CN112546203A - 一种用于白塞病口腔溃疡的漱口水、制备方法及其用途 - Google Patents
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Abstract
本发明涉及医药技术领域，提供一种用于白塞病口腔溃疡的药物，地塞米松20～60，甲硝唑250～750，利多卡因200～600，白细胞介素‑110.15‑1.5。本发明提供一种漱口水，包括溶剂和第一方面所述的药物，所述药物的有效组分在所述溶剂的浓度为2.6～14.1015mg/mL。本发明提供一种漱口水的制备方法，所述的药物和所述溶剂混合获得漱口水。本制备的药物和漱口水具有安全性，可明显缩短口腔溃疡愈合时间，可明显减轻口腔溃疡疼痛。
Description
技术领域
本发明涉及医药技术领域，特别是涉及一种用于白塞病口腔溃疡的漱口水、制备方法及其用途。
背景技术
白塞病(Behcet’s disease,BD)是以口腔溃疡、生殖器溃疡、眼炎“三联症”为特征的自身免疫性疾病，并可累及皮肤、眼、中枢神经、消化道等多个器官，复发性口腔溃疡疼痛是其最常见的临床症状之一，严重影响患者的生活质量。中国是白塞病发病率较高地区之一，未见详细的发病率报告，相关专家预测在2-14/10万，在欧美罕见，在东地中海和亚洲地区是该病高发区域，故也被称为“丝绸之路病”。
发明内容
鉴于以上所述现有技术的缺点，本发明的目的在于提供一种用于白塞病口腔溃疡的漱口水、制备方法及其用途，用于解决现有技术的问题。
为实现上述目的及其他相关目的，本发明第一方面提供一种用于白塞病口腔溃疡的药物，地塞米松20～60，甲硝唑250～750，利多卡因200～600，白细胞介素-11 0.15-1.5。
本发明第二方面提供一种第一方面所述的药物用于制备漱口水的用途。
本发明第三方面，提供一种漱口水，包括溶剂和第一方面所述的药物，所述药物的有效组分在所述溶剂的浓度为2.6～14.1015mg/mL。
本发明第四方面，提供一种漱口水的制备方法，第一方面所述的药物和所述溶剂混合获得漱口水。
本发明的第五方面，提供一种方面所述的药物和第三方面所述的漱口水用于制备治疗白塞病产品的用途。
如上所述，本发明具有以下有益效果：
本发明制备的药物使用的是市场常规的试剂，具有安全性，可明显缩短口腔溃疡愈合时间，可明显减轻口腔溃疡疼痛。
附图说明
图1显示为漱口水组/实验组的口腔溃疡愈合时间。
图2显示为漱口水组/实验组的口腔溃疡疼痛评分。
图3显示为舌溃疡漱口水治疗5天愈合图。
图4.咽舌溃疡漱口水治疗7天愈合图。
具体实施方式
以下通过特定的具体实例说明本发明的实施方式，本领域技术人员可由本说明书所揭露的内容轻易地了解本发明的其他优点与功效。本发明还可以通过另外不同的具体实施方式加以实施或应用，本说明书中的各项细节也可以基于不同观点与应用，在没有背离本发明的精神下进行各种修饰或改变。
本发明的第一方面提供一种治疗白塞病口腔溃疡的药物，所述药物包括以下质量份的有效组分：地塞米松20～60，甲硝唑250～750，利多卡因200～600，白细胞介素-110.15-1.5。
本发明将针对白塞病口腔溃疡将多种西药进行组合配置，经过多年的组分优化及其质量比调整，制备出了可缩短口腔溃疡愈合时间和减轻口腔溃疡疼痛的药物。
在一实施例中，所述药物还包括质量份为800的阿米卡星。
本发明使用的利多卡因、地塞米松、阿米卡星和白细胞介素-11均为市售常规的试剂。
本发明第二方面提供一种第一方面所述的药物用于制备漱口水的用途。
本发明使用的所述药物均可与溶剂进行混合，获得用于治疗白塞病口腔溃疡的漱口水。
本发明第三方面，提供一种漱口水，包括溶剂和第一方面所述的药物，所述药物的有效组分在所述溶剂的浓度为2.6～14.1015mg/mL。
