CN114891576A - 一种角膜接触镜护理溶液、制备方法及其应用 - Google Patents
一种角膜接触镜护理溶液、制备方法及其应用 Download PDFInfo
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- CN114891576A CN114891576A CN202210613279.5A CN202210613279A CN114891576A CN 114891576 A CN114891576 A CN 114891576A CN 202210613279 A CN202210613279 A CN 202210613279A CN 114891576 A CN114891576 A CN 114891576A
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- care solution
- contact lens
- corneal contact
- lens care
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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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- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
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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
本发明公开了一种角膜接触镜护理溶液、制备方法及其应用，护理溶液包括液体组分(护理溶液)和具有延迟释放包衣的固体组分(中和剂)，所述液体组分的pH为3.0‑7.0，以质量分数计包括2.0‑5.0wt％过氧化氢、0.01wt％‑1.0wt％非离子表面活性剂或阴离子表面活性剂、甜菜碱类表面活性剂和0.01wt％‑2.0wt％渗透压调节剂，97.98％‑92.0wt％H2O；所述固体组分包括：以质量分数计，20.0wt％‑60.0wt％过氧化氢还原剂、10.0wt％‑75.0wt％赋形剂和5.0wt％‑30.0wt％延迟释放包衣。其应用方式为在装有角膜接触镜的容器内倒入液体组分(10mL)，随后加入固体组分(1.4‑10.8g)，进行中和反应，同时进行消毒程序。本发明的角膜接触镜护理组合物处理时间更短，消毒效果更高，安全性更好。
Description
技术领域
本发明涉及角膜接触镜护理溶液技术领域，尤其涉及一种角膜接触镜护理溶液、制备方法及其应用。
背景技术
随着电子产品的普及，近视是最常见的一种屈光不正眼科疾病类型。相比于框架眼镜，角膜接触镜更加方便、舒适、美观和影像真实。角膜接触镜可分为角膜塑形镜、硬性透气性角膜接触镜和软性角膜接触镜。但镜片与角膜、结膜、泪膜等直接接触，如果消毒不当，容易引发急慢性结膜炎、角膜上皮剥脱、巨乳头性结膜炎、角膜无菌性浸润等，最严重的是会引起感染性角膜炎。
常用的角膜接触镜护理液主要有化学类消毒和H2O2消毒两大类。化学消毒中，常用的杀菌剂有肉豆蔻酰胺基丙基二甲胺、季铵盐类和胍类等，虽然其应用简便、杀菌效果好，但是对真菌和棘阿米巴作用较弱，同时，残留的化学物质使有些患者可能产生过敏反应。而过氧化氢是一类广谱有效的消毒试剂，广泛应用于工业漂白、外科消毒和家居消毒等领域，能生成活性自由氧，有效杀灭微生物。但是由于残余的H2O2对眼具有高度刺激性，因此，需要在佩戴前进行中和。
市面上多使用贵金属催化剂分解H2O2，但贵属于稀有资源且成本高，虽分解双氧水效率高，但也使得双氧水的有效作用时间缩短的问题，对彻底消毒不利。而固体中和剂可以延缓中和剂的释放，消毒效果更好。因此开发非贵金属的中和剂将对于降低双氧水角膜接触镜护理液的成本和提高消毒效率均有着重要意义。
发明内容
针对上述存在的问题，本发明旨在提供一种角膜接触镜护理溶液、制备方法及其应用，以克服现有技术存在的缺点，本发明的角膜接触镜护理溶液处理时间更短，安全性更好。
为了实现上述目的，本发明所采用的技术方案如下：一种角膜接触镜护理溶液，其特征在于：所述护理溶液包括：
液体组分：以质量分数计的2.0-5.0wt％消毒剂、0.01wt％-1.0wt％非离子表面活性剂或阴离子表面活性剂、甜菜碱类表面活性剂、0.01wt％-2.0wt％渗透压调节剂和97.98％-92.0wt％H2O；
