CN108201589A - 一种治疗肝炎的中药组合物 - Google Patents
一种治疗肝炎的中药组合物 Download PDFInfo
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- CN108201589A CN108201589A CN201611176793.8A CN201611176793A CN108201589A CN 108201589 A CN108201589 A CN 108201589A CN 201611176793 A CN201611176793 A CN 201611176793A CN 108201589 A CN108201589 A CN 108201589A
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Abstract
一种治疗肝炎的中药组合物,其特征在于,包括下列重量份配比的原料药:榼藤子1‑10份、兔耳草1‑10份、西红花1‑10份、诃子15‑50份、蔓菁8‑50份、人参1‑20份、石榴子7‑50份,以及选自棘豆3‑50份、花椒0.5‑5份、川木香10‑35份中的至少一种。本发明可以治疗肝炎,具有清热解毒、培元健身。
Description
技术领域:
本发明涉及一种治疗肝炎的中药制剂,属于中药技术领域。
背景技术
肝脏是承担人体重要生理功能的实质性器官,位于右上腹,肝脏体积大,容易遭受物理性或者化学性的侵害,造成肝损伤。肝损伤的原因主要包括暴力性肝损伤病理性肝损伤、化学性肝损伤等。暴力性肝损伤主要是由于收到机械或物理性的侵害所导致,通常表现明显、出现快速、并且严重。病理性肝损伤和化学性肝损伤最为常见,但病理性和化学性肝损伤,在临床中表现相似、发展也较为缓慢,因此容易混靖。化学性肝损伤通常是由化学性肝脏毒性物质所造成的肝损伤这些化学物质通常包括酒精、化学毒物以及某些药物。
目前,我国肝炎的治疗以化药为主,但是化学药物沉积和身体耐药性带来的损伤是长久而不以根除的。从某种意义上来讲,服药也是在服毒。需长期服药的患者,在急性发病期用药物控制病情是必要的,但不能为“治病”而让毒副作用对身体进行持续的伤害。
发明内容:
本发明提供了一种由传统草药组成的复方口含片。该制剂可以治疗肝炎,具有清热解毒、培元健身。
肝病的发病原因,据《四部医典》记载,主要分为内因和外因。藏医认为外因多由感受湿热疫毒之邪所致,内因则与患者正气虚弱有关。人由于长期或过量食用酒类及咸、酸、辛辣及陈旧、发霉、油腻等热性食物,加之强力劳作、剧烈运动等,致使身体受到损伤。饮食起居不当,且由此导致体内隆、赤巴、培根、血、黄水五种基本物质失调、紊乱,从而形成“培根木布病”,迁延不愈造成肝损伤(“木布”病是以肝、血热为主的综合性消化系统疾病)。或说肝本性为热,发病初期表现以热为主症,表里藏有邪热,从而激发了赤巴、血热的增亢,造成赤巴热毒素(病毒)侵入肝脏,肝脏长期被赤巴热毒素侵害,形成陈旧性热潜伏于肝脏,继而长期或反复损伤肝脏,且迁延不愈,致使肝脏组织受到损伤,血液生化及代谢功能失调、减退,最终导致了肝脏淤血不化,进而造成肝实质病变,以至引发多种不同症型的肝病。
症状为肝区浮肋下时有刺痛感,胃烧灼,面色暗紫、口略苦而有异味,厌油腻食物,巩膜、皮肤略呈暗黄,疲乏无力,手掌略呈紫色、大便时有黄色出现。舌象:舌干燥而苔灰黄,舌苔边沿略发紫色。脉象:脉洪而实,关脉明显沉弱。尿象:尿色呈红黄而异味及蒸汽大,具有沉淀或漂浮物。尿液泡沫大小不均,易散。
