CN102389509B - 一种治疗艾滋病的中药组合物及其制备方法 - Google Patents
一种治疗艾滋病的中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明涉及一种治疗艾滋病的药物及其制备方法,特别涉及一种治疗艾滋病的纯中药制剂及其制备方法。主要解决现有治疗艾滋病的药物见效慢、价格昂贵、对于晚期、临终期艾滋病患者治疗效果差的技术问题。技术方案是:一种治疗艾滋病的纯中草药制剂,其组成组分的重量百分比为:熟大黄25-35%、茯苓5-15%、鸭跖草5-15%、香附5-15%、陈皮5-15%、桑白皮5-15%、炒扁豆5-15%、生甘草5-15%。制备工艺如下:按组成原料组分的重量百分比取料,加水煎煮两次,每次加水量没过药面为宜,合并两次水煎过滤液,浓缩至比重为1:1.2-1:1.4的浓缩液,放置于干净的不锈钢干燥盘中,经80℃干燥后粉碎,过80目筛,可制成任何一种常用内服剂型。本发明对患有临终期的艾滋病并发症感染者(伴有肺结核、淋巴肿大、口腔溃呼吸道感染、腹泻、皮肤病等)有着很好的疗效。
Description
技术领域
本发明涉及一种治疗艾滋病的药物及其制备方法,特别涉及一种治疗艾滋病的复方鸭跖草胶囊及其制备方法,对改善艾滋病患者症状,降低西药治疗艾滋病的副作用,提高艾滋病患者生命质量有着很好的疗效。
背景技术
全世界大约已有6000万人左右感染了艾滋病的病毒,2500万人死于此病,2000万艾滋病病人将到死亡的边缘。流行最严重的地区是非洲和亚洲。几乎没有一个国家免遭艾滋病的打击。每天大约有2万人感染上艾滋病病毒。南部非洲共十六个国家有近4500万艾滋病患者,南非有4300万人口,有450万艾滋病患者。到目前为止,世界上乃未成功研究出可以彻底治疗艾滋病的方法,也未成功制造疫苗以预防艾滋病毒的感染。
近年来,世界卫生组织及联合国,各国政府都投入大量资金,试图征服艾滋病,目前全球每年投入资金约10亿美元研制治疗艾滋病新药。其中有54个药已经通过美国FDA批准上市,尽管如此,还赶不上艾滋病病毒株的变异和感染的速度。如今艾滋病西药的抗药性和副作用一直困扰着对艾滋病的治疗。现在科学家已经宣布用疫苗来治疗艾滋病是不可能的事。这就让研究者不得不把目光集中到天然草药上来。中国是一个有着悠久 中草药用药和研究历史的国家,中草药博大精深,所以,中药是目前世界上最有希望攻克艾滋病的药。
全球有40%的发展中国家都处于贫穷落后的生活状态,他们的国家对昂贵的西药艾滋病治疗都表示无奈。许多艾滋病患者就是由于付不起药费,得不到治疗而死亡。中药的成本远远低于西药,而且无副作用,因此,挖掘中草药治疗艾滋病,已是目前投资者的热点,具有无限的经济价值和深远的社会意义。
目前已知治疗艾滋病的技术发展状况:目前,国际通用是哈特疗法(HAART,高效抗逆转录病毒疗法,既“鸡尾酒疗法”,既HIV蛋白酶抑制剂和HIV逆转录酶抑制剂,免疫机能调节剂,抗机会性感染及营养支持疗法联合应用,治疗艾滋病人取得了显著效果,被称为是“当今世界治疗艾滋病最有效的疗法,”它能使病人CD4细胞提高到正常水平,同时有效抑制HIV复制,使病毒载量迅速降至测不出,降低HIV的负荷。降低病死率,延长艾滋病的发病时间,提高病人的生存质量。目前只要应用核苷类药物和蛋白酶抑制剂联合应用治疗HIV感染者和艾滋病人,常用的药组合如下:茚地那韦(Indinavir)+AZT+3TC;奈非那韦(Nelfinavir)+沙奎那韦(Saquinavir)+AZT+3TC:AT+沙奎那韦(Saquinavir)+141W984+1592U89;依法韦仑(Efavirenz)+茚地那韦(Indinavir)。在用了哈特疗法后,除血中的艾滋病病毒迅速降至测不出以外,还会出现免疫功能上生,造成哈特疗法能够解决病毒和免疫两大问题的现象,使人误认为这一疗法是解决艾滋病问题的唯一疗法。其实,哈特疗法对艾滋病病毒的作用是相当有规律的,在用药1~2个月内,血中既不能测到艾滋病病毒。但是,当感染发生的时候,病毒基因的复制很容易发生错误,和我们人的DNA的复制是完全不一样的,所以,因为有很高的突变率,每一天都会出现大量的病毒突变,突变基因数高达一千万。有些突变可使病毒出现新的优势。它使病毒能够逃脱人体免疫系统的攻击,而且也可以逃避治疗药物的打击,使得病毒能够继续或更快的繁殖。它主要的副作用有:1 ,改变生活习惯,且预期将终生如此;2, 如果治疗失败了,减少了将来的选择;HIV并没被完全消灭,只是被大大抑制,数量减至50个拷贝/MM3以下,此时HIV变为不活动,躲在淋巴结等器官中,一旦停药,立即就反跳出来,形成复发;3 ,哈特疗法十分昂贵,以至于广大发展中国家的患者无力购买,得不到治疗。
