CN103920126A - 一种用于类风湿性膝关节炎的贴剂及其制备方法 - Google Patents
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Abstract
本发明用于类风湿性膝关节炎的贴剂；由以下重量份数的原料药：白头翁4～7份、磁铁矿8～12份、鬼箭羽10～15份、羌活10～18份、桑耳5～8份、干姜5～10份、海风藤13～20份、沙苑子9～13份、甲壳素15～25份、胡麻油13～17份、沙棘油8～12份、活性炭粉末25～35份、凡士林55～70份制成。本药物，祛风止痛，利水消肿，制成贴剂；各成分协同作用药效突出，方便有效成分穿透皮肤快速进入病痛位置；无过敏反应，更无毒副作用；治疗类风湿性膝关节炎效果显著。
Description
技术领域
本发明属于医药领域，具体为一种用于类风湿性膝关节炎的贴剂及其制备方法。
背景技术
类风湿性膝关节炎是一种非特异性炎症的多发性和对称性关节炎．严重影响膝关节功能，危害人们的健康。
类风湿膝关节炎的临床治疗一般包括药物治疗、外科治疗和心理康复治疗等。常用临床治疗药物分为四大类：非甾体抗炎药(NSAIDs)、抗风湿药(DMARDs)、糖皮质激素和其他药物li01。随着对本病认识的不断提高，国外提出了治疗类风湿性关节炎的模式：包括金字塔模式，波浪式模式，上台阶模式及下台阶模式。金字塔模式首先选用阿司匹林或其它NSAIDs，反复选用多种NSAIDs，无效时才选用金制剂、青霉胺等改变病情抗风湿药；波浪式模式，即锯齿形模式，以一种药物为基础，病情活动或加重时加用其他药，待病情稳定后再恢复基础疗，这样将多种慢性作用药物循环使用；上台阶模式，即分级治疗模式，主张按类风湿性关节炎病情严重度分为轻、中、重后进行相应的联合治疗；下台阶模式，主张一开始即用多种药物联合治疗，早期使用改善病情药物，一旦控制病情，逐渐撤药，最后以一种副作用小的药物维持。
发明内容
本发明的目的是提供一种用于类风湿性膝关节炎的贴剂及其制备方法。
本发明用于类风湿性膝关节炎的贴剂；由以下重量份数的原料药：白头翁4～7份、磁铁矿8～12份、鬼箭羽10～15份、羌活10～18份、桑耳5～8份、干姜5～10份、海风藤13～20份、沙苑子9～13份、甲壳素15～25份、胡麻油13～17份、沙棘油8～12份、活性炭粉末25～35份、凡士林55～70份制成。
作为优化，本用于类风湿性膝关节炎的贴剂，由以下重量份数的原料药：白头翁5份、磁铁矿9份、鬼箭羽11份、羌活12份、桑耳6份、干姜7份、海风藤15份、沙苑子10份、甲壳素20份、胡麻油15份、沙棘油10份、活性炭粉末30份、凡士林60份制成。所述活性炭粉末平均粒径为80μm。
制备本用于类风湿性膝关节炎的贴剂的方法，包括以下步骤：
a、将所述重量份数的白头翁、磁铁矿、羌活、桑耳、干姜、沙苑子分别制成200～600目的粉末，然后加入到v型搅拌机中搅拌均匀；
b、将所述重量份数的海风藤、鬼箭羽分别制成400～600目的粉末，然后连同所述重量分数的胡麻油、沙棘油加入超声混合搅拌机搅拌均匀，放置5～10小时；
c、将所述重量份数甲壳素和活性炭粉末混合均匀；
d、将所述重量份数的凡士林加热到75～80℃，加入步骤c中的混合物, 搅拌均匀；然后将温度降到55～65℃，依次加入步骤b中的混合物和步骤a中的混合物，搅拌均匀，冷却即成。
本发明贴剂组方中，白头翁具有清热解毒，凉血止痢，燥湿杀虫的功效。用于热毒痢疾，鼻衄，血痔，带下，阴痒，痈疮，瘰疬。
磁铁矿《本草纲目》中关于医药用磁铁矿治疗的疾病就有耳卒聋闭、肾虚耳聋、老人耳聋、老人虚损、眼昏内障、小儿惊痫、子宫不收、大肠脱肛、金疮肠出、金疮血出、误吞针铁、丁肿热毒、诸般肿毒等10多种疾病。
鬼箭羽破血通经；解毒消肿；杀虫。主症瘕结块；心腹疼痛；闭经；痛经；崩中漏下；产后瘀滞腹痛；恶露不下；疝气；历节痹痛；疮肿；跌打伤痛；虫积腹痛；烫火伤；毒蛇咬伤。
羌活用于阳痿遗精，遗尿尿频，腰膝冷痛，肾虚作喘，五更泄泻；外用治白癜风，斑秃；外感风寒、头痛无汗、油印寒湿痹、风水浮肿、疮疡肿毒。
桑耳能凉血止血；活血散结，主治衄血；尿血；便血；痔血；崩漏；喉痹；症瘕积聚等。
干姜温中散寒，回阳通脉，燥湿消痰，温肺化饮。用于脘腹冷痛、呕吐、泄泻、亡阳厥逆、寒饮喘咳、寒湿痹痛。
海风藤具有祛风湿，通经络，行气止痛，利水消肿的功效；主治风寒湿痹，筋脉拘挛，脘腥冷痛，跌打损伤，水肿，脚气。
沙苑子补肝，益肾，明目，固精。治肝肾不足，腰膝酸痛，目昏，遗精早泄，小便频数，遗尿，尿血，白带。
