CN1684711A - 一种广谱消毒剂 - Google Patents

一种广谱消毒剂 Download PDF

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CN1684711A
CN1684711A CNA028296427A CN02829642A CN1684711A CN 1684711 A CN1684711 A CN 1684711A CN A028296427 A CNA028296427 A CN A028296427A CN 02829642 A CN02829642 A CN 02829642A CN 1684711 A CN1684711 A CN 1684711A
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CN100342917C (zh
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A·沙皮罗
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Alda Pharmaceuticals Corp
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Abstract

本发明公开了制造广谱消毒剂的方法和广谱消毒剂的用途，所述消毒剂包括作为组分的醇、邻苯基苯酚、氯己定葡萄糖酸盐、壬苯醇醚－9、苯扎氯铵和去离子双蒸水，其中以重量/体积比所述醇包含50至80％，邻苯基苯酚包含0.1至0.8％，氯己定葡萄糖酸盐包含0.01至1％，壬苯醇醚－9包含0.02至1％，以及苯扎氯铵包含0.15至1％。

Description

一种广谱消毒剂
发明领域
本发明一般地涉及消毒剂领域，并特别涉及广谱消毒剂。
发明背景
在所述领域中已知有许多能起消毒剂作用的化合物。然而，消毒剂在它们的杀灭不同微生物的能力方面不同。例如，一些化合物可能仅起杀菌剂的作用，其它的仅起杀病毒剂的作用，以及还有其它的仅起杀真菌剂的作用。一些化合物是已知的，它可以杀死革兰氏阳性细菌，然而在杀死革兰氏阴性细菌方面是无效的。因此，为了提供一种广谱消毒剂，一种能有效地杀死大多数如果不是所有微生物的消毒剂可能需要具有互补活性的已知消毒剂的组合。
消毒剂的组合能复合与单个使用任何那些物质相关的危险。由于消毒剂之间的相互作用，组合可能在使用中引入新的危险，例如消毒剂的功效降低，对使用者的刺激，环境危险例如易燃性和消毒剂的残留效果降低。
美国再版专利No.32,300描述了抗微生物剂与聚乙二醇组合作为一种皮肤清洁组合物的用途。聚乙二醇被用作起泡剂并且缺乏任何抗微生物特性。在那份再版专利中提示的抗微生物剂有有限的功效。特别是描述的组合缺乏杀结核菌活性并且有有限的抗病毒活性。进一步，在那份再版专利中描述的抗微生物剂除非它们被保持在非离子环境中，否则会失去抗微生物活性。
加拿大专利No.1,290,250涉及一种防腐流体它，干燥后形成一层具有残留抗细菌特性的皮肤保护薄膜。所描述的流体的残留活性依赖于一种形成携带特定杀菌剂聚合体的可丢弃的膜。由于它的有限谱的功效，所述膜限于它的应用范围内，并且不适用于高传染危险的环境中。
加拿大专利No.1,332,136描述了应用与一种非离子表面活性剂复合的相对高浓度氯己定盐以保持杀菌活性，特别地抗金黄色葡萄球菌(Staphylococcus aureus)。然而，在加拿大专利No.1,332,136中描述的以相对高浓度的氯己定盐类，例如氯己定葡萄糖酸盐不可逆地沾染。
