CN104383041B - 一种治疗h1n1流感引起的病毒性肺损伤的中药组合物及制备方法 - Google Patents
一种治疗h1n1流感引起的病毒性肺损伤的中药组合物及制备方法 Download PDFInfo
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Abstract
本发明涉及一种治疗H1N1流感引起的病毒性肺损伤的中药组合物，该组合由有效成分和医学上可接受的辅料组成，其中所述的有效成分由以下重量份的原料药制成：岗梅根20‑40份，广藿香10‑20份，羌活5‑15份，柴胡10‑20份，红花8‑20份，金银花10‑20份，防风10‑20份，荆芥10‑20份，连翘9‑20份，苍术5‑15份，桃仁8‑20份，人工牛黄0.35‑1份。本发明所述的中药组合物具有透邪解表，解毒宣肺，化痰祛瘀等作用，可用于治疗H1N1流感引起的病毒性肺损伤。
Description
发明领域
本发明涉及医用配制品，具体涉及含有来自冬青科植物的未确定结构的中药制剂，该药物制剂适用于治疗H1N1流感引起的病毒性肺损伤。
技术背景
流感病毒引致的呼吸道病毒感染(Respiratory virus infection，RVI)具有高传染性、高变异性的特点，疫苗免疫难以达到完全的防护作用，并且近年来发该病发病率不断升高。而RVI发展为急性肺损伤(Acute lung injury，ALI)和急性呼吸窘迫综合征(AcuteRespiratory Distress Syndrome，ARDS)是临床导致死亡的主要原因，由于其危重性、高死亡率的特点，一直是危急重病症的研究热点和难点。因此RVI-ALI的相关机制研究和治疗药物研发一直是本学科前沿的热点问题。而病毒性肺损伤是指由呼吸道病毒严重感染引起的急性肺损伤(acute lung injury，ALI)，临床主要表现为急性进行性加重的呼吸困难和难治性低氧血症，进一步发展可演变为急性呼吸窘迫综合征(acute respiratory distresssyndrome，ARDS)，出现急性、进行性缺血性呼吸衰竭，为临床常见的危重症。近年来对ALI以及ARDS的认识逐渐发展到对炎症、免疫调控的认识。大量实验和临床证据表明，重度病毒感染可以引起机体内各种细胞因子大量产生，机体促炎和抗炎细胞因子严重失衡，形成细胞因子风暴，通常以肺为靶器官，造成急性肺损伤，从而引发ALI甚至ARDS。
中医观念认为急性肺损伤是由肺通调水道功能失司至水液内停。在用药时根据上早期宜用通腑泻下类和清热解毒类药物，辅助使用益气活血类药物，病情缓解后，继续清热解毒，逐渐增加益气养阴等药物，减轻病人的痛苦，降低急性肺损伤疾病的死亡率。
中医药治疗病毒感染引起的肺损伤(RVI-ALI)有广泛的临床和实验基础，多项研究从现代药理学和分子生物学角度，证明了中医药治疗呼吸道病毒的有效性表现在调节机体免疫功能，重建促炎和抗炎细胞因子平衡，协调细胞因子的释放，阻断炎性介质的瀑布反应。中药针对病毒感染的不同阶段，多个层面，多个环节，多个部位发挥治疗作用，特别是多靶点作用对比西医药有着不可低估的独特优势。而且中医药是我国独具民族特色的科学领域，其可能存在新的作用机制或靶点。
