CN106039062A - 一种治疗慢性痛风性关节炎的中药及其制备方法 - Google Patents
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Abstract
本发明提供了一种治疗慢性痛风性关节炎的中药及其制备方法,中药中包括以下原料药材:灵寿茨、李根皮、绿豆皮、金发草、铁苋、女儿茶、蛇见怕、花椒簕、罗伞树、和合草、山合香、长瓦韦、石芥菜、黄桷叶和七角风。本发明的有益效果:本发明的中药联合常规西药治疗慢性痛风性关节炎,治疗效果更好,无毒副作用,能够减少或消除西药引起的不良反应,制备工艺简单。
Description
技术领域
本发明涉及中医药工程技术领域,尤其涉及一种治疗慢性痛风性关节炎的中药及其制备方法。
背景技术
痛风性关节炎是由于尿酸盐沉积在关节囊、滑囊、软骨、骨质和其他组织中而引起病损及炎性反应,它多有遗传因素和家族因素,好发于40岁以上的男性,多见于拇趾的跖趾关节,也可发生于其他较大关节,尤其是踝部与足部关节。主要表现为关节的剧痛,常常为单侧性突然发生。关节周围组织有明显肿胀、发热、发红和压痛。作血尿酸检查可以确诊。应用药物治疗有较好的疗效。
关于痛风性关节病的发病机理,许多学者普遍认为与多形核白血球有关,痛风时滑膜组织和关节软骨释放的尿酸钠晶体被关节液的白血球吞噬,白血球又破坏释放出蛋白酶和炎性因子进入滑液,酶炎性因子使关节中的白血球增多,于是有更多的吞噬了尿酸盐结晶的白血球相继破裂释放出酶和炎性成分,形成恶性循环进一步导致急性滑膜炎和关节软骨破坏,尿酸在组织中的浓度很低,特别是体液pH值低时,当血尿酸浓度超过80mg/L时,即有尿酸盐沉积,常见部位为关节囊,软骨和骨端骨松质,亦可见于肾脏及皮下结缔组织,局部积聚过多,则形成痛风石。
典型的首次发作的痛风性关节炎多为单关节炎,以第一跖趾及拇趾关节为多见,其次为踝,膝,肘,腕,手及足部其他关节,急性期多起急骤,常在夜间突发,可因疼痛而醒并且彻夜不能入睡,病情反复发作,则可发展为多关节炎,或游走性关节炎,受累关节红,肿,热,痛,活动受限,大关节受累时常有渗液,可伴有发热,寒战,疲倦,厌食,头痛等症状,一般历时1-2周症状缓解,局部皮肤红肿转为棕红色而逐渐恢复正常,有时可出现脱屑和瘙痒,慢性期尿酸钠在关节内沉着逐渐增多,发作逐渐频繁,间歇期缩短,受累关节增多,疼痛加剧,炎症不能完全消退,出现痛风石,痛风石以关节和肾脏较多见,外耳的耳轮,跖趾,指间和掌指关节等处也会出现痛风石,随着风石的不断沉积增多,导致关节肥大,畸形,僵硬,活动受限。
发病开始可累及包括第一跖趾关节在内的2个或3个关节,第一跖趾关节病变约占痛风病人的50%,为本病多发关节,踝,跗,膝,肘和腕关节也可见到,近年来由于抗癌治疗的开展,继发性痛风有增加趋势,原发性痛风掌发现于40岁以上男性,女性较少且多为绝经期妇女,通常分为4期:(一)无症状期:时间较长,仅血尿酸增高,约1/3病人以后有关节症状。(二)急性关节炎期:多在夜间突然发病,受累关节剧痛,首发关节常累及拇趾关节,其次为踝,膝等,关节红,肿,热和压痛,全身无力,发热,头痛等,可持续3~11天,饮酒,暴食,过劳着凉,手术刺激,精神紧张均可成为发作诱因。(三)间歇期:为数月或数年,随病情反复发作间期变短,病期延长,病变关节增多,渐转成慢性关节炎。(四)慢性关节炎期:关节出现僵硬畸形,运动受限,30%左右病人可见痛风石和发生肾脏合并症以及输尿管结石等,晚期有高血压,肾脑动脉硬化,心脏梗塞,少数病人死于肾功能衰竭和心血管意外,继发性痛风病程相似,继发于血液病,糖原储存病的间歇期较短,血尿酸检查增高,最高达20mg%(正常:男7mg%,女6mg%),偏光显微镜发现关节滑液中吞噬了尿酸盐结晶的白血球,急性期时白血球增高,血沉加快,X线检查显示关节软骨下骨的穿凿样破坏以及局部的骨质疏松,腐蚀或皮质断裂,关节间隙狭窄和边缘性骨质增生,痛风结石可为钙化阴影。本病的间歇期可持续数月或数年,但随着病情加重,间歇期可越来越短,可在耳轮,耳垂,关节皮下出现玉米粒大的痛风石,可因酗酒,暴食,过劳或精神紧张而诱发,部分患者可转为慢性,严重者关节因破坏而强直。
