CN108192771A - 一种手术器械两腔多酶凝珠及其制备方法 - Google Patents
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Abstract
本发明公开了一种手术器械两腔多酶凝珠,所述多酶凝珠采用水溶性高分子薄膜作为包覆材料构成含有两腔的凝珠;分别为腔室1和腔室2,腔室1放置固体酶,腔室2放置超浓缩清洗剂;所述超浓缩清洗剂包括非离子表面活性剂、两性表面活性剂、缓蚀剂、螯合剂、杀菌剂和溶剂;所用的固体酶是由蛋白酶、脂肪酶、淀粉酶、纤维素酶四种组成。本发明中的手术器械两腔多酶凝珠清洗能力强,酶活稳定性高,安全无毒,适用于医疗器械的清洗。
Description
技术领域
本发明属于医疗器械领域,具体涉及一种手术器械两腔多酶凝珠及其制备方法。
背景技术
医院预防和控制感染,需要对手术器械照标准严格流程进行清洗,这是医疗器械灭菌前和再处理中消毒的最重要环节,这既是物品达到灭菌效果合格的必要条件,且能保证消毒供应中心工作人员免受交叉感染,对于提高医院手术器械灭菌有效性也有重要作用
清洗手术器械需要严格按照流程进行,操作步骤为冲洗,洗涤,漂洗,纯水二次漂洗、润滑干燥等过程。一般来说,多数情况下复杂的器械必须拆下手工清洗,有时还需要进行超声清洗,因为器械越复杂,其清洗的难度也随之增加。目前消毒供应中心用到的清洗均为液体清洗剂,配置一定比例的清洗剂需要去手工量取,给工作人员造成了很大的困扰。另外,因为规范清洗的普及,清洗剂一用一换越来越成为常态,消毒供应中心手工清洗时如何快速有效的进行清洗剂的配比,成为目前一个热点和难点。
同时目前的多酶清洗均存在酶活稳定性会下降的问题,即随着时间存放的推移,酶活逐渐下降,导致清洗剂的清洗力下降,这也是困扰医疗清洗行业的一个难题。
发明内容
本发明所要解决的技术问题是:克服现有手术器械手工及超声清洗中存在的麻烦,降低临床工作人员的工作量,克服液体清洗剂酶活下降难题,本发明提供一种手术器械两腔多酶凝珠,其液体清洗剂定量化,无需工作人员用量杯量取,方便使用者取用。且固体酶可以长时间有效的保持酶活,维持清洗力在一个较高的水平。
为解决上述技术问题,本发明采用的技术方案为:将一种水溶性高分子薄膜作为包覆材料,做成含有两腔的凝珠。该两腔凝珠一个腔体放置固体酶,另一个腔体放置无水超浓缩清洗剂。在存放时,液体清洗剂和多酶处于互不接触的状态。使用时,将该凝珠投放到清洗用水液面下,水溶性薄膜溶解,多酶和清洗剂一起释放混合,共同发挥作用,彻底清洗手术器械表面污物。
一种手术器械两腔多酶凝珠,其特征在于:包括超浓缩清洗剂、固体酶和包覆材料水溶系高分子薄膜。.
超浓缩清洗剂是由以下组分及各组分的质量百分比分别为:
非离子表面活性剂30%~80%
两性表面活性剂 2%~10%
缓蚀剂 2%~15%
螯合剂 0.1%~2%
杀菌剂 1%~10%
溶剂余量
总量为100%。
所述非表面活性剂为脂肪醇聚氧乙烯醚、脂肪酸甲酯乙氧基化物、异构醇聚氧乙烯醚中的两种或者两种以上。
所述两性表面活性剂为磺基甜菜碱、氨基酸型两性离子表面活性剂中的一种或者两种。
所述溶剂为丙二醇、异丙醇、乙醇、乙二醇、乙二醇乙醚、丙二醇丁醚、二丙二醇丁醚、聚乙二醇中的一种或几种。
所述螯合剂为三聚磷酸钠、谷氨酸二乙酸四钠盐和羟基乙叉二膦酸中的一种或者几种。
所述的防锈剂为有机聚羧酸、苯丙三氮唑中的一种或者两种。
所述所用的复合酶是由蛋白酶、脂肪酶、淀粉酶、纤维素酶四种组成。包括以下的百分比
蛋白酶 10~60%
脂肪酶 5~20%
淀粉酶 5~20%
纤维素酶 5~10%
总量为100%
按配方比例将纯水加入搅拌釜中,开启搅拌器,先加2%~10%两性表面活性剂,再加0.1%~2%螯合剂溶解,溶解完成后加入30%~80%非离子表面活性剂,1%~10%杀菌剂、2%~15%缓蚀剂,再添加余量的溶剂,再搅拌均匀后过滤,即得超浓缩清洗剂。