近几年的实验报道中抗病毒中药实验研究的主要对象可涉及:单味中草药,如:败酱草、熟大黄、丹参等。单味药的有效成分,如:汉防己甲素、穿琥宁、莪术油、人参多糖等。经典成方加减的煎剂,如麻杏石甘汤加味的清肺饮；柴胡桂枝汤加杏仁、瓜蒌、牛蒡子、大黄、赤芍方；银翘散、桂枝麻黄各半汤、新加香薷饮、桂枝汤、升降散等。较成熟的临床制剂,如清肺口服液、青蚤颗粒、四合一口服液、感冒康宁颗粒、柴芩感冒药、熊胆牛黄胶囊、炎康颗粒剂、退热微型灌剂、众生丸、双黄连粉针剂、蛭丹化瘀口服液等。中药制剂与抗病毒西药的联合应用,如柴胡注射液、护肺口服液或穿琥宁分别与病毒唑联合应用等。
面对日益严峻的流感疫情，发挥传统中医药的优势，通过科学筛选和药效评价，对岭南医家防治流感的临床经验进行发掘，发现防治呼吸道感染的创新药物，开发具有中医药特色的治疗病毒性肺损伤的复方药物具有重大的现实意义。
发明内容
本发明所要解决的技术问题是提供一种治疗H1N1流感引起的病毒性肺损伤的中药组合物，该药物组合可多环节，多靶点调节机体，改善肺损伤临床症状和体征，降低病毒载量，改善肺通气情况及肺部炎症反应。
本发明解决上述技术问题的方案如下所述：
一种治疗H1N1流感引起的病毒性肺损伤的中药组合物，该组合由有效成分和医学上可接受的辅料组成，其中所述的有效成分由以下重量份的原料药制成：
岗梅根20-40份，广藿香10-20份，羌活5-15份，柴胡10-20份，红花8-20份，金银花10-20份，防风10-20份，荆芥10-20份，连翘9-20份，苍术5-15份，桃仁8-20份，人工牛黄0.35-1份。
本发明所述中药组合物中，制成所述有效成分的原料药的最优配比是，岗梅根30份，广藿香10份，羌活10份，柴胡10份，红花10份，金银花10份，防风10份，荆芥10份，连翘15份，苍术9份，桃仁10份，人工牛黄0.35份。
上述中药组合物中，岗梅为冬青科植物梅叶冬青Ilex asprella(Hook.et Arm.)Champ.ex Benth的干燥根；广藿香为唇形科植物广藿香Pogostemon cablin(Blanco)Benth的干燥的全草；羌活为伞形科植物羌活Notopterygium incisum的干燥根；柴胡为伞形科植物北柴胡Bupleurum chinense DC的干燥根；红花为菊科植物Carthamus tinctorius L干燥管状花；金银花为忍冬科植物忍冬Lonicera japonica Thunb的干燥花蕾或初开的花；防风为伞形科植物防风Saposhnikovia divaricata(Trucz.)Schischk.的根；荆芥为唇形科植物荆芥Nepeta cataria L.的干燥地上部分；连翘为木犀科植物连翘Forsythiasuspensa(Thunb.)Vahl的成熟果实；苍术为菊科植物苍术Atractylodes Lancea(Thunb.)DC.的干燥根；桃仁为蔷薇科植物桃Amygdalus persica L.或山桃Prunus davidianaFranch.的种子。
本发明所述中药组合物是常规的颗粒剂、胶囊、片剂或丸剂。
上述药物制剂的制备方法由以下步骤组成：
(1)超临界萃取广藿香、羌活、红花、金银花、防风、荆芥、苍术、连翘和桃仁粉碎中的挥发油和脂肪油，药渣备用。
(2)取步骤(1)的药渣与岗梅根和柴胡，加入5～8倍量蒸馏水提取2-3次，收集提取液真空浓缩，喷雾干燥，得粉末B；
(3)采用研磨等方法将步骤(1)得到的挥发油和脂肪油制备成β-CD包合物，冷冻干燥得粉末A；
(4)将粉末A、粉末B和人工牛黄混匀加入辅料制成颗粒剂、胶囊、片剂或丸剂。
