CN111904976A - 含碘制剂体内杀灭微生物的方法 - Google Patents
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- ZCYVEMRRCGMTRW-UHFFFAOYSA-N 7553-56-2 Chemical compound [I] ZCYVEMRRCGMTRW-UHFFFAOYSA-N 0.000 title claims abstract description 56
- 239000011630 iodine Substances 0.000 title claims abstract description 56
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- CPKVUHPKYQGHMW-UHFFFAOYSA-N 1-ethenylpyrrolidin-2-one;molecular iodine Chemical compound II.C=CN1CCCC1=O CPKVUHPKYQGHMW-UHFFFAOYSA-N 0.000 claims abstract description 24
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Abstract
本发明属于医药领域,特别是涉及一种含碘制剂体内杀灭微生物的方法。经过发明人对20只小鼠静脉注射的急性毒性试验得出结论,含碘制剂(聚维酮碘)小鼠静脉以黏膜消毒要求浓度的3.3倍量是比较安全的。含碘制剂可用于动脉注射、静脉注射和口服治疗微生物侵害引起的疾病。当对体内特定器官或部位进行高浓度动脉注射时,杀灭作用超强,而注射之后,含碘药物通过人体血液稀释并代谢排出体外,因此是毒性最低而疗效最显著的方法。含碘药物对微生物机体具有极强的破坏杀灭作用,但对于高等动物细胞,在一定量内却损伤极其微小,其有益效果是,用安全性较高的含碘制剂杀灭病源微生物,高效、低毒且不会产生抗药性。
Description
技术领域
本发明涉及医药领域,特别是涉及一种含碘制剂体内杀灭微生物的方法,以体外消毒原理进行体内微生物杀灭,可用于动脉注射、静脉注射和口服治疗微生物感染性疾病。
背景技术
2019年德国科学家发表在《传染病及治疗》(Eggers,Maren.Infectious DiseaseManagement and Control with Povidone Iodine[J].Infectious Diseases&Therapy,2019,8(4):581-593.doi:10.1007/s40121-019-00260-x)。该论文显示,可以用聚维酮碘对抗传染病,聚维酮碘漱口液能显著减少口腔和口咽部的病毒载量,可以有效对抗SARS和MERS冠状病毒的传染。含碘药物对微生物机体具有极强的破坏杀灭作用,但对高等动物细胞,在一定量内损伤极其微小。
同时,目前临床上增强CT静脉注射造影剂使用的较高浓度的碘水或碘油,也从侧面印证了动脉、静脉注射碘剂的安全性。
发明内容
聚维酮碘是否可以静脉给药?安全性如何?如果能静脉给药的话,是否可以用于新冠病毒病的预防或治疗?基于这样的考虑,我们做了小鼠静脉注射聚维酮碘的急性毒性预试验,结果没有找到致死剂量。具体情况如下:首先,药物的毒性与其质量密切相关。我们选择了质量可靠的药品。含量1%的“猪猪金盾”牌聚维酮碘溶液由河北呈盛堂动物药物公司惠赠,其原料药来自全国质量第二碘制备公司。因此,此受试药液质量不是第一,但比一般商品化聚维酮碘质量高【稳定性好,刺激性小,小猪可灌服,即口服(兽药药典至今没有口服碘制剂,只有外用制剂,故此制剂仍标外用,实际上可以灌服)。质量可靠】。黏膜及创伤冲洗用0.1%浓度。
