CN111529667A - 一种用于治疗腰椎间盘突出症的中药组合物及应用 - Google Patents

一种用于治疗腰椎间盘突出症的中药组合物及应用 Download PDF

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CN111529667A
CN111529667A CN202010529463.2A CN202010529463A CN111529667A CN 111529667 A CN111529667 A CN 111529667A CN 202010529463 A CN202010529463 A CN 202010529463A CN 111529667 A CN111529667 A CN 111529667A
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刘一震
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Zhejiang Yizhentang Health Management Co ltd
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Abstract

本发明提供一种用于治疗腰椎间盘突出症的中药组合物及应用，组合物由以下原料组成：海风藤，透骨草，苏木，红花，怀牛膝、三棱、莪术、秦艽、麻黄、桂枝、丝瓜络、赤芍、鸡血藤、细辛、小茴香、杜仲、补骨脂、羌活、金毛狗脊。本发明组合物有坚实的中医骨伤经典理论的支持，经临床研究验证了其治疗腰椎间盘突出症的适用性和有效性，效果显著，为外用药物，安全性好，剂型制备容易。可在制备用于治疗腰椎间盘突出症的中药组合物中应用。

Description

一种用于治疗腰椎间盘突出症的中药组合物及应用
技术领域
本发明属中药组合物，涉及一种用于治疗腰椎间盘突出症的中药组合物，可在制备用于治疗腰椎间盘突出症的药物中应用。
背景技术
腰椎间盘突出症俗称“腰突症”，是腰椎间盘的退行性改变。因腰椎间盘变性、纤维环破裂、髓核突出压迫或刺激神经根、马尾神经，而引起以腰腿痛为主要表现的疾病。内因：1.椎间盘先天发育异常。2.椎间盘退变髓核含水量减少，弹性和抗负荷能力减退。外因：1.一次较重的外伤。2.反复多次轻度外伤，积累性损伤。3.寒冷刺激。症状与体征：1.腰痛与放射性腿痛特点：根性放射痛；疼痛与腹压有关；疼痛与活动、体位有明显关系。2.跛行：患肢不能正常迈步及负重，常需扶拐行走。3.腰肌痉挛、脊柱畸形和活动受限。4.棘突间旁侧压痛与放射痛。5.神经功能损害。运动：受累神经所支配的肌肉发生萎缩。感觉：受累神经根分布区可出现感觉过敏、减退或消失。反射：L4一5胫后肌L5一S1跟腱L3一4膝。
本病属腰痹，骨痹，腰腿痛范畴。中医学认为：气血、经络与脏腑功能的失调和腰痛的发生有密切的关系，引发本病的原因，一是外伤；二是劳损；三是肾气不足、精气衰微、筋脉失养；四为风、寒、湿、热之邪流注经络，使经络困阻，气滞血瘀，不通则痛。《灵枢·百病始生》：“是故虚邪之中人也……留而不去则传舍于输，在输之时，六经不通，四肢则肢节痛腰脊乃强。”《诸病源候论.腰脚疼痛候》：“肾气不足，受风邪之所为也，劳伤则肾虚，虚则受于风冷，风冷与正气交争，故腰脚痛。”《素问·刺腰痛篇》中说："衡络之脉令人腰痛，不可以俯仰，仰则恐仆，得之举重伤腰"，又云："肉里之脉令人腰痛，不可以咳，咳则筋缩急。"《医学心悟》也说："腰痛拘急，牵引腿足"。
本病主要病机是督脉瘀堵，阳气不足，多因气血不调，肝肾亏虚所致。中药组合物因其疗效确切，外用无毒副作用，用药方便，价格便宜等特点在治疗腰椎间盘突出症具有明显优势。
发明内容
本发明的目的是提供一种用于治疗腰椎间盘突出症的中药组合物，该中药组合物每1000个剂量单位的制剂由以下配比的原料组成：海风藤150-450份，透骨草100-300份，苏木100-300份，红花100-300份，怀牛膝100-300份、三棱100-300份、莪术100-300份、秦艽100-300份、麻黄100-300份、桂枝100-300份、丝瓜络150-450份、赤芍120—300份、鸡血藤100—300份、细辛50—150份、小茴香50-200份、杜仲150-450份、补骨脂100-300份、羌活100-300份、金毛狗脊150-300份。
