CN111434758A - 一种缓释杀菌的多酶清洗剂及其制备方法 - Google Patents

一种缓释杀菌的多酶清洗剂及其制备方法 Download PDF

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CN111434758A
CN111434758A CN201910027894.6A CN201910027894A CN111434758A CN 111434758 A CN111434758 A CN 111434758A CN 201910027894 A CN201910027894 A CN 201910027894A CN 111434758 A CN111434758 A CN 111434758A
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徐睿杰
潘越
李宁
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Shanghai Puma Industrial Co ltd
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Abstract

本发明公开了一种缓释杀菌的多酶清洗剂及其制备方法,所述多酶清洗剂包括以下重量份的各组分:去离子水100份、防冻剂10~40份、表面活性剂20~40份、消泡剂0.5~2份、防腐剂0.1~1份、阻垢剂0.5~2份、生物酶10~40份、缓释杀菌剂20‑40份。采用本发明技术方案的有益之处在于,所配置的多酶清洗剂,在清洗手术后的器械,即能有效去除器械沾染的污物,同时去除器械取出后水中石灰沉淀物及矿物质所形成的水垢,以及其他无机物形成的污迹和斑点等,并且使清洗液能保持高效的抑菌效果,可有效防止清洗槽内菌落和菌群增殖。

Description

一种缓释杀菌的多酶清洗剂及其制备方法
技术领域
本发明涉及清洗剂技术领域,尤其涉及一种医用缓释杀菌的多酶清洗剂及其制备方法。
背景技术
随着我国国民经济的发展,我国医疗水平和医疗技术发展迅速,医疗器械的用量也大幅增加。许多医疗器械都是非一次性的重复使用器械,这些器械在与病患接触后通常表面残留大量污物(包扩血液、组织、蛋白质等)及部分微生物,需要通过足够的清洗才能满足其再次使用。目前医疗器械清洗用清洗剂主要有传统的化学清洗剂和医用多酶清洗剂。传统的化学清洗剂用量大、污染大,对金属的医疗器械具有腐蚀作用。而医用多酶清洗剂多由表面活性剂和各种生物酶复配而成,其中的生物酶主要包括蛋白酶、脂肪酶、纤维素酶、淀粉酶等,这些酶能有效地分解和去除粘附在医疗器械上的蛋白、多糖、脂肪和碳水化合物,使残留在医疗器械上的有机物、微生物的数量减至最少。且酶清洗剂的pH值接近中性,基本没有腐蚀性,其抗沉积的作用使经浸泡后的器械更易于清洁,无需反复擦洗,解决了过去因使用化学清洗剂或手工擦洗使器械表面容易出现毛糙、锈蚀,具有高效清洗、省时省力的双重优点,并减少了器械的损耗,提高了使用效率。
