CN105381272A - 一种治疗骨关节炎的中药汤剂及其制备方法 - Google Patents
一种治疗骨关节炎的中药汤剂及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗骨关节炎的中药汤剂及其制备方法,所述中药由下述重量份数的药材制成:怀牛膝17-35份,黄芪12-29份,鸡骨草8-16份,瓜蒌子11-24份,肉苁蓉10-18份,西青果5-12份,苦玄参15-28份,宽筋藤7-16份,广东紫珠3-9份,天麻5-15份,苦地丁4-16份,枳壳5-21份,卜芥9-23份,川射干10-19份,杜仲12-28份。本发明的中药组合物具有补肾益精、气血双补、活血化瘀、通络强筋、祛风除湿、止痛祛痹作用,对多种病因引起的骨关节炎具有显著的治疗效果;本发明所选材料皆为传统中药材料,药源易得,疗效显著,无任何毒副作用。
Description
技术领域
本发明涉及一种治疗骨关节炎的中药,属于医药技术领域。
背景技术
骨关节炎是以关节软骨退变为主的病理改变,临床以关节疼痛、肿胀、及活动受限为主要症状的慢性骨关节病。发病机制受年龄因素、遗传因素、外部刺激等因素的多重作用导致滑膜、软骨和骨的代谢改变,进而产生炎症。
骨关节炎的另一个症状为关节积液。手术能较好的排出积液并能有效防止在手术过程中造成感染,但是手术费用高昂。且手术排出关节积液为治标不治本的方式,无法根除病症,一段时间过后,关节积液往复出现。
中医认为,骨关节炎属于“骨痹”范畴。认为其发病不外乎外感风寒湿邪,内伤于肝肾不足,气血失和或有跌仆损伤,均使气血运行不畅,络脉阻滞不通,病久则肝肾两亏,筋软骨萎,功能障碍。该疾患的治疗,主要为中西药物治疗和非药物治疗,其中非药物治疗为患者健康教育、自我训练、关节活动度训练、肌力训练、助行工具的使用、膝内翻的楔行鞋垫、职业治疗及关节保护、日常生活的辅助设施等;药物治疗包括:透明质酸钠关节腔内注射,口服氨基葡萄糖,口服或外用非甾体镇痛抗炎药。
发明内容
本发明所要解决的技术问题是:提供一种治疗骨关节炎的纯中药配方,该中药组合物配制方便、疗效显著、无副作用。
为解决上述技术问题,本发明采用的技术方案是:
提供的治疗骨关节炎的中药汤剂由下述重量份数的药材制成:怀牛膝17-35份,黄芪12-29份,鸡骨草8-16份,瓜蒌子11-24份,肉苁蓉10-18份,西青果5-12份,苦玄参15-28份,宽筋藤7-16份,广东紫珠3-9份,天麻5-15份,苦地丁4-16份,枳壳5-21份,卜芥9-23份,川射干10-19份,杜仲12-28份。
优选的,所述重量份数的药材制成:怀牛膝20-30份,黄芪15-25份,鸡骨草10-14份,瓜蒌子13-20份,肉苁蓉12-16份,西青果7-10份,苦玄参17-25份,宽筋藤9-14份,广东紫珠4-8份,天麻7-13份,苦地丁5-15份,枳壳8-18份,卜芥12-20份,川射干12-17份,杜仲15-25份。
进一步的,所述中药由下述重量份数的药材制成:怀牛膝25份,黄芪20份,鸡骨草12份,瓜蒌子17份,肉苁蓉14份,西青果10份,苦玄参21份,宽筋藤12份,广东紫珠6份,天麻10份,苦地丁10份,枳壳13份,卜芥16份,川射干15份,杜仲20份。
进一步的,所述中药由下述重量份数的药材制成:怀牛膝35份,黄芪29份,鸡骨草16份,瓜蒌子24份,肉苁蓉18份,西青果12份,苦玄参28份,宽筋藤16份,广东紫珠9份,天麻15份,苦地丁16份,枳壳21份,卜芥23份,川射干19份,杜仲28份。