目前国内中药治疗艾滋病的技术发展状况:我国的艾滋病研究工作者在药物筛选、方剂组成、临床观察、研究方法、研究设计、特别在研究思路方面进行了深入的探讨,取得了以免疫定位为主,抑制病毒为辅的共识。在此基础上,已有研究较深入的方药,特别是研究进展较快的已经进行并通过三期临床实验的唐草片,还有在国内开发研究,在国外开花结果,被评为国内十大医学成果的SH方的临床研究,其他还有如中研2号、XQ-9302、金龙胶囊、复方三黄散、安体维康、大蒜G0889、金生宝胶囊、艾通冲剂、箬叶多糖、新世纪康宝、生命泉、乾坤宁、克艾特胶囊、硒力口服液、艾灵颗粒、爱可扶正片等试验研究成果。但都存在一些技术缺陷:1.在改善艾滋病病人症状比较慢;2.只能用在早、中期艾滋病患者;3.对晚期、临终期艾滋病患者治疗效果差;4.到目前为止始终连一个获得经过正式批准的临床方药也没有,要求作为辅助免疫增强剂也不可得。
发明内容
本发明的目的是提供一种对于改善艾滋病患者症状,降低西药治疗艾滋病的副作用,提高艾滋病患者生命质量的治疗艾滋病的中药组合物及其制备方法。本发明需要解决的技术问题是:改善艾滋病患者症状,抑制降低西药治疗带来的副作用,加快药物产生疗效的时间,提高艾滋病患者治疗效果,提高艾滋病患者生存质量。
根据中医理论,人体的生理、病理虽截然不同,却同样通过气血来实现的。前者是正常运行,则身体健康,而曰生理,后者是运行失常而发病,发病的病情复杂,不出变化不一,都称病理。如把病理纠正过来,变为生理,病就好了。故曰护生。从正常生理到病理,各有原因,这许多原因,都能使正常运行的气血发生变化,则气血运行具有生理、病理学,中医是如此概括的。招致气血运行失常,发生病理变化的原因,中医概括为三因所伤,也与正气衰弱,免疫力低下有关。怎样来纠正气血运行的变化呢?中医就是畅通气血,和其虚实盛衰来抵御疾病。
现代医学认为艾滋病是由人类免疫缺陷病毒侵入人体,而且这种病毒终生会传染,侵入人体后破坏人体的免疫系統,那么人体就丧失了抵抗各种疾病的能力,人就会产生很多症状,最终导致人体各个脏器的衰竭直至死亡。从中医病机学的角度去理解艾滋病,它事实上包括两大病机,一个是瘟疫,一个是虚损。人体受到外界唳气侵入以后,体内产生了各种变异,阻塞了气血运行。那么长期各种障碍导致人体的五脏六腑虚损,直至衰竭,最后人体死亡。理解了中医对艾滋病的认识,那么它的治疗就有的放矢了。要扫除阻碍人体气血运行的各种障碍,然后使虚损的五脏六腑自我恢复,使人体达到健康状态。
本发明的技术方案是:一种治疗艾滋病的中药组合物,其组成原料组分的重量百分比为:熟大黄25-35%、茯苓5-15%、鸭跖草5-15%、香附5-15%、陈皮5-15%、桑白皮5-15%、炒扁豆5-15%、生甘草5-15%。
其优选组成原料组分的重量百分比为:熟大黄30%、茯苓10%、鸭跖草10%、香附10%、陈皮10%、桑白皮10%、炒扁豆10%、生甘草10%。
大黄:味苦性寒,清热解毒,凉血止痛。主要含有蒽醌类衍生物,大黄素,大黄酚。
主要药理:大黄提取液有有保护胃黏膜及促进溃疡愈合作用。大黄对CCL4引起的肝损伤确有预防作用。大黄素可对抗乙酰胆碱引起的小鼠肠管痉挛。大黄可减轻内毒素性低血压,减轻内毒素引起的肠壁血管通透性升高,阻止肠腔中的细菌、毒素进入血循环,维持跨肠黏膜电位差,维护肠黏膜屏障完整性,表明大黄可以保护肠黏膜屏障。大黄有抑菌作用,其中大黄酸和大黄素的抗菌作用最好。对金黄色葡萄球菌、痢疾杆菌、伤寒杆菌、大肠杆菌、绿脓杆菌、链球菌等均有不同程度的抑菌或抗菌作用。大黄挥发油具有体外抗HBV作用,在同一浓度下,大黄油抑制HbsAg的作用要比抑制HbeAg更强一些。大黄能加快单纯疱疹病毒感染鼠脑、心、肝、神经节和血液内病毒的清除,且显示出量效关系,对不同组织中病毒的检测发现,神经节中病毒滴度下降较慢,肝脏病毒滴度下降较快,表明大黄在体内具有抗单纯疱疹病毒的作用。大黄可使血清和肠壁组织中血小板活化因子(PAF)含量显著下降,显著降低内毒素引起的磷脂酶A2(PLA2)活性升高,从而有效阻止了炎性介质的扩增及其生物学作用的发挥,防止了炎性介质介导的严重并发症的发生,可见大黄对内毒素性休克所致炎症反应有明显的预防和治疗作用。大黄还具有抗衰老作用,具有抑制小鼠肝匀浆过氧化脂质生成的作用。从波叶大黄中提取的波叶大黄多糖(RHP)能明显延长两性果蝇的平均寿命和最高寿命,可增加12月龄小鼠红细胞内和脑中SOD活力,降低心肌组织中和和肝组织中脂褐质含量,抑制脑中B型单胺氧化酶活力。复方大黄制剂也能明显延长黑腹果蝇的平均寿命和最高寿命。大黄对免疫系统的作用有典型的双向性或双向调节作用。大黄在体内的作用还与其所处的机能状态有关,如大黄素既能活化单核细胞分泌IL-1、IL-6、IL-8和TNF,又能抑制内毒素诱导的上述因子的大量释放。临床应用在病毒感染性疾病,如病毒性肝炎,单纯性疱疹,艾滋病病毒感染,带状疱疹,肺炎,急性细菌性痢疾,急性化脓性扁桃体炎,败血症,急性出血性坏死性肠炎。还有免疫性疾病,如慢性肾功能衰竭,红斑狼疮,银屑病。对感染性发热,病毒引起的淋巴肿大以及全身疼痛有很好的治疗效果。对皮肤感染以及急性感染时血浆内毒素的降低也有很强的作用。
