CN103908542B - 一种治疗类风湿性关节炎的复方制剂及其制备方法 - Google Patents
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Abstract
本发明的治疗类风湿性关节炎的复方制剂；由以下重量份数的原料药：薜荔11～15份、地榆5～8份、黄柏5～7份、射干5～7份、夜交藤4～6份、千年健6～9份、酸枣仁8～12份、独角莲1～3份、螺旋藻11～15份、硫酸软骨素8～12份、美洛昔康9～13份制成。制备方法，包括以下步骤：a、将所述重量份数的地榆、黄柏、射干、夜交藤、酸枣仁分别采用回流提取法，提取浸膏，烘干制粉，混合均匀；b、将所述重量份数的薜荔、千年健、独角莲、螺旋藻、硫酸软骨素、美洛昔康分别制成200～400目粉末，连同步骤a中的混合物，加入到V型混合机中，混合均匀。c、将步骤b中的药粉，按照每粒0.64克装入胶囊中。
Description
技术领域
本发明属于医药领域，具体为一种治疗类风湿性关节炎的复方制剂及其制备方法。
背景技术
类风湿性关节炎是一种以关节病变为主的慢性全身自身免疫性疾病。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。在我国类风湿性关节炎的患病率为0．24-0．5%，女性多于男性，约2-3:1，任何年龄均可发病，以20-50岁最多。本病多为一种反复发作性疾病，致残率较高，预后不良，目前还没有很好的根治方法。
药物疗法：（一）水杨酸盐：阿斯匹林仍为治疗类风湿性关节炎的首选药物。（二）消炎痛：非类固醇抗炎药，效果较好，其镇痛、退热及抗炎作用都较强。（三）异丁苯丙本酸：抗炎、镇痛及退热作用均较阿斯匹林强10倍以上，副作用较阿斯匹林小。（四）皮质激素：对急性炎症有显著疗效，长期应用副作用较多，停药后极易复发。（五）青霉胺：应用青霉胺治疗，除使关节症状缓解外，可使血沉及C反应蛋白降低，类风湿因子转为阴性。（六）疏甲丙脯酸。（七）雷公藤：具有消炎、抗菌、调节免疫、活血化瘀、杀虫等作用。（八）金制剂：可能干扰细胞的生化反应。对关节疼痛及晨僵有明显疗效，也能使血沉及C反应蛋白好转，有效率可达70－90％。（九）免疫抑制剂：对本病有一定疗效，常用者有环磷酰胺、硫唑嘌呤。（十）类风湿性关节炎高效治疗药物：坎离砂。
发明内容
本发明的目的是提供一种治疗类风湿性关节炎的复方制剂及其制备方法。
本发明的治疗类风湿性关节炎的复方制剂；由以下重量份数的原料药：薜荔11～15份、地榆5～8份、黄柏5～7份、射干5～7份、夜交藤4～6份、千年健6～9份、酸枣仁8～12份、独角莲1～3份、螺旋藻11～15份、硫酸软骨素8～12份、美洛昔康9～13份制成。
作为优化，本治疗类风湿性关节炎的复方制剂，由以下重量份数的原料药：薜荔12份、地榆6份、黄柏5份、射干5份、夜交藤4份、千年健8份、酸枣仁10份、独角莲2份、螺旋藻13份、硫酸软骨素10份、美洛昔康11份制成。
制备本治疗类风湿性关节炎的复方制剂的方法，包括以下步骤：
a、将所述重量份数的地榆、黄柏、射干、夜交藤、酸枣仁分别采用回流提取法，提取浸膏，烘干制粉，混合均匀；
b、将所述重量份数的薜荔、千年健、独角莲、螺旋藻、硫酸软骨素、美洛昔康分别制成200～400目粉末，连同步骤a中的混合物，加入到V型混合机中，混合均匀；