市场上通用的酶清洗剂主要依靠表面活性剂与酶的联合作用使污物从器械表面分离,再依靠酶对溶解在清洗液中的污物进行分解。在表面活性剂的选择上常见的包括非离子表面活性剂,如聚氧化乙烯己基醚、聚氧化乙烯辛基醚、聚氧化乙烯癸基醚、聚氧化乙烯月桂基醚、聚氧化乙烯十六烷基醚,吐温系列或AEO系列表面活性剂,这些表面活性剂的应用已经被广泛的在各类技术报告中进行说明,如中国专利CN106010807B,CN104073368A,CN107937156A等。酶清洗剂中常用的生物酶主要包括蛋白酶、脂肪酶、纤维素酶、淀粉酶等,生物酶的活性决定着医用酶清洗剂的清洗效果的好坏及用量。在已有的技术方案中,部分技术方案认为应该将蛋白酶液与其它酶液分开贮存,只在使用时将蛋白酶液和其它酶液按一定比例混合在一起,这样可以抑制蛋白酶对其他酶的分解,导致酶活性低、清洗效果差的问题,如中国专利CN102604754A,但总的来说这样的方法给酶清洗剂的使用和贮存带来不便。大部分的技术方案对几种酶是否需要分开贮存并没有特别说明,如中国专利CN101921671、CN102071113A、CN105385512A、CN104962402A等,显然蛋白酶对其他活性酶的影响可能是有限的,混合使用对酶的活性影响几乎不产生巨大的影响。
但值得注意的是,各类酶的反应活性与温度息息相关,在一定温度下污物被分解,死去的酶也会转化为各类小分子氨基酸。在一定温度下,大量的分解产物溶解在清洗槽内成为微生物再次富集的温床,如果清洗液或清洗槽不能得到有效的清洗,显然这一潜在的危险将长期存在,可能导致医疗器械的二次污染问题。显然这一潜在的二次污染问题急需使用新的技术方案解决。
发明内容
本发明的目的是提供一种长效避免医疗器械被二次污染的酶清洗剂,这种酶清洗剂能够快速去除医疗器械上的医疗污染物,不会粘结在器械表面,分解效果好,清洁效果稳定,且能通过特定的生化反应让残留的有机污渍发出荧光,为实现复用医疗器械的清洗效果实时在线检测提供便利。此外,本发明还要提供一种长效避免医疗器械被二次污染的酶清洗剂的制备方法。
为了解决上述问题,本发明采用以下技术方案:
本发明的第一方面,提供一种含有可缓释杀菌的多酶清洗剂,包括以下重量份的各组分:去离子水100份、防冻剂10~40份、表面活性剂20~40份、消泡剂0.5~2份、防腐剂0.1~1份、阻垢剂0.5~2份、生物酶10~40份、缓释杀菌剂20~40份。
其中,所述防冻剂是乙醇、乙二醇、丙醇、正丁醇、甘油、聚乙二醇中的一种或几种,所述聚乙二醇的分子量为800~4000。
其中,所述表面活性剂为非离子型表面活性剂或阴-非离子型表面活性剂。
所述非离子型表面活性剂是碳链长度为C10~C18的脂肪醇聚氧乙烯醚、碳链长度为C10~C18的烷基酚聚氧乙烯醚、聚氧乙烯烷基酰醇胺、脂肪酸聚氧乙烯、聚氧乙烯烷基胺、聚氧乙烯-聚氧丙烯嵌段共聚醚中的一种。
所述阴-非离子型表面活性剂是聚壬基酚聚氧乙烯醚硫酸钠、十二醇聚氧乙烯醚硫酸钠,十二烷基硫酸钠、正辛醇聚氧乙烯醚羧酸盐、十二烷基醇聚氧乙烯醚羧酸钠、脂肪醇聚氧乙烯醚磺酸盐、烷基酚聚氧乙烯醚磺酸盐、乙二酰胺十二醇聚氧乙烯(12)酯磺酸钠中的一种。
其中,所述消泡剂是高碳醇脂肪酸酯复合物、聚氧乙烯聚氧丙烯季戊四醇醚、聚氧乙烯聚氧丙醇胺醚、聚氧丙烯甘油醚和聚氧丙烯聚氧乙烯甘油醚中的一种。
其中,所述防腐剂是5-氯-2甲基-4异噻唑啉-3酮、2-甲基-4-异噻唑啉-3-酮、对羟基苯甲酸丙酯、对羟基苯甲酸丁酯、甲基异塞唑啉酮中的一种。
