CN116211926A - 荆防制剂在制备抗幽门螺杆菌药物中的应用 - Google Patents
荆防制剂在制备抗幽门螺杆菌药物中的应用 Download PDFInfo
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Abstract
本发明提供了一种荆防制剂在制备治疗或预防幽门螺杆菌感染的药物或保健品中的应用，所述荆防制剂包括荆芥、防风、羌活、独活、柴胡、前胡、川穹、枳壳、茯苓、桔梗、甘草以及其他药剂学上可接受的辅料；本发明通过实验证明其对幽门螺杆菌及耐药菌有明显的抑制作用，同时，荆防制剂的安全性高，毒副作用小，兼具散风解表，祛风胜湿，通利关节，活血行气，疏风宣肺，祛痰止咳，健脾利湿止痛等作用。
Description
技术领域
本发明属于医药技术领域，具体涉及一种荆防制剂在制备治疗或预防幽门螺杆菌感染的药物或保健品中的用途。
背景技术
幽门螺杆菌(Helicobacter pylori，Hp)是一种螺旋状的、微需氧的革兰氏阴性杆菌，具有较强的感染能力。目前Hp已成为世界上感染最广泛的细菌之一，在世界范围内，约有一半人口被感染。虽然近年来公共卫生条件得到很大改善，但很多国家的Hp感染率依然很高，特别是发展中国家的感染率高达70％，我国的Hp人群感染率约为50％-70％。早在1994年世界卫生组织下属的国际肿瘤研究机构就将Hp列为胃癌第一类致癌原。
目前Hp的治疗主要包括标准三联疗法和铋剂四联疗法，其他治疗方案还包括伴同疗法、序贯疗法、混合疗法和微生态制剂疗法等。标准三联疗法和铋剂四联疗法都是以抗生素为主体的根除疗法。标准三联疗法为：一种质子泵抑制剂(Proton pump inhibitor，PPI)+两种抗菌药物，疗程为7～14天；铋剂四联疗法为：一种PPI+一种铋剂+两种抗菌药物，疗程为10天或14天；常用的抗生素主要包括克拉霉素、阿莫西林、甲硝唑、四环素、呋喃唑酮、左氧氟沙星等六种。其他几种疗法也都是以抗生素疗法为主体的变种疗法。
随着这些药物的广泛使用，Hp对这些抗生素的耐药率也缓慢增加，2015年伊朗的一项研究统计了该地区Hp菌株对阿莫西林、四环素以及呋喃唑酮的耐药率分别为16.0％、12.2％和21.6％，阿莫西林和四环素的耐药率在1997年至2013年之间呈现快速增长的趋势。面对世界范围内耐药Hp菌株比例的不断攀升，在新的不易耐药抗生素越来越难发现的情况下，目前临床上除不断变换抗生素组合、加大抗生素剂量和延长治疗时间外也没太多有效办法。
因为研究更多能有效抗幽门螺杆菌的药物，是一个亟待解决的问题。
发明内容
本发明提供了一种荆防制剂在制备治疗或预防幽门螺杆菌感染的药物或保健品中的用途。
优选的，本发明所述的荆防制剂为颗粒剂、合剂、丸剂、滴丸剂、糖浆剂、散剂或冲剂。
优选的，所述治疗或预幽门螺杆菌感染的药物为荆防合剂。
优选的，所述荆防制剂可以与其他药物联合使用治疗或预防幽门螺杆菌感染。
优选的，本发明所述的荆防制剂包括以下成分：荆芥、防风、羌活、独活、柴胡、前胡、川穹、枳壳、茯苓、桔梗、甘草以及其他药剂学上可接受的辅料。
优选的，所述荆防合剂由以下重量份组成：荆芥97g、防风97g、羌活97g、独活97g、柴胡97g、前胡97g、川穹97g、枳壳97g、茯苓97g、桔梗97g、甘草32.4g。
优选的，本发明所述的荆防制剂按照本领域的常规方法制备获得。
优选的，本发明所述的荆防合剂的处方及制备方法可以参照卫生部标准WS3-B-1377-93。
本发明的有益效果：
本发明提供了荆防制剂用于抗幽门螺杆菌的新用途，并通过实验证明其对幽门螺杆菌有明显的抑制作用，并且中药的应用能减少抗生素的使用从而降低幽门螺杆菌耐药率。同时，荆防制剂的安全性高，毒副作用小，兼具散风解表，祛风胜湿，通利关节，活血行气，疏风宣肺，祛痰止咳，健脾利湿止痛等作用，可促进体内器官协调运转，增强人体免疫力。
具体实施方式
下面通过实施例来进一步说明本发明，应该正确理解的是：本发明的实施例仅仅是用于说明本发明，而不是对本发明的限制，所以，在本发明的方法前提下对本发明的简单改进均属本发明要求保护的范围。
一、荆防制剂的来源
荆防合剂，每支装10mL，鲁南厚普制药有限公司，批号：245200022。
二、荆防制剂的体外抑菌实验
1、MIC值测定
受试药物：荆防合剂(10ml/支)，阳性对照药为克拉霉素(MCE公司、批号：16542)。
菌株：幽门螺杆菌标准菌株ATCC43504、ATCC700392、SS1、NCTC26695；耐药菌株：QYZ-001、QYZ-003。
方法：荆防合剂用0.22μm滤膜过滤后，按二倍稀释法配制500μl/m1、250μl/ml、125μl/ml、62.5μl/ml、31.25μl/ml、15.625μl/ml等多个浓度梯度药物，抗生素克拉霉素作为阳性对照，用DMSO溶解配制成储备液，使用时稀释至相应的多个浓度梯度(DMSO含量≤1％)，将上述配制好的药液吸取50μl加入96孔板，每个药物浓度至少设置3个复孔，设置阴性对照孔(只含有药物、不接种菌株)、生长对照孔(不含任何药物、只接种菌株)以及克拉霉素阳性对照孔(含药物克拉霉素并接种菌株)。从培养箱取出菌株，润湿的灭菌棉签刮取菌苔至PBS中，用含20％ FBS的BHI调节菌悬液浊度为1McF，稀释10倍接种于上述含药96孔板中(最终在96孔板中的菌悬液浊度约为1×106CFU/ml)，立即将96孔板置于培养箱，37℃、微需氧条件、150rpm振荡培养72h后取出观察结果。当生长对照呈现纽扣状或明显浑浊时结果才可用，肉眼从下往上观察，细菌浑浊度明显降低时的药物浓度即为MIC，MIC值的测定在复苏后3代内完成，MIC值测定重复3次。荆防合剂对幽门螺杆菌的抑制结果见表1。
表1.
