CN106039271A - 一种治疗膝骨关节炎的膏药 - Google Patents
一种治疗膝骨关节炎的膏药 Download PDFInfo
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- CN106039271A CN106039271A CN201610589865.5A CN201610589865A CN106039271A CN 106039271 A CN106039271 A CN 106039271A CN 201610589865 A CN201610589865 A CN 201610589865A CN 106039271 A CN106039271 A CN 106039271A
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Abstract
本发明之目的就是提供一种治疗膝骨关节炎的膏药,以有效解决膝骨关节炎的治疗问题。本发明解决的技术方案是,由以下重量份数计的原料药物制成:藤黄15‑30份、白花蛇舌草15‑30份、半枝莲15‑30份、木瓜15‑30份、川牛膝30‑40份、川椒15‑30份、干姜15‑30份、细辛10‑20份、花椒15‑30份、透骨草15‑30份、制川草乌5‑15份、青风藤15‑30份、苏木15‑30份、全虫10‑20份、蜈蚣2‑3份。本发明组方科学,使用方便,效果好,是中医外治法治疗膝骨关节炎的一大创新,经济和社会效益巨大。
Description
技术领域
本发明涉及医药,特别是一种治疗膝骨关节炎的膏药。
背景技术
骨关节炎(OA)是一种以关节软骨的变性、破坏及关节边缘、软骨下骨质增生,关节内组织的炎性改变为特征的慢性、退行性关节炎疾病。目前对膝骨关节炎的药物治疗主要分口服及局部注射。口服药物主要有:①非甾体抗炎药:有良好的消炎镇痛作用,但也引起一定胃肠道症状及肝肾功能损伤,影响血小板功能,增加心血管不良事件发生;②阿片类药物:虽然有良好止痛效果,缓解中重度疼痛,但有依赖性;③软骨保护剂:具有消炎、镇痛、保护关节软骨的作用,但缺乏公认的理想药物,一般如氨基葡萄糖、双醋瑞因等药物作用较慢,且需长期应用。局部药物主要有:①糖皮质激素对缓解疼痛、较少渗出效果可,但激素类药物在止痛的同时对关节软骨有一定损伤,不宜长期应用;②玻璃酸钠,可减轻疼痛、增加关节活动度,保护关节软骨。但这类关节灌注类药物对注射时操作要求高,一旦感染,其损害远大于其疾病本身,因此,结合膝骨关节炎的中医病因病机,应用中医药理论,开发一种对缓解关节疼痛、肿胀,增加关节活动度的外服膏药势在必行。
发明内容
针对上述情况,为解决现有技术之不足,本发明之目的就是提供一种治疗
膝骨关节炎的膏药,以有效解决膝骨关节炎的治疗用药问题。
本发明解决的技术方案是,由以下重量份数计的原料药物制成:藤黄15-30份、白花蛇舌草15-30份、半枝莲15-30份、木瓜15-30份、川牛膝30-40份、川椒15-30份、干姜15-30份、细辛10-20份、花椒15-30份、透骨草15-30份、制川草乌5-15份、青风藤15-30份、苏木15-30份、全虫10-20份、蜈蚣2-3份和蜂蜡及小磨香油;
其中,先将藤黄、白花蛇舌草、半枝莲、木瓜、川牛膝、川椒、干姜、细辛、花椒、透骨草、制川草乌、青风藤份、苏木、全虫、蜈蚣分别粉碎混合成中药粉;然后将蜂蜡及小磨香油以重量比5:1混合在一起,加热熔融成液体,再与熔融液体等重量的中药粉混合均匀,于400—500℃下熬制1小时,冷却至室温,放入清水中,没24小时更换一次清水,更好5—7次成药膏,均匀平摊药布上,即成。
本发明组方科学,使用方便,效果好,是中医外治法治疗膝骨关节炎的一大创新,经济和社会效益巨大。
具体实施方式
以下结合实施例对本发明的具体实施方式作进一步详细说明。