美国专利No.5,030,659描述了一种使用杀微生物的化合物以特定比例组合以扩大抗微生物活性谱的水性消毒剂。然而，该消毒剂使用了相对高相对浓度的苯扎氯铵。描述的消毒剂还缺少变性剂或清洁剂导致潜在消毒能力的损失。进一步，在此专利中建议的一些乙醇浓度下，所描述的消毒剂也是易燃的。
加拿大专利No.1,335,352描述了一种想用来防止或抑制牙齿表面上细菌的生长的口服杀菌溶液。描述的溶液包括至少一种具有一个或多个侧聚环氧烷基团的聚合体。它声明这种溶液增强了牙齿表面的抗粘附和抗菌特性，降低了沾染氯己定的危险。然而，它没有提示该溶液具有广谱的活性，或者它能起杀病毒剂或杀真菌剂的作用。因此，该溶液可能被限于它对牙齿表面的应用。
美国专利No.5,985,931描述了应用水溶液中抗微生物剂的组合以达到所述组分抗微生物剂的协同效应。这种溶液受到许多限制。首先，因为溶液为大约70％的水，它将具有一些腐蚀特性。第二，虽然有一些协同效应，但没有提示所述组分抗微生物剂能杀死的生物谱更广。因此，该溶液将不适用于医院级别产品中所要求的许多用途，因为它将不显著地减少或杀死结核分枝杆菌(Mycobacterium tuberculosis)，只能有限地用于杀死革兰氏阴性细菌和真菌。
加拿大专利申请No.2,132,688描述了一种使用苯扎氯铵和壬苯醇醚的组合能起杀精子剂和杀病毒剂作用的制剂。所描述制剂的目的是作为一种阴道应用以保护不受性传播病毒和其他感染的传播并保护不受孕。在描述中没有提示这种制剂作为杀真菌剂或杀细菌剂具有广谱活性。进一步，有一些关于使用相对高浓度的壬苯醇醚以及当阴道应用壬苯醇醚时，可能引起阴道溃疡的可能性的健康关注。
加拿大专利申请No.2,309,353描述了一种水溶液，该溶液含有大至20％重量的表面活性剂和一种抗微生物季铵化合物。这种溶液的抗微生物活性受所提出的季铵化合物功效的限制。另外，高含水水平能使产品具有腐蚀性因此限制其对皮肤，甲，口和粘膜应用的使用。
美国专利No.4,870,108描述了一种液体防腐剂，该防腐剂含有乙醇，丙酮，甘油，水和一种季铵化合物。据说这种防腐剂快速起作用并在重复使用后对皮肤无刺激。然而，使用这种液体的组分存在问题。防腐剂中的甘油阻止了溶液在硬表面上，器械上和高危险区域中的应用。这种防腐剂具有有限的残留抗微生物活性，例如，不是杀结核菌的。进一步，丙酮与乙醇的组合非常地易燃，因此在使用中可能存在安全风险。
加拿大专利No.2,023,287描述了应用包含苯甲醇的醇类的组合以提供一种广谱抗微生物组合物。据说所述醇类的特定组合当与以前可用的混合物相比时具有降低的闪点同时提供抗微生物活性的协同效应。然而，所述制剂遭受缺陷，即它是非常毒性的并且不适用于医院级别的消毒。进一步，描述的所述组合也是水和湿气敏感的。
美国专利No.5,800,827描述了使用有机酸，具有浓度大于50％重量的乙醇中的氯己定的组合物。有机酸被认为使乙醇中的氯己定稳定同时维持氯己定的杀菌活性。描述的使氯己定稳定的有机酸是乳酸和柠檬酸。然而，虽然氯己定被稳定了，但其活性谱没有变化。因而，所描述的组合物限于氯己定的活性谱。
发明概述
现在本发明的目的是提供一种广谱消毒剂，其中所述消毒剂快速杀死微生物，使遗传物质变性，并且对使用者来说还是安全的以及不是环境有害的。