茯苓:味甘淡,性平。健脾补中、利水渗湿、养心安神。主要含有多糖类和三萜类,还含有树胶、蛋白质、卵磷脂、胆碱及铁、钙、钠、钾等。
主要药理:茯苓可以明显增加腹腔巨嗜细胞的吞噬功能,有对抗可的松的免疫抑制作用,有抗胸腺萎缩及拮抗脾脏增大的作用。茯苓还能使免疫球蛋白IgG含量明显上升,提高人体的免疫功能。茯苓多糖对抗可的松的免疫机制作用,与对照组相比巨嗜细胞吞噬功能提高了两倍。茯苓多糖抗胸腺萎缩,增加酸性非特异性酯酶阳性淋巴细胞的数量和胸腺抗体分泌细胞的数量以及增强T淋巴细胞功能的作用,并能促进白细胞介素-2的产生。茯苓多糖可以激活C3,C5及其因子,提高小鼠的体液免疫功能。茯苓能够提高红细胞中2,3-二磷酸甘油酸的水平,增强红细胞的输氧功能,改善机体的缺氧状态。
鸭跖草:味甘,寒,无毒,行水,清热,凉血,解毒。
主要药理:鸭跖草煎剂用试管稀释法,1∶210对金黄色葡萄球菌、1∶140对大肠杆菌等有抑制作用。鸭跖草地上部分甲醇提取物对引起龋齿的细菌变异链球菌有杀灭作用。1-甲氧甲酰基-β-咔啉、哈尔满和去甲哈尔满对该菌的最小抑制浓度(MIC)为100ug/ml。
香附:味微苦甘,性辛平,理气解郁,调经止痛。
主要药理:香附有解热镇痛作用,给小鼠皮下注射20%香附醇提取物,能明显提高小鼠的痛阈,香附醇提取物中所含的三萜类化合物(IV一B)5mg/kg灌服的镇痛效果与30mg/kg乙酰水杨酸相当。香附醇提取物对注射酵母菌引起的大鼠发热有解热作用,其效价约为水杨酸钠的6倍,其解热有效成分也是三萜类化合物;降温作用:给大鼠腹腔注射香附挥发油0.1ml/kg,以腹腔注射氯丙嗪5mg/kg作阳性对照,给药前后分别测定大鼠直肠体温。结果表明,给予香附挥发油30分钟后可明显降低大鼠正常体温(P<0.05),较氯丙嗪的降温作用强,但作用不及氯丙嗪持久,随后大鼠体温逐渐恢复正常;抗炎作用:香附醇提取物100mg/kg 腹腔注射,对角叉菜胶和甲醛引起的大鼠脚肿有明显的抑制作用。此作用强于5-10mg/kg氢化考的松。Gupta MB 研究证明其抗炎成分为三萜类化合物。其中成分IV-B对角叉菜胶所致脚肿的抗炎作用,比氢化考的松强8倍,安全范围大3倍。对甲醛性脚肿亦有抑制作用。灌胃和腹腔注射的效力之比为1∶3,说明可能在消化道内只部分吸收。抗菌作用:体外试验,香附挥发油对金黄色葡萄球菌有抑制作用,对其他细菌无效。香附烯Ⅰ和Ⅱ的抑菌作用比挥发油强,且对宋内氏痢疾杆菌亦有效。氢化不影响其抗菌作用。香附酮则完全无效。香附提取物对某些真菌亦有抑制作用。
陈皮:味苦、辛,性温。理气健脾,燥湿化痰。含多种挥发油和20余种类胡萝卜素。
主要药理:陈皮对消化道有缓和的刺激作用,有利于胃肠积气排出,能促进胃液分泌,有助于消化;对胃肠平滑肌有松弛作用,能对抗氯化钡、毛果芸香碱所致痉挛。陈皮所含柠檬烯有刺激性祛痰作用,能刺激呼吸道黏膜,使分泌增多,痰液稀释,有利于排出。陈皮提取物有维生素P样作用,能对抗组织胺所致的血管通透性增加,对大鼠巴豆性肉芽肿的炎症反应也有抑制作用,还有明显的抗溃疡作用。陈皮在试管内能抑制葡萄球菌、卡奈氏菌、溶血性嗜血杆菌的生长。陈皮还具有抗衰老作用。用陈皮醇提取液观察对果蝇寿命、飞翔能力及对其SOD活性和MDA含量的影响,发现给药组能明显延长果蝇的半数存活期、平均寿命和最高寿命,提高SOD活性,降低MDA含量。
桑白皮:味甘寒,泻肺平喘,利水消肿。