其中,所述阻垢剂是苯骈三氮唑钠,巯基苯骈噻唑钠,甲基苯骈三氮唑中的一种。
其中,所述生物酶包括纤维素酶、中性蛋白酶、淀粉酶、脂肪酶、木聚糖酶,纤维素酶、中性蛋白酶、淀粉酶、脂肪酶、木聚糖酶的重量比例为1:3:1:4:1。
其中,所述缓释杀菌剂是以明胶-海藻酸钙为负载物,烯唑醇、苯基甲烷二异氰酸酯和甲基-苯骈咪唑-2-氨基甲酸甲酯共聚物为负载杀菌剂的缓释杀菌剂。
本发明的第二方面,提供一种缓释杀菌的多酶清洗剂的制备方法,用于制备上述的多酶清洗剂,包括以下步骤:
步骤一、称取相应重量份的各组份;
步骤二、在去离子水中加入防冻剂、表面活性剂,搅拌溶解后加入消泡剂、防腐剂、阻垢剂搅拌至完全溶解;
步骤三、依次加入纤维素酶,中性蛋白酶,淀粉酶,脂肪酶和木聚糖酶,前一种酶溶解后再加入后一种酶,搅拌2h;
步骤四、加入缓释杀菌剂,搅拌2小时,再用盐酸调整PH到7,混合均匀即得所述多酶清洗剂。
其中,缓释杀菌剂的制备方法如下:
(1)、制备空白明胶微球。具体步骤包括:配置明胶溶液置于水浴中预热,将预热的明胶溶液逐滴滴加到液体石蜡中,边滴加边搅拌,滴加完后继续搅拌均匀,然后迅速转入冰水浴中进行处理,再加入交联剂交联,交联完成后用洗涤液进行洗涤,得到淡黄色微球,再置于低温环境下继续固化一段时间,最后用洗涤液再次充分洗涤,过筛,分装;
(2)、将步骤一制备得到的空白明胶微球作为原料,并与海藻酸钠溶液混合制备明胶/海藻酸钙空白核-壳结构缓释微球;
(3)、将步骤二制备得到的明胶海藻酸钠空白核-壳结构缓释微球加入到烯唑醇-苯基甲烷二异氰酸酯-甲基-苯骈咪唑-2-氨基甲酸甲酯共聚物溶液中,充分震荡后,得到载有大分子杀菌剂的明胶-海藻酸钠缓释微球。
烯唑醇-苯基甲烷二异氰酸酯-甲基-苯骈咪唑-2-氨基甲酸甲酯共聚物是将烯唑醇、苯基甲烷二异氰酸酯、甲基-苯骈咪唑-2-氨基甲酸甲酯以1:0.8~1.2:1~2.5的质量比加入到丙酮中,在120℃反应60min,保温3h降至室温,过滤得到共聚物杀菌剂。
上述缓释型杀菌剂所述水浴中预热的温度控制在30~50℃,预热时间为2~5min;所述冰水浴中进行处理的时间控制在5~10min。在前述优选的工艺参数条件下,能保证获得球形度更好、表面更光滑平整的微球。上述的制备方法中,优选的,所述明胶溶液的浓度为0.2g/ml,所述液体石蜡中含有1%质量分数的吐温40;所述交联剂为戊二醛,交联反应时间为0.5~2h;所述洗涤液为丙酮-水混合溶液,低温环境下继续固化的时间为4~8h。
上述的制备方法中,优选的,所述海藻酸钠溶液的质量浓度为0.5%-2%;所述油相中含有1%-5%质量分数的吐温40;所述油相中含有0.1%-0.5%质量分数的吐温40;所述水相、油相的体积比为1:1-1:6;所述CaCl2溶液的质量浓度为4%。
上述的制备方法中,优选的,所述水浴锅中预热的温度为40~60℃,预热时间为10min;所述高速乳化的时间控制在5min,加入所述CaCl2溶液后继续搅拌均匀的时间为20min。
上述的制备方法中,优选的,所述海藻酸钠的用量与所述空白明胶微球的质量比为5:1~15:1;所述灭菌共聚物浓度为800μg/ml,加入微球的质量为100mg。
采用本发明技术方案的有益之处在于,所配置的多酶清洗剂,在清洗手术后的器械,即能有效去除器械沾染的污物,同时去除器械取出后水中石灰沉淀物及矿物质所形成的水垢,以及其他无机物形成的污迹和斑点等,并且使清洗液能保持高效的抑菌效果,可有效防止清洗槽内菌落和菌群增殖。