发明内容
本发明所要解决的技术问题在于,利用我国传统的中医理论,提供一种疗效确切且无毒性作用的治疗慢性痛风性关节炎的中药及其制备方法。
为了解决上述技术问题,本发明提供了一种治疗慢性痛风性关节炎的中药,所述中药包括以下原料药材:灵寿茨、李根皮、绿豆皮、金发草、铁苋、女儿茶、蛇见怕、花椒簕、罗伞树、和合草、山合香、长瓦韦、石芥菜、黄桷叶和七角风。
所述中药中的各种原料药材的重量份数比可以优选为:灵寿茨10~20份、李根皮25~35份、绿豆皮15~25份、金发草5~15份、铁苋20~30份、女儿茶10~20份、蛇见怕5~15份、花椒簕20~30份、罗伞树10~20份、和合草15~25份、山合香20~30份、长瓦韦25~35份、石芥菜10~20份、黄桷叶25~35份和七角风10~20份。
所述中药中的各种原料药材的重量份数比还可以进一步优选为:灵寿茨12~17份、李根皮27~32份、绿豆皮18~23份、金发草8~13份、铁苋22~27份、女儿茶13~18份、蛇见怕9~14份、花椒簕23~28份、罗伞树13~18份、和合草17~22份、山合香25~30份、长瓦韦28~33份、石芥菜15~20份、黄桷叶28~33份和七角风15~20份。
所述中药中的各种原料药材的重量份数比也可以进一步优选为:灵寿茨16份、李根皮28份、绿豆皮22份、金发草9份、铁苋26份、女儿茶14份、蛇见怕13份、花椒簕24份、罗伞树17份、和合草18份、山合香28份、长瓦韦29份、石芥菜20份、黄桷叶30份和七角风20份。
所述中药中的各种原料药材的重量份数比也可以进一步优选为:灵寿茨12份、李根皮31份、绿豆皮19份、金发草12份、铁苋23份、女儿茶17份、蛇见怕10份、花椒簕28份、罗伞树14份、和合草20份、山合香26份、长瓦韦32份、石芥菜16份、黄桷叶32份和七角风16份。
当所述中药的剂型为口服液剂时,其制备方法包括以下步骤:
第一步,将灵寿茨、李根皮、绿豆皮、金发草、铁苋、女儿茶和蛇见怕按比例混合,加相对于混合物3倍~5倍量醇浓度为55%~65%的乙醇回流提取2次~4次,每次2小时~3小时,过滤,滤液合并,回收乙醇,浓缩至70℃相对密度为1.30~1.32的膏体,备用;
第二步,将剩余原料药材按比例混合,加相对于混合物3~5倍量水,煮沸2~4小时,过滤,浓缩至70℃相对密度为1.27~1.29的膏体;
第三步,将第一步、第二步获得的所述膏体混合,55℃~65℃减压真空干燥,得干膏粉;
第四步,将第三步获得的所述干膏粉中加入乙醇,得到含醇膏体,所述含醇膏体的含醇量为65%~70%;将所述含醇膏体依次进行冷藏处理、沉淀处理、过滤处理、回收乙醇处理,得到脱醇膏体,其中,冷藏处理时间为30~40小时,冷藏温度为2℃~6℃;
第五步,将所述脱醇膏体中加入蔗糖粉、活性炭,依次进行加热处理、过滤处理、稀释处理,得到半成品;所述脱醇膏体与所述蔗糖粉的重量比为1∶0.1~0.3;所述脱醇膏体与所述活性炭的重量比为1∶0.001~0.002;所述加热处理的时间为20~40分钟,温度为100℃~110℃;
第六步,再将第五步获得的所述半成品依次进行过滤处理、灌封处理、灭菌处理,即得所述中药制剂口服液成品。
当所述中药的剂型为片剂时,其制备方法包括以下步骤:
第一步,将灵寿茨、李根皮、绿豆皮、金发草、铁苋、女儿茶、蛇见怕和花椒簕混合,加相对于混合物3倍~5倍量醇浓度为55%~65%的乙醇回流提取2次~4次,每次2小时~3小时,过滤,滤液合并,回收乙醇,浓缩至70℃相对密度为1.30~1.32的膏体,备用;
第二步,将剩余原料药材按比例混合,加相对于混合物3~5倍量水,煮沸2~4小时,过滤,浓缩至70℃相对密度为1.27~1.29的膏体;