以上组份的重量以生药计算。每1份可以是1g，也可以是公斤或吨，如果用克为单位，该配方组成可制成药物制剂1000剂。所述1000剂指，制成的成品药物制剂，如制成颗粒剂1000g等，作为颗粒剂也可以制成大包装，如100-500袋，具体可以是100袋、125袋、200袋、250袋、500袋等，每袋可作为一次外用剂量。
以上组成，可制成50-1000次服用剂量的制剂，如作为颗粒剂，制成125袋，每次外用1-2袋，共可外用62.5-125次。
以上组成是按重量作为配比的，在生产时可按照相应比例增大或减小，如大规模生产可以以公斤为单位，或以吨为单位，小规模生产也可以毫克为单位，重量可以增大或减小，但各组成之间的生药材重量配比的比例不变。
上述配比的中药组合物，根据需要加入适宜的赋形剂制成适合药用的任何一种制剂形式，该制剂可以是颗粒剂、散剂、液体等多种合适的剂型。
本发明的另一个目的是提供的中药组合物在制备用于治疗腰椎间盘突出症药物中的应用。所述组合物与赋形剂制成药物的制剂形式为液体制剂、颗粒剂、散剂。本发明药物为外用药物。
腰椎间盘突出症诊治方法多种多样，能保守不手术为广大临床医师的共识，本发明的治疗腰椎间盘突出症的中药组合物，利用熏蒸机器，进行外用熏蒸治疗，经过多年临床使用和大量的临床案例证明，其疗效肯定，值得医疗临床应用与推广。本发明的有益之处是：(1)本发明药物组合物经临床研究验证了其治疗腰椎间盘突出症的适用性和有效性，可在制备用于治疗腰椎间盘突出症的中药组合物中应用；(2)本发明药物为外用药物，安全性好，剂型制备容易。(3)有坚实的中医骨伤经典理论的支持。
具体实施方式
本发明通过具体实施例作进一步的说明。
实施例1本发明颗粒剂制备
药物组合物组成：海风藤150-450份，透骨草100-300份，苏木100-300份，红花100-300份，怀牛膝100-300份、三棱100-300份、莪术100-300份、秦艽100-300份、麻黄100-300份、桂枝100-300份、丝瓜络150-450份、赤芍120—300份、鸡血藤100—300份、细辛50—150份、小茴香50-200份、杜仲150-450份、补骨脂100-300份、羌活100-300份、金毛狗脊150-300份。
制备方法：
(1)以上十九味药，海风藤、透骨草、苏木、红花、怀牛膝、三棱、莪术、秦艽、麻黄、桂枝、丝瓜络、赤芍、鸡血藤、细辛、小茴香、杜仲、补骨脂、羌活、金毛狗脊，加10倍量70％乙醇回流提取1.0小时，共提取二次，合并提取液，回收乙醇。60℃减压浓缩至药液相对密度1.05(30℃测)，用管式离心机14000转/分钟离心除杂。离心液与醇提药液合并，60℃减压浓缩至药液相对密度1.15(60℃测)。浓缩液用喷雾干燥器(控制喷液速度为2000ml/min，进风口温度140℃，出风口温度85℃)制备浸膏粉。
(2)按1g干膏粉加0.75g糊精和1g糖粉量混合，用85％乙醇润湿制粒，湿颗粒干燥(风温50℃)，整粒，制成颗粒剂1000剂，即得。
实施例2本发明药液制备
药物组合物组成：海风藤150-450份，透骨草100-300份，苏木100-300份，红花100-300份，怀牛膝100-300份、三棱100-300份、莪术100-300份、秦艽100-300份、麻黄100-300份、桂枝100-300份、丝瓜络150-450份、赤芍120—300份、鸡血藤100—300份、细辛50—150份、小茴香50-200份、杜仲150-450份、补骨脂100-300份、羌活100-300份、金毛狗脊150-300份。
制备方法：
