CN109985223A - 一种祛风湿膏 - Google Patents
一种祛风湿膏 Download PDFInfo
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Abstract
本发明涉及中药领域,公开了一种祛风湿膏,包括:邬梢蛇,地龙,防风,防已,络石藤,海风藤,甘草,干姜,米仁,丹参,葛根,川牛滕,威灵仙,海桐皮,升麻,桂枝,玄参,狗脊,羌活,炙龟板,细辛,太子参,黄芪,神曲,黄芩,人参,核桃。本发明的祛风湿膏,口服后能够缓解关节疼痛,关节肿胀和压痛,用于治疗风湿、类风湿以及强直性脊柱炎等引起的腰酸背痛和晨僵。
Description
技术领域
本发明涉及中药领域,尤其涉及一种祛风湿膏。
背景技术
目前,由于风湿、类风湿以及强直性脊柱炎而引起的腰酸背痛和晨僵的人群越来越多,患者深受其痛,其中由强直性脊柱炎引起的尤为严重。
强直性脊柱炎是一种以中轴关节和肌腱韧带骨附着点的慢性炎症为主的全身性疾病,以炎性腰痛、肌腱端炎、外周关节炎和关节外表现为特点。主要累及骶髂关节、脊柱及四肢关节,表现为关节和关节周围组织、韧带、椎间盘的钙化,椎间关节和四肢关节滑膜的增生,最终发展为骨性强直。主要中医证候表现为腰臀胯疼痛,僵硬不舒,牵及膝腿痛或酸软无力,畏寒喜暖,得热则舒,俯仰受限活动不利。
目前,西医治疗主要应用非甾体类消炎药、糖皮质激素、柳氮磺砒啶、生物制剂等为主,但这些药物不良反应及毒副作用较为明显,多数患者难以坚持长期用药。中医药治疗强直性脊柱炎注重标本兼顾,多采用分期和分型论治、辨病与论证相结合、内治与外治相结合等方法,具有疗效确切,副作用少等优势。
发明内容
为了解决上述技术问题,本发明提供了一种祛风湿膏,本发明的祛风湿膏,其口服后能够缓解关节疼痛,关节肿胀和压痛,用于治疗风湿、类风湿以及强直性脊柱炎等引起的腰酸背痛和晨僵。
本发明的具体技术方案为:一种祛风湿膏,包括以下重量份的组分:邬梢蛇80-120份,地龙100-140份,防风100-140份,防已100-140份,络石藤100-140份,海风藤130-170份,甘草50-90份,干姜100-140份,米仁200-280份,丹参160-200份,葛根130-160份,川牛滕130-160份,威灵仙100-140份,海桐皮100-140份,升麻50-90份,桂枝100-140份,玄参130-160份,狗脊100-140份,羌活100-140份,炙龟板100-140份,细辛40-60份,太子参160-200份,黄芪160-200份,神曲100-140份,黄芩100-140份,人参150-250份。
本发明团队知晓,在现有技术中或许已有不少文献报道了本发明上述配方中的单一组分,并公开了其疗效。但是本发明想要强调的是,本发明的核心并非是在于发现了何种新的中药原料,而是在于如何从现有技术茫茫已有药材中进行配伍组合,以获得一种专用于祛风湿的、疗效显著的配方。原因在于,在中药领域,对于每一味药材的使用,都需要符合相关法律法规在安全性方面的要求,并不能随意地添加新的药材。而能够选用的药材,也必然是事先被报道过并经过允许添加的。因此在本领域中几乎不可能将新药材的选用来作为创造点。绝大多数的中药专利均是利用现有药材进行组合,通过定量的药效数据来体现创造性。
本发明的上述配方并非是简单的拼凑组合,而是多种药材之间在药理上能够协同增效,与现有的同类中药或医药相比,疗效更好(与现有技术相比取得了显著的进步)。由于中药领域是一门实践性科学,影响疗效的因素是多方面的、相互交叉且错综复杂的,有的原理甚至是迄今仍无法解释的(在中药领域尤其常见),其可预测性较差。只替换某药材或者修改小部分的配比,就可能带来完全不同的技术效果,因此本领域技术人员在未进行具体的临床实验前,通常无法准确预知结果。因此,中药领域创造性的体现严重依赖于量化的临床结果,而不能简单地以配方的组成来判断其创造性,更不能将配方中各组成一一拆解后再进行比对,而应该从整体上来判断其技术效果。