甲壳素是一种线型的高分子多糖，即天然的中性粘多糖，若经浓碱处理去掉乙酰基即得脱乙酰壳多糖。甲壳质化学上不活泼，不与体液发生变化，对组织不起异物反应，无毒，具有抗血栓、耐高温消毒等特点。脱乙酰壳多糖是碱性多糖，有止酸、消炎作用，可降低胆固醇、血脂。
胡麻油能修复更新脑神经细胞膜的不饱和脂肪酸链，起到健脑、促智、降血脂、抗血小板聚集、扩张小动脉和预防血栓形成等。可以预防前列腺肥大。
沙棘油是沙棘的精华，沙棘中含有的苹果酸、草酸等有机酸具有缓解抗生素和其他药物的毒性作用，保护肝脏，赖氨酸是肝细胞再生剂。沙棘中的生物活性成分花青素、苦木素、香豆素、5-羟色胺等可阻断黄曲霉菌等致癌物质或病菌的侵害，具有明显辅助抑制癌细胞生长的作用。沙棘总黄酮等生物活性成分对免疫系统的多环节具有不同程度的调节能力，对体液免疫和细胞免疫具有明显的调节作用。
活性炭粉末以优质果壳和木屑为原料，经蒸汽活化后，精制处理，粉碎而成，外观为黑色细微粉末状，无毒、无味,具有比表面积大，吸附能力强。用途：本品适用于医药、食品添加剂、味精、化工、饮料等产品的脱色、除杂、精致，适用于水的净化处理。
凡士林的学名叫石油脂，它的主要原料是从原油经过常压和减压蒸馏后留下的渣油中脱出的蜡膏，同时还需按照要求掺和不同量的高、中黏度润滑油。从石油渣油中脱出来的黄色蜡膏中含有诸多杂质，而无论是药用或是化妆用，都不容许含有任何对人体有害的物质，也不能有异味，所以还必须要加以深度的精制，充分脱除各种杂质后才能使用。按其使用要求的不同，可分为普通凡士林、医药凡士林、化妆用凡士林、工业凡士林和电容器凡士林等。诸药配伍，祛风止痛，利水消肿，制成贴剂；各成分协同作用药效突出，方便有效成分穿透皮肤快速进入病痛位置；无过敏反应，更无毒副作用；治疗类风湿性膝关节炎效果显著。
有关临床资料如下：一般资料：病人150例。其中男性33例、女性117例，年龄24岁～80岁，平均年龄49岁。病程3个月～14年，平均病程5年；150例病人中．右膝59例，左膝31例，双膝60例。
诊断依据：西医诊断根据1987年美国风湿病协会修订 类风湿性关节炎诊断标准既进行诊断。诊断标准包括：(1)晨僵至少1h(病程≥6周)；(2)3个或3个以上关节删中；(3)腕、掌指关节或近端指问关节肿；(4)对称性关节肿；(5)皮下结节；(6)手x线片改变；(7)类风湿因子阳性(滴度>1：32)。凡具备以上4条标准，且患者以联部症状为主者诊为类风湿性膝关节炎。
中医诊断根据中医病症诊断疗效标准中痹证的诊断依据嘲进行诊断。患者表现为关节肿胀疼痛，痛有定处，晨僵屈伸不利，遇寒则痛剧，局部畏寒怕冷，舌苔薄白，脉浮紧或沉紧者诊断为风寒湿阻型痹证。闩。具备以上条件，且患者以膝部症状为主者诊为类风湿性膝关节炎。纳入标准：同时满足西医诊断标准及中医诊断标准。
治疗方法：随机分为3组，每组50例；三组疗程均为50天。
组别1，单纯口服正清风痛宁片，每次2片，日3次。
组别2，本发明实施例1中的贴剂，贴在膝盖位置，3克一贴,每日两次，早一次，晚一次。
组别3，采用白头翁5份、磁铁矿9份、鬼箭羽11份、羌活12份、桑耳6份、干姜7份、海风藤15份、沙苑子10份制成200目的药粉，加入60份凡士林中，搅拌均匀，制成贴剂，3克一贴,每日两次，早一次，晚一次。
疗效评定：疗效评定根据中医病症诊断疗效标准中痹证的疗效评定标准评定。(1)临床治愈：关节疼痛、肿胀消失，活动功能正常，实验室检查正常；(2)好转：关节疼痛、肿胀减轻，活动功能好转，实验室检查有改善；(3)未愈：关节疼痛、肿胀及实验室检查无变化。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、取白头翁5克、磁铁矿9克、羌活12克、桑耳6克、干姜7克、沙苑子10克分别制成200～600目的粉末，然后加入到v型搅拌机中搅拌均匀；b、取海风藤15克、鬼箭羽11克分别制成400～600目的粉末，然后连同胡麻油15克、沙棘油10克加入超声混合搅拌机搅拌均匀，放置5～10小时；c、取甲壳素20克和平均粒径为80μm的活性炭粉末30克混合均匀；d、取凡士林60克加热到75～80℃，加入步骤c中的混合物, 搅拌均匀；然后将温度降到55～65℃，依次加入步骤b中的混合物和步骤a中的混合物，搅拌均匀，冷却即成。将其按照3克一贴，贴在膝盖位置，每日两次，早一次，晚一次。
实施例2，a、取白头翁4克、磁铁矿8克、羌活10克、桑耳5克、干姜5克、沙苑子9克分别制成200～600目的粉末，然后加入到v型搅拌机中搅拌均匀；b、取海风藤13克、鬼箭羽10克分别制成400～600目的粉末，然后连同胡麻油13克、沙棘油8克加入超声混合搅拌机搅拌均匀，放置5～10小时；c、取甲壳素15克和活性炭粉末25克混合均匀；d、取凡士林55克加热到75～80℃，加入步骤c中的混合物, 搅拌均匀；然后将温度降到55～65℃，依次加入步骤b中的混合物和步骤a中的混合物，搅拌均匀，冷却即成。将其按照3克一贴，贴在膝盖位置，每日两次，早一次，晚一次。
