CN106109538A - 治疗丙肝的药物组合物 - Google Patents
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Abstract
本发明公开了治疗丙肝的药物组合物,该药物组合物是由下述重量份的原料药制成:黑蚂蚁15‑17份、田七13‑15份、黑木耳14‑16份、苦瓜7‑9份、罗汉果4‑6份,克服现有治疗丙肝药物的不足,提供治疗丙肝效果较好的药物组合物。
Description
技术领域
本发明涉及中药技术领域,具体涉及治疗丙肝的药物组合物。
背景技术
丙型肝炎是由丙型肝炎病毒(hepatitis C virus,HCV)引起的全身性感染疾病。HCV是1989年由美国Choo等从受感染的黑猩猩血液标本中找到的,同年HCV基因首次克隆成功,使HCV在病原学、流行病学、HCV的传播预防、慢性化机制等方面均取得突破性进展。HCV属于黄病毒科(flaviviridae),其基因组为单股正链RNA,其非结构蛋白3(NS3)蛋白是一种多功能蛋白;非结构蛋白5B(NS5B)是RNA依赖的RNA聚合酶,二者为HCV复制所必需的蛋白,是抗病毒治疗的重要位点。HCV是一种经血传播性病毒,是由于机体破损黏膜暴露于被感染的血液或体液中而传播的,以隐匿性感染为主。研究表明,我国慢性丙型肝炎患者的感染途径多为输血或使用血制品,经手术等有创操作感染(包括外科、内镜检查、牙科治疗等)也不可忽视。而除此之外,静脉注射毒品、血液透析、中医针灸等感染亦有所增加。职业传播、母婴传播和性传播也占近年来丙肝病毒感染的一部分。丙肝病毒在异性恋中的传播少见,但仍要进行病毒的检测以防万一。此外尚有部分HCV感染者的传播途径不明。丙型肝炎症状不明显,感染后HCV高度复制且复制过程中RNA依赖性RNA聚合酶校正功能的缺乏使得HCV变异病毒株多达20余种,造成抗原呈递DC细胞功能失调,病毒清除能力减弱,故丙型肝炎容易发展为慢性感染,其慢性化率为50%-85%,约20%的患者经过10-20年可发展成为肝硬化,肝硬化患者中每年约1%-4%的患者发展成为肝细胞癌(HCC),严重危害着患者的健康和生命。
目前慢性丙型肝炎的发病机理尚不明确。丙型肝炎的病理学表现与甲、乙、丁型肝炎相似,主要为肝细胞的坏死和以淋巴细胞为主的炎症细胞的浸润,其病理学基础可能为肝细胞内氧自由基(OFR)过量产生,引起细胞生物膜不饱和脂肪酸发生脂质过氧化反应,增加溶酶体膜的通透性,从而导致肝细胞损伤。HCV感染所引起肝脏的病变还可能与自身免疫机制有关,与HBV感染后相似,HCV病毒感染后可诱发人体免疫反应导致对肝细胞的免疫损伤。现代病理学研究者在HCV感染者肝脏汇管区检测出类HBV感染的淋巴细胞聚集、胆管损伤和脂肪变。
目前用于慢性丙型肝炎抗病毒治疗的药物比较单一,主要为干扰素。现行公认最有效的抗病毒治疗方案是聚乙二醇干扰素α(PEG-IFN)与利巴韦林联合,其次是普通IFNα或复合IFN联合利巴韦林,均优于单独使用IFNα的治疗方案。干扰素由分泌蛋白组成,分为Ⅰ型和Ⅱ型,各包括IFNα、IFNβ、IFNτ、IFNω和IFNγ。其中18IFNα、IFNβ抗病毒治疗有效,其余各型一般治疗无效。干扰素一方面通过诱导细胞产生PKR酶,PKR酶可中止蛋白合成的过程,从而抑制病毒蛋白的翻译,病毒将不能成功的感染;另一方面增强NK细胞的杀伤活性、激活静息的巨噬细胞起到免疫增强作用。PEG-IFN是将聚乙二醇分子(Polyethylene Glycol,PEG)交联在IFNα分子上形成的。PEG是一种易溶于水、无活性、无毒性的分子,对人体无毒且进入人体后能以原形排出,从而延缓IFNα吸收和体内清除过程,改变治疗分子的药代动力学,进而改变药效。