本发明配方中各药材的君臣佐使分布如下:
君药为:邬梢蛇、地龙、防风、海风藤、海桐皮、威灵仙、羌活、络石藤;
臣药为:防已、米仁、丹参、葛根、川牛滕、升麻、玄参、狗脊、炙龟板、细辛、太子参、黄芪、黄芩;
佐药为:干姜、桂枝;
使药为:甘草、神曲。
本发明配方具体的配伍机理如下:本发明团队结合中药理论基础和大量实践,发现将乌梢蛇、地龙、防风、络石藤、海风藤、威灵仙按照特定比例复配后可协同配合,可使祛风止痛作用更佳,在此基础上再配合丹参和川牛滕能够起到更好的活血通络效果(效果优于单独使用),再在上述基础上配合米仁和防已可排出湿气,配合太子参、玄参和葛根滋阴,补津液以及配合神曲和黄芪的调理脾胃,降躁;能够发生协同增效的作用,起到“1+1>2”的效果。而若采用其他同类药材替代,则效果会明显打折。
作为进一步优选,祛风湿膏包括以下重量份的组分:邬梢蛇90-110份,地龙110-130份,防风110-130份,防已110-130份,络石藤110-130份,海风藤140-160份,甘草60-80份,干姜110-130份,米仁220-260份,丹参170-190份,葛根140-150份,川牛滕140-150份,威灵仙110-130份,海桐皮110-130份,升麻60-80份,桂枝110-130份,玄参140-150份,狗脊110-130份,羌活110-130份,炙龟板110-130份,细辛45-55份,太子参170-190份,黄芪170-190份,神曲110-130份,黄芩110-130份,人参180-220份。
最优选地,祛风湿膏包括:邬梢蛇100份,地龙120份,防风120份,防已120份,络石藤120份,海风藤150份,甘草70份,干姜120份,米仁240份,丹参180份,葛根144份,川牛滕144份,威灵仙120份,海桐皮120份,升麻72份,桂枝120份,玄参144份,狗脊120份,羌活120份,炙龟板120份,细辛48份,太子参180份,黄芪180份,神曲120份,黄芩120份,人参200份。
作为优选,祛风湿膏还包括阿胶200-300份,核桃250-350份,芝麻250-350份,冰糖150-250份,黄酒150-250份。
作为进一步优选,祛风湿膏还包括阿胶220-280份,核桃280-320份,芝麻280-320份,冰糖180-220份,黄酒180-220份。
最优选地,祛风湿膏还包括阿胶250份,核桃300份,芝麻300份,冰糖200份,黄酒200份。
有本发明产品为口服制剂,但是基础配方的口感较差,为此,本发明针对本发明特定基础配方,再添加上述物质的添加,一方面能够使祛风湿膏的口感更佳,另一方面使产品具有适当的粘稠度,可以成形,易于保存。
作为优选,所述祛风湿膏为口服制剂。
作为优选,所述祛风湿膏的给药量为80-120g/天。
作为优选,所述祛风湿膏给药量为40-60g/次,2次/天。
作为优选,所述祛风湿膏给药量周期为2-4个月。
与现有技术对比,本发明的有益效果是:本发明的祛风湿膏,其口服后能够缓解关节疼痛,关节肿胀和压痛,用于治疗风湿、类风湿以及强直性脊柱炎等引起的腰酸背痛和晨僵。
具体实施方式
下面结合实施例对本发明作进一步的描述。
总实施例
一种祛风湿膏,包括以下重量份的组分:邬梢蛇80-120份,地龙100-140份,防风100-140份,防已100-140份,络石藤100-140份,海风藤130-170份,甘草50-90份,干姜100-140份,米仁200-280份,丹参160-200份,葛根130-160份,川牛滕130-160份,威灵仙100-140份,海桐皮100-140份,升麻50-90份,桂枝100-140份,玄参130-160份,狗脊100-140份,羌活100-140份,炙龟板100-140份,细辛40-60份,太子参160-200份,黄芪160-200份,神曲100-140份,黄芩100-140份,阿胶200-300份,人参150-250份,核桃250-350份,芝麻250-350份,冰糖150-250份,黄酒150-250份。
