CN110575506B - 一种治疗腰间盘突出的中药组合物 - Google Patents

一种治疗腰间盘突出的中药组合物 Download PDF

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CN110575506B
CN110575506B CN201910970779.2A CN201910970779A CN110575506B CN 110575506 B CN110575506 B CN 110575506B CN 201910970779 A CN201910970779 A CN 201910970779A CN 110575506 B CN110575506 B CN 110575506B
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陈文学
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Abstract

本发明提供了一种治疗腰间盘突出的中药组合物，包含杜仲25份、山茱萸25份、茯苓10份、车前子10份、巴戟天8份、五味子20份、白茅根8份、黄柏5份、苍术8份、仙鹤草5份、接骨木10份、骨碎补10份、威灵仙4份；其中以清热利尿，补肾益气的成分车前子、巴戟天、五味子、白茅根作为治疗腰间盘突出的中药组方的臣药，并使用酿酒酵母发酵的方式处理这些成分，提高疗效的同时避免了使用车前子时的常见过敏反应。

Description

一种治疗腰间盘突出的中药组合物
一技术领域
本发明涉及中药领域，具体地说，本发明涉及一种治疗腰间盘突出的中药组合物。
二背景技术
腰椎间盘突出症(Lumbar disc herniation，LDH)属于常见腰椎疾病，在各国人群中的发病率约在10-30％的水平，严重影响患者的生活和工作，甚至造成残废。腰椎间盘突出症主要成因为腰椎间盘各部分出现不同程度的退行性病变后，在外力因素的影响下，椎间盘的纤维环出现异常而破裂，髓核组织从破裂之处突出或脱出于后方或椎管内，导致相邻脊神经根遭受刺激或压迫，从而产生腰部疼痛，双下肢或单侧下肢疼痛、麻木等一系列临床不适的症状。
目前治疗腰间盘突出症的手术主要为椎板、关节突和椎间盘切除术或椎间盘蛋白酶注入术，适用范围窄且预后不佳，因此大多数患者均采用非手术治疗方式缓解病情。非手术治疗中除卧床休息和锻炼外，西医一般用硫酸软骨素等药物，中医一般用活血化瘀，强筋健骨，补中益气类内外用中药或舒筋健腰丸等辅助治疗。由于腰椎间盘突出病程长，治疗起效慢，中药成分外用时常见过敏等不良反应，本领域中有进一步提高药效和用药便利性的需求。
三发明内容
发明人在长期诊疗实践中从组方到炮制方式多方面逐步摸索增强现有中药组合物疗效的途径。申请人发现现有治疗腰间盘突出等腰椎疾病的内服和外用中药组合物多将重点放在活血化瘀，强筋健骨方面，忽视了腰间盘突出等腰椎疾病患者普遍存在的腰腹部热毒淤积造成肾脏损伤的问题，在中药组合物中加入清热利尿，补肾益气的相应成分作为臣药能有效提高疗效。进一步地，申请人发现对所用的清热利尿，补肾益气成分车前子、巴戟天、五味子、白茅根进行混合发酵处理能在进一步提高疗效的同时减少车前子等成分的过敏源性。
一方面，本发明提供了一种治疗腰间盘突出的中药组合物，其特征在于，按重量计包含杜仲20-30份、山茱萸20-30份、茯苓5-15份、车前子5-15份、巴戟天5-10份、五味子10-25份、白茅根5-10份、黄柏2-8份、苍术5-10份、仙鹤草2-8份、狗脊5-15份、桑寄生2-10份、接骨木5-15份、骨碎补5-15份、威灵仙2-5份。