具体实施方式
下面结合具体实施例对本发明做进一步的说明。
实施例1
步骤一、称取相应重量份的各组分。
步骤二、在100份去离子水中加入10份乙醇、20份脂肪醇聚氧乙烯醚(碳链长度C10),搅拌溶解后加入0.5份高碳醇脂肪酸酯复合物,1份2-甲基-4-异噻唑啉-3-酮,2份巯基苯骈噻唑钠搅拌至完全溶解。
步骤三、依次加入纤维素酶、中性蛋白酶、淀粉酶、脂肪酶、木聚糖酶,前一种酶溶解后再加入后一种酶,搅拌2h,所述生物酶中几种酶的重量例为1:3:1:4:1,生物酶的总重量份为40份。
步骤四、加入40份明胶-海藻酸钙负载物烯唑醇-苯基甲烷二异氰酸酯-甲基-苯骈咪唑-2-氨基甲酸甲酯共聚物缓释杀菌剂,搅拌2h,再用盐酸调整pH到7,混合均匀即得所述多酶清洗剂。
实施例2
步骤一、称取相应重量份的各组分。
步骤二、在100份去离子水中加入40份丙醇、40份烷基酚聚氧乙烯醚(碳链长度C18),搅拌溶解后加入2份聚氧乙烯聚氧丙烯季戊四醇醚,0.1份5-氯-2甲基-4异噻唑啉-3酮,0.5份苯骈三氮唑钠搅拌至完全溶解。
步骤三、依次加入纤维素酶、中性蛋白酶、淀粉酶、脂肪酶、木聚糖酶,前一种酶溶解后再加入后一种酶,搅拌2h,所述生物酶中几种酶的重量例为1:3:1:4:1,生物酶的总重量份为10份。
步骤四、加入20份明胶-海藻酸钙负载物烯唑醇-苯基甲烷二异氰酸酯-甲基-苯骈咪唑-2-氨基甲酸甲酯共聚物缓释杀菌剂,搅拌2h,再用盐酸调整pH到7,混合均匀即得所述多酶清洗剂。
实施例3
步骤一、称取相应重量份的各组分。
步骤二、在100份去离子水中加入30份聚乙二醇800、30份聚氧乙烯烷基酰醇胺,搅拌溶解后加入1份聚氧乙烯聚氧丙醇胺醚,0.8份对羟基苯甲酸丙酯,0.8份甲基苯骈三氮唑搅拌至完全溶解。
步骤三、依次加入纤维素酶、中性蛋白酶、淀粉酶、脂肪酶、木聚糖酶,前一种酶溶解后再加入后一种酶,搅拌2h,所述生物酶中几种酶的重量例为1:3:1:4:1,生物酶的总重量份为30份。
步骤四、加入30份明胶-海藻酸钙负载物烯唑醇-苯基甲烷二异氰酸酯-甲基-苯骈咪唑-2-氨基甲酸甲酯共聚物缓释杀菌剂,搅拌2h,再用盐酸调整PH到7,混合均匀即得所述多酶清洗剂。
对比例
购买市售的两款多酶清洗剂,编号为S1、S2。实施例1、实施例2、实施例3的多酶清洗剂,编号分别为D1、D2、D3。
性能测试:
将使用后的药碗、镊子、止血钳和髋臼锉各30个,放入多酶清洗剂和水质量比为1:500的溶液中浸泡30min,流动水下冲洗,然后放入称有多酶清洗剂和水质量比为1:500溶液的超声清洗机中超声10min,取出用刷子清洗并用流动清水反复冲洗,确定无污物后擦拭干净,放入烘干槽内烘干。采用目测和放大镜检查的方法对清洗效果进行检查,以水垢斑、锈斑、污迹无残留为合格。
将清洗后的器械包装24h后进行细菌培养并进行细菌分离及鉴定。无细菌检出为合格。
将清洗液在清洗温度下停放24h后进行细菌培养并进行细菌分离及鉴定。无细菌检出为合格。
实验结果
使用的D1、D2、D3的清洗合格率为100%,使用S1、S2、S3清洗后器械表面有残留水垢斑、锈斑,合格率为65%。