(1)以上十九味药，海风藤、透骨草、苏木、红花、怀牛膝、三棱、莪术、秦艽、麻黄、桂枝、丝瓜络、赤芍、鸡血藤、细辛、小茴香、杜仲、补骨脂、羌活、金毛狗脊，把药物倒入药锅内摊平，然后加常温水--室温水浸泡，轻压药材时水高出药平面约2厘米。浸泡60分钟开始入煎；用武火煎沸，沸后用文火--小火保持微沸状态40分钟，避免药汁溢出或过快熬干，减慢水份蒸发，把有效成份溶出。将药液滤出，重新加水煎煮，二煎30分钟，煎煮好的中药液要趁热滤出，避免有效成份沉淀在药渣上；
(2)将第一次和第二次药液混合，常压下封装,室温下保质期为3-5天,保鲜冷藏(不能冻)保质期为6-7天,如果是真空封装，加冷藏，保质期极限为20天。
实施例3本发明散剂制备
药物组合物组成：海风藤150-450份，透骨草100-300份，苏木100-300份，红花100-300份，怀牛膝100-300份、三棱100-300份、莪术100-300份、秦艽100-300份、麻黄100-300份、桂枝100-300份、丝瓜络150-450份、赤芍120—300份、鸡血藤100—300份、细辛50—150份、小茴香50-200份、杜仲150-450份、补骨脂100-300份、羌活100-300份、金毛狗脊150-300份。
制备方法：
以上十九味药，海风藤、透骨草、苏木、红花、怀牛膝、三棱、莪术、秦艽、麻黄、桂枝、丝瓜络、赤芍、鸡血藤、细辛、小茴香、杜仲、补骨脂、羌活、金毛狗脊，将以上药材饮片粉碎，120目，过9号筛，混匀，灭菌，即得。
实施例4
1.一般资料：选择2014年3月-2015年3月门诊筛查的腰椎间盘突出症120例，年龄28-45岁。
2.诊断依据：
(1)有腰部外伤、慢性劳损或受寒湿史。大部分患者在发病前有慢性腰痛史。
(2)常发生于青壮年。
(3)腰痛向臂部及下肢放射，腹压增加(如咳嗽、喷嚏)时疼痛加重。
(4)脊柱侧弯，腰生理孤度消失，病变部位椎旁有压痛，并向下肢放射，腰活动受限。
(5)下肢受累神经支配区有感觉过敏或迟钝，病程长者可出现肌肉萎缩。直腿抬高或加强试验阳性，膝、跟腱反射减弱或消失，拇趾背伸力减弱。
(6)X线摄片检查:脊柱侧弯，腰生理前凸消失，病变椎间盘可能变窄，相邻边缘有骨赘增生。CT检查可显示椎间盘突出的部位及程度。
3.治疗方法
药物组合物组成:海风藤15g，透骨草10g，苏木10g，红花10g份，怀牛膝10g份、三棱15g、莪术15g、秦艽10g、麻黄10g、桂枝10g、丝瓜络15g份、赤芍12g、鸡血藤10g、细辛10g、小茴香15g、杜仲20g、补骨脂15g、羌活10g份、金毛狗脊15g。将组合物的散剂、颗粒剂冲调成适量液体，通过熏蒸机器，调试合适温度，熏蒸作用于人体腰部，症状严重时，熏蒸治疗每日2次，间隔3小时，每次熏蒸60分钟。症状缓解后，每日熏蒸1次，每次45分钟。
连续外用熏蒸14天后疗效评定，以后每3个月复查1次，临床观察症状和阳性体征改善情况。
4.疗效判定：
(1)治愈：腰腿痛消失，直腿拾高70°以上，能恢复原工作。
(2)好转：腰腿痛减轻，腰部活动功能改善。
(3)未愈：症状、体征无改善。
5.治疗结果
治疗后治愈40例、好转79例，未愈1例，总有效率为99.2％。治疗过程中未见任何不良反应发生。

Claims (4)

1.一种用于治疗腰椎间盘突出症的中药组合物，其特征是：该中药组合物每1000个剂量单位的制剂由以下配比的原料组成：海风藤150-450份，透骨草100-300份，苏木100-300份，红花100-300份，怀牛膝100-300份、三棱100-300份、莪术100-300份、秦艽100-300份、麻黄100-300份、桂枝100-300份、丝瓜络150-450份、赤芍120—300份、鸡血藤100—300份、细辛50—150份、小茴香50-200份、杜仲150-450份、补骨脂100-300份、羌活100-300份、金毛狗脊150-300份。
2.根据权利要求1所述的一种用于治疗腰椎间盘突出症的中药组合物在制备用于腰椎间盘突出症药物中的应用。
3.根据权利要求2所述的应用，其特征是：所述组合物与赋形剂制成药物的制剂形式为液体制剂、颗粒剂、散剂。
4.根据权利要求2所述的应用，其特征是：所述药物为外用药。
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