、茯苓15份、醋柴胡8份、炒白芍15份、醋香附15份、陈皮15份、醋青皮15份、法半夏15份、荷叶(大)15份、泽泻15份、焦山楂15份、路路通15份、炙甘草5份。
一种具有治疗代谢相关脂肪性肝病的中药组合物,所述的中药组合物包括:麸炒枳壳20份、酒黄芩20份、垂盆草60份、党参20份、黄芪30份、麸炒白术20份、茯苓20份、醋柴胡12份、炒白芍20份、醋香附20份、陈皮20份、醋青皮20份、法半夏20份、荷叶(大)20份、泽泻20份、焦山楂20份、路路通20份、炙甘草6份。
作为优选方案,以上所述的具有治疗代谢相关脂肪性肝病的中药组合物的制备方法,包括以下步骤:
按重量份数取麸炒枳壳、酒黄芩、垂盆草、党参、黄芪、麸炒白术、茯苓、醋柴胡、炒白芍、醋香附、陈皮、醋青皮、法半夏、荷叶(大)、泽泻、焦山楂、路路通、炙甘草,先加水浸泡,然后煎煮提取,合并煎煮液,浓缩,然后加入药学上可接受的载体制备成中药制剂。
作为优选方案,以上所述的具有治疗代谢相关脂肪性肝病的中药组合物的制备方法,包括以下步骤:
按重量份数取麸炒枳壳、酒黄芩、垂盆草、党参、黄芪、麸炒白术、茯苓、醋柴胡、炒白芍、醋香附、陈皮、醋青皮、法半夏、荷叶(大)、泽泻、焦山楂、路路通、炙甘草,先加6~20倍量的水浸泡0.5~2小时,然后煎煮提取1~3次,每次0.5~2小时,合并煎煮液,浓缩,然后加入药学上可接受的载体制备成汤剂、膏剂、颗粒剂、片剂、胶囊剂或口服液。
本发明在制成汤剂时,取上述中药加6~20倍量的水浸泡0.5~2小时,然后煎煮,冷却后滤去残渣即可。
本发明在制成膏剂时,把中药提取物浸膏加入炼蜜,搅拌收膏,分装,即得。
本发明在制成胶囊剂时,把中药提取物浸膏与糊精或淀粉混合均匀,制粒,然后装胶囊制成胶囊剂。
本发明在制成颗粒剂时,把中药提取物浸膏加糊精等混合均匀,制粒,干燥,制成颗粒剂。
本发明在制成口服液时,把中药提取物加纯化水溶解,加入甜菊素或阿斯巴甜,调pH,制成口服液。
本发明所述的具有治疗代谢相关脂肪性肝病的中药组合物在制备防治代谢相关脂肪性肝病的药物中的应用。
本发明提供的中药复方,方中党参健脾益气,白术燥湿运脾,茯苓健脾利湿,脾运则痰湿自消,配伍黄芪补中益气,共为君药。柴胡、白芍配伍,一散一收,疏肝理气,以调达肥胖患者气机的阻滞;香附、枳壳、青皮理肝脾之气兼能燥湿,既可消肥胖患者体内痰湿,脾气调达则痰浊不生,又可调畅肝脾气机,肝主疏泄,肝气调达则气郁解,配伍陈皮、法半夏燥湿化痰,为臣药。荷叶性平清暑化湿、升发清阳,消膏化浊,泽泻清热泻火、利水渗湿,黄芩清热燥湿、泻火解毒,垂盆草利湿退黄、清热解毒,四药合用共消肥人之湿,配伍山楂活血,路路通通利之功,使药物补而不滞,通达周身,为佐药。炙甘草缓中补虚,调和诸药,为使药。
有益效果:
本发明采用辨证论治的方法,通过大量实验筛选出最佳的组方,本发明从中医角度对代谢相关脂肪性肝病(MAFLD)患者进行辨证论治,从脾论治,以化痰祛湿为大法,发挥减重的功效,以减轻MAFLD,本发明所述的中药组合物经临床证实对代谢相关脂肪性肝病具有显著的治疗作用。
本发明提供的治疗MAFLD的中药复方组合物,可以方便和药学载体制备成多种剂型,临床上服用方便,且实验结果表明本发明提供的组合物,疗效可靠,使用安全,长期服用无毒副作用。
具体实施方式
下面通过实施例的方式进一步说明本发明,但并不因此将本发明限制在所述的实施例范围之中。在阅读了本发明之后,本领域技术人员对本发明的各种非实质性的修改均落于本申请所附权利要求所限定的范围。
实施例1
1、一种具有治疗代谢相关脂肪性肝病的中药组合物,所述的中药组合物包括:麸炒枳壳10份、酒黄芩10份、垂盆草30份、党参10份、黄芪15份、麸炒白术10份、茯苓10份、醋柴胡6份、炒白芍10份、醋香附10份、陈皮10份、醋青皮10份、法半夏10份、荷叶(大)10份、泽泻10份、焦山楂10份、路路通10份、炙甘草3份。