c、将步骤b中的药粉，按照每粒0.64克装入胶囊中。
本发明治疗类风湿性关节炎的复方制剂中，薜荔祛风，利湿，活血，解毒。治凤湿痹痛，泻痢，淋病，跌打损伤，痈肿疮疖，抗炎。
地榆凉血止血，清热解毒，消肿敛疮。主吐血，咯血，衄血，尿血，便血，痔血，血痢，崩漏，赤白带下，疮痈肿痛，湿疹，阴痒，水火烫伤，蛇虫咬伤。
黄柏清热。燥湿，泻火，解毒。治热痢，泄泻，消渴，黄疸，痿躄，梦遗，淋浊，痔疮，便血，亦白带下，骨蒸劳热，目赤肿痛，口舌生疮，疮疡肿毒。
射干用于感受风热，或痰热壅盛所致的咽喉肿痛等症。用于痰涎壅盛，咳嗽气喘等症。咽喉肿痛，喉痹不通，二便不通，诸药不效，腹部积水，皮肤发黑，乳痈初起。
夜交藤性平无毒，味甘微苦，入心、肝经，有安神养血、祛风通络的功效，主治阴虚血少、虚烦不眠、风湿痹痛、皮肤痒疹等症。
千年健具有祛风湿、舒筋活络、止痛、消肿等功效。主治风湿痹痛、肢节酸育、筋骨痿软、跌打损伤、胃痛、痈疽疮肿等。
酸枣仁主烦心不得眠，脐上下痛，血转久泄，虚汗烦渴，补中，益肝气，坚筋骨，助阴气，令人肥健。
独角莲块茎用供药，能祛风痰、逐寒湿、镇痉，治头痛、口眼歪斜、半身不遂、破伤风、跌打劳伤、肢体麻木、中风不语、***核、蛇虫咬伤等。
螺旋藻中含很高的γ亚麻酸，有促进钙吸收、提高免疫力、防止代谢紊乱和防止衰老的功能。γ亚麻酸是***素的前体，在加氧酶的作用下变为***素，***素对生殖，心血管、呼吸、消化及神经***均有作用。螺旋藻中的多糖，有抗辐射的功能，并通过增强机体免疫力。另外螺旋藻多糖能提高血浆中的SOD的活性，减少脂质过氧化物的生成，有抗衰老的作用。
硫酸软骨素主要用于治疗高脂血症。其临床应用包括：1．硫酸软骨素作为保健食品或保健药品长期应用于防治冠心病、心绞痛、心肌梗死、冠状动脉粥样硬化、心肌缺血等疾病，无明显的毒副作用，能显著降低冠心病患者的发病率和死亡率。2．硫酸软骨素用于治疗神经痛、神经性偏头痛、关节痛、关节炎以及肩胛关节痛，腹腔手术后疼痛等。
美洛昔康，为4-羟基-2-甲基-N-(5-甲基-2-噻唑基)-2H-1；非甾体抗炎药，适用于类风湿关节炎、疼痛性骨关节炎的治疗。本复方制剂，祛风除湿，通络止痛、舒筋活络、各组分之间协同效应突出；治疗类风湿性关节炎效果显著。
有关临床资料如下：
一般资料：选取类风湿性关节炎患者200例，随机分为治疗组100例和对照组100例，两组性别、年龄、病程、病情轻重等资料比较，差异无统计学意义，无具体可比性。
诊断标准：所有患者均符合美国风湿病协会1987年的诊断标准及《中医病证诊断疗效标准》中关于痹症的临床诊断标准。禁忌证：① 严重肝肾功能不全或血液***异常或活动性溃疡病者、肿瘤、精神疾病、骨折；②高度过敏体质者；③1个月内曾用英平顽痹消片、甲氨蝶呤、青霉胺、氯喹金制剂等药物者；④孕妇、哺乳期妇女。患者关节疼痛及肿胀，有压痛，晨僵。x线。
治疗方法：治疗组,本发明实施例1中复方制剂，1日3次，1次3粒，口服；对照组,采用正清风痛宁缓释片1日3次，1次3片，口服，连续服用1个月1疗程，观察时间3个疗程。治疗前、治疗1个月、2个月、3个月各做类风湿因子、血沉、抗O、C反应蛋白、x线拍片等理化检查1次。
