CN104000814A - 一种防治痛风性关节炎的药物组合物及其用途 - Google Patents
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Abstract
本发明公开了一种防治痛风性关节炎的药物组合物及其用途，该组合物由活性成分和辅料制备而成，所述的活性成分包括后莫紫檀素。本发明的药物够减缓痛风性关节炎致足肿胀，降低肿胀足组织中炎性因子PGE2和NO的含量，从而减轻足组织炎性反应。
Description
技术领域
本发明属于医药技术领域，具体而言，涉及一种防治痛风性关节炎的药物组合物及其用途。
背景技术
痛风性关节炎(gouty arthritis)是由于尿酸钠微结晶在关节周围组织沉积引发的急性炎症反应。临床以关节红肿热痛反复发作及尿尿酸、血尿酸增高为主要表现，日久痛风石在关节软骨沉积，关节畸形，甚至可并发肾结石。本病属祖国传统医学的痹证范畴，俗称顽痹、血痹等。目前对痛风性关节炎的治疗还没有什么特效药，临床主要用秋水仙碱、别嘌呤醇和非甾体类抗炎药等药冶疗，疗效尚可，但毒副作用较大（致白细胞减少、再生障碍性贫血、肝肾损伤、糖尿病、高血压等症），给患者带来极大的痛苦。因此，寻找更有效，毒性更低的治疗药物是迫切需要解决的重要问题。
后莫紫檀素是从江苏盐城产刺果甘草(Glycyrrhiza pallidiflora Maxim.)中分离得到的黄酮类化合物，对其进行体外抗肿瘤细胞活性筛选，发现其有明显的抗人肝癌细胞(Hep-2)作用（李伟东等，后莫紫檀素、美迪紫檀素对人肝癌细胞抑制作用的研究，沈阳药科大学学报，第18卷第3期，2001年5月）。然而，通过检索国内外文献，目前尚没有发现后莫紫檀素具有防治痛风性关节炎的生物活性的文献报道。
发明内容
本发明的目的在于通过对天然药物进行研究，提供一种植物源性的防治痛风性关节炎的药物。该治疗药物以后莫紫檀素为活性成分，可用于痛风性关节炎症患者的治疗。
本发明的目的是这样实现的：
一种防治痛风性关节炎的药物组合物，由活性成分和辅料制备而成，所述的活性成分包括后莫紫檀素。
优选地，如上所述防治痛风性关节炎的药物组合物，其中所述的活性成分由后莫紫檀素作为唯一组分组成。
本发明所述防治痛风性关节炎的药物组合物，其中后莫紫檀素作为活性成分以灌胃方式进行了相关动物试验，结果药物经胃肠吸收显著，因此所述的药物组合物可以为口服制剂。其中所述的口服制剂包括片剂、胶囊剂、颗粒剂。
需要说明的是，按照制剂领域的常规工艺，本领域的技术人员很容易将后莫紫檀素与药剂学上可用的辅料制备成常用的固体口服制剂，如颗粒剂、片剂、胶囊剂。其中，药剂学上可用的辅料包括填充剂、崩解剂、粘合剂、矫味剂、润滑剂等等。
本发明采用5％尿酸钠混悬液注入大鼠右后足内踝的胫跗关节腔内，建造大鼠急性痛风性关节炎模型，对照组采用注射生理盐水，6h后测量大鼠右后足踝周长，结果显示模型组和药物实验组大鼠足踝周长较对照组明显增加，说明建模成功。而后莫紫檀素实验低、高剂量组大鼠的足踝周长明显低于模型组，说明后莫紫檀素具有减缓痛风性关节炎致足爪肿胀的作用。
痛风性关节炎发作的主要原因是尿酸钠沉积与关节组织中，诱使炎症细胞聚集到关节周围发生吞噬反应，在吞噬反应过程中吞噬细胞破裂释放出多种致痛因子，引起局部组织血管扩张、充血、毛细血管通透性增加，炎性物质大量渗出。使关节周围组织发生广泛的炎症反应，局部关节表现为明显的红肿热痛。因此，抑制炎性物质渗出是治疗和预防急性痛风性关节炎的重要措施。PGE2和NO是炎症反应的重要介质，在痛风性关节炎中，关节组织炎症的发生、发展与关节局部的PGE2和NO含量密切相关。PGE2可增加毛细血管的通透性，提高痛觉敏感性，引起炎症反应性水肿、渗出、充血、发红、疼痛和发热。NO可通过细胞毒作用使软骨间质细胞受损，并损伤血管内皮细胞导致骨微循环障碍，增强滑膜微血管的通透性，增加反应氧介质水平介导关节损伤。本发明结果显示后莫紫檀素实验组大鼠足爪组织中NO和PGE2的含量较模型组均有明显降低，且呈一定剂量反应关系。这说明后莫紫檀素能明显降低大鼠足爪组织中炎性因子NO和PGE2的含量，有效抑制关节组织炎性反应，减缓痛风性关节炎致足爪肿胀。
基于以上研究结果，本发明还提供一种制药用途，即：后莫紫檀素在制备防治痛风性关节炎的药物中的用途。
