CN112472776A - 一种治疗痛风的中药丸剂及其制备方法 - Google Patents
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Abstract
本发明涉及一种治疗痛风的中药丸剂及其制备方法,属中草药技术领域。本发明中药丸剂为天然纯中药丸剂,采用特定用量的苍术、黄柏、牛膝、薏苡仁、菊苣、百合、白芷、虎杖、桑叶、葛根、栀子和青钱柳十二味中药的综合协同作用,具有补益肝肾、活血去淤、消肿止痛、通络除痹之功效,且制备工艺简单,见效快,相对传统西药,价格低廉,毒副作用小,且降低了患者的治疗成本。
Description
技术领域
本发明涉及一种治疗痛风的中药丸剂及其制备方法,属中草药技术领域。
背景技术
痛风是一种人体嘌呤代谢紊乱所致的疾病,早期多无明显症状而易漏诊,其临床表现为高尿酸血症及其由此引起的痛风性关节炎反复发作,累积到肾脏形成慢性间质性肾炎和尿酸肾结石。痛风中医辨证属痹证范畴,其临床表现急性期以单个或多个关节红肿热痛为主症,多属热痹,慢性期以关节肿大,僵硬或畸形为主症。
目前,治疗痛风还没有特效办法,现有痛风治疗是根据临床症状针对给药,主要是在发作期吃秋水仙碱等加止痛药,以便快速消炎,解除痛苦,间歇期吃别嘌呤等药物降低尿酸,预防再次发作。消炎止痛药治标不治本;秋水仙碱有严重的毒副反应;别嘌呤等降尿酸药物,不但停药反弹较快,而且经常因为尿酸溶解过快而引起转移性痛风发作。最可怕的是,长期吃这些药物,会损伤肝肾脾,导致无法逆转的痛风反复加剧发作。所以目前很多痛风患者宁可忍着剧痛也不肯吃药。从中医的整体观念出发,用中医药整体辨证施治,不失为治疗痛风疾病的一条佳径;中药不但本身的毒副作用小,而且可降低长期单纯服用西药所带来的副作用。但目前市场上治疗痛风的中成药也有不少,疗效较好的相对缺乏,患者仍然只能靠大量服用毒副作用较大的西药来稳定病情。因此,有必要研发一种安全有效治疗痛风的中药。发明内容
本发明的目的在于:提供一种具有活血去淤、消肿止痛、通络除痹,可有效降低血尿酸,且制备方法简单,见效快,相对传统西药,价格低廉,副作用小,且极大的降低了患者治疗成本的治疗痛风的中药丸剂及其制备方法。
本发明的技术方案是:
一种治疗痛风的中药丸剂,其特征在于:它是由下述重量份的原料制成的:
苍术6—15 黄柏5—9 牛膝6—15
薏苡仁9—30 菊苣5—9 百合5—12
白芷 5—9 虎杖7—15 桑叶5—7
葛根7—15 栀子5—9 青钱柳5—9
所述的治疗痛风的中药丸剂,是由下述重量份的原料制成的:
苍术9—13 黄柏7—8 牛膝8—12
薏苡仁12—24 菊苣7—9 百合7—9
白芷 6—8 虎杖9—12 桑叶5—7
葛根9—12 栀子7—9 青钱柳7—9
所述的治疗痛风的中药丸剂,是由下述重量份的原料制成的:
苍术12 黄柏7 牛膝9
薏苡仁15 菊苣9 百合7
白芷 6 虎杖12 桑叶5
葛根10 栀子9 青钱柳9
上述治疗痛风的中药丸剂的制备方法,包括以下步骤:
首先按上述重量份取黄柏、牛膝、桑叶、虎杖、菊苣、青钱柳煎煮二次,合并煎煮液,静置,取上清液浓缩至规定量,备用;然后将剩余的原料药进行混合,干燥后粉碎成细粉,过100目筛,每100份过筛细粉与30份炼蜜加适量水和备用的浓缩液稀释后作为粘合剂泛丸,将丸剂进行进一步干燥、打光后;得治疗痛风的中药丸剂成品。