本发明所述的中药组合物如下所述:
一种治疗肝炎的中药组合物,包括以下重量份配比的原料药:榼藤子1-10份、兔耳草1-10份、西红花1-10份、诃子15-50份、蔓菁8-50份、人参1-20份、石榴子7-50份,以及选自棘豆3-50份、花椒0.5-5份、川木香10-35份中的至少一种;
进一步其特征在于,原料包括榼藤子1-10份、兔耳草1-10份、西红花1-10份、诃子15-50份、蔓菁8-50份、人参1-20份、石榴子7-50份,以及选自棘豆3-50份、花椒0.5-5份、川木香10-35份中的至少两种;
进一步其特征在于,原料包括榼藤子1-10份、兔耳草1-10份、西红花1-10份、诃子15-50份、蔓菁8-50份、人参1-20份、石榴子7-50份、棘豆3-50份、花椒0.5-5份、川木香10-35份;
更进一步其特征在于,原料包括榼藤子1-5份、兔耳草3-7份、西红花3-10份、诃子20-35份、蔓菁10-26份、人参3-7份、石榴子9-17份、棘豆4-15份、花椒0.5-2份、川木香16-27份;
本发明的中药组合物的原料药还包括至少一种选自红景天、獐牙菜、波棱瓜子。原料药还包括至少一种选自石菖蒲、余甘子、肉豆蔻。
方选诃子为国王药,诃子有六味、八性、十七效,对治赤巴病的润、锐、热、轻、气味浓、泻、湿等七属性,以清肝“赤巴”邪热。方选西红花和人参为后妃药。西红花色性重,味甘,甘味生自土水,因而具有润、重、缓、稳、稀、凉、钝、柔八性,在加上自身的重可辅助国王药治疗赤巴病中的锐、热、轻。方选人参味苦、涩,功效治一切毒病、热病,为凉药之王,可辅助国王药清热解毒。
方选榼藤子、兔耳草、蔓菁、花椒、棘豆五味药为大臣药。榼藤子味微苦、涩,性平,兔耳草性凉、糙。二药合用可清热解毒治肝毒症,清血、赤巴烦热,使赤巴热毒素不继续损伤肝。蔓菁味辛,性温,治培根病、隆病,棘豆功效愈疮伤、炎症、清热、消肿。花椒:味辛,性糙,治隆病入心,为舒脉络之上品药。三药合用可调节三因五源的失调与紊乱引起的肝损伤。
石榴子酸、甘,温、润,胃寒症及一切胃病,可调节胃阳使食物转化为精华滋养全身,同时可以调和诸药之药效为佐使之药。
诸药配伍,以主治赤巴、赤巴隆合并症为主,清肝“赤巴”邪热解毒,活血化瘀,综合均衡,调和“隆”、“赤巴”、“培根”,使初液化为营养进入各脏腑、组织及血液、恶液不生,固本培元,消肿解毒。
为强化本中药组合物其中一个方面的功效,本发明所提供的组合物还可以包含至少一种选自红景天、獐牙菜、波棱瓜子、石菖蒲、余甘子、肉豆蔻。上述药物具有补气、健胃、清肝、消食作用之一。在临床实践中,有部分患者积食不化,导致的消化的食物不能转化为精华滋润各脏腑,同时,转化的精华在体内运转不顺,精华在各脏腑中转变为糟粕后亦不能及时运转出体内导致肝炎的产生,上述几味药的能够很好的加强本方的在以上方面的功能。
本发明提供的的中药组合物,可选的添加合适的药学上可接受的辅料,可以制备能够治疗肝炎的中药制剂,其方法可以使任意常规的中药制剂的生产方法,生产任意常规的剂型。考虑到患者的顺应性和药效,所述制剂优选为口服剂型,更优选为散剂、胶囊剂或口服液,更优选为散剂、口服液,最优选为胶囊剂。
制剂的方法可以是:
1、 各原料经挑杂后,称取,分组放好备用;
2、各组原料切段,分别研磨成粉,过2号标准筛;
3、将粉末混合,即得所述药物活性成分组合物;
4、 将上步得到的活性成分组合物,按标准制剂工序,依据所制剂型的不同添加药用辅料,进行加工制成制剂。
例如,将提供的中药组合物制备成散剂的方法为:使用提供的中药组合物,将各原料药切段、研磨成粉,混匀即得散剂。