主要药理:利尿作用:桑白皮水煎剂2g/kg给家兔灌胃, 6小时内排尿量及氯化物均显著增加, 7~24小时恢复正常.给大鼠灌胃或腹腔注射回提取物或正丁醇提取物300~500mg/kg;均呈明显的利尿作用, 尿量、Na+、K+和氯化物排出量均增加.对心血管系统的作用:桑根皮提取物, 按3~10mg/kg给麻醉兔静脉注射, 产生明显的血压下降, 切断两侧迷走神经对降压无影响,但给予阿托品可完全对抗其降压0.0001%~0.00001%的提取物对离体蛙心呈抑制作用, 对离体兔耳血管有扩张作用, 对蛙后肢血管有收缩作用, 并能兴奋离体兔肠管和子宫;毒扁豆碱能增强提取物对蛙腹直肌等的收缩.根据以上实验, 认为提取物是和乙酰胆碱相似的物质.桑白皮提取物对小鼠有镇静作用.桑白皮中提得的乙酰胆碱样物质能兴奋兔离体子宫, 轻度促进兔耳下腺的分泌;如直接涂于颈交感神经节上, 则可抑制电刺激节前纤维引起的瞬膜收缩, 但注射(动脉或静脉)给药对猫瞬膜收缩则无影响.抗人艾滋病病毒HIV1作用:体外试验表明,艾滋病的病原体HIV是借助外膜糖蛋白(gp120)附着于T辅助细胞的 CD4细胞受体上,通过细胞融合形成合胞体启动感染环的。由于桑白皮的有效成分1一脱氧野尻霉素是o一葡糖甘酶的抑制剂,可干扰 gpl2ON一侧链多聚糖结构的合成,从而阻断 gp2O一CD4之间的结合,减少或阻止合胞体形成,减弱HIV的感染力。体外实验还证明,1一脱氧野尻霉素2.Ommol/L时,HIV对C8166细胞株的感染力可由10。降至10以下。桑白皮中的黄酮momrusin,kuwanon H和 morusin4-glucoside也具有一定的抗HlV活性。抗菌作用 桑皮根素AuwanonC、J、L和sanggenon A、B、C、D对金葡菌和枯草杆菌有抗菌活性, kuwanon J、L和sanggenon A、B、C对类链球菌及桑皮根素,kuwanon C、L、A对耻垢分支杆菌各有抗菌活性。桑皮根素、kuwanonC和sa"8 genonA、C对革兰氏阴性菌和真菌(除稻梨孢外)无效或只有极弱的活性。
炒扁豆:甘,微温,补脾和中,化湿消暑。
主要药理:扁豆中含有对人的红细胞的非特异性凝集素,他具有某些球蛋白特性;对牛、羊红细胞并无凝集作用。在扁豆中可以分离出二处不同的植物凝集素,凝集素A不溶于水,无抗胰蛋白酶活性,如混于食物中饲喂大鼠可抑制其生长,甚至引起肝脏区域性坏死;加热后则毒性明显减弱,故凝集素A是粗制扁豆粉中的部分有毒成分。对胰蛋白酶有非竞争性抑制作用,由于抑制了凝血酶,可使酸血浆的凝固时间延长。扁豆对火星E-玫瑰花结的形成有促进作用,但扁豆对体外淋巴细胞的转化反映无明显作用。扁豆对哥伦比亚SK病毒有抗病毒作用。
生甘草:甘,平,补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。
主要药理:抗菌作用:甘草中黄酮类化合物中抗菌成分较多,作用较强。黄酮单体化合物甘草查尔酮A( licochalconeA), 甘草查尔酮B(licochalconeB),甘草黄酮(glabridin),光甘草素(glabrene),等对革兰氏阳性菌中的金黄色葡萄球菌和枯草杆菌的抑制作用相当于链霉素,对酵母菌和真菌抑制作用高于链霉素;对革兰氏阴性菌中的大肠杆菌和绿脓杆菌抑制作用远低于链霉素GlepidoLin A、glepidolinB、glad-ranin等化合物对用链霉素无效的白色念珠菌有不同程度的抑制作用,对金黄色葡萄球茵也有抑制作用。黄甘草(Glabrol),欧甘草素(hispaglabridin )A和B等化合物对金黄色葡萄球菌的抑制作用不低于链霉素。光甘草素,甘草查尔酮甲(Glabrol),欧甘草素(hispaglabridin )A和B,3-羟基丁酸黄甘草(3-hybroxyglatbrol)等化合物对包皮污分支杆菌都有不同程度的抑制作用。甘草查尔酮A体外对革兰氏阳性球菌、杆菌和棒型菌有明显的抑制作用,对军团病杆菌属的抑制作用各不相同,表明甘草查尔酮A 可能开发为一个治疗呼吸道感染的新药。抗寄生虫作用:体外试验表明,甘草查尔酮A可抑制杜氏利什曼原虫(leishmania donovani)和硕大利会什曼原虫(L. magior)的前鞭毛体和无鞭毛体的生长,并可抑制硕大利什曼原虫对小鼠的感染和杜氏利什曼原虫对仓鼠的感染,可认为它是一个有效的抗利什曼原虫的新药。抗病毒作用:抗HIV作用:日本学者从甘草鞣质活性成分研究中所得到的活性成分(包括黄酮类成分)加强了人体免疫缺陷病毒HIV对ATL-IK(来源于成人T细胞白血病患者的细胞株)的拮抗作用,其中2种新甘草查尔酮低浓度时显示出对HIV 增殖的抑制作用。甘草根中常见的单体成分甘草苷(liquiritin)、甘草素(Iiquritigenin)、 异甘草素(isoliquiritin)、异甘草酸(isoliquiritigenin)对新城艾滋病毒有抑制作用。甘草甜素(GL)也有抗HIV作用,已应用于处理输血用的血制品,以预防因输血引起的艾滋病病毒(HIV)传播,并已获美国专利。