CN113663016A - 一种药物组合物及其应用 - Google Patents
一种药物组合物及其应用 Download PDFInfo
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Abstract
本发明属于主要制备技术领域,具体涉及一种药物组合物及其应用,其包括以下重量份的原料:鳖甲10‑30份、丹参10‑30份、赤芍10‑30份、鸡血滕10‑30份、黃芪10‑30份、鸡内金10‑20份、龙牙楤木10‑30份、沙棘5‑15份、叶下珠20‑40份、苦参5‑15份、连翘10‑20份、香附5‑15份、五味子5‑15份。本发明的目的是提供一种对肝纤维化治疗有防治效果,能减轻纤维化的发展,能使形成早期肝硬化患者能阻断和逆转,对慢性肝炎及肝硬化患者也有较好效果的药物组合物及其应用。
Description
技术领域
本发明属于中药制备技术领域,具体涉及一种药物组合物及其应用。
背景技术
肝纤维化是指由各种致病因子所致肝内结缔组织异常增生,导致肝内弥漫性细胞外基质过度沉淀的病理过程。它不是一个独立的疾病,许多慢性肝脏疾病均可引起肝纤维化。我国是病毒性肝炎流行的高发区,病毒性肝炎是引起肝纤维化和肝硬化的常见病因,慢性肝炎患者达数千万,其中又有约1/10-1/3可发展为肝硬化。肝纤维化是各种病因导致肝硬化的病理基础。
近年来,随着医学分子生物学的迅速发展和应用,对肝纤维化的认识不断深入,为治疗提供了不少可能的途径。目前认为,肝纤维化是可逆转的,通过抗纤维化治疗可使肝纤维化程度明显减轻。而多数治疗目前仍处于实验研究阶段。肝纤维化的形成与发展是极其复杂的过程,在肝纤维化的治疗中多种治疗联合应用非常重要,主要包括肝纤维化的病因治疗、肝细胞保护与再生治疗、免疫治疗、肝星状细胞的活化与抑制治疗、细胞外基质的调节治疗等方法。
中医药在干预肝纤维化方面已显示出较明显的优势。中药治疗肝纤维化的方法有单味中药治疗及中药复方治疗。单味中药有丹参、黄芪、大黄、冬虫夏草、莪术等。目前研究较多的中药复方有复方861合剂、芪术颗粒、扶正化瘀319方、汉丹肝乐、小柴胡汤、鳖甲煎丸等。中药复方具有多成分、多环节、多层次、多靶点的药理学优势,其治疗肝纤维化疗效更加显著。
发明内容
针对上述现有技术存在的问题,本发明的目的是提供一种对肝纤维化治疗有防治效果,能减轻纤维化的发展,能使形成肝纤维化患者能阻断和逆转,对慢性肝炎及早期肝硬化患者也有较好效果的药物组合物及其应用。
为实现该目的,本发明采用如下技术方案:
一种药物组合物,包括以下重量份的原料:鳖甲10-30份、丹参10-30份、赤芍10-30份、鸡血滕10-30份、黃芪10-30份、鸡内金10-20份、龙牙楤木10-30份、沙棘5-15份、叶下珠20-40份、苦参5-15份、连翘10-20份、香附5-15份、五味子5-15份。
进一步地,所述的鳖甲为炙鳖甲。
进一步地,所述的鸡内金为炙鸡内金。
进一步地,所述的香附为炙香附。
进一步地,所述的药物组合物为原料制备的口服制剂。
进一步地,所述的口服制剂为散剂、丸剂、片剂、胶囊剂、颗粒剂或口服液。
进一步地,所述药物组合物在制备治疗肝纤维化药物中的应用。
各原料组份的药理如下:
鳖甲:味咸,性平,有滋阴潜阳、软坚散结、“入络搜邪,主治心腹癓瘕坚积”等作用。鳖甲攻坚,不损正气,阴阳上下有痞滞者,皆宜用之。现代研究证实能抑制结缔组织增生,对试验性肝纤维化有较好的抗纤维化作用,能软缩肝脾。
丹参:性味苦寒,归心,肝经,具有活血祛祛瘀,通经止痛,养心安神,凉血消肿之功。研究表明,丹参抗肝纤维化,能抑制胶原的增生,减少胶原的合成,并促进其降解。能使已形成的肝内纤维消散、吸收,明显逆转肝纤维化病理改变,降低转氨酶(ALT)降脂,促肝脾回缩,对四氯化碳(CCl4)引起的动物中毒有较好的解毒作用。