进一步的,所述中药由下述重量份数的药材制成:怀牛膝17份,黄芪12份,鸡骨草8份,瓜蒌子11份,肉苁蓉10份,西青果5份,苦玄参15份,宽筋藤7份,广东紫珠3份,天麻5份,苦地丁4份,枳壳5份,卜芥9份,川射干10份,杜仲12份。
为了更好地表达本发明的中药组合物,本发明的中药组合物可以制备成临床上常用的剂型。比如,粉状制剂、散剂、丸剂、丹剂、膏剂、颗粒剂、口服液、糖浆、片剂、胶囊剂等制剂,所述药物制剂均可按照本领域技术人员所熟知的中药制剂制备方法制备得到。优选的,本发明中药组合物按照常规制备工艺制备成汤剂、片剂或胶囊剂。
本发明还提供了一种上述所述中药组合物的制备方法,其主要包含下述步骤:将所述配方量中药怀牛膝、黄芪、鸡骨草、瓜蒌子、肉苁蓉、西青果、苦玄参、宽筋藤、广东紫珠、天麻、苦地丁、枳壳、卜芥、川射干、杜仲粉碎,过100-130目筛,得细粉;将粉混合均匀,置于通透袋内,用温度为25-35℃的清水浸泡24小时(优选22小时),用水量为所述细粉量的6倍;武火煮沸,文火煎煮50分钟后取出通透袋,所得液体浓缩至原体积的0.3-0.5倍,得浓缩液;浓缩液中可加入适量的蜂蜜,得到混合液,所得混合液无菌灌装,每袋100mL,既得中药汤剂。
本发明的中药为口服,服用方法:每日三次,每次1袋,饭后1小时后温服。14天为1个疗程。
有益效果:本发明的中药组合物具有补肾益精、气血双补、活血化瘀、通络强筋、祛风除湿、止痛祛痹作用,对多种病因引起的骨关节炎具有显著的治疗效果;本发明所选材料皆为传统中药材料,药源易得,疗效显著,无任何毒副作用。
具体实施方式
实施例1
本实施例的中药汤剂由下述重量份数的药材制成:怀牛膝25份,黄芪20份,鸡骨草12份,瓜蒌子17份,肉苁蓉14份,西青果10份,苦玄参21份,宽筋藤12份,广东紫珠6份,天麻10份,苦地丁10份,枳壳13份,卜芥16份,川射干15份,杜仲20份。
制备方法及使用方法:将所述配方量中药怀牛膝、黄芪、鸡骨草、瓜蒌子、肉苁蓉、西青果、苦玄参、宽筋藤、广东紫珠、天麻、苦地丁、枳壳、卜芥、川射干、杜仲粉碎,过100-130目筛,得细粉;将粉混合均匀,置于通透袋内,用温度为25-35℃的清水浸泡24小时(优选22小时),用水量为所述细粉量的6倍;武火煮沸,文火煎煮50分钟后取出通透袋,所得液体浓缩至原体积的0.3-0.5倍,得浓缩液;浓缩液中可加入适量的蜂蜜,得到混合液,所得混合液无菌灌装,每袋100mL,既得中药汤剂。每日三次,每次1袋,饭后1小时后温服。14天为1个疗程。
实施例2
本实施例的中药汤剂由下述重量份数的药材制成:怀牛膝35份,黄芪29份,鸡骨草16份,瓜蒌子24份,肉苁蓉18份,西青果12份,苦玄参28份,宽筋藤16份,广东紫珠9份,天麻15份,苦地丁16份,枳壳21份,卜芥23份,川射干19份,杜仲28份。
制备方法及使用方法:将所述配方量中药怀牛膝、黄芪、鸡骨草、瓜蒌子、肉苁蓉、西青果、苦玄参、宽筋藤、广东紫珠、天麻、苦地丁、枳壳、卜芥、川射干、杜仲粉碎,过100-130目筛,得细粉;将粉混合均匀,置于通透袋内,用温度为25-35℃的清水浸泡24小时(优选22小时),用水量为所述细粉量的6倍;武火煮沸,文火煎煮50分钟后取出通透袋,所得液体浓缩至原体积的0.3-0.5倍,得浓缩液;浓缩液中可加入适量的蜂蜜,得到混合液,所得混合液无菌灌装,每袋100mL,既得中药汤剂。每日三次,每次1袋,饭后1小时后温服。14天为1个疗程。
实施例3