实施例1:本发明在具体实施时,可由以下重量份数计的原料药物制成:藤黄15份、白花蛇舌草30份、半枝莲15份、木瓜30份、川牛膝30份、川椒30份、干姜15份、细辛20份、花椒15份、透骨草30份、制川草乌5份、青风藤30份、苏木15份、全虫20份、蜈蚣2份和蜂蜡及小磨香油;
其中,先将藤黄、白花蛇舌草、半枝莲、木瓜、川牛膝、川椒、干姜、细辛、花椒、透骨草、制川草乌、青风藤份、苏木、全虫、蜈蚣分别粉碎混合成中药粉;然后将蜂蜡及小磨香油以重量比5:1混合在一起,加热熔融成液体,再与熔融液体等重量的中药粉混合均匀,于400—500℃下熬制1小时,冷却至室温,放入清水中,没24小时更换一次清水,更好5—7次成药膏,均匀平摊药布上,药膏平摊面积为10×20cm,厚度为0.3—0.5cm,即成。
实施例2:本发明在具体实施时,可由以下重量份数计的原料药物制成:藤黄30份、白花蛇舌草15份、半枝莲30份、木瓜15份、川牛膝40份、川椒15份、干姜30份、细辛10份、花椒30份、透骨草15份、制川草乌15份、青风藤15份、苏木30份、全虫10份、蜈蚣3份和蜂蜡及小磨香油;
其中,先将藤黄、白花蛇舌草、半枝莲、木瓜、川牛膝、川椒、干姜、细辛、花椒、透骨草、制川草乌、青风藤份、苏木、全虫、蜈蚣分别粉碎混合成中药粉;然后将蜂蜡及小磨香油以重量比5:1混合在一起,加热熔融成液体,再与熔融液体等重量的中药粉混合均匀,于400—500℃下熬制1小时,冷却至室温,放入清水中,没24小时更换一次清水,更好5—7次成药膏,均匀平摊药布上,药膏平摊面积为10×20cm,厚度为0.3—0.5cm,即成。
实施例3:本发明在具体实施时,可由以下重量份数计的原料药物制成:藤黄22份、白花蛇舌草22份、半枝莲22份、木瓜22份、川牛膝35份、川椒22份、干姜22份、细辛15份、花椒22份、透骨草22份、制川草乌10份、青风藤22份、苏木22份、全虫15份、蜈蚣2份和蜂蜡及小磨香油;
其中,先将藤黄、白花蛇舌草、半枝莲、木瓜、川牛膝、川椒、干姜、细辛、花椒、透骨草、制川草乌、青风藤份、苏木、全虫、蜈蚣分别粉碎混合成中药粉;然后将蜂蜡及小磨香油以重量比5:1混合在一起,加热熔融成液体,再与熔融液体等重量的中药粉混合均匀,于400—500℃下熬制1小时,冷却至室温,放入清水中,没24小时更换一次清水,更好5—7次成药膏,均匀平摊药布上,药膏平摊面积为10×20cm,厚度为0.3—0.5cm,即成。
实施例4:本发明在具体实施时,可由以下重量份数计的原料药物制成:藤黄16-21份、白花蛇舌草16-21份、半枝莲16-21份、木瓜16-21份、川牛膝31-34份、川椒16-21份、干姜16-21份、细辛11-14份、花椒16-21份、透骨草16-21份、制川草乌6-9份、青风藤16-21份、苏木16-21份、全虫11-14份、蜈蚣2份和蜂蜡及小磨香油;
其中,先将藤黄、白花蛇舌草、半枝莲、木瓜、川牛膝、川椒、干姜、细辛、花椒、透骨草、制川草乌、青风藤份、苏木、全虫、蜈蚣分别粉碎混合成中药粉;然后将蜂蜡及小磨香油以重量比5:1混合在一起,加热熔融成液体,再与熔融液体等重量的中药粉混合均匀,于400—500℃下熬制1小时,冷却至室温,放入清水中,没24小时更换一次清水,更好5—7次成药膏,均匀平摊药布上,药膏平摊面积为10×20cm,厚度为0.3—0.5cm,即成。
实施例5:本发明在具体实施时,可由以下重量份数计的原料药物制成:藤黄23-29份、白花蛇舌草23-29份、半枝莲23-29份、木瓜23-29份、川牛膝36-39份、川椒23-29份、干姜23-29份、细辛16-19份、花椒23-29份、透骨草23-29份、制川草乌11-14份、青风藤23-29份、苏木23-29份、全虫16-19份、蜈蚣3份和蜂蜡及小磨香油;
其中,先将藤黄、白花蛇舌草、半枝莲、木瓜、川牛膝、川椒、干姜、细辛、花椒、透骨草、制川草乌、青风藤份、苏木、全虫、蜈蚣分别粉碎混合成中药粉;然后将蜂蜡及小磨香油以重量比5:1混合在一起,加热熔融成液体,再与熔融液体等重量的中药粉混合均匀,于400—500℃下熬制1小时,冷却至室温,放入清水中,没24小时更换一次清水,更好5—7次成药膏,均匀平摊药布上,药膏平摊面积为10×20cm,厚度为0.3—0.5cm,即成。