用法用量:
本发明中药丸剂采用温开水送服,一日2次,每次15—20克,9天为一个疗程,连续服用3~4个疗程可痊愈,病情严重者遵医嘱酌增用量或增加疗程。
本发明各组分原料的药性特点及功效如下:
苍术味辛、苦;性温。归脾、胃、肝经。功能燥湿健脾、祛风散寒,明目。用于湿阻中焦,脘腹胀满,泄泻,水肿,脚气痿蹙,风湿痹痛,肢节酸痛、风寒感冒,及表证夹湿、头身重痛。《本草纲目》:大风痹,筋骨软弱,散风除湿解郁。
黄柏性味苦,性寒,归肾、膀胱经。功能清热燥湿;泻火解毒。主湿热痢疾、泄泻、黄疸;梦遗、淋浊、带下;骨蒸劳热;以及口舌生疮;目赤肿痛;痈疽疮毒;皮肤湿疹。《医学启源》:黄檗,治肾水膀胱不足,诸痿厥,腰无力,于黄芪汤中加用,使两膝中气力涌出,痿软即时去矣二制治上焦,单制治中焦,不制治下焦也。
牛膝味苦、甘、酸,性平。归肝、肾经。功能逐瘀通经,补肝肾,强筋骨,利尿通淋,引血下行。治腰膝酸痛,肝肾亏虚,跌打瘀痛。可用于腰膝酸痛,筋骨无力等症。李时珍说:“牛膝乃足厥阴、少阴之药。所主之药,大抵得酒则能补肝、肾,生用则能去恶血,二者而已。其治腰膝骨痛、足痿阴消,失溺、久疟、伤中少气诸病,非取其补肝肾之功欤”。
薏苡仁,为禾本科多年生草本植物薏苡的成熟种仁。味甘、淡,性寒,归脾、胃、肺经。功能健脾渗湿,除痹止泻,清热排浓。用于水肿,脚气,小便不利,湿痹拘挛,脾虚泄泻等。薏苡仁健脾去湿,清热除浊,具有功力和缓,除湿而不助燥,清热而不损阴,益气而不滋湿,又能舒筋脉,缓和挛急,在风湿拘挛时,确有疏筋展臂的伸筋作用。《药品化义》:薏米,味甘气和,清中浊品,能健脾阴,大益肠胃。主治脾虚泻,致成水肿,风湿盘缓,致成手足无力,不能屈伸。盖因湿胜则土败,土胜则气复,肿自消而力自生。取其入肺,滋养化源,用治上焦消渴,肺痈肠痈。又取其味厚沉下,培植部,用治脚气肿痛,肠红崩漏。若咳血久而食少者,假以气和力缓,倍用无不效。《本草新编》:薏苡仁,味甘,气微寒,无毒。入脾、肾二经,兼入肺。疗湿痹有神,舒筋骨拘挛,止骨中疼痛,消肿胀,利小便,开胃气,亦治肺痈。但必须用至一、二两,始易有功,少亦须用五钱之外,否则,力薄味单耳。薏仁最善利水,又不损耗真阴之气。凡湿感在下体者,最宜用之。
菊苣为菊科植物毛菊苣和菊苣的地上部分,性味微苦、咸,凉。功能清肝利胆,健胃消食,利尿消肿。用于湿热黄疸,胃痛食少,水肿尿少。菊苣是维吾尔族习惯使用的药材。维吾尔族人一般会在秋季采挖菊苣,除去杂质,再晒干备用。
百合性味甘;微苦;微寒,归经心、肺经;功能养阴润肺;清心安神。亦可用于痈肿;湿疮等症。《本草述》谓:百合之功,在益气而兼之利气,在养正而更能去邪,故李氏谓其为渗利和中之美药也。
白芷,性味辛,温。归肺、脾、胃经。功能祛风燥湿,消肿,止痛;清毒祛湿,通络益气,主治风湿型痛风。可用于活动受限的痛风患者服用,而且生津益气、除湿祛痹的功效。《本草经疏》:白芷,味辛气温无毒,其香气烈,亦芳草也。入手足阳明、足太阴,走气分,亦走血分,升多于降,阳也。性善祛风,能蚀脓,故主妇人漏下赤白。辛以散之,温以和之,香气入脾,故主血闭阴肿,寒热,头风侵目泪出。辛香散结而入血止痛,故长肌肤。芬芳而辛,故能润泽。辛香温散,故疗风邪久泻,风能胜湿也。香入脾,所以止呕吐。疗两胁风痛,头眩目痒,祛风之效也。《本草汇言》:白芷,上行头目,下抵肠胃,中达肢体,遍通肌肤以至毛窍,而利泄邪气。如头风头痛,目眩目昏;如四肢麻痛,脚弱痿痹。
