CN1307881C - 含银杀菌剂H4Ag2O6的新用途及其制备的药物 - Google Patents
含银杀菌剂H4Ag2O6的新用途及其制备的药物 Download PDFInfo
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Abstract
本发明提供了一种以含银杀菌剂H4Ag2O6为有效成分的防治妇女生殖道感染和皮肤浅部真菌感染的药物，其凝胶剂药物组方是，浓度3000ppm的H4Ag2O6溶液100ml，聚乙二醇55.690g，卡伯母42.690g，羟基苯甲酸甲酯0.5，蒸馏水加至组方总量为1000g。本发明以含银杀菌剂H4Ag2O6为有效成分制备的药物，可用于治疗妇科生殖道感染，包括细菌性阴道炎、念珠菌性阴道炎、滴虫性阴道炎、混合性阴道炎、支原体衣原体感染、淋球菌感染、宫颈炎和宫颈糜烂等；还可用于治疗治疗皮肤浅部真菌感染，包括痤疮、粉刺、发癣、须癣、体癣、股癣、手癣、足癣或脚气、黄癣、甲癣、牛皮癣和迭癣。
Description
技术领域
本发明涉及的是医用杀菌剂，特别是关于含银杀菌剂H4Ag2O6的新用途及其制备的药物。
背景技术
妇科生殖道感染疾病是妇女的常见病和多发病，临床上大多用抗生素及一些中药产品来治疗。但是，抗生素的大量使用，会导致抗药性致病菌的迅速蔓延，加上女性本身的生理特点，使临床对这类疾病的治疗力不从心，因此，目前人们正在寻找更好的解决方案。
皮肤浅部真菌病，是一种由寄生于角蛋白组织的致病真菌所引起的皮肤疾病，其流行颇广，遍布在世界各地，在我国也是常见多发病。据上海有关医院报告，该类皮肤疾病的发病率，占皮肤科门诊患者总数的第二位或第三位，有的甚至居首位。目前对于这种疾病，主要应用抗真菌的化学药品全身或局部给药治疗，但是，存在着真菌的耐药性和治愈后易复发等问题。
银具有杀菌性能，并且不产生耐药性，其抗菌机理是：1、银与致病菌代谢酶中的巯基结合，使酶失活，致使致病菌不能代谢而死亡；2、银和细菌细胞壁上暴露的肽聚糖反应，形成可逆性复合物，使其不能把氧转运进细胞，阻止病菌活动，导致其死亡；3、银离子和致病菌中的DNA碱基结合，银离子彼此形成交叉链接，导致DNA结构变性，抑制其复制，使致病菌失活。
银在金属状态下本身不能杀菌，只有银离子状态才具有抗菌性能。在银的化合物中，硝酸银溶于水，溶液中银为离子状态，但是，溶液中存在的大量硝酸根限制了银离子的应用。还有一些银盐，如：蛋白银、乙酸银、乳酸银、柠檬酸银和磺胺嘧啶银等，被应用到伤口敷料中。现有技术中未见有关于高浓度银离子溶液应用于医疗方面的报道。
本发明申请人持有专利权的中国专利ZL97108681.8，公开了一种含银杀菌剂的制备方法，具体步骤如下：(1)取银的氧化物(包括氧化银或过氧化银)，加入蒸馏水；(2)搅拌后，加入浓硫酸，调整pH值；(3)澄清后倒出澄清液，得到沉淀物；(4)向沉淀物中加入过氧化氢，得到含银杀菌剂。该含银杀菌剂为含银水合物，分子式表示为H4Ag2O6，该方法为含银杀菌剂H4Ag2O6在制药方面的应用提供了必要的条件。
发明内容
本发明的目的是提供含银杀菌剂H4Ag2O6的一种新用途及其制备的药物。
本发明发明人的研究表明，含银杀菌剂H4Ag2O6具有防治妇女生殖道感染和皮肤浅部真菌感染的作用，可用于制备防治妇女生殖道感染和皮肤浅部真菌感染的药物。
所述妇女生殖道感染包含细菌性阴道炎、念珠菌性阴道炎、滴虫性阴道炎、混合性阴道炎、支原体衣原体感染、淋球菌感染、宫颈炎和宫颈糜烂。
所述皮肤浅部真菌感染包含痤疮、粉刺、发癣、须癣、体癣、股癣、手癣、足癣或脚气、黄癣、甲癣、牛皮癣和迭癣。