再例如,将提供的中药组合物制备成口服液的方法:将提供的组合物经水煎煮,之后浓缩水煎液,再添加药学上可接受的矫味剂、掩味剂、稀释剂,如蔗糖、炼蜜等与之搭配,制成口服液,经灭菌后灌装成瓶。如何进行煎煮,遵循本领域的一般指导原则和惯用手段,例如处方中需添加肉豆蔻,则在煎煮时,肉豆蔻应后下。
再例如,将提供的中药组合物制备成口含片的方法:将提供的中药组合物粉末与制备口含片用的适合的片剂辅料,如甘露醇、硬脂酸镁、糊精等,混合制粒,整粒,压片即得。
为了使组合物中各原料药更好的发挥药效,优选的对各原料药进行水提取或醇提取,如何选择提取的溶剂,遵循本领域的通常做法。如若选用了红景天,则对红景天进行水提取,取其水提液浓缩喷雾干燥得红景天水提物进行制剂;若选择肉豆蔻,则对肉豆蔻进行醇提取,取其醇提液经浓缩进行制剂。但这些不能用于限制本发明的保护范围。
本发明开的的中药制剂具有清肝“赤巴”邪热解毒,活血化瘀,综合均衡,调和“隆”、“赤巴”、“培根”,使初液化为营养进入各脏腑、组织及血液、恶液不生,固本培元,消肿解毒。
另外,本发明提供的组合物还可作为添加成分,制成具有调节免疫力功能的保健食品。所述保健食品可以是狭义的、形式上与药品类似的保健食品,如硬胶囊剂、软胶囊剂、片剂等。也可以是软糖、咀嚼糖等广义上的食品。其添加量根据食品的形式不同,以0.1-30%的重量比例为宜。应当理解,所述保健食品的存在形式不能限制本发明的保护范围。
优选的,本发明所使用的组合物各组分用量为:榼藤子1-8份、兔耳草2-8份、西红花2-10份、诃子17-40份、蔓菁9-35份、人参1-15份、石榴子8-27份、棘豆3-35份、花椒0.5-4份、川木香12-30份。
更优选的,本发明所使用的组合物各组分用量为:榼藤子1-5份、兔耳草3-7份、西红花3-10份、诃子20-35份、蔓菁10-26份、人参3-7份、石榴子9-17份、棘豆4-15份、花椒0.5-2份、川木香16-27份;
本发明涉及到的中药材说明如下:
蔓菁:别名蔓菁、诸葛菜、圆菜头、圆根、盘菜,东北人称卜留克、苤蓝,新疆人称恰玛古,拉丁文名Brassica rapa,芸薹属芸薹种芜菁亚种,能形成肉质根的二年生草本植物。肥大肉质根供食用,肉质根柔嫩、致密,供炒食、煮食。欧洲、亚洲和美洲均有栽培。味辛,性温,治培根病、隆病,生赤巴,可防病毒。
研究表明,芜菁含有如下化学成分: 皂苷、黄酮类、糖类及其苷、生物碱类、挥发油、酚类、鞣质、氨基酸、蛋白质、谷甾醇、正十六烷、β-胡萝卜苷、槲皮素、正三十二烷醇、油酸、亚油酸、芥酸、二十碳烯酸、棕榈酸和硬脂酸等脂肪酸、异硫氰酸丁酯、异硫氰酸烯丙酯、硫代葡糖糖苷等。蔓菁具有的功效与上述有效成分有关。
西红花:为鸢尾科植物番红花(Crocus sativus L)的干燥柱头。现北京、山东、浙江、四川等地有栽培。色红黄,油润,性重,味甘,气浓而香,培元健身,能封闭脉口止血,为众药之本,治一切热症之药。目前研究表明西红花柱头有效成分主要是类胡萝卜素类及其糖苷类物质,即西红花酸二甲酯(crocetin-dimethylester)、西红花醛(crocetindial)、西红花酸(crocetin)和西红花糖苷(crocins),后者为西红花酸与不同糖基结合形成的酯苷, 其中西红花糖苷和西红花酸在抑制肿瘤细胞生长方面具有很强的生理活性。西红花具有的功效与上述有效成分有关。
