CN105412898A - 一种中药组合物在制备治疗急性肾炎的药物中的应用 - Google Patents
一种中药组合物在制备治疗急性肾炎的药物中的应用 Download PDFInfo
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Abstract
本发明公开了一种中药组合物在制备治疗急性肾炎的药物中的应用,涉及中医药技术领域。所述中药组合物以连翘、栀子、蝉蜕、罗星草、重楼、百合、夏枯草、泽泻、枸杞、蛇床子、川芎、白芷、白茅根、白芍、干姜、甘草、升麻、决明子为原料制得。本发明中的中药组合物为天然纯中药制剂,不良反应和副作用显著降低,在急性肾炎治疗中具有显著的协同作用,不仅能够显著改善急性肾炎的症状,还能延缓急性肾炎的发展,有助于急性肾炎患者的痊愈过程。
Description
本申请是申请人王雪雁提出的发明专利申请(发明名称为:一种治疗急性肾炎的中药组合物及其制备方法,申请号为:2014100476215,申请日为:2014年2月11日)的分案申请。
技术领域
本发明属于医药技术领域,涉及一种中药组合物在制备治疗急性肾炎的药物中的应用。
背景技术
急性肾小球肾炎简称急性肾炎,急性肾炎是一种由于感染后变态反应引起的两侧肾脏弥漫性肾小球损害为主的急性疾病,本病的特点是起病较急,在感染后1-3周出现血尿、蛋白尿、管型尿、水肿、少尿、高血压等系列临床表现。
肾炎是原发于肾小球的疾病。临床上有急性和慢性两种,急性肾炎多见于儿童,常发生于感染后,尤以溶血性链球菌“致肾炎菌株”感染后多见;起病急、病程短,主要表现为血尿、蛋白尿、少尿、水肿、高血压及氮质血症,积极治疗愈后较好,少数可发展为慢性肾炎。肾炎在祖国属中医“水肿”范畴,部分病例“水肿”不明显,而以血尿为主,则属血证中的“尿血”范畴。按急性肾炎水肿的特点,可归属风水、阳水类,其发病与风邪外袭,风水相后搏,或饮食不节,水湿浸渍,或房劳过度,阴虚邪淫有关,上述致病因素可单独致病,也可兼杂为病,但不离风、湿、毒三因,涉及肺、脾、肾三脏,当风湿毒邪伤及肺脾肾三脏,使肺失通调,脾失转输,肾失开合,三焦水道失畅,膀胱气化无权,而致水湿,毒邪内侵,水谷精微大量流失,而出现临床诸症。
急性肾小球肾的的病理改变是肾脏体积可较正常增大,病变主要累及肾小球。以内皮细胞及系膜细胞增生为主要表现,急性期可伴有中性粒细胞和单核细胞浸润。病变严重时,增生和浸润的细胞可压迫毛细血管袢使毛细血管腔变窄、甚至闭塞,并损害肾小球滤过膜,可出现血尿、蛋白尿及管型尿等;并使肾小球滤过率下降,发生水钠潴留,因此临床上有水肿、尿少、全身循环充血状态如呼吸困难、肝大、静脉压增高等。
急性肾小球肾炎治疗:
1、西药治疗首选青霉素800万单位静脉滴注,10-14天,但其必需性现有争议。对症治疗时,针对利尿、消肿、降血压,常用噻嗪类利尿剂,如双氢氯噻嗪。利尿后高血压值仍不满意时,可加用钙通道阻滞剂如硝苯啶20-40mg/d,分次口服或血管扩张药如肼酞嗪25mg,每日3次。但保钾利尿药(如氨苯蝶啶及安体舒通)及血管紧张素转化酶抑制剂,少尿时应慎用,以防诱发高血钾。
2、中医药治疗:中医中药治疗副作用小,注重肾脏的修复和保护,还具有标本兼治的效果。本病多属实证。根据辨证可分为风寒、风热、湿热,分别予以宣肺利尿,凉血解毒等疗法。本病恢复期脉证表现不很明确,辨证不易掌握,仍以清热利湿为主,佐以养阴,但不可温补。风热型:发热不恶寒、咽喉肿痛,面部轻度浮肿,舌苔薄黄,尿短赤涩,可见肉眼血尿;治则疏风清热,凉血解毒。湿热型:可有发热、唇干口苦、舌苔黄、脉滑数、尿少色红、头面或全身浮肿;治则清热利湿或清热解毒。风寒型:发病急,恶寒、发热、咳嗽、头面浮肿、尿少、血压高、舌苔薄白、脉浮紧;治则宣肺利水。