一种以含银杀菌剂H4Ag2O6为有效成分的防治妇女生殖道感染和皮肤浅部真菌感染的药物。
所述以含银杀菌剂H4Ag2O6为有效成分的防治妇女生殖道感染和皮肤浅部真菌感染的药物组分，包括含银杀菌剂H4Ag2O6和制药学上允许的载体。
所述以含银杀菌剂H4Ag2O6为有效成分的防治妇女生殖道感染和皮肤浅部真菌感染的药物，其凝胶剂药物组方是，浓度3000ppm的H4Ag2O6溶液100ml，聚乙二醇55.690g，卡伯母42.690g，羟基苯甲酸甲酯0.5g，蒸馏水加至组方总量为1000g。
本发明所述的含银杀菌剂H4Ag2O6，是按照中国专利ZL97108681.8公开的制备方法，以氧化银或过氧化银为原料制备而成的，避免了现有技术中常用硝酸银为原料制备含银杀菌剂，溶液中易存在大量硝酸根限制银离子应用的缺点。因此，H4Ag2O6溶液具有银离子浓度高，不含硝酸根，抗菌性能强等优点。以含银杀菌剂H4Ag2O6为有效成分制备的防治妇女生殖道感染和皮肤浅部真菌感染药物，有很强的抗菌性能，具有广阔的应用前景。
具体实施方式
以下通过实施例说明本发明的详细内容。
实施例1：含银杀菌剂H4Ag2O6的制备方法。
按中国专利ZL97108681.8所公开的H4Ag2O6溶液制备方法，包括以下步骤：
(1)取银的氧化物(包括氧化银或过氧化银)10g，加入蒸馏水1000ml；(2)搅拌15～60分钟后，逐滴加入浓硫酸，调整PH值为2～3.5；(3)澄清至少2小时，倒出澄清液；(4)向沉淀物中加入30％的过氧化氢(H2O2)10ml，得到H4Ag2O6溶液。
实施例2、含银杀菌剂H4Ag2O6体外抗菌试验。
体外抗菌试验采用的含银杀菌剂H4Ag2O6浓度为4000mg/L；对照品为成都恩威制药有限公司生产的洁尔阴洗液；试验菌株为：金黄色葡萄球菌ATCC 6538，白色念珠菌ATCC 10231，枯草芽孢杆菌ATCC 6633。试验数据如表1所示。
表1：含银杀菌剂H4Ag2O6体外抗菌试验数据表
| 试验菌株 | 样品浓度mg/L | 不同时间(min)杀菌率(％) | |||
| 1 | 3 | 5 | 10 | ||
| 金黄色葡萄球菌ATCC6538 | 200 | 99.86％ | 99.89％ | 99.97％ | 100％ |
| 100 | 97.9％ | 99.83％ | 99.97％ | 100％ | |
| 50 | 94.5％ | 99.74％ | 99.94％ | 99.94％ | |
| 对照 | 84.7％ | 95.33％ | 96.37％ | 97.18％ | |
| 枯草芽孢杆菌ATCC6633 | 200 | 92.33％ | 92.61％ | 92.94％ | 92.96％ |
| 100 | 90.97％ | 91.43％ | 91.43％ | 91.54％ | |
| 50 | 90.82％ | 91.18％ | 91.32％ | 91.61％ | |
| 对照 | 91.0％ | 91.32％ | 91.36％ | 91.90％ | |
| 白色念珠菌ATCC10231 | 200 | 99.76％ | 99.84％ | 99.84％ | 100％ |
| 100 | 99.27％ | 99.66％ | 99.84％ | 99.92％ | |
| 50 | 95.3％ | 94.73％ | 98.31％ | 96.11％ | |
| 对照 | 76.62％ | 84.0％ | 90.08％ | 93.71 | |