第三步,将第一步、第二步获得的膏体混合,55℃~65℃减压真空干燥,得干膏粉;
第四步,将所述的干膏粉与淀粉进行混匀处理,得到膏体混合物;所述的膏体和淀粉的重量比为1∶0.01~0.02;将所述膏体混合物进行制粒处理、干燥处理,得到的膏体混合物颗粒;
第五步,将所述的膏体混合物颗粒与滑石粉、硬脂酸镁依次进行混匀处理、压片处理、包衣处理,即得中药制剂片剂成品;所述的颗粒、滑石粉、硬脂酸镁的重量比为100∶1~3∶0.15~0.3。
本发明的有益效果:本发明的中药联合常规西药治疗慢性痛风性关节炎,治疗效果更好,无毒副作用,能够减少或消除西药引起的不良反应,制备工艺简单。
具体实施方式
本发明提供了一种治疗慢性痛风性关节炎的中药,中药中包括以下原料药材:灵寿茨、李根皮、绿豆皮、金发草、铁苋、女儿茶、蛇见怕、花椒簕、罗伞树、和合草、山合香、长瓦韦、石芥菜、黄桷叶和七角风。
各种原料药材的药理如下:
灵寿茨:【别名】降龙木、黑果木、龙须木。【来源】药材基源:为清风藤科植物泡花树和笔罗子的根皮。【性味】甘;微辛;平。【归经】心;脾;胃经。【功能主治】利水解毒。主水肿;臌胀;无名肿毒;毒蛇咬伤。【摘录】《中华本草》
李根皮:【别名】甘李根白皮、李根白皮。【来源】药材基源:为蔷薇科植物李的根皮。【性味】苦;咸;寒;无毒。【归经】肝;脾;心经。【功能主治】降逆,燥湿,清热解毒。主气逆奔豚,湿热痢疾,赤白带下,消渴,脚气,丹毒疮痈。【摘录】《中华本草》
绿豆皮:【别名】绿豆壳、绿豆衣。【来源】药材基源:为豆科植物绿豆的种皮。【性味】味甘;性寒。【归经】肺;肝经。【功能主治】清暑止渴;利尿解毒;退目翳。主暑热烦渴;泄泻;痢疾;水肿;丹毒;目翳。【摘录】《中华本草》
金发草:【别名】竹蒿草、笔须、龙奶草、羊丕草。【来源】药材基源:为禾本科植物金发草的全草。【性味】甘;凉。【功能主治】清热;利湿;消积。主热病烦渴;黄疸型肝炎;脾肿大;糖尿病;消化不良;小儿疳积。【摘录】《中华本草》
铁苋:【别名】人苋、海蚌含珠、撮斗撮金珠、六合草、半边珠、野黄麻、血见愁、小耳朵草、玉碗捧真珠、粪斗草、凤眼草、肉草、喷水草、痢疾草、野麻草、蚌壳草、铁灯碗、七盏灯、血布袋、布袋口、皮撮珍珠、田螺草、野苦麻、猫眼菜、寒热草、叶里仙桃、金畚斗、金盘野苋菜、沙罐草、灯盏窝、金石榴、茶丝黄、水芥、下合草、瓦片草。【来源】药材基源:为大戟科植物铁苋菜及短穗铁苋菜的全草。【性味】苦;涩;凉。【归经】心;肺;大肠;小肠经。【功能主治】清热利湿;凉血解毒;消积。主痢疾;泄泻;吐血;衄血;尿血;崩漏;小儿疳积;痈疖疮疡;皮肤湿疹。【摘录】《中华本草》
女儿茶:【别名】岩果紫(《贵州民间药物》),黄茶根、女儿红(《四川常用中草药》)。【来源】为鼠李科植物崖枣树的根或枝叶。4~5月采嫩枝叶;秋冬采根。【性味】《贵州民间药物》:"性凉,味涩微苦,无毒"。【功能主治】清热,凉血,止血。治吐血,痔血,崩漏,月经不调,痢疾。【摘录】《中药大辞典》
蛇见怕:【别名】细样倒扣草、镜面草、拔子弹草、小马鞭草[广西]。【来源】苋科杯苋属植物杯苋,以根或全草入药。四季可采,鲜用或晒干。【性味】苦、甘,平。【功能主治】根:清热解毒。用于细菌性痢疾。全草:消积除痰,消肿止痛。用于小儿疳积,肝脾肿大,肺结核,蛇咬伤,跌打损伤,疮疡肿毒。【摘录】《全国中草药汇编》
花椒簕:【别名】通墙虎、山花椒、见血飞、乌口簕藤、花椒藤。【来源】药材基源:为芸香科植物花椒簕的茎叶或根。【性味】辛;温。【归经】肝经。【功能主治】活血;散瘀;止痛。主脘腹瘀滞疼痛;跌打损伤。【摘录】《中华本草》
罗伞树:【别名】铁罗伞、筷子根、高脚凉伞、火屎炭树、火泡树、鸡眼树、火炭树。【来源】药材基源:为紫金牛科植物罗伞树的茎叶或根。【性味】苦;辛;性凉。【功能主治】清热解毒;散瘀止痛。主咽喉肿痛;疮疖痈肿;跌打损伤;风湿痹痛。【摘录】《中华本草》