本发明所述中药组合物由岗梅根、广藿香、金银花、连翘、防风、羌活、柴胡、红花、桃仁、苍术、荆芥、人工牛黄组成。方中，岗梅根及广藿香均为岭南地区常用中药，岗梅根其性寒味甘苦，主清热生津，活血解毒，广藿香味辛、性微温，具有芳香化浊、开胃止呕、发表解暑等功效。两者相伍，温清结合，共奏解毒抗感之效，加以人工牛黄清热解毒，芳香开窍，合为君药。羌活气香性散，善散在表之邪，荆芥、防风、辛温祛风散寒解表，金银花、连翘辛凉透邪、清热解毒。五药清散结合，清解邪热，是为臣药。柴胡轻清升散而解表退热，桃仁、红花活血化瘀，三者相配通肺络以加强化痰祛瘀之功，是为佐药。苍术为使，辛温行气以助祛邪解毒。本方清、轻、辛、散，温凉并用，共奏发散风热，清热解毒之功。
本发明所述的中药组合物具有透邪解表，解毒宣肺，化痰祛瘀等作用，可用于治疗H1N1流感引起的病毒性肺损伤。此外，本发明所述中药组合物还具有疗效明显、稳定，无毒副作用的优点。
附图说明
图1是制备本发明所述有效成分的一个具体实施的工艺流程图。
具体实施方式
例1(颗粒剂)
1、处方：
岗梅根30kg，广藿香10kg，羌活10kg，柴胡10kg，红花10kg，金银花10kg，防风10kg，荆芥10kg，连翘15kg，苍术9kg，桃仁10kg，人工牛黄0.35kg。
2、制备方法：
参见图1，
将广藿香、羌活、红花、金银花、防风、荆芥、苍术、连翘和桃仁粉碎，过20目筛。采用超临界二氧化碳萃取(萃取压力18mpa，温度，60℃，解析压力，10mpa)其中的挥发油和脂肪油，采用研磨等方法将提取到的挥发油和脂肪油制备成β-环糊精包合物，冷冻干燥得粉末A。上述经提取挥发油、脂肪油的药渣与岗梅根、柴胡混匀，加入8倍量蒸馏水提取2次，滤过、合并滤液。真空浓缩，喷雾干燥，得到粉末B，将粉末A和粉末B混合，过筛，加人工牛黄和辅料混匀。加入糊精、糖粉等辅料黏合剂混匀，干挤制粒机压成薄片，再粉碎成颗粒。分装成50000袋，每袋10g。
3、用法和用量：
口服，一次1袋，一天2次，连续服7天。
例2(胶囊剂)
1、处方：
岗梅根40kg，广藿香20kg，羌活15kg，柴胡20kg，红花10kg，金银花10kg，防风10kg，荆芥10kg，连翘15kg，苍术9kg，桃仁10kg，人工牛黄0.35kg。
2、制备方法：
参见图1，将广藿香、羌活、红花、金银花、防风、荆芥、苍术、连翘和桃仁粉碎，过筛20目，采用超临界二氧化碳萃取(萃取压力18mpa，温度，60℃，解析压力，10mpa)，其中的挥发油和脂肪油，采用研磨等方法将提取到的挥发油和脂肪油制备成β-环糊精包合物，冷冻干燥得粉末A；上述经提取挥发油、脂肪油的药渣与岗梅根、柴胡加8倍量蒸馏水提取2次，滤过、合并滤液。真空浓缩，喷雾干燥，得到粉末B，将粉末A和粉末B混合，过筛，加人工牛黄和辅料混合，选择合适硬胶囊，加入蔗糖、改性淀粉等辅料与赋形剂混匀，填充，制成胶囊剂，200000粒。
3、用法和用量：
口服，一次4粒，一天3次，连续服7天。
例3(片剂)
1、处方：
岗梅根20kg，广藿香10kg，羌活10kg，柴胡10kg，红花20kg，金银花20kg，防风10kg，荆芥10kg，连翘15kg，苍术15kg，桃仁20kg，人工牛黄0.35kg。
2、制备方法：