Bailon等用40kD的分枝状PEG修饰IFNα-2a,经研究发现其理化特性较好,半衰期明显延长,溶解性显著增加,pH稳定性和热稳定性均增强,毒性和免疫性降低,药动学特性和体内分布都有一定程度的改善。干扰素与利巴韦林均为慢性丙型肝炎非特异性的抗病毒治疗药物。随着对丙肝病毒蛋白序列的深入认识和新研究靶点的出现,针对抗HCV的新药的研究发展迅猛,目前已有50余种抗HCV药物正在或已获批准进行临床试验。目前正在开发的新药物有:三氮哇核昔类药物;HCV解旋酶抑制剂;HCV蛋白酶抑制剂;HCV NS5B RNA聚合酶抑制剂;阻断HCV蛋白翻译的HCV IRES(internal ribosomalentry site)抑制剂;p7离子通道抑制剂;免疫调节剂;RNA干扰(RNAi)、反义核酸、Hvc特异性核酶等基因治疗剂。近年国内外研究者在基因水平上研究丙肝疫苗方面亦取得了不少成就,目前研究比较成熟的主要有DNA疫苗和表位疫苗。其中HCV DNA疫苗主要有C区DNAE区DNA疫苗、C+E区DNA疫苗、Ns区DNA疫苗等。目前已有HCV DNA疫苗获准进入临床试验。但是这些新药的有效性、安全性及是否造成HCV的耐药性变异等方面尚须进一步研究,因而近期内很难应用于HCV感染者的治疗。
发明内容
本发明要解决的技术问题是克服现有治疗丙肝药物的不足,提供治疗丙肝效果较好的药物组合物。
本发明药物组合物中各组分的用量是发明人经过大量实践总结得出的,由下述重量份的原料药制成:
黑蚂蚁15-17份、田七13-15份、黑木耳14-16份、苦瓜7-9份、罗汉果4-6份。
优选地,它是由下述重量份的原料药制成:
黑蚂蚁16份、田七14份、黑木耳15份、苦瓜8份、罗汉果5份。
本发明所述药物组合物的剂型可以是胶囊、丸剂、片剂等医学上可接受的剂型,它们的制备方法、辅料用量按现有常规工艺进行。
本发明所述药物组合物优选按照以下方法制备:
按配比量称取以上各原料,打碎,加水煎煮两次,第一次加7倍量水,煎煮1.5小时,第二次加8倍量水,煎煮1.5小时,合并煎液,过滤,滤液浓缩至相对密度为1.30(70℃时测)的浸膏,加入适量的硬脂酸镁,按常规工艺制成胶囊剂。
本发明还包括上述药物组合物在制备治疗丙肝药物中的应用。
本发明组方中:
黑蚂蚁,Polyrhachis vicina Roger,学名叫拟黑多刺蚁,蚁科多刺蚁属的一种昆虫。蚂蚁治疗、保健、养生之法,自有文献记载以来在我国及世界各国已有三千多年历史。云南西双版纳以它独特的热带雨林自然地理环境,成了拟黑多刺蚁的生长栖息地。因为拟黑多刺蚁生活环境的特殊,造就了它特殊的药用价值。蚁疗,即应用蚂蚁为人们治疗、保健、养生,就是以蚂蚁(拟黑多刺蚁)的均衡营养、平衡机体、异病同治、药食两用的特质,融合蚂蚁滋补营养、健脾补肾、通经活络、益气活血、双向调节免疫、抗病毒、抗炎镇痛镇静等功能,防治疗风湿、类风湿、乙肝、咳喘、糖尿病等虚损性疑难杂症;均衡营养平衡机体,提高免疫祛病强,提高耐力抗疲劳增强性功能,延缓衰老等保健养生功效。
田七,是中药材中的一颗明珠,清朝药学著作《本草纲目拾遗》中记载:“人参补气第一,三七补血第一,味同而功亦等,故称人参三七,为中药中之最珍贵者。”性味:味甘;微苦;性温。归经:归肝经;胃经;心经;肺经;大肠经。功能:止血;散血;定痛。主治:跌扑瘀肿,胸痹绞痛,症瘕;血瘀经闭;痛经;产后瘀阴腹痛;疮痈肿痛。用法用量:煎汤,3-9克;研末,1-3克;或入丸、散。外用:适理,磨汁涂;或研末调敷。生态环境:野生于山坡丛林下,今多栽培于海拔800-1000m的山脚斜披、土丘缓坡上或人工荫棚下。资源分布:分布于江西、湖北、广东、广西、四川、云南等地。野生者已少见,多为栽培。据药物分析,田七主要含六种皂甙和谷甾醇、胡萝卜甙、黄酮类化合物。皂甙是人参的主要成分,对增强体力,改善心肌氧代谢,提高动物缺氧的耐受力很有作用。
