CN104547800A - 一种中药制剂在制备治疗酒精性脂肪肝药物中的用途 - Google Patents
一种中药制剂在制备治疗酒精性脂肪肝药物中的用途 Download PDFInfo
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Abstract
本发明属于中药领域,具体涉及一种中药制剂在制备治疗酒精性脂肪肝药物中的用途。该中药制剂的主要原料有败酱草、木香、白花蛇舌草、牡丹皮、赤芍、薏仁、桃仁、红花、三棱、皂角刺、芒硝、川芎、夏枯草、蒲公英、桂枝、白芷、甘草等多味药材。该中药制剂在治疗酒精性脂肪肝方面,具有治疗效果好、标本兼治、调理与治疗结合、不易复发等显著的治疗优势,并且还具有制备工艺简便、药效稳定、普适性强、易于推广应用等技术优势。
Description
技术领域
本发明属于中药领域,具体涉及一种中药制剂在制备治疗酒精性脂肪肝药物中的用途。
背景技术
酒精性脂肪肝是由于长期饮酒导致的脂肪肝,是目前临床上最为常见的肝病之一。随着我国人们生活方式的变化,人民饮食结构的调整以及老龄化人口的增加,酒精性肝病的发病率也同益增加。
酒精性脂肪肝的临床症状为右上腹胀痛,食欲不振,乏力,体重减轻或无症状的非特异性症状,因此,酒精性脂肪肝很容易被人们所忽略。如果患上酒精性脂肪肝而没有得到及时的治疗则会对人体健康产生极大的危害,酒精性脂肪肝会对肝细胞造成死亡,降低肝脏分解、代谢、解毒功能,降低人体免疫力;酒精性脂肪肝使血液中甘油三酯高,常伴有高脂血症,血液黏稠度增加,促进动脉粥样硬化的形成;酒精性脂肪肝患者合并高血压、冠心病,容易导致心肌梗塞而猝死;酒精性脂肪肝极易发展为肝纤维,从而导致肝硬化的形成,最终发展成肝癌;酒精性脂肪肝加快向肝硬化发展,乙肝、丙肝合并脂肪肝会增加肝纤维化的发生和发展,缩短向肝硬化的发展时间;酒精性脂肪肝患者脂代谢失调,会引发和加重糖代谢失调,加重糖尿病的发生。严重威胁人类的健康。
目前,酒精性脂肪肝主要是药物治疗,S-腺苷蛋氨酸治疗可以改善酒精性脂肪肝患者的临床症状和生物化学指标;多烯磷脂酰胆碱对酒精性脂肪肝患者有防止组织学恶化的趋势。甘草酸制剂,水飞蓟素类、多烯磷脂酰胆碱和还原型谷胱甘肽等药物有不同程度的抗氧化,抗炎、保护肝细胞膜及细胞器等作用,临床应用可改善肝脏生物化学指标;还有常用的一些维生素B、C、E,卵磷脂、熊去氧胆酸、肌苷、辅酶A、牛磺酸、肉毒碱乳清酸盐以及一些降脂药物等,起到保护干细胞,降脂和抗氧化的作用,以达到治疗酒精性脂肪肝的目的。但是,这些药物在治疗过程中存在治疗靶点单一,长期用药容易出现耐受性等问题很难对酒精性脂肪肝达到全面持续治疗效果,因此寻找一种安全有效的酒精性脂肪肝治疗药物具有十分重要的社会意义和经济意义。
发明内容
本发明要解决的技术问题是提供一种中药制剂在制备治疗酒精性脂肪肝药物中的用途,公开一种对酒精性脂肪肝有较好的治疗效果的中药制剂,已解决现代酒精性脂肪肝治疗效果,治疗效果难以持续的问题。
为解决上述技术问题,根据现代制药技术的特点,依据中药配伍原理,通过临床实践反复调整,研究出一组对酒精性脂肪肝有明显治疗效果的中药制剂,所述的中药制剂由如下重量份的中药材制成:
败酱草18-32份、木香25-35份、白花蛇舌草14-26 份、牡丹皮12-20份、赤芍5-16份、薏仁6-18份、桃仁4-14份、红花5-15份、三棱7-17份、皂角刺4-12份、芒硝8-20份、川芎7-22份、夏枯草6-18份、蒲公英8-20份、桂枝2-10份、白芷2-10份、甘草6-16份。
在临床实践中优选出的1个具有最佳治疗效果的配比为:
败酱草22份、木香28份、白花蛇舌草18份、牡丹皮16份、赤芍10份、薏仁12份、桃仁10份、红花9份、三棱13份、皂角刺8份、芒硝14份、川芎12份、夏枯草8份、蒲公英11份、桂枝6份、白芷4份、甘草10份。
将中药组方做成中药制剂的制备工艺为以下步骤:
(1)、按中药组方分别称取各味药材,粉碎,备用;
(2)、将所有药材加入初始药材6倍重量的蒸馏水,浸泡10小时,回流煎煮2小时,过滤,再加入初始重量5倍重量的纯化水,回流煎煮1小时,过滤并保留滤渣,合并滤液,浓缩至65℃相对密度为1.20的浓缩液备用;
(3)、将步骤(2)的滤渣加5倍重量的浓度65%的乙醇,回流提取2次,每次2小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至65℃相对密度为1.20的浓缩液备用;
(4)、将步骤(2)和(3)所得的浓缩液合并,继续浓缩至65℃相对密度为1.30的中药浸膏,备用;
(5)、将步骤(4)的中药浸膏添加辅料,利用现代通用的中药制剂技术制成临床需要的成品制剂,如口服液、片剂、丸剂、胶囊剂、散剂或颗粒剂等剂型。
本发明所用中药材的来源、性味、归经及功用:
败酱草:本品为败酱草科植物黄花龙芽,白花败酱(苦斋),以根状茎和根、全草入药。味辛、苦,性凉;入胃、大肠、肝经;清热解毒,消痈排脓,活血行瘀,疏肝解郁。
木香:本品为菊科植物木香的干燥根。味辛、苦,性温;归脾、胃、大肠、三焦、胆经;行气止痛,健脾消食。
白花蛇舌草:本品为茜草科耳草属植物白花蛇舌草的全草。味甘、淡,性凉;入胃、大肠、小肠经;清热解毒,利尿消肿,活血止痛。
牡丹皮:本品为毛茛科植物牡丹的干燥根皮。味苦、辛,性微寒;归心、肝、肾经;清热凉血,活血化瘀,益气补肝。
赤芍:本品为毛茛科植物芍药或川赤芍的干燥根。味苦,性微寒;归肝经;清热凉血,散瘀止痛。
薏仁:本品为禾本科植物薏苡的干燥成熟种仁。味甘、淡,性凉;归脾、胃、肺经;健脾渗湿,除痹止泻,清热排浓。
桃仁:本品为蔷薇科植物桃或山桃的干燥成熟种子。味苦、甘,性平;归心、肝、大肠经;活血祛瘀,润肠通便。
红花:别名红蓝花、刺红花,菊科、红花属植物。味辛,性温;入心、肝经;活血通经,去瘀止痛,祛瘀通络。
三棱:本品为黑三棱科植物黑三棱的干燥块茎。味辛、苦,性平;归肝、脾经;破血行气,消积止痛。
皂角刺:本品为豆科植物皂荚的干燥棘刺。味辛,性温;归肝、胃经;消肿托毒,排脓,杀虫。
芒硝:本品为硫酸盐类矿物芒硝族芒硝,经加工精制而成的结晶体。味咸、苦,性寒;归胃、大肠经;泻热通便,润燥软坚,清火消肿。
川芎:本品为伞形科植物川芎的干燥根茎。味辛,性温;归肝、胆、心包经;活血行气,祛风止痛。
夏枯草:本品为唇形科植物夏枯草的干燥果穗。味辛、苦,性寒;归肝、胆经;清火,明目,散结,消肿。
蒲公英:本品为菊科植物蒲公英、碱地蒲公英或同属数种植物的干燥全草。味苦、甘,性寒;归肝、胃经;清热解毒,消肿散结,利尿通淋。
桂枝:本品为樟科植物肉桂的干燥嫩枝。味辛、甘,性温;归心、肺、膀胱经;发汗解肌,温通经脉,助阳化气,平冲降气。
白芷:本品为伞型科植物白芷或杭白芷的干燥根。味辛,性温;归胃、大肠、肺经;散风除湿,通窍止痛,消肿排脓。
甘草:本品为豆科植物甘草、胀果甘草或光果甘草的干燥根。味甘,性平;归心、肺、脾、胃经;补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。
本发明中药组方的组方分析:
本发明中药组方是以败酱草、白花蛇舌草、木香、皂角刺、牡丹皮、桃仁为君药,活血止痛、消肿托毒、清热凉血、疏肝解郁、健脾消导、益气补肝、解毒化浊、活血祛瘀;以赤芍、薏仁、蒲公英、白芷为臣药,散瘀止痛、祛瘀通络、除痹止泻、清热解毒、散风除湿、化痰祛湿;以红花、三棱、川芎、芒硝为佐药,活血通经、破血行气、祛风止痛、清火消肿;以夏枯草、桂枝为使药,散结消肿、温通经脉、疏肝解毒;以甘草调和诸药性,使君臣佐使诸药配合,协同作用,共同达到疏肝解郁、健脾消导、益气补肝、解毒化浊、清热解毒、活血通经等功效,对酒精性脂肪肝具有显著的治疗效果。
与现有技术相比,本发明中药制剂在治疗酒精性脂肪肝方面,具有治疗效果好、标本兼治、调理与治疗结合、不易复发等显著的治疗优势,并且还具有制备工艺简便、药效稳定、普适性强、易于推广应用等技术优势。
具体实施方式
实施例1、本发明胶囊剂制备
(1)、按中药组方分别称取:败酱草18kg、木香25kg、白花蛇舌草14kg、牡丹皮12kg、赤芍5kg、薏仁6kg、桃仁4kg、红花5kg、三棱17kg、皂角刺12kg、芒硝20kg、川芎22kg、夏枯草18kg、蒲公英20kg、桂枝10kg、白芷10kg、甘草16kg,粉碎,备用;
(2)、将所有药材加入初始药材6倍重量的蒸馏水,浸泡10小时,回流煎煮2小时,过滤,再加入初始重量5倍重量的纯化水,回流煎煮1小时,过滤并保留滤渣,合并滤液,浓缩至65℃相对密度为1.20的浓缩液备用;
(3)、将步骤(2)的滤渣加5倍重量的浓度65%的乙醇,回流提取2次,每次2小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至65℃相对密度为1.20的浓缩液备用;
(4)、将步骤(2)和(3)所得的浓缩液合并,继续浓缩至65℃相对密度为1.30的中药浸膏,备用;
(5)、将步骤(4)的中药浸膏添加辅料,利用现代通用的中药制剂技术制成胶囊剂。
实施例2、本发明胶囊剂制备
(1)、按中药组方分别称取:败酱草22kg、木香28kg、白花蛇舌草18kg、牡丹皮16kg、赤芍10kg、薏仁12kg、桃仁10kg、红花9kg、三棱13kg、皂角刺8kg、芒硝14kg、川芎12kg、夏枯草8kg、蒲公英11kg、桂枝6kg、白芷4kg、甘草10kg,粉碎,备用;
(2)、将所有药材加入初始药材6倍重量的蒸馏水,浸泡10小时,回流煎煮2小时,过滤,再加入初始重量5倍重量的纯化水,回流煎煮1小时,过滤并保留滤渣,合并滤液,浓缩至65℃相对密度为1.20的浓缩液备用;
(3)、将步骤(2)的滤渣加5倍重量的浓度65%的乙醇,回流提取2次,每次2小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至65℃相对密度为1.20的浓缩液备用;
(4)、将步骤(2)和(3)所得的浓缩液合并,继续浓缩至65℃相对密度为1.30的中药浸膏,备用;
(5)、将步骤(4)的中药浸膏添加辅料,利用现代通用的中药制剂技术制成胶囊剂。
实施例3、本发明片剂制备
(1)、按中药组方分别称取:败酱草32kg、木香35kg、白花蛇舌草26kg、牡丹皮20kg、赤芍16kg、薏仁18kg、桃仁14kg、红花15kg、三棱7kg、皂角刺4kg、芒硝8kg、川芎7kg、夏枯草6kg、蒲公英8kg、桂枝2kg、白芷2kg、甘草6kg,粉碎,备用;
(2)、将所有药材加入初始药材6倍重量的蒸馏水,浸泡10小时,回流煎煮2小时,过滤,再加入初始重量5倍重量的纯化水,回流煎煮1小时,过滤并保留滤渣,合并滤液,浓缩至65℃相对密度为1.20的浓缩液备用;
(3)、将步骤(2)的滤渣加5倍重量的浓度65%的乙醇,回流提取2次,每次2小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至65℃相对密度为1.20的浓缩液备用;
