CN108113996A - 一种用于化学毒剂防护的水溶性皮肤防护剂及其制备方法和用途 - Google Patents
一种用于化学毒剂防护的水溶性皮肤防护剂及其制备方法和用途 Download PDFInfo
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- CN108113996A CN108113996A CN201611068089.0A CN201611068089A CN108113996A CN 108113996 A CN108113996 A CN 108113996A CN 201611068089 A CN201611068089 A CN 201611068089A CN 108113996 A CN108113996 A CN 108113996A
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Abstract
本发明公开了一种用于化学毒剂防护的水溶性皮肤防护剂及其制备方法，属于化学毒剂皮肤医学防护领域。该水溶性皮肤防护剂含有丁酮酰二肟金属盐，无机酸盐，增稠剂以及药学上可接受的辅料，其中丁酮酰二肟金属盐的重量是防护剂总重量的1‑20％，无机酸盐的重量是软膏剂总重量的1‑50％，增稠剂的重量是凝胶剂总重量的0.1‑50％，余量为药学上可接受的辅料及水。该水溶性皮肤防护剂通过在皮肤表面及角质层形成物理性屏障膜层，能有效地阻止、延缓各类化学毒剂(可防护神经毒剂、糜烂性毒剂，刺激性毒剂、工业毒性腐蚀性化学物质等)对皮肤的渗透，而且还能在毒剂进入血液循环之前将毒剂降解破坏，从而大大降低毒剂对皮肤及身体的危害。
Description
技术领域
本发明属化学毒剂皮肤医学防护领域，涉及一种含有丁酮酰二肟金属盐，无机酸盐，增稠剂以及药学上可接受的辅料的水溶性皮肤防护剂配方及其制备方法和用途，适用于糜烂性毒剂、神经性毒剂、刺激性毒剂等化学毒剂染毒皮肤之前的防护。
背景技术
化学毒剂皮肤防护剂是指在染毒前使用的预防性制剂，通过在皮肤表面形成物理性屏障膜层，能有效地阻止、延缓毒剂对皮肤的渗透，从而为后续的洗消与救治提供充裕的时间，以显著降低在化学战条件下的战斗减员。
目前外军装备的化学毒剂皮肤防护剂(美军SERPACWA)虽然具有防毒谱广、防毒效果好、成膜性能好等优点，但是由于其防护机制是在皮肤表面形成非常粘稠的疏水性膜层，所以具有非常粘稠、在皮肤表面不易涂布、不易清除等不足，并且该皮肤防护剂只是对毒剂的物理性防护，不能将毒剂分解破坏，仍能引起染毒和中毒的可能。所以研制易于涂布、易于清除、既能阻止毒剂和皮肤直接接触，又能在毒剂渗透到达皮肤之前将其分解破坏，使之变成低毒甚至无毒物质的水溶性皮肤防护剂是当前皮肤医学防护领域的研究重点。
因此本领域提供一种水溶性皮肤防护剂，该新型皮肤防护剂事先涂抹于皮肤，在化学毒剂沾染皮肤前能有效预防中毒，具有防毒时间长，防护效果更佳、成膜性能更好和使用性能更好，易涂展、无油腻性，对皮肤和黏膜无刺激性、无过敏性等优点。
发明内容
1.本发明旨在提供一种水溶性的易于涂展的化学毒剂皮肤防护剂。
2.本发明的另一个目的是提供所述水溶性的化学毒剂皮肤防护剂的制备方法。
