CN106138044B - 一种治疗腰椎间盘突出症的药物 - Google Patents
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Abstract
本发明涉及一种治疗腰椎间盘突出症的药物组合物，所述药物组合物包含有效量的化合物和药学上可接受的载体，所述化合物具有下列结构：
Description
技术领域
本发明涉及医药领域，具体的说，本发明涉及一种治疗腰椎间盘突出症的药物。
背景技术
腰间盘突出是一种多发病、常见病，它主要是因椎间盘劳损退变，纤维破裂或髓核脱出等刺激或压迫脊神经、坐骨神经引起一系列症状群。如腰疼、腰酸、一侧或两侧坐骨神经痛等。
腰椎间盘突出具体可分为四种：(1)椎间盘正常，椎间盘无退变，所有椎间盘组织均在椎间盘内表现轻微腰酸痛，休息好转。(2)腰椎间盘膨出，腰椎间盘纤维环状均匀性超出椎间隙范围，椎间组织没有呈局限性突出。患者出现腰痛、腿痛。沿坐骨神经走向有明显压痛点，并向臀部及腿部放射。(3)腰椎间盘突出，椎间盘组织局限性移位超过椎间隙，移位椎间盘组织尚与原椎间盘组织相连，其基底连线部直径大于超出椎间隙的移位椎间盘部分。患者腰部，坐骨神经严重疼痛，行走困难，脊椎后仰，侧弯、咳嗽、打喷嚏加重。(4)腰椎间盘脱出，移位椎间盘组织的直径大于基底连续部，并移向于椎间隙之外，脱出的椎间盘组织大于破裂的椎间盘间隙，并通过此裂隙位于椎管内。患者行走困难，活动障碍，患腿肌肉萎缩，感觉迟钝，可出现腰椎管狭窄，骨质增生等退化性改变。有些病人手术治疗，风险大，副作用大，复发率高，能保守治疗尽量不手术。
发明内容
本发明的目的在于提供一种治疗腰椎间盘突出症的药物组合物。
为了实现本发明的目的，本发明提供一种治疗腰椎间盘突出症的药物组合物，所述药物组合物包含有效量的化合物和药学上可接受的载体，所述化合物具有下列结构：
优选地，所述药学上可接受的载体为稀释剂、崩解剂、粘合剂、润滑剂、稳定剂或矫正剂。
优选地，所述稀释剂为糖衍生物、淀粉衍生物或纤维素衍生物。
优选地，所述稀释剂为乳糖。
优选地，所述药物组合物为散剂、微粒剂、颗粒剂、胶囊剂或片剂。
本发明还提供化合物在制备治疗腰椎间盘突出症的药物中的用途，该化合物具有下列结构：
本文所用的术语“药学上可接受的”指不消除本文所述的化合物的生物学活性或性质的物质，如载体或稀释剂。这类物质被施用于个体不导致不希望的生物学作用或者不以有害方式与包含它的组合物中的任何组分相互作用。
如本文所用的术语“药学上可接受的载体”包括任何和所有的溶剂、分散介质、包衣材料、表面活性剂、抗氧化剂、防腐剂(例如抗菌剂、抗真菌剂)、等渗剂、吸收延迟剂、盐、防腐剂、药物稳定剂、粘合剂、赋形剂、崩解剂、润滑剂、甜味剂、矫味剂、染料等和其组合，这是本领域技术人员所熟知的(例如参见Remington's Pharmaceutical Sciences,18thEd.Mack Printing Company,1990,pp.1289-1329)。除了与活性成分不相容的载体外，在治疗或药物组合物中考虑使用任何常规载体。
本发明的药物组合物包括上述化合物或其药学上可接受的盐、溶剂化物、异构体、基于上述化合物基础上的药物前体或以上所述形式的任意混合物。这些化合物可用于制备预防和/或治疗腰椎间盘突出症的药物。
具体实施方式
以下通过具体实施方式的描述对本发明作进一步说明，但这并非是对本发明的限制，本领域技术人员根据本发明的基本思想，可以做出各种修改或改进，但是只要不脱离本发明的基本思想，均在本发明的范围之内。
实验例 本发明药物对腰椎间盘突出症大鼠血清IgG的影响
目标化合物：
实验动物
健康、雄性SD大鼠50只，清洁级，体质量250g左右。
实验药物
10％水合氯醛(南京军区南京总医院提供)；红霉素软膏(上海第九制药厂)；硫唑嘌呤(上海信谊药厂有限公司)。
主要试剂
大鼠免疫球蛋白G(IgG)ELISA试剂盒，由英国Abeam生产。
主要仪器
