CN116942740A - 一种治疗腰椎间盘突出症的中药组合物及其应用 - Google Patents
一种治疗腰椎间盘突出症的中药组合物及其应用 Download PDFInfo
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Abstract
本发明提供一种治疗腰椎间盘突出症的中药组合物，是由以下重量份的原料药制成：苏木46‑54份、花椒8‑12份、制没药8‑12份、制乳香8‑12份、制草乌13‑17份、制川乌13‑17份、红花8‑12份、木瓜8‑12份、桂枝13‑17份、伸筋草13‑17份、炒路路通13‑17份、甘草4‑8份、小茴香4‑8份、白芷7‑11份。本发明还提供了中药组合物的用途。其优点在于：该中药组合物君臣分明、佐使得当，共奏活血祛瘀，行气止痛，温中散寒，祛风除湿，舒筋活络之功效。临床研究结果表明该中药组合物对腰椎间盘突出有确切的治疗效果，疗程短、显效快、治愈率高。
Description
【技术领域】
本发明涉及一种治疗腰椎间盘突出症的中药组合物及其应用，具体地说，是以中草药为原料制备的中成药。
【背景技术】
腰间盘突出症是一种非常普遍的腰腿部的疾病，严重影响着人们的健康，病人不仅经历不同程度的疼痛，而且很大程度降低或者完全丧失劳动能力，甚至部分患者造成终身残疾。从国内外流行病分析来看，其发病率的人口比率和绝对数值均呈上升趋势，更可怕的是腰椎间盘突出患者越来越年轻化。目前临床上对其治疗方法很多，患者面临着选择难，耗时长，疗效差等诸多问题。
浙江中医杂志，2000(07)，公开了“手法加中药热敷治疗腰椎间盘突出症103例”，文章提及到中药热敷药物是由红花、钻地风、宣木瓜、乳香、没药各10g，伸筋草、千年健、桂枝、紫草、路路通、制川乌、制草乌各15g，香樟木、苏木各50g。但是本发明申请是发明人经过方药配伍严格遵循中医传统理论，是对前期公开组合物进行药味味数、剂量和个别药材进行炮制的优化。方中去掉了紫草，香樟木，千年健，地枫皮；添加了甘草、花椒、小茴香、白芷；对路路通和乳香进行了炮制。优化后的组方严谨新颖，临床研究结果表明该中药组合物对腰椎间盘突出有确切的治疗效果，成本较低，无毒副作用、疗程短、显效快、治愈率高。
【发明内容】
本发明的目的是针对现有技术中的不足，提供一种治疗腰椎间盘突出病的中药组合物。
本发明的再一的目的是，提供一种上述药物的用途。
为实现上述目的，本发明采取的技术方案是：
一种治疗腰椎间盘突出症的中药组合物，是由以下重量份的原料药制成：苏木46-54份、花椒8-12份、制没药8-12份、制乳香8-12份、制草乌13-17份、制川乌13-17份、红花8-12份、木瓜8-12份、桂枝13-17份、伸筋草13-17份、炒路路通13-17份、甘草4-8份、小茴香4-8份、白芷7-11份。
优选地，所述的中药组合物是由以下重量份的原料药制成：苏木48-52份、花椒9-11份、制没药9-11份、制乳香9-11份、制草乌14-16份、制川乌14-16份、红花9-11份、木瓜9-11份、桂枝14-16份、伸筋草14-16份、炒路路通14-16份、甘草5-7份、小茴香5-7份、白芷8-10份。
更优选地，所述的中药组合物是由以下重量份的原料药制成：苏木50份、花椒10份、制没药10份、制乳香10份、制草乌15份、制川乌15份、红花10份、木瓜10份、桂枝15份、伸筋草15份、炒路路通15份、甘草6份、小茴香6份、白芷9份。