在上述组分中,其中:
藤黄:酸;涩;凉;有毒;功主消肿,化毒,止血,杀虫。《纲目拾遗》:"治痈疽,止血化毒,敛金疮,亦能杀虫。"
白花蛇舌草:味苦、淡,性寒。主要功效是清热解毒、消痛散结、利尿除湿。《泉州本草》:清热散瘀,消痈解毒。治痈疽疮疡,瘰疬。
半枝莲:味辛,苦,性寒;归肺经,肝经,肾经;功主清热解毒,散瘀止血,利尿消肿。《泉州本草》:清热,解毒,法风,散血,行气,利水,通络,破瘀,止痛。内服主血淋,吐血,衄血;外用冶毒蛇咬伤,痈疽,疔疮,无名肿毒。
木瓜:性温,味酸;归肝、脾经;功主舒筋活络,和胃化湿。《本草经疏》:下部腰膝无力,由于精血虚、真阴不足者不宜用。伤食脾胃未虚、积滞多者,不宜用。
川牛膝:甘、微苦,平;归肝、肾经;功主逐瘀通经,通利关节,利尿通淋。《四川中药志》:祛风利湿,通经散血。治寒湿腰腿骨痛,足痿筋挛,妇女经闭及症瘕麻牛膝,淋病,尿血,阴痿、失溺。
川椒:辛、温,有小毒,麻;功主芳香健胃、温中散寒、除湿止痛、杀虫解毒、止痒解腥的功效。
干姜:辛,性热,归脾、胃、肾经,功主温中散寒,回阳通脉。《药性论》云:“治腰肾中疼冷,冷气,破血,去风,通四肢关节,开五脏六腑,去风毒冷痹。”
细辛:辛,温;归心、肺、肾经;功主解表散寒,祛风止痛,通窍,温肺化饮。《本经》:主咳逆,头痛脑动,百节拘挛,风湿痹痛,死肌。明目,利九窍。
花椒:辛,温;归脾、胃、肾经;功主温中止痛,杀虫止痒。《本经》:主风邪气,温中,除寒痹,坚齿发,明目。主邪气咳逆,温中,逐骨节皮肤死肌,寒湿痹痛,下气。
透骨草:辛、苦,温;有小毒;归肝、肾经。功主祛风除湿,解毒止痛。用于风湿关节痛;外用治疮疡肿毒。《纲目》:"治筋骨一切风湿疼痛挛缩,寒湿脚气。"
制川草乌:味辛;性温;有毒;祛风除湿,散寒通络。
青风藤:味苦、辛; 归肝、脾经;功主祛风湿,通经络,利小便。《纲目》:治风湿流注,历节鹤膝,麻痹瘙痒,损伤疮肿,入酒药中用。《浙江天目山药植志》:行水利尿,泻下焦血分湿热。治风水肿,脚气,风湿关节疼痛,口眼歪斜,痈肿恶疮。
苏木:甘、咸,平,归心、肝、脾经。功主行血祛瘀,消肿止痛。用于经闭痛经,产后瘀阻,胸腹刺痛,外伤肿痛。《日华子本草》:排脓止痛,消痈肿扑损瘀血,女人失音,血噤,赤白痢并后分急痛。
全虫:辛,平;有毒;归肝经。功主息风镇痉,攻毒散结,通络止痛。《玉楸药解》:"穿筋透骨,逐湿除风。"
蜈蚣:辛,温;有毒。归肝经。功主熄风镇痉,功毒散结,通络止痛。《医学衷中参西录》:“外治经络中风,口眼歪斜,手足麻木。”
具体使用时,将膏药置于微波炉内,在70—80℃下加热5-8分钟,放置冷却到45-50℃,将膏药均匀贴敷于患处即可。
本发明制成的膏药,治疗阳虚寒凝型膝骨关节炎,证见膝关节疼痛酸重,遇寒加重,得温则减,膝关节肿胀、僵硬拘紧,关节屈伸不利,活动后加重,手足不温,大便溏泄,小便清长;舌脉: 舌质淡白或有齿痕,苔腻,脉沉细涩,效果良好。其有关资料如下:
(一)一般资料
选取于河南省中医院2015年1月—2016年1月收治的KOA患者,共90例,其中男32例,女58例;年龄38~87岁,平均(46.9±5.8);病程2月15年,平均(1.9±0.5)年。均有不同程度的膝关节疼痛、活动受限病史。所有患者随机分为2组。治疗组45例,男15例,女30例;平均年龄(47.2±6.1)岁;平均病程(2.0±0.6)年、体质指数(B M I)27.3±4.6;病变部位单膝24例,双膝21例。对照组45例,男16例,女29例;平均年龄(46.6 ±7.7)岁;平均病程(1.8±0.5)年、B M I:26.9±4.5;病变部位单膝23例,双膝22例。2 组一般资料比较,差异无统计学意义(P>0.05),具有可比性。
(二)诊断标准