和合草:【别名】合情草、合掌草、合叶草、土蛇床、午时合、对叶接骨草。【来源】药材基源:为远志科植物排钱金不换的全草。【性味】苦;微辛;凉。【功能主治】清热解毒;散瘀止血。主感冒发热;咽喉肿痛;痈肿疮疡;跌打损伤;骨折;外伤出血。【摘录】《中华本草》
山合香:【来源】药材基源:为唇形科植物粉红动蕊花的全草。【性味】味辛;苦;性凉。【功能主治】清热明目;散风通络;祛湿解毒。主目赤肿痛;风湿热痹;劳伤;疮肿;湿疹;癣痒。【摘录】《中华本草》
长瓦韦:【别名】扎柏。【来源】药材基源:为水龙骨科植物长瓦韦的全草。【性味】微甘;微苦;微寒。【归经】肝;心;肺经。【功能主治】清热利湿;止咳;止血。主小便淋痛;尿血;痢疾;痨热咳嗽;内伤吐血;外伤出血。【摘录】《中华本草》
石芥菜:【别名】龙骨七、石格菜。【来源】药材基源:为十字花科植物紫花碎米荠的全草。【性味】苦;平。【功能主治】散瘀通络;祛湿;止血。主跌打损伤;风湿痹痛;黄水疮;外伤出血。【摘录】《中华本草》
黄桷叶:【别名】大榕叶。【来源】药材基源:为桑科植物黄葛树的叶。【性味】涩;性平。【功能主治】祛风通络;止痒敛疮;活血消肿。主筋骨疼痛;迎风流泪;皮肤病痒;赚疮;跌打损伤;骨折。【摘录】《中华本草》
七角风:【别名】接骨丹、五爪金、七叶莲、七叶风。【来源】药材基源:为五加科植物短梗大参的根和叶。【性味】味甘;性平。【功能主治】祛风除显;化瘀通络;健脾。主风湿痹痛;跌打伤肿;骨折;小儿疳积。【摘录】《中华本草》
所述中药中的各种原料药材的重量份数比可以优选为:灵寿茨10~20份、李根皮25~35份、绿豆皮15~25份、金发草5~15份、铁苋20~30份、女儿茶10~20份、蛇见怕5~15份、花椒簕20~30份、罗伞树10~20份、和合草15~25份、山合香20~30份、长瓦韦25~35份、石芥菜10~20份、黄桷叶25~35份和七角风10~20份。
所述中药中的各种原料药材的重量份数比还可以进一步优选为:灵寿茨12~17份、李根皮27~32份、绿豆皮18~23份、金发草8~13份、铁苋22~27份、女儿茶13~18份、蛇见怕9~14份、花椒簕23~28份、罗伞树13~18份、和合草17~22份、山合香25~30份、长瓦韦28~33份、石芥菜15~20份、黄桷叶28~33份和七角风15~20份。
所述中药中的各种原料药材的重量份数比也可以进一步优选为:灵寿茨16份、李根皮28份、绿豆皮22份、金发草9份、铁苋26份、女儿茶14份、蛇见怕13份、花椒簕24份、罗伞树17份、和合草18份、山合香28份、长瓦韦29份、石芥菜20份、黄桷叶30份和七角风20份。
所述中药中的各种原料药材的重量份数比也可以进一步优选为:灵寿茨12份、李根皮31份、绿豆皮19份、金发草12份、铁苋23份、女儿茶17份、蛇见怕10份、花椒簕28份、罗伞树14份、和合草20份、山合香26份、长瓦韦32份、石芥菜16份、黄桷叶32份和七角风16份。
所述中药的剂型为口服液剂时,其制备方法包括以下步骤:
第一步,将灵寿茨、李根皮、绿豆皮、金发草、铁苋、女儿茶和蛇见怕按比例混合,加相对于混合物3倍~5倍量醇浓度为55%~65%的乙醇回流提取2次~4次,每次2小时~3小时,过滤,滤液合并,回收乙醇,浓缩至70℃相对密度为1.30~1.32的膏体,备用;
第二步,将剩余原料药材按比例混合,加相对于混合物3~5倍量水,煮沸2~4小时,过滤,浓缩至70℃相对密度为1.27~1.29的膏体;
第三步,将第一步、第二步获得的所述膏体混合,55℃~65℃减压真空干燥,得干膏粉;
第四步,将第三步获得的所述干膏粉中加入乙醇,得到含醇膏体,所述含醇膏体的含醇量为65%~70%;将所述含醇膏体依次进行冷藏处理、沉淀处理、过滤处理、回收乙醇处理,得到脱醇膏体,其中,冷藏处理时间为30~40小时,冷藏温度为2℃~6℃;
第五步,将所述脱醇膏体中加入蔗糖粉、活性炭,依次进行加热处理、过滤处理、稀释处理,得到半成品;所述脱醇膏体与所述蔗糖粉的重量比为1∶0.1~0.3;所述脱醇膏体与所述活性炭的重量比为1∶0.001~0.002;所述加热处理的时间为20~40分钟,温度为100℃~110℃;