因此本发明提供了一种广谱消毒剂，该消毒剂包含SDAG-3乙醇(95％)，苦精(bitrex)，邻苯基苯酚，苯扎氯铵，氯己定葡萄糖酸盐，壬苯醇醚-9和去离子的双蒸水。所述消毒剂还可以选择性地包括一种芳香剂。
本发明进一步提供了一种生产广谱消毒剂的方法，该方法包括缓慢地将去离子的双蒸水放入乙醇溶液中以避免乙醇中成核点的步骤。
本发明进一步提供了所述消毒剂在医药和化妆品应用中的用途。
本发明提供一种环境友好的广谱消毒剂，生产所述消毒剂的方法，以及所述消毒剂在医药和化妆品应用中的用途。
发明详述
在本发明的一个实施方案中，描述了一种快速起作用的消毒剂，该消毒剂包括下列(w/v)：至少50％醇；0.1至0.8％邻苯基苯酚；0.01至1％氯己定葡萄糖酸盐；0.02至1％壬苯醇醚-9；0.15至1％苯扎氯铵，和去离子的双蒸水。本发明的一个实施方案还包括苦精(用作催吐剂，阻燃剂变性剂)和芳香剂例如柠檬芳香剂431号。这种实施方案的配方为：
  成分                含量(v/v)
SDAG-3乙醇95％          70.0％
苦精                    3.68％
邻苯基苯酚              0.28％
苯扎氯铵                0.20％
氯己定葡萄糖酸盐        0.01％
壬苯醇醚-9              0.05％
柠檬芳香剂431号         0.10％
去离子/双蒸水           25.68％
在选择医院级产品中，杀死分枝杆菌的能力是一个关键的考虑。使用下面的方案测试了本发明范围内的制剂杀死分枝杆菌的能力。55×13mm直径的无菌盖玻片用大约105结核分枝杆菌株Erdman ATCC#35801涂布。这是通过向盖玻片添加10ul 107/ml分枝杆菌悬液，用均布器的尖端均匀地涂布并允许空气干燥而实现的。用于估计盖玻片上存活细菌数目的阳性对照组，通过将5块涂布的盖玻片置于500ul肉汤中，用探针超声波发生器超声10秒钟以分散细菌和于琼脂生长培养基(Middlebrook 7H10)上铺平板的连续稀释进行处理。还使用5块没有细菌接种的盖玻片制备了阴性对照组，但用如上不同的方法进行处理。测试样品通过从12英寸距离喷洒测试消毒剂三次涂布盖玻片来制备。然后在1分钟或5分钟后使用Whatman滤纸吸干盖玻片，将其放入500ul肉汤中并按上面关于对照描述的进行处理。使用以前已知的消毒剂还制备了另外的对照。这些消毒剂对分枝杆菌的效果研究显示，落入本发明范围内的上面制剂具有目前已知最高的log106.54衰减评分。
残留的杀分枝杆菌消毒剂能力也通过用形成试验主题的制剂从12英寸距离喷洒测试盖玻片三次并在1分钟或5分钟之后如上所述吸干盖玻片进行了测试。一个对照组包含没有接种(innoculate)分枝杆菌的盖玻片而第二个对照组包含接种时没有用测试消毒剂制剂处理的盖玻片。试验显示本发明的实施方案具有适合于快速杀死分枝杆菌的残留的消毒活性。
进一步，描述的制剂是一种强力的广谱消毒剂。谱研究证实上面制剂是100％杀细菌，杀真菌，杀病毒和杀结核杆菌的。不同的细菌、真菌和病毒培养物暴露于落入本发明范围内的消毒剂3分钟，确立这些消毒剂的广谱属性包括杀死微生物的能力，这些微生物包括金黄色葡萄球菌(ATCC6538)，猪霍乱沙门菌(Salmonella cholerawsuis)，ATCC 10708，绿脓杆菌(Pseudomonas aeruginosa，ATCC 15442)，须发癣菌(Trichophyton mentagrophytes)和脊髓灰质炎病毒I型。