参见图1，将广藿香、羌活、红花、金银花、防风、荆芥、苍术、连翘和桃仁粉碎，过筛20目，采用超临界二氧化碳萃取(萃取压力18mpa，温度，60℃，解析压力，10mpa)，其中的挥发油和脂肪油，采用研磨等方法将提取到的挥发油和脂肪油制备成β-环糊精包合物，冷冻干燥得粉末A；上述经提取挥发油、脂肪油的药渣与岗梅根、柴胡加5倍量蒸馏水提取2次，滤过、合并滤液。真空浓缩，喷雾干燥，得到粉末B，将粉末A和粉末B混合，过筛，加人工牛黄和辅料混合，加入淀粉、糖粉、糊精，制软材，制颗粒，干燥，整粒，加入崩羟丙基甲基纤维素、硬脂酸镁，压片，制成片剂，200000片。
3、用法和用量：
口服，一次5片，一天3次，连续服7天。
例4(丸剂)
1、处方：
岗梅根20kg，广藿香10kg，羌活10kg，柴胡10kg，红花10kg，金银花20kg，防风20kg，荆芥20kg，连翘15kg，苍术9kg，桃仁10kg，人工牛黄1kg。
2、制备方法：
参见图1，将广藿香、羌活、红花、金银花、防风、荆芥、苍术、连翘和桃仁粉碎，过筛20目，采用超临界二氧化碳萃取(萃取压力18mpa，温度，60℃，解析压力，10mpa)，其中的挥发油和脂肪油，采用研磨等方法将提取到的挥发油和脂肪油制备成β-环糊精包合物，冷冻干燥得粉末A；上述经提取挥发油、脂肪油的药渣与岗梅根、柴胡加8倍量蒸馏水提取2次，滤过、合并滤液。真空浓缩，喷雾干燥，得到粉末B，将粉末A和粉末B混合，过筛，加人工牛黄和辅料混合，加入适量炼蜜，制丸块，制丸条，分粒，搓圆，干燥，整丸，制成丸剂300000粒。
3、用法和用量：
口服，一次5粒，一天3次，连续用7天。
例5(治疗病毒性肺损伤的药效学实验)
1、实验目的
评价本发明所述中药组合物对流感病毒感染小鼠的存活时间、肺指数、肺湿干重比、血气、肺组织病毒载量、细胞炎症因子、白细胞及其分类的影响
2、实验材料
2.1实验试剂：CBA试剂盒、PCR试剂盒，PBS缓冲溶液。
2.2实验动物：KM小鼠，雌雄各半，体重13～15g。正常喂养。饲养环境：室温20±2℃，相对湿度50±10％。
2.3药物：利巴韦林制成的混悬液，本发明所述中药组合物制成的混悬液。
3、试验方法
3.1混悬液的制备
A、本发明所述中药组合物制成的混悬液：
采用上述实施例1、2和4的处方分别按实施例1所述的方法制成颗粒剂，再分别加入蒸馏水配成浓度为每毫升含2000毫克颗粒剂的混悬液。其中，实施例1的处方制备的混悬液为下述实验组1所用药物；实施例2的处方制备的混悬液为下述实验组2所用药物；实施例4的处方制备的混悬液为下述实验组3所用药物。
B、利巴韦林制成的混悬液：
取利巴韦林3片，研磨成细粉，用蒸馏水溶解至80ml。
3.2模型的建立及给药
3.2.1死亡保护
KM小鼠60只，体重13.0-15.0g，雌雄各半。随机分为6组，即正常组、模型组、利巴韦林组、实验组1、实验组2、实验组3，每组10只。在乙醚轻度麻醉下，用10LD50的H1N1型流感病毒液滴鼻感染小鼠，分两次滴鼻，每次25uL。正常组以等体积生理盐水滴鼻。感染4h后各组分别给药，各组给药体积均为0.2ml/10g，正常组和模型组灌胃等体积生理盐水，连续给药15天。逐日观察动物发病症状，记录体重、死亡时间，死亡数，观察15天，计算死亡保护率、延长生命率。
3.2.2血气分析
KM小鼠36只，体重13.0-15.0g，雌雄各半。随机分为6组，即正常组、模型组、利巴韦林组、实验组1、实验组2、实验组3，每组6只，连续给药5天。逐日观察小鼠发病状态，记录体重。末次给药后30min，取各组小鼠轻微麻醉，腹主动脉取肝素抗凝血0.5ml，使用全自动血气分析仪立即测定血气指标。
3.2.3肺指数、湿干重比及组织形态学观察