诃子,为使君子科诃子属植物诃子(Terminalia chebula Retz.)的成熟果实,又称诃黎勒,微毛诃子。诃子具敛肺止咳、涩肠止泻、降火利咽的功效。在藏药系统中,诃子为最常用的藏药材,被奉为“藏药之王”。诃子的果实含鞣质3.60%-37.36%,内含:诃子酸,诃黎勒酸,鞣料云实精,诃子鞣质,2,3-O-连二没食子酰石榴皮鞣质,榄仁黄素,原诃子酸,葡萄糖没食子鞣甙,1,3,6-三没食子酰葡萄糖,没食子酸,并没食子酸等。又含三萜类成分:榄仁萜酸,诃王醇。还含莽草酸,去氢莽草酸,奎宁酸,三十碳酸,棕榈酸,没食子酸已酯,诃子次酸三已酯,胡萝卜甙,β-谷甾醇,阿拉伯糖,果糖,葡萄糖,蔗糖,鼠李糖和氨基酸等。另含番泻甙,诃子素以及鞣酸酶,多酚氧化酶,过氧化物酶,抗坏血酸氧化酶等。现代研究表明,诃子还具有一定的抗癌功效。
榼藤子:为豆科植物榼藤的茎藤,茎的块片呈不规则形,大小不等,斜而扭曲,厚1-2cm。外皮棕褐色或灰棕色,粗糙,有地衣斑,具明显纵纹或沟纹,可见侧枝痕和点状皮也,常有1条棱脊状突起。切面皮部深棕色,有红棕色或棕黑色树脂状物,木部棕色或浅棕色,有多数小孔,可见红棕色树脂状物环绕髓部呈偏心环纹,髓部常呈小空洞状,偏于有棱脊一侧。质坚硬,不易折断。 味微苦、涩,性平。治肝毒症,并且治疗脉劳损。根据表明榼藤子乙醇提取物中分离得到25个化合物,包括4个榼藤酰胺类化合物,3个倍半萜类化合物,8个芳香苷类化合物,9个三萜皂苷类化合物及一个蔗糖。根据相关的理化性质和波谱数据对其进行结构解析,鉴定了20个化合物,其中9个未见报道的新化合物,6个为从该属植物中首次分离得到。榼藤子具有的功效与上述有效成分有关。
兔耳草:双子叶植物纲合瓣花亚纲的一科。大多为草本,少数灌木或乔木。约200属3000余种,广布于全球各地,多数在温带地区。研究表明兔耳草中含有多种有效成分,它们分别是琥珀酸、芹菜素、柯伊利素、柯伊利素-7-O-β-D-葡萄糖苷、木樨草素-7-O-β-D-葡萄糖苷、芹菜素-7-O-β-D-葡萄糖苷、尿嘧啶、[2-(3,4一二羟基苯乙醇基)]-3-O-β-D-(4-甲氧基)-木糖-(l-3)-(4-O-咖啡酰基)-β-D一葡萄糖苷、毛蕊花糖苷和β-谷甾醇。兔耳草具有的功效与上述有效成分有关。
人参:是多年生草本植物,喜阴凉,叶片无气孔和栅栏组织,无法保留水分,温度高于32度叶片会灼伤,郁闭度0.7-0.8。通常3年开花,5-6年结果,花期5-6月,果期6-9月。生长于北纬33度—48度之间的海拔,数百米的以红松为主的针阔混交林或落叶阔叶林下。味苦、涩,功效治一切毒病、热病,为凉药之王。研究表明人参中活性成分主要有原人参二醇、原人参三醇和齐墩果酸为苷元的皂苷和其他类型的皂苷包括奥克狄龙型皂苷和皂苷元骨架与侧链发生变化的皂苷。单体多糖有半乳糖醛酸基、半乳糖基、阿拉伯糖基、鼠李糖基。脂肪酸包括十四烷酸甲酯、5-十八烯酸甲酯、十五烷酸甲酯、9-十六烯酸甲酯、棕榈酸甲、1-(+)-抗坏血酸-2,6-十六碳二酯、3-辛基-环氧乙烷基辛酸甲酯、十七酸甲酯、亚油酸甲酯、油酸甲酯、异油酸甲酯、硬脂酸甲酯、11-二十烯酸甲酯、山酸甲酯、二十三酸甲酯、(Z)-15-二十四碳烯酸甲酯、二十四酸甲酯。挥发油包括有十五烷、十六烷、2,6,10,15-四甲基-十七烷、n-十六烷酸、7,11-二甲基-3-压甲基-1,6,10-十二碳三烯、1,2-苯二羧酸二异辛酯。人参具有的功效与上述有效成分有关。