HIV繁殖过程包括吸附、穿入、脱壳、早期蛋白的合成、病毒基因组核酸的复制、晚期蛋白质的合成、核蛋白质合成、核壳体装配、病毒成熟、释放等。其中最关键的步骤是基因核酸复制,核蛋白质的合成以及参与合成特异性的酶。GL通过抑制细胞膜蛋白激酶C和蛋白激酶P的活性抑制艾滋病毒的感染,而且也可以通过抑制艾滋病毒逆转录酶的活性而发挥作用。又有研究发现GL的硫化物GLS不仅可以通过与GL相同作用机理抑制 HIV感染,而且也可抑制HIV的禽类骨髓母细胞瘤病毒AMV逆转录酶活性,由于 GL不具抑制逆转录酶活性,因此认为GLS作为治疗AIDS药物比GL更有效。炎抗变态反应作用:前苏联学者研究表明甘草香豆素(glycycoumarin)有较强的消炎和抗变态作用,比黄胺和抗生素的药效要好,日本学者小菅卓夫等从甘草中分离得到了有抗炎活性的黄酮成分甘草甙。另外,从新疆甘草中分离得到的甘草查尔酮 A对十二氧十四烷酰大戟二萜醇醋酸酯所致肿瘤和炎性水肿均有抑制作用。甘草中的异甘草酸( isoliquiriLigenin)和甘草素(Iiquiritigenin ) 对透明酯酸酶的活性和免疫刺激所诱导的肥大细胞的组胺释放都有抑制作用。甘草查尔酮A和B还可抑制人多形核嗜中性白细胞中自三烯的生物合成,并可抑制该细胞的脱颗粒。有报道说从光果甘草地上部分分离到的光甘草宁(glabranin)、高良姜素(galangin)、松属素(pinocembrin)及松属素的衍生物有明显的抗炎作用。此外,甘草还有解痉,镇痛,解热,镇静的作用;有降血脂,抗动脉粥样硬化,抑制血小板聚集的作用;疫调节作用:甘草甜素能使一些免疫器官的重量显著增加,使正常小鼠对静脉碳粒的廓清指数显著提高,有非特异性免疫增强作用。甘草酸可促进干扰素和白细胞介素-2产生,增强自然杀伤细胞活性。
中医理论认为艾滋病属于“疫病”、“伏气温病”、“虚劳”等范畴,乃邪毒之袭,很多古代专著对此有过论述,《温疫论》 “瘟疫之为病,非风、非寒、非暑、非湿,乃天地间别有一种异气所感”。《温热逢源》堪称是伏气温病的专著,他提出:“伏温之邪,冬时之寒热也。其伤人也,本因肾气之虚,始得入而据之。”由此我们可以看出,艾滋病虽然临床病情复杂,但总的来说无非是邪实、正虚两个方面的消长变化,而邪气乃整个病变之罪魁,最终导致邪愈盛正愈虚,正愈虚而邪愈猖的恶性循环,邪毒内盛,气血不畅,精微不布,脏腑至损而然也;邪毒壅盛,毒遏热伏,故见发热;邪毒上壅,则见咽痛、口疮;毒气壅滞,脾虚而运化不利,则中焦湿聚,气机逆乱,故见食欲不振、恶心、呕吐、腹泻;热毒浸淫肌肤血络,故见皮肤斑疹;气滞湿聚日久则为痰结,则见瘰疬;邪盛日久,正气日衰,故见乏力;脾为后天之本,运化水谷精微至全身,肌体才能得到濡养,脾气受损,则输布功能不利,后天失养,即见肌体消瘦;脾为痰之源,肺为痰之器,脾之功能失司,则水液输布失常,中焦湿聚为痰,痰毒上壅于肺,则见咳嗽咳痰;而肺为脾之子,脾气虚衰,进而导致肺气,出现咳嗽气短等症状;受损气行则血行,气滞、气虚则血行不利,加之痰湿阻络,故痰瘀互结于关节、肌肉,肌肉关节出现疼痛,此乃“不通则痛”之理也;综观其病,无外乎邪正之争,痰、瘀、毒随之而煽煽然作祟也;忆景岳之言,尤然而明矣:“医者一心也,病者万象也,譬之北极者医之一心也,万星者病之万象也……彼此相照,何得有差?……医道虽繁而可以一言蔽之者曰阴阳”。邪正之争譬之若敌我之争,退其敌,则我必有修养生息之机也。故除之邪,驱之敌,虚才得复,吾才得息。简而言之:祛其邪乃当务之急,只有扫除阻碍人体气血运行的各种障碍,虚损的五脏六腑自我恢复,人体达到健康状态,正如张子和所言:“邪气去而元气自复矣。”邪和正是一个相对概念,“邪”可以是外感邪气,也可以是内在病理产物,是阻碍人体阴阳平衡、气血运行的障碍;“正”是人体抵抗疾病的能力。“祛邪扶正”的主要作用机理是扫除阻碍人体气血运行的各种障碍,同时使虚损的五脏六腑自我恢复,人体达到健康状态。复方鸭跖草胶囊是基于以上祛其邪而扶其正的中医理论研发的治疗艾滋病、各类感染以及改善人体免疫力的中成药。
复方鸭跖草胶囊由大黄、鸭跖草、桑白皮、茯苓、炒扁豆、陈皮、香附、甘草等组成。大黄味苦性寒,清热解毒,凉血止痛,通利血脉方中为君。艾滋病整个发病过程均以热毒充斥卫气营血而致的急性热病及正气不足虚衰乏力为二大主要症状,鸭跖草性寒,味甘、淡,清热解毒,利水消肿,故以鸭跖草、为臣,可助君药祛邪,加强清热解毒之功;艾滋病除以热毒症状外,其本质还是正虚,脾为后天之本,脾虚运化不利,湿热内停,致使湿热郁阻气机,出现呕逆、腹泻等症状,脾虚母病及子,导致肺气亦受损,故见咳嗽气短、乏力,茯苓味甘淡,性平,健脾补中、利水渗湿、养心安神;炒扁豆味甘性平,健脾和中,消暑化食;陈皮味苦、辛,性温,理气健脾,燥湿化痰;桑白皮甘寒,止咳平喘利水消肿。故以茯苓、陈皮、炒扁豆、桑白皮为臣,健脾益肺、培土生金、利水渗湿,止咳平床、补益后天,扶正祛邪;以香附为佐,宣通气血,调血安神;甘草为使以助君臣宣通气机,补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。以上诸药配伍有祛邪扶正,健脾和中,清热解毒,和解表里的协同效应作用 。