黑木耳,又名黑菜,桑耳、本菌、树鸡、木蛾、木茸,因形似耳,加之其颜色黑褐色而得名,黑木耳为木耳科植物,其性平味甘,人胃、大肠经。具有滋补、润燥、养血益胃、活血止血、润肺、润肠的作用。历代医学家对于黑木耳的药效都有详细的记载,如明代李时珍在《本草纲目》中记载:"木耳生于朽木之上,性甘干,主治益气不饥,轻身强志,并有治疗痔疮、血痢下血等作用。"我国医学历来认为黑木耳有滋润强壮,清肺益气,补血活血,镇静止痛等功效。是中医用来治疗腰腿疼痛,手足抽筋麻木,痔疮出血和产后虚弱等病症常用的配方药物。据国外报道,黑木耳能减低血液凝块,缓和冠状动脉粥样硬化,对预防和治疗冠心病有特殊的效益。黑木耳所含的多糖类物质,具有一定抗肿瘤作用,据报道对小白鼠肉瘤180的抑制率为42.6%。我国民间也有用黑木耳加水煎服,来治疗妇女子宫颈癌和阴道癌。
苦瓜,学名:Momordica charantia L.葫芦科苦瓜属植物,一年生攀援状柔弱草本,多分枝;茎、枝被柔毛。卷须纤细,不分歧。叶柄细长;叶片膜质,上面绿色,背面淡绿色,叶脉掌状。雌雄同株。雄花花梗纤细,被微柔毛;苞片绿色,稍有缘毛;花萼裂片卵状披针形,被白色柔毛;花冠黄色,裂片被柔毛;雄蕊离生。雌花单生,花梗被微柔毛;子房纺锤形,柱头膨大。果实纺锤形或圆柱形,多瘤皱,成熟后橙黄色。种子长圆形,两面有刻纹。花、果期5-10月。苦瓜原产东印度,广泛栽培于世界热带到温带地区。中国南北均普遍栽培。苦瓜果味甘苦,主作蔬菜,也可糖渍;成熟果肉和假种皮也可食用;根、藤及果实入药,有清热解毒的功效。药用:苦瓜根、藤、叶及果实:苦,寒。清热解毒,明目。用于中暑发热,牙痛,泄泻,痢疾,便血。【佤药】介耸:果实治烦渴,眼赤疼痛,痈肿丹毒,恶疮。花治胃气痛,眼疼;叶治丹火毒气,恶疮结毒,杨梅疮,大疔疮《滇省志》。【基诺药】阿能歌尻:叶、藤治肝炎,热病烦渴,暑,痢疾;外治蛇虫咬伤《基诺药》。【畲药】苦瓜:苦瓜捣烂,绞汁治热痢。【侗药】散鬼拱(sanglGueelGaemc):根治霍乱呕吐,腹泻,痰痢,急性肠炎。【傣药】麻坏(西傣):果实、叶治久病频渴,咽喉脓肿,疔疮疽肿《滇药录》、《版纳傣药》、《傣药录》。
罗汉果,葫芦科多年生藤本植物的果实。别名拉汗果、假苦瓜、光果木鳖、金不换、罗汉表、裸龟巴,被人们誉为“神仙果”,其叶心形,雌雄异株,夏季开花,秋天结果。主要产于广西壮族自治区桂林市永福县龙江乡、龙胜和百寿等镇,永福县和龙胜县是罗汉果之乡种植历史比较悠久,其中永福种植罗汉果已经有300多年历史,龙胜县种植罗汉果已经有200多年历史,中国百分之九十罗汉果产于永福县和龙胜县,罗汉果是桂林名贵的土特产,也是国家首批批准的药食两用材料之一,其主要功效是能止咳化痰。果实营养价值很高,含丰富的维生素C(每100克鲜果中含400毫克-500毫克)以及糖甙、果糖、葡萄糖、蛋白质、脂类等。罗汉果为卫生部首批公布的药食两用名贵中药材,其所含罗汉果甜甙比蔗糖甜300倍,不产生热量,是饮料、糖果行业的名贵原料,是蔗糖的最佳替代品。常饮罗汉果茶,可防多种疾病,现代医学证明,罗汉果对支气管炎、高血压等疾病有显著疗效,还是起到防治冠心病、血管硬化、肥胖症的作用。营养价值高,有清热解暑、化痰止咳、凉血舒骨、清肺润肠和生津止渴等功效;可治急慢性气管炎、咽喉炎、支气管哮喘、百日咳、胃热、便秘、急性扁桃体炎等症,糖尿病患者亦宜服用。中医药学认为,罗汉果甘、酸、性凉、有清热凉血、生津止咳、滑肠排毒、嫩肤益颜、润肺化痰等功效,可用于益寿延年、驻颜悦色及治疗痰热咳嗽、咽喉肿痛、大便秘结、消渴烦躁诸症。