目前,治疗急性肾炎的西药很多,但大多数药物治疗效果差,并且还有治疗成本高、副作用大等缺点,严重时甚至影响患者健康。抗生素对急性肾炎的治疗效果较好,但抗生素的长期使用可以导致人体产生抗生素耐药性,且其使用会破坏肠道菌群的平衡,给患者的身心健康造成了严重的影响。另外,还有很多治疗急性肾炎的中药,但大多数具有治疗效果差、治愈率低和治疗周期长等缺点。本发明目的即在于提供一种作用全面,临床效果好的治疗急性肾炎的中药组合物。
纵观世界新药的研究方向,80年代以前主要是研究开发单一的化学药物及其制剂,80年代以后开始发展生物技术和天然植物药物,药物研究方向趋于多样性。结合现代中医药发展理论,从提高药物疗效、降低副作用的角度出发,经过对中药成分进行筛选提取和/或配伍制得的制剂,其副作用小,安全性高,具有化学合成药不能比拟的优势。
发明内容
现有技术中化学药物治标不治本,且容易损伤胃肠道粘膜,药物毒副作用大,而中药则存在疗效不确定,缺少相应药物制剂。为了克服现有急性肾炎化学治疗药物毒副作用大,急性肾炎治疗效果难以持续的现有技术不足,本发明提供了一种治疗急性肾炎的中药组合物,该中药组合物疗效好,副作用小,它主要由以下原料制得:连翘10-50份,栀子10-20份,蝉蜕5-20份,罗星草5-15份,重楼5-10份,百合5-15份,夏枯草5-15份,泽泻1-10份,枸杞5-15份,蛇床子9-15份,川芎9-15份,白芷5-15份,白茅根0.2-9份,白芍5.5-15份,干姜6-9份,甘草10-15份。
连翘:味苦;性微寒。入肺;心;胆经。清热解毒;消肿散结。主治风热感冒;温病;热淋尿闭;痈疽;肿毒;瘰疬;瘿瘤;喉痹。《神农本草经》载:“主寒热,鼠瘘,瘰疬,痈肿恶疮,瘿瘤,结热。”临床医学研究表明,连翘有广谱抗菌作用,对金黄色葡萄球菌、贺氏痢疾杆菌有很强的抑制作用,对其他致病菌、流感病毒、真菌都有一定的抑制作用,所含的齐墩果酸有强心、利尿及降血压作用,维生素P可降低血管通透性及脆性,防止溶血,此外还有抗炎、镇吐、抗肝损伤作用。
栀子:甘,苦,寒。归肝,胆,胃经。清热利湿,凉血止血。主黄疸型肝炎,痢疾,肾炎,感冒高热,吐血,衄血,尿路感染,肾炎水肿,乳腺炎,风火牙痛,疮痈肿毒,跌打损伤。
蝉蜕:味甘;咸;性凉。入肺;肝经。宣散风热;透疹利咽;退翳明目;祛风止痉。主治风热感冒;咽喉肿痛;咳嗽音哑;顽疹不透;风疹瘙痒;目赤翳障;惊痫抽搐;破伤风。《纲目》载:“治头风眩运,皮肤风热,痘疹作痒,破伤风及疗肿毒瘤,大人失音,小儿噤风天吊,惊哭夜啼,阴肿。”现代医学研究证实,蝉蜕具有明显的抗惊厥、镇静作用,能阻断颈上副交感神经的传导,广泛应用于治疗破伤风、慢性荨麻诊、化脓性中耳炎、血管神经性水肿,此外还有止咳嗽,特别是喉痒之咳的作用。
罗星草:苦,寒。清热解毒,散瘀止痛。主治肝炎,肾炎,急性肠炎,痢疾,扁桃体炎,跌打骨折,关节肿痛。
重楼:性微寒,味苦;有小毒。入肝经。清热解毒,消肿止痛,凉肝定惊。作于疔肿痈肿、咽喉肿痛、毒蛇咬伤、跌扑伤痛、惊风抽搐。《本草纲目》载:“蛇虫之毒,得此治之即休,故有蚤休、螫休诸名。重台、三层,因其叶状也。”