固体酶依次在固体混合股罐中加入10~60%蛋白酶、5~20%脂肪酶和淀粉酶,最后加入5~10%的纤维素酶,混合均匀。
将上述制备好的超浓缩清洗剂,在设备第一成型机上通过模具和水溶性薄膜热封成型形成腔室1,再与第二成型机上与固体酶通过模具和水溶性薄膜热封形成腔室2,最后切割成小袋状两腔凝珠。
本发明的有益效果是:与现有技术相比,所述一种手术器械两腔多酶凝珠,在使用前液体清洗剂和多酶处于互不接触的状态;使得液体清洗剂定量化,无需工作人员用量杯量取,方便使用者取用。且固体酶可以长时间有效的保持酶活,使用时,水溶性薄膜溶解,多酶和清洗剂一起释放混合,共同发挥作用,彻底清洗手术器械表面污物。
附图说明:
图1本发明所述一种手术器械两腔多酶凝珠结构示意图。
附图标记:1-腔室1; 2-腔室2。
具体实施方式
实施例1:手术器械两腔多酶凝珠结构及使用说明
手术器械两腔多酶凝珠采用水溶性高分子薄膜作为包覆材料,做成含有两腔的凝珠。该两腔凝珠一个腔体放置固体酶,另一个腔体放置无水超浓缩清洗剂。所述高分子薄膜优选聚乙烯醇、聚乙烯吡咯烷酮、纤维素中的一种或者两种;
所述超浓缩清洗剂是由以下组分及各组分的质量百分比分别为:
非离子表面活性剂:30%~80%
两性表面活性剂:2%~10%
缓蚀剂 :2%~15%
螯合剂:0.1%~2%
杀菌剂: 1%~10%
溶剂余量
总量为100%。
所述非表面活性剂为脂肪醇聚氧乙烯醚、脂肪酸甲酯乙氧基化物、异构醇聚氧乙烯醚中的两种或者两种以上。
所述两性表面活性剂为磺基甜菜碱、氨基酸型两性离子表面活性剂中的一种或者两种。
所述溶剂为丙二醇、异丙醇、乙醇、乙二醇、乙二醇乙醚、丙二醇丁醚、二丙二醇丁醚、聚乙二醇中的一种或几种。
所述螯合剂为三聚磷酸钠、谷氨酸二乙酸四钠盐和羟基乙叉二膦酸中的一种或者几种。
所述的缓蚀剂为有机聚羧酸、苯丙三氮唑中的一种或者两种
所述所用的复合固体酶是由蛋白酶、脂肪酶、淀粉酶、纤维素酶四种组成。各组分的质量百分比分别为:
蛋白酶 10~60%
脂肪酶 5~20%
淀粉酶 5~20%
纤维素酶 5~10%
总量为100%。
手术器械两腔多酶凝珠在存放时,液体清洗剂和多酶处于互不接触的状态。使用时,将该凝珠投放到清洗用水液面下,水溶性高分子薄膜溶解,固体酶和超浓缩清洗剂一起释放混合,共同发挥作用,彻底清洗手术器械表面污物。
实施例2手术器械两腔多酶凝珠制备方法
超浓缩清洗剂是由以下组分及各组分的质量百分比分别为:
AEO-9 :80%
Crodateric PI:2%
Crodacor BE :2%
谷氨酸二乙酸四钠盐:2%
卡松: 1%
聚乙二醇余量
总量为100%。
按配方比例将部分聚乙二醇加入搅拌釜中,开启搅拌器,先加2%两性表面活性剂咪唑啉两性表面活性剂Crodateric PI,再加2%螯合剂谷氨酸二乙酸四钠盐溶解,溶解完成后加入80%非离子表面活性剂脂肪醇聚氧乙烯醚AEO-9,1%杀菌剂卡松、2%缓蚀剂有机硼酸酯Crodacor BE,再添加余量的溶剂聚乙二醇,再搅拌均匀后过滤,即得超浓缩清洗剂。
依次在固体混合股罐中按照质量比加入60%蛋白酶、15%脂肪酶和15%淀粉酶,最后加入10%的纤维素酶,混合均匀。
将上述制备好的超浓缩清洗剂,在设备第一成型机上通过模具和水溶性薄膜热封成型形成腔室1,再与第二成型机上与固体酶通过模具和水溶性薄膜热封形成腔室2,最后切割成小袋状两腔凝珠。
实施例2手术器械两腔多酶凝珠制备方法
超浓缩清洗剂是由以下组分及各组分的质量百分比分别为:
AEO-9 :70%
十二烷基二甲基甜菜碱:10%
苯并三氮唑:2%
羟基乙叉二膦酸 :0.1%
卡松:2%
丙二醇余量
总量为100%。
开启搅拌器,先加10%两性表面活性剂十二烷基二甲基甜菜碱,再加0.1%螯合剂羟基乙叉二膦酸溶解,溶解完成后加入70%非离子表面活性剂AEO-9脂肪醇聚氧乙烯醚AEO-9,2%卡松、2%缓蚀剂苯并三氮唑,再添加余量的丙二醇,再搅拌均匀后过滤,即得超浓缩清洗剂。