参考 1995 年美国风湿病学会(A C R )关于 KO A分类诊断标准[1]:①近 1 月内经常反复膝关节疼痛;②活动时有摩擦音;③膝关节晨僵≤30 m in;④中老年者≥40 岁;⑤膝关节骨端肥大伴有骨质增生。符合①+②+③+④项或①+②+③+⑤项,可诊断 KO A 。
中医辨证标准: 参照《中药新药临床研究指导原则》辨证为阳虚寒凝证[2]:膝关节疼痛酸重,遇寒加重,得温则减,膝关节肿胀、僵硬拘紧,关节屈伸不利,活动后加重,手足不温,大便溏泄,小便清长;舌脉: 舌质淡白或有齿痕,苔腻,脉沉细涩。
纳入标准:①符合 1995 年美国风湿病学会推荐的膝骨关节炎的临床诊断标准 ;②符合《中药新药临床研究指导原则》辨证为阳虚寒凝证的中医诊断标准。③年龄在38~87岁;④签署知情同意书。
排除标准:①风湿相关疾病、结缔组织疾病、肿瘤等疾病导致膝关节炎病变者;②关节严重变性者,关节间隙严重狭窄及骨性强直者;③过敏体质者,训练及治疗依从性差者;④合并明显心脑血管疾病及精神病需治疗者。
(三)治疗方案
对照组给予双醋瑞因(安必丁,国药准字J20100150):50mg,qd,po,口服三个月。
治疗组给予安必丁的基础上,配合膏药外用,日一次,外用,应用15天。
两组患者治疗后均随访1月。
(四)主要观测指标及疗效评定
① 症状体征评价:采用国际骨关节炎的评分标准 Lequesne 指数[3]进行评分,包括膝关节静息痛、运动痛、压痛、肿胀、晨僵、行走能力;
②临床疗效评定;参照 《中药新药临床研究指导原则(试行)》 [2]拟定。临床痊愈:中医临床症状、体征消失或基本消失,证候积分减少≥95% ;显效:中医临床症状、体征明显改善,70% ≤证候积分减少<95% ;有效:中医临床症状、体征均有好转,30% ≤证候积分减少<70% 。无效:中医临床症状、体征均无明显改善,甚或加重,证候积分减少<30% 。注:计算公式:[(治疗前积分-治疗结束时积分)/ 治疗前积分]×100%
(六)统计学处理
统计学处理 采用 SPSS18.0 进行数据处理分析。计量资料以(±s)表示,两样本组内采用配对 t 检验,组间采用成组 t 检验;计数资料采用 χ 2 检验。
(七)结果
2组治疗后及末次随访时疗效比较(见表1)。治疗后治疗组总有效率97.8%,对照组总有效率75.6%,2组疗效比较具有显著性差异(P<0.05),治疗组疗效优于对照组。末次随访时治疗组总有效率97.8%,对照组总有效率75.6%,2组疗效比较具有显著性差异(P<0.05),治疗组疗效优于对照组。
表1 2组患者疗效比较
注:治疗后,与对照组比较,①P<0.05;治疗组内,与末次随访时比较,②P>0.05;末次随访时,与对照组比较,③P<0.05。
2组治疗前后临床观察指标结果比较(见表2)。治疗后 2 组各项评分均较治疗前明显下降(P< 0.05),且治疗组各项评分下降较对照组更显著(P< 0.05)。
表2 2组治疗前后观察指标评分比较(±s)
注:两组组内比较,①P<0.01;组间比较,与对照组治疗后比较,②P<0.05
五、结论
临床观察发现,本发明对依据国家食品药品监督管理局修订的《中药新药临床研究指导原则》中凡辨证符合阳虚寒凝证的膝骨关节炎患者有明显疗效。现代医学认为其机理是:消炎镇痛、调节神经-免疫-内分泌系统。其药物应用上多会引起不良的胃肠道反应、肝肾功能损伤,血小板功能异常,增加心血管不良事件发生;甚至出现关节软骨本身的损伤及关节感染,本发明单纯应用于局部,且临床观察中并未发现有过敏等不良反应的发生,避免了胃肠道的吸收引起的相应不良反应及局部关节灌注的感染风险。经临床运用观察发现疗效显著,免除了副作用小,使用方便,具有实际的临床意义。
Claims (6)
1.一种治疗膝骨关节炎的膏药,其特征在于,由以下重量份数计的原料药物制成:藤黄15-30份、白花蛇舌草15-30份、半枝莲15-30份、木瓜15-30份、川牛膝30-40份、川椒15-30份、干姜15-30份、细辛10-20份、花椒15-30份、透骨草15-30份、制川草乌5-15份、青风藤15-30份、苏木15-30份、全虫10-20份、蜈蚣2-3份和蜂蜡及小磨香油;