优选地，所述的中药组合物的使用方法是：将药物缝入一布袋，放入锅内隔水蒸10分钟，药袋降温至50-60℃的皮肤可耐受程度，稍拧干以不滴药液为度；并在药袋外裹上毛巾可延长热敷时间并防止烫伤，将药袋置于清洁后的腰部疼痛僵硬处；每日热敷1次，每次20分钟，每周5次为一个疗程，治疗2个疗程。
为实现上述第二个目的，本发明采取的技术方案是：
如上任一所述的中药组合物在制备治疗腰椎间盘突出症药物中的应用。
本发明优点在于：
苏木活血祛瘀，消肿止痛；红花活血通经，祛瘀止痛。两药配伍，活血通经、消瘀止痛之力增强。乳香辛温，以行气活血为主，善于调气，止痛力强；没药苦泄，以活血散瘀为要，长于散瘀，破泄力胜。两药伍用，气血并治，取效尤捷。以上四药共奏宣通经络，活血祛瘀，消肿止痛之功，共为君药。臣以川乌、草乌祛风除湿，温经止痛，花椒、桂枝、白芷、小茴香温中散寒止痛。佐以炒路路通祛风活络，利水通经，伸筋草、木瓜舒筋活络。甘草调和诸药。方中用药气血并治，全方协同共奏活血祛瘀，行气止痛，温中散寒，祛风除湿，舒筋活络之效。
【附图说明】
图1为两组患者JOA评分图；
图2为三组患者JOA评分图。
【具体实施方式】
下面对本发明提供的具体实施方式作详细说明。
实施例1治疗腰椎间盘突出症的中药组合物(一)
苏木50份、花椒10份、制没药10份、制乳香10份、制草乌15份、制川乌15份、红花10份、木瓜10份、桂枝15份、伸筋草15份、炒路路通15份、甘草6份、小茴香6份、白芷9份。
实施例2治疗腰椎间盘突出症的中药组合物(二)
苏木50份、花椒9份、制没药11份、制乳香8份、制草乌17份、制川乌15份、红花9份、木瓜11份、桂枝13份、伸筋草17份、炒路路通15份、甘草5份、小茴香7份、白芷7份。
实施例3治疗腰椎间盘突出症的中药组合物(三)
苏木48份、花椒11份、制没药8份、制乳香12份、制草乌15份、制川乌14份、红花11份、木瓜8份、桂枝17份、伸筋草15份、炒路路通14份、甘草7份、小茴香4份、白芷11份。
实施例4治疗腰椎间盘突出症的中药组合物(四)
苏木52份、花椒8份、制没药12份、制乳香10份、制草乌14份、制川乌16份、红花8份、木瓜12份、桂枝15份、伸筋草14份、炒路路通16份、甘草4份、小茴香8份、白芷9份。
实施例5治疗腰椎间盘突出症的中药组合物(五)
苏木46份、花椒12份、制没药10份、制乳香9份、制草乌16份、制川乌13份、红花12份、木瓜10份、桂枝14份、伸筋草16份、炒路路通13份、甘草8份、小茴香6份、白芷8份。
实施例6治疗腰椎间盘突出症的中药组合物(六)
苏木54份、花椒10份、制没药9份、制乳香11份、制草乌13份、制川乌17份、红花10份、木瓜9份、桂枝16份、伸筋草13份、炒路路通17份、甘草6份、小茴香5份、白芷10份。
实施例7治疗腰椎间盘突出症的中药组合物(七)
苏木50份、花椒11份、制没药8份、制乳香12份、制草乌15份、制川乌14份、红花11份、木瓜8份、桂枝17份、伸筋草15份、炒路路通14份、甘草7份、小茴香4份、白芷11份。
实施例8治疗腰椎间盘突出症的中药组合物(八)
苏木48份、花椒8份、制没药12份、制乳香10份、制草乌14份、制川乌16份、红花8份、木瓜12份、桂枝15份、伸筋草14份、炒路路通16份、甘草4份、小茴香8份、白芷9份。
实施例9治疗腰椎间盘突出症的中药组合物(九)
苏木52份、花椒12份、制没药10份、制乳香9份、制草乌16份、制川乌13份、红花12份、木瓜10份、桂枝14份、伸筋草16份、炒路路通13份、甘草8份、小茴香6份、白芷8份。
实施例10治疗腰椎间盘突出症的中药组合物(十)