第六步,再将第五步获得的所述半成品依次进行过滤处理、灌封处理、灭菌处理,即得所述中药制剂口服液成品。
当所述中药的剂型为片剂,其包括以下步骤:
第一步,将灵寿茨、李根皮、绿豆皮、金发草、铁苋、女儿茶、蛇见怕和花椒簕混合,加相对于混合物3倍~5倍量醇浓度为55%~65%的乙醇回流提取2次~4次,每次2小时~3小时,过滤,滤液合并,回收乙醇,浓缩至70℃相对密度为1.30~1.32的膏体,备用;
第二步,将剩余原料药材按比例混合,加相对于混合物3~5倍量水,煮沸2~4小时,过滤,浓缩至70℃相对密度为1.27~1.29的膏体;
第三步,将第一步、第二步获得的膏体混合,55℃~65℃减压真空干燥,得干膏粉;
第四步,将所述的干膏粉与淀粉进行混匀处理,得到膏体混合物;所述的膏体和淀粉的重量比为1∶0.01~0.02;将所述膏体混合物进行制粒处理、干燥处理,得到的膏体混合物颗粒;
第五步,将所述的膏体混合物颗粒与滑石粉、硬脂酸镁依次进行混匀处理、压片处理、包衣处理,即得中药制剂片剂成品;所述的颗粒、滑石粉、硬脂酸镁的重量比为100∶1~3∶0.15~0.3。
以下采用实施例来详细说明本发明的实施方式,借此对本发明如何应用技术手段来解决技术问题,并达成技术效果的实现过程能充分理解并据以实施。
实施例1:口服液剂
取灵寿茨120g、李根皮310g、绿豆皮190g、金发草120g、铁苋230g、女儿茶170g、蛇见怕100g、花椒簕280g、罗伞树140g、和合草200g、山合香260g、长瓦韦320g、石芥菜160g、黄桷叶320g和七角风160g。
其制备方法包括以下步骤:
第一步,将灵寿茨、李根皮、绿豆皮、金发草、铁苋、女儿茶和蛇见怕按比例混合,加相对于混合物4倍量醇浓度为55%的乙醇回流提取3次,每次3小时,过滤,滤液合并,回收乙醇,浓缩至70℃相对密度为1.31的膏体,备用;
第二步,将剩余原料药材按比例混合,加相对于混合物4倍量水,煮沸3小时,过滤,浓缩至70℃相对密度为1.28的膏体;
第三步,将第一步、第二步获得的所述膏体混合,60℃减压真空干燥,得干膏粉;
第四步,将第三步获得的所述干膏粉中加入乙醇,得到含醇膏体,所述含醇膏体的含醇量为70%;将所述含醇膏体依次进行冷藏处理、沉淀处理、过滤处理、回收乙醇处理,得到脱醇膏体,其中,冷藏处理时间为35小时,冷藏温度为5℃;
第五步,将所述脱醇膏体中加入蔗糖粉、活性炭,依次进行加热处理、过滤处理、稀释处理,得到半成品;所述脱醇膏体与所述蔗糖粉的重量比为1∶0.2;所述脱醇膏体与所述活性炭的重量比为1∶0.002;所述加热处理的时间为30分钟,温度为110℃;
第六步,再将第五步获得的所述半成品依次进行过滤处理、灌封处理、灭菌处理,即得所述中药制剂口服液成品。
实施例2:片剂
取灵寿茨160g、李根皮280g、绿豆皮220g、金发草90g、铁苋260g、女儿茶140g、蛇见怕130g、花椒簕240g、罗伞树170g、和合草180g、山合香280g、长瓦韦290g、石芥菜200g、黄桷叶300g和七角风200g。
其制备方法包括以下步骤:
第一步,将灵寿茨、李根皮、绿豆皮、金发草、铁苋、女儿茶、蛇见怕和花椒簕混合,加相对于混合物4倍量醇浓度为60%的乙醇回流提取3次,每次3小时,过滤,滤液合并,回收乙醇,浓缩至70℃相对密度为1.31的膏体,备用;
第二步,将剩余原料药材按比例混合,加相对于混合物4倍量水,煮沸3小时,过滤,浓缩至70℃相对密度为1.28的膏体;
第三步,将第一步、第二步获得的膏体混合,60℃减压真空干燥,得干膏粉;
第四步,将所述的干膏粉与淀粉进行混匀处理,得到膏体混合物;所述的膏体和淀粉的重量比为1∶0.01;将所述膏体混合物进行制粒处理、干燥处理,得到的膏体混合物颗粒;
第五步,将所述的膏体混合物颗粒与滑石粉、硬脂酸镁依次进行混匀处理、压片处理、包衣处理,即得中药制剂片剂成品;所述的颗粒、滑石粉、硬脂酸镁的重量比为100∶2∶0.2。