虎杖,味微苦,性微寒;归肝、胆经。具有,清热解毒,活血散瘀止痛、祛风通络的功效。可用于风湿痹痛。药理研究表明虎杖提取物有解热镇痛作用。虎杖既能调整胃肠,通过大小便排出潴留于关节间的代谢废物,又有清热活血、通络止痛之功。《本草拾遗》谓其“主风在骨节间及血瘀”《滇南本草》谓其“攻诸肿毒,利小便、走经络”故应视为痛风性关节病不可或缺之品。
桑叶性味苦甘,寒。归肺、肝经。功能祛风清热,凉血明目。治风温发热,头痛,目赤,口渴,肺热咳嗽,风痹。《本草经疏》:“桑叶,甘所以益血,寒所以凉血,甘寒相合,故下气而益阴,是以能主阴虚寒热及因内热出汗。”其性兼燥,故又能除脚气水肿,利大小肠,除风。
葛根味甘、辛,性凉。归肺、胃经。功能解肌退热,透疹,生津止渴,升阳止泻。葛根《神农本草经》:“葛根,味甘平,主消渴,身大热,呕吐,诸痹,起阴气,解诸毒”。《本草汇言》:“葛根,清风寒,净表邪,解肌热,止烦渴。泻胃火之药也。尝观发表散邪之药,其品亦多,如麻黄拔太阳营分之寒,桂枝解太阳卫分之风,防风、紫苏散太阳在表之风寒,藁本、羌活散太阳在表之寒湿,均称发散药也,而葛根之发散,亦入太阳,亦散风寒,又不同矣,非若麻、桂、苏、防,辛香温燥,发散而又有损中气之误也;非若藁本、羌活,发散而又有耗营血之虞也。”现代研究认为葛根治疗痛风作用机理,与葛根能扩张心脑血管.促进体内血液循环,增加对体内尿酸的排泄有关。
栀子,味苦,性寒;归心、肺、三焦经。功能泻火除烦,清热利湿,凉血解毒;外用消肿止痛。用于热病心烦,湿热黄疸,淋证涩痛,血热吐衄,目赤肿痛,火毒疮疡,外治扭挫伤痛。栀子既能清气分热,又能清血分热。至于泄热利湿,可用治黄疸,也是它的特长。本品配黄柏,能泻相火而清热利湿;配以桑叶,能清泻三焦之火;药理研究证明,栀子具利胆作用,其醇提物和栀子苷、藏红花素等均能使胆汁分泌量增加。
青钱柳,胡桃科青钱柳属乔木青钱柳的干燥树叶,功能清热、消肿、止痛。《中国中药资源志要》记载,青钱柳叶具清热解毒、治疗消渴之功效。《全国中草药名鉴》 记载:青钱柳树皮、叶、根有杀虫止痒,消炎止痛祛风之功效。青钱柳在临床使用中有一定的降低尿酸的效果,在改善痛风的同时,还能够辅助降低血糖。由于它可以利尿消肿,对于高尿酸以及痛风都有适当缓解作用。
本发明治病机理:
中医认为痛风的发生多是因过食肥甘厚味及辛辣之品,导致痰浊、湿热内生,致使脾失健运、痰淤痹阻,流注关节经络,阻碍气血运行,从而发肿胀、疼痛等痛风症候。痛风急性发作时,常见下肢关节红肿疼痛,局部灼热,舌质红,苔黄腻,实验室检查提示血尿酸增高。治则应以健脾祛湿、化瘀通络、清热利尿为主。
申请人治疗痛风从调整脏腑整体功能入手,促进尿酸排泄,减少尿酸盐沉积,从而达到治疗痛风的目的。《内经》有“膏粱之变,足生大疔”之戒,明代医学家龚廷贤在《万病回春》中亦指出:“一切痛风肢体痛者,痛属火,肿属湿……所以膏粱之人,多食煎炒、炙煿、酒肉,热物蒸脏腑,所以患痛风。”我院内分泌科根据痛风之病因病机,结合多年临证经验,从健脾利湿,泄浊化瘀,通利经脉入手,以四妙散为基本方,加清热利湿泄浊,化瘀通经活络之品,组成专科制剂痛风丸。