本发明制备方法包括如下步骤:按组成原料组分的重量百分比取料,加水煎煮两次,每次加水量没过药面为宜,合并两次水煎过滤液(优选方案为:加4倍原料重量的饮用水煎煮,第一次1.5小时,过滤,药渣再加其三倍重量的饮用水煎煮1小时,过滤,合并水煎液),浓缩至比重为1:1.2-1:1.4的浓缩液,放置于干净的不锈钢干燥盘中,经80℃干燥后粉碎,过80目筛,胶囊充填(±值0.02),检验,装瓶,装箱入库即得。
本发明的中药制剂可以加入制备不同剂型时所需的各种常规辅料,如崩解剂、润滑剂、粘合剂等以常规的中药制剂方法制备成任何一种常用的口服剂型,如丸剂、散剂、片剂、口服液、膏剂、冲剂等。
本发明的有益效果:1.治疗范围广泛,不仅能改善中晚期艾滋病患者的生存质量,对早期艾滋病患者以及艾滋病感染者也有较好疗效;配合西药使用可提高疗效,同时能够抑制西药治疗的副作用。故在南非MCC的批准下,在南非ST教会医院进行了53例的分组随机对照双盲试验,治疗组使用复方鸭跖草胶囊与西药哈特疗法交合治疗,对照组仅仅使用西药哈特疗法治疗。
本发明治疗HIV/AIDS临床研究报告
患者一般资料见表1。
本研究共有54例患者进入,其中治疗组27例,对照组27例,有4例患者脱落,最后参与统计者50例,其中治疗组27例,对照组23例。两组在性别、年龄、病程上经统计学分析无明显差异,P>0.05,具有可比性。表1为两组一般情况比较。
表1:治疗组和对照组一般情况对比结果
结果:两组在性别、年龄、病程、体重等一般资料上经统计学分析无明显差异,P>0.05,具有可比性。
两组患者病情程度的比较见表2。
表2:治疗组和对照组患者病情程度的比较结果
组别 | 例数 | ARC期 | AIDS期 |
治疗组 | 27 | 19 (70.3%) | 8(29.7%) |
对照组 | 23 | 16 (69.6%) | 6 (30.4%) |
结果:经X2检验,两组差异无显著性,P>0.05,具有可比性。
两组患者治疗前症状体征比较见表3:
表3:治疗组和对照组患者治疗前症状体征比较结果(注:治疗前组间比,P>0.05)
两组治疗前各症状积分,经t检验,P>0.05,两组间无明显差异,具有可比性。两组患者治疗前后症状体征比较见表4、表5。
组别 | 治疗前 | 治疗后 | 差值 | t值 | P值 |
治疗组 | 20.52±5.99 | 7.85±3.59 | 12.67±4.61 | 14.28 | 0.000* |
对照组 | 18.26±5.54 | 14.78±6.95 | 3.48±7.56 | 2.21 | 0.038* |
注:与治疗前比,*P<0.05;
经配对资料t检验,两组治疗前后P<0.05,均有显著性差异,提示两组对症状的改善均有疗效。经两组差值独立样本t检验,P=0.001<0.05,提示两组之间治疗效果有显著性差异,治疗组比对照组疗效好。
表5:两组患者治疗前后各项症状评分变化(±S,分)
注:与治疗前比,*P<0.05, ** P<0.01;与治疗前比,△P>0.05。
结果:其中治疗组患者发热、口腔溃疡、肌肉关节疼痛、纳呆、乏力、失眠、咽痛症状改善明显,P<0.01;腹泻、咳嗽、恶心呕吐症状有改善,P<0.05;淋巴结肿大、皮疹、盗汗症状无明显改善,P>0.05;对照组患者发热、口腔溃疡、关节疼痛症状有明显改善P<0.01,肌肉疼痛、纳呆、乏力、失眠、咽痛、腹泻、咳嗽、恶心呕吐、淋巴结肿大、皮疹、盗汗症状无明显改善,P>0.05。
两组患者治疗前后生存质量比较见表6:
组别 | 治疗前 | 治疗后 | 差值 | t值 | P值 |
治疗组 | 80.67±14.43 | 71.67±7.64 | 9.00±7.77 | 6.022 | 0.000* |
对照组 | 74.26±11.57 | 71.30±6.87 | 2.96±10.65 | 1.331 | 0.197△ |
注:与治疗前比,*P<0.05,与治疗前比,△P>0.05。
经配对资料t检验,治疗组P<0.05,而对照组P>0.05,提示治疗组对患者生存质量的影响有显著性差异,能显著改善生活质量。经两组差值独立样本t检验,P=0.025<0.05,提示两组之间治疗效果有显著性差异,治疗组优于对照组。