作为优选,祛风湿膏包括以下重量份的组分:邬梢蛇90-110份,地龙110-130份,防风110-130份,防已110-130份,络石藤110-130份,海风藤140-160份,甘草60-80份,干姜110-130份,米仁220-260份,丹参170-190份,葛根140-150份,川牛滕140-150份,威灵仙110-130份,海桐皮110-130份,升麻60-80份,桂枝110-130份,玄参140-150份,狗脊110-130份,羌活110-130份,炙龟板110-130份,细辛45-55份,太子参170-190份,黄芪170-190份,神曲110-130份,黄芩110-130份,阿胶220-280份,人参180-220份,核桃280-320份,芝麻280-320份,冰糖180-220份,黄酒180-220份。
进一步地,祛风湿膏包括:邬梢蛇100份,地龙120份,防风120份,防已120份,络石藤120份,海风藤150份,甘草70份,干姜120份,米仁240份,丹参180份,葛根144份,川牛滕144份,威灵仙120份,海桐皮120份,升麻72份,桂枝120份,玄参144份,狗脊120份,羌活120份,炙龟板120份,细辛48份,太子参180份,黄芪180份,神曲120份,黄芩120份,阿胶250份,人参200份,核桃300份,芝麻300份,冰糖200份,黄酒200份。
作为优选,所述祛风湿膏为口服制剂。所述祛风湿膏给药量为80-120g/天。进一步优选为40-60g/次,2次/天。给药量周期为2-4个月。
以下病例采用以下配方:
邬梢蛇100份,地龙120份,防风120份,防已120份,络石藤120份,海风藤150份,甘草70份,干姜120份,米仁240份,丹参180份,葛根144份,川牛滕144份,威灵仙120份,海桐皮120份,升麻72份,桂枝120份,玄参144份,狗脊120份,羌活120份,炙龟板120份,细辛48份,太子参180份,黄芪180份,神曲120份,黄芩120份,阿胶250份,人参200份,核桃300份,芝麻300份,冰糖200份,黄酒200份。
给药量为50g/次,2次/天。
病例1
刘某某,47岁,男,B27呈阳性,背部酸胀疼痛,夜里2-3点疼痛加强,难以入睡。脊柱侧弯、后伸、旋转受限。服用该膏方2个月后,腰背疼痛减轻,夜间不再出现痛感,颈椎活动自如。
病例2
陆某某,35岁,经诊断患腰突症,间歇性腰痛2年,脊柱活动受限半年,无法弯腰,阴雨天疼痛加剧,服用膏方2年后,腰突症彻底治愈,不再疼痛,活动自如。
病例3
李某,38岁,男,B27呈阳性,经诊断患强直性脊柱炎,脊柱4-5节疼痛,夜里3、4点疼痛加剧,脸色发灰,大便干涩。服用膏方2个月后,饮食正常,面色红润,二便正常,脊柱疼痛消失。
病例4
黄某,男,35岁,B27呈阳性,因上升性腰背酸痛8年,伴左下肢疼痛、麻木1年,病人8年前因跌伤腰骶部,外感风湿后感腰肌僵痛,昼轻夜重,逐渐加重,晨僵时间30-60分钟。诊断:脊柱腰段活动受到限制轻度左侧弯、脊柱及骶骨关节压痛,骨盆挤压与分离试验阳性;舌红、苔黄腻,脉滑数。在化验血红蛋白95g/L,血沉32mm/1h。X线显示:腰椎后关节间隙模糊、消失,后纵韧带轻度钙化;关节面硬化、间隙毛糙、左侧可见囊性变,关节下1/3韧带钙化明显。连续服用该膏方30日,病人自觉症状消失,活动如常,血沉12mm/1h,血红蛋白120g/L。
病例5
刘某,男,19岁,患者3年前出现腰骶部疼痛及右膝关节疼痛,自服止痛片缓解。1年前腰骶部疼痛加重,伴腰部僵硬,阴雨天尤甚,不能久坐久立。诊见:腰部活动明显受限,HLA-b27阳性,血沉68mm/h,C反应蛋白阴性,类风湿因子阴性。X线显示关节间隙模糊,轻度变窄。诊断为强直性脊柱炎。服用该膏方后,7日后疼痛明显减轻,15剂后疼痛基本消失,腰椎活动范围增大;继续服用60日,检查血沉14mm/h,C反应蛋白阴性。