细菌24h后检处情况:使用D1、D2、D3无细菌检出,合格率为100%,使用S1、S2合格率为60%,有细菌检出的器械,细菌数量为5到22个。清洗液停放24h后检处情况:使用D1、D2、D3无细菌检出,合格率为100%,使用S1、S2合格率为20%,有细菌检出的器械,细菌数量为30到170个。
以上应用了具体个例对本发明进行阐述,只是用于帮助理解本发明,并不用以限制本发明。对于本发明所属技术领域的技术人员,依据本发明的思想,还可以做出若干简单推演、变形或替换。

Claims (10)

1.一种缓释杀菌的多酶清洗剂,其特征在于,包括以下重量份的各组分:去离子水100份、防冻剂10~40份、表面活性剂20~40份、消泡剂0.5~2份、防腐剂0.1~1份、阻垢剂0.5~2份、生物酶10~40份、缓释杀菌剂20-40份。
2.如权利要求1所述的一种缓释杀菌的多酶清洗剂,其特征在于:所述防冻剂是乙醇、乙二醇、丙醇、正丁醇、甘油、聚乙二醇中的一种或几种,所述聚乙二醇的分子量为800~4000。
3.如权利要求1所述的一种缓释杀菌的多酶清洗剂,其特征在于:所述表面活性剂为非离子型表面活性剂或阴-非离子型表面活性剂。
4.如权利要求3所述的一种缓释杀菌的多酶清洗剂,其特征在于:所述非离子型表面活性剂是碳链长度为C10~C18的脂肪醇聚氧乙烯醚、碳链长度为C10~C18的烷基酚聚氧乙烯醚、聚氧乙烯烷基酰醇胺、脂肪酸聚氧乙烯、聚氧乙烯烷基胺、聚氧乙烯-聚氧丙烯嵌段共聚醚中的一种。
5.如权利要求3所述的一种缓释杀菌的多酶清洗剂,其特征在于:所述阴-非离子型表面活性剂是聚壬基酚聚氧乙烯醚硫酸钠、十二醇聚氧乙烯醚硫酸钠,十二烷基硫酸钠、正辛醇聚氧乙烯醚羧酸盐、十二烷基醇聚氧乙烯醚羧酸钠、脂肪醇聚氧乙烯醚磺酸盐、烷基酚聚氧乙烯醚磺酸盐、乙二酰胺十二醇聚氧乙烯(12)酯磺酸钠中的一种。
6.如权利要求1所述的一种缓释杀菌的多酶清洗剂,其特征在于:所述消泡剂是高碳醇脂肪酸酯复合物、聚氧乙烯聚氧丙烯季戊四醇醚、聚氧乙烯聚氧丙醇胺醚、聚氧丙烯甘油醚和聚氧丙烯聚氧乙烯甘油醚中的一种。
7.如权利要求1所述的一种缓释杀菌的多酶清洗剂,其特征在于:所述防腐剂是5-氯-2甲基-4异噻唑啉-3酮、2-甲基-4-异噻唑啉-3-酮、对羟基苯甲酸丙酯、对羟基苯甲酸丁酯、甲基异塞唑啉酮中的一种。
8.如权利要求1所述的一种缓释杀菌的多酶清洗剂,其特征在于:所述阻垢剂是苯骈三氮唑钠,巯基苯骈噻唑钠,甲基苯骈三氮唑中的一种。
9.如权利要求1所述的一种缓释杀菌的多酶清洗剂,其特征在于:所述生物酶包括纤维素酶、中性蛋白酶、淀粉酶、脂肪酶、木聚糖酶,纤维素酶、中性蛋白酶、淀粉酶、脂肪酶、木聚糖酶的重量比例为1:3:1:4:1。
10.一种缓释杀菌的多酶清洗剂的制备方法,用于制备权利要求1-9任一项所述的多酶清洗剂,包括以下步骤:
步骤一、称取相应重量份的各组份;
步骤二、在去离子水中加入防冻剂、表面活性剂,搅拌溶解后加入消泡剂、防腐剂、阻垢剂搅拌至完全溶解;
步骤三、依次加入纤维素酶,中性蛋白酶,淀粉酶,脂肪酶和木聚糖酶,前一种酶溶解后再加入后一种酶,搅拌2h;
步骤四、加入缓释杀菌剂,搅拌2小时,再用盐酸调整PH到7,混合均匀即得所述多酶清洗剂。
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