腹主动脉采血后，打开胸腔取出全肺，肉眼观察肺部病变，记录肺部病变的程度，用生理盐水洗净，后用干净滤纸吸掉残余盐水，称量湿重，计算肺指数。将左肺肺于60℃烘箱中干燥至恒重，取出称量干重，计算湿干重比。小鼠右肺一部分固定于10％多聚甲醛液中，按常规处理。HE染色、切片。观察肺组织组织的病理病变。
3.2.4细胞因子测定和白细胞计数及其分类
KM小鼠36只，体重13.0-15.0g，雌雄各半。随机分为6组，即正常组、模型组、利巴韦林组、实验组1、实验组2、实验组3，每组6只，连续给药5天。逐日观察小鼠发病状态，记录体重。末次给药后30min，取各组小鼠，眼静脉丛取血1.5mL，按CBA试剂盒方法测定血清中IL-6、IL-10、IL-12、IFN-γ、TNF-α、MCP-1含量。麻醉取血后小鼠，切开颈部皮肤分离气管，插入灌洗针并结扎，抽取0.5mLPBS缓冲溶液注入肺中，回收液体，重复3次。共1.5mL。稀释肺泡灌洗液至适于浓度，取10uL于血细胞计数板上进行白细胞总数计数，另取5uL肺泡灌洗液常规瑞氏染色，光学显微镜(油镜)下计数至少200个细胞并进行淋巴细胞，巨噬细胞和中性粒细胞分类计数。
3.2.5病毒载量及组织形态学观察
KM小鼠36只，体重13.0-15.0g，雌雄各半。随机分为6组，即正常组、模型组、利巴韦林组、实验组1、实验组2、实验组3，每组6只，连续给药5天。逐日观察小鼠发病状态，记录体重。末次给药后30min，取各组小鼠轻微麻醉，打开胸腔取出全肺，肉眼观察肺部病变，记录肺部病变的程度，用生理盐水洗净，小鼠左肺固定于10％多聚甲醛液中，按常规处理。HE染色、切片。观察肺组织组织的病理病变。小鼠右肺组织样本(200-300mg)，定量RT-PCR方法测定肺组织中病毒载量。
3.3统计学处理各指标数据均采用SPSS20.0统计软件单因素方差分析法进行统计，统计结果以均数±标准差表示。
4、实验结果
4.1本发明所述中药组合物对小鼠生存时间的影响
表1本发明所述中药组合物对小鼠生存时间的影响
与正常组比较#p<0.05，##p<0.01；模型组比较*p<0.05,**p<0.01；
表1结果显示：与正常组比较，模型组小鼠血平均存活时间显著减少(p<0.01)。提示采用此方法可成功建立流感病毒感染小鼠模型。
与模型组比较，利巴韦林能显著改善流感病毒感染小鼠生存质量，延长小鼠存活时间，提示实验方法可行；和模型组相比，实验组1小鼠平均存活时间显著延长(p<0.01)，实验组2小鼠平均存活时间显著延长(p<0.05)，实验组3无显著性差异(p>0.05)。但各实验组均有延长小鼠生存时间趋势。提示该处方具有体内抗流感作用，可改善流感病毒小鼠生存质量，延长流感病毒感染小鼠存活时间。
4.2本发明所述中药组合物对病毒感染小鼠肺指数、湿干重比的影响
表2本发明所述中药组合物对病毒感染小鼠肺指数、湿干重比的影响
与正常组比较#p<0.05，##p<0.01；模型组比较*p<0.05,**p<0.01；
表2结果显示：和正常组相比，模型组小鼠肺指数显著升高(p<0.01)，肺湿干重比明显升高(p<0.01)。既流感病毒感染后小鼠肺组织中炎性介质的大量生成和渗出，导致肺组织中量增加。
和模型组相比：利巴韦林能明显降低流感病毒感染小鼠肺指数(p<0.01)、肺湿干重比(p<0.01)，提示实验方法可行；和模型组比较，实验组1能降低病毒感染小鼠的肺指数(p<0.01)和肺湿干重比(p<0.01)。实验组2能降低病毒感染小鼠的肺指数(p>0.05)和肺湿干重比(p<0.05)。实验组3能降低病毒感染小鼠的肺指数(p<0.05)和肺湿干重比(p<0.05)。既本发明所述中药组合物高、低剂量组能抑制流感病毒感染小鼠炎性介质的生成和渗出。