(4)、将步骤(2)和(3)所得的浓缩液合并,继续浓缩至65℃相对密度为1.30的中药浸膏,备用;
(5)、将步骤(4)的中药浸膏添加辅料,利用现代通用的中药制剂技术制成片剂。
实施例4、本发明颗粒剂制备
(1)、按中药组方分别称取:败酱草20kg、木香26kg、白花蛇舌草16kg、牡丹皮20kg、赤芍9kg、薏仁8kg、桃仁12kg、红花7kg、三棱8kg、皂角刺8kg、芒硝10kg、川芎14kg、夏枯草6kg、蒲公英17kg、桂枝6kg、白芷6kg、甘草10kg,粉碎,备用;
(2)、将所有药材加入初始药材6倍重量的蒸馏水,浸泡10小时,回流煎煮2小时,过滤,再加入初始重量5倍重量的纯化水,回流煎煮1小时,过滤并保留滤渣,合并滤液,浓缩至65℃相对密度为1.20的浓缩液备用;
(3)、将步骤(2)的滤渣加5倍重量的浓度65%的乙醇,回流提取2次,每次2小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至65℃相对密度为1.20的浓缩液备用;
(4)、将步骤(2)和(3)所得的浓缩液合并,继续浓缩至65℃相对密度为1.30的中药浸膏,备用;
(5)、将步骤(4)的中药浸膏添加辅料,利用现代通用的中药制剂技术制成颗粒剂。
实施例5、本发明口服液制备
(1)、按中药组方分别称取:败酱草24kg、木香28kg、白花蛇舌草14kg、牡丹皮12kg、赤芍6kg、薏仁6kg、桃仁10kg、红花8kg、三棱9kg、皂角刺10kg、芒硝16kg、川芎8kg、夏枯草10kg、蒲公英8kg、桂枝8kg、白芷6kg、甘草16kg,粉碎,备用;
(2)、将所有药材加入初始药材6倍重量的蒸馏水,浸泡10小时,回流煎煮2小时,过滤,再加入初始重量5倍重量的纯化水,回流煎煮1小时,过滤并保留滤渣,合并滤液,浓缩至65℃相对密度为1.20的浓缩液备用;
(3)、将步骤(2)的滤渣加5倍重量的浓度65%的乙醇,回流提取2次,每次2小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至65℃相对密度为1.20的浓缩液备用;
(4)、将步骤(2)和(3)所得的浓缩液合并,继续浓缩至65℃相对密度为1.30的中药浸膏,备用;
(5)、将步骤(4)的中药浸膏添加辅料,利用现代通用的中药制剂技术制成口服液。
实施例6、本发明中药制剂对酒精性脂肪肝的治疗试验
1、酒精性脂肪肝模型的制备
使用体重为130~ 150g 的清洁级健康成年雄性SD 大鼠,自由饮用55°二锅头白酒配制成不同浓度及含10% 白糖的酒水饮料,其白酒度按照5%、10%、15%、20%、25%、30%、35%、40%(V/V) 逐渐递增,每个浓度持续10 天,40%时维持20 周,总造模时间30 周,构建酒精性脂肪肝病理动物模型。各组大鼠实验期间均予自由进食全价营养颗粒饲料。
2、分组与给药
模型大鼠适应性饲养1周后,随机分成对照组、模型组、水飞蓟宾组、低剂量组、中剂量组和高剂量组,每组12只。每天下午14:30时灌胃药物,各组的给药量如下:
对照组:灌胃给予同体积的蒸馏水;
模型组:灌胃给予同体积的蒸馏水;
水飞蓟宾组:灌胃给予20mg/(kg.d)水飞蓟宾;
低剂量组:灌胃给予本发明实施例2所制备胶囊剂,50m g/(kg.d);
中剂量组:灌胃给予本发明实施例2所制备胶囊剂,100mg/(kg.d);
高剂量组:灌胃给予本发明实施例2所制备胶囊剂,200mg/(kg.d);
3 检测指标
末次给药后,戊巴比妥钠麻醉大鼠,解剖,腹主静脉取血测定生化指标,取肝脏进行称重。