其次,给药量。我们按小鼠静脉一次最大注射容积(每10克体重静脉注射0.3ml)给药,即1%聚维酮碘药液不加稀释,直接静脉注射,剂量为0.3ml/10g体重。
第三,结果。一次注射后,观察一周,14只雌性小鼠无一死亡,10只雄性小鼠有一只死亡。小鼠体重在19.8g-25.5g之间。
我们认为,1%聚维酮碘溶液(猪猪金盾)静脉注射小鼠是安全的。既然聚维酮碘能够体外杀灭冠状病毒,同时动物静脉注射又有较高的安全性,由此推断,聚维酮碘注射可用于新冠病毒肺炎的治疗。
进一步,聚维酮碘注射还可用于其他病毒诸如狂犬病毒、埃博拉病毒、肝炎病毒等的治疗。
试验结果记录见附件《小鼠聚维酮碘毒性试验记录(20200609)》。
山西农业大学动科院 小鼠聚维酮碘毒性试验记录
2020年5月 小鼠聚维酮碘毒性试验记录
2020年5月23日从山西医科大实验动物中心购买小鼠30只,其中雌性20只,雄性10只。体重在21克至25克。动物在生理实验室适应一周后,5月30日下午开始工作。
地点:牧楼180-120号 动物生理实验室
参与者:姚志勇、王文魁
29日下午分组,第一组标①(雌性),第二组(雌性)贴纸,第三组雄注:
1.根据网上“表1常见实验动物的一般生物血数据参考值”每100克体重血液量5.85ml、血浆量3.15ml进行用药计算。
2.猪猪金盾牌“聚维酮碘”由河北呈盛堂动物药业有限公司(张瑞锋)友情提供;批号19101502,生产日期20191015,有效期至20211014.包装100ml瓶装。主要成分:碘。浓度1%。
3.五月30日预试,先选第一组体重相同的三只小鼠(2、3、4号体重22.6克)分别进行静脉注射、腹腔注射及灌胃。剂量换算:22.6克×0.585ml血液/10克重=1.32ml总血量;按血液浓度0.1%碘浓度进行计算,需要1%碘药液量0.132ml,在此基础上加一倍为0.264ml原药液(2号静脉注射、3号腹腔注射),六倍量为0.79ml原药液(4号灌胃)。
4.五月31日下午,静脉注射第一组四只(5、6、7、8号)小鼠,按10克体重静脉注射最大容积0.3ml注射原药液(最大容受剂量)。6号注射中间发生意外,静脉血管太细,只注入(0.75ml-0.2ml=)0.55ml原药液。
5.六月1号,第一组三只小鼠(1号静注0.66ml、9静注0.67ml、10号静注0.67m1)全部静脉最大容受量注射原药液,另外再分别其他途径加量,其中1号腹腔注射0.4ml原药液,9号灌胃0.4ml原药液,10号灌胃0.4ml+腹腔注射0.4ml原药液。10号给药后约20小时(6月2号中午)死亡,剖检见肝、肾发黑,心发黑(有瘀血),胃内有食物,有一段空肠内有红棕色(碘伏色)液体。
6.六月3号,第二组1--4号上下午各静脉注射最大剂量原药液(1号下午注药失败),2号静注药液后各灌水0.8ml(促进排泄),4号注药后给水1次。上药11点给药给水,下午4点给药给水。6月4日上下午给2号(前右)灌水各一次。6月5日上午发现4号小鼠死亡,剖检未见异常,胃内有食物,肝、肾大小颜色均正常,心发黑(有瘀血)。
7.六月5号,给第三组(雄性)四号小鼠(1、3、6、9号)静脉注射最大容积聚维酮碘原药液。约3--4小时后6号(标中)死亡,剖检发现胆囊内有红棕色透亮液体,胃内空虚,12指肠、空肠呈棕色,心发黑(有瘀血),肝肾颜色较正常略深。
8.六月8号上午,给第三组(雄性)2、4、5、7号静注碘液。
9.
