CN116286209A - 一种多酶低泡沫医疗器械清洗剂及其制备方法 - Google Patents
一种多酶低泡沫医疗器械清洗剂及其制备方法 Download PDFInfo
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- CN116286209A CN116286209A CN202111562029.5A CN202111562029A CN116286209A CN 116286209 A CN116286209 A CN 116286209A CN 202111562029 A CN202111562029 A CN 202111562029A CN 116286209 A CN116286209 A CN 116286209A
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Classifications
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- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
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- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
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- C—CHEMISTRY; METALLURGY
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- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
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- C—CHEMISTRY; METALLURGY
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- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
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- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
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- C11D3/2065—Polyhydric alcohols
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- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
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- C—CHEMISTRY; METALLURGY
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- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
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Abstract
本发明公开了一种多酶低泡沫医疗器械清洗剂及其制备方法,解决现有多酶清洗剂无法兼顾低泡沫、高效清洁、高酶活性以及无法同时适用于手洗机洗的技术问题。本发明包括质量比为10‑40%的生物表面活性剂、10‑30%的生物活性酶、5‑20%的多羟基化合物、0.1‑5%的蛋白酶抑制剂、0.1‑2%的防腐剂、0.1‑1%的复合酶稳定性助剂、余量为去离子水。本发明优选多种生物活性酶,通过复合技术使其与生物表面活性剂、多羟基化合物、蛋白酶抑制剂、酶稳定助剂等复配,提高了多酶清洗剂的酶活稳定性和分解效率,还具有极低的泡沫,并且便于清洗,不污染环境、安全无毒,适用于自动清洗系统和手工清洗,对各种医疗器械具有优良清洗效果。
Description
技术领域
本发明属于生物酶清洗技术领域,具体涉及一种多酶低泡沫医疗器械清洗剂及其制备方法。
背景技术
医院的无菌物品种类多,大量的医疗器械需要重复清洁使用。研究表明,重复使用的医疗器械是患者院内感染的主要途径之一,医疗器械清洗消毒是控制医源性感染的重要环节,而清洗是保证医疗器械成功消毒的关键所在,污染医疗器械的有效清洗是消毒成功的前提与基础。
医疗器械在进行灭菌处理前,确保彻底清洁是保证灭菌效果的前提。因复用性医疗器械经使用后会残留脓液、血液或组织等,有机物质附着后难以彻底清洗,且易形成生物膜,对消毒灭菌介质渗入造成影响。医疗器械清洗时需要将有机物与细菌消除,降低生物负载量,从而提高消毒灭菌质量。以往主要选择全自动清洗消毒机进行清洗消毒,其工作效率高,但是除了清除器械表面大面积微生物外,难以对器械的腔、凹槽等清洗盲区进行有效清洁,清洁效果并不理想,进一步影响病原微生物杀灭效果。清洗是一个复杂且重要的过程,特别是对于医疗器械,清洗不洗不彻底,残留在器具上的有机物和无机物会干扰消毒的效果,再次用于其他患者,容易造成感染,直接影响到整个医疗的安全。
为提高医疗器械的洗涤质量,预防院内交叉感染发生,近年来酶类清洗剂在医疗器械清洗中得到了推广,特别是《内镜清洗消毒技术操作规范(2004年版)》、《WS 507-2016软式内镜清洗消毒技术规范》中明确要求,内镜必须用多酶清洗剂清洗,使得酶类清洗剂在临床清洁工作中的应用更为普遍。多酶医疗器械清洗剂用于医疗器械的浸泡清洗,可以有效分解和去除物品上的污染物,能快速、高效地完成清洗过程,从而提高了工作效率,在一定程度上延长了医疗器械的使用寿命。多酶医疗器械清洗剂可以彻底清洗干净医疗器械上污染的各种有机物。
多酶清洗剂作为一种对蛋白质、脂肪、糖类、组织碎片、碳水化合物、组织纤维、有机物等有溶解、分解功能的清洗剂,酶的专一性特强,不同的酶催化作用于不同的污染物,多种酶作用于多种不同的污染物,是较为理想地解决了再生医疗器械残留物清洗的难题。然而,多酶清洗剂中的蛋白酶能分解其他生物酶,导致多酶清洗剂中其他生物活性酶的酶活性降低甚至失效,使多酶清洗剂清洗效果变差,为此,开发出同时具备优良的清洗效果和多酶协同作用稳定性和安全性高的多酶医疗器械清洗剂产品是本领域研究人员难题。
因此,本发明提供了一种多酶低泡沫医疗器械清洗剂,不仅适用于自动清洗机使用,也便于手工刷洗,其使用生物表面活性剂安全环保,不会对环境造成二次污染,同时易于漂洗过水,污染物不会再附回器械上。
发明内容
本发明要解决的技术问题是:提供一种多酶低泡沫医疗器械清洗剂及其制备方法,解决现有多酶清洗剂无法兼顾低泡沫、高效清洁、高酶活性以及无法同时适用于手洗机洗的技术问题。
为实现上述目的,本发明采用的技术方案如下:
一种多酶低泡沫医疗器械清洗剂,由以下重量份的组分组成:
进一步地,生物表面活性剂由鼠李糖脂、槐糖脂、磷脂组成;