中医认为百合具有润肺止咳、清心安神的作用,尤其是鲜百合更甘甜味美。百合特别适合养肺、养胃的人食用,比如慢性咳嗽、肺结核、口舌生疮、口干、口臭的患者。百合不仅具有良好的营养滋补功效,而且对于病后虚症、结核病、神经官能症等患者大有裨益,对各种癌症都有较好的疗效。在肿瘤的预防和治疗方面,百合多用于治疗肺癌、鼻咽癌、皮肤癌等。在对上述癌症进行放射治疗后出现的体虚乏力、口干、心烦、干咳痰等症状时,用鲜百合与粳米一起煮粥,再调入适量的冰糖或蜂蜜后食用,对增强体质、抑制癌细胞生长、缓解放疗的反应,具有较好的效果。再如,将鲜百合与白糖适量共捣敷患处,对皮肤癌破溃出血、渗水者也有一定的治疗作用。
夏枯草:味苦;辛;性寒。归肝;胆经。清肝明目;散结解毒。主治目翳羞明;目珠疼痛;头痛眩晕;耳鸣;瘰疬;瘿瘤;乳痈;痄腮;痈疖肿毒;急慢性肝炎;高血压病。《滇南本草》载:“祛肝风,行经络。治口眼歪斜,行肝气,开肝郁,止筋骨疼痛,目珠痛,散瘰疬,周身结核。”现代医学研究证实,夏枯草具有显著的降压和抗菌作用。
泽泻为泽泻科植物泽泻的块茎。中医理论认为其性寒,具有利水渗湿的功效。现代医学研究,泽泻可降低血清总胆固醇及三酰甘油含量,减缓动脉粥样硬化形成;泽泻及其制剂现代还用于治疗内耳眩晕症、血脂异常、遗精、脂肪肝及糖尿病等。但泽泻具有肝毒性、肾毒性,服用不当,能让肝脏、肾脏出现肿胀以及其他中毒症状。
枸杞(学名:Lyciumchinense)是茄科枸杞属的多分枝灌木植物,高0.5-1米,栽培时可达2米多。国内外均有分布。枸杞全身是宝,明李时珍《本草纲目》记载:“春采枸杞叶,名天精草;夏采花,名长生草;秋采子,名枸杞子;冬采根,名地骨皮”。枸杞嫩叶亦称枸杞头,可食用或作枸杞茶。现代研究,枸杞子有降低血糖、抗脂肪肝作用,并能抗动脉粥样硬化的效果。
蛇床子为伞形科植物蛇床的果实。别名:蛇米、蛇珠、蛇粟、蛇床仁、蛇床实、气果、双肾子、癞头花子、野茴香。有温肾壮阳;燥湿杀虫;祛风止痒的功效。治男子阳痿;阴囊湿痒;女子宫寒不孕;寒湿带下;阴痒肿痛;风湿痹痛;湿疮疥癣。唐代用于阳痿及宫冷不孕。蛇床子有温肾助阳之功,治疗肾阴虚衰引起的男子阳痿,女子宫冷不孕,可与枸杞子、菟丝子、五味子、肉桂等同用,以益肾补火,助阳兴痿;《千金方》治肾阳虚寒,阳痿不起的天雄丸,即以本品配伍而成。用于男子阴囊湿痒,女子阴痒带下,湿疹疥癣。蛇床子可燥湿祛风,杀虫止痒。治阴囊湿疹,女子阴痒带多,可单用或与苦参、黄柏、明矾等煎汤外洗。
川芎辛温香燥,走而不守,既能行散,上行可达巅顶;又入血分,下行可达血海。活血祛瘀作用广泛,适宜瘀血阻滞各种病症;祛风止痛,效用甚佳,可治头风头痛、风湿痹痛等症。昔人谓川芎为血中之气药,殆言其寓辛散、解郁、通达、止痛等功能。本品辛温升散,凡阴虚阳亢及肝阳上亢者不宜应用;月经过多、孕妇亦忌用。
白芷,性温,味辛微甘,具有祛风除湿;通窃止痛;消肿排脓的功效。主感冒头痛;眉棱骨痛;牙痛;鼻塞;鼻渊;湿胜久泻;妇女白带;痈疽疮疡;毒蛇咬伤。临床用于感冒头痛,眉棱骨痛,鼻塞,鼻渊,牙痛,白带,疮疡肿痛。也可用于解表散寒,祛风止痛,通鼻窍,燥湿止带,消肿排脓。治头痛,眉棱骨痛,齿痛,鼻渊,寒湿腹痛,肠风痔漏,赤白带下,痈疽疮疡,皮肤燥痒,疥癣。苍术具有燥湿健脾,祛风散寒,明目的功效,用于湿阻脾胃、脘腹胀满,寒湿白带,湿温病以及湿热下注、脚膝肿痛、痿软无力。治湿阻脾胃,而见脘腹胀满、食欲不振、倦怠乏力、舌苔白腻厚浊等症,常与厚朴、陈皮等配伍应用。