3.本发明的再一个目的是提供所述水溶性的易于涂展的化学毒剂皮肤防护剂对于刺激性毒剂、糜烂性毒剂、神经性毒剂等危险化学物的防护用途。
在本发明的第一方面，提供了一种水溶性的易于涂展的化学毒剂皮肤防护剂，它含有丁酮酰二肟金属盐，无机酸盐，增稠剂以及药学上可接受的辅料，其中丁酮酰二肟金属盐的重量是防护剂总重量的1-20％，无机酸盐的重量是防护剂总重量的1-50％，增稠剂的重量是凝胶剂总重量的0.1-50％，余量为药学上可接受的辅料及水。
在另一优选例中，1g皮肤防护剂含有0.01-0.2g丁酮酰二肟金属盐，0.01-0.5g无机酸盐，0.001-0.5g增稠剂。
在另一优选例中，所述的丁酮酰二肟金属盐选自下述中的一种或多种：丁K+、Na+、Zn2+、Mg2+。
在另一优选例中，无机酸盐为硫酸钠，硫酸镁，氯化镁，硫酸锌，氯化锌，葡萄糖酸镁，葡萄糖酸钙，氯化钙，硫代硫酸钠的一种或几种。
在另一优选例中，所述的增稠剂选自下述的一种或几种：羧甲基纤维素钠、甲基纤维素、羟丙甲纤维素、泊洛沙姆407、泊洛沙姆188、N-异丙基丙烯酰胺共聚物、醋酸纤维素钛酸酯，丙烯酸聚合物卡波姆，结冷胶，海藻酸钠、硫酸软骨素，透明质酸，聚乙二醇，甘油，丙二醇，甘露醇、山梨醇，黄原胶、阿拉伯胶，西黄耆胶，卡拉胶，文莱胶。
在另一优选例中，所述的药学上可接受的辅料，选自pH调节剂、稳定剂和或防腐剂。
在本发明的第二方面，它提供了一种如上述的水溶性的易于涂展的化学毒剂皮肤防护剂的制备方法，它包括步骤：
将增稠剂和辅料分别溶于水中，溶解后混合，再将一定量丁酮酰二肟金属盐和无机酸盐加入已经制好的增稠剂溶液中，进行搅拌，即得。所述的皮肤防护剂中丁酮酰二肟金属盐的重量是防护剂总重量的1-20％，无机酸盐的重量是防护剂总重量的1-50％，增稠剂的重量是凝胶剂总重量的0.1-50％，余量为药学上可接受的辅料及水。
在本发明的第三方面，它提供了一种如上述的皮肤防护剂的用途，其特征在于染毒前涂抹于皮肤，不仅可防护刺激性毒剂、糜烂型毒剂、神经性毒剂等液态或气态危险化学物，而且还具有对毒剂具有分解消毒功能，从而显著减轻或避免毒剂染毒导致的中毒人员伤亡。
据此，本发明提供了一种具有防护谱广(可防护神经毒剂、糜烂性毒剂，刺激性毒剂等)、防护时间长、安全性好的皮肤防护剂，具有易涂展、无油腻性，对皮肤和黏膜无刺激性、过敏性或变态反应，药膜的附着性和均匀性好等优点。
具体实施方式
发明人提供了一种水溶性的皮肤防护剂，它含有丁酮酰二肟金属盐，无机酸盐，增稠剂、以及药学上可接受的辅料。
皮肤防护剂
本发明提供一种皮肤外用皮肤防护剂，在染毒前使用的皮肤外用制剂，能有效地阻止、延缓毒剂对皮肤的渗透，从而为后续的洗消与救治提供充裕的时间， 明显降低化学战及化学突发事件中的人员伤亡。所述的皮肤防护剂，它含有丁酮酰二肟金属盐的重量是防护剂总重量的1-20％，无机酸盐的量含1-50％，增稠剂的量0.1-50％，余量为药学上可接受的辅料及水。
如本文所用，术语“药学上可接受的辅料”指用于治疗剂给药的辅料，包括各种赋形剂和稀释剂，该术语指这样一些药剂辅料：它们本身并不是必要的活性成分，且使用后没有过分的毒性，合适的辅料是本领域技术人员熟知的，在(Remington’s PharmaceuticalSciences(Mack Pub.Co.，N.J.1991)中可找到关于药学上可接受的赋形剂的充分讨论.在本发明提供的药学上可接受的辅料可包括溶剂，如水，盐水，甘油和乙醇.另外这些辅料中还可能存在辅助性的物质，如渗透压调节剂，pH调节剂，促渗透剂，稳定剂，防腐剂等。