4.3对肺组织中病毒拷贝数的影响
表3肺组织中病毒拷贝数对数
与正常组比较#p<0.05，##p<0.01；模型组比较*p<0.05,**p<0.01；
表3结果显示：与模型组比较，利巴韦林能明显减少病毒复制量(p<0.01)，提示实验方法可行。
与模型组比较，实验组1能明显降低病毒复制数(p<0.01)；实验组2能明显降低病毒复制数(p<0.05)；实验组3能降低病毒复制数(p>0.05)。
4.4本发明所述中药组合物对病毒感染小鼠血气的影响
表4本发明所述中药组合物对小鼠血气的影响
与正常组比较#p<0.05，##p<0.01；模型组比较*p<0.05,**p<0.01；
表4结果表明：和正常组比较，模型组小鼠动脉血中PCO2明显升高(p<0.01)；PO2、SO2明显降低(p<0.01、p<0.01)，PH无差别(p>0.05)；和模型组相比，利巴韦林组小鼠动脉血中PCO2明显降低(p<0.05)；PO2、SO2明显升高(p<0.05、p<0.05)，PH无差别(p>0.05)；提示实验方法可行。
和模型组比较，实验组1中PCO2明显降低(p<0.05)；PO2、SO2明显升高(p<0.01、p<0.01)，PH无差别(p>0.05)；实验组2中PCO2明显降低(p<0.05)；PO2、SO2明显升高(p<0.01、p<0.05)，PH无差别(p>0.05)；实验组3中PCO2降低(p>0.05)；PO2、SO2明显升高(p<0.05、p<0.05)，pH无差别(p>0.05)。
4.5本发明所述中药组合物对血液中细胞因子的影响
表5本发明所述中药组合物对血液中细胞因子的影响
表6本发明所述中药组合物对血液中细胞因子的影响
与正常组比较#p<0.05，##p<0.01；模型组比较*p<0.05,**p<0.01；
表5、表6结果表明：和正常组相比，模型组小鼠中IL-6、IL-10、IFN-γ、TNF-α、MCP-1显著升高(p<0.01、p<0.01、p<0.01、p<0.01、p<0.01)，IL-12升高不明显(p>0.05)。
和模型组比较，利巴韦林组IL-6、IL-10、IFN-γ、TNF-α、MCP-1显著降低(p<0.01、p<0.01、p<0.01、p<0.01、p<0.01)，IL-12降低不明显(p>0.05)，提示实验方法可行。
和模型组相比，实验组1中IL-6、IL-10、IFN-γ、TNF-α、MCP-1显著降低(p<0.05、p<0.01、p<0.01、p<0.01、p<0.01)，IL-12降低不明显(p>0.05)；实验组2中IL-6、IL-10、IFN-γ、TNF-α、MCP-1显著降低(p<0.05、p<0.01、p<0.01、p<0.01、p<0.05)，IL-12降低不明显(p>0.05)；实验组3中IL-10、IFN-γ、TNF-α、MCP-1显著降低(p<0.01、p<0.01、p<0.01、p<0.05)，IL-6、IL-12降低不明显(p>0.05、p>0.05)。
4.6本发明所述中药组合物对肺泡灌洗液中白细胞及其分类的影响
表7本发明所述中药组合物对白细胞及其分类的影响