白茅根又名茅草、白茅草、茅根,为禾本科茅根属多年生草本植物。有凉血止血,清热解毒的功效。主治:用于吐血,尿血,热淋,水肿,黄疸,小便不利,热病烦渴,胃热呕哕,咳嗽。
白芍为我国著名的传统常用中药材,应用历史悠久,芍药始载于东汉《神农本草经》,列为中品,记有“主邪气,白芍腹痛,除血痹,破坚积,寒热疝瘕,止痛,利小便,益气”。养血柔肝,缓中止痛,敛阴收汗。治胸腹胁肋疼痛,泻痢腹痛,自汗盗汗,阴虚发热,月经不调,崩漏,带下等症。现代药理学研究显示,芍药甙对豚鼠、大鼠的离体肠管和在胃运动,以及大鼠子宫平滑机均表现抑制,并能拮抗催产素所引起的收缩;用醋酸注射于小鼠腹腔,以扭体反应作为疼痛的指标,芍药甙有显著的镇痛效果;芍药的浸膏能拮抗士的宁所引起的惊厥;白芍煎剂在试管内对志贺氏痢疾杆菌有抑菌作用,浸剂对某些致病性真菌亦有抑制作用。芍药甙对小白鼠正常体温有降温作用,对人工发热的小鼠也有解热作用。对大鼠实验性后足跖浮肿有抗炎作用;芍药甙在试管内或静脉注射时对二磷酸腺苷诱导的大鼠血小板聚集有抑制作用;芍药甙对由于紧张剌激而诱发的大鼠消化道溃疡有明显的抑制作用。
干姜《神农本草经》列为中品,生姜《名医别录》列为中品。陶弘景谓:“凡作干姜法:水淹三日,去皮置流水中六日,更乱去皮,然后晒干,置瓷缸中酿三日,乃成。”李时珍谓干姜以母姜造之,以白净结实者为良,凡入药并宜泡用。干姜用于暖脾阳,偏治脾寒腹痛泄泻。又能回阳通脉,温肺化饮,用治亡阳证,四肢厥逆,脉微欲绝,以及寒饮咳喘,形寒背冷,痰多清稀等症。
本发明中药组合物在中药组分选择上以除积痹、散风寒、祛风湿、强筋骨为主要标准,本发明中药组合物组合后具有显著的抗炎、镇痛和活血化淤效果。本发明对上述诸味中药的重量份数进行了优选,优选的条件是中西药配伍使用后药物对急性肾炎治疗效果的增强。作为本发明的一个优选实施例,本发明中药组合物主要由以下重量份的原料制得:连翘30份,栀子15份,蝉蜕15份,罗星草10份,重楼8份,百合10份,夏枯草10份,泽泻6份,枸杞10份,蛇床子12份,川芎12份,白芷10份,白茅根5.5份,白芍10份,干姜8份,甘草12份。
优选地,本发明的中药组合物还进一步含有升麻5份,决明子9份。升麻为毛茛科植物大三叶升麻、兴安升麻或升麻的干燥根茎。别名:周升麻、鸡骨升麻、鬼脸升麻、莽牛卡架、龙眼根、窟窿牙根。有清热解毒;发表透疹;升阳举陷的功效。幼叶同样可作凉拌菜,炒菜或主食菜馅。具有解毒、利咽、消肿的功效。治胃炎、牙痛、咽喉肿痛、口舌生疮等。决明子为豆科植物决明和小决明的成熟种子。有清肝益肾,明目,利水通便的功效。主治目赤肿痛,羞明泪多、青盲、雀目、头痛头晕、视物昏暗、肝硬化腹水、小便不利,习惯性便秘。外治肿毒、癣疾。对风热赤眼、高血压、肝炎、肝硬腹水习惯性便秘等有疗效。决明子用于目赤肿痛、羞明多泪、青盲内障等症。目赤肿痛,羞明多泪等症,系肝火上扰,或风热上壅头目所致。决明子既能清泄肝胆郁火,又能疏散风热,为治目赤肿痛要药。风热者,常与蝉衣、菊花等同用;肝火者,常配龙胆草、黄芩、夏枯草等同用。青盲内障,多由肝肾不足所引起。决明子清肝而明目,常与补养肝肾药如沙苑蒺藜、女贞子、枸杞子、生地等同用,以治青盲内障。决明子苦寒入肝,既能清泻肝火,又兼能平抑肝阳,故可用治肝阳上亢之头痛、眩晕,常配菊花、钩藤、夏枯草等药用。决明子性味甘咸寒,兼入大肠经而能清热润肠通便,用于内热肠燥,大便秘结,可与火麻仁、瓜蒌仁等同用。