所述的渗透压调节剂可以是氯化钠、葡萄糖、乳糖、甘露糖、甘露醇和或山梨醇中的一种或几种。
所述的pH调节剂可以是盐酸、磷酸、硼酸、醋酸、硫酸、氢氧化钠、氢氧化钾、三乙醇胺和或三羟基甲基氨基甲烷得一种或数种。
所述的稳定剂包括抗氧化剂和或螯合剂，抗氧化剂选自亚硫酸钠、亚硫酸氢钠、硫代硫酸钠、焦亚硫酸钠、抗坏血酸、硫脲、半胱氨酸、生育酚、卵磷脂中的一种或数种。
所述的防腐剂可以使苯甲醇、苯乙醇、苯扎氯铵、苯扎溴胺、山梨酸、山梨酸钾、苯甲酸钠、三氯叔丁醇、柳硫汞、尼泊金酯类的一种或数种。
用途
本发明提供的皮肤防护剂对于刺激性毒剂、糜烂性毒剂、神经性毒剂等危险化学物的防护用途。其使用方式是一次性应用，根据危险物化学物沾染的数量 以及皮肤损伤面积，本防护剂的用量为1-100g。
本发明提到的上述特征，或实施例提到的特征可任意组合。本案说明书所揭示的所有特征可与任何组合物形式并用，说明书中所揭示的各个特征，可以任何可提供相同、均等或相似目的的替代性特征取代。因此除有特殊说明，所揭示的特征仅为均等或相似特征的一般性例子。
本发明的主要优点在于：
1、本发明提供的防护剂在染毒前或沾染化学物前使用，能有效地阻止、延缓毒剂对皮肤的渗透，具有防毒时间长，防护效果更佳等特点，从而为后续的洗消与救治提供充裕的时间，明显降低化学战及化学突发事件中的人员伤亡。
2、本发明提供的防护剂易涂展，成膜性能好，使用性能好，无油腻性，对皮肤和黏膜无刺激性、无过敏性等优点。
下面结合具体实施例，进一步阐述本发明。应理解这些实施例仅用于说明本发明而不用于限制本发明的范围。下列实施例中未注明具体条件的试验方法，通常按照常规条件或按照制造厂商所建议的条件，除非另外说明，否则所有的百分比和份数按重量计。
除非另行定义，文中所使用的所有专业与科学用语与本领域熟练人员所熟悉的意义相同。此外，任何与所记载内容相似或均等的方法及材料皆可应用于本发明方法中。文中所述的较佳实施方法与材料仅作示范之用。
实施例1-10
防护剂制备例
制备方法：
将增稠剂和辅料分别溶于水中，溶解后混合，再将一定量丁酮酰二肟金属盐和无机酸盐加入已经制好的增稠剂溶液中，进行搅拌，即得。所述的皮肤防护剂中丁酮酰二肟金属盐的重量是防护剂总重量的1-20％，无机酸盐的重量是防护剂总重量的1-50％，增稠剂的重量是凝胶剂总重量的0.1-50％，余量为药学上可接受的辅料及水
实施例1
按以下配比制备皮肤防护剂：
| 丁酮酰二肟金属钠盐 | 9.5g |
| 壳聚糖 | 0.2g |
| 硫酸镁 | 10g |
| 尼泊金甲酯 | 0.2g |
| 加水至 | 100g |
实施例2
按以下配比制备皮肤防护剂：
| 丁酮酰二肟金属钾盐 | 2.0g |
| 甘油 | 60g |
| 硫代硫酸钠 | 15g |
| 尼泊金甲酯 | 0.5g |
| 加水至 | 100g |
实施例3
按以下配比制备皮肤防护剂：
| 丁酮酰二肟金属镁盐 | 1.0g |
| 甘露醇 | 15g |
| 硫酸镁 | 0.5g |
| 山梨酸钾 | 0.2g |
| 加水至 | 100g |
实施例4