体外杀菌试验结果表明：含银杀菌剂H4Ag2O6对金黄色葡萄球菌具有很强的杀伤作用，三种浓度(50mg/L、100mg/L、200mg/L)下作用5分钟，杀菌率可达到99.9％以上；对枯草芽孢杆菌也有一定的杀伤作用，三种浓度(50mg/L、100mg/L、200mg/L)下，杀菌率可以达到90％以上；对白色念珠菌具有较强的杀伤作用，三种浓度(50mg/L、100mg/L、200mg/L)下作用10分钟，杀菌率平均可以达到98.7％以上。
实施例3：含H4Ag2O6的洗液剂药物的制备。
处方：H4Ag2O6溶液(浓度2000ppm) 100ml
甘油 10ml
丙二醇 8ml
薄荷油 5ml
合计加蒸馏水至 1000ml
按常规方法制备，规格100ml/瓶，浓度2000ppm。
用药方式：直接或稀释10～20倍后冲洗、擦洗使用。用完以纸巾拭干皮肤即可，无需用水清洗。
实施例4：含H4Ag2O6的凝胶剂药物的制备。
处方：H4Ag2O6溶液(浓度3000ppm) 100.000ml
聚乙二醇 55.690g
卡伯母 42.690g
羟基苯甲酸甲酯 0.500g
合计加蒸馏水至 1000.000g
按照凝胶的常规方法制备，再装入特制的给药器中，规格：10g/支或3g/支。
使用方法：每晚睡前，将载有抗菌凝胶剂药物的给药器轻轻插入阴道深部，用推杆将抗菌凝胶剂药物推入即可。每晚1支，3～6天为一疗程。治疗阴道炎：1个疗程，重者酌情增加疗程；治疗宫颈炎：1～2个疗程，重者酌情增加疗程。
实施例5：含H4Ag2O6的泡沫剂药物的制备。
处方：H4Ag2O6(浓度2000ppm) 100ml
甘油 10ml
薄荷油 8ml
土温80 5ml
合计加蒸馏水至 1000ml
制备方法：
(1)取上述配量的H4Ag2O6作为A液。
(2)将上述配量的薄荷油、甘油、土温80混合搅拌均匀，成为B液。
(3)将A、B两液混合并搅拌均匀，再加入蒸馏水至1000ml，搅拌均匀得C液。
(4)将C液罐入耐压容器中并加入抛射剂，制为成品，规格：100ml/瓶。
使用方法：每晚睡前，用一次性导管轻轻插入阴道，按1～2下喷嘴即可。每晚1次，3～6天为一疗程。治疗阴道炎：1个疗程，重者酌情增加疗程；治疗宫颈炎：1～2个疗程，重者酌情增加疗程。
实施例6：含H4Ag2O6的软膏剂药物的制备。
处方：H4Ag2O6溶液(浓度1000ppm) 100ml
白凡士林 800g
橄榄油 100g
合计 1000g
制备方法：将含银杀菌剂H4Ag2O6分散于橄榄油中，搅拌融化了的白凡士林，同时加入含有H4Ag2O6的橄榄油，混匀后灌装，规格10g/支。
使用方法：用手涂抹到真菌感染的部位，每日2～3次。
实施例7：含H4Ag2O6的喷雾剂药物的制备。
利用实施例3所制做的H4Ag2O6的洗液剂药物，装于喷雾装置中，即可成喷雾剂药物，可以用于治疗皮肤真菌感染。
实施例8：含H4Ag2O6的栓剂药物的制备。
处方：H4Ag2O6溶液(浓度4000ppm) 10ml
甘油明胶 85g
甘油 5g
合计 100g
制备方法：将含银杀菌剂H4Ag2O6分散于甘油中，搅拌融化了的甘油明胶，同时加入含银杀菌剂H4Ag2O6的甘油，混匀后灌装，规格：5g/只或3g/只。
使用方法：每晚睡前，将栓轻轻插入阴道深部即可，每晚1只，3～6天为一疗程；治疗阴道炎：1个疗程，重者酌情增加疗程；治疗宫颈炎：1～2个疗程，重者酌情增加疗程。
实施例9、以含银杀菌剂H4Ag2O6为有效成分制备的洗液剂药物用于皮肤浅部真菌感染的防治试验。
以含银杀菌剂H4Ag2O6为有效成分制备的洗液剂作为本试验的药物；选用由中国微生物菌种保藏管理委员会医学真菌中心提供的常见5属12种致病真菌的标准菌株作为试验对象；所用培养基以不含任何抗生素的沙堡氏液体培养基为基础培养基；以液体微量稀释法作为检测方法。实验结果如表2所示。