注:小鼠最大给药容积:一次性肌肉注射(0.01ml/g体重)、静脉注射(0.03ml/g体重)。每克体重血液量为0.0585ml(0.585ml/10g体重)。
一次静脉给药后血药浓度相当于0.339%碘。原药浓度是1%,建议粘膜消毒浓度为0.1%。故静脉给药后血药浓度相当粘膜消毒要求的3.3倍。
以上实验,排除过量给药,也就是每天给药量超过粘膜消毒要求的3.3倍的小鼠死亡例(第一组,雄性,10号鼠,静脉、灌胃、腹腔叠加量等于黏膜消毒浓度的9.9倍;第二组,雄性,4号鼠,上、下午各注射一次,等于一天注射量是粘膜消毒要求的6.6倍;),得出的结论是:
共购入小鼠30只,实验给药小鼠22只,其中有2只属于超出粘膜消毒要求的3.3倍的给药量,排除在外,实际按粘膜消毒要求的3.3倍给药量给药的小鼠为20只;20只参与实验的小鼠死亡一只雄鼠。其余未做试验的小鼠,原因是尾部静脉太细未能注射成功。
由本实验还得出一个结论,静脉给药较之于灌胃和腹腔注射给药刺激性更小,安全性也更高,原因是碘在血管内更快地代谢排出体外。截止本专利申请提交前,实验小鼠均健康生存,并且还将继续饲养观察中。
一种含碘制剂体内杀灭微生物的方法,以体外消毒原理进行体内微生物杀灭,可用于口服和动脉注射、静脉注射、肌肉注射,以灭杀细菌、真菌、病原虫等微生物。
实现本发明所采取的具体技术方案是,一种含碘制剂体内杀灭微生物的方法,包括但不限于碘伏、优维显(碘普罗胺)、欧乃派克(碘海醇)、泛影葡胺、泛影酸钠、碘化油,以体外消毒原理进行体内微生物杀灭,可用于动脉注射、静脉注射和口服,所述微生物包括但不限于病毒、细菌、真菌、病原虫,所述体内包括人体内和动物体内;所述碘伏包括聚维酮碘。
体内杀灭微生物药剂分为药剂级和注射级;碘的体内杀灭微生物药剂包括碘水和碘油;根据小白鼠试验的数据,常规使用含碘总量一般不超过每公斤体重0.3克的量。含碘制剂体内杀灭微生物的方法使用对象包括人和动物:体内杀灭微生物药剂注射时,可选择局部器官或局部区域高浓度药物滞留以杀灭微生物,然后经血液循环在体内稀释后代谢排出。
含碘的体内杀灭微生物药剂用于静脉注射使用时,经动物试验及人体试验取得的数据,以致病微生物产生抑制或灭活为指标,并使人体的自身药物反应在允许的范围内,可治疗或辅助治疗包括但不限于病毒、细菌、真菌、病原虫微生物等主要用药。
含碘的体内杀灭微生物药剂用于口服时,常规使用含碘总量一般不超过每公斤体重0.3克的量,经动物试验及人体试验取得的数据,以致病微生物产生抑制或灭活为指标,并使人体的自身药物反应在允许的范围内,可治疗包括但不限于细菌、真菌、病原虫微生物等主要用药。
使用本技术方案的有益效果是,用刺激性和毒副作用尽可能低的药物,对人体或动物体进行类似体外杀毒且近似靶向治疗设计来杀灭微生物。含碘药物对微生物杀灭作用极强,但对高等动物细胞损害极其微弱。当对体内特定器官或部位进行高浓度注射时,杀灭作用超强,而注射之后,含碘药物通过人体全身血液稀释,又不会从总体上超过每公斤体重0.3克的量,因此可以看作是毒性最低而疗效最显著的方法。
具体实施方式
下面结合实施例对本发明加以进一步说明.
实施例1,将聚维酮碘溶液稀释,总量控制在不超过每公斤体重0.3克的量内,凉开水冲服,治疗微生物性疾病诸如病毒、细菌、真菌、病原虫等微生物等,特别是对于治疗幽门螺旋杆菌引起的胃炎和胃溃疡等疾病。
实施例2,静脉注射聚维酮碘溶液、优维显(碘普罗胺)、欧乃派克(碘海醇)、泛影葡胺、泛影酸钠、碘化油等其中之一,总量控制在不超过每公斤体重0.3克的量内,治疗微生物性疾病诸如病毒、细菌、真菌、病原虫等微生物等,特别是对于治疗疟原虫引起的疟疾等疾病。
实施例3,动脉注射聚维酮碘溶液、优维显(碘普罗胺)、欧乃派克(碘海醇)、泛影葡胺、泛影酸钠、碘化油等其中之一,总量控制在不超过每公斤体重0.3克的量内,治疗诸如细菌性肺炎、骨髓炎、脑膜炎等微生物相对集聚某一器官的微生物疾病。
