CN104491761A - 一种治疗类风湿性关节炎的药物制剂的制备方法 - Google Patents
一种治疗类风湿性关节炎的药物制剂的制备方法 Download PDFInfo
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Abstract
本发明涉及一种治疗类风湿性关节炎的药物制剂的制备方法,分别对原料药物进行醇提、水提,充分提取有效成分,本发明方法制备的药物制剂对类风湿性关节炎标本兼治、对人体无毒无害、无副作用、价格低廉,制作简便,具有广阔的应用前景。
Description
技术领域
本发明属于中药技术领域,具体涉及一种治疗类风湿性关节炎的药物制剂的制备方法。
背景技术
类风湿性关节炎是由于风寒湿热等外邪入侵,闭阻经络关节,气血运行不畅,主要临床表现为全身关节呈游走性红、肿、重着、疼痛。主要临床表现为小关节滑膜所致的关节肿痛,继而软骨破坏、关节间隙变窄,晚期因严重骨质破坏、吸收导致关节僵直、畸形、功能障碍。是一种常见的多发病。关节腔滑膜炎症、渗液、细胞增殖、肉芽肿形成,软骨及骨组织破坏,最后关节强直及功能障碍。主要侵害关节及心脏,表现为关节肌肉疼痛,麻木,肿胀,红热,血清中可查到自身抗体,故认为本病是自身性疾病。发病年龄多在20~50岁。女性多于男性。如何合理用药,早期控制病情进展,阻止骨关节破坏,已成为当前国内外的研究热点。
目前,西医对于类风湿性关节炎的治疗,不同意见各持一说。有所谓“经典金字塔”模式;所谓“倒金字塔模式”,即开始治疗就使用强有力的药物,如细胞毒性免疫抑制剂等改变病情的抗风湿药;所谓“下台阶式”,即开始用多种药物联台“围剿”,然后把组合药物逐渐分别停用,最后选择一种有效而副作用小的药物维持;所谓“波浪式模式”,即在一种药治疗基础上,加以阶段性治疗,在病情呈波动上升时给予加强治疗。以后再恢复基础治疗,如此重复多次。
祖国医学认为类风湿性关节炎乃因虚、邪、痰、瘀、毒而致,虚是肝肾不足,气血亏虚,是类风湿性关节炎发病的内在因素,正所谓“正气存在,不可干,邪之所凑,其气必虚”,故宜益气养血、补肾壮骨以扶正,祛风、散寒、除湿、清热以祛邪,兼以通络。
近年来大量研究发现,某些中药及其有效成分对类风湿性关节炎有显著的治疗作用,取得了一些可喜的成果,临床报道均取得良好的疗效,因此寻求一种高效低毒、标本兼治的用于类风湿性关节炎的药物是摆在医学界面前的一项技术难题。
发明内容
本发明的目的是发挥中医配伍用药、全面调整人体功能的特点,提供一种祛风散寒, 除湿通络的用于类风湿性关节炎的药物制剂。
类风湿性关节炎在中医学中属“痹证”范畴,中医理论认为“痹者,闭也,不通也”。在类风湿性关节炎的发病过程中,风、寒、湿、热、淤均为致病因素。现代中医将类风湿性关节炎分为四型,初期为风寒湿邪侵入关节经络,气血不通所致;中期及急性发作期为湿热痰瘀型,为湿热痰瘀痹阻经络、关节所致;肝肾亏损型,是由于痹病日久、肝肾亏损所致;气血两虚型见于本病的晚期。就类风湿性关节炎病症发生发展的病因病机特点来说,尤其以风、寒、湿三种邪气最为多见,故内经曰“风寒湿三气杂至而为痹,其风盛者为行痹,寒气盛者为痛痹,湿气盛者为着痹”,其次乃是久病不愈,久病成瘀,瘀阻经络而成,本方所治主证为临床常见的风寒夹湿兼瘀血阻络型痹症,其病机为风寒湿邪侵犯人体,阻滞经络,日久气血运行不畅,瘀血内生而阻络,经络不通,发为痹症,故确定了祛风散寒,除湿通络,活血止痛的治则。
本申请发明人根据前人经验及自己多年的医疗实践,通过对传统中药的研究,并结合辩证论证,多方收集众家之长,寻求最佳治疗方案,结合传统中医技术精心配制成本发明的治疗类风湿性关节炎的药物制剂,对类风湿性关节炎有治标治本的功效。
为实现上述目的,本发明采用的技术方案如下:
一种治疗类风湿性关节炎的药物制剂的制备方法,所述制剂由下述重量配比的原料制备而得:
川芎35份、羌活35份、木瓜35份、杜仲30份、制川乌30份、
莪术25份、蒲公英25份、草果25份、续断25份、大腹皮20份、
丹参20份、蒲黄20份、山楂20份、乌梅20份、桑椹20份、
肉桂15份、白芷15份、没药10份、骨碎补10份、独活10份、
五味子10份、淫羊藿10份、桂枝10份、鸡血藤10份、虎杖10份;
所述药物制剂的制备方法为:
(1)按照重量配比称取原料;
(2)将川芎、羌活、草果、续断、大腹皮、丹参、蒲黄、白芷、没药、骨碎补、独活、鸡血藤、虎杖按照所述比例混合,加3倍重量90%乙醇浸渍24小时,回流提取两次,每次1小时,合并提取液,浓缩成密度为1.2 g/ml的清膏;
(3)剩余成分用水煎煮提取2次,第一次提取加5倍重量的水,提取时间为1小时;第二次提取加2倍重量的水,提取时间为1小时;滤过,合并滤液,浓缩至密度为1.2 g/ml的清膏;
(4)将步骤(2)、步骤(3)制备的清膏充分混匀后,用软胶囊机压制成软胶囊。
本发明所述的技术方案是在中医治疗关节炎的临床经验基础上,结合众家之长辩证获得本申请技术方案,其具有很强地消炎镇痛作用,可以迅速改善症状、有效控制炎症,阻止病程发展,保护关节功能,对类风湿性关节炎有治愈的功效,克服现有技术中药物起效慢及停药容易反复等副作用,达到标本兼治的目的,用法用量每次0.2g,一日两次。
本发明药物的剂型组方合理,配伍精简,治疗原则切中风湿病的发病病机,所以疗效确切,临床应用反应很好。长期服用没有毒副作用,原材料价廉质优易得。
具体实施方式
实施例1
一种治疗类风湿性关节炎的药物制剂的制备方法,其由下述重量配比的原料制备而得:
川芎35份、羌活35份、木瓜35份、杜仲30份、制川乌30份、
莪术25份、蒲公英25份、草果25份、续断25份、大腹皮20份、
丹参20份、蒲黄20份、山楂20份、乌梅20份、桑椹20份、
肉桂15份、白芷15份、没药10份、骨碎补10份、独活10份、
五味子10份、淫羊藿10份、桂枝10份、鸡血藤10份、虎杖10份。
所述药物制剂的制备方法为:
(1)按照重量配比称取原料;
(2)将川芎、羌活、草果、续断、大腹皮、丹参、蒲黄、白芷、没药、骨碎补、独活、鸡血藤、虎杖按照所述比例混合,加3倍重量90%乙醇浸渍24小时,回流提取两次,每次1小时,合并提取液,浓缩成密度为1.2 g/ml的清膏;
(3)剩余成分用水煎煮提取2次,第一次提取加5倍重量的水,提取时间为1小时;第二次提取加2倍重量的水,提取时间为1小时;滤过,合并滤液,浓缩至密度为1.2 g/ml的清膏;
(4)将步骤(2)、步骤(3)制备的清膏充分混匀后,用软胶囊机压制成软胶囊。
用法用量每次0.2g,一日两次。
实施例2
药效实验
药效的测量通过测量脚掌的肿胀程度和所能承受的砝码重量压力。
借助美国专利5,908,628弗氏完全佐剂皮内注射到每只大鼠的左后脚掌诱发原发性关节炎。以阿司匹林作为参照药物(0.15克/kg)。
雄性大鼠随机分为3组,每组10只,各组的单只重量是160-170克,并对大鼠后爪的周长进行了测定。以0.1毫升弗氏佐剂的皮内注射到每只大鼠的左后脚掌诱发炎症。一个星期后,注射弗氏佐剂的完成。每个组的老鼠分别喂食蒸馏水(对照组),阿司匹林,或本发明的药物组合物。第3天,皮内注射0.1毫升弗氏佐剂诱发炎症,并测量2,4,6,24,48和72小时后炎症肿胀程度和受压能力。结果表明,本发明药物制剂对炎症和疼痛有明显的抑制作用。具体见表1:
表1
实施例3
临床资料
临床资料:选自具有完整病例的门诊病人共110例。随机分为治疗组55例,对照组55例。治疗组年龄为29-60岁;对照组年龄在30-61岁,年龄及病程经卡方检验,无统计学显著差异(p>0.05)。
诊断标准:
西医诊断标准:参照1989年美国风湿学学会类风湿关节炎的诊断标准:①晨僵:关节及其周围僵硬感至少持续1h(病程≥6周);②3个或3个以上区域关节部位的关节炎:医生观察到14个区域(左侧或右侧的近端指间关节、掌关节、腕、肘、膝、踝及跖趾关节)中累及3个,且同时软组织肿胀或积液(不是单纯骨隆起)(病程≥6周);③手关节炎:腕、掌指或近端指间关节炎中,至少有一个关节肿胀(病程≥6周);④对称性关节炎:两侧关节同时受累(双侧近端指间关节、掌指关节及跖趾关节受累时,不一定绝对对称)(病程≥6周);⑤类风湿结节:医生观察到在骨突部位,伸肌表面或关节周围有皮下结节;⑥类风湿因子阳性:任何检测方法证明血清类风湿因子含量异常,而该方法在正常人群中的阳性率小于5%;⑦放射学改变:在手和腕的后前位相上有典型的类风湿关节炎放射学改变:必须包括骨质侵蚀或受累关节及其邻近部位有明确的骨质脱钙。以上7条满足4条以上并排除其他关节炎即可诊断为类风湿性关节炎。
中医诊断标准:①主要临床表现:关节、肌肤、筋骨等部位疼痛或肿胀晨僵,麻木重着,屈伸不利,甚至关节肿大变形、强直不伸、肌肉萎缩等:②发病特点:多与气候变化有关;③性别、年龄特点:好发于青壮年,女多于男;④理化检查:类风湿因子阳性或血沉增快,X线可见骨质侵蚀。具备上述①、④两项,结合②或③项即可确诊。
治疗方法:治疗组按照本发明所述方法服用实施例1制备药物组合物,治疗2个疗程,每个疗程1个月;
对照组采用青霉素800万U加入0.9%氯化钠注射液250ml静脉滴注,每天一次,配合双氯芬酸钠缓释片75mg口服,每天一次,一个月为1个疗程,治疗2个疗程。
疗效评定标准:①治愈:关节疼痛、肿胀消失(指数减少≥90%),活动功能正常,实验室检查正常;②显效:关节疼痛、肿胀减轻(指数减少60%~89%),活动功能好转,实验室检查有好转;③好转:关节疼痛、肿胀有所减轻(指数减少31%~59%),活动功能好转,实验室检查有所改善;④无效:关节疼痛、肿胀(指数减少≤30%)症状及实验室检查无改善。
治疗结果:两组治疗结果如下所示(P<0.01):
组别 | 例次 | 治愈 | 显效 | 好转 | 无效 | 总有效率 |
治疗组 | 55 | 26 | 12 | 14 | 3 | 94.5% |
对照组 | 55 | 12 | 13 | 13 | 17 | 69.1% |
可以看出本发明药物组较之常规治疗差异显著。
本发明采用的上述各中草药互作配伍,能发挥其协同治病作用,所用中药原料各成分之间具有药效相互交织相互促进和协调效能,经临床验证,对类风湿性关节炎有很好的治疗效果,本申请人多年的医疗实践中,治愈的病例数目众多,均取得良好的效果,而且成本低廉,减轻患者的负担。
Claims (2)
1. 一种治疗类风湿性关节炎的药物制剂的制备方法,其特征在于,所述方法包括如下步骤:
(1)按照重量配比称取原料;其中,
芎35份、羌活35份、木瓜35份、杜仲30份、制川乌30份、
莪术25份、蒲公英25份、草果25份、续断25份、大腹皮20份、
丹参20份、蒲黄20份、山楂20份、乌梅20份、桑椹20份、
肉桂15份、白芷15份、没药10份、骨碎补10份、独活10份、
五味子10份、淫羊藿10份、桂枝10份、鸡血藤10份、虎杖10份;
(2)取川芎、羌活、草果、续断、大腹皮、丹参、蒲黄、白芷、没药、骨碎补、独活、鸡血藤、虎杖,混合,加3倍重量90%乙醇浸渍24小时,回流提取两次,每次1小时,合并提取液,浓缩成密度为1.2 g/ml的清膏;
(3)取剩余原料,用水煎煮提取2次,第一次提取加5倍重量的水,提取时间为1小时;第二次提取加2倍重量的水,提取时间为1小时;滤过,合并滤液,浓缩至密度为1.2 g/ml的清膏;
(4)将步骤(2)制备的清膏和步骤(3)制备的清膏充分混匀即得。
2.权利要求1所述的制备方法用于类风湿性关节炎的用途。
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