3.1.肝功能
试验结果表明(详见表1),酒精性脂肪肝模型组大鼠血清ALT、AST含量与对照组相比大幅度升高,水飞蓟宾组和本发明的低、中和高剂量组的大鼠血清ALT、AST含量与模型组相比明显下降,其中,本发明的高剂量组与模型组相比具有极显著性差异;本发明的高剂量与水飞蓟宾组相比具有显著性差异。这说明本发明中药制剂各中药在对大鼠脂肪肝的预防或治疗上取得了协同性的作用。
表1 本发明中药制剂对大鼠模型肝功能的影响
与模型组比较,*P<0.05,**P<0.01;
与水飞蓟宾组比较,#P<0.05;
3.2血脂
试验结果表明(详见表2),本发明的低、中和高剂量组的总胆固醇、甘油三酯、高密度脂蛋白胆固醇和低密度脂蛋白胆固醇的水平与大鼠脂肪肝模型组相比有显著性差异或极显著性差异,本发明的高剂量组与水飞蓟宾组相比具有显著性差异差异(高密度脂蛋白水平除外),这说明本发明中药制剂中中药联合应用,在大鼠脂肪肝模型上,在降低TG、TC和LDL-C上取得了很好的协同作用。
表2 本发明中药制剂对大鼠模型血脂的影响
与模型组比较,*P<0.05,**P<0.01;
与水飞蓟宾组比较,#P<0.05;
3.3.肝指数
试验结果表明(详见表3),本发明的低、中和高剂量组和水飞蓟宾组的大鼠的肝指数与模型组相比有显著性差异,尤其是,本发明的高剂量组与模型组相比极显著性差异,说明本发明中药制剂各中药在大鼠脂肪肝模型上,在降低肝脏指数这个指标上取得了很好的协同作用。
表3 本发明中药制剂对大鼠脏器指数的影响
与模型组比较,*P<0.05,**P<0.01;
与水飞蓟宾组比较,#P<0.05。
Claims (4)
1.一种中药制剂在制备治疗酒精性脂肪肝药物中的用途,其特征在于,所述的中药制剂由如下重量份的中药材制成:
败酱草18-32份、木香25-35份、白花蛇舌草14-26 份、牡丹皮12-20份、赤芍5-16份、薏仁6-18份、桃仁4-14份、红花5-15份、三棱7-17份、皂角刺4-12份、芒硝8-20份、川芎7-22份、夏枯草6-18份、蒲公英8-20份、桂枝2-10份、白芷2-10份、甘草6-16份。
2.如权利要求1所述的用途,其特征在于,所述的中药制剂由如下重量份的中药材制成:
败酱草22份、木香28份、白花蛇舌草18份、牡丹皮16份、赤芍10份、薏仁12份、桃仁10份、红花9份、三棱13份、皂角刺8份、芒硝14份、川芎12份、夏枯草8份、蒲公英11份、桂枝6份、白芷4份、甘草10份。
3.如权利要求1或2所述的用途,其特征在于,所述的中药制剂的制备工艺为:
(1)、按中药组方分别称取各味药材,粉碎,备用;
(2)、将所有药材加入初始药材6倍重量的蒸馏水,浸泡10小时,回流煎煮2小时,过滤,再加入初始重量5倍重量的纯化水,回流煎煮1小时,过滤并保留滤渣,合并滤液,浓缩至65℃相对密度为1.20的浓缩液备用;
(3)、将步骤(2)的滤渣加5倍重量的浓度65%的乙醇,回流提取2次,每次2小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至65℃相对密度为1.20的浓缩液备用;
(4)、将步骤(2)和(3)所得的浓缩液合并,继续浓缩至65℃相对密度为1.30的中药浸膏,备用;
(5)、将步骤(4)的中药浸膏添加辅料,利用现代通用的中药制剂技术制成临床需要的成品制剂。
4.如权利要求1-3任一所述的用途,其特征在于,所述的中药制剂制成口服液、片剂、丸剂、胶囊剂、散剂或颗粒剂。
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