CN1195415C - 具有触变性质的局部用无细胞毒素的抗菌水凝胶 - Google Patents
具有触变性质的局部用无细胞毒素的抗菌水凝胶 Download PDFInfo
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- CN1195415C CN1195415C CNB008145296A CN00814529A CN1195415C CN 1195415 C CN1195415 C CN 1195415C CN B008145296 A CNB008145296 A CN B008145296A CN 00814529 A CN00814529 A CN 00814529A CN 1195415 C CN1195415 C CN 1195415C
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Abstract
一种触变的无细胞毒素的局部用水凝胶,它含有证明是安全和有效的广谱抗菌剂,该抗菌剂基于以独特的电解法得到的次氯酸钠溶液。
Description
发明的技术领域
本发明涉及用于包括组织在内的底物(substrate)消毒的组合物以及消毒方法。本发明的组合物含有电解氯氧化剂、粘度-增高剂、电解质和水。
发明的技术背景
表面局部感染典型地是如慢性尿失禁原发性疾病的结果,或直接地与触染性的医院源或地方病源相关。皮肤长期处于潮湿或湿的状态常常导致其皮肤浸渍和皮肤完整性的其他变化,这通常为腐生细菌和真菌侵袭该部位并发生感染提供了机会。
在皮肤感染的潮湿环境中最流行的微生物是白色念珠菌,一种酵母样的真菌。这类感染的通常特征是红斑、水肿和强烈的搔痒。其他非普遍的细菌源局部感染可以是与污染媒介物紧贴接触的直接结果。一种在医院招致最严重的触染性细菌感染是抗甲氧苯青霉素的金黄色葡萄球菌,它常常藏在皮肤蜂窝织炎、脓窝疮、疔疮和伤口感染处。有时,感染的病因学因子是细菌与真菌的结合。这称之混合感染,其中不同的微生物共存对宿主有好处,也有不利。在比较严重的皮肤病的情况下,其中皮肤破裂,特别是在慢性伤口和溃疡处破裂,各种病原性的和非病原性的微生物污染破裂的部位。非病原性的微生物构成完整皮肤的正常菌丛,但在伤口环境下这些微生物数量压制自然宿主的自卫能力时,它们可能就变成病原性的微生物,因此接着引起感染。
从数量上看,Kucan等人曾指出,开放性伤口每克组织可能保持约105个微生物的生物负荷(bioburden)还不引起临床感染症状。“磺胺嘧啶银与生理盐水在治疗慢性压迫性溃疡中的比较”,
Amer.Ger.Soc.29:232-235(1981)。但是,超过105个微生物就对局部伤口组织的防御提出严重挑战。因此,每克106个微生物经常会造成伤口感染。
受到微生物严重污染、但在临床上还没有感染的伤口,其特征常常是发炎期延长,伤口愈合和康复缓慢。通过干扰白细胞吞噬作用和正常组织颗粒需要的营养和氧的耗竭而延缓伤口康复时,污染伤口的微生物已被视为是一个延缓伤口康复的重要因素。Ree等人“皮肤组织的愈合:现有知识的实用意义,第II部分”,
Jour.of the Amer.Academy of Dermatology 13(6):919-941(1985)。
相关技术的描述
历史上,曾使用从醋酸到以卤素为基础的溶液(例如络合碘)的许多不同种类的防腐剂清洁并消毒伤口。局部用的防腐剂具有公认的抑制或破坏产生感染的微生物的能力;但是,它们直接用于伤口部位时还会引起化学创伤,致使宿主防卫细胞(例如巨噬细胞)坏死(Branemark等人,“由伤口消毒剂所引起的组织伤害”,
Bone Joint Surg.Am 49:48-62(1967);Lineweaver等人,“局部的抗菌活性”
Arch.Surg.120:267-70(1985))。此外,人们知道的局部用防腐剂有严重的细胞毒素,引人注目地破坏伤口康复过程,并且大大削弱了宿主的防卫机制。Viljanto,“不抑制正常伤口康复的外科伤口消毒”,
Arch. Surg.,115:253-6(1980)。
经常地,在外科介入之前,使用局部抗菌剂或防腐剂清洁完整的皮肤。为此目的使用的抗菌剂被视为“外科的皮肤Preps”,用于从静脉穿刺到主要外科手术的所有标准的皮肤消毒方案。另外,作为一种减少交叉感染危险的手段,抗菌剂和防腐剂常规地用作健康护理个人用的洗手剂。