赤芍:味酸,苦,性凉,有清热凉血,散祛止痛作用,研究表明抗血栓形成降门脉高压作用显著,抑制血小板聚集(PLT),抑制过氧化脂质(MDA)的产生,抗肝损伤,降低转氨酶,治瘀血内结之症,促进纤维化吸收,抑制乙肝病毒却有疗效。
鸡血藤:味苦,性甘,温,入肝、肾经。有补血活血,舒筋活络,为强壮性补血药。用于养血、补血,调经止痛,其功能能攻能守、能行能止、能消能补,凡一切血证,或由血症引起的一切病症,均可采用,为血分之圣药。研究证明对免疫系统有双向调节作用,能扩张血管,抗血小板凝集,抗肝纤维化,降低胆固醇(TC)升白细胞(WBC)等作用。
黄芪:性温,味甘,归肺、脾经。有补气升阳,益气固表,利水、消肿、托毒敛疮生肌之功效。现代药理表明对免疫功能有双向调节作用,对CCl4中毒性肝炎及人白蛋白免疫性大鼠肝纤维化有明显抑制作用,降低ALT及丙二酫(MDA)抗乙肝病毒,软缩肝脾等作用。
鸡内金:味甘,性平、入脾、胃、小肠、膀胱经。有消积滞,健脾胃,乃为消化水谷之所,入肝而除肝热,入脾而消脾积,无论脏腑何处有积,鸡内金皆能消之,此方中用于化其经络之瘀滞,促脾胃之健旺,增进食物以促益气生血,清肝之瘀积,抑制肝纤维化的产生。
刺老鸦(龙牙楤木):味苦,辛,性平,归肝、心、肾三经。具有补气,安神,祛风利湿,活血止痛,强精滋肾等功效。研究表明,用于肝病。楤木皂甙对CCl4引起小鼠肝中毒有显著抑制作用,显著减少乙醇中毒肝组织中过氧化脂质丙二酫(MDA)含量,提高过氧化氢酶(CAT)活性;提高血清中超氧化歧酶(SOD)活性。有抗炎、清除自由基,对自身免疫有明显抑制作用,有降血脂、降血糖、消水肿、增加红血球、白血球数量等作用。
沙棘:味酸涩,性温。健脾消食,活血化瘀,其成分含大量维生素、黄酮、氨基酸、磷脂及大量超氧化歧酶;能促进免疫,提高免疫功能,抗心肌缺氧,对心肌缺血有保护作用。临床应用:治疗造血功能障碍及白血病。在肝病中用于治疗慢性肝炎,抑制血小板凝聚,有促纤溶作用,明显降低纤维蛋白的含量,降低血清胆固醇、甘油三脂及低密度脂蛋白,有保肝,抗溃疡,抗肿瘤,抗过敏,抗放射,抗氧化,延缓衰老等作用。
叶下珠(珍珠草):味甘,苦,性凉,入肝、肺经,有平肝清热、利水消肿、解毒、消积之功。药理研究,有保肝抗肝纤维化作用,对CCl4及半乳糖胺诱导肝损伤有保护作用。对肝组织纤维化增生有抑制作用,抗乙肝病毒,抑制病毒复制。
苦参:味苦,性寒,入心、肝、肾、大肠、膀胱经。有清热燥湿、杀虫,利尿等作用。研究表明有保肝及抗肝纤维化作用。对大鼠CCl4中毒性肝炎及免疫性肝损伤有较好的降血清ALT活性,有较强的抗乙肝病毒作用。苦参碱对实验性小鼠脾脏T细胞增殖抑制作用,故有软缩肝脾之作用。
连翘:有清热解毒,消肿散结之功。有抗菌、抗炎、抗病毒,止呕,抗过敏等药理作用。抗肝留滞之邪毒。经大鼠试验,有明显减轻CCl4所致的肝细胞变性和坏死,并能增加肝糖原的蓄积,降低血清谷丙转氨酶,清肝利胆,抑制内毒素等作用。
香附:味甘、苦,性微辛、微温,入肝三焦经。有疏肝理气,调经止痛的作用,研究证明香附明显降低CCl4所致肝的损伤,能降低谷丙转氨酶(ALT)、谷草转氨酶(AST)的活性,减轻肝细胞损伤,促进胆汁分泌,增加胆汁流量,有利胆作用。
五味子:味酸,性温,归肝、脾、肾经,有收敛固涩,益气生津,补肾宁心之功。肝病药理证明降酶效果非常好,对CCl4引起动物的肝损伤有保护作用,抑制脂质过氧化物(LPO)和丙二酫(MDA)的生成作用,抗乙肝病毒。
此复方活血化瘀中药,对肝纤维化治疗有防治效果,能减轻纤维化的发展,能使形成早期肝硬化患者能阻断和逆转,对慢性肝炎及肝硬化患者也有较好效果,其表现服此中药后症状明显改善或减轻,消炎,能软肝缩脾,调理蛋白比值,保护肝功能,扶正祛邪,兼顾脾胃,综合治疗。