为了更好地表达本发明的中药组合物,本发明的中药组合物可以制备成临床上常用的剂型。比如,粉状制剂、散剂、丸剂、丹剂、膏剂、颗粒剂、口服液、糖浆、片剂、胶囊剂等制剂。优选地,本发明中药组合物按照常规制备工艺制备成散剂、水剂、片剂或胶囊剂。
本发明还提供了一种上述所述中药组合物的制备方法,其主要包含下述步骤:取处方量上述中药材碎成粗粉,按照粗粉总重量的4-9倍加入体积浓度为40%-95%的乙醇溶液,回流提取三次,回流时间为2-5h,滤过,滤液回收乙醇,冷却过滤,用水洗涤,干燥后即得中药浸膏;本领域技术人员可在该制备方法技术上制备得到临床上常用中药药物剂型,如片剂、胶囊剂等。
本发明还请求保护上述中药组合物在制备治疗急性肾炎药物中的用途。本发明药物组合物在治疗急性肾炎时,显示出显著的抗炎镇痛、活血化淤活性。本发明药效实施例19显示,与模型组比较,本发明中药组合物低中高三个剂量组均可以显著降低二甲苯所致小鼠的耳肿胀值(P<0.01),表明本发明中药组合物具有显著抑制二甲苯诱导的小鼠耳肿胀的作用,且其对耳肿胀的降低效果存在显著的量效关系。同样实验条件下,阳性对照药肾炎安胶囊组也显著降低耳肿胀值(P<0.05),但其抗炎效果明显不及本发明中药组合物。本发明药效实施例20显示,小鼠舔足反应潜伏期时间显示,与模型组比较,给药后1h和2h后,本发明中药组合物各个给药组的小鼠添足反应的潜伏期均大于模型组,存在剂量依赖关系,并且高剂量组的潜伏期显著大于模型组(P<0.05)。说明该本发明中药组合物能够延长小鼠对热板刺激的添足反应潜伏期,有一定的镇痛作用。同样实验条件下,阳性对照药利福昔明胶囊组(P<0.05)和肾炎安胶囊组(1h,P<0.05;2h,P<0.01)也显著延长了小鼠添足反应的潜伏期,都有一定的镇痛作用。本发明药效实施例21显示,模型组与正常对照比较,全血低切指数、红细胞聚集指数、卡松粘度和血浆粘度均有显著增高(P<0.05)。与模型组比较,本发明中药组合物低、中、高各个剂量组均显著或极显著地降低了全血低切指数、红细胞聚集指数、卡松粘度和血浆粘度,降低幅度存在量效关系,其中高剂量有显著差异(P<0.05)。同样实验条件下,阳性对照药利福昔明胶囊组也降低了全血高切指数、全血低切指数、红细胞聚集指数,但其对血液流变学指数的改善效果均不及本发明中药组合物。肝脏指数的结果统计显示,模型组与正常对照比较,肝脏指数显著增高。而与模型组比较,本发明中药组合物低、中、高各个剂量组显著降低了肝脏指数(P<0.01),阳性对照药利福昔明胶囊和本发明中药组合物本发明中药组合物高剂量组能够显著的降低肝脏指数(P<0.05),但效果不及本发明中药组合物。实施例22结果显示,本发明中药组合物对大多数的肠道致病菌均具有很好的抑菌效果,这表明本发明中药组合物对于多种细菌或真菌引发的急性肾炎均具有显著的治疗效果,能够对感染性急性肾炎起到标本兼治的作用。且更难能可贵的是,本发明中药组合物中含有多种有效成分,用于急性肾炎感染治疗时靶点多,不易产生耐药性,显著优于现有临床中广泛使用的抗生素类药物。
总之,本发明药物组合物在治疗急性肾炎方面,与现有技术相比具有如下优势:
1)与阳性对照药利福昔明胶囊或肾炎安胶囊相比,本发明药物组合物中药物成分不仅在抗炎和镇痛方面更为显著,而且在活血化淤方面也显著优于阳性药物,这表明本发明组合物在急性肾炎治疗中具有显著的协同作用,不仅能够显著改善急性肾炎的症状,还能延缓急性肾炎的发展,有助于急性肾炎患者的痊愈过程;
