CN100496492C - 治疗慢性鼻窦炎的甲苯咪唑新剂型 - Google Patents
治疗慢性鼻窦炎的甲苯咪唑新剂型 Download PDFInfo
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Abstract
本发明涉及使用甲苯咪唑制备喷雾剂、气雾剂、粉雾剂和滴鼻剂，以及这些含有甲苯咪唑的喷雾剂、气雾剂、粉雾剂和滴鼻剂在治疗慢性鼻窦炎中的应用。
Description
本发明涉及使用甲苯咪唑制备喷雾剂、气雾剂、粉雾剂和滴鼻剂，以及这些含有甲苯咪唑的喷雾剂、气雾剂、粉雾剂和滴鼻剂在治疗慢性鼻窦炎中的应用。
一、慢性鼻窦炎简介
慢性鼻窦炎一般即指慢性化脓性鼻窦炎，是鼻窦粘膜慢性化脓性炎症，其中以慢性上颌窦炎最多，常与慢性筛窦炎合并存在，多因急性化脓性鼻窦炎未得到及时合理地治疗迁延而致。感染、变应性鼻炎也是其主要原因。近年来，鼻道复合体的病变引起鼻窦引流障碍被引起广泛重视，并因此开展了功能性鼻内窥镜下的鼻窦炎手术。
1、主要症状为：脓涕、鼻塞、头痛(常表现为钝痛或头部沉重感，白天重，夜间轻)、痰多、异物感或咽干痛等，有时可有耳鸣、耳聋，病程超过6-8周，如果病程较短，可能为急性或者亚急性鼻窦炎。
2、一般的治疗包括呋麻液滴鼻、抗菌素及上颌窦穿刺冲洗术等.
3、如果一般治疗效果欠佳。应进行详细的鼻内窥镜下鼻腔检查或者鼻窦CT检查，主要了解有无影响鼻窦引流的病变。左侧的CT摄片示双侧上颌窦的炎症，并有液平。
4、手术治疗，包括去除除病因的手术，(如高位鼻中隔偏曲行鼻中隔矫正术；对肥大或息肉样变的中鼻甲，可行中鼻甲部分切除术，若有鼻息肉则行鼻息肉摘除术)、上颌窦根治术。
5、目前较流行的手术方法为功能性鼻内窥镜手术。此方法手术损伤小，符合正常生理解剖，效果较好。如有可能尽量行此手术
二、甲苯咪唑简介
甲苯咪唑，英文通用名称为Mebendazole；一般名称为：5-苯甲酰苯并咪唑氨甲酸甲酯、苯甲酰咪胺甲酯、二苯酮胍甲酯、二苯酮米胺酯、甲苯达唑、甲基咪唑等。为广谱驱虫药。可影响虫体多种生化代谢途径。本药可以抑制肠道寄生虫对葡萄糖的摄取，导致虫体内的糖原耗竭；也可与虫体微管蛋白结合抑制微管聚集，从而抑制分泌颗粒转运和其它亚细胞器运动；还可抑制虫体线粒体延胡索酸还原酶系统，减少ATP生成，从而干扰虫体生存和繁殖而导致其死亡。本药有完全杀死钩虫卵和鞭虫卵以及部分杀死蛔虫卵的作用。体外试验证明5mg/L可抑制钩虫幼虫的发育。此外，大剂量、长疗程使用本药，还有治疗旋毛虫病和包虫病的作用。人口服甲苯咪唑吸收少(5％-10％)。口服后2-5小时血药浓度达峰值，但不到服药量的0.3％。每日服用200mg，3日后血药浓度不超过0.3mg/L。药物在体内分布于血浆、肝、肺等部位，主要在肝内代谢。半衰期为2.5-5.5小时，肝功能不良(胆汁淤积)时则可达35小时。本药口服后24小时内以原形或2-氨基代谢物经消化道排泄，5％-10％随尿排泄。
三、迄今，国内外都尚未见任何将甲苯咪唑用于治疗慢性鼻窦炎的报道或文献记载。
本发明将甲苯咪唑作为单独的有效成分或与其它药物一起配成复方，制成鼻腔给药的剂型，这些剂型包括，但不限于：滴鼻剂、喷雾剂、气雾剂和粉雾剂。
本发明所述的用甲苯咪唑或用含甲苯咪唑的复方制成的滴鼻剂、喷雾剂、气雾剂和粉雾剂的适应症，包括，但不限于以下病症：慢性鼻窦炎、鼻息肉或鼻息肉病、鼻炎、咽炎、气管炎和支气管炎。
使用本发明所述的用甲苯咪唑或用含甲苯咪唑的复方制成的滴鼻剂、喷雾剂、气雾剂和粉雾剂，对于慢性鼻窦炎患者，直接鼻腔给药，可有效地缓解相关的症状。
本发明所述的滴鼻剂、喷雾剂、气雾剂和粉雾剂，均符合《中华人民共和国药典》(2000年版二部)关于滴鼻剂、喷雾剂、气雾剂和粉雾剂的定义。