两组患者治疗前后体重变化比较见表7:
组别 | 治疗前 | 治疗后 | 差值 | t值 | P值 |
治疗组 | 50.44±6.09 | 52.30±7.47 | 1.85±3.13 | 3.07 | 0.005* |
对照组 | 48.74±5.56 | 48.57±5.78 | 0.17±1.64 | 0.51 | 0.617 |
注:与治疗前比,*P<0.05。
经配对资料t检验,治疗组P<0.05,而对照组P>0.05,提示治疗组对体重的影响有显著性差异。经两组差值独立样本t检验,P=0.006<0.05,提示两组之间治疗效果有显著性差异,治疗组在增加体重方面比对照组疗效好。
两组患者治疗前后CD4+淋巴细胞变化比较见表8(注:治疗前组间比,P>0.05)
两组治疗前CD4+淋巴细胞计数,经t检验,P>0.05,两组间无明显差异,具有可比性。
组别 | 治疗前 | 治疗后 | 差值 | t值 | P值 |
治疗组 | 139.19±126.55 | 229.07±279.61 | 89.89±222.03 | 2.10 | 0.045* |
对照组 | 112.48±63.99 | 150.52±80.70 | 38.04±28.82 | 6.33 | 0.000* |
注:与治疗前比,*P<0.05。
经配对资料t检验,两组治疗前后P<0.05,均有显著性差异,提示两组对血CD4+的升高均有较好的疗效。经两组差值独立样本t检验,P=0.272>0.05,提示两组之间治疗效果无显著差异。
两组患者治疗前后HIV病毒载量变化比较见表9:
表9:两组患者治疗前后HIV载量变化(±s,log copy/mL)
组别 | 治疗前(log) | 治疗后(log) | 差值 | t值 | P值 |
治疗组 | 4.675±0.66 7 | 3. 361± 1.230 | 1.314±1.113 | 6.132 | 0.000* |
对照组 | 4.657±0.660 | 4.035±1.166 | 0.622±0.575 | 5.190 | 0.000* |
注:与治疗前比,*P<0.05。
经配对资料t检验,两组治疗前后P<0.05,均有显著性差异,提示两组对血HIV载量的转阴均有较好的疗效。经两组差值独立样本t检验,P=0.010<0.05, 提示两组之间治疗效果有显著性差异,治疗组比对照组疗效好。
两组患者治疗前后总体疗效比较见表10:
表10:两组患者临床总体疗效比较(n,%)
组别 | 总例数N | 显效n | 有效n | 无效n | 总有效率% | P值 |
治疗组 | 27 | 11 | 10 | 6 | 77.8 | 0.057 |
对照组 | 23 | 2 | 10 | 11 | 52.2% |
注:两组间比较,P>0.05.
两组疗效经X2检验,P>0.05,提示两组疗效无显著性差异。
两组脱落病例原因分析见表11、表12:
表11: 两组患者脱落人数分布情况
治疗组(%) | 对照组(%) | 合计(%) | |
随机入组 | 27(100.00) | 27 (100.00) | 54 (100.00) |
完成试验 | 27(100.00) | 23 (85.20) | 50(92.60) |
试验期间脱落 | 0 (0.00) | 4 (14.80) | 4 (7.40) |
表12:脱落原因分析
脱落原因 | 治疗组(%) | 对照组(%) | 合计(%) |
不良事件 | 0 | 0 | 0 |
缺乏疗效 | 0 | 2(7.40) | 2(3.70) |
违背试验方案 | 0 | 1(3.70) | 1(1.85) |
失访 | 0 | 0 | 0 |
其他 | 0 | 1(3.70) | 1(1.85) |
本试验共脱落4例患者,脱落率为7.4%(<20%),4例患者均来自治疗组,1例患者违背试验方案,自行服用其他药物; 2例患者治疗中症状加重明显缺乏疗效而退出,1例患者因对西药无法耐受而退出。
结论:
1、本发明中药组合物够缓解艾滋病患者临床症状,治疗后患者发热、口腔溃疡、肌肉关节疼痛、纳呆、乏力、失眠、咽痛、消瘦症状改善明显(P<0.01),疗效优于对照组(P<0.05)。
2.能明显改善艾滋病患者生存质量,治疗后评分较前明显降低(P<0.01),且治疗组优于对照组(P<0.05)。
3.有一定抑制HIV的作用(P<0.05),其结合西药使用抑制病毒作用要优于单纯使用西药(P<0.05),并需进一步验证。