本实施例的中药汤剂由下述重量份数的药材制成:怀牛膝17份,黄芪12份,鸡骨草8份,瓜蒌子11份,肉苁蓉10份,西青果5份,苦玄参15份,宽筋藤7份,广东紫珠3份,天麻5份,苦地丁4份,枳壳5份,卜芥9份,川射干10份,杜仲12份。
制备方法及使用方法:将所述配方量中药怀牛膝、黄芪、鸡骨草、瓜蒌子、肉苁蓉、西青果、苦玄参、宽筋藤、广东紫珠、天麻、苦地丁、枳壳、卜芥、川射干、杜仲粉碎,过100-130目筛,得细粉;将粉混合均匀,置于通透袋内,用温度为25-35℃的清水浸泡24小时(优选22小时),用水量为所述细粉量的6倍;武火煮沸,文火煎煮50分钟后取出通透袋,所得液体浓缩至原体积的0.3-0.5倍,得浓缩液;浓缩液中可加入适量的蜂蜜,得到混合液,所得混合液无菌灌装,每袋100mL,既得中药汤剂。每日三次,每次1袋,饭后1小时后温服。14天为1个疗程。
临床资料
1.资料与方法
1.1临床资料
1.1.1病例选择
诊断标准参照美国风湿病学会(ACR)1987年膝OA诊断标准:(1)近1个月大多数有膝关节痛;(2)活动时有磨擦响声;(3)晨僵≤30min;(4)年龄≥38岁;(5)有骨性膨大。具(1)+(2)+(3)+(4)条或(1)+(2)+(5)或(1)+(4)+(5)即可诊断为膝OA。痹症的中医辨证诊断标准参照国家中医药管理制定的标准。其中,肝肾亏虚,经络阻塞症的具症:中年以上,腰腿酸软,膝关节疼痛,屈伸不利,不能久立远行,久痛不已,舌紫暗或有瘀斑,脉弦涩或沉紧。
1.1.2纳入标准
①符合诊断标准和中医辨证标准。②年龄为40-70岁,有明显夜间痛,病程大于1个月,均作膝关节X摄片.X线分级按Kcllgren标准达到2-3级,但不伴有肝、肾功能损害及心、肺、血液病及其他关节炎和脊柱疾病.RF阴性者。③入选前1个月均未接受过非甾体抗炎药和其他改善关节功能药治疗。
1.1.3排除标准
患者曾发生两次或两次以上的活动性消化生溃疡、胃肠道出血或胃、十二指肠溃疡;活动性胃肠道疾病(克隆氏病或溃疡性结肠炎),或研究者认为不应使用NSAID的其他情况;患者合并其他关节炎(如RA)或活动性恶性疾病(基底细胞癌除外);患者肝肾功能不全;患者在人选前8周内曾接受皮质类固醇激素的关节内/肌肉内注射.或透明质酸关节内注射;患者在接受首剂研究用药前30大内已经使用过任何一种研究药物。
1.1.4一般资料
将100例(男38例,女62例)按随机数字表法分为对照组(50例)和治疗组(50例)。两组患者性别、年龄、病程、关节疼痛的视觉模糊评分VAS值,Womac评分及lequesne指数差异,无统计学意义。
1.2方法
1.2.1问卷调查。所有受试对象均完成临床调查表,并逐项填表。
1.2.2给药方法
对照组:口服双醋瑞因(50mg,bid)和塞来昔布(0.2g/d)治疗,疼痛症状缓解以后停用塞来昔布,双醋瑞因继续使用,每2周为1疗程。
治疗组:服用本发明的中药汤剂,每日三次,每次1袋,饭后1小时后温服。14为1个疗程。
连续治疗2个疗程。
1.2.3疗效评价
(1)西医标准:采用国际骨关节炎的评分标准lequesne指数(包括休息时痛、运动时痛、关节压痛、关节肿胀、关节晨僵及行走能力等6局部症状指标)及Womac评分(包括疼痛分量表;关节僵硬分量表;关节分量表三个部分共24项指标),患者VAS评分用0~100mm的比例尺,0mm为正常,100mm为最严重的状态。分别于治疗前和治疗4周后及停药2周后,评定患侧膝关节VAS值,Womac评分及lequesne指数的改善值,此3项总分平均下降≥30%,≤50%为有效,≥51%,≤75%为显效,≥76%为临床控制,≤29%为无效,总有效率表示为:改善病例数/总病例数×100%。