石榴子为安石榴科植物安石榴Punicagranatum L.的干燥种子。秋季果实成熟后除去果皮,晒干。根据目前的研究报道,石榴中的化学成分以鞣质类、生物碱、有机酸和黄酮类为主。根据植物体的部位不同,其化学成分的种类及含量有所不同。石榴子中鞣质类化合物主要有3,3’-二甲氧基鞣花酸、3,3’,4’-三甲氧基鞣花酸,3-甲氧基鞣花酸、4,4’-而甲氧基鞣花酸,黄酮类成分主要有黄酮、黄酮醇、花色素、黄烷-3-醇。不饱和脂肪酸类化合物含有柠檬酸、L-苹果酸、酒石酸、草酸、奎宁酸和琥珀酸。酚酸类化合物有咖啡酸、阿魏酸、绿原酸、对香豆酸和邻-香豆酸。哌啶类和吡咯烷生物碱包括石榴碱、N-甲基石榴碱、伪石榴碱、N-乙酰石榴碱、降伪石榴碱、2-(2’-羟丙基)-1-哌啶、2-(2’-烯丙基)-1-哌啶、古豆碱、降古豆碱、sedridine和N-乙酰sedridine。石榴子具有的功效与上述有效成分有关。
棘豆为豆科植物镰形棘豆OxytropisfalcataBunge和轮叶棘.chiliophyllaRoyle的干燥全草。本品多皱缩,碎断。根圆锥状,多分枝,表皮黄褐色,与木质部易剥离,质韧,断面纤维状。茎短粗,丛生。托叶大而明显,密被白柔毛。奇数羽状复叶多破碎,小叶展开呈线状披针形,长7~12mm,宽2~3mm,两面密被白色长柔毛和腺体。总状花序由6~10朵花组成,花序梗被白色绵毛;花冠黄白色。稀见幼嫩荚果,密被白色绵毛和疣状腺点。气异,味微苦。苦,寒;有毒。清热解毒,生肌愈疮,涩脉止血、通便。用于治疗疫疠,中毒病,黄水病,便秘,炭疽;外敷治疮疖肿痛。
花椒为芸香科植物竹叶花椒Zanthoxylumarmatum Candolle 的干燥成熟果皮。秋季果实成熟时采收,干燥,除去种子及杂质。辛,温。归脾、胃、肾经,温中止痛,杀虫止痒。用于脘腹冷痛,呕吐泄泻,虫积腹痛;外用治湿疹瘙痒。味辛,性糙,治隆病入心,为舒脉络之上品药。花椒的化学成分主要有挥发油、生物碱、酰胺、香豆素、黄酮。其中挥发油中a-萜品醇、β-萜品醇、r-萜品醇、水芹醇、a-杜松醇、r-杜松醇、喇叭茶醇、3-甲氧基-1,2-丙二醇。生物碱主要有白屈蔡红碱、香草木宁碱、和帕落平碱、伪茵芋碱。酰胺类物质有花椒素、异花酵素、双氢花椒素、四氢花椒素、α-山椒素、羟基-α山椒素、羟基-β-山椒素、脱氢-γ-山椒素、γ-山椒素、2’-羟基-N-异丁基-2,4,8,10,12-十四烷五烯酰胺、2’-羟基-N-异丁基-2,6,8,10-十二烷四烯酰胺。黄酮类化合物有金丝桃苷、槲皮苷、茴香苷、芦丁和Isorhamnetin 7-glucoside。花椒具有的功效与上述有效成分有关。
川木香:为菊科植物川木香Vladimiriasouliei( Franch.)Ling或灰毛川木香Vladimiriasouliei(Franch.)I.ingvar.cinerea Ling的干燥根。秋季采挖,除去须根、泥沙及根头上的胶状物,干燥。味辛、苦,温。功能主治为行气止痛。用于胸胁、脘腹胀痛,肠鸣腹泻,里急后重。研究表明,川木香主要含有去氢木香内酯、愈创木-1(10)-烯-11-醇、α-佛手柑油烯、β-榄香烯、γ-广藿香烯、α-葎草烯、α姜黄烯、β-桉叶醇、γ-榄香烯、γ-古芸烯、木香烃内酯、木香醇、桉叶油醇、邻二甲苯、间苯二酚、雪松烯、三甲苯、依兰烯、香木兰烯、愈创木烷型内酯、桉叶烷型内酯、吉马烷型内酯。川木香具有的功效与上述有效成分有关。
红景天为景天科植物大花红景天Rhodiolacrenulata Hook .f.et.Thoms.)H.Ohba干燥根及根茎。秋季采挖,除去粗皮,晒干。甘、苦、涩;寒。活血,清肺,止咳解热止痛。用于腊度(高山反应),恶心,呕吐,嘴唇和手心等发紫,全身无力,胸闷,难于透气,身体虚弱等症。研究表明红景天的有效成分为红景天苷、红景天苷元络醇、酪萨维、二苯甲基六氢吡啶、红景天素以及21种微量元素和18种氨基酸,氨基酸包含7种人体必需氨基酸。红景天具有的功效与上述有效成分有关。