固体酶依次在固体混合股罐中加入50%蛋白酶、20%脂肪酶和淀粉酶,最后加入10%的纤维素酶,混合均匀。
将上述制备好的超浓缩清洗剂,在设备第一成型机上通过模具和水溶性薄膜热封成型形成腔室1,再与第二成型机上与固体酶通过模具和水溶性薄膜热封形成腔室2,最后切割成小袋状两腔凝珠。
实施例3
将上述手术器械两腔多酶凝珠与市面上的传统液体多酶清洗剂在蛋白酶酶活进行评价,结果见下表。
以上显示和描述了本发明的基本原理、主要特征和本发明的优点。本行业的技术人员应该了解,本发明不受上述实施例的限制,上述实施例和说明书中描述的只是说明本发明的原理,在不脱离本发明精神和范围的前提下,本发明还会有各种变化和改进,这些变化和改进都落入要求保护的本发明范围内。本发明要求保护范围由所附的权利要求书及其等效物界定。
Claims (9)
1.一种手术器械两腔多酶凝珠,其特征在于,所述多酶凝珠采用水溶性高分子薄膜作为包覆材料构成含有两腔的凝珠;分别为腔室(1)和腔室(2),腔室(1)放置固体酶,腔室(2)放置超浓缩清洗剂。
2.根据权利要求1所述手术器械两腔多酶凝珠,其特征在于:所述超浓缩清洗剂所含组分及各组分的质量百分比分别为:
非离子表面活性剂:30%~80%
两性表面活性剂:2%~10%
缓蚀剂:2%~15%
螯合剂:0.1%~2%
杀菌剂: 1%~10%
溶剂余量
总量为100%;
所用的固体酶是由蛋白酶、脂肪酶、淀粉酶、纤维素酶四种组成,其质量百分比为:
蛋白酶:10~60%
脂肪酶:5~20%
淀粉酶:5~20%
纤维素酶:5~10%
总量为100%。
3.根据权利要求2所述手术器械两腔多酶凝珠,其特征在于:所述非表面活性剂为脂肪醇聚氧乙烯醚、脂肪酸甲酯乙氧基化物、异构醇聚氧乙烯醚中的两种或者两种以上。
4.根据权利要求2所述手术器械两腔多酶凝珠,其特征在于所述两性表面活性剂为磺基甜菜碱、氨基酸型两性离子表面活性剂中的一种或者两种。
5.根据权利要求2所述手术器械两腔多酶凝珠,其特征在于:所述溶剂为丙二醇、异丙醇、乙醇、乙二醇、乙二醇乙醚、丙二醇丁醚、二丙二醇丁醚中、聚乙二醇中的一种或几种。
6.根据权利要求2所述手术器械两腔多酶凝珠,其特征在于:所述螯合剂为三聚磷酸钠、谷氨酸二乙酸四钠盐和羟基乙叉二膦酸中的一种或者几种。
7.根据权利要求2所述手术器械两腔多酶凝珠,其特征在于:所述的缓蚀剂为有机聚羧酸、苯丙三氮唑中的一种或者两种。
8.根据权利要求1所述手术器械两腔多酶凝珠,其特征在于所述的包覆材料水溶性高分子薄膜为聚乙烯醇、聚乙烯吡咯烷酮、纤维素中的一种或者两种。
9.一种如权利要求2所述手术器械两腔多酶凝珠的制备方法:
Ⅰ制备超浓缩清洗剂:按配方比例将部分溶剂加入搅拌釜中,开启搅拌器,先加2%~10%两性表面活性剂,再加0.1%~2%螯合剂溶解,溶解完成后加入30%~80%非离子表面活性剂,1%~10%杀菌剂、2%~15%缓蚀剂,再添加余量的溶剂,搅拌均匀后过滤,即得超浓缩清洗剂;
Ⅱ制备固体酶:依次在固体混合股罐中加入10~60%蛋白酶、5~20%脂肪酶和淀粉酶,最后加入5~10%的纤维素酶,混合均匀;
Ⅲ热封成型:将上述制备好的超浓缩清洗剂,在设备第一成型机上通过模具和水溶性薄膜热封成型形成腔室(1),再与第二成型机上与固体酶通过模具和水溶性薄膜热封形成腔室(2),最后切割成小袋状手术器械两腔多酶凝珠。
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CN113444584A (zh) * | 2021-06-25 | 2021-09-28 | 山东新华莎罗雅生物技术有限公司 | 固体酶清洗剂及其制备方法 |
CN113444588A (zh) * | 2021-06-25 | 2021-09-28 | 山东新华莎罗雅生物技术有限公司 | 医疗器械固体清洗剂及其生产工艺 |
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