具体实施方式
实施例1
一种药物组合物,包括以下重量份的原料:鳖甲10g、丹参10g、赤芍10g、鸡血滕10g份、黃芪10g、鸡内金10g、龙牙楤木10g、沙棘5g、叶下珠20g、苦参5g、连翘10g、香附5g、五味子5g。
将上述原料制备成口服剂,包括但不限于散剂、丸剂、片剂、胶囊剂、颗粒剂或口服液。
实施例2
一种药物组合物,包括以下重量份的原料:鳖甲30g、丹参30g、赤芍30g、鸡血滕30g、黃芪30g、鸡内金20g、龙牙楤木30g、沙棘15g、叶下珠40g、苦参15g、连翘20g、香附15g、五味子15g。
上述原料制备成口服剂,包括但不限于散剂、丸剂、片剂、胶囊剂、颗粒剂或口服液。
实施例3
一种药物组合物,包括以下重量份的原料:鳖甲20g、丹参20g、赤芍20g、鸡血滕20g、黃芪20g、鸡内金15g、龙牙楤木20g、沙棘10g、叶下珠30g、苦参10g、连翘15g份、香附10g、五味子10g。
上述原料制备成口服剂,包括但不限于散剂、丸剂、片剂、胶囊剂、颗粒剂或口服液。
实施例4
一种药物组合物,包括以下重量份的原料:炙鳖甲10g、丹参10g、赤芍10g、鸡血滕10g份、黃芪10g、炙鸡内金10g、龙牙楤木10g、沙棘5g、叶下珠20g、苦参5g、连翘10g、炙香附5g、五味子5g。
将上述原料制备成口服剂,包括但不限于散剂、丸剂、片剂、胶囊剂、颗粒剂或口服液。
实施例5
一种药物组合物,包括以下重量份的原料:炙鳖甲30g、丹参30g、赤芍30g、鸡血滕30g、黃芪30g、炙鸡内金20g、龙牙楤木30g、沙棘15g、叶下珠40g、苦参15g、连翘20g、炙香附15g、五味子15g。
上述原料制备成口服剂,包括但不限于散剂、丸剂、片剂、胶囊剂、颗粒剂或口服液。
实施例6
一种药物组合物,包括以下重量份的原料:炙鳖甲20g、丹参20g、赤芍20g、鸡血滕20g、黃芪20g、炙鸡内金15g、龙牙楤木20g、沙棘10g、叶下珠30g、苦参10g、连翘15g份、炙香附10g、五味子10g。
上述原料制备成口服剂,包括但不限于散剂、丸剂、片剂、胶囊剂、颗粒剂或口服液。
应用实施例1
钟某,男,40岁,建筑师
主诉:2012年体验时发现感染乙型肝炎病毒,转氨酶升高,嗜酒,有时夜间2-3点钟时腹部胀痛,难于入睡,偶尔服中药,但仍感腹胀,效果不佳,其余通好。体查:精神尚可,面色暗红,舌质瘀紫,肝未扪及,脾于肋下0.5cm处扪及,胃区有压通感,腹软,心率整齐,70次/分,肺部呼吸音粗糙,皮肤无痒感,余好。经肝肾功能、全血常规、肝血清纤维化四项指标、肝脏硬度、超声波等检测,诊断为慢性乙型病毒性肝炎,肝纤维化(F3)。
使用本发明,经三个月的治疗后患者丙氨酸氨基转移酶由97U/L下降为56U/L,肝纤维化四项指标下降,肝硬度由11.5(肝纤维化F3)逆转为肝硬度6.8(FOF1),患者症状有所改善,睡眠很好,夜间已无腹部胀痛现象,食欲增加,精神佳,肝脾未扪及。
应用实施例2
棍某,男,60岁,农民
自诉:2019年发现颜面浮肿6日,精神差,胃区阵发性疼痛,腹胀,便溏,小便深黄,既往无不适之处。到医院门诊就诊。查:一般情况尚可,神清,面色灰暗,巩膜轻度黄染,听力减弱,舌质暗紫,胸壁见两颗蜘蛛痣,肝未,扪及,脾于肋下2指处扪及,脉弦细,心率齐68次/分,肺(—),余未发现异常。经实验室:血清纤维四项指标、肝肾功能、全血常规、乙、丙肝指标检测及肝脏硬度、超声波等检测,诊断为慢性乙型病毒性肝炎,肝硬化。
使用本发明,服药3月后复查,血清纤维四项指标数据均有明显下降,肝脏硬度由15.1(F4)逆转至10.5(F2F3)。临床症状有所改善,颜面浮肿消退,精神好,无恶心、呕吐、腹胀、腹痛,大便正常,小便清畅,睡眠好,食欲好,肝脾未扪及。