鼠李糖脂是由铜绿假单胞菌培菌的单鼠李糖脂Rha-C10-C10,槐糖脂是由酵母菌代谢产生的糖脂类内酯型槐糖脂。
进一步地,生物活性酶由强效蛋白酶、脂肪酶、淀粉酶、纤维素酶、果胶酶、糖苷酶、核酸酶、溶菌酶复合组成。
进一步地,强效蛋白酶、脂肪酶、淀粉酶、纤维素酶、果胶酶、糖苷酶、核酸酶、溶菌酶质量之比为2~6:1~3:1~3:1~3:0.5~1.5:0.5~1.5:0.5~1.5:0.2~0.8。
进一步地,多羟基化合物为甘油、1,3-丙二醇、丙二醇、三丙二醇、山梨糖醇、甘露糖醇、聚乙二醇(PEG)任意一种或多种。
进一步地,聚乙二醇(PEG)分子量为1000。
进一步地,蛋白酶抑制剂由丙二醇、硼砂、4-甲酰基苯硼酸复配组成。
进一步地,丙二醇、硼砂、4-甲酰基苯硼酸质量之比为2:1:0.25或1:1:0.25。
进一步地,复合酶稳定性助剂由金属化合物和糖类组成;
金属化合物为硫酸亚铁、氯化钙、硫酸镁、硫酸锌、氯化钾的任意一种或多种,糖类为葡萄糖、海藻糖、蔗糖的任意一种或多种。
一种多酶低泡沫医疗器械清洗剂的制备方法,包括以下步骤:
A、向配料锅中加入去离子水总质量的50%,缓慢地启动搅拌器,搅拌频率为15~30r/min;
B、加入复合酶稳定性助剂,搅拌至完全溶解;
C、加入生物表面活性剂,启动加热器加热到50~60℃,搅拌频率为45~65r/min,搅拌至完全溶解;
D、加入多羟基化合物和剩余的去离子水,开始降温;
E、待锅内物料温度降至低于35℃时,加入防腐剂,降低搅拌器的搅拌速度,搅拌频率为10~20r/min;
F、将事先溶解的蛋白酶抑制剂然后加入配料锅中,搅拌均匀;
G、加入生物活性酶,缓慢搅拌至完全溶解均匀;
H、得到pH为6.5~7.8、比重为0.95~1.15的淡黄色透明液体,检验合格后灌装包装、即为多酶低泡沫医疗器械清洗剂产品原液。
与现有技术相比,本发明具有以下有益效果:
酶是由活细胞产生的、且具有催化功能的大分子蛋白质。酶不同于一般催化剂,它具有极高的催化效率,在常温下其催化效率是一般催化剂的107~1010倍。同时,酶具有专一性,每种酶只能催化一种类型的分子,表现出高度的特异性和选择性。酶在医疗器械清洗中的应用原理是将大分子的脂肪、蛋白质、糖类等大分子有机物分解成水溶性的小分子物质,从而达到清洗的目的。鉴于酶具有的专一性,在医疗器械清洗中使用的酶类清洗剂必须采为多酶、即由多种的生物活性酶复配而成,才可分解医疗器械上的所有生物污染物,如血液、脂肪、蛋白质、糖类等,使用后将酶冲洗干净,不需要解毒处理,也不会污染环境,不伤害器械表面涂层。
本发明针对目前多酶清洗剂中蛋白酶能分解溶液中的其他种类生物酶,导致多酶清洗剂中的生物酶活性降低、清洗效果差的问题,以及使用常规表面活性剂泡沫多而不易过水冲洗、泡沫过多而不利于机洗等问题,优选多种生物活性酶,通过复合技术使其与生物表面活性剂、多羟基化合物、蛋白酶抑制剂、酶稳定助剂等复配形成所述多酶清洁剂。其中多羟基化合物与酶形成多个氢键并与水分子相互作用,在酶分子周围形成水膜防止酶水解而变性,提高了多酶清洗剂的酶活稳定性,使之能更迅速有效分解去除医疗器械上的各种污染物。
本发明具有极低的泡沫,便于清洗,不影响光学分辨率,可生物降解、不污染环境、安全无毒。本发明适用于自动清洗系统和手工清洗,对各种软式、硬式内窥镜,口腔科器械,内、外科用具,外科手术器械,橡胶,医用塑料,牙科仪器,超声探针,可重复使用导管和实验室器皿等各种医疗器械具有优良清洗效果。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白,以下本发明进一步详细说明。显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