(2)中医标准:采用《中药新药的临床研究指导原则》将休息痛、活动痛、关节压痛、关节肿胀、关节活动度,综合计算百分数:疗效=(治疗前总分数-治疗后总分数)/治疗前总分数×100%。综合疗效判断标准:临床治愈:疗效≥90%;显效,75%≤疗效<90%;有效,35%≤疗效<75%;无效,疗效指数<35%。有效率(%)=(治愈+显效+有效病例数)/总病例数×100%。
1.2.4检测指标的测定
(1)血液流变学测定
患者治疗前及治疗4周后清晨空腹静脉采血2mL。用MS/XW-E血流变微循环仪(成都麦塞科贸公司),经综合传感法测定高切和低切变率下的全血粘度,用毛细管粘度计测定血浆粘度,用综合传感浊度测定相对粘度,用比浊法测定聚集指数。(2)血清IL-1β,TNF-α测定患者治疗前及治疗4周后清晨空腹静脉采血2mL,待血液凝固后立即分离血清,-20℃保存备检。采用酶标双抗体夹心ELISA法检测血清中IL-1β,TNF-α的水平,采用美国产Multiskan全自动酶标仪,配置一系列标准溶液测吸光度后,绘制标准曲线,自动计算待测样品含量。
(3)血清NO,iNOS测定
患者治疗前及治疗4周后清晨空腹静脉采血2mL,待血液凝固后立即分离血清,-20℃保存备检。NO及iNOS试剂盒购自南京建成生物工程公司,严格按照说明书操作。UV755B分光光度计530nm测定吸光度,计算结果。
(4)血浆过氧化脂质(LPO)超氧化物岐化酶(SOD)的测定
患者治疗前后清晨空腹静脉采血2.5mL,肝素抗凝,采用TBA荧光法测定血浆过氧化脂质(LPO),采用黄嘌呤氧化酶法测定超氧化物岐化酶(SOD)。
1.2.5不良反应监测
记录治疗过程中发生的各种不良反应,包括眩晕、皮疹、胃肠道反应、注射局部红肿及全身水肿等及其持续时间和转归,治疗后查血、尿常规及肝、肾功能。
2.结果
2.1观察指标比较
治疗4周以后,两组患者的VAS值、Womac评分及lequesne指数及膝关节休息痛、活动痛、关节压痛、关节肿胀、关节活动度均有明显改善,治疗组的改善程度明显优于对照组,其差别有显著性。
2.2疗效比较
治疗4周,按西医的疗效评判标准治疗组的临床控制率达到35.3%,明显高于对照组的21.8%;按中医的疗效评判标准,治疗组的治愈率达39.5%,明显高于对照组的22.8%。
2.3观察指标比较
2.3.1血液流变学测定结果
治疗4周后治疗组的血液流变学4项指标均有显著改善,明显优于对照组,而对照组的改善不明显,
2.3.2血清IL-1β、TNF-α、NO、iNOS的测定结果
治疗4周后两组患者的IL-1β、TNF-α、NO、iNOS均有显著改善,尤以治疗组的改善更明显,差别有显著性。
2.3.3血浆LPO、SOD的测定结果
治疗4周后两组患者LPO、SOD均有显著改善,尤以治疗组的改善更明显,差别有显著性。
2.4不良反应监测结果
治疗4周期间,所有患者均未报告有主观不适,血常规、肝功能、肾功能检查亦无异常。
3.结论
本发明的中药的疗效优于传统的治疗方案(双醋瑞因+塞来昔布)而无不良反应。
典型病例
病例1:王某,女,67岁,双膝关节疼痛四年,活动受限,不能下蹲、上厕所、上下楼困难。经查:其双侧膝关节部轻度肿胀,服用本发明药物,治疗2个疗程后,后两膝关节酸痛减轻,其余症状减轻。继续服用2个疗程,痊愈,一年后随访无复发。
病例2:郭某,男,51岁,右膝关节肿痛10个月,加重2周;左膝关节肿痛3年,加重1月。以前,无明显诱因出现左膝关节的疼痛症状,以上、下楼梯时症状为重。近期出现左膝关节的肿胀、疼痛症状加剧。服用本发明中药2个疗程,双膝关节疼痛大大减轻,左膝关节肿胀减轻,右膝关节肿消失;继续服药3个疗程,复查,双膝关节肿疼消失,活动行走正常。