应用实施例3
赵某,女,50岁,美容师
主诉:1997年感染上乙肝病毒,原因不明,曾用干扰素治疗过一段时间,余无不适之处。去年以来感到精神欠佳,疲倦无力,睡眠差。体查:一般情况尚可,腹软,肝区有轻微触痛感,肝脾未扪及,舌质稍紫,心肺(—),余好。经实验室查血清纤维四项指标、肝肾功能、全血常规、乙肝指标及肝脏硬度、超声波检测等,诊断为慢性乙型病毒性肝炎早期肝纤维化。
使用本发明,用药3月后复查,肝纤维化四项指标比原来有所下降,转氨酶正常,乙肝病毒载量有所下降,肝弹分期由原来8.4(F2)逆转为4.0(FO),症状明显改善,自觉心情倍感舒畅,有精力,无倦怠之感,肝区无压痛,睡眠、食欲均好。
应用实施例4
岳某,女,48岁,文艺工作者
自诉:于2007年生小孩时查出感染乙型肝炎病毒,因未有任何症状,故从未进行任何治疗。近来感觉尿黄、尿少,有时腹胀。体查:精神尚可,面色稍暗,舌质边缘紫红,腹软,肝脾未扪及,肝区有轻微触痛,心率齐72次/分,肺(—),大便正常。经血清纤维化四项指标、肝肾功能、全血常规、肝脏硬度、超声波等检测、诊断为乙型病毒性肝炎,肝纤维化。
使用本发明,经三个月的治疗后,复查对比,血清纤维化四项指标数计全有下降:丙氨酸氨基转移酶由原来54U/L下降至21U/L,乙肝病毒载量下降,肝硬度8.3(F2)逆转到3.4(FOF1),总蛋白57.3g/L上升至69.4g/L,服药后自觉精神,良好,睡眠质量大有改善,食欲增加,颜面及下肢末有浮肿,小便清畅量多,余好。
Claims (7)
1.一种药物组合物,其特征在于,包括以下重量份的原料:鳖甲10-30份、丹参10-30份、赤芍10-30份、鸡血滕10-30份、黃芪10-30份、鸡内金10-20份、龙牙楤木10-30份、沙棘5-15份、叶下珠20-40份、苦参5-15份、连翘10-20份、香附5-15份、五味子5-15份。
2.根据权利要求1所述的一种药物组合物,其特征在于,所述的鳖甲为炙鳖甲。
3.根据权利要求2所述的一种药物组合物,其特征在于,所述的鸡内金为炙鸡内金。
4.根据权利要求3所述的一种药物组合物,其特征在于,所述的香附为炙香附。
5.根据权利要求1-4任意一项所述的一种药物组合物,其特征在于,所述的药物组合物为原料制备的口服制剂。
6.根据权利要求5所述的一种药物组合物,其特征在于,所述的口服制剂为散剂、丸剂、片剂、胶囊剂、颗粒剂或口服液。
7.一种权利要求1所述的一种药物组合物的应用,其特征在于,所述药物组合物在制备治疗肝纤维化药物中的应用。
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CN1682868A (zh) * | 2005-02-07 | 2005-10-19 | 上海中医药大学附属曙光医院 | 一种治疗肝纤维化的复方制剂及其制备方法 |
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CN1682868A (zh) * | 2005-02-07 | 2005-10-19 | 上海中医药大学附属曙光医院 | 一种治疗肝纤维化的复方制剂及其制备方法 |
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Title |
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谢志春等: "叶下珠复方抗小鼠肝纤维化作用的实验研究", 《医学文选》 * |
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