本发明提供的提供一种多酶低泡沫医疗器械清洗剂,由以下重量份的组分组成:
所述生物表面活性剂由鼠李糖脂、槐糖脂、磷脂组成;
鼠李糖脂是由铜绿假单胞菌培菌的单鼠李糖脂Rha-C10-C10,槐糖脂是由酵母菌代谢产生的糖脂类内酯型槐糖脂。
鼠李糖脂是由微生物产生的阴离子生物表面活性剂,溶于甲醇、氯仿和乙醚,在碱性水溶液中也表现出良好的溶解特性。鼠李糖脂兼具良好的化学和生物特性,具有油、水两亲性,可以降低水表面张力,作为润湿剂、乳化剂和发泡剂使用。鼠李糖脂作为生物表面活性剂可以在温度、pH值及盐度处于极端状况下使用,并且无毒、可以生物降解。
槐糖脂是一种糖脂类生物表面活性剂,采用发酵工艺制成,完全是微生物代谢产物,菌种通过自然选育,不使用基因工程菌。槐糖脂具有常规表面活性剂的增溶、乳化、润湿、发泡、分散、降低表面张力等通用性能,而且还具有无毒、100%可生物降解、耐温、耐高盐、适应pH范围广及对环境友好等特性。
所述生物活性酶由强效蛋白酶、脂肪酶、淀粉酶、纤维素酶、果胶酶、糖苷酶、核酸酶、溶菌酶复合组成。更优选地,强效蛋白酶、脂肪酶、淀粉酶、纤维素酶、果胶酶、糖苷酶、核酸酶、溶菌酶质量之比为2~6:1~3:1~3:1~3:0.5~1.5:0.5~1.5:0.5~1.5:0.2~0.8。
所述多羟基化合物为甘油、1,3-丙二醇、丙二醇、三丙二醇、山梨糖醇、甘露糖醇、聚乙二醇(PEG)任意一种或多种。更优选地,多羟基化合物为甘油、1,3-丙二醇、聚乙二醇PEG。聚乙二醇(PEG)分子量为1000。
所述蛋白酶抑制剂由丙二醇、硼砂、4-甲酰基苯硼酸复配组成。更优选地,丙二醇、硼砂、4-甲酰基苯硼酸质量之比为2:1:0.25或1:1:0.25。
所述防腐剂优选商品名为桑普K15(SupGuard K15)的卡松和商品名为 PE9010的苯氧乙醇。更优选地,商品名为桑普K15(SupGuard K15)的卡松其有效物质含量为1.5%,主要有效物质成份甲基氯异噻唑啉酮和甲基异噻唑啉酮按3:1的比例复合;更优选地,商品名为/> PE 9010的苯氧乙醇是德国舒美的防腐剂,主要成份苯氧乙醇和乙基己基甘油按9:1的比例复合。
所述复合酶稳定性助剂由金属化合物和糖类组成;金属化合物为硫酸亚铁、氯化钙、硫酸镁、硫酸锌、氯化钾的任意一种或多种,糖类为葡萄糖、海藻糖、蔗糖的任意一种或多种。更优选地,复合酶稳定性助剂为氯化钙和葡萄糖。
其中的一些实施例中,生物活性酶的强效蛋白酶、脂肪酶、淀粉酶、纤维素酶、果胶酶、糖苷酶、核酸酶、溶菌酶的质量比为6:1:1:1:0.5:0.5:0.5:0.2;生物酶活性与生物表面活性剂的质量比为1~2:1~3。
其中的一些实施例中,生物活性酶与生物表面活性剂的质量比为1:2。
本发明提供的一种多酶低泡沫医疗器械清洗剂,原液较为稳定,稀释后生物活性酶被激活。医疗器械清洗前要先浸泡,以便生物活性酶发挥作用分解有机物,然后再刷洗。一般浸泡时间为5-10分钟,如污染严重的至少浸泡20分钟。使用酶类清洗剂要控制水温,一般控制在30-40℃,此时生物酶活性最强,使用大于50℃的水,会造成器械上的残存血液凝固、生物活性酶失活,增加了清洗的难度。本发明所述的多酶清洗剂选用超声清洗机或自动清洗机配合多酶清洗效果更佳,稀释比例是机洗为1:200-400,手洗为1:100-200,用前现配即用。同时,需要注意的是稀释水的离子强度会影响到清洗的效果。
实施例1
一种多酶低泡沫医疗器械清洗剂,由以下重量份的组分组成:
生物表面活性剂:
鼠李糖脂(Rha-C10-C10) 8%
槐糖脂(SLMP-I) 2.5%