Crotty的US 3,666,679涉及胶凝组合物,它们含有阴离子的杂多糖生物聚合物胶凝剂、直链烷基苯磺酸酯和各种添加剂。该胶凝组合物可以含有释放氯的添加剂,例如氯化磷酸三钠、氯化异氰酸酯、次氯酸钠等。但是,为了达到所要求的结果,这样的组合物需要高浓度的释放氯添加剂的稀释溶液。
Bunyan的US 4,035,483涉及防腐材料,它含有如纤维蛋白、胶原或明胶之类的蛋白质与次氯酸盐的反应产物。该发明的优选实施方案是将反应产物浸渍在片状载体中或包裹在片状载体上。在另一个实施方案中,次氯酸盐与基本过量的蛋白质反应生成薄膜。这样的组合物不具有触变凝胶的优良性能。
Columbus等人的US 5,015,228涉及具有针状物的灭菌设备,该设备包括盖板和凝胶介质。优选的凝胶介质是一种水凝胶,它含有琼脂和与N,N’-亚甲基双丙烯酰胺单体交联的丙烯酰胺的共聚物的交织网络。优选的灭菌剂包括次氯酸钠。为了达到希望的灭菌效果,有效量的次氯酸钠应该是高度稀释的。
现有技术的含氯消毒剂对于局部施用一般是不能令人满意的。通常通过氯在浓氢氧化钠溶液中鼓泡可生产出一般的次氯酸盐溶液(也称之苏打漂白液)。这些漂白液应该含有大量的氢氧化钠以避免分解。这样使得一般次氯酸盐溶液在涂敷到皮肤或粘膜上时具有高的、缓冲的pH以及腐蚀性质,并对组织具有细胞毒素作用。
一般形式的局部消毒组合物倾向于固有地存在一些问题。这样的一些组合物一般为液体或凝胶形式,这两种形式都存在一些固有的缺陷。液体产品涂到要治疗的部位是难以控制的,如流掉、溢出,不易保留也是通常遇到的问题。稠的凝胶不易分散,但也不能像液体那样容易地到达伤口的整个表面部位。
发明的简要说明
因此,本发明的一个目的是克服现有技术组合物的缺陷,提供一种消毒组合物,该组合物含有一种电解氯氧化剂、粘度增高剂、电解质和水。这样的组合物是安全有效的广谱的局部抗菌剂,并呈可触变的无细胞毒素的水凝胶形式。一个相关的目的是提供一种局部消毒底物的方法,该方法包括往所述底物上涂敷有效量的消毒组合物,该组合物含有一种电解氯氧化剂、粘度增高剂、电解质和水。
本发明的另一个目的是提供一种治疗局部感染的方法,该方法包括向需要治疗病人的感染部位和/或感染部位周围涂敷有效量的消毒组合物,该组合物含有一种电解氯氧化剂、粘度增高剂、电解质和水。本技术领域的普通技术人员理解的局部感染一般是指本质上细菌和/或真菌的较小感染,这种感染典型地是表面的和局部的。
本发明的另一个目的是提供一种治疗严重污染或感染伤口的方法,该方法包括向需要治疗病人的污染或感染部位和/或污染或感染部位周围涂敷有效量的组合物,该组合物含有电解氯氧化剂、粘度增高剂、电解质和水。本技术领域的普通技术人员理解的严重污染伤口是指被微生物严重污染,但在临床上未感染的伤口。这样的伤口特征是炎症期延长,伤口康复或愈合缓慢。本技术领域的普通技术人员理解的严重感染伤口是指每克组织有105个以上微生物的生物负荷的伤口。
本发明的另一个目的是提供一种在施行外科或侵入手术之前消毒完整皮肤部位的方法,该方法包括向需要治疗大病人涂敷有效量的组合物,该组合物含有一种电解氯氧化剂、粘度增高剂、电解质和水。
使用本发明的触变水凝胶可以达到这些目的。在触变性流变学特性中,当采用搅拌或摇动方法扰动系统时,其表观粘度降低,然后在停止搅拌或摇动的期间又回复,这种触变性流变学特性在服用或使用本文描述的本发明组合物时是特别有用的。若在治疗部位不能容纳稀的液体,稠的凝胶始终不易分散时,使用简单的送药设备(例如泵喷雾器和挤压管)将产品施用到皮肤上的能力可消除分散稀液体和稠凝胶的典型缺陷。从凝胶到溶胶再到凝胶的流变相转变提供了产品的使用范围。
该组合物优选地呈触变水凝胶形式。触变水凝胶的性质是由粘度增高剂赋予的。电解氯氧化剂含有次氯酸根离子和次氯酸,该氯氧化剂可通过部分电解浓氯化钠溶液、以避免在最后产品中有任何氢氧化钠这样一种方式制备得到。
本发明有广泛的应用,其中包括有效治疗局部细菌和真菌感染,治疗严重污染或感染的伤口,以及在外科或侵入手术之前准备完整的皮肤部位。可以实施这样一些应用同时没有类似抗菌剂和防腐剂的细胞毒素性质。
本发明的描述