进一步地，中药组合物包含杜仲25份、山茱萸25份、茯苓10份、车前子10份、巴戟天8份、五味子20份、白茅根8份、黄柏5份、苍术8份、仙鹤草5份、狗脊10份、桑寄生7份、接骨木10份、骨碎补10份、威灵仙4份。
进一步地，中药组合物的有效成分为杜仲25份、山茱萸25份、茯苓10份、车前子10份、巴戟天8份、五味子20份、白茅根8份、黄柏5份、苍术8份、仙鹤草5份、狗脊10份、桑寄生7份、接骨木10份、骨碎补10份、威灵仙4份组成。
进一步地，中药组合物为外用剂。
进一步地，中药组合物为软膏剂。
进一步地，中药组合物中的车前子、巴戟天、五味子、白茅根经过过混合发酵处理。
进一步地，所述中药组合物按照以下方法制备：(1)称取所需重量份的各中药成分；(2)将车前子、巴戟天、五味子、白茅根烘干、粉碎、过200目筛，加入纯净水200份、酿酒酵母适量，混合均匀后30℃发酵14日；(3)将其余成分粉碎、过200目筛，与200份纯净水水加入发酵液中，水提6小时；(4)提取液浓缩至相对密度为1.5，加入乙醇至30体积％，静置12小时取上清，回收乙醇至无醇味，进一步浓缩成半固体状；(5)将15份米醋和10份蜂蜜混合加热至80℃，冷却形成基质；(6)当基质冷却到50℃时，将步骤(4)所得半固体状提取物与基质混合，搅拌均匀，冷却成软膏剂。
另一方面，本发明提供了车前子、巴戟天、五味子、白茅根在制备治疗腰间盘突出的中药组合物中的用途。
进一步地，车前子、巴戟天、五味子、白茅根经过过混合发酵处理。
进一步地，车前子、巴戟天、五味子、白茅根经过过酿酒酵母发酵处理。
本申请以清热利尿，补肾益气的成分车前子、巴戟天、五味子、白茅根作为治疗腰间盘突出的中药组方的臣药，相比现有类似组方和中成药，无论在患者中还是动物模型中均显著提高了药效。此外，使用酿酒酵母发酵的方式结合酒制、醇提和发酵化学变化的优点，进一步提高疗效的同时避免了使用车前子时的常见过敏反应。
四附图说明
图1为实施例3中中药组合物1组典型显微图像；
图2为实施例3中安慰剂组典型显微图像；
五具体实施方式
实施例1中药组合物的制备
杜仲、山茱萸、茯苓、车前子、巴戟天、五味子、白茅根、黄柏、苍术、仙鹤草、狗脊、桑寄生、接骨木、骨碎补、威灵仙均购自正规药材经销商；米醋、蜂蜜购自正规食品经销商；酿酒酵母干粉为安琪牌葡萄球果酒用酿酒酵母(购于京东商城，未标注活菌数，仅标注重量)。中药组合物1：
(1)称取所需重量份的各中药成分；(2)将车前子、巴戟天、五味子、白茅根烘干、粉碎、过200目筛，加入纯净水200份、酿酒酵母1份(可根据酿酒酵母品牌和效果适当调整)，混合均匀后30℃发酵14日；(3)将杜仲、山茱萸、茯苓、黄柏、苍术、仙鹤草、狗脊、桑寄生、接骨木、骨碎补、威灵仙粉碎、过200目筛，与200份水加入发酵液中，水提6小时；(4)提取液浓缩至相对密度为1.5，加入乙醇至30体积％，静置12小时取上清，回收乙醇至无醇味，进一步浓缩成半固体状；(5)将15份米醋和10份蜂蜜混合加热至80℃，冷却形成基质；(6)当基质冷却到50℃时，将步骤(4)所得半固体状提取物与基质混合，搅拌均匀，冷却成软膏剂。
中药组合物2：
(1)称取所需重量份的各中药成分；(2)将各成分粉碎，过200目筛，加入纯净水300份，水提8小时；(3)提取液浓缩至相对密度为1.5，加入乙醇至30体积％，静置12小时取上清，回收乙醇至无醇味，进一步浓缩成半固体状；(4)将15份米醋和10份蜂蜜混合加热至80℃，冷却形成基质；(4)当基质冷却到50℃时，将步骤(3)所得半固体状提取物与基质混合，搅拌均匀，冷却成软膏剂。