磷脂 1.2%;
生物活性酶:
多羟基化合物:
聚乙二醇1000(PEG1000) 1.5%
斯文甘油 6.5%;
蛋白酶抑制剂:
丙二醇、硼砂、4-甲酰基苯硼酸 3%;
防腐剂:
桑普K15(SupGuard K15) 0.1%
复合酶稳定性助剂:
氯化钙 0.01%
葡萄糖 0.15%;
去离子水加至 100%。
其中,蛋白酶抑制剂中,丙二醇、硼砂、4-甲酰基苯硼酸的质量比为2:1:0.25。
桑普K15(SupGuard K15)为复配原料,其中主要活性成份甲基氯异噻唑啉酮、甲基异噻唑啉酮的质量比为3:1;苯氧乙醇( PE 9010)为复配原料,其中主要成份苯氧乙醇、乙基己基甘油的质量比为9:1。
一种多酶低泡沫医疗器械清洗剂的制备方法,包括以下步骤:
A、向配料锅中加入去离子水总质量的50%,缓慢地启动搅拌器,搅拌频率为15~30r/min;
B、加入复合酶稳定性助剂,搅拌至完全溶解;
C、加入生物表面活性剂,启动加热器加热到50~60℃,搅拌频率为45~65r/min,搅拌至完全溶解;
D、加入多羟基化合物和剩余的去离子水,开始降温;
E、待锅内物料温度降至低于35℃时,加入防腐剂,降低搅拌器的搅拌速度,搅拌频率为10~20r/min;
F、将事先溶解的蛋白酶抑制剂然后加入配料锅中,搅拌均匀;
G、加入生物活性酶,缓慢搅拌至完全溶解均匀;
H、得到pH为6.5~7.8、比重为0.95~1.15的淡黄色透明液体,检验合格后灌装包装、即为多酶低泡沫医疗器械清洗剂产品原液。
实施例2
一种多酶低泡沫医疗器械清洗剂,由以下重量份的组分组成:
生物表面活性剂:
鼠李糖脂(Rha-C10-C10) 2%
槐糖脂(SLMP-I) 15.5%
磷脂 5%;
生物活性酶:
多羟基化合物:
聚乙二醇1000(PEG1000) 5.5%
斯文甘油 3%;
蛋白酶抑制剂:
丙二醇、硼砂、4-甲酰基苯硼酸 3%;
防腐剂:
桑普K15(SupGuard K15) 0.1%
复合酶稳定性助剂:
氯化钙 0.05%
葡萄糖 0.5%;
去离子水加至 100%。
其中,蛋白酶抑制剂中,丙二醇、硼砂、4-甲酰基苯硼酸的质量比为2:1:0.25。
桑普K15(SupGuard K15)为复配原料,其中主要活性成份甲基氯异噻唑啉酮、甲基异噻唑啉酮的质量比为3:1;苯氧乙醇( PE 9010)为复配原料,其中主要成份苯氧乙醇、乙基己基甘油的质量比为9:1。
一种多酶低泡沫医疗器械清洗剂的制备方法,包括以下步骤:
A、向配料锅中加入去离子水总质量的50%,缓慢地启动搅拌器,搅拌频率为15~30r/min;
B、加入复合酶稳定性助剂,搅拌至完全溶解;
C、加入生物表面活性剂,启动加热器加热到50~60℃,搅拌频率为45~65r/min,搅拌至完全溶解;
D、加入多羟基化合物和剩余的去离子水,开始降温;
E、待锅内物料温度降至低于35℃时,加入防腐剂,降低搅拌器的搅拌速度,搅拌频率为10~20r/min;
F、将事先溶解的蛋白酶抑制剂然后加入配料锅中,搅拌均匀;
G、加入生物活性酶,缓慢搅拌至完全溶解均匀;
H、得到pH为6.5~7.8、比重为0.95~1.15的淡黄色透明液体,检验合格后灌装包装、即为多酶低泡沫医疗器械清洗剂产品原液。
实施例3
一种多酶低泡沫医疗器械清洗剂,由以下重量份的组分组成:
生物表面活性剂:
鼠李糖脂(Rha-C10-C10) 0.5%
槐糖脂(SLMP-I) 5.5%
磷脂 15%;
生物活性酶:
多羟基化合物:
聚乙二醇1000(PEG1000) 1%
斯文甘油 8.5%;
蛋白酶抑制剂:
丙二醇、硼砂、4-甲酰基苯硼酸 1.2%;
防腐剂:
桑普K15(SupGuard K15) 0.1%
复合酶稳定性助剂:
氯化钙 0.05%
葡萄糖 0.5%;
去离子水加至 100%。
其中,蛋白酶抑制剂中,丙二醇、硼砂、4-甲酰基苯硼酸的质量比为2:1:0.25。
桑普K15(SupGuard K15)为复配原料,其中主要活性成份甲基氯异噻唑啉酮、甲基异噻唑啉酮的质量比为3:1;苯氧乙醇( PE 9010)为复配原料,其中主要成份苯氧乙醇、乙基己基甘油的质量比为9:1。
一种多酶低泡沫医疗器械清洗剂的制备方法,包括以下步骤:
A、向配料锅中加入去离子水总质量的50%,缓慢地启动搅拌器,搅拌频率为15~30r/min;
B、加入复合酶稳定性助剂,搅拌至完全溶解;
C、加入生物表面活性剂,启动加热器加热到50~60℃,搅拌频率为45~65r/min,搅拌至完全溶解;
D、加入多羟基化合物和剩余的去离子水,开始降温;
E、待锅内物料温度降至低于35℃时,加入防腐剂,降低搅拌器的搅拌速度,搅拌频率为10~20r/min;
F、将事先溶解的蛋白酶抑制剂然后加入配料锅中,搅拌均匀;
G、加入生物活性酶,缓慢搅拌至完全溶解均匀;
H、得到pH为6.5~7.8、比重为0.95~1.15的淡黄色透明液体,检验合格后灌装包装、即为多酶低泡沫医疗器械清洗剂产品原液。
实施例4
一种多酶低泡沫医疗器械清洗剂,由以下重量份的组分组成:
生物表面活性剂:
鼠李糖脂(Rha-C10-C10) 8%
槐糖脂(SLMP-I) 2.5%
磷脂 1.2%;
生物活性酶:
多羟基化合物:
聚乙二醇1000(PEG1000) 1.5%
斯文甘油 6.5%;
蛋白酶抑制剂:
丙二醇、硼砂、4-甲酰基苯硼酸 3%;
防腐剂:
桑普K15(SupGuard K15) 0.1%
复合酶稳定性助剂:
氯化钙 0.01%
葡萄糖 0.15%;
去离子水加至 100%。
其中,蛋白酶抑制剂中,丙二醇、硼砂、4-甲酰基苯硼酸的质量比为2:1:0.25。
桑普K15(SupGuard K15)为复配原料,其中主要活性成份甲基氯异噻唑啉酮、甲基异噻唑啉酮的质量比为3:1;苯氧乙醇( PE 9010)为复配原料,其中主要成份苯氧乙醇、乙基己基甘油的质量比为9:1。
一种多酶低泡沫医疗器械清洗剂的制备方法,包括以下步骤:
A、向配料锅中加入去离子水总质量的50%,缓慢地启动搅拌器,搅拌频率为15~30r/min;
B、加入复合酶稳定性助剂,搅拌至完全溶解;
C、加入生物表面活性剂,启动加热器加热到50~60℃,搅拌频率为45~65r/min,搅拌至完全溶解;
D、加入多羟基化合物和剩余的去离子水,开始降温;
E、待锅内物料温度降至低于35℃时,加入防腐剂,降低搅拌器的搅拌速度,搅拌频率为10~20r/min;
F、将事先溶解的蛋白酶抑制剂然后加入配料锅中,搅拌均匀;
G、加入生物活性酶,缓慢搅拌至完全溶解均匀;
H、得到pH为6.5~7.8、比重为0.95~1.15的淡黄色透明液体,检验合格后灌装包装、即为多酶低泡沫医疗器械清洗剂产品原液。
一种多酶低泡沫医疗器械清洗剂的制备方法,包括以下步骤:
A、向配料锅中加入去离子水总质量的50%,缓慢地启动搅拌器,搅拌频率为15~30r/min;
B、加入复合酶稳定性助剂,搅拌至完全溶解;
C、加入生物表面活性剂,启动加热器加热到50~60℃,搅拌频率为45~65r/min,搅拌至完全溶解;
D、加入多羟基化合物和剩余的去离子水,开始降温;
E、待锅内物料温度降至低于35℃时,加入防腐剂,降低搅拌器的搅拌速度,搅拌频率为10~20r/min;
F、将事先溶解的蛋白酶抑制剂然后加入配料锅中,搅拌均匀;