2)与当前治疗急性肾炎的化学治疗药物相比,本发明中药组合物为天然纯中药制剂,不良反应和副作用显著降低,特别是其对于肠道黏膜不产生任何破坏作用,且本发明中药组合物作用全面,药物治疗效果更佳,显著提高了急性肾炎患者的用药依从性,并提高了患者的生活质量;
3)现有的抗生素药物在急性肾炎初期治疗效果尚可,但随着治疗时间的延长均出现明显的药物耐受问题,其对于急性肾炎的治疗效果下降;本发明中药组合物中含有多种药物组分,作用靶点众多,有效地解决了急性肾炎治疗药物的耐受问题,其对急性肾炎的治疗效果不因治疗时间延长而下降。
具体实施方式
以下通过具体实施例进一步描述本发明,本发明不仅仅限于以下实施例。在本发明的范围内或者在不脱离本发明的内容、精神和范围内,对本发明进行的变更、组合或替换,对于本领域的技术人员来说是显而易见的,均包含在本发明的范围之内。
第一部分本发明中药组合物制剂的制备及其使用方法
实施例1-6中药组合物散剂
表1本发明中药组合物散剂处方
实施例1制备方法:取组合物中各药材,按照常规工艺研磨成粉状,过100目筛,小火烘干备用。使用时,用水溶解后直接冲服。实施例2-6制备方法同实施例1。
实施例7-12中药组合物水剂
表2本发明中药组合物水剂处方
实施例7制备方法:取处方中各药材,按照常规中药煎煮工艺操作,滤除药渣即得。该水剂(或称汤剂)用于急性肾炎治疗时,每日服用2-3次。实施例8-12制备方法和使用方法同实施例7。
实施例13-18本发明中药组合物片剂/胶囊剂
表3本发明中药组合物片剂/胶囊剂处方
实施例13制备工艺:取处方量的各中药材粉碎成粗粉,按照粗粉总重量的5倍加入体积浓度为80%的乙醇溶液,回流提取三次,回流时间每次3h,滤过,滤液回收乙醇,冷却过滤,用水洗涤,干燥后即得中药浸膏;将中药浸膏经干燥、粉碎制成干膏粉,再加入常规辅料成分利用现有技术制备成片剂或胶囊剂。实施例14-18制备工艺同实施例13。
第二部分本发明中药组合物药效学研究
实施例19本发明中药组合物对二甲苯致小鼠耳肿胀的影响
取健康ICR小鼠72只,♀♂各半,分6组,12只/组,即模型组、利福昔明胶囊(海南三叶制药厂有限公司,下同)、肾炎安胶囊组(广西梧州制药有限公司)、本发明中药组合物(按实施例1所述中药组合物处方和制备工艺制得)低剂量组、中剂量组和高剂量组。每只ig给药1次/d;给药14d,末次药后60min,在小鼠右耳均匀涂抹二甲苯0.03mL/只致肿,2h后剪下双耳打耳片称重,计算耳肿胀值(mg)。肿胀值=右耳重量-左耳重量。
结果显示,与模型组比较,本发明中药组合物低中高三个剂量组均可以显著降低二甲苯所致小鼠的耳肿胀值(P<0.01),表明本发明中药组合物具有显著抑制二甲苯诱导的小鼠耳肿胀的作用,且其对耳肿胀的降低效果存在显著的量效关系。同样实验条件下,阳性对照药肾炎安胶囊组也显著降低耳肿胀值(P<0.05),但其抗炎效果明显不及本发明中药组合物。
表4本发明中药组合物对二甲苯所致小鼠耳肿胀的影响(
)
注:与模型组比较,*P<0.05,**P<0.01。
实施例20本发明中药组合物对小鼠热板镇痛的影响
1小鼠热板疼痛模型制作
将体重20g左右雌性小鼠放在热板测痛仪上,筛选合格♀性小鼠90只(舔后足时间<5s或>30s弃置,为防止足部烫伤,也应设截止时间,一般为60s),以小鼠添后足反应的潜伏期为痛阈指标,取72只雌性动物,分为6组,12只/组,即模型组、利福昔明胶囊、肾炎安胶囊组、本发明中药组合物(按实施例1所述中药组合物处方和制备工艺制得)低剂量组、中剂量组和高剂量组。各组均为灌胃给药,1次/天,连续给药14d后,测定末次药后60min、120min发生添足反应的时间。