本发明涉及用不同浓度的粘度增高剂制备的局部抗菌的触变水凝胶,该粘度增高剂赋予水凝胶具有从重质液体到稠的微混浊凝胶的稠度。优选的抗菌剂是独特的电解氯氧化剂,它可通过部分电解浓氯化钠溶液、以避免在最后产品中有任何氢氧化钠这样一种方式制备得到。
原则上在电解氯氧化剂的广谱抗菌作用中包含了抗感染性质,其氯氧化剂由意大利,Genova,Amuchina S.p.A生产,以注册商标Amuchina销售。
电解氯氧化剂在最大浓度时的活性氯含量是11000ppm,生成约30-40ppm的次氯酸(HOCl),也通称为可利用的游离氯残留物。次氯酸是所有氯残留物中最有效的。次氯酸的效率是由于它可以相对容易地穿透细菌的细胞壁。由于它的低分子量和电中性(没有电荷),所以次氯酸穿透细胞是与水可比的。White,
氯 化作用手册,Van Nostrand Reinhold Company,纽约,N.Y.第216页(1972)。
在生产电解氯氧化剂期间,pH随同时生成次氯酸而降低,次氯酸是普通漂白液中次氯酸根离子活性的近一百倍(100)。同上,第223页,图4-15。因此,由于它较低的pH和次氯酸的增加生成,要得到同样的结果,Amuchina的活性氯含量明显低于标准次氯酸钠(漂白剂)溶液的活性氯含量时,它也是有效的。准确的次氯酸微生物作用机制是不清楚的,但早在1946年,Green和Stump就得出结论,次氯酸的氯与细菌的酶系统进行不可逆反应,从而杀死细菌。Green和Stump“氯的作用模式”,
Jour.AWWA,38:1301(1946)。
这种抗菌剂可与粘度增高剂联用。粘度增高剂系指当在含水介质中以各种浓度应用时能导致生成具有触变性质的稳定水凝胶的任何试剂。例如,粘度增高剂可以是天然或合成的粘土。在一个本发明的实施方案中,使用在结构和组成上与天然粘土矿物锂蒙脱石类似的完全合成矿物可以达到水凝胶的粘度。与天然粘土不同,该合成矿物典型地无杂质。在美国化学学会化学文摘服务(CAS)中在钠锂镁硅酸盐名下(Reg.No.53320-86-8)以及在化妆品、化妆用品和香料协会(CTFA)词典中的钠镁硅酸盐条目下,列出了这样一种合成矿物。由德克萨斯州,Gonzales,Southern Clay Products公司的注册商标,以商品名Laponite在市场上销售这种合成矿物。
除了Laponite外,它是优选的本发明粘度增高剂,某些半合成的和天然存在的粘土矿物其中包括它们的混合物在本技术中都是有用的。按照本发明,也可使用按照结构分类的下述粘土矿物:
I、无定形的
水铝英石组
II、结晶的
A)双层型(由一层二氧化硅和一层氧化铝八面体单元组成的片状结构)
1、等尺寸晶体
高岭石组
高岭石,珍珠石(nacarite)
2、伸长的晶体
多水高岭土
B)三层型(由两层二氧化硅四面体和一层中心二八面体或三八面体层组成的片状结构)。蒙脱石、锌蒙脱石、蛭石、绿脱石、皂石、锂蒙脱石、膨润土。
C)链结构型(闪石(hornblende),像由含有Al和Mg原子的氧和羟基八面体基团连接在一起的二氧化硅四面体链),坡缕石(attapulgite)、海泡石和坡缕石(playgorskite)。
这些天然的粘土矿物的膨胀性质允许在水合时生成胶体微粒。这些胶体微粒具有排斥电表面电荷的性质,这些电荷能够保持在溶液中均匀的悬浮。随着往胶体悬浮液加入离子化合物(例如氯化钠、氯化钾等),有排斥作用的微粒电荷大大降低,这样生成了具有使用粘土矿物典型流变特性的凝胶。生成的凝胶证明了通常称之触变性质的流动性质和流变性能,其中可以通过摇动或搅拌使半固体凝胶变成溶胶(稀的液体),放置时再一次回复到半固体凝胶。
在另一个实施方案中,可以结合使用有机改性剂和粘土矿物粘度增高剂,以便使其两者都达到最好的性能。按照约4份粘土矿物与1份有机改性剂的比例结合使用时,粘土和有机改性剂可以结合起来提供粘度提供剂。有机改性剂在本质上是纤维素的,在本技术中典型地用来生成非-触变凝胶。这样的有机改性剂的非限制性实例包括羟丙基甲基纤维素、瓜尔羟丙基trimonium chloride、聚羟乙烯制剂(carbomer)、黄原酸胶和聚乙烯基吡咯烷酮。