G、加入生物活性酶,缓慢搅拌至完全溶解均匀;
H、得到pH为6.5~7.8、比重为0.95~1.15的淡黄色透明液体,检验合格后灌装包装、即为多酶低泡沫医疗器械清洗剂产品原液。
将上述4种实施例的多酶清洗剂分别进行性能测试,其中包括安全性测试和清洗效果测试。
安全性测试的测试方法采用体外眼刺激试验-改进CAMVA方法,CAMVA刺激反应包括鬼影、充血、出血等,其现象与刺激评分如表1所示。
表1CAMVA刺激反应现象及其评分
评分 | 血管效应 | 观察描述 |
0 | 正常 | 观察不到反应,CAM正常 |
1 | 鬼影 | 血管白色无血管,管壁清晰 |
2 | 充血 | 充血,或CAM小血管血流加速 |
3 | 轻微出血 | 环内出血点覆盖面积<10% |
4 | 轻度出血 | 环内出血点覆盖面积10-35% |
5 | 中度出血 | 环内大量出血或小区域出血范围覆盖35-75% |
6 | 严重出血 | 环内出血点区域>75%,深色结痂可能形成 |
安全性测试结果评价,根据表1的评分,每个样品做10只有效鸡胚,记录样品的刺激性评价,求出平均值,得样品的刺激平均分(AS值)。
AS值与样品的眼刺激性对应关系见表2。
表2眼刺激性评价
刺激评分 | 刺激等级 |
0≤AS<0.5 | 无刺激性 |
0.5≤AS<1.5 | 微刺激性 |
1.5≤AS<3.5 | 轻刺激性 |
3.5≤AS<5 | 中度刺激性 |
5.0≤AS<6.0 | 强刺激性/腐蚀性 |
实施例1-实施例4的多酶清洗剂的CAMVA试验观察结果如表3所示。
表3CAMVA试验观察结果
实施例1-实施例4的多酶清洗剂的CAMVA试验观察评分如表4所示。
表4CAMVA试验观察评分
从表4可知,体外眼刺激试验结果说明,实施例1-实施例4的多酶清洗剂是安全的。
为了更好的说明本发明的优点,下面给出本发明实施例1~实施例4清洗效果测试。
实验材料:
实施例1-实施例4的多酶清洗剂原液、放大镜、白纱布、再生医疗器械(包括:剪刀、镊子、止血钳、持针器、刀柄、各种拉钩等)。
实验方法:
随机抽取600件同质污染的再生器械分成试验组与对照组,每组120件,试验组用实施例1-实施例4的多酶清洗剂原液按1:100比例,在水温40℃配制稀释液。手工清洗,将再生医疗器械先用常水冲洗后完全浸泡在配好的多酶清洗剂稀释液中,再生医疗器械的轴节等需要完全打开,浸泡5~10min取出,用流动的温水冲洗干净,洗后的器械浸泡在除锈剂内除锈10min,后用常水冲洗除锈剂,最后浸泡于润滑油30~60s,取出干燥,不宜用水冲洗润滑油。
结果判定:
目测方法,放大镜与白纱布相结合,用放大镜目测受洗医疗器械、以及用白纱布擦拭轴节,表面光滑、无斑点、无污渍模、纹处无血迹、无锈迹、无污渍为合格,反之视为不合格。
表5多酶清洗剂医疗器械手工清洗效果对照
组别 | n | 合格数 | 合格率% |
实验组实施例1 | 120 | 119 | 99.17 |
实验组实施例2 | 120 | 117 | 97.50 |
实验组实施例3 | 120 | 118 | 98.33 |
实验组实施例4 | 120 | 120 | 100.00 |
对照组 | 120 | 102 | 85.00 |
由表5可知,实验组均优于对照组,实验组器械光滑度和洁净明显好于对照组,器械表面原有斑点、污渍大部分消失,轴节、模纹处污渍也消失,器械也变光亮,而对照组清洗效果和合格率明显差于实验组。