取黄柏走下焦除肝肾之湿热;苍术燥湿健脾除湿邪之来源;白芷清毒祛湿,通络益气;薏苡仁入阳明胃经祛湿热而利筋络;葛根、栀子、虎杖、菊苣、桑叶、青钱柳清热消肿止痛,牛膝补肝肾兼领诸药之力以直入下焦,百合能清能润,调和诸药。全方以黄柏清热燥湿为君药,取其寒以胜热,苦以燥湿,且善除下焦之湿热,是以为君。苍术苦温,健脾燥湿除痹,白芷祛风,燥湿,消肿,止痛。二者共为臣药,薏苡仁利水渗湿、虎杖清热活血散瘀、葛根解肌泻热、栀子清三焦热、菊苣利尿消肿、桑叶疏风清热、青钱柳清热消肿为佐药。苍术与黄柏配伍应用可共奏清热燥湿之功效,使湿去而热除。宗《黄帝内经》:“治痿独取阳明”之旨,故用能独入阳明经脉之薏苡仁以淡渗利湿,清热除痹,舒利筋络。且苍术和薏苡仁配伍,强化健脾利湿之功,断湿热之源。栀子配黄柏,能增强清热利湿之功。牛膝活血通经络,补肝肾,强筋骨,引苍术、黄柏入下焦而祛湿清热;且引药直达下焦,是为使药,百合味甘、微寒,润肺止咳、清心安神,具有止遍身疼痛之效,且取其能清能润,调和诸药,共奏健脾祛湿、清热利尿、活血消肿止痛之功。
方中黄柏味苦而性寒、沉降,善清湿热且尤长于清下焦湿热。“黄柏之苦寒,降湿热为痿,乘于肾,救足膝无力,亦除阴汗、阴痿,而益精”,“如脚膝痿软,行步乏力,或疼痛,乃肾肝中伏湿热,少加黄柏”。苍术味苦能燥湿、性辛温、可散寒除痹,是燥湿健脾之要药,《珍珠囊》有云:“能健胃安脾,诸湿肿非此不能除。”方中黄柏味苦而性寒、沉降,善清湿热且尤长于清下焦湿热。“黄柏之苦寒,降湿热为痿,乘于肾,救足膝无力,亦除阴汗、阴痿,而益精”,“如脚膝痿软,行步乏力,或疼痛,乃肾肝中伏湿热,少加黄柏”。苍术味苦能燥湿、性辛温、可散寒除痹,是燥湿健脾之要药,《珍珠囊》有云:“能健胃安脾,诸湿肿非此不能除。” 牛膝味苦酸、性平,“补中续绝,填骨髓,除脑中痛腰脊痛,妇人月水不通,血结,益精,利阴气。”《神农本草经》原文:“牛膝,味苦,主寒湿痿痹,四肢拘挛,膝痛不可屈伸,逐血气。” 栀子味苦,性寒。归心、肺、三焦经。功能泻火除烦,清热利湿,凉血解毒。白芷,性味辛,温。归肺、脾、胃经。功能主治祛风,燥湿,消肿,止痛。清毒祛湿、通络益气、主治风湿型痛风。可用于活动受限的痛风患者服用,而且生津益气、除湿祛痹的功效。薏苡仁,性味甘、淡、微寒,具有利水渗湿、健脾止泻、除痹、清热等功效。主筋急,拘挛不可屈伸,风湿痹,下气,久服轻身益气。是以方中用薏苡仁健脾胃、除湿痹、缓拘挛、舒筋络。用它配伍治疗痛风,既可以发挥其利尿作用,以排出更多的尿酸,又可以利用其祛风除痹的功效,改善痛风病人关节炎的症状。菊苣配伍栀子、青钱柳可以缓解痛风,降低尿酸。众所周知,肥胖和糖尿病是痛风的诱因,而且痛风患者常伴有高血压、高血脂、糖尿病等并发症。而青钱柳具有调节血糖,激活胰岛器官的功能,促进血糖代谢的功效。
本发明的有益效果在于:
本发明中药丸剂为天然纯中药丸剂,采用特定用量的苍术、黄柏、牛膝、薏苡仁、菊苣、百合、白芷、虎杖、桑叶、葛根、栀子和青钱柳十二味中药的综合协同作用,具有补益肝肾、活血去淤、消肿止痛、通络除痹之功效,且制备工艺简单,见效快,相对传统西药,价格低廉,毒副作用小,且降低了患者的治疗成本。
为了表面本发明对痛风的治疗效果,申请人对260例痛风患者进行临床观察,观察结果如下:
1、病例选择
病人随机分成治疗组和对照组,治疗组130例,其中男性90例,女性40例,年龄30-75岁,平均年龄50岁,病程最短者1个月,最长者8年,对照组130例,其中男性100例,女性30例,年龄30-75岁,病程最短者2个月,最长者7年。