在本发明中制备的漱口水使用方便，只需2.8天完成口腔溃疡愈合，常用药物治疗口腔溃疡需要5.8天才能使口腔溃疡愈合，明显缩短口腔溃疡愈合时间，可明显减轻口腔溃疡疼痛。
在本实施例中，所述溶剂为水溶液，具体为蒸馏水。
在一实施例中，所述簌口水还包阿米卡星，所述阿米卡星在所述漱口水中的浓度为4.4～8mg/mL。
实验人员根据自己患者状况选择阿米卡星在所述漱口水中的浓度，例如可以是4.4～5mg/mL、5～6mg/mL、6～7mg/mL或7～8mg/mL。
在实际使用过程中，如果患者口干，需要在所述漱口水中添加辅助溶剂试剂用于缓解口干，所述阿米卡星在所述漱口水中的浓度为4.4mg/mL，如果患者无口干状况，所述阿米卡星在所述漱口水中的浓度可以为8mg/mL。
在一实施例中，所述簌口水还包括氯化钠。所述氯化钠在所述漱口水中的浓度为4.4～10mg/mL。
实验人员根据自己患者状况选择氯化钠在所述漱口水中的浓度，例如可以是4.4～5mg/mL、5～6mg/mL、6～7mg/mL或7～8mg/mL。
在实际使用过程中，如果患者口干，需要在所述漱口水中添加辅助溶剂试剂用于缓解口干，所述氯化钠在所述漱口水中的浓度为4.4mg/mL，如果患者无口干状况，所述氯化钠在所述漱口水中的浓度可以为8mg/mL。
本发明可使用甲硝唑氯化钠溶液与第一方面所述的药物混合制备簌口水，且甲硝唑氯化钠溶液为市售常规的医用试剂。
在一实施例中，所述簌口水的有效组分还包括甘露醇。
优选地，所述甘露醇在所述漱口水中的浓度为0.075-0.1mg/mL。具有消肿的作用，还具有甜味，调节甲硝唑、阿米卡星、利多卡因的苦味，有利于增加患者依从性，同时还具有减轻患口水肿作用。
本发明第四方面，提供一种漱口水的制备方法，第一方面所述的药物和所述溶剂混合获得漱口水。
将第一方面所述的药物、氯化钠、甲硝唑和甘露醇加入到蒸馏中，并均匀混合，或将第一方面所述的药物加入到含有甲硝唑氯化钠溶液与质量浓度为20wt％的甘露醇溶液的混合液中，并搅拌均匀。
优选地，将甲硝唑氯化钠溶液与质量浓度为20wt％的甘露醇溶液混合，且甲硝唑氯化钠溶液与20wt％的甘露醇溶液的体积比为5：4。易于溶解，形成标准规格液体总量。
本发明的第四方面，提供一种方面所述的药物和第二方面所述的漱口水用于制备治疗白塞病产品的用途。
本发明制备的药物使用的是市场常规的试剂，具有安全性，可抑制口腔内的细菌，预防激素和抗生素诱发的真菌感染，可用于制备治疗白塞病产品。
产品可以是所述药物与溶剂混合制备成漱口水或膏体，还可以是将所述药物研磨成粉末制备成粉末药。
实施例1
分别取利多卡因4支(100mg/支)、地塞米松8支(5mg/支)、阿米卡星4支(0.2g/支)、IL-11 1支(1.5mg/支)，将其均匀混合获得用于白塞病口腔溃疡的药物。
注射用甲硝唑氯化钠100ml、利多卡因4支(100mg/支)、地塞米松8支(5mg/支)、阿米卡星4支(0.2g/支)+IL-11 1支(1.5mg/支)、甘露醇80ml，将上述试剂均匀混合获得漱口水，所述在4～8℃环境中保存。
在本实施例中，L-11为白细胞介素-11。
实施例2
纳入从2016年5月至2019年5月共300例诊断为白塞病的患者纳入本研究。患者达到国际白塞病研究组(International Study Group for BD)的诊断标准。每一位患者的确诊由2位资深风湿病医生诊断。对患者进行全身检查或筛查，包括头颅磁共振成像(MRI)、胸部电脑断层扫描(CT),胃肠道内窥镜检查,腹部超声、重要血管的血管超声，以及血液检查包括肝、肾功能,葡萄糖，癌症标记物，T.SPORT、乙肝病毒(HBV)、梅毒螺旋体、艾滋病毒(HIV)和自身抗体等以排除内部器官责任人和其他疾病，如感染、糖尿病、风湿性关节炎、癌症、克罗恩病和溃疡性结肠炎。所有参与者均仅有BD的皮肤黏膜表现，包括口腔溃疡、生殖器溃疡、皮肤结节性红斑。角膜炎、结膜炎、前葡萄膜炎可能出现在他们的历史,但后葡萄膜炎，可能会影响视力，需要强化治疗的亦予以排除。