苏木46份、花椒10份、制没药9份、制乳香11份、制草乌13份、制川乌17份、红花10份、木瓜9份、桂枝16份、伸筋草13份、炒路路通17份、甘草6份、小茴香5份、白芷10份。
实施例11治疗腰椎间盘突出症的中药组合物(十一)
苏木54份、花椒9份、制没药11份、制乳香8份、制草乌17份、制川乌15份、红花9份、木瓜11份、桂枝13份、伸筋草17份、炒路路通15份、甘草5份、小茴香7份、白芷7份。
实施例12治疗腰椎间盘突出症的中药组合物片剂/胶囊的制备
取实施例1-11任一所述的中药组合物，加9-11倍量水，煎煮2-3.5小时，滤出药汁。再加9倍量水，煎煮2.5小时，滤出药汁，合并二次煎液，静置，滤取上清液，浓缩，放冷，加浓缩液3倍量酒精，搅拌沉淀过夜。取上清液，浓缩至稠浸膏；加入制药辅料，真空干燥，粉碎制粒，压制成片剂或填充装胶囊。
实施例13治疗腰椎间盘突出症的中药组合物颗粒的制备
取实施例1-11任一所述的中药组合物，加8-10倍量水，煎煮3小时，滤出药汁。再加10倍量水，煎煮2.5小时，滤出药汁，合并二次煎液，静置，滤取上清液，浓缩，放冷，加浓缩液2倍量酒精，搅拌沉淀过夜。取上清液，浓缩至稠浸膏；加适当制药辅料，制粒，干燥，整粒，分装15g/袋。
实施例14治疗腰椎间盘突出症的中药组合物合剂/口服液/糖浆剂的制备
取实施例1-11任一所述的中药组合物，加8-11倍量水，煎煮3小时，滤出药汁。再加8倍量水，煎煮3小时，滤出药汁，合并二次煎液，静置，滤取上清液，浓缩，放冷，加浓缩液3.5倍量酒精，搅拌沉淀过夜。取上清液，浓缩至稠浸膏；加适当制药辅料，制成合剂、口服液或糖浆剂。
实施例15临床实验
1.资料与方法
1.1临床资料
本研究病例均为上海中医药大学附属岳阳中西医结合医院脊柱科住院的腰椎间盘突出症患者。根据诊断、纳入、排除标准，筛选出符合要求的患者60例，签署知情同意书后。按照随机方法将入组的患者分成试验组和对照组各30例。
1.2诊断标准
参照《脊柱外科学》第一版(贾连顺等主编，第二军医大学出版社，2009年)
1)腰痛合并下肢放射痛，放射至小腿或足，直腿抬高试验阳性；
2)棘突间旁有明显压痛并放射至小腿或足；
3)小腿前或后外侧皮肤感觉消失或减退，伸踇或踝背伸力下降或无力，跟腱反射减弱或消失；
4)影像学检查提示有椎间盘突出。
1.3纳入标准
1)性别不限，年龄在20岁至80岁之间者；
2)符合诊断标准且不合并马尾神经损害者；
3)无腰椎手术史；
4)同意配合试验，并签署知情同意书者。
1.4排除标准
1)不符合上述诊断标准者；
2)患严重的心、肺、脑及血液系统疾病者，肝、肾功能检查异常者；
3)伴有严重骨质疏松及神经肌肉系统疾病；
4)经常使用其它药物或可能对研究干预方式不耐受者；
5)哺乳、妊娠或正准备妊娠的妇女；
6)对外用中药过敏者；
7)依从性差者,不能配合治疗者，拒绝参与试验或拒绝签订知情同意书。
1.5中止标准
1)纳入后未经治疗或无任何治疗后访视记录者
2)纳入后因个人原因或不可抗拒原因退出试验者。
3)纳入后出现严重药物不良反应者。
1.6治疗方法
(1)试验组采用中药热敷，方法为：将实施例1中的中药组合物按重量份缝入一布袋，放入锅内隔水蒸10分钟后，待药袋降温至50-60℃的皮肤可耐受程度。稍拧干后，以药袋不滴药液为度，并在药袋外裹上毛巾可延长热敷时间并防止烫伤。将药袋置于清洁后的腰部疼痛僵硬处(预先评估患处皮肤情况，注意有无过敏，皮肤破损，皮疹等情况)，每日热敷1次，每次20分钟，每周5次为一个疗程，治疗2个疗程，药物袋每日加温，可连续应用5次。