治疗组和对照组两组病例的病程、症状轻重程度基本一致,无显著差异,具有可比性。
2、药物选择
治疗组服用本发明中药丸剂,温开水送服,一日2次,每次15—20克,9天为一个疗程,连续服用3~4个疗程可痊愈,病情严重者遵医嘱酌增用量。
对照组服用双苯溴马隆片,每次50~100mg,每天1次;7天为1个疗程,轻者1个疗程,重者2~3个疗程。
3、疗效判定
(1)治愈:红、肿、热、剧烈疼痛等症状消失,局部炎症消除,关节活动自如。
(2)显效:上述症状明显减轻,关节活动明显好转。
(3)有效:上述症状有所缓解,关节活动有所改善。
(4)无效:临床症状无明显改善。
(5)总有效率: 治愈+显效+有效
表1:治疗组与对照组的比对结果
表1结果表明:本发明中药丸剂在治疗患者痛风时取得了很好疗效,治疗组的总有效率明显高于对照组。
中医有着“不传之秘在于量的说法”为了表明(验证)本发明不同的各原料药用量对痛风治疗效果的影响,申请人对不同原料药用量组方的中药丸剂进行了比对试验,申请人对120例痛风患者进行临床比对观察,比对观察结果如下:
病人随机分成治疗组和对照组,各60人,治疗组和对照组两组病例的病程、症状轻重程度基本一致,无显著差异,具有可比性。
治疗组服用本发明中药丸剂, 对照组采用与本发明相同的各原料药,但各原料药的用量均在本发明各原料药用量范围之外的中药丸剂。治疗组和对照组服药方法相同,服药量相同。
其结果如下:
表2: 原料药的不同用量对痛风治疗效果的影响
由上述表2结果可以看出:本发明各原料药的用量,相比不同原料药用量组方的中药丸总有效率显著高于对照组,表面本发明各原料药的用量对痛风治疗效果好于对照组。
中医药理论认为,药物的协同对治疗效果有着直接的影响;为了表面本发明各原料药的协同配伍对痛风治疗效果的影响,申请人在各原料药用量相同的情况下,对其中的几味原料药采用药性类似的中草药进行了替换,并对240名患者其治疗效果进行了比对试验,其结果如下:
病人随机分成治疗组、对照1组、对照2组和对照3组,每组各60人,治疗组和对照组两组病例的病程、症状轻重程度基本一致,无显著差异,具有可比性。
治疗组服用本发明中药丸剂, 对照组采用与本发明用量相同、但各原料药用药有所不同的中药丸剂。治疗组和各对照组服药方法相同,服药量相同。
表3:不同药物的协同对治疗效果的影响;
由上述表3结果表明:本发明相比各对照组的总有效率明显高于对照组,表面本发明用药及协同效果好于对照组。
具体实施方式
下面结合具体实施例对本发明作进一步的说明,但并不因此将本发明限制在所述的实施例范围之中。
首先按上述各实施例重量份取黄柏、牛膝、桑叶、虎杖、青钱柳,煎煮二次,合并煎煮液,静置,取上清液浓缩至规定量,备用;然后将剩余的各原料药进行混合,干燥后粉碎成细粉,过100目筛,每100份过筛细粉与30份炼蜜加适量水和备用的浓缩液稀释后作为粘合剂泛丸,将丸剂进行进一步干燥、打光后;得治疗痛风的中药丸剂成品。