患者随机分为2组，即对照组和漱口水干预组。实验前，两组患者在性别、年龄、病程、病情严重程度方面无差异。对照组150例，采用沙利度胺50mg，睡前口服、秋水仙碱1mg，每天一次口服，根据病情调整基线治疗。口腔溃疡发作期间加用生理盐水进行漱口，每日4次(三餐后+睡前)，每次10-15分钟。治疗组150例，口服药物与对照组相同；口腔溃疡发作期间加用本漱口水进行漱口，每日4次(三餐后+睡前)，每次10-15分钟，疗程3～7天。2组患者随访半年，可以观察到结果如图1所示：
如图1所示，用口服药物的情况下，仍有口腔溃疡的发作。每次发作平均愈合时间5.8天，漱口水组为2.8天明显低于对照组(p<0.0001)。
如图2所示，采用视觉模拟评分法(visual analogue scale，VAS)评估患者口腔溃疡所导致的疼痛，可发现我们发明的漱口水可明显减轻口腔溃疡疼痛(p<0.0001)。
实施例3
患者男性，24岁，广东湛江人。“复发性口腔溃疡15年”来诊。每月反复发作。发作时2-10个。每月多次发作，常常一批口腔溃疡尚未愈合，下一次口腔溃疡又发作。伴有外阴溃疡病史，发作过5次。近1年来关节疼痛、主要累计双侧肘关节、右侧膝关节、踝关节。就诊于广州多家三甲医院，服用激素、免疫调节剂等，病情控制尚不佳。患者苦于口腔溃疡反复发作，情绪低落、饮食下降。
如图3和图4所示，查体：神态疲乏；口腔溃疡，5枚，直径3mm-8mm，分布于口唇、舌或者咽喉部等处。辅助检测：可除外结核、乙肝等感染性疾病、胃肠镜检测、眼底镜检查无明显异常。血沉60mm/h。给予漱口水，嘱患者漱口，每日4次，每次10-15分钟。患者漱口后感觉口唇麻木，无口腔疼痛；次日口腔水肿消失，第5-7日舌和咽喉部2个深大口腔溃疡逐渐愈合。调整患者基础抗风湿药物，随访2年，口腔溃疡仅复发1次。
综上所述，本发明有效克服了现有技术中的种种缺点而具高度产业利用价值。
上述实施例仅例示性说明本发明的原理及其功效，而非用于限制本发明。任何熟悉此技术的人士皆可在不违背本发明的精神及范畴下，对上述实施例进行修饰或改变。因此，举凡所属技术领域中具有通常知识者在未脱离本发明所揭示的精神与技术思想下所完成的一切等效修饰或改变，仍应由本发明的权利要求所涵盖。
Claims (10)
1.一种用于白塞病口腔溃疡的药物，其特征在于，所述药物包括以下质量份的有效组分：地塞米松20～60，甲硝唑250～750，利多卡因200～600，白细胞介素-11 0.15～1.5。
2.根据权利要求1所述的药物，其特征在于，所述药物还包括质量份为800的阿米卡星。
3.一种如权利要求1或2所述的药物用于制备漱口水的用途。
4.一种漱口水，其特征在于：包括溶剂和权利要求1或2所述药物，所述药物的有效组分在所述溶剂的浓度为2.6～14.1015mg/mL。
5.根据权利要求4所述的漱口水，其特征在于：所述簌口水还包阿米卡星，所述阿米卡星在所述漱口水中的浓度为4.4～8mg/mL。
6.根据权利要求5所述的漱口水，其特征在于：所述簌口水的有效组分还包括氯化钠，所述氯化钠在所述漱口水中的浓度为4.4～10mg/mL。
7.根据权利要求6所述的漱口水，其特征在于：所述簌口水的有效组分还包括甘露醇。
8.根据权利要求7所述的漱口水，其特征在于：所述甘露醇在所述漱口水中的浓度为0.075-0.1mg/mL。
9.一种权利要求4至7任一项所述漱口水的制备方法，其特征在于：将所述溶剂和权利要求1或2所述药物混合获得漱口水。
10.一种如权利要求1或2所述的药物和权利要求3至7任一项所述的簌口水用于制备治疗白塞病产品的用途。
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