酶标仪(美国Bio-TEK，Synergy HT，波长450nm)，高速冷冻离心机(ThermoSCIENTIFIC,Mi-croCl 21R)隔水式电热恒温培养箱(上海跃进医疗器械一厂，PYX-DHS-40X50-S-II)，自动脱水机(德国LEICA公司，TP1020)，石蜡切片机(德国LEI-CA公司，RM2235)，摊片烤片机(湖北孝感宏业医用仪器有限公司，CS-VI)，组织包埋中心(日本SAKURA公司，Tissue-Tek TEL)，光学显微镜(德国LEICA公司，DM1000)，图像分析软件(德国LEICA公司，Qwin V3)。
动物分组
适应性喂养5d后，进行标记、称质量，用随机数字表法将大鼠分为5组：空白组、假手术组、模型组、目标化合物组、对照组，每组10只，分笼饲养。
造模方法(刘锦涛，姜宏，王拥军，等.大鼠破裂型椎间盘突出模型的建立及突出物重吸收机制的研究[J].中国骨伤,201023(5):370-372.Liu JT，Jiang H，Wang YJ，et a1.Astudy of a rat lumbar discherniation model and the mechanism spontaneous ofresorption[J].China J Orthop Traumatol，2010，23(5):370-372.)
经10％的水合氯醛(40g/kg)腹腔注射麻醉成功后，剃去背部体毛，固定，外科常规消毒。无菌条件下，每只切取尾椎椎间盘2个，包含上下软骨终板。用无菌10ml二注射器针头刺破上下终板，使髓核暴露，造成游离或破裂状态。用7号手术线“米”形包绕椎间盘，放入生理盐水器皿中备用。然后无菌条件下后正中线后路依次切开皮肤、皮下组织、筋膜、肌肉，将取出尾椎间盘放入L4～L5处左侧肌肉层中，逐层缝合。伤口处涂以红霉素软膏，连续换药3d。假手术组仅切开背部和尾巴相应部位，不作尾椎椎间盘移植，余同造模。空白组不做任何处理。完成造模。
造模后第5天开始干预。目标化合物组将化合物溶于生理盐水，按10mg/kg·d的剂量灌胃给药。对照组用硫唑嘌呤溶于生理盐水，按10mg/kg·d的剂量灌胃给药。疗程：每日1次，连续治疗10天。空白组和假手术组正常饲养，不做任何处理。模型组给予等剂量的生理盐水。
用眼眶后静脉丛采血法，分别于造模前1d、造模后第4天(干预前)、干预后第5天、干预后第10天(干预结束后)采集外周血约5m I,，静置1h后，离心机离心，取上清液，20℃保存。采用ELISA法测定各组大鼠血清中IgG的含量。按照试剂盒说明书严格操作。
应用SPSS 18.0统计软件进行数据处理分析。计量资料以表示，基线资料及造模对血清IgG的影响使用One-Way ANOVA进行分析，造模后药物对血清IgG的影响使用多组重复资料的方差分析方法，P<0.05为差异有统计学意义。
血清IgG的测定
基线资料
造模前ld，各组大鼠血清IgG值差异无统计学意义(P>0.05)，具有可比性。
各组造模前后血清IgG值的变化见表1。空白组、假手术组，2次血清IgG值没有显著性差异(Ρ>0.05)，说明手术本身对IgG值没有影响；模型组、化合物组、对照组造模前后血清IgG值有显著性差异(P<0.01)，说明是由于造模引起的自身免疫反应导致IgG值升高。详见表1。
表1各组造模前后血清IgG的比较(ng·mL-1)
注:与造模前比较，*P<0.01。
干预前后血清IgG的变化见下表2
表2模型组、刮痧组、药物组血清IgG值组间比较(ng·mL-1，n＝10)
注:与模型组比较，*P<0.01；与干预前比较，△P<0.01。
血清IgG值随着干预时间的延长而显著下降(P<0.01)，提示本发明化合物和对照药物对于造模引起的自身免疫反应均有较好的抑制效果。
Claims (1)
1.化合物在制备治疗腰椎间盘突出症的药物中的用途，其特征在于，该化合物具有下列结构：
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| EGFR酪氨酸激酶抑制剂的设计、合成及生物活性筛选和类药性化合物库的构建;刘燊;《中国博士学位论文全文数据库 医药卫生科技辑》;20151015;第2015卷(第10期);正文第178页 * |
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