本发明所述的一种多酶低泡沫医疗器械清洗剂,可作为专业清洗剂应用于医疗器械清洗中,其含有强效蛋白酶、脂肪酶、淀粉酶、纤维素酶、果胶酶、糖苷酶、核酸酶、溶菌酶等多种生物酶,环保配方,中性无毒无味,透明低泡沫,能快速分解附着在器械上的脂肪、粘液、淀粉、蛋白质等多种污物,能彻底清洗积累的污物,并能防止器械老化生锈。所述多酶清洗剂还易于清洗过水,降低了人力物力消耗,还减少器械腐蚀、延长器械使用期限,值得推广和应用。
最后应说明的是:以上各实施例仅仅为本发明的较优实施例用以说明本发明的技术方案,而非对其限制,当然更不是限制本发明的专利范围;尽管参照前述各实施例对本发明进行了详细的说明,本领域的普通技术人员应当理解:其依然可以对前述各实施例所记载的技术方案进行修改,或者对其中部分或者全部技术特征进行等同替换;而这些修改或者替换,并不使相应技术方案的本质脱离本发明各实施例技术方案的范围;也就是说,但凡在本发明的主体设计思想和精神上作出的毫无实质意义的改动或润色,其所解决的技术问题仍然与本发明一致的,均应当包含在本发明的保护范围之内;另外,将本发明的技术方案直接或间接的运用在其他相关的技术领域,均同理包括在本发明的专利保护范围内。
Claims (10)
2.根据权利要求1所述的一种多酶低泡沫医疗器械清洗剂,其特征在于,生物表面活性剂由鼠李糖脂、槐糖脂、磷脂组成;
鼠李糖脂是由铜绿假单胞菌培菌的单鼠李糖脂Rha-C10-C10,槐糖脂是由酵母菌代谢产生的糖脂类内酯型槐糖脂。
3.根据权利要求1所述的一种多酶低泡沫医疗器械清洗剂,其特征在于,生物活性酶由强效蛋白酶、脂肪酶、淀粉酶、纤维素酶、果胶酶、糖苷酶、核酸酶、溶菌酶复合组成。
4.根据权利要求3所述的一种多酶低泡沫医疗器械清洗剂,其特征在于,强效蛋白酶、脂肪酶、淀粉酶、纤维素酶、果胶酶、糖苷酶、核酸酶、溶菌酶质量之比为2~6:1~3:1~3:1~3:0.5~1.5:0.5~1.5:0.5~1.5:0.2~0.8。
5.根据权利要求1所述的一种多酶低泡沫医疗器械清洗剂,其特征在于,多羟基化合物为甘油、1,3-丙二醇、丙二醇、三丙二醇、山梨糖醇、甘露糖醇、聚乙二醇(PEG)任意一种或多种。
6.根据权利要求5所述的一种多酶低泡沫医疗器械清洗剂,其特征在于,聚乙二醇(PEG)分子量为1000。
7.根据权利要求1所述的一种多酶低泡沫医疗器械清洗剂,其特征在于,蛋白酶抑制剂由丙二醇、硼砂、4-甲酰基苯硼酸复配组成。
8.根据权利要求7所述的一种多酶低泡沫医疗器械清洗剂,其特征在于,丙二醇、硼砂、4-甲酰基苯硼酸质量之比为2:1:0.25或1:1:0.25。
9.根据权利要求1所述的一种多酶低泡沫医疗器械清洗剂,其特征在于,复合酶稳定性助剂由金属化合物和糖类组成;
金属化合物为硫酸亚铁、氯化钙、硫酸镁、硫酸锌、氯化钾的任意一种或多种,糖类为葡萄糖、海藻糖、蔗糖的任意一种或多种。
10.根据权利要求1-9任意一项所述的一种多酶低泡沫医疗器械清洗剂的制备方法,其特征在于,包括以下步骤:
A、向配料锅中加入去离子水总质量的50%,缓慢地启动搅拌器,搅拌频率为15~30r/min;
B、加入复合酶稳定性助剂,搅拌至完全溶解;
C、加入生物表面活性剂,启动加热器加热到50~60℃,搅拌频率为45~65r/min,搅拌至完全溶解;
D、加入多羟基化合物和剩余的去离子水,开始降温;
E、待锅内物料温度降至低于35℃时,加入防腐剂,降低搅拌器的搅拌速度,搅拌频率为10~20r/min;
F、将事先溶解的蛋白酶抑制剂然后加入配料锅中,搅拌均匀;
G、加入生物活性酶,缓慢搅拌至完全溶解均匀;
H、得到pH为6.5~7.8、比重为0.95~1.15的淡黄色透明液体,检验合格后灌装包装、即为多酶低泡沫医疗器械清洗剂产品原液。
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