通过上述病例可知,本发明祛风湿膏具有较好的抗炎、镇痛作用,为进一步探讨其抗炎、镇痛作用机制,本发明以58例患者为基础,评估在长期临床规律口服祛风湿膏疗法下治疗强直性脊柱炎和此后每12个星期的基线。
1.资料与方法
1.1一般资料
选取58例强直性脊柱炎(43名男性和15名女性,平均年龄35岁,平均病程6年)为实验对象。
1.2治疗方案
在这项研究中,所有2018年1月至2018年12月确诊为AS患者开始每天使用2次,每次50g口服祛风湿膏并在2019年1月评估为疾病缓解。治疗是持续到疾病突然恶化。在方案开始之前,每个患者被告知其性质、持续时间、研究目的,以及所有可预期的潜在好处和缺点。所有的参与者都上交他们的书面知情同意书。
关节内注射,全身糖皮质激素和非甾体类抗炎药物均不允许在治疗期间使用。在发生疼痛情况下,患者可以使用镇痛药(曲马多类)。任一组患者均不接受心理治疗或理疗。
1.3定义
疾病缓解期:指患者BASDA评分<4,没有额外的轴向外周关节炎,趾炎,腱鞘炎,或前葡萄膜炎的表现,红细胞沉降率和C反应蛋白正常水平,则被认为是在缓解期。
疾病爆发:患者在随访BASDAI>4或任何其他上面提到的外周关节和关节外表现急性期反应物独立性升高。
指(趾)炎:整个手指或脚趾弥漫性压痛,肿胀腊肠外观。
附着点炎:肌腱压痛和肿胀、韧带及关节囊钙化,马斯特里赫特强直性脊柱炎评分为20。
炎症性脊椎疼痛:当患者符合克林标准的临床特征,则其被定义为具有炎症性脊椎疼痛。
1.4随访
患者都由同一风湿病专家随访,并且后续随访被安排一个月后,之后每3个月随访。在出现紧急的临床问题时缩短访问间隔。当出现有关任何轴向恶化或并发症,关节外临床表现或不良反应,所有的患者均要求告知医生。
在每一次随访中,患者均接受一个全面的身体检查包括所有前面列出的检测结果。同时进行血常规类检查,包括血沉、C反应蛋白、类风湿因子、全血细胞计数和分类计数,肾功能和肝功能检查,抗核抗体等。所有的临床和实验室数据被记录在电子病历中。
1.5统计分析
临床疗效分析采用的两样本秩和检验和t检验,t检验被用来计算两个治疗组之间的差异。采用Windows11统计软件包的社会科学版本计算描述性统计和统计差异。P值小于0.05为具有统计学意义。
2.结果
患者在登记之后的随访中疾病的缓解作为主要结果评估标准。次要结果评估标准是病人在研究结束时实现缓解的比例,即ASAS 20、50、70反应,BASMI,BASDAI,BASFI分数改善,扩胸实验,手指撑地实验,压痛、关节肿胀、疼痛指数,指(趾)炎表现指数、红细胞沉降率和C反应蛋白的水平,不良反应的频率和严重程度。
从2018年1月至2018年12月,58例强直性脊柱炎患者口服祛风湿膏100g/天。下表总结了病人在基线的人口统计学和临床特征(其中有6例未全程服用)。
【缩写】ASAS:评估强直性脊柱炎;BASDAI:巴氏强直性脊柱炎疾病活动指数;BASFI:巴氏强直性脊柱炎功能指数;BASMI:巴氏强直性脊柱炎计量指数;SD:标准差;ESR:红细胞沉降率(魏氏);CRP:C-反应蛋白。
与类风湿性关节炎不同,抗肿瘤坏死因子的治疗肯定能抑制强直性脊柱炎患者影像学发展,所以临床缓解在我们的研究中被定义为抑制疾病的症状和体征,在接受祛风湿膏每天2次,每次50g口服治疗平均时间为11±4.9个月后,52例患者中有29例(55.8%)达到这一结果(强直性脊柱炎为慢性病,目前的医学水平基本很难作为完全根治)。此外,有94%的患者具有疗效(ASAS20),73.1%的患者具有较好疗效(ASAS50)。