按以下配比制备含有金属有机骨架化合物的皮肤防护剂：
| 丁酮酰二肟金属钾盐 | 18.0g |
| 甘油 | 10g |
| 葡萄糖酸钙 | 1.5g |
| 尼泊金甲酯 | 0.5g |
| 加水至 | 100g |
实施例5
按以下配比制备含有金属有机骨架化合物的皮肤防护剂：
| 丁酮酰二肟金属钠盐 | 1.0g |
| 甲基纤维素 | 0.5g |
| 硫酸镁 | 20g |
| 尼泊金甲酯 | 0.2g |
| 加水至 | 100g |
实施例6
体外防护效果试验
利用化学毒剂侦检纸评价皮肤防护剂的体外防护性能。取实施例1，2，3，4，5制备的皮肤防护剂均匀涂抹在毒剂侦检纸上，而后将20μL梭曼、16μL维埃克斯、15μL芥子气，分别滴于皮肤防护剂上，观察毒剂透过防护剂涂层的时 间，即为防护时间(见表1)。
表1皮肤防护剂对毒剂和强酸碱的体外防护时间
结果表明，实施例1，2，3，4，5制备的皮肤防护剂对梭曼、维埃克斯、芥子气的防护时间均超过6h。
实施例7扩散池穿透试验
将毒剂液滴或毒剂蒸汽置于扩散池硝酸纤维素负载的防护剂涂层上(防护剂涂布量100μl/cm2)，连续检测毒剂含量，记录毒剂的穿透时间和毒剂的累积透过量(20h)(表2，表3)。穿透时间指的是最小量为1000ng芥子气或1000ng梭曼、维埃克斯透过时耗费的时间。
表2 1000ng毒剂穿透防护剂涂层时间
结果表明，1000ng梭曼蒸汽透过实施例1，2，3，4，5制备的皮肤防护剂涂层时间均在900min以上，1000ng维埃克斯蒸汽透过实施例1，2，3，4，5制备的皮肤防护剂涂层时间均在1000min以上，1000ng芥子气蒸汽透过实施例1，2，3，4，5制备的皮肤防护剂涂层时间均在4000min以上。
表3毒剂蒸汽的累积透过防护层的量
结果表明，实施例1，2，3，4，5制备的皮肤防护剂涂层对梭曼蒸汽、维埃克斯蒸汽、芥子气蒸汽的20h累积透过量最多分别为210，260，20ng。
实施例8防护剂对于猪芥子气皮肤染毒的防护效果试验。
实验前用家猪用30％水合氯醛，静脉15ml麻醉。两侧腹背部皮肤分别标画4块区域，每个区域4cm2，用实施例1防护剂预先涂抹于每块皮肤，微量加样器将芥子气模拟剂(2μL)滴加于每块皮肤中心部位，未防护对照组不做防护处理，仅仅染毒处理。
芥子气模染毒后6h，染毒对照组即见染毒部位出现明显的红斑，实施例1防护组与染毒组比较，红斑面积显著变小，说明采用防护剂防护处理，可明显减轻损伤(P＜0.05)。(见表4)。
表4防护剂对于猪芥子气染毒的皮肤损伤面积的影响
*与染毒对照组比较，n＝6。
采用实施例2-5制备的防护剂进行的芥子气皮肤染毒防护效果试验，结果类似。
实施例9防护剂对于小鼠皮肤神经性毒剂染毒的防护效果
实验前1天小鼠背部皮肤8％硫化钠溶液脱毛，试验时，随机将小鼠随分为实施例1防护剂处理组和神经性毒剂染毒对照组共2组，共进行43只小鼠的试验，其中防护剂处理组22只，染毒对照组21只。染毒时用微量加样器将神经性毒剂模拟剂(2μL)滴加于每只小鼠脱毛皮肤中心部位。染毒对照组不做任何处理。观察24h的小鼠存活情况。
小鼠皮肤神经性染剂染毒，防护剂处理的25只小鼠中，全部存活，25只 染毒对照组小鼠中，全部死亡，采用两组样本率比较的2×2表卡方检验，χ2＝6.2351＞3.84，P＜0.05，防护剂处理组的存活率与染毒对照组之间具有显著性差别(表5)。