氯化钠在此实施方案中是优选的电解质。其他离解成电解质的化合物,其中包括碱金属盐和碱土金属盐,例如钾、镁和钙盐,也可以用于在生成触变凝胶时建立离子键。.选择性的电解质可生成具有与使用氯化钠时相当性质的凝胶。在含有电解氯氧化剂,粘度-增高剂、电解质和水的消毒组合物中,电解质的量是以组合物重量计为约0.01-约10%。
根据本发明的一个实施方案,在本发明的消毒组合物中,电解氯氧化剂的活性氯含量是约100-约11 000ppm。活性氯含量系指以ppm计溶液中游离氯离子的量。
根据另一个实施方案,在本发明的消毒组合物中,电解氯氧化剂的活性氯含量是约200-约1100ppm。
根据一个优选实施方案,在本发明的消毒组合物中,由11 000ppm浓的电解氯氧化剂溶液稀释得到游离氯含量约500-825ppm。根据另一个优选实施方案,在本发明的消毒组合物中,由11 000ppm浓的电解氯氧化剂溶液稀释得到游离氯含量约550-约825ppm。曾显示出这种浓度对各种各样的细菌、真菌和病毒致病种都是有效的。
稀释全强度(11 000ppm活性氯)电解氯氧化剂的方法是本技术领域的普通技术人员所知的常规方法。例如,98份去离子水与2份电解氯氧化剂混合得到含有220ppm活性氯的消毒组合物;95份去离子水与5份电解氯氧化剂混合得到含有550ppm活性氯的消毒组合物;90份去离子水与10份电解氯氧化剂混合得到含有1100ppm活性氯的消毒组合物。
稀释的电解氯氧化剂溶液再与锂蒙脱石粘度增高剂、水和氯化钠合并,得到一种溶胶,放置时,不搅动可凝结成凝胶,但再搅拌或摇动时很快液化。对于带负电荷胶束(带电荷的胶体微粒)的粘土悬浮液,锂和钠的氢氧化物和卤化物可生成典型的触变系统。具有其粘土型结构的Laponite会分离成许多细的片晶,与离子键一起排列形成触变构造。Laponite在去离子水中分散时,电双层沿片晶周围发育,结果导致片晶间电排斥,因此该系统仍处于静止的溶胶状态。接着加电解氯氧化剂,例如氯化钠,或加抗菌的电解氯氧化剂,致使片晶周围的双电层弱化,从而使静电吸引力和范德瓦斯吸引力成为主要的力,于是该系统发育离子键,这样促使从溶胶态转变到凝胶态。
根据本发明的实施方案,使用由次氯酸根离子(OCL)和次氯酸(HOCL)组成的电解氯氧化剂,其浓度(重量/重量)为约0.022-约0.11%,它是广谱抗菌剂的可利用氯。使用符合经验式Na0.7+[(Si8Mg5.5Li0.3)O20(OH4)]0.7的触变的粘度增高剂,其浓度以重量/重量计为0.1-10%,一旦离子键完成就作为凝胶基体。在一种优选实施方案中,加入符合经验式NaCl的高纯度的U.S.P.级氯化钠,其浓度以重量/重量计为0.1-10%。氯化钠起到在触变粘度增高剂的锂蒙脱石胶束片晶之间建立离子键的作用。
可以将本发明的消毒组合物用于局部地消毒底物,该方法包括向所述的底物涂敷有效量的消毒组合物,该组合物含有电解氯氧化剂、粘度增高剂、电解质和水。
本发明的消毒组合物还可以用于治疗局部感染的方法,该方法包括向需要治疗病人的感染部位和/或感染部位周围涂敷有效量的所述消毒组合物。
本发明的消毒组合物还可以用于治疗严重污染或感染伤口的方法,该方法包括向需要治疗病人的污染或感染部位和/或污染或感染部位周围涂敷有效量的所述消毒组合物。
另外,本发明的消毒组合物可以用于在外科手术或侵入手术之前消毒完整皮肤部位的方法,该方法包括向需要治疗的病人涂敷有效量的消毒组合物,该组合物含有电解氯氧化剂、粘度增高剂、电解质和水。
实施例
触变水凝胶的生产方法:
(1)在连续的高剪力,高速混合下,以重量/重量计,将约0.1-约10%Laponite(取决于所要求的最后粘度)缓慢地分散到装有U.S.P.去离子水的合适尺寸的容器中。混合继续进行直到Laponite完全水合和溶液透明。
(2)在连续高剪力、高速混合下,以重量/重量计,将约2-约10%全强度电解氯氧化剂(11 000ppm活性氯。取决于最后产品中所要求的活性氯浓度)缓慢地加到步骤(1)的混合物中。混合物的粘度会明显增加。继续进行高剪力、高速混合直到溶液透明。
(3)在连续的高剪力,高速混合下,以重量/重量计,将约0.1-约10%U.S.P.级氯化钠(取决于在步骤(1)混合物中Laponite浓度)加到步骤(2)的混合物中。混合物的粘度会急剧增加。得到的组合物具有优良的触变性质。放置时,它是半固体凝胶,但摇动或搅拌时,它变成稀的液体。再放置,它又变成半固体凝胶。