本发明所述的慢性鼻窦炎，是本领域的技术人员所熟知的，现代的医学书籍中有其准确的定义。其病理学改变如前所述。本发明所述的鼻炎、咽炎、气管炎和支气管炎，也是本领域的技术技术人员所熟知的，现代的医学书籍中有其准确的定义。
通过以下实施例对本发明的甲苯咪唑滴鼻剂、喷雾剂、气雾剂和粉雾剂的制备，以及用甲苯咪唑滴鼻剂、喷雾剂、气雾剂和粉雾剂治疗慢性鼻窦炎的应用进行描述。需说明的是，下述实施例只是用来说明而非限制本发明，本领域技术人员所熟知的通过其他给药途径将甲苯咪唑用于治疗鼻息肉或鼻息肉病、鼻炎、咽炎、气管炎和支气管炎的技术均在本发明的范围内。
实施例1 甲苯咪唑鼻腔喷雾剂的制备
在万级环境中，将甲苯咪唑溶于生理盐水，制备成1mg/ml的溶液，加入洁尔灭，使洁尔灭的浓度为0.02％。将此药液灌装于鼻腔喷雾剂瓶中，拧上喷雾阀即得甲苯咪唑鼻腔喷雾剂。
实施例2 甲苯咪唑鼻腔气雾剂的制备
在万级环境中，将甲苯咪唑溶于生理盐水，制备成1mg/ml的溶液，加入洁尔灭，使洁尔灭的浓度为0.02％。将此药液灌装于鼻腔气雾剂瓶中，加入抛射剂，装上气雾阀，即得甲苯咪唑鼻腔气雾剂。
实施例3 甲苯咪唑鼻腔粉雾剂的制备
在万级环境中，将甲苯咪唑20mg、羟丙基纤维素(HPC)980mg、氯苄烷铵0.1mg共混合，得到均一的甲苯咪唑为1μg/mg的粉体，粉体粒径应为30～150μm，充填入硬胶囊内，得鼻腔给药甲苯咪唑粉雾剂。使用时经鼻用粉雾装置喷入给药。
实施例4 甲苯咪唑滴鼻剂的制备
在万级环境中，将甲苯咪唑溶于生理盐水，制备成1mg/ml的溶液，加入洁尔灭，使洁尔灭的浓度为0.02％。将此药液灌装于滴鼻剂瓶中，即得甲苯咪唑滴鼻剂。
实施例5 使用甲苯咪唑鼻腔喷雾剂治疗慢性鼻窦炎
10例患者中，男5例，女5例；年龄15～43岁；病程4月～1年。其中上颌窦炎3例，额窦炎4例，筛窦炎3例。症状均有鼻塞、流黄浊涕、头痛，或有畏寒、发热、恶心等症状。五官科检查：鼻粘膜充血水肿，鼻腔内有脓性分泌物。X线摄片：窦腔密度增高，急性期白细胞总数和中性粒细胞升高。
治疗方法：每天使用甲苯咪唑鼻腔喷雾剂喷鼻二次，持续1月。
结果：治愈(症状消失，X线鼻窦摄片无异常)2例，好转(症状明显改善，鼻腔检查粘膜充血肿胀减轻，X线鼻窦摄片明显改善)6例，无效(服药中断)2例。全部病例随访6个月，半年未复发者9例。
实施例6 使用甲苯咪唑鼻腔气雾剂治疗慢性鼻窦炎
重复“实施例1”所述的实验，除治疗药采用的是盐酸甲苯咪唑鼻腔气雾剂和观察的病人病情和数量不同外，病人入组标准、治疗方案、疗效判断标准均同“实施例1”，实验结果与“实施例1”类似。
实施例7 使用甲苯咪唑鼻腔粉雾剂治疗慢性鼻窦炎
一位44岁妇女，确诊为慢性鼻窦炎，用盐酸甲苯咪唑鼻腔粉雾剂治疗，每天给药一次，持续15天，症状明显改善。
实施例8 使用甲苯咪唑滴鼻剂治疗慢性鼻窦炎
一位成年女性，脓涕、鼻塞、头痛，诊断为慢性鼻窦炎，用“实施例7”所述的磷酸甲苯咪唑滴鼻剂治疗，每天二次，持续25天，鼻塞、头痛明显缓解，脓涕减少。
Claims (1)
1、甲苯咪唑在制备治疗慢性鼻窦炎的药物中的应用。
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| Title |
|---|
| 单剂量甲苯达唑对桑西巴土源性线虫流行与感染度的影响. 沈继龙等.国外医学.寄生虫病分册，第22卷第4期. 1995 |
| 单剂量甲苯达唑对桑西巴土源性线虫流行与感染度的影响. 沈继龙等.国外医学.寄生虫病分册，第22卷第4期. 1995 * |
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