慢性病毒性丙型肝炎属西医学病名,中医学无慢性病毒性丙型肝炎病名的记载,但根据其发病的规律和症状,可以归属中医“胁痛”、“黄疸”、“疫毒”、“瘕积”、“虚损”、“肝瘟”等范畴。本发明以黑蚂蚁为君药,取其增强免疫力、清除人体自由基、均衡机体营养功效,以田七为臣药,取其调节全身功能、提高免疫能力、散血定痛的功效,以黑木耳为臣药,取其增强免疫力、抗肿瘤功效,苦瓜做佐药,清热解毒,罗汉果做使药,清热凉血。
具体实施方式
下面以具体实施例对本发明作进一步说明,但本发明并不局限于这些实施例。
实施例1
黑蚂蚁150g、田七150g、黑木耳160g、苦瓜70g、罗汉果60g。
按配比量称取以上各原料,打碎,加水煎煮两次,第一次加7倍量水,煎煮1.5小时,第二次加8倍量水,煎煮1.5小时,合并煎液,过滤,滤液浓缩至相对密度为1.30(70℃时测)的浸膏,加入适量的辅料,按常规工艺制成颗粒剂。
实施例2
黑蚂蚁170g、田七130g、黑木耳140g、苦瓜90g、罗汉果40g。
按配比量称取以上各原料,打碎,加水煎煮两次,第一次加7倍量水,煎煮1.5小时,第二次加8倍量水,煎煮1.5小时,合并煎液,过滤,滤液浓缩至相对密度为1.30(70℃时测)的浸膏,加入适量的辅料,按常规工艺制成片剂。
实施例3
黑蚂蚁160g、田七140g、黑木耳150g、苦瓜80g、罗汉果50g。
按配比量称取以上各原料,打碎,加水煎煮两次,第一次加7倍量水,煎煮1.5小时,第二次加8倍量水,煎煮1.5小时,合并煎液,过滤,滤液浓缩至相对密度为1.30(70℃时测)的浸膏,加入适量的硬脂酸镁,按常规工艺制成胶囊剂。
实验例:本发明实施例3治疗丙肝临床疗效观察:
本发明所述的中药组合物临床试验统计如下:
1、病例及方法
2013年1月-2016年6月,在广西某省级医院针对丙肝患者进行治疗,患者60例,男性31例,女性29例,平均年龄34岁。所有病例自愿接受临床研究,从未接受过抗病毒药物治疗。
诊断标准:
1)西医诊断标准参照2004年中华医学会肝病学会、中华医学会传染病与寄生虫病学分会修订的《丙型肝炎防治指南》指定诊断标准如下:HCV感染超过6个月,或发病日期不明、无肝炎史,但肝脏组织病理学检查符合慢性肝炎,或根据症状、体征、实验室及影像学检查结果综合分析,亦可诊断。
2)中医证候诊断标准综合本病常见的中医证候,参考2002版《中药新药临床研究指导原则》中的“中药新药治疗病毒性肝炎的临床研究指导原则”中的有关规定及《中医诊断学》中的相关内容,并结合有关临床研究,以辨病为主,辨证为辅,拟制定慢性丙型肝炎中医基本兼证的分型参考标准。
病例纳入标准:
1)符合上述诊断标准,并且HCV RNA阳性;签署知情同意书者;年龄18-65岁的男性或女性;病例资料完整,可靠性强,配合调查者。
2)病例排除标准:入组时ALT≥10ULN和/或TBIL≥5ULN和/或Alb≤32g/L;合并其他嗜肝病毒及HIV感染的肝炎;肝硬化失代偿和肝癌;合并心、肾、肺、内分泌、血液、代谢及胃肠道严重原发病者或精神病患者;哺乳、妊娠或正准备妊娠的妇女;不能合作者。
3)病例的剔除和脱落:受试者发生严重不良反应、并发症等不能继续接受治疗者;观察中自然脱落、失访者。
治疗方法:
病例分组及疗程将纳入病例采用随机对照临床试验方法分为试验组和对照组,每组各30例,试验组服用实施例3,胶囊0.5g/粒,每日2次,每次3粒,口服,对照组给予皮下注射长效干扰素并口服利巴韦林,两组均以24周为疗程。
2、疗效判定
疗效评价标准参照2004年中华医学会制定的慢性丙型肝炎防治指南的疗效判断标准、国家中医药管理局发布的《中华人民共和国中医药行业标准—中医病症诊断疗效标准》和《中药新药临床研究指导原则》[制定。
1)中医证候疗效评定标准
计算公式(尼莫地平法):中医证候疗效指数(N)=[(治疗前积分-治疗后积分)÷治疗前积分]×100%。
临床痊愈:中医证候疗效指数(N)≥95%;
显效:中医证候疗效指数(N)≥70%;