Claims (9)
1.一种消毒触变水凝胶组合物,该组合物含有:
(A)一种电解氯氧化剂;其
(i)由氯化钠溶液的部分水解制备,其中通过次氯酸的同时形成降低pH;
(ii)含有次氯酸根离子和次氯酸;并且
(iii)提供活性氯的含量为100-11,000ppm;
(B)包含天然或合成粘土的粘度增高剂,当应用于含水介质时,其形成显示触变性质的稳定水凝胶;
(C)电解质;和
(D)水。
2.根据权利要求1所述的组合物,其中所述的粘土是合成粘土。
3.根据权利要求2所述的组合物,其中所述的合成粘土具有下式:
Na0.7[(Si8Mg5.5Li0.3)O20(OH4)]0.7
4.根据权利要求2所述的组合物,其中所述的具有下式的合成粘土:
Na0.7[(Si8Mg5.5Li0.3)O20(OH4)]0.7的量以组合物重量计为0.1-10%。
5.根据权利要求1所述的组合物,其中所述的粘度增高剂含有组合的粘土和有机改性剂。
6.根据权利要求1所述的组合物,其中所述的电解质的量以组合物重量计为0.1-10%。
7.根据权利要求6所述的组合物,其中所述的电解质是氯化钠。
8.根据权利要求1所述的组合物,其中所述电解氯氧化剂的活性氯含量为200-1100ppm。
9.根据权利要求1所述的组合物,其中:
(A)存在电解氯氧化剂,其量可提供活性氯的含量为200-1100ppm;
(B)粘度增高剂是合成的层状硅酸盐,其量为0.1-10重量%;
(C)电解质是氯化钠,其量为0.1-10重量%;组合物的余量包括水。
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US09/422,327 US6333054B1 (en) | 1999-10-21 | 1999-10-21 | Topical, non-cytotoxic, antimicrobial hydrogel with thixotropic properties |
US09/422,327 | 1999-10-21 |
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CN1195415C true CN1195415C (zh) | 2005-04-06 |
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EP (1) | EP1259114B1 (zh) |
JP (1) | JP5546086B2 (zh) |
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CN (1) | CN1195415C (zh) |
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CA2388809A1 (en) | 2001-04-26 |
UA73531C2 (en) | 2005-08-15 |
KR20020075364A (ko) | 2002-10-04 |
EA200200476A1 (ru) | 2003-02-27 |
AU2467501A (en) | 2001-04-30 |
GEP20043399B (en) | 2004-07-12 |
HK1049764B (zh) | 2005-06-10 |
JP5546086B2 (ja) | 2014-07-09 |
CA2388809C (en) | 2009-07-07 |
HU229274B1 (en) | 2013-10-28 |
PL200322B1 (pl) | 2008-12-31 |
PL355393A1 (en) | 2004-04-19 |
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JP2003511473A (ja) | 2003-03-25 |
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CZ301637B6 (cs) | 2010-05-12 |
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