獐牙菜为龙胆科植物川西獐牙菜SwertiamussotiiFranch.的干燥全草,秋季花期采收,晾干。甘、苦,凉、糙。清肝利胆,退诸热。用于黄疸型肝炎,病毒性肝炎,血病。研究表明獐牙菜的主要活性成份包括,1-羟基-3,5-二甲氧基山酮、1-羟基-3,7,8-三甲氧基山酮、1-羟基-2,3,4,5-四家氧基山酮、8-羟基-1,3-二甲氧基山酮、8-羟基-1,2,6-三甲氧基山酮、8-羟基-1,3,5-三甲氧基山酮、1,3-二羟基-6,7-二甲氧基山酮、1,7-二羟基-3,8-二甲氧基山酮、1,7-二羟基-6,7-二甲氧基山酮等,獐牙菜具有的功效与上述有效成分有关。
波棱瓜子为葫芦科植物波棱瓜Herpetospermumpedunculosum(Sex.)。清肝利胆;健脾助运。主黄疸型传染性肝炎;胆囊炎;消化不良。根据研究表明波棱瓜子中含有波棱醛、波棱醇、木脂素二聚物、木脂素三聚物、木脂素四聚物、木脂素五聚物、波棱内酯、波棱酮、去氢双松柏醇。波棱瓜子具有的功效与上述有效成分有关。
石菖蒲,属天南星科菖蒲属禾草状多年生草本植物石菖蒲(Acorustatarinowii)的干燥根,又名九节菖蒲、山菖蒲、药菖蒲、金钱蒲、菖蒲叶、水剑草、香菖蒲、黑菖蒲。石菖蒲根茎作药用。生长于海拔20米至2600米的地区,具有化湿开胃,开窍豁痰,醒神益智的功效。人参:味苦、涩,功效治一切毒病、热病,为凉药之王。
肉豆蔻,为肉豆蔻科肉豆蔻属植物肉豆蔻(MyristicafragransHoutt.)的干燥种仁,有温中行气,涩肠止泻的功效。生肉豆蔻油脂较多,有部分滑肠作用,经面裹、麦麸裹或滑石粉裹后煨制,可除去大部分油脂,消除滑肠作用,更加强了涩肠止泻的功效。现代技术可从肉豆蔻提取物中分离出甲基丁香酚和甲基异丁香酚,是肉豆蔻止泻的有效成分。
余甘子为大戟科植物余甘子Phyllan-thus emblica L.的干燥成熟果实。冬季至次春果实成熟时采收,除去杂质.干燥。本品呈球形或扁球形,直径1.2~2cm。表面棕褐色或墨绿色,有浅黄色颗粒状突起,具皱纹及不明显的6棱,果梗长约1mm。外果皮厚1~4mm,质硬而脆。内果皮黄白色,硬核样,表面略具6棱,背缝线的偏上部有数条筋脉纹,干后可裂成6瓣,种子6,近三棱形,棕色。气微,味酸涩,回甜。甘,酸、涩,凉。清热凉血,消食健胃,生津止咳。用于血热血瘀,消化不良,腹胀,咳嗽,喉痛,口干。
具体实施例
以下通过数个实施例进一步说明本发明。应当理解,所列举的所有实施例均为帮助本领域技术人员理解和实施本发明,并非任何形式的对本发明的任何限制。一切在本发明基础上进行的简单改进和调整,以及将其中的原料进行等同或等效的替换,而未能产生新的实质性特点和显著进步的,均应在本发明的保护范围之内。
实施例1 组合物处方示例
以下给出数个示例处方,并指出了各处方适用范围和对象。需要注意,所列处方并非是任何对处方组成的限定,仅为具体举例说明之用。本领域技术人员可以根据疾病表现的证状不同,病人的体质差异对处方进行调整,这些调整应同样纳入本发明的保护范围之内。
处方1
榼藤子:19.5g兔耳草:25g 西红花:37.5g 诃子:150g
蔓菁:60g 人参:25g 石榴子:50g 棘豆:29g
花椒:2.25g 川木香:75g
处方2
榼藤子:12.5g兔耳草:25g 西红花:37.5g 诃子:125g
蔓菁:50g 人参:25g 石榴子:50g 棘豆:25g
红景天:15g 波棱瓜子:22.5g 獐牙菜:12.5g
处方3