实施例4,肌肉注射聚维酮碘溶液、优维显(碘普罗胺)、欧乃派克(碘海醇)、泛影葡胺、泛影酸钠、碘化油等其中之一,总量控制在不超过每公斤体重0.3克的量内,治疗微生物性疾病诸如病毒、细菌、真菌、病原虫等微生物。
需要补充说明的是,含碘药物主要通过释放单质碘(I2),结合菌体蛋白质的氨基酸使病毒、细菌等微生物体变性,同时氧化细菌原浆蛋白的活性基团,导致微生物死亡。在碱性介质里,I2发生歧化反应,生成I2和IO3-,使I2含量降低而失去杀菌作用;用盐酸或冰醋酸降低I2溶液的pH值,可提高其对病毒、细菌及芽孢的杀灭率。含碘药物杀菌谱广,作用持久,能杀灭病毒,也能杀灭细菌繁殖体、真菌、原虫等,但对细菌芽孢杀灭作用差。碘过敏者、甲状腺疾病及肾功能损害者禁用碘制剂。含碘药物起杀灭病毒、细菌作用的主要是碘元素,它可卤化菌体蛋白质,使酶失去活性,导致微生物死亡,对病毒、细菌、真菌、霉菌孢子等都有较强的杀灭作用。在15ppm的浓度下,一分钟能杀死各种病毒、细菌的繁殖体,杀死真菌需一个半小时,对芽孢则需更长时间;含碘药物是一种广谱抗微生物制剂,对病毒、细菌、真菌、衣原体、支原体、病毒均能有效杀灭。
一般人们对于体外消毒药剂用于体内微生物感染治疗的主要疑惑是安全性问题,而事实上最常用的含氯消毒液比如84消毒液,即使浓度很低,如果进行体内注射也是有剧毒的;甚至于,目前用于自来水消毒最安全的二氧化氯消毒剂,经过我们对小鼠静脉注射试验(一例),居然在数秒钟内立即死亡。而只有含碘制剂消毒液进行体内注射,实验证明是相对安全的,目前临床上增强CT静脉注射造影剂使用的较高浓度的碘水或碘油,也从侧面印证了动脉、静脉注射碘剂的安全性。为了进一步说明问题,这里不妨打一个很不专业但很形象的比喻:一般普通治疗微生物感染疾病的药物,贴别是抗病毒药物,药物与微生物之间的关系相当于一把钥匙开一把锁,也就是说能够治疗肝炎病毒的药物不一定能用于治疗艾滋病毒;而消毒液对于微生物的杀灭作用则相当于一把利剑之于一种动物,能够杀死老虎的匕首也应该能够杀死狮子。
Claims (4)
1.一种含碘制剂体内杀灭微生物的方法,包括但不限于碘伏、优维显(碘普罗胺)、欧乃派克(碘海醇)、泛影葡胺、泛影酸钠、碘化油,以体外消毒原理进行体内微生物杀灭,可用于动脉注射、静脉注射和口服,所述微生物包括但不限于病毒、细菌、真菌、病原虫,所述体内包括人体内和动物体内;所述碘伏包括聚维酮碘。
2.根据权利要求1所述的含碘制剂体内杀灭微生物的方法,其特征之一是体内杀灭微生物药剂分为药剂级和注射级;其特征之二是碘的体内杀灭微生物药剂包括碘水和碘油;其特征之三是根据小白鼠试验的数据,常规使用含碘总量一般不超过每公斤体重0.001——0.3克的量。其特征之四是,含碘制剂体内杀灭微生物的方法使用对象包括人和动物:其特征之五是,体内杀灭微生物药剂注射时,可选择局部器官或局部区域高浓度药物滞留以杀灭微生物,然后经血液循环在体内稀释后排出。
3.根据权利要求1所述的含碘制剂体内杀灭微生物的方法,其特征是,含碘的体内杀灭微生物药剂用于静脉注射使用时,经动物试验及人体试验取得的数据,以致病微生物产生抑制或灭活为指标,并使人体的自身药物反应在允许的范围内,可治疗或辅助治疗包括但不限于病毒、细菌、真菌、病原虫微生物等主要用药。
4.根据权利要求1所述的含碘制剂体内杀灭微生物的方法,其特征是,含碘的体内杀灭微生物药剂用于口服时,常规使用含碘总量一般不超过每公斤体重0.3克的量,经动物试验及人体试验取得的数据,以致病微生物产生抑制或灭活为指标,并使人体的自身药物反应在允许的范围内,可治疗包括但不限于细菌、真菌、病原虫微生物等主要用药。
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