2、本发明所述的具有治疗代谢相关脂肪性肝病的中药组合物的制备方法,包括以下步骤:
按重量份数取麸炒枳壳10份、酒黄芩10份、垂盆草30份、党参10份、黄芪15份、麸炒白术10份、茯苓10份、醋柴胡6份、炒白芍10份、醋香附10份、陈皮10份、醋青皮10份、法半夏10份、荷叶(大)10份、泽泻10份、焦山楂10份、路路通10份、炙甘草3份,先加10倍量的水浸泡1小时,然后煎煮提取2次,第一次2小时,第二次1小时,合并二次煎煮液,浓缩,过滤制得汤剂。
实施例2
1、一种具有治疗代谢相关脂肪性肝病的中药组合物,所述的中药组合物包括:麸炒枳壳10份、酒黄芩10份、垂盆草30份、党参10份、黄芪15份、麸炒白术10份、茯苓10份、醋柴胡6份、炒白芍10份、醋香附10份、陈皮10份、醋青皮10份、法半夏10份、荷叶(大)10份、泽泻10份、焦山楂10份、路路通10份、炙甘草3份g。
2、本发明所述的具有治疗代谢相关脂肪性肝病的中药组合物的制备方法,包括以下步骤:
按重量份数取麸炒枳壳20份、酒黄芩20份、垂盆草60份、党参20份、黄芪30份、麸炒白术20份、茯苓20份、醋柴胡12份、炒白芍20份、醋香附20份、陈皮20份、醋青皮20份、法半夏20份、荷叶(大)20份、泽泻20份、焦山楂20份、路路通20份、炙甘草6份,先加15倍量的水浸泡2小时,然后煎煮提取3次,第一次2小时,第二和第三次1小时,合并三次煎煮液,浓缩,加入炼蜜,搅拌收膏,分装,即得膏剂。
实施例3
1、一种具有治疗代谢相关脂肪性肝病的中药组合物,所述的中药组合物包括:麸炒枳壳15份、酒黄芩15份、垂盆草45份、党参10份、黄芪20份、麸炒白术15份、茯苓15份、醋柴胡8份、炒白芍15份、醋香附15份、陈皮15份、醋青皮15份、法半夏15份、荷叶(大)15份、泽泻15份、焦山楂15份、路路通15份、炙甘草5份。
2、本发明所述的具有治疗代谢相关脂肪性肝病的中药组合物的制备方法,包括以下步骤:
按重量份数取麸炒枳壳20份、酒黄芩20份、垂盆草60份、党参20份、黄芪30份、麸炒白术20份、茯苓20份、醋柴胡12份、炒白芍20份、醋香附20份、陈皮20份、醋青皮20份、法半夏20份、荷叶(大)20份、泽泻20份、焦山楂20份、路路通20份、炙甘草6份,先加20倍量的水浸泡1小时,然后煎煮提取3次,第一次2小时,第二和第三次1小时,合并三次煎煮液,浓缩,加入糊精混合均匀,制粒,然后装胶囊制成胶囊剂。
实施例4
1、一种具有治疗代谢相关脂肪性肝病的中药组合物,所述的中药组合物包括:麸炒枳壳20份、酒黄芩20份、垂盆草60份、党参20份、黄芪30份、麸炒白术20份、茯苓20份、醋柴胡12份、炒白芍20份、醋香附20份、陈皮20份、醋青皮20份、法半夏20份、荷叶(大)20份、泽泻20份、焦山楂20份、路路通20份、炙甘草6份。
2、本发明所述的具有治疗代谢相关脂肪性肝病的中药组合物的制备方法,包括以下步骤:
按重量份数取麸炒枳壳20份、酒黄芩20份、垂盆草60份、党参20份、黄芪30份、麸炒白术20份、茯苓20份、醋柴胡12份、炒白芍20份、醋香附20份、陈皮20份、醋青皮20份、法半夏20份、荷叶(大)20份、泽泻20份、焦山楂20份、路路通20份、炙甘草6份,先加10倍量的水浸泡1.5小时,然后煎煮提取2次,第一次2小时,第二次1.5小时,合并两次煎煮液,浓缩,加糊精等混合均匀,制粒,干燥,制成颗粒剂。
实施例5
1、病例选择
选择江苏省中医院内分泌科MAFLD患者,服药1月者45人,其中男性24人,女性21人;服药3月者29人,其中男性13人,女性16人。治疗3月后复查肝脏CAP患者11人。
治疗周期:1月观察短期疗效,3月观察长期疗效。
2、服用方法:
治疗药物为本发明实施例1的制得的中药复方组合物。