榼藤子:12.5g兔耳草:25g 西红花:37.5g 诃子:125g
蔓菁:50g 人参:25g 石榴子:50g 棘豆:25g
石菖蒲:15g 余甘子:22.5g 肉豆蔻:12.5g
处方4
榼藤子:19.5g兔耳草:25g 西红花:37.5g 诃子:150g
蔓菁:60g 人参:25g 石榴子:50g 棘豆:29g
川木香:65g
实验例1体外药理实验
ICR小鼠60只,体重17~21 g,雌雄各半。60只ICR小鼠,雌雄各半,随机分为6组(n=10),正常组,模型组,处方1、处方2、处方3、处方4组。各组小鼠每天灌胃给药,所有药物均混悬于0.5%的羧甲基纤维素钠(CMC-Na)溶剂中,处方1-4组分别给予混合生药粉100 mg/kg,正常组和模型组给予空白溶剂。共给药10 d,末次给药1 h后,除正常组腹腔注射橄榄油外,其余各组均腹腔注射0.12%CCl4橄榄油溶液10 ml/kg,16 h后取血处死,于3 000 r/min离心l0min分离血清,并迅速剪取相同部位的小块肝脏组织用预冷生理氯化钠溶液进行匀浆,制成10%匀浆液,于4 000 r/min离心10min分离上清液,将分离的血清和肝匀浆液-20℃保存待测。
各组实验数据均以均数±标准差( x±s)表示,采用统计软件SPSS l3.0进行组间t检验。
表1
附注:①丙氨酸氨基转移酶(ALT);
②天门冬氨酸氨基转移酶(AST)
**P<0.01vs正常组;#P<0.05,##P<0.01vs模型组
表二
附注:③、丙二醛
④、超氧化物歧化酶
⑤、谷胱甘肽过氧化物酶
**P<0.01vs正常组;#P<0.05,##P<0.01vs模型组
与正常组比较,模型组小鼠血清中ALT和AST显著性升高(P<0.01,表1),提示造模成功。与模型组比较,处方组各剂量组小鼠血清ALT和AST显著降低(P<0.05,P<0.01)。结果表明处方组能显著对抗CCl4导致的肝损伤小鼠血清中ALT,AST的活性升高。
与正常组比较,模型组小鼠肝组织中MDA显著性升高(P<0.01,表2),GSH-Px和SOD显著性降低(P<0.01),提示造模成功。与模型组比较,处方组各剂量组能够显著抑制MDA的升高(P<0.05,P<0.01),并且能够显著升高GSH-Px和SOD的含量(P<0.05,P<0.01)。增加(P<0.05,P<0.01),说明各处方组具有很好的肝损伤保护作用。
实验例2.本发明提供的组合物所制成的药物用于治疗肝炎患者临床观察(个体患者)
例1,患者赵某,女,25岁。2015年10月7 日两对半检测:表面抗原(HB s A g)和乙肝e 抗体(HB e A b)阳性,其他阴性。表明处在乙肝乙肝病毒携带。2015年12 月7 日的生化检验:丙氨酸氨基转移酶532U/L(正常值5 - 40),门冬氨酸氨基转移酶465U/L(正常值8- 40),球蛋白38.2g/L(正常值20 - 30),总胆红素43.1umol/L(正常值5.1 - 19),结合胆红素23.5 umol/L(正常值1.7 - 6.8)。服用本发明处方2月后;2016年1月2 日检验报告显示两对半均为阴性,体征表现正常中。
例2,患者陈某,男32 岁。2014年4 月两对半检查:表面抗原(HB s A g)阳性;生化检验:丙氨酸氨基转移酶202U/L(正常值5 - 40),2014年6 月19 日检查报告显示两对半:大三阳。体征表现:(1)全身症状:容易疲劳;(2)消化道症状:食欲不振、恶心、厌油;(3)肝区疼痛:右上腹、右季肋部不适、隐痛;(4)肝外表现:黝黑。服用本发明处方4药物后3个月,做两对半检测,结果均为阴性;生化检验,总胆红素26.5 umol/L(正常值2 - 20),体征表现正常,患者生活质量明显改善,疼痛感消失。