进一步，测定抗病毒活性的试验表明本发明的实施方案在预防病毒复制中是高效的。使用HIV-1(HTLV-IIIB，NIAID AIDS Reference ReagentProgram，马里兰州罗克维尔)的实验室分离物使病毒原液最初在悬浮于补充有10％胎牛血清的RPMI病毒培养基中的H9淋巴细胞中生长至高滴度。为进一步使用，在适当数量的传代之后，收获培养物上清液并以1mL等分量储存于-70℃。在实验进行以前，滴定病毒原液并稀释以得到103传染微粒/培养基。将稀释的病毒液加到吐弃块2×106PHA-刺激的外周血单核细胞中，所述单核细胞已经在有10％胎牛血清并补充青霉素，链霉素，谷氨酰胺，rhIL-2和PHA-P(1ug/mL)的RPMI中保持了3天。在病毒及细胞吐弃块在37℃孵育2小时后，清洗吐弃块(去掉任何粘附的病毒)，然后在存在或缺少上面描述的消毒剂制剂的稀释液下重悬于新鲜的病毒培养基中，并且将培养基保持到第7天。然后为了随后评价p24抗原水平(Organon Teknika，Mississauga ON)，作为HIV在给定培养物中复制的度量，收获上清液并储存于-70℃。将在给定化合物稀释液存在下的p24抗原水平的降低作为它的抗逆转录病毒活性的度量。在该实验中包含一种未感染的(unifected)培养物和一种阳性对照培养物。所有的实验重复进行三次，结果表示为三个同样培养物的平均数。这些研究显示上面描述的本发明实施方案作为一种对人类免疫缺陷病毒(HIV)和相关逆转录病毒的消毒剂接触后是100％有效的。
在上面提到的本发明实施方案中的氯己定葡萄糖酸盐还起变性剂的作用。作为进一步可选择的成分，还可加入另外的变性剂。这些变性剂提供了另外的消毒特性，因为它们使遗传物质，即DNA和RNA变性。落入本发明范围内的消毒剂在使DNA和RNA变性，和具有广谱活性方面，提供了比以前知道的那些消毒剂更有效的感染控制方法。在上面描述的本发明优选的实施方案中，苦精被用作变性剂。然而，苦精还起催吐剂的作用以预防或降低滥用所述溶剂的可能性。苦精还起阻燃剂的作用以预防消毒剂自发的燃烧。
本发明的消毒剂在它们的消毒能力方面也是快速起作用的。研究表明上面描述的本发明实施方案在3分钟内提供了最大消毒。
另外，毒理学研究证实上面的制剂对使用者和环境都是安全的。对上面描述的消毒剂制剂进行的毒性研究显示，按照卫生效果测试准则(Health Effects Test Guidelines)：
    测试         结果      使用的方案
急性口服毒性   LD50＞5,000mg/kg  OPPTS 870.1100(1998)
急性皮肤毒性   LD50＞2,000mg/kg  OPPTS 870.1200(1998)
急性吸入毒性   LD50＞2.02mg/L  OPPTS 870.1300(1998)
眼睛刺激   平均刺激评分未冲洗的29.0冲洗的27.3  OPPTS 870.2400(1998)
皮肤刺激   PDII 0.0  OPPTS 870.2500(1998)
皮肤敏化   不是接触敏化剂  OPPTS 870.2600(1998)
最后，考虑到落入本发明范围内的消剂的广谱活性，变性剂的存在，消毒剂的快速作用，以及它们的使用者和环境友好特性，本发明的消毒剂在医学环境例如医院中和对护理人员特别有用。