本发明中药组合物对小鼠热板镇痛实验中舔足反应潜伏期的影响
小鼠舔足反应潜伏期时间显示,与模型组比较,给药后1h和2h后,本发明中药组合物各个给药组的小鼠添足反应的潜伏期均大于模型组,存在剂量依赖关系,并且高剂量组的潜伏期显著大于模型组(P<0.05)。说明该本发明中药组合物能够延长小鼠对热板刺激的添足反应潜伏期,有一定的镇痛作用。同样实验条件下,阳性对照药利福昔明胶囊组(P<0.05)和肾炎安胶囊组(1h,P<0.05;2h,P<0.01)也显著延长了小鼠添足反应的潜伏期,都有一定的镇痛作用。结果见表5。
表5小鼠舔足反应潜伏期时间表(
)
注:与模型组比较,*P<0.05,**P<0.01。
实施例21本发明中药组合物对大鼠血瘀模型的改善作用
取健康SD大鼠,体重180-200g,70只,雌雄各半,按体重随机分为7组:正常对照组、模型组、利福昔明胶囊组、肾炎安胶囊组、以及本发明中药组合物(按实施例1所述中药组合物处方和制备工艺制得)低、中、高组,每组10只。灌胃给药,连续给药14天,正常对照组和模型组给0.5%CMC,其余给对应的药物,给药剂量如表7。
给药第13天、14天,除正常对照组外,其余组动物按1mg/kg皮下注射盐酸肾上腺素,2次/天,间隔4h,第一次注射后2h将动物放进4℃冰水中15min。给药第15天取4-5ml血肝素抗凝测定血液流变学参数,取肝脏称重折算脏器系数。
结果显示,模型组与正常对照比较,全血低切指数、红细胞聚集指数、卡松粘度和血浆粘度均有显著增高(P<0.05)。与模型组比较,本发明中药组合物低、中、高各个剂量组均显著或极显著地降低了全血低切指数、红细胞聚集指数、卡松粘度和血浆粘度,降低幅度存在量效关系,其中高剂量有显著差异(P<0.05)。同样实验条件下,阳性对照药利福昔明胶囊组和肾炎安胶囊组也降低了全血高切指数、全血低切指数、红细胞聚集指数,但其对血液流变学指数的改善效果均不及本发明中药组合物。肝脏指数的结果统计显示,模型组与正常对照比较,肝脏指数显著增高。而与模型组比较,本发明中药组合物低、中、高各个剂量组显著降低了肝脏指数(P<0.01),阳性对照药利福昔明胶囊和本发明中药组合物本发明中药组合物高剂量组能够显著的降低肝脏指数(P<0.05),但效果不及本发明中药组合物。
表6本发明中药组合物对大鼠血瘀模型血流变的影响(
)
注:与正常对照比较,#P<0.05,##P<0.01;与模型组比较,*P<0.05,**P<0.01。
表7本发明中药组合物对大鼠血瘀模型肝脏系数的影响(
)
注:与正常对照比较,##P<0.01;与模型组比较,*P<0.05,**P<0.01。
实施例22本发明中药组合物对常见肠道致病细菌的体外抑菌实验
1实验材料及方法
本实验所使用的菌种及培养基分别为白色念珠菌、痢疾杆菌、大肠埃希氏菌、普通变形杆菌、沙门氏菌、痢疾志贺氏菌、金黄色葡萄球菌、耐甲氧金黄色葡萄球菌、以及空肠弯曲菌、肠梭菌,营养琼脂培养基(中国药品生物制品检定所);比浊管(中国细菌浊度标准,中国药品生物制晶检定所)。