因此,我们认为一半以上强直性脊柱炎患者长期使用祛风湿膏每天2次,每次50g口服可以有效缓解。说明祛风湿膏治疗强直性脊柱炎具有较好的临床疗效,我院长期临床观察显示规律口服祛风湿膏后,患者纤维蛋白原、血液黏稠度等指标明显下降,说明祛风湿膏对于改善血循环有着积极的作用,可以促进患者的血液循环,改善血液的微凝状态,从而改善临床症状。服用祛风湿膏后,患者的腰脊背胸颈及关节等部位疼痛、僵硬、基本消失或明显减轻,无发热、血沉、C反应蛋白等实验室检查结果基本在正常范围,全方具有补肾祛寒、壮督除湿、散风除湿、强壮筋骨、燮理肝肺、通络利节的作用。
通过上述数据可知,本发明配方的祛风湿膏与目前的医药相比,具有显著的疗效。
本发明中所用原料、设备,若无特别说明,均为本领域的常用原料、设备;本发明中所用方法,若无特别说明,均为本领域的常规方法。
以上所述,仅是本发明的较佳实施例,并非对本发明作任何限制,凡是根据本发明技术实质对以上实施例所作的任何简单修改、变更以及等效变换,均仍属于本发明技术方案的保护范围。
Claims (10)
1.一种祛风湿膏,其特征在于包括以下重量份的组分:邬梢蛇80-120份,地龙100-140份,防风100-140份,防已100-140份,络石藤100-140份,海风藤130-170份,甘草50-90份,干姜100-140份,米仁200-280份,丹参160-200份,葛根130-160份,川牛滕130-160份,威灵仙100-140份,海桐皮100-140份,升麻50-90份,桂枝100-140份,玄参130-160份,狗脊100-140份,羌活100-140份,炙龟板100-140份,细辛40-60份,太子参160-200份,黄芪160-200份,神曲100-140份,黄芩100-140份,人参150-250份。
2.如权利要求1所述的一种祛风湿膏,其特征在于包括以下重量份的组分:邬梢蛇90-110份,地龙110-130份,防风110-130份,防已110-130份,络石藤110-130份,海风藤140-160份,甘草60-80份,干姜110-130份,米仁220-260份,丹参170-190份,葛根140-150份,川牛滕140-150份,威灵仙110-130份,海桐皮110-130份,升麻60-80份,桂枝110-130份,玄参140-150份,狗脊110-130份,羌活110-130份,炙龟板110-130份,细辛45-55份,太子参170-190份,黄芪170-190份,神曲110-130份,黄芩110-130份,人参180-220份。
3.如权利要求2所述的一种祛风湿膏,其特征在于包括以下重量份的组分:邬梢蛇 100份,地龙120份,防风120份,防已120份,络石藤120份,海风藤150份,甘草70份,干姜120份,米仁240份,丹参180份,葛根144份,川牛滕144份,威灵仙120份,海桐皮120份,升麻72份,桂枝120份,玄参144份,狗脊120份,羌活120份,炙龟板120份,细辛48份,太子参180份,黄芪180份,神曲120份,黄芩120份,人参200份。
4.如权利要求1-3之一所述的一种祛风湿膏,其特征在于,还包括阿胶200-300份,核桃250-350份,芝麻250-350份,冰糖150-250份,黄酒150-250份。
5.如权利要求4所述的一种祛风湿膏,其特征在于,还包括阿胶220-280份,核桃280-320份,芝麻280-320份,冰糖180-220份,黄酒180-220份。
6.如权利要求5所述的一种祛风湿膏,其特征在于,还包括阿胶250份,核桃300份,芝麻300份,冰糖200份,黄酒200份。
7.如权利要求1-6之一所述的一种祛风湿膏,其特征在于,所述祛风湿膏为口服制剂。
8.如权利要求7所述的一种祛风湿膏,其特征在于,所述祛风湿膏的给药量为80-120g/天。
9.如权利要求8所述的一种祛风湿膏,其特征在于,所述祛风湿膏给药量为40-60g/次,2次/天。
10.如权利要求9所述的一种祛风湿膏,其特征在于,所述祛风湿膏给药量周期为2-4个月。
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