(2)对照组采用与药袋大小相同的暖水袋进行热敷，倒入约50-60℃的热水后给予患者热疗。每日热疗1次，每次20分钟，每周5次为一个疗程，治疗2个疗程。
1.7疗效评价标准
采用日本骨科学会评分法JOA，评分的总分为29分，最高分是29分，最低分是0分。JOA评分总分越低，那么表示该患者腰椎功能障碍越显著。分别记录两组患者治疗前、治疗后14天的JOA评分。
JOA改善指数＝治疗后评分-治疗前评分。JOA治疗后评分改善率＝[(治疗后评分-治疗前评分)/29-治疗前评分]×100％。通过改善指数能够反映患者治疗前、后腰椎功能的改善情况。通过改善率则能够了解治疗干预后的疗效情况。分别记录两组患者治疗后14天的JOA改善率。
此外，JOA改善率还能够对应我们通常采用的疗效评判标准：即在改善率为100％时为治愈，在改善率大于60％为显效，25％～60％为有效，小于25％则为无效。根据疗效评判标准分别计算、统计两组患者的显效率。
1.8统计学方法
比较两组上述指标和评分在统计学上差异。临床资料中分类变量采用卡方分析，计量数据符合满足正态分布时采用student t检验，不满足正态分布采用非参数检验。P＜0.05代表具有统计学差异。统计分析使用IBM SPSS Statistics27.0软件进行。
2.结果
2.1两组患者JOA评分结果
两组患者在治疗之前，JOA评分无显著性差异，具有可比性；用药14天后，JOA评分有显著性差异，p<0.05，见表1、图1。
表1两组患者JOA评分结果
2.2两组患者治疗14天后JOA改善率的疗效比较
两组患者治疗14天后JOA改善率疗效比较，见表2。
表2两组患者治疗14天后JOA改善率的疗效比较
实施例16临床实验
1.资料与方法
1.1临床资料
本研究病例均为上海中医药大学附属岳阳中西医结合医院脊柱科住院的腰椎间盘突出症患者。根据诊断、纳入、排除标准，筛选出符合要求的患者90例，签署知情同意书后。按照随机方法将入组的患者分成试验组、对照组一、对照组二各30例。
1.2诊断标准：同实施例15临床实验
1.3纳入标准：同实施例15临床实验
1.4排除标准：同实施例15临床实验
1.5中止标准：同实施例15临床实验
1.6治疗方法
(1)试验组采用中药热敷，中药组合物为：苏木50份、花椒10份、制没药10份、制乳香10份、制草乌15份、制川乌15份、红花10份、木瓜10份、桂枝15份、伸筋草15份、炒路路通15份、甘草6份、小茴香6份、白芷9份。方法为：将中药组合物缝入一布袋，放入锅内隔水蒸10分钟后，待药袋降温至50-60℃的皮肤可耐受程度。稍拧干后，以药袋不滴药液为度，并在药袋外裹上毛巾可延长热敷时间并防止烫伤。将药袋置于清洁后的腰部疼痛僵硬处(预先评估患处皮肤情况，注意有无过敏，皮肤破损，皮疹等情况)，每日热敷1次，每次20分钟，每周5次为一个疗程，治疗2个疗程，药物袋每日加温，可连续应用5次。
(2)对照组一采用中药热敷，中药组合物为：红花、钻地风、宣木瓜、乳香、没药各10g，伸筋草、千年健、桂枝、紫草、路路通、制川乌、制草乌各15g，香樟木、苏木各50g(优化前的复方)，方法同试验组。
(3)对照组二采用中药热敷，中药组合物为：苏木48份、花椒11份、制没药8份、制乳香12份、制草乌15份、制川乌14份、红花11份、木瓜8份、防风17份、桑寄生15份、炒路路通14份、甘草7份、小茴香4份、紫苏叶11份；方法同试验组。
1.7疗效评价标准
采用日本骨科学会评分法JOA，评分的总分为29分，最高分是29分，最低分是0分。JOA评分总分越低，那么表示该患者腰椎功能障碍越显著。分别记录三组患者治疗前、治疗后14天的JOA评分。