毒性实验:
急性毒性实验:应用小鼠60只,雌雄各半,体重24-38g,进行急性毒性试验。小鼠随机分为两组,即对照组和给药组,实验前禁食12小时,将本发明的实施例1制备的中药口服液剂溶解在水中,(浓度为8.69g生药/ml,最高浓度)灌胃,灌胃容积为5ml/kg(即单次给药剂量为43.45生药/kg),对照组给予等量生理盐水,一天给药2次,给药间隔时间6小时,给药后连续观察14天,并记录小鼠的的毒性反应及死亡数。实验结果表明:与对照组比较,给药后小鼠未见明显差异,实验连续观察14天,小鼠全身状况、饮食、饮水、体重增长均正常。小鼠口服灌胃本发明的口服液剂LD50>43.45生药/kg,每日最大给药量为86.9生药/kg/日。本发明的中药临床用药量为8.2g生药/日/人,成人体重以60KG计,平均用药剂量为0.137g生药/kg/日。按体重计:小鼠(平均体重以31g计)口服灌胃本发明的中药的耐受量为临床用量的634倍。因此本发明的中药急性毒性极低,临床用药安全。
长期毒性实验:本发明中药实施例1口服液剂对三组小鼠(每组20只)按13.25、25.43和42.37g生药/kg连续用药15周(1.0ml/100g体重,每天2次)及停药3周后,结果表明:本发明中药对小鼠的毛发、行为、大小便、体重、脏器重量、血象、肝肾功能、血糖、血脂等指标均无明显影响,脏器肉眼没有发现异样变化和组织学检查结果表明,用药15周及停药3周后,小鼠各脏器均无明显改变。说明本发明中药对小鼠长期用药后毒性小,停药后也没有异样反应,应用安全。
临床资料:
病例选择:所有100例病例均来源于本院的慢性痛风性关节炎患者,将患者随机分为两组,治疗组50例患者,对照组50例患者。治疗组50例患者中,男39例,女11例;年龄37~72岁;病程8个月~17年。对照组50例患者,男38例,女12例;年龄38~73岁;病程7个月~15年。治疗组与对照组在性别、年龄、病程和临床症状等各方面比较无明显差异,具有可比性。
诊断标准:1、关节滑液中有尿酸结晶或组织中有尿酸盐沉积。2、具备下列4项中至少2项:a、四肢关节肿痛发作至少2次(突然严重的发作,中间有1-2个星期的完全临床缓解期);b、明确的痛风足(典型的发作累及大脚趾);c、痛风石(痛风结节肿);d、对秋水仙碱治疗反应好,正规治疗48小时以内炎症明显减轻。
治疗方法:
对照组:嘱咐患者卧床休息;嘱咐患者低嘌呤、低脂、低糖、清淡饮食,控制或避免肉汤、动物内脏、海鲜及豆制品等高嘌呤食物,禁酒;血尿酸高时,口服别嘌醇片,每次100~200mg,每日3次;血尿酸降至正常后,别嘌醇片改为每次100mg,每日1~3次;疼痛剧烈时,暂停口服别嘌醇片,改为口服秋水仙碱片,每次0.5~1mg,2~3次,3~7天疼痛缓解后停用,继续口服别嘌醇片;4周为一个疗程。
治疗组:在对照组西医常规治疗基础上,同时口服本发明中药实施例1口服液剂,每次30ml,每天3次;4周为一个疗程。
疗效判断标准:(1)临床治愈:症状完全消失,关节功能恢复正常,血尿酸等主要理化检查指标正常。(2)显效:主要症状消失,关节功能基本恢复,血尿酸等主要理化检查指标基本正常。(3)有效:主要症状基本消失,主要关节功能及血尿酸等主要理化指标有所改善。(4)无效:与治疗前相比,各方面均无改善。
治疗结果:两组分别治疗4周后,统计结果参见表1。
表1两组分别治疗4周后临床疗效比较(单位:例)
组别 | 例数 | 临床治愈 | 显效 | 有效 | 无效 | 总有效率 |
治疗组 | 50 | 25 | 17 | 7 | 1 | 49(98%) |
对照组 | 50 | 14 | 18 | 10 | 8 | 42(84%) |
从表1可以看出,治疗组采用本发明的中药,配合西医治疗慢性痛风性关节炎,相对于对照组,在治疗效果上,具有显著的改进。