实施例3，a、取白头翁7克、磁铁矿12克、羌活18克、桑耳8克、干姜10克、沙苑子13克分别制成200～600目的粉末，然后加入到v型搅拌机中搅拌均匀；b、取海风藤20克、鬼箭羽15克分别制成400～600目的粉末，然后连同胡麻油17克、沙棘油12克加入超声混合搅拌机搅拌均匀，放置5～10小时；c、取甲壳素25克和活性炭粉末35克混合均匀；d、取凡士林70克加热到75～80℃，加入步骤c中的混合物, 搅拌均匀；然后将温度降到55～65℃，依次加入步骤b中的混合物和步骤a中的混合物，搅拌均匀，冷却即成。将其按照3克一贴，贴在膝盖位置，每日两次，早一次，晚一次。
Claims (4)
1.一种用于类风湿性膝关节炎的贴剂；其特征在于是由以下重量份数的原料药：白头翁4～7份、磁铁矿8～12份、鬼箭羽10～15份、羌活10～18份、桑耳5～8份、干姜5～10份、海风藤13～20份、沙苑子9～13份、甲壳素15～25份、胡麻油13～17份、沙棘油8～12份、活性炭粉末25～35份、凡士林55～70份制成。
2.根据权利要求1所述的用于类风湿性膝关节炎的贴剂，其特征在于是由以下重量份数的原料药：白头翁5份、磁铁矿9份、鬼箭羽11份、羌活12份、桑耳6份、干姜7份、海风藤15份、沙苑子10份、甲壳素20份、胡麻油15份、沙棘油10份、活性炭粉末30份、凡士林60份。
3.根据权利要求1所述的用于类风湿性膝关节炎的贴剂，其特征在于所述活性炭粉末平均粒径为80μm。
4.一种制备权利要求1所述贴剂的方法，其特征在于包括以下步骤：
a、将所述重量份数的白头翁、磁铁矿、羌活、桑耳、干姜、沙苑子分别制成200～600目的粉末，然后加入到v型搅拌机中搅拌均匀；
b、将所述重量份数的海风藤、鬼箭羽分别制成400～600目的粉末，然后连同所述重量分数的胡麻油、沙棘油加入超声混合搅拌机搅拌均匀，放置5～10小时；
c、将所述重量份数甲壳素和活性炭粉末混合均匀；
d、将所述重量份数的凡士林加热到75～80℃，加入步骤c中的混合物, 搅拌均匀；然后将温度降到55～65℃，依次加入步骤b中的混合物和步骤a中的混合物，搅拌均匀，冷却即成。
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| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| CB03 | Change of inventor or designer information | ||
| CB03 | Change of inventor or designer information |
Inventor after: Xiao Jing Inventor after: Liu Yuxia Inventor before: Liu Dezhen Inventor before: Wang Dandan Inventor before: Liu Suhua |
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| TR01 | Transfer of patent right | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20171122 Address after: No. 288 Shengdong street, Kuiwei District, Weifang, Shandong Patentee after: Xiao Jing Address before: 261000 No. 1, unit 1, building 20, Reservoir Road 502, railway station, Weicheng District, Weifang, Shandong Patentee before: Liu Dezhen |
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| CF01 | Termination of patent right due to non-payment of annual fee | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20160824 Termination date: 20180430 |