JOA改善指数＝治疗后评分-治疗前评分。JOA治疗后评分改善率＝[(治疗后评分-治疗前评分)/29-治疗前评分]×100％。通过改善指数能够反映患者治疗前、后腰椎功能的改善情况。通过改善率则能够了解治疗干预后的疗效情况。分别记录三组患者治疗后14天的JOA改善率。
此外，JOA改善率还能够对应我们通常采用的疗效评判标准：即在改善率为100％时为治愈，在改善率大于60％为显效，25％～60％为有效，小于25％则为无效。根据疗效评判标准分别计算、统计三组患者的显效率。
1.8统计学方法
比较三组上述指标和评分在统计学上差异，采用单因素方差分析。P＜0.05代表具有统计学差异。统计分析使用IBM SPSS Statistics 27.0软件进行。
2.结果
2.1三组患者JOA评分结果
三组患者在治疗之前，JOA评分无显著性差异，具有可比性。用药14天后，试验组与对照组一JOA评分有显著性差异，p<0.05；试验组与对照组二JOA评分有显著性差异，p<0.05；对照组一与对照组二JOA评分无显著性差异，p＞0.05。见表3、表4、图2。
表3三组患者JOA评分结果
表4多重比较
注：*平均值差值的显著性水平为0.05。
2.2三组患者治疗14天后JOA改善率的疗效比较
三组患者治疗14天后JOA改善率疗效比较，见表5。
表5两组患者治疗14天后JOA改善率的疗效比较
以上所述仅是本发明的优选实施方式，应当指出，对于本技术领域的普通技术人员，在不脱离本发明方法的前提下，还可以做出若干改进和补充，这些改进和补充也应视为本发明的保护范围。
Claims (5)
1.一种治疗腰椎间盘突出症的中药组合物，其特征在于，是由以下重量份的原料药制成：苏木46-54份、花椒8-12份、制没药8-12份、制乳香8-12份、制草乌13-17份、制川乌13-17份、红花8-12份、木瓜8-12份、桂枝13-17份、伸筋草13-17份、炒路路通13-17份、甘草4-8份、小茴香4-8份、白芷7-11份。
2.根据权利要求1所述的中药组合物，其特征在于，是由以下重量份的原料药制成：苏木48-52份、花椒9-11份、制没药9-11份、制乳香9-11份、制草乌14-16份、制川乌14-16份、红花9-11份、木瓜9-11份、桂枝14-16份、伸筋草14-16份、炒路路通14-16份、甘草5-7份、小茴香5-7份、白芷8-10份。
3.根据权利要求2所述的中药组合物，其特征在于，是由以下重量份的原料药制成：苏木50份、花椒10份、制没药10份、制乳香10份、制草乌15份、制川乌15份、红花10份、木瓜10份、桂枝15份、伸筋草15份、炒路路通15份、甘草6份、小茴香6份、白芷9份。
4.根据权利要求1-3所述的中药组合物，其特征在于，所述的中药组合物的使用方法是：将药物缝入一布袋，放入锅内隔水蒸10分钟，药袋降温至50-60℃的皮肤可耐受程度，稍拧干以不滴药液为度；并在药袋外裹上毛巾可延长热敷时间并防止烫伤，将药袋置于清洁后的腰部疼痛僵硬处；每日热敷1次，每次20分钟，每周5次为一个疗程，治疗2个疗程。
5.权利要求1-3任一所述的中药组合物在制备治疗腰椎间盘突出症药物中的应用。
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| CN106236859A (zh) * | 2016-08-29 | 2016-12-21 | 李威 | 中药热敷袋配方 |
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