不良反应:对照组50例患者,治疗过程中,7例患者出现恶心、呕吐和腹泻等胃肠道反应,2例出现皮疹,1例出现白细胞减少。治疗组50例患者,治疗过程中,均未出现肝肾功能损伤或其他不良反应。
具体病例:李某,男,61岁,慢性痛风性关节炎病史6年有余,中秋节因大量饮酒、食肉复发,至本院求诊。经各项临床检查,确诊为慢性痛风性关节炎。给予对照组西医常规治疗,同时口服本发明中药实施例1口服液剂;治疗4周后,症状完全消失,关节功能恢复正常,主要理化检查指标正常,临床治愈,随访12个月无复发。
所有上述的首要实施这一知识产权,并没有设定限制其他形式的实施这种新产品或新方法。本领域技术人员将利用这一重要信息,上述内容修改,以实现类似的执行情况。但是,所有修改或改造基于本发明新产品属于保留的权利。
以上所述,仅是本发明的较佳实施例而已,并非是对本发明作其它形式的限制,任何熟悉本专业的技术人员可能利用上述揭示的技术内容加以变更或改型为等同变化的等效实施例。但是凡是未脱离本发明技术方案内容,依据本发明的技术实质对以上实施例所作的任何简单修改、等同变化与改型,仍属于本发明技术方案的保护范围。
Claims (9)
1.一种治疗慢性痛风性关节炎的中药,其特征在于,所述中药包括以下原料药材:灵寿茨、李根皮、绿豆皮、金发草、铁苋、女儿茶、蛇见怕、花椒簕、罗伞树、和合草、山合香、长瓦韦、石芥菜、黄桷叶和七角风。
2.如权利要求1所述的中药,其特征在于,所述原料药材的重量份数比为:灵寿茨10~20份、李根皮25~35份、绿豆皮15~25份、金发草5~15份、铁苋20~30份、女儿茶10~20份、蛇见怕5~15份、花椒簕20~30份、罗伞树10~20份、和合草15~25份、山合香20~30份、长瓦韦25~35份、石芥菜10~20份、黄桷叶25~35份和七角风10~20份。
3.如权利要求1或2所述的中药,其特征在于,所述原料药材的重量份数比为:灵寿茨12~17份、李根皮27~32份、绿豆皮18~23份、金发草8~13份、铁苋22~27份、女儿茶13~18份、蛇见怕9~14份、花椒簕23~28份、罗伞树13~18份、和合草17~22份、山合香25~30份、长瓦韦28~33份、石芥菜15~20份、黄桷叶28~33份和七角风15~20份。
4.如权利要求1至3所述的中药,其特征在于,所述原料药材的重量份数比为:灵寿茨16份、李根皮28份、绿豆皮22份、金发草9份、铁苋26份、女儿茶14份、蛇见怕13份、花椒簕24份、罗伞树17份、和合草18份、山合香28份、长瓦韦29份、石芥菜20份、黄桷叶30份和七角风20份。
5.如权利要求1至4所述的中药,其特征在于,所述原料药材的重量份数比为:灵寿茨12份、李根皮31份、绿豆皮19份、金发草12份、铁苋23份、女儿茶17份、蛇见怕10份、花椒簕28份、罗伞树14份、和合草20份、山合香26份、长瓦韦32份、石芥菜16份、黄桷叶32份和七角风16份。
6.如权利要求1至5所述的中药,其特征在于,所述中药的剂型为口服液剂,其制备方法包括以下步骤:
第一步,将灵寿茨、李根皮、绿豆皮、金发草、铁苋、女儿茶和蛇见怕按比例混合,加相对于混合物3倍~5倍量醇浓度为55%~65%的乙醇回流提取2次~4次,每次2小时~3小时,过滤,滤液合并,回收乙醇,浓缩至70℃相对密度为1.30~1.32的膏体,备用;
第二步,将剩余原料药材按比例混合,加相对于混合物3~5倍量水,煮沸2~4小时,过滤,浓缩至70℃相对密度为1.27~1.29的膏体;
第三步,将第一步、第二步获得的所述膏体混合,55℃~65℃减压真空干燥,得干膏粉;
第四步,将第三步获得的所述干膏粉中加入乙醇,得到含醇膏体,所述含醇膏体的含醇量为65%~70%;将所述含醇膏体依次进行冷藏处理、沉淀处理、过滤处理、回收乙醇处理,得到脱醇膏体,其中,冷藏处理时间为30~40小时,冷藏温度为2℃~6℃;