实施例2临床疗效观察
按照以下标准：
治愈：腰痛、下肢痛消失，腰腿活动不受限制；好转：腰痛、下肢痛减轻，腰腿活动轻微受限但不影响一般工作和生活；无效：腰痛、下肢痛无好转或好转幅度不足以使患者正常工作和生活。
近5年来本诊所使用杜仲20-30份、山茱萸20-30份、茯苓5-15份、车前子2-8份，白茅根5-10份、黄柏2-8份、白术2-10份、仙鹤草2-8份、狗脊5-15份、桑寄生2-10份、骨碎补5-15份、威灵仙2-5份(随症适当加减)制备的外用软膏剂治疗轻、中度腰间盘突出患者累计200例以上，每日睡前、午后涂抹2次治疗2个月后治愈率约35％，有效率80％以上。其中有接近10％的患者涂抹处出现过不同程度的皮疹红肿等过敏反应，有数位患者甚至因过敏严重无法继续治疗。
为验证新型软膏的效果，将实施例1中的中药组合物1和2各用于中度L3-L5腰间盘突出患者各30名，患者除必要的牵引和推拿外，不使用任何其他药物治疗。每日睡前、午后涂抹2次治疗2个月后，统计结果如下：
表1中药组合物1和2的临床治疗效果
药物组合物 治愈(例) 好转(例) 无效(例)
1 18 7 5
2 13 12 4*
*组合物2中1例患者因皮痒红肿无法继续使用该药物治疗。
从治愈率和有效率看，中药组合物1均优于组合物2和先前本诊所所用药方，而且30例患者中仅1例有轻微皮疹出现，相比前本诊所所用药方10％的过敏率和组合物2中4例过敏出现。有效性和安全性都取得了显著的进步。
实施例3大鼠模型上的效果观察
为验证本申请中药组合物的效果，委托大连理工大学动物实验中心制备腰间盘大鼠模型进一步验证药效，模型基本制备过程如下：
取200g±20g的雄性SD大鼠(大连理工大学动物实验中心提供)；麻醉后脱毛消毒；每只大鼠切取尾椎椎间盘2个；用剥离上下终板暴露髓核；采用“米”字型的方式用手术线包绕目标椎间盘；沿大鼠后背脊柱正中线切开背部皮肤、肌肉，暴露脊椎，剔除椎板；将保存好的尾椎间盘嵌入剔除的椎板的间隙；缝合，注射抗生素；14日后大鼠出现机械刺激痛觉超敏现象证明造模成功；在造模成功的大鼠中选取健康状况较好的20只。
对10只造模成功的大鼠每日一次使用实施例1的中药组合物1，另10只施用米醋和蜂蜜制成的安慰剂软膏；连续施用21日后取出包埋的脊椎间隙的目标尾椎椎间盘组织，于多聚甲醛中固定，HE颜色进行病理组织学观察。
用药组的情况明显好于安慰剂组：增生和炎性细胞明显较少，其中的典型图像见图1和2。

Claims (1)

1.一种治疗腰间盘突出的中药组合物，其特征在于，按重量计，原料药为：杜仲25份、山茱萸25份、茯苓10份、车前子10份、巴戟天8份、五味子20份、白茅根8份、黄柏5份、苍术8份、仙鹤草5份、狗脊10份、桑寄生7份、接骨木10份、骨碎补10份、威灵仙4份组成；所述中药组合物为软膏剂；所述中药组合物按照以下方法制备：(1)称取所需重量份的各中药成分；(2)将车前子、巴戟天、五味子、白茅根烘干、粉碎、过200目筛，加入纯净水200份、加入酿酒酵母1份，混合均匀后30℃发酵14日；(3)将其余成分粉碎、过200目筛，与200份水加入发酵液中，水提6小时；(4)提取液浓缩至相对密度为1.5，加入乙醇至30体积％，静置12小时取上清，回收乙醇至无明显醇味，进一步浓缩成半固体状；(5)将15份米醋和10份蜂蜜混合加热至80℃，冷却形成基质；(6)当基质冷却到50℃时，将步骤(4)所得半固体状提取物与基质混合，搅拌均匀，冷却成软膏剂。
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