与现有技术相比，本发明涉及的含有后莫紫檀素的药物组合物具有如下突出的优势：（1）够减缓痛风性关节炎致足肿胀，降低肿胀足组织中炎性因子PGE2和NO的含量，从而减轻足组织炎性反应，并且不会产生耐药性；（2）为防治痛风性关节炎症提供了新的候选药物，可以单独作为防治痛风性关节炎症的药物使用，具有非常重要的临床意义。
具体实施方式
本发明采用5％尿酸钠混悬液注入大鼠右后足内踝的胫跗关节腔内，建造大鼠急性痛风性关节炎模型，并通过给药后证明后莫紫檀素够减缓痛风性关节炎致足肿胀，降低肿胀足组织中炎性因子PGE2和NO的含量，从而减轻足组织炎性反应。以下实施例是具体的试验过程：
实施例1 后莫紫檀素抗痛风性关节炎的试验研究
清洁级Wistar雄性大鼠40只，体重18O～200g。大鼠按右后足足踝周长随机分为如下四组：正常对照组、模型对照组、药物高、低剂量组，每组10只大鼠。各组大鼠按照如下剂量灌胃给予相应的受试物：
正常对照组：灌胃5%羧甲基纤维素钠溶液，1mL/100g；
模型对照组：灌胃5%羧甲基纤维素钠溶液，1mL/100g；
药物高剂量组：灌胃后莫紫檀素，30mg/kg；
药物低剂量组：灌胃后莫紫檀素，60mg/kg；
大鼠每日给药一次，共给药6周，给药期间自由进食、饮水。0.2g尿酸钠与4ml无菌生理盐水充分混合，配成5％尿酸钠混悬液。最后一次给药1h后，模型对照组和药物高、低剂量组大鼠的右后足内踝的胫跗关节腔，用4号注射针头注入5％尿酸钠混悬液50μl，正常对照组大鼠注射等量无菌生理盐水，每只动物注射1次。注射后6h测量左右足足踝的周长，肿胀度用注射后右后足相对于注射前右后足的周长的增加值和增加百分比表示，试验结果统计后见表1。
通过分析表1的试验结果可知，与注射生理盐水的正常对照组相比，注射尿酸钠后的其他各组动物出现更为严重的足踝肿胀，说明尿酸钠建造痛风性关节炎大鼠模型成功。另外，药物低、高剂量组大鼠足踝周长增加值和增加百分比均低于模型对照组，其中，高剂量组与模型组的差异具有极为显著的统计学意义（P＜0.01）。
表1 各组大鼠足肿胀度比较
模型对照组与正常对照组比较，* P＜0.05，** P＜0.01；药物组与模型对照组比较，# P＜0.05，## P＜0.01。
处死动物，按如下方法测定足爪组织中NO和PGE2水平：肿胀右后足爪从踝关节上方0.5cm处剪下，称重，放入液氮保存。检测前用1：4的无水乙醇和生理盐水配成匀浆介质，将足爪组织剪碎，放入乙醇与生理盐水溶液浸泡2h，浸泡液以3500r/min的速度离心15min，取上清液，按照一氧化氮试剂盒(硝酸还原酶法,南京建成生物工程研究所)和PGE2放射免疫试剂盒（东亚放免技术研究所）的说明书检测足组织中NO和PGE2水平，试验结果统计后见表2。
通过分析表2的试验结果可知，与正常对照组相比，模型对照组大鼠足爪组织中NO和PGE2的含量均明显上升（P＜0.01）。与模型对照组相比，低、高剂量的后莫紫檀素能明显降低尿酸钠致痛风性关节炎大鼠足跖组织中NO和PGE 的含量（P＜0.05或P＜0.01）。
表2 各组大鼠足爪NO和PGE2水平比较
模型对照组与正常对照组比较，* P＜0.05，** P＜0.01；药物组与模型对照组比较，# P＜0.05，## P＜0.01。
Claims (5)
1.一种防治痛风性关节炎的药物组合物，由活性成分和辅料制备而成，其特征在于：所述的活性成分包括后莫紫檀素。
2.根据权利要求1所述防治痛风性关节炎的药物组合物，其特征在于：所述的活性成分由后莫紫檀素作为唯一组分组成。
3.根据权利要求1或2所述防治痛风性关节炎的药物组合物，其特征在于：所述的药物组合物为口服制剂。
4.根据权利要求3所述防治痛风性关节炎的药物组合物，其特征在于：所述的口服制剂包括片剂、胶囊剂、颗粒剂。
5.后莫紫檀素在制备防治痛风性关节炎的药物中的用途。
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| CN108096236A (zh) * | 2018-01-04 | 2018-06-01 | 武汉大学 | 益母草碱在制备治疗痛风性关节炎的药物中的应用 |
| CN111617067A (zh) * | 2020-06-29 | 2020-09-04 | 海南师范大学 | 一种紫檀烷类化合物的应用及其制备方法 |
| CN111617067B (zh) * | 2020-06-29 | 2022-01-18 | 海南师范大学 | 一种紫檀烷类化合物的应用及其制备方法 |
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