第五步,将所述脱醇膏体中加入蔗糖粉、活性炭,依次进行加热处理、过滤处理、稀释处理,得到半成品;所述脱醇膏体与所述蔗糖粉的重量比为1∶0.1~0.3;所述脱醇膏体与所述活性炭的重量比为1∶0.001~0.002;所述加热处理的时间为20~40分钟,温度为100℃~110℃;
第六步,再将第五步获得的所述半成品依次进行过滤处理、灌封处理、灭菌处理,即得所述中药制剂口服液成品。
7.如权利要求1至5所述的中药,其特征在于,所述中药的剂型为片剂,其制备方法包括以下步骤:
第一步,将灵寿茨、李根皮、绿豆皮、金发草、铁苋、女儿茶、蛇见怕和花椒簕混合,加相对于混合物3倍~5倍量醇浓度为55%~65%的乙醇回流提取2次~4次,每次2小时~3小时,过滤,滤液合并,回收乙醇,浓缩至70℃相对密度为1.30~1.32的膏体,备用;
第二步,将剩余原料药材按比例混合,加相对于混合物3~5倍量水,煮沸2~4小时,过滤,浓缩至70℃相对密度为1.27~1.29的膏体;
第三步,将第一步、第二步获得的膏体混合,55℃~65℃减压真空干燥,得干膏粉;
第四步,将所述的干膏粉与淀粉进行混匀处理,得到膏体混合物;所述的膏体和淀粉的重量比为1∶0.01~0.02;将所述膏体混合物进行制粒处理、干燥处理,得到的膏体混合物颗粒;
第五步,将所述的膏体混合物颗粒与滑石粉、硬脂酸镁依次进行混匀处理、压片处理、包衣处理,即得中药制剂片剂成品;所述的颗粒、滑石粉、硬脂酸镁的重量比为100∶1~3∶0.15~0.3。
8.一种权利要求1至5所述的中药的制备方法,其特征在于,所述中药的剂型为口服液剂,其包括以下步骤:
第一步,将灵寿茨、李根皮、绿豆皮、金发草、铁苋、女儿茶和蛇见怕按比例混合,加相对于混合物3倍~5倍量醇浓度为55%~65%的乙醇回流提取2次~4次,每次2小时~3小时,过滤,滤液合并,回收乙醇,浓缩至70℃相对密度为1.30~1.32的膏体,备用;
第二步,将剩余原料药材按比例混合,加相对于混合物3~5倍量水,煮沸2~4小时,过滤,浓缩至70℃相对密度为1.27~1.29的膏体;
第三步,将第一步、第二步获得的所述膏体混合,55℃~65℃减压真空干燥,得干膏粉;
第四步,将第三步获得的所述干膏粉中加入乙醇,得到含醇膏体,所述含醇膏体的含醇量为65%~70%;将所述含醇膏体依次进行冷藏处理、沉淀处理、过滤处理、回收乙醇处理,得到脱醇膏体,其中,冷藏处理时间为30~40小时,冷藏温度为2℃~6℃;
第五步,将所述脱醇膏体中加入蔗糖粉、活性炭,依次进行加热处理、过滤处理、稀释处理,得到半成品;所述脱醇膏体与所述蔗糖粉的重量比为1∶0.1~0.3;所述脱醇膏体与所述活性炭的重量比为1∶0.001~0.002;所述加热处理的时间为20~40分钟,温度为100℃~110℃;
第六步,再将第五步获得的所述半成品依次进行过滤处理、灌封处理、灭菌处理,即得所述中药制剂口服液成品。
9.一种权利要求1至5所述的中药的制备方法,其特征在于,所述中药的剂型为片剂,其包括以下步骤:
第一步,将灵寿茨、李根皮、绿豆皮、金发草、铁苋、女儿茶、蛇见怕和花椒簕混合,加相对于混合物3倍~5倍量醇浓度为55%~65%的乙醇回流提取2次~4次,每次2小时~3小时,过滤,滤液合并,回收乙醇,浓缩至70℃相对密度为1.30~1.32的膏体,备用;
第二步,将剩余原料药材按比例混合,加相对于混合物3~5倍量水,煮沸2~4小时,过滤,浓缩至70℃相对密度为1.27~1.29的膏体;
第三步,将第一步、第二步获得的膏体混合,55℃~65℃减压真空干燥,得干膏粉;
第四步,将所述的干膏粉与淀粉进行混匀处理,得到膏体混合物;所述的膏体和淀粉的重量比为1∶0.01~0.02;将所述膏体混合物进行制粒处理、干燥处理,得到的膏体混合物颗粒;
第五步,将所述的膏体混合物颗粒与滑石粉、硬脂酸镁依次进行混匀处理、压片处理、包衣处理,即得中药制剂片剂成品;所述的颗粒、滑石粉、硬脂酸镁的重量比为100∶1~3∶0.15~0.3。
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