其中,先将藤黄、白花蛇舌草、半枝莲、木瓜、川牛膝、川椒、干姜、细辛、花椒、透骨草、制川草乌、青风藤份、苏木、全虫、蜈蚣分别粉碎混合成中药粉;然后将蜂蜡及小磨香油以重量比5:1混合在一起,加热熔融成液体,再与熔融液体等重量的中药粉混合均匀,于400—500℃下熬制1小时,冷却至室温,放入清水中,没24小时更换一次清水,更好5—7次成药膏,均匀平摊药布上,即成。
2.根据权利要求1所述的治疗膝骨关节炎的膏药,其特征在于,由以下重量份数计的原料药物制成:藤黄15份、白花蛇舌草30份、半枝莲15份、木瓜30份、川牛膝30份、川椒30份、干姜15份、细辛20份、花椒15份、透骨草30份、制川草乌5份、青风藤30份、苏木15份、全虫20份、蜈蚣2份和蜂蜡及小磨香油。
3.根据权利要求1所述的治疗膝骨关节炎的膏药,其特征在于,由以下重量份数计的原料药物制成:藤黄30份、白花蛇舌草15份、半枝莲30份、木瓜15份、川牛膝40份、川椒15份、干姜30份、细辛10份、花椒30份、透骨草15份、制川草乌15份、青风藤15份、苏木30份、全虫10份、蜈蚣3份和蜂蜡及小磨香油。
4.根据权利要求1所述的治疗膝骨关节炎的膏药,其特征在于,由以下重量份数计的原料药物制成:藤黄22份、白花蛇舌草22份、半枝莲22份、木瓜22份、川牛膝35份、川椒22份、干姜22份、细辛15份、花椒22份、透骨草22份、制川草乌10份、青风藤22份、苏木22份、全虫15份、蜈蚣2份和蜂蜡及小磨香油。
5.根据权利要求1所述的治疗膝骨关节炎的膏药,其特征在于,由以下重量份数计的原料药物制成:藤黄16-21份、白花蛇舌草16-21份、半枝莲16-21份、木瓜16-21份、川牛膝31-34份、川椒16-21份、干姜16-21份、细辛11-14份、花椒16-21份、透骨草16-21份、制川草乌6-9份、青风藤16-21份、苏木16-21份、全虫11-14份、蜈蚣2份和蜂蜡及小磨香油。
6.根据权利要求1所述的治疗膝骨关节炎的膏药,其特征在于,由以下重量份数计的原料药物制成:藤黄23-29份、白花蛇舌草23-29份、半枝莲23-29份、木瓜23-29份、川牛膝36-39份、川椒23-29份、干姜23-29份、细辛16-19份、花椒23-29份、透骨草23-29份、制川草乌11-14份、青风藤23-29份、苏木23-29份、全虫16-19份、蜈蚣3份和蜂蜡及小磨香油。
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CN107854683A (zh) * | 2017-12-25 | 2018-03-30 | 河南中医药大学 | 一种治疗湿热痹阻型膝骨关节炎的膏药 |
CN108273027A (zh) * | 2018-04-02 | 2018-07-13 | 史兰 | 一种治疗膝骨关节炎的药膏 |
CN111759905A (zh) * | 2020-08-10 | 2020-10-13 | 武汉苓桂医疗科技有限公司 | 一种治疗骨关节炎的巴布剂及其制备方法 |
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CN107854683A (zh) * | 2017-12-25 | 2018-03-30 | 河南中医药大学 | 一种治疗湿热痹阻型膝骨关节炎的膏药 |
CN108273027A (zh) * | 2018-04-02 | 2018-07-13 | 史兰 | 一种治疗膝骨关节炎的药膏 |
CN111759905A (zh) * | 2020-08-10 | 2020-10-13 | 武汉苓桂医疗科技有限公司 | 一种治疗骨关节炎的巴布剂及其制备方法 |
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