本发明以黄柏清热燥湿为君药,取其寒以胜热,苦以燥湿,且善除下焦之湿热,是以为君。苍术苦温,健脾燥湿除痹,白芷祛风燥湿、消肿止痛,二者共为臣药;薏苡仁利水渗湿、虎杖清热活血散瘀、葛根解肌泻热、栀子清三焦之热、菊苣利尿消肿、桑叶疏风清热、青钱柳清热消肿为佐药。苍术与黄柏配伍应用可共奏清热燥湿之功效,使湿去而热除。宗《黄帝内经》:“治痿独取阳明”之旨,故用能独入阳明经脉之薏苡仁以淡渗利湿,清热除痹,舒利筋络。且苍术和薏苡仁配伍,强化健脾利湿之功,断湿热之源。栀子配黄柏,能增强清热利湿之功。牛膝活血通经络,补肝肾,强筋骨,引苍术、黄柏入下焦而祛湿清热;且引药直达下焦,是为使药,百合味甘、微寒,润肺止咳、清心安神,具有止遍身疼痛之效,且取其能清能润,调和诸药,共奏健脾祛湿、清热利尿、活血消肿止痛之功。
典型病例:
1、周XX,男,45岁,患痛风3年,患处位于左手中指关节处和腕部关节处,有饮酒嗜好,期间采用西药秋水仙碱,别嘌醇,苯溴马隆等治疗,短时间内有一定的疗效,易复发不能断根,来我院治疗时临床症状为红肿疼痛,检查血尿酸值为550umol/l,诊断为高尿酸血症。服用本发明中药丸剂1个疗程后,血尿酸值明显下降,2个疗程后,检查血尿酸值降至420umol/l的临界点,服药3个疗程后,检查血尿酸值回复正常,继续巩固服药1个疗程后,随访2年未复发。
2、李XX,男,70岁,患处位于右足脚指头关节处,有饮酒嗜好和较长的吸烟史,患痛风6年,期间采用西药治疗,副作用较大,经常复发,来我院治疗时临床症状为红肿疼痛,肿大明显,足部不能穿鞋和落地行走,检查血尿酸值为620umol/l,诊断为高尿酸血症。服用本发明中药丸剂一个疗程后,症状明显减轻,足部可落地,服药2个疗程后,检查血尿酸值回复正常,继续服药2个疗程后,临床症状消失,可行走,增服1个疗程以巩固,随访2年未复发。
3、张XX,女,50岁,患痛风5年,患处位于手腕部关节处,无饮酒、吸烟嗜好,患病之前好食海鲜,患病后对海鲜忌口,期间采用西药治疗,来我院治疗时临床症状为红肿疼痛,患处不能触碰,触碰后有剧烈的刺痛感。检查血尿酸值为480umol/l,诊断为高尿酸血症。服用本发明中药丸剂一个疗程后,症状明显减轻,腕部关节可触碰,服药2个疗程后,临床症状消失,检查血尿酸值回复正常;继续服药2个疗程以巩固,随访3年未复发。
Claims (1)
1.一种治疗痛风的中药丸剂,其特征在于:它是由下述重量份的原料制成的:
苍术6—15 黄柏5—9 牛膝6—15
薏苡仁9—30 菊苣5—9 百合5—12
白芷 5—9 虎杖7—15 桑叶5—7
葛根7—15 栀子5—9 青钱柳5—9
所述的治疗痛风的中药丸剂,是由下述重量份的原料制成的:
苍术9—13 黄柏7—8 牛膝8—12
薏苡仁12—24 菊苣7—9 百合7—9
白芷 6—8 虎杖9—12 桑叶5—7
葛根9—12 栀子7—9 青钱柳7—9
所述的治疗痛风的中药丸剂,是由下述重量份的原料制成的:
苍术12 黄柏7 牛膝9
薏苡仁15 菊苣9 百合7
白芷 6 虎杖12 桑叶5
葛根10 栀子9 青钱柳9
上述治疗痛风的中药丸剂的制备方法,包括以下步骤:
首先按上述重量份取黄柏、牛膝、桑叶、虎杖、菊苣、青钱柳煎煮二次,合并煎煮液,静置,取上清液浓缩至规定量,备用;然后将剩余的原料药进行混合,干燥后粉碎成细粉,过100目筛,每100份过筛细粉与30份炼蜜加适量水和备用的浓缩液稀释后作为粘合剂泛丸,将丸剂进行进一步干燥、打光后;得治疗痛风的中药丸剂成品。
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