疗效评价：治疗前后对两组患者进行下列指标评估：晨僵、双手平均握力、关节疼痛(压痛)数、关节肿胀数、关节活动障碍指数、血沉(ESR)、类风湿因子(RF)定量、休息痛、患者评价、医生评价。显效为RF转阴或显著下降，血沉正常，晨僵及关节肿痛消失，关节活动自如。有效为RF下降2／3，血沉正常或<30 mm／h关节肿胀、压痛数减少50％。改善为RF及血沉均有下降，晨僵时间较前缩短，关节肿痛减少。无效为症状无改善。结果见表1。
具体实施方式
下面给出的实施例拟对本发明作进一步说明，但不能理解为是对本发明保护范围的限制，本领域技术人员根据本发明内容对本发明的一些非本质的改进和调整，仍属于本发明的保护范围。
实施例1，a、取地榆6克、黄柏5克、射干5克、夜交藤4克、酸枣仁10克分别采用回流提取法，提取浸膏，烘干制粉，混合均匀；b、取薜荔12克、千年健8克、独角莲2克、螺旋藻13克、硫酸软骨素10克、美洛昔康11克分别制成200～400目粉末，连同步骤a中的混合物，加入到V型混合机中，混合均匀。c、将步骤b中的药粉，按照每粒0.64克装入胶囊中。
实施例2，a、取地榆5克、黄柏5克、射干5克、夜交藤4克、酸枣仁8克分别采用回流提取法，提取浸膏，烘干制粉，混合均匀；b、取薜荔11克、千年健6克、独角莲1克、螺旋藻11克、硫酸软骨素8克、美洛昔康9克分别制成200～400目粉末，连同步骤a中的混合物，加入到V型混合机中，混合均匀。c、将步骤b中的药粉，按照每粒0.64克装入胶囊中。
实施例3，a、取地榆8克、黄柏7克、射干7克、夜交藤6克、酸枣仁12克分别采用回流提取法，提取浸膏，烘干制粉，混合均匀；b、取薜荔15克、千年健9克、独角莲3克、螺旋藻15克、硫酸软骨素12克、美洛昔康13克分别制成200～400目粉末，连同步骤a中的混合物，加入到V型混合机中，混合均匀。c、将步骤b中的药粉，按照每粒0.64克装入胶囊中。
Claims (2)
1.一种治疗类风湿性关节炎的复方制剂；其特征在于是由以下重量份数的原料药：薜荔11～15份、地榆5～8份、黄柏5～7份、射干5～7份、夜交藤4～6份、千年健6～9份、酸枣仁8～12份、独角莲1～3份、螺旋藻11～15份、硫酸软骨素8～12份、美洛昔康9～13份；通过以下步骤制成：
a、将所述重量份数的地榆、黄柏、射干、夜交藤、酸枣仁分别采用回流提取法，提取浸膏，烘干制粉，混合均匀；
b、将所述重量份数的薜荔、千年健、独角莲、螺旋藻、硫酸软骨素、美洛昔康分别制成200～400目粉末，连同步骤a中的混合物，加入到V型混合机中，混合均匀；
c、将步骤b中的药粉，按照每粒0.64克装入胶囊中。
2.根据权利要求1所述的治疗类风湿性关节炎的复方制剂，其特征在于是由以下重量份数的原料药：薜荔12份、地榆6份、黄柏5份、射干5份、夜交藤4份、千年健8份、酸枣仁10份、独角莲2份、螺旋藻13份、硫酸软骨素10份、美洛昔康11份制成。
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| 甲氨蝶呤和硫酸软骨素联合雷公藤小剂量治疗类风湿关节炎临床疗效观察;朱春来等;《中国社区医师 医学专业》;20121231;第14卷(第12期);第135页正文第1段 * |
| 类风湿关节炎四大主症用药体会;王宗怡;《山东中医杂志》;20040731;第23卷(第7期);第413-414页 * |
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