例2,患者王某,男49岁。2015年6月两对半检查:表面抗原(HB s A g)阳性;生化检验:丙氨酸氨基转移酶202U/L(正常值5 - 40),检查报告显示两对半:大三阳。体征表现:(1)全身症状:容易疲劳;(2)消化道症状:食欲不振、恶心、厌油;(3)肝区疼痛:右上腹、右季肋部不适、隐痛;(4)肝外表现:黝黑。服用本发明处方2药物后3个月,做两对半检测,结果均为阴性;生化检验,总胆红素32.5 umol/L(正常值2 - 20),体征表现正常,患者生活质量明显改善,食欲增强、疼痛感减少。
例2,患者曾某,男22岁。2013年12月两对半检查:表面抗原(HB s Ag)阳性;生化检验:丙氨酸氨基转移酶160U/L(正常值5 - 40),检查报告显示两对半:大三阳。体征表现:(1)全身症状:容易疲劳;(2)消化道症状:食欲不振、恶心、厌油;(3)肝区疼痛:右上腹、右季肋部不适、隐痛;(4)肝外表现:黝黑。服用本发明处方3药物后2.5个月,做两对半检测,结果均为阴性;生化检验,总胆红素28.1umol/L(正常值2 - 20),体征表现正常。
Claims (10)
1.一种治疗肝炎的中药组合物,其特征在于,包括下列重量份配比的原料药:榼藤子1-10份、兔耳草1-10份、西红花1-10份、诃子15-50份、蔓菁8-50份、人参1-20份、石榴子7-50份,以及选自棘豆3-50份、花椒0.5-5份、川木香10-35份中的至少一种。
2.根据权利要求1所述的中药组合物,其特征在于,包括下列重量份配比的原料药:榼藤子1-10份、兔耳草1-10份、西红花1-10份、诃子15-50份、蔓菁8-50份、人参1-20份、石榴子7-50份,以及选自棘豆3-50份、花椒0.5-5份、川木香10-35份中的至少两种。
3.根据权利要求1所述的中药组合物,其特征在于,包括下列重量份配比的原料药:榼藤子1-10份、兔耳草1-10份、西红花1-10份、诃子15-50份、蔓菁8-50份、人参1-20份、石榴子7-50份、棘豆3-50份、花椒0.5-5份、川木香10-35份。
4.根据权利要求1-3任意之一所述的中药组合物,其特征在于,原料药还包括至少一种选自红景天、獐牙菜、波棱瓜子。
5.根据权利要求1-3任意之一所述的中药组合物,其特征在于,原料药还包括至少一种选自石菖蒲、余甘子、肉豆蔻。
6.根据权利要求3所述的组合物,其特征在于,各原料重量用量为:榼藤子1-8份、兔耳草2-8份、西红花2-10份、诃子17-40份、蔓菁9-35份、人参1-15份、石榴子8-27份、棘豆3-35份、花椒0.5-4份、川木香12-30份。
7.根据权利要求3所述的组合物,其特征在于,各原料重量用量为:榼藤子1-5份、兔耳草3-7份、西红花3-10份、诃子20-35份、蔓菁10-26份、人参3-7份、石榴子9-17份、棘豆4-15份、花椒0.5-2份、川木香16-27份。
8.一种中药制剂,其特征在于,由权利要求1-3任意一项提供的中药组合物,以及药学上可以接受的辅料制成。
9.根据权利要求8所述的中药制剂,其特征在于,将中药组合物与赋形剂制成口含片。
10.一种保健食品,其特征在于,将权利要求1-3任意一项提供的中药组合物,作为添加剂或成分之一制成。
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