体外抑菌实验:①制备含药琼脂平板;将受试物按倍比稀释配制不同药物浓度的培养基,加热,调制各自所需pH值,121℃灭菌30min,冷至45℃;倾注成无菌平板(平皿d=65mm,10ml/平皿),最终使培养基中含受试物原液(2g/ml)的稀释倍数分别为l:2,1:4……1:1024;同时做各自的空白对照培养基;②接种;取传至第三代的幼龄菌,分别用0.9%氯化钠溶液按标准比浊管校正浓度为108cfu/ml的待检菌液,分别接种于不同倍比稀释的各自含药琼脂表面,同时接种平行点3点,使每点含2一菌液。每一接种点的液滴直径为5-8mm;待接种点干燥后,翻转平板于36℃恒温培养箱培养20h观察结果(同时做空白对照);③判定标准;以不出现菌落的琼脂平板上的最低稀释受试物浓度为其最低抑菌浓度(MIC);本实验中中药组合物对各致病菌株的最小抑菌浓度如表8所示。
实验结果及分析
表8中药组合物对常见致病菌住的最小抑菌浓度测定结果
结果显示,本发明中药组合物对大多数的肠道致病菌均具有很好的抑菌效果,这表明本发明中药组合物对于多种细菌或真菌引发的急性肾炎均具有显著的治疗效果,能够对感染性急性肾炎起到标本兼治的作用。且更难能可贵的是,本发明中药组合物中含有多种有效成分,用于急性肾炎感染治疗时靶点多,不易产生耐药性,显著优于现有临床中广泛使用的抗生素类药物。
实施例23本发明中药组合物治疗急性肾炎的临床资料:
病例选择:选择2011年3月至2013年6月急性肾炎患者200例,其中男性95例,女性105例;年龄15-73岁,平均(34±8)岁;均有腹痛、发热,腹痛位于右上腹部或剑突下并伴有恶心、呕吐者184例,体温37.5-38.9℃者142例;出现黄疸者115例,中性白细胞升高者168例。按随机数字表法分为治疗组与对照组各100例。两组患者性别、年龄、症状等差异无显著性(P>0.05),具有可比性。
1、病例选择选择我院或外院确诊的急性肾炎患者200例临床观察,病人随机分成两组。治疗组100例,其中儿童58例,年龄在3-8岁,成人42例,年龄在27-55岁。对照组100例,儿童55例,年龄在4-7岁,成人45例,年龄在31-58岁。两组资历基本一致,无显著差异,具有可比性。
2、治疗过程治疗组患者服用本发明药物,治疗组每日3次,成人每次3片,儿童每次1片,症状严重者,每日3次,每次4片,7天为一个疗程,3-6个月内完全恢复。对照组根据诊断出的急性肾炎,分别予以肌注青酶素或其他有效抗生素,严重者静注速尿和安定,静滴硝普钠、酚妥拉明等治疗手段,10天为一个疗程,5-12个月内才逐渐消失,少数病例1-2年后逐渐康复。
疗效判断标准:①临床治愈:水肿、尿少、血尿、高血压等症状全消失,实验室检查各项指标均正常;②显效:水肿、尿少、血尿、高血压等症状显著减轻,各项实验室正常或仅一项稍高于正常值;③有效:水肿、尿少、血尿、高血压等症状改善,血清尿素氮、肌酐清除率稳定,尿常规在正常范围值;④无效:症状、体征未见明显改善,甚至恶化或转手术治疗。
表9本发明中药组合物对于肾炎的治疗效果
表10急性肾炎患者治疗前后的白细胞数目
Claims (2)
1.一种中药组合物在制备治疗急性肾炎的药物中的应用,其特征在于所述中药组合物由以下重量份的原料制得:连翘30份,栀子15份,蝉蜕15份,罗星草10份,重楼8份,百合10份,夏枯草10份,泽泻6份,枸杞10份,蛇床子12份,川芎12份,白芷10份,白茅根5.5份,白芍10份,干姜8份,甘草12份,升麻5份,决明子9份。
2.如权利要求1所述的中药组合物在制备治疗急性肾炎的药物中的应用,其特征在于:所述中药组合物为散剂、水剂、片剂或胶囊剂。
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