表2：以H4Ag2O6为有效成分制备的洗液剂药物
体外抗常见5属12种致病真菌的MIC测定结果
| 菌名 | 培养基H4Ag2O6浓度(ppm/ml) | MIC(ppm/ml) | |||||||||
| 350 | 175 | 87.5 | 44 | 22 | 11 | 5.5 | 2.75 | 1.4 | 0.7 | ||
| 红色毛癣菌 | - | - | - | - | - | - | - | + | + | 5.5 | |
| 须癣毛癣菌 | - | - | - | - | - | - | + | + | + | + | 11 |
| 许兰毛癣菌 | - | - | - | - | - | - | + | + | + | + | 11 |
| 紫色毛癣菌 | - | - | - | - | - | - | - | + | + | + | 5.5 |
| 断发毛癣菌 | - | - | - | - | - | - | + | + | + | + | 11 |
| 犬小孢子菌 | - | - | - | - | - | - | + | + | + | + | 11 |
| 石膏样小孢子菌 | - | - | - | - | - | - | + | + | + | + | 11 |
| 絮状表皮癣菌 | - | - | - | - | - | - | - | - | + | + | 2.75 |
| 白色念珠菌 | - | - | - | - | - | - | + | + | + | + | 11 |
| 糠秕马拉色菌 | - | - | - | - | - | + | + | + | + | + | 22 |
| 含轴马拉色菌 | - | - | - | - | + | + | + | + | + | + | 44 |
| 球形马拉色菌 | - | - | - | - | - | + | + | + | + | + | 22 |
注：“+”菌生长，表示无抗菌作用，“-”菌未生长，表示有抑菌作用。
实施例10、以H4Ag2O6为有效成分制备的凝胶剂药物治疗皮肤真菌病的临床试验。
本实施例临床试验采用的凝胶药物含银离子500ppm。皮肤真菌病受试患者共60例，男53例，女7例，其中体股癣35例，病程1周至5年；手足癣25例，病程1周至20年。真菌培养分离出红色毛癣菌25株，其它皮肤癣菌6株。临床试验疗效评价如表3所示。
表3以H4Ag2O6为有效成分制备的凝胶药物
治疗皮肤真菌病的临床及真菌学疗效评价
| 例数 | 治愈 | 显效 | 有效 | 无效 | 有效率 | 真菌清除率 | |
| 体股癣 | 35 | 7(20) | 8(22.9) | 14(40) | 6(17.1) | 82.9％ | 62.9％ |
| 手足癣 | 25 | 4(16) | 6(24) | 7(28) | 8(32) | 68％ | 60.0％ |
| 合计 | 60 | 11(18.3) | 14(23.3) | 21(35) | 14(23.3) | 76.6％ | 61.7％ |
不良反应评价：整个临床试验期间内均无不良反应发生。
Claims (1)
1、一种以含银杀菌剂H4Ag2O6为有效成分的防治妇女生殖道感染和皮肤浅部真菌感染的药物，其凝胶剂药物组方是，浓度3000ppm的H4Ag2O6溶液100ml，聚乙二醇55.690g，卡伯母42.690g，羟基苯甲酸甲酯O.5g，蒸馏水加至组方总量为1000g。
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