本发明消毒剂的特性在广泛的应用领域中是可期望的。它们适用于医学领域，特别是存在高污染和感染危险的医学领域。除第一应答者例如救护车，法律实施和消防人员外，本发明能在牙科专业具有应用。本发明的消毒剂也能被用于预防或减少性传播疾病传播的可能性。例如它们能被用作个人润滑剂的成分以减少并预防疱疹，HIV和衣原体的传播。
除了作为强力的消毒剂以外，本发明的实施方案还起卫生消毒剂，清洁剂的作用并特别是当在制剂中使用芳香剂作为除臭剂。除其抗微生物特性外，包含在产品中的去污剂(壬苯醇醚-9)被高度地看作为强力的去污剂。本发明的这些附加的特性使得本发明的制剂对公共卫生行业特别有吸引力，在该行业中消毒剂在公共场所例如矿泉疗养地，旅馆，餐馆，疗养院和机关例如刑罚机关特别重要。
本发明对美容行业具有应用，特别是作为一些化妆品的添加剂。本发明的一些制剂作为抗微生物组分以百分比添加到霜剂和软膏中，或作为一种组分用于单或多用途的擦布(wipes)。
本发明还包括制造广谱消毒剂制剂的方法。在一个实施方案中，所述方法包括如下步骤
1.在乙醇中溶解至少一种抗微生物剂并继续搅拌溶液；
2.在去离子的双蒸水中溶解至少第二种抗微生物剂；
3.继续搅拌的同时向所述乙醇溶液中添加一种去污剂；
4.继续搅拌的同时以足够慢的速度向所述乙醇溶液中添加所述去离子的双蒸水溶液，以防止成核点。
使用上面所描述制剂的特定实施例能更清楚地阐明制造本发明消毒剂的方法。通过如下步骤制造所述制剂：
1.向接地的混合槽中加入含有苦精的乙醇；
2.向含有乙醇的所述混合槽中缓慢地加入邻苯基苯酚，直到邻苯基苯酚完全溶解。一旦完全溶解，优选继续混合另外15分钟；
3.向所述接地的混合槽中加入并继续混合芳香剂，氯己定葡萄糖酸盐和壬苯醇醚-9；
4.以足够慢的速度将双蒸去离子水放入所述混合槽中，以防止对槽中溶液的冲击并避免成核点。
5.向所述混合槽中加入并混合苯扎氯铵，优选继续混合另外30分钟。
然后使用0.20微米过滤器过滤所述混合物并储存于灭菌的瓶中。
成分添加的次序对创造期望的消毒剂是重要的。在上面描述的实施例中，应首先将OPP溶解于乙醇中。可以代替乙醇被应用的这类其它醇，包括甲醇或1-丙醇。进一步，使用醇浓度大约50-80％(w/v)也能实现本发明的优势。OPP缓慢添加到乙醇中保证了在溶液中完全混溶。因此形成了络合化合物，允许OPP保留一个自由基，不与乙醇结合。将OPP有效地溶解于乙醇中形成络合物。
壬苯醇醚-9，芳香剂(如果期望)及氯己定葡萄糖酸盐在加水之前加入。
当制造本发明的消毒剂时，由于邻苯基苯酚(“OPP”)和加入的成分将可能与溶液分离并沉淀，致使溶液失败，在向乙醇中加入双蒸去离子水时必须注意以避免冲击混合物。
进一步，使用双蒸去离子水以避免将引起邻苯基苯酚离开溶液的成核点是重要的。平常的水将允许OPP离开溶液，(‘成核点’)。OPP具有一种天然趋势想要离开或形成a guam，因此当被暴露于平常的水时，与醇分离。另外地，双蒸去离子水提供了一种环境，由此微电压和电场支持最终消毒剂产品与靶向的微生物的完全粘附，进行蛋白质水解，细胞溶解并最终细胞死亡，以及DNA和RNA的全部破坏。
通过0.20微米过滤器过滤消毒剂的可选择但可期望的步骤保证了消毒剂无任何可能潜在地损害消毒剂质量和功效的营养生长。本步骤使得最终产品无任何杂质。本步骤与存储消毒剂瓶的箔热诱导密封结合，创造了高质量，无孢子的消毒剂。
因此通过实施例详细描述了本发明不同的实施方案，对本领域的技术人员来说不偏离本发明可以进行变化和修改将是显而易见的。本发明包括落入附加权利要求范围内的所有这样的变化和修改。