好转:中医证候疗效指数(N)≥30%;
无效:中医证候疗效指数(N)<30%。
2)血清肝功能指标疗效评价标准
显效:血清肝功能指标(ALT、AST、GGT、AKP、TBIL、ALB、GLB)恢复正常或ALT下降≥50%,AST、GGT下降≥30%;
有效:血清ALT下降≥30%但<50%,AST、GGT下降≥20%但<30%;
无效:血清ALT下降<30%,AST、GGT下降<20%,甚或加重;
稳定:肝功能恢复正常的患者,停药6-12个月后仍为显效者;
复发:治疗结束时疗效较为显著,但停药6-12个月内出现肝功能(ALT为主)异常者。
3)病毒学疗效评定标准
早期病毒学应答(EVR):治疗12周时血清HCV RNA定量检测低于最低检测限或定量检测降低2个对数级(Log)以上者;
治疗结束时病毒学应答(ETVR):治疗期间HCV RNA呈逐步下降趋势,治疗结束时血清HCV RNA定量检测小于最低检测限;
无应答(NR):治疗期间从未获得早期病毒学应答、治疗结束时病毒学应答及持续病毒学应答者;
反弹:治疗期间出现HCV RNA载量降低或转阴,但尚未停药即出现HCV RNA载量上升或阳转;
复发:治疗结束时血清HCV RNA定量检测小于最低检测限,但停药后HCV RNA又变为阳性者;
稳定:获得早期病毒学应答及治疗结束时病毒学应答的患者,停药6-12个月后血清HCV RNA水平仍小于最低检测限。
4)肝脏B超疗效判定标准
显效:肝脏B超声像图减轻≥1度者;
好转:肝脏B超声像图较前减轻,但不及1度者;
无效:肝脏B超声像图较前无明显变化,甚或加重者。
5)综合疗效评定标准
显效:临床症状体征消失或明显减轻,中医证候疗效指数(N)≥70%;血清中肝功能指标恢复正常;血清HCV RNA定量检测低于最低检测限;肝脏B超声像图提示肝脾无明显异常改变或肝脏B超声像图减轻≥1度者;
有效:临床症状体征缓解,中医证候疗效指数(N)≥30%;血清中ALT恢复正常或血清HCV RNA定量检测低于最低检测限;肝脏B超声像图较前减轻,但不及1度者;
无效:临床症状体征无明显改善,中医证候疗效指数(N)<30%。血清中ALT下降<30%,AST、GGT下降<20%,甚或加重;治疗期间从未获得早期病毒学应答、治疗结束时病毒学应答及持续病毒学应答;肝脏B超图像较治疗前无变化,甚或加重者。
3、疗效总结
1)临床综合疗效分析
对临床综合疗效分析发现,试验组总有效率96.67%;对照组总有效率为63.33%。经Mann-Whitney U秩和检验,P<0.05,两组间疗效具有显著性差异。
2)中医证候改善情况
经多元方差分析,时间因素P<0.01,说明各时间点患者中医证候积分不等或不全相等,即不论对照组还是试验组中医证候积分均随时间变化;时间因素与组别因素的交互作用P<0.01,说明组别因素与时间因素有交互作用,即试验组与对照组的时间变化有差异;组别因素P<0.05,认为两组患者中医证候积分不等,疗效差异具有可比性。
作为比较,本发明申请人还分别对黑蚂蚁、田七、黑木耳单方,以及黑蚂蚁和田七、黑蚂蚁和黑木耳的组合做了对比试验,实验结果显示本发明组方的效果远远超过以上对比实验效果。
Claims (3)
1.治疗丙肝的药物组合物,其特征在于:该药物组合物是由下述重量份的原料药制成:
黑蚂蚁15-17份、田七13-15份、黑木耳14-16份、苦瓜7-9份、罗汉果4-6份。
2.根据权利要求1所述的治疗丙肝的药物组合物,其特征在于:该药物组合物是由下述重量份的原料药制成:
黑蚂蚁16份、田七14份、黑木耳15份、苦瓜8份、罗汉果5份。
3.权利要求1-2中任一项所述的药物组合物在制备治疗丙肝的药物中的应用。
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