3、有效性分析
采用Excel表格收集、GraphPad Prism8.0.2统计分析软件处理。因收集病例数据中体重、BMI皆不符合正态分布,采用非参数检验,结果如下:
患者治疗前后体重及BMI变化如表1和表2所示:
表1治疗1月45位患者体重及BMI变化(±s)
指标 | 治疗前 | 治疗后 | P |
体重(kg) | 78.42±13.16 | 75.00±11.38 | <0.0001 |
BMI(kg/m2) | 28.03±4.29 | 26.81±3.68 | <0.0001 |
由表1的结果表明,治疗1月后体重及BMI均出现明显下降,差异具有统计学意义(P<0.0001)。
表2治疗3月29位患者体重及BMI变化(±s)
指标 | 治疗前 | 治疗后 | P |
体重(kg) | 82.42±14.11 | 77.84±12.10 | <0.0001 |
BMI(kg/m2) | 28.87±4.07 | 27.31±3.77 | <0.0001 |
由表2的结果表明,治疗3月后体重及BMI均出现明显下降,差异具有统计学意义(P<0.0001)。
表3治疗3月11位患者肝脏顺势弹性成像技术检测受控衰减参数(CAP)变化(±s)
指标 | 治疗前 | 治疗后 | P |
CAP | 287.55±39.67 | 235.30±41.15 | <0.001 |
由表3的结果表明,治疗3月后患者肝脏CAP值出现明显下降,差异具有统计学意义(P<0.0001)。
结论:由表1、表2和表3可得,MAFLD患者不论是短期还是长期均可从中获益,对减重、减轻肝脏脂肪含量、治疗MAFLD均有较好的效果。
以上所述仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以做出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。
Claims (5)
1.一种具有治疗代谢相关脂肪性肝病的中药组合物,其特征在于,所述的中药组合物由下列重量份数的原料制成:麸炒枳壳10~20份、酒黄芩10~20份、垂盆草30~60份、党参10~20份、黄芪15~30份、麸炒白术10~20份、茯苓10~20份、醋柴胡6~12份、炒白芍10~20份、醋香附10~20份、陈皮10~20份、醋青皮10~20份、法半夏10~20份、荷叶10~20份、泽泻10~20份、焦山楂10~20份、路路通10~20份、炙甘草3~6份。
2.权利要求1所述的具有治疗代谢相关脂肪性肝病的中药组合物的制备方法,其特征在于,包括以下步骤:
按重量份数取麸炒枳壳、酒黄芩、垂盆草、党参、黄芪、麸炒白术、茯苓、 醋柴胡、炒白芍、醋香附、陈皮、醋青皮、法半夏、荷叶、泽泻、焦山楂、路路通、炙甘草,先加水浸泡,然后煎煮提取,合并煎煮液,浓缩,然后加入药学上可接受的载体制备成中药制剂。
3.根据权利要求2所述的具有治疗代谢相关脂肪性肝病的中药组合物的制备方法,其特征在于,包括以下步骤:
按重量份数取麸炒枳壳、酒黄芩、垂盆草、党参、黄芪、麸炒白术、茯苓、 醋柴胡、炒白芍、醋香附、陈皮、醋青皮、法半夏、荷叶、泽泻、焦山楂、路路通、炙甘草,先加6~20倍量的水浸泡0.5~2小时,然后煎煮提取1~3次,每次0.5~2小时,合并煎煮液,浓缩,然后加入药学上可接受的载体制备成中药制剂。
4.根据权利要求2或3所述的具有治疗代谢相关脂肪性肝病的中药组合物的制备方法,其特征在于,所述的中药制剂包括汤剂、膏剂、颗粒剂、片剂、胶囊剂或口服液。
5.权利要求1所述的具有治疗代谢相关脂肪性肝病的中药组合物在制备防治代谢相关脂肪性肝病的药物中的应用。
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