与正常组比较#p<0.05，##p<0.01；模型组比较*p<0.05,**p<0.01；
表7结果表明：和正常组比较，模型组中白细胞总数显著升高(p<0.01)，淋巴细胞百分比、中性粒细胞百分比显著升高(p<0.01、p<0.01)，巨噬细胞百分比显著降低(p<0.01)。和模型组比较，利巴韦林组白细胞总数显著降低(p<0.01)，淋巴细胞百分比、中性粒细胞百分比、巨噬细胞百分比降低(p>0.05、p>0.05)，巨噬细胞百分比升高(p>0.05)提示实验方法可行。
和模型组相比，实验组1显著降低白细胞总数(p<0.01)，淋巴细胞百分比、中性粒细胞百分比降低(p<0.05、p<0.01)，巨噬细胞百分比显著升高(p<0.05)；实验组2显著降低白细胞总数(p<0.01)，淋巴细胞百分比、中性粒细胞百分比降低(p<0.05、p<0.01)，巨噬细胞百分比升高(p<0.05)。实验组3显著降低白细胞总数(p<0.01)，淋巴细胞百分比、中性粒细胞百分比降低(p<0.05、p<0.01)，巨噬细胞百分比升高(p<0.05)。
以上结果表明本发明所述中药组合物水煎浓缩液给予流感病毒感染小鼠灌胃，结果显示本发明所述中药组合物能明显延长小鼠存活时间，改善病毒感染小鼠生存质量。本发明所述中药组合物能抑制流感病毒在肺组织中的复制，使肺组织中病毒载量降低；抑制炎性介质的渗出和生成，使病毒感染小鼠肺指数、肺湿干重比降低；改善病毒感染小鼠肺组织的呼吸换气功能，使小鼠动脉血中PO2、SO2含量升高、PCO2含量降低；减轻肺组织中的炎症，白细胞总数减少，增强巨噬细胞对病毒的吞噬作用。同时调节病毒感染小鼠体内炎症因子，提高IL-10、IFN-γ等抗炎因子水平；降低IL-6、TNF-α、MCP-1等促炎因子水平。本发明所述中药组合物具有综合的抗H1N1病毒作用,疗效确切。
Claims (4)
1.一种治疗H1N1流感引起的病毒性肺损伤的中药组合物，该组合由有效成分和医学上可接受的辅料组成，其中所述的有效成分由以下重量份的原料药制成：
岗梅根20-40份，广藿香10-20份，羌活5-15份，柴胡10-20份，红花8-20份，金银花10-20份，防风10-20份，荆芥10-20份，连翘9-20份，苍术5-15份，桃仁8-20份，人工牛黄0.35-1份。
2.根据权利要求1所述的一种治疗H1N1流感引起的病毒性肺损伤的中药组合物，其特征在于，所述的有效成分由以下重量份的原料药制成：
岗梅根30份，广藿香10份，羌活10份，柴胡10份，红花10份，金银花10份，防风10份，荆芥10份，连翘15份，苍术9份，桃仁10份，人工牛黄0.35份。
3.根据权利要求1或2所述的一种治疗H1N1流感引起的病毒性肺损伤的中药组合物，其特征在于，该中药组合物为颗粒剂、胶囊、片剂或丸剂。
4.一种制备权利要求3所述的一种治疗H1N1流感引起的病毒性肺损伤的中药组合物的方法，该方法由以下步骤组成：
(1)超临界萃取广藿香、羌活、红花、金银花、防风、荆芥、苍术、连翘和桃仁粉碎中的挥发油和脂肪油，药渣备用；
(2)取步骤(1)的药渣与岗梅根和柴胡，加入5～8倍量蒸馏水提取2-3次，收集提取液真空浓缩，喷雾干燥，得粉末B；
(3)采用研磨等方法将步骤(1)得到的挥发油和脂肪油制备成β-CD包合物，冷冻干燥得粉末A；
(4)将粉末A、粉末B和人工牛黄混匀加入辅料制成所述的中药组合物。
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