病例3:任某,女,62岁,经常出现膝关节疼痛,工作时偶发膝关节无法正常弯曲。后淋雨后,膝关节疼痛明显加重,走路时亦无法正常弯曲,服用本发明中药2个疗程后,膝关节疼痛症状明显减轻,继续服用4个疗程后,膝关节疼痛症状消失,痊愈,半年回访无复发。
病例4:王某,男,53岁,患膝关节炎3年,伴随有少量积液。膝关节积液影响正常晨练、生活。服用本发明中药2个疗程后,症状明显减轻,继续服用2个疗程,疼痛完全消失,检查膝关节积液消失,痊愈,一年内回访无复发。
以上实施例的说明只是用于帮助理解本发明的方法及其核心思想。应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以对本发明进行若干改进和修饰,这些改进和修饰也落入本发明权利要求的保护范围内。
Claims (6)
1.一种治疗骨关节炎的中药汤剂,其特征在于,所述中药由下述重量份数的药材制成:怀牛膝17-35份,黄芪12-29份,鸡骨草8-16份,瓜蒌子11-24份,肉苁蓉10-18份,西青果5-12份,苦玄参15-28份,宽筋藤7-16份,广东紫珠3-9份,天麻5-15份,苦地丁4-16份,枳壳5-21份,卜芥9-23份,川射干10-19份,杜仲12-28份。
2.根据权利要求1所述的中药汤剂,其特征在于,所述中药由下述重量份数的药材制成:怀牛膝20-30份,黄芪15-25份,鸡骨草10-14份,瓜蒌子13-20份,肉苁蓉12-16份,西青果7-10份,苦玄参17-25份,宽筋藤9-14份,广东紫珠4-8份,天麻7-13份,苦地丁5-15份,枳壳8-18份,卜芥12-20份,川射干12-17份,杜仲15-25份。
3.根据权利要求1所述的中药汤剂,其特征在于,所述中药由下述重量份数的药材制成:怀牛膝25份,黄芪20份,鸡骨草12份,瓜蒌子17份,肉苁蓉14份,西青果10份,苦玄参21份,宽筋藤12份,广东紫珠6份,天麻10份,苦地丁10份,枳壳13份,卜芥16份,川射干15份,杜仲20份。
4.根据权利要求1所述的中药汤剂,其特征在于,所述中药由下述重量份数的药材制成:怀牛膝35份,黄芪29份,鸡骨草16份,瓜蒌子24份,肉苁蓉18份,西青果12份,苦玄参28份,宽筋藤16份,广东紫珠9份,天麻15份,苦地丁16份,枳壳21份,卜芥23份,川射干19份,杜仲28份。
5.根据权利要求1所述的中药汤剂,其特征在于,所述中药由下述重量份数的药材制成:怀牛膝17份,黄芪12份,鸡骨草8份,瓜蒌子11份,肉苁蓉10份,西青果5份,苦玄参15份,宽筋藤7份,广东紫珠3份,天麻5份,苦地丁4份,枳壳5份,卜芥9份,川射干10份,杜仲12份。
6.制备上述任一项权利要求所述的中药汤剂的方法,其特征在于,配方量中药怀牛膝、黄芪、鸡骨草、瓜蒌子、肉苁蓉、西青果、苦玄参、宽筋藤、广东紫珠、天麻、苦地丁、枳壳、卜芥、川射干、杜仲粉碎,过100-130目筛,得细粉;将粉混合均匀,置于通透袋内,用温度为25-35℃的清水浸泡24小时(优选22小时),用水量为所述细粉量的6倍;武火煮沸,文火煎煮50分钟后取出通透袋,所得液体浓缩至原体积的0.3-0.5倍,得浓缩液;浓缩液中可加入适量的蜂蜜,得到混合液,所得混合液无菌灌装,每袋100mL,既得中药汤剂。
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