表5防护剂对于小鼠皮肤神经性毒剂模拟剂染毒的存活数的影响
| 组别 | 存活数(只) | 死亡数(只) | 合计 |
| 防护剂处理组 | 25 | 0 | 25 |
| 染毒对照组 | 0 | 25 | 25 |
| 合计 | 25 | 25 | 43 |
采用实施例2-5制备的防护剂进行的神经性毒剂皮肤染毒防护效果试验，结果类似。
实施例10皮肤刺激性试验
观察了实施例1制备的防护剂样品对兔无损伤皮肤及破损皮肤的一次性刺激作用。大耳白兔腹部皮肤以8％硫化钠糊剂脱毛。试验时标出3块无损伤皮肤，其中2块分别用于研究基质对照、实施例1的防护剂对无损伤皮肤的刺激作用。第三块皮肤用针头划破，用于研究防护剂对破损皮肤的刺激作用。分别取0.5g基质对照、0.5mL防护剂涂抹于皮肤，包扎，无刺激性胶布固定，24h后去除受试物。去除受试物后1、24、48、72h观察受试部位皮肤有无红斑、水肿等反应。
防护剂单次给药、破损皮肤单次给药的皮肤刺激反应评分见(表6，表7)，根据2002年版《消毒技术规范》皮肤刺激强度评价标准，防护剂对完整皮肤及破损皮肤都没有刺激性。
表6完整皮肤单次给药组皮肤刺激反应评分总分值
表7破损皮肤单次给药组皮肤刺激反应评分总分值
*动物皮肤在去除药物后1h有轻微水肿，24h症状消失.可能与受损皮肤保鲜膜下通透性差有关.
采用实施例2-5制备的防护剂进行的皮肤刺激性试验，结果类似。
Claims (7)
1.一种用于化学毒剂防护的水溶性皮肤防护剂，其特征在于含有丁酮酰二肟金属盐，无机酸盐，增稠剂以及药学上可接受的辅料，其中丁酮酰二肟金属盐的重量是防护剂总重量的1-20％，无机酸盐的重量是软膏剂总重量的1-50％，增稠剂的重量是凝胶剂总重量的0.1-50％，余量为药学上可接受的辅料及水。
2.如权利要求1所述的水溶性皮肤防护剂，丁酮酰二肟金属盐是含有K+、Na+、Zn2+、Mg2+的一种或几种。
3.如权利要求1所述的水溶性皮肤防护剂，无机酸盐为以下硫酸钠，硫酸镁，氯化镁，硫酸锌，氯化锌，葡萄糖酸镁，葡萄糖酸钙，氯化钙，硫代硫酸钠的一种或几种。
4.如权利要求1所述的水溶性皮肤防护剂，增稠剂选自下述的一种或几种：羧甲基纤维素钠、甲基纤维素、羟丙甲纤维素、泊洛沙姆407、泊洛沙姆188、N-异丙基丙烯酰胺共聚物、醋酸纤维素钛酸酯，丙烯酸聚合物卡波姆，结冷胶，海藻酸钠、硫酸软骨素，透明质酸，聚乙二醇，甘油，丙二醇，甘露醇、山梨醇，黄原胶、阿拉伯胶，西黄耆胶，卡拉胶，文莱胶。
5.如权利要求1所述的水溶性皮肤防护剂，其特征在于，所述的药学上可接受的辅料，选自pH调节剂、稳定剂、防腐剂，表面活性剂、伪装涂料和防晒剂。
6.一种如权利要求1所述的水溶性皮肤防护剂的制备方法，将增稠剂和辅料分别溶于水中，溶解后混合，再将一定量丁酮酰二肟金属盐和无机酸盐加入已经制好的增稠剂溶液中，进行搅拌，即得。
7.一种如权利要求1所述的水溶性皮肤防护剂的用途，其特征在于在染毒前涂抹于皮肤，不仅可防护刺激性毒剂、糜烂性毒剂、神经性毒剂等，而且还具有对毒剂具有分解消毒功能，从而显著减轻染毒人员伤亡。
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