Claims (23)

1.一种广谱消毒剂，该消毒剂包括作为组分的醇，邻苯基苯酚，氯己定葡萄糖酸盐，壬苯醇醚-9，苯扎氯铵和去离子的双蒸水，其中以重量/体积比所述醇占50至80％，邻苯基苯酚占0.1至0.8％，氯己定葡萄糖酸盐占0.01至1％，壬苯醇醚-9占0.02至1％，和苯扎氯铵占0.15至1％。
2.权利要求1的广谱消毒剂，其中所述醇选自由甲醇，乙醇，丙醇和丁醇组成的组。
3.权利要求1的广谱消毒剂，其中所述醇为乙醇。
4.权利要求1至3中任一项的广谱消毒剂，其中以重量/体积比所述醇占60至75％。
5.权利要求1至3中任一项的广谱消毒剂，其中以重量/体积比所述醇占70％。
6.权利要求1至5中任一项的广谱消毒剂，其中以重量/体积比邻苯基苯酚占0.2至0.5％。
7.权利要求1至5中任一项的广谱消毒剂，其中以重量/体积比邻苯基苯酚占0.28％。
8.权利要求1至7中任一项的广谱消毒剂，其中以重量/体积比氯己定葡萄糖酸盐占0.01％。
9.权利要求1至8中任一项的广谱消毒剂，其中以重量/体积比壬苯醇醚-9占0.04至0.1％。
10.权利要求1至8中任一项的广谱消毒剂，其中以重量/体积比壬苯醇醚-9占0.05％。
11.权利要求1至10中任一项的广谱消毒剂，其中以重量/体积比苯扎氯铵占0.2％。
12.权利要求1至11中任一项的广谱消毒剂，它包括变性剂。
13.权利要求12的广谱消毒剂，其中所述变性剂是苦精。
14.权利要求13的广谱消毒剂，其中苦精以3至4％的重量/体积比存在。
15.权利要求13的广谱消毒剂，其中苦精以3.68％的重量/体积比存在。
16.权利要求1至15中任一项的广谱消毒剂，它包括芳香剂。
17.权利要求16的广谱消毒剂，其中所述芳香剂为柠檬芳香剂431号。
18.权利要求17的广谱消毒剂，其中柠檬芳香剂431号以0.1％的重量/体积比存在。
19.一种制造权利要求1的广谱消毒剂的方法，该方法包括如下步骤：在醇中溶解至少一种抗微生物剂并继续搅拌溶液；在去离子的双蒸水中溶解至少第二种抗微生物剂；继续搅拌的同时向所述醇溶液中加入去污剂；继续搅拌的同时以足够慢的速度向所述醇溶液中加入所述去离子的双蒸水溶液以防止成核点。
20.一种制造权利要求1至11中任一项的广谱消毒剂的方法，该方法包括如下步骤：在醇中溶解邻苯基苯酚并继续搅拌溶液；在去离子的双蒸水中溶解苯扎氯铵；继续搅拌的同时向所述醇溶液中加入壬苯醇醚-9和氯己定葡萄糖酸盐；继续搅拌的同时以足够慢的速度向所述醇溶液中加入所述去离子的双蒸水溶液以防止成核点。
21.一种制造权利要求1至15中任一项的广谱消毒剂的方法，该方法包括如下步骤：在含有变性剂的醇中溶解邻苯基苯酚并继续搅拌溶液；在去离子的双蒸水中溶解苯扎氯铵；继续搅拌的同时向所述醇溶液中加入壬苯醇醚-9和氯己定葡萄糖酸盐；继续搅拌的同时以足够慢的速度向所述醇溶液中加入所述去离子的双蒸水溶液以防止成核点。
22.一种制造权利要求1至18中任一项的广谱消毒剂的方法，该方法包括如下步骤：在含有变性剂的醇中溶解邻苯基苯酚并继续搅拌溶液；在去离子的双蒸水中溶解苯扎氯铵；继续搅拌的同时向所述醇溶液中加入壬苯醇醚-9、氯己定葡萄糖酸盐和芳香剂；继续搅拌的同时以足够慢的速度向所述醇溶液中加入所述去离子的双蒸水溶液以防止成核点。
23.权利要求1至18中任一项的广谱消毒剂在化妆品中的用途。
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