4. 本发明中药组合物具有一定稳定甚至提升艾滋病患者CD4+T淋巴细胞的作用,是否有进一步抑制HIV病毒的作用,以及对其安全性作出客观评价,这一系列问题还需进一步大样本、长时间观察来验证。
具体实施方式
实施例1,本发明胶囊剂的制备,按组成组分的重量百分比取料熟大黄150g、茯苓50g、陈皮50g、香附50g、鸭跖草50g、桑白皮50g、炒扁豆50g、生甘草50g。加2000克的饮用水煎煮,第一次1.5小时,过滤,药渣再加其三倍重量的饮用水煎煮1小时,过滤,合并水煎液,浓缩至密度为1:1.2的浓缩液,放置于干净的不锈钢干燥盘中,在80℃干燥后粉碎,过80目筛,胶囊充填(±值0.02),检验,装瓶,装箱入库即得。
本品为硬胶囊,每粒含量为500mg。
服用方法:免疫系统低下或缺损者、重症和中症患者:每次四粒,每日两次;症状消除后改为每次三粒,每日两次。轻症患者:每次三粒,每日两次。12岁以下儿童:每次两粒,每日两次。免疫系统正常者、成人:每次两粒,每日两次。
12岁以下儿童:每次一粒,每日两次。
注意事项和禁忌:妊娠及哺乳期服用请遵医嘱。有效期:五年。
实施例2,本发明胶囊剂的制备,按组成组分的重量百分比取料熟大黄125g、茯苓60g、陈皮60g、香附40g、鸭跖草75g、桑白皮40g、炒扁豆60g、生甘草40g。加2000克的饮用水煎煮,第一次1.5小时,过滤,药渣再加其三倍重量的饮用水煎煮1小时,过滤,合并水煎液,浓缩至密度为1:1.3的浓缩液,放置于干净的不锈钢干燥盘中,在80℃干燥后粉碎,过80目筛,胶囊充填(±值0.02),检验,装瓶,装箱入库即得。其余同实施例1。
实施例3,本发明胶囊剂的制备,按组成组分的重量百分比取料熟大黄175g、茯苓40g、陈皮40g、香附60g、鸭跖草45g、桑白皮55g、炒扁豆25g、生甘草60g。加2000克的饮用水煎煮,第一次1.5小时,过滤,药渣再加其三倍重量的饮用水煎煮1小时,过滤,合并水煎液,浓缩至密度为1:1.4的浓缩液,放置于干净的不锈钢干燥盘中,在80℃干燥后粉碎,过90目筛,胶囊充填(±值0.02),检验,装瓶,装箱入库即得。其余同实施例1。
实施例4,本发明片剂的制备,按组成组分的重量百分比取料:熟大黄150g、茯苓50g、陈皮50g、香附50g、鸭跖草50g、桑白皮50g、炒扁豆50g、生甘草50g。加2000克的饮用水煎煮,第一次1.5小时,过滤,药渣再加其三倍重量的饮用水煎煮1小时,过滤,合并水煎液,浓缩至密度为1:1.3的浓缩液,放置于干净的不锈钢干燥盘中,80℃干燥后粉碎,过80目筛,加入辅料制成颗粒,并干燥,喷入通用挥发油压制成片剂。其余同实施例1。
实施例5,本发明颗粒剂的制备,按组成组分的重量百分比取料:熟大黄150g、茯苓50g、陈皮50g、香附50g、鸭跖草50g、桑白皮50g、炒扁豆50g、生甘草50g。加2000克的饮用水煎煮,第一次1.5小时,过滤,药渣再加其三倍重量的饮用水煎煮1小时,过滤,合并水煎液,浓缩至密度为1:1.4的浓缩液,放置于干净的不锈钢干燥盘中,75℃干燥后粉碎,过100目筛,加入乙醇作粘合剂,加入淀粉作填充剂,压制成颗粒剂。其余同实施例1。
Claims (4)
1.一种治疗艾滋病的中草药制剂,其组成原料组分的重量百分比为:熟大黄25-35%、茯苓5-15%、鸭跖草5-15%、香附5-15%、陈皮5-15%、桑白皮5-15%、炒扁豆5-15%、生甘草5-15%。
2.根据权利要求1所述的一种治疗艾滋病的中草药制剂,其特征是:其组成原料组分的重量百分比为:熟大黄30%、茯苓10%、陈皮10%、香附10%、鸭跖草10%、桑白皮10%、炒扁豆10%、生甘草10%。
3.权利要求1所述的治疗艾滋病的中草药制剂的制备方法,其特征是包括以下步骤:
a、按组成原料组分的重量百分比取料:熟大黄25-35%、茯苓5-15%、鸭跖草5-15%、香附5-15%、陈皮5-15%、桑白皮5-15%、炒扁豆5-15%、生甘草5-15%;
b、加水煎煮两次,每次加水量没过药面为宜,合并两次水煎过滤液;
c、浓缩至比重为1:1.2-1:1.4的浓缩液;
d、放置于干净的不锈钢干燥盘中,经80℃干燥后粉碎;
e、过80--100目筛,得到本发明中草药制剂的活性组分。
4.根据权利要求3所述的治疗艾滋病的中草药制剂的制备方法,其特征是:在步骤b中:加原料4倍重量的饮用水煎煮,第一次1.5小时,过滤,药渣再加其三倍重量的饮用水煎煮1小时,过滤,合并水煎液。
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