注：“-”为无细菌生长、“+～++++”为细菌生长情况。
根据上述试验结果，荆防合剂对不同来源幽门螺杆菌的抑制结果见表2。
表2.
| 菌种 | ATCC43504 | ATC700392 | SS1 | NCTC26695 | QYZ-001 | QYZ-003 |
| MIC(μl/ml) | 31.25 | 62.5 | 31.25 | 31.25 | 62.5 | 31.25 |
2、MBC值的测定
取出微量肉汤测定法中培养72h的96孔板，分别从1倍MIC、2倍MIC、4倍MIC药物浓度孔中吸取100μL的液体均匀涂布于新鲜血平板上，培养72h后取出观察结果，以杀死99.9％细菌数量的药物浓度为MBC。荆防合剂对多种幽门螺杆菌的抑制结果见表3。
表3
| 菌种 | ATCC43504 | ATCC700392 | SS1 | NCTC26695 | QYZ-001 | QYZ-003 |
| MBC(μl/ml) | 31.25 | 62.5 | 31.25 | 31.25 | 62.5 | 62.5 |
如表1-3所示，荆防合剂对多个敏感/耐药的幽门螺杆菌菌株均有良好抑制活性，MIC值在31.25-62.5μl/mL，MBC值在31.25-62.5μl/ml之间。说明荆防合剂对幽门螺杆菌标准菌株和耐药菌株在体外都有非常有效的抑制和杀灭作用。
三、荆防合剂对幽门螺杆菌的阴转疗效影响
实验方法：
菌液制备：将幽门螺杆菌ATCC43504菌株接种于布氏琼脂培养基中，在微需氧环境中，37℃培养3天，进行革兰氏染色镜检，尿激酶、过氧化物和过氧化氢酶试验确定幽门螺杆菌后，采用布氏肉汤培养3天得到菌液备用；
造模及试验：Wistar大鼠雌雄各半，先使用5％碳酸氢钠溶液灌胃后(灌胃量2mL/只)，15min后使用菌液灌胃大鼠(灌胃量为1.5mL/只)，每周一次，共进行5次。造模结束后，取尾血检查抗幽门螺杆菌相关抗体，显阳性即为造模成功。随机选取40只，分为2组，每组20只，分别设为模型对照组，以及实验组，实验组大鼠灌胃荆防合剂(3mL/kg)，每日1次共计10天，模型对照组灌胃等量生理盐水。给药结束后禁食1天，处死大鼠，剪开胃腔，取用3块胃部组织，分别进行胃粘膜涂片、细菌培养以及快速尿激酶试验后，统计阳性数，以三项指标同时为阴性为根除指标，计算根除率，将结果记录在表4中。
表4.
由上表4可知，本发明中的组合物能够有效抑制幽门螺杆菌，在较低剂量的前提下，最终对于幽门螺杆菌的根除率可达到75％以上。
Claims (5)
1.一种荆防制剂的新用途，其特征在于，所述荆防制剂可用于制备治疗或预防幽门螺杆菌感染的药物或保健品。
2.根据权利要求1所述的荆防制剂的用途，其特征在于，所述荆防制剂包括以下成分：
荆芥、防风、羌活、独活、柴胡、前胡、川穹、枳壳、茯苓、桔梗、甘草以及其他药剂学上可接受的辅料。
3.根据权利要求1所述的荆防制剂的用途，其特征在于，所述荆防制剂为颗粒剂、合剂、丸剂、滴丸剂、糖浆剂、散剂或冲剂。
4.根据权利要求1所述的荆防制剂的用途，其特征在于，所述荆防制剂为荆防合剂。
5.根据权利要求4所述的荆防制剂的用途，其特征在于，所述荆防合剂由以下重量份组成：荆芥97g、防风97g、羌活97g、独活97g、柴胡97g、前胡97g、川穹97g、枳壳97g、茯苓97g、桔梗97g、甘草32.4g。
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