固体组分：以质量分数计的20.0wt％-60.0wt％过氧化氢还原剂、10.0wt％-75.0wt％赋形剂和5.0wt％-30.0wt％延迟释放包衣；
所述液体组分的pH为3.0-7.0。
优选的，所述非离子表面活性剂为聚氧乙烯/聚氧丙烯缩聚物，
和
系列、Poloxamer、Poloxamine、高分子山梨酸醋80、硬脂酸聚氧醋40和聚氧乙烯硬化蓖麻油60等中的一种或两种；
所述阴离子表面活性剂为低聚-羧甲基-D-吡喃葡萄糖-C10-16-烷基苷钠盐、Proteol TMAPL。
优选的，所述渗透压调节剂为磷酸盐、硼酸盐、柠檬酸盐、碳酸盐、酒石酸盐、氨肌醇、氯化钠中的一种或两种。
优选的，所述过氧化氢还原剂为硫代硫酸钠、亚硫酸钠、抗坏血酸、L-半胱氨酸、亚硫酸钙和谷胱甘肽中的一种。
优选的，所述赋形剂为聚乙烯吡咯烷酮、淀粉、阿拉伯胶、聚乙烯醇、环糊精、聚乙二醇、改性纤维素、硬脂酸镁、微晶纤维素、羟丙基纤维素、低取代羟丙纤维素、羟丙基甲基纤维素、羧甲淀粉钠、羧甲纤维素钠中的一种或两种。
优选的，所述延迟释放包衣由从羟乙基纤维素、羟丙基纤维素、羟丙基甲基纤维素、聚乙二醇和明胶中的一种或两种。
一种角膜接触镜护理溶液的制备方法，其特征在于，包括所述液体组分的制备和固体组分的制备：
所述液体组分制备过程包括以下步骤：
步骤1.1、在无菌容器中加入H2O、消毒剂，搅拌直至完全溶解；
步骤1.2、在上述溶液中加入渗透压调节剂，搅拌至完全溶解；
步骤1.3、加入非离子表面活性剂，搅拌溶解后，静止至气泡消失，得到护理溶液；
所述固体组分制备过程包括以下步骤：
步骤2.1、将过氧化氢还原剂和赋形剂混合研磨至细粉末状；
步骤2.2、将研磨样品通过压片机压制成合适大小的颗粒；
步骤2.3、将颗粒用延迟释放包衣进行包裹，得到固体颗粒。
一种角膜接触镜护理溶液的应用，其特征在于：在装有角膜接触镜的容器内倒入所述护理溶液，随后加入所述固体颗粒，待所述固体颗粒完全溶解反应后完成消毒。
优选的，所述护理溶液与固体颗粒的配比为：每10mL液体组分添加固体组分范围为1.4-10.8g。
一种角膜接触镜护理溶液在义齿清洁中的应用。
本发明的有益效果是：第一，本发明公开的护理溶液与使用铂环进行中和相比，H2O2的有效作用时间可控，杀菌效果更好；第二，固体颗粒的中和剂对眼睛无刺激，生物安全性好；第三，非离子表面活性剂的加入，可以有效的去除蛋白。
附图说明
图1为本发明护理溶液对大肠杆菌的消毒效果对照图示。
图2为本发明护理溶液对白色念珠菌的消毒效果对照图示。
具体实施方式
为了使本领域的普通技术人员能更好的理解本发明的技术方案，下面结合附图和实施例对本发明的技术方案做进一步的描述。
一种角膜接触镜护理溶液，所述护理溶液包括：
液体组分：以质量分数计的2.0-5.0wt％消毒剂、0.01wt％-1.0wt％非离子表面活性剂或阴离子表面活性剂、甜菜碱类表面活性剂、0.01wt％-2.0wt％渗透压调节剂和97.98％-92.0wt％H2O；所述液体组分的pH为3.0-7.0。
所述消毒剂优选为H2O2；所述非离子表面活性剂为聚氧乙烯/聚氧丙烯缩聚物，
和
系列、Poloxamer、Poloxamine、高分子山梨酸醋80、硬脂酸聚氧醋40和聚氧乙烯硬化蓖麻油60等中的一种或两种。
所述阴离子表面活性剂为低聚-羧甲基-D-吡喃葡萄糖-C10-16-烷基苷钠盐、Proteol TMAPL。
所述渗透压调节剂为磷酸盐、硼酸盐、柠檬酸盐、碳酸盐、酒石酸盐、氨肌醇、氯化钠中的一种或两种。
所述液体组分制备过程包括以下步骤：
步骤1.1、在无菌容器中加入H2O、消毒剂，搅拌直至完全溶解；
步骤1.2、在上述溶液中加入渗透压调节剂，搅拌至完全溶解；
步骤1.3、加入非离子表面活性剂，搅拌溶解后，静止至气泡消失，得到护理溶液。
固体组分：以质量分数计的20.0wt％-60.0wt％过氧化氢还原剂、10.0wt％-75.0wt％赋形剂和5.0wt％-30.0wt％延迟释放包衣；
所述过氧化氢还原剂为硫代硫酸钠、亚硫酸钠、抗坏血酸、L-半胱氨酸、亚硫酸钙和谷胱甘肽中的一种。
优选的，所述赋形剂为聚乙烯吡咯烷酮、淀粉、阿拉伯胶、聚乙烯醇、环糊精、聚乙二醇、改性纤维素、硬脂酸镁、微晶纤维素、羟丙基纤维素、低取代羟丙纤维素、羟丙基甲基纤维素、羧甲淀粉钠、羧甲纤维素钠中的一种或两种。
优选的，所述延迟释放包衣由从羟乙基纤维素、羟丙基纤维素、羟丙基甲基纤维素、聚乙二醇和明胶中的一种或两种。
所述固体组分制备过程包括以下步骤：
步骤2.1、将过氧化氢还原剂和赋形剂混合研磨至细粉末状；
步骤2.2、将研磨样品通过压片机压制成合适大小的颗粒；
步骤2.3、将颗粒用延迟释放包衣进行包裹，得到固体颗粒。
实施例角膜接触镜护理溶液的制备
液体组分各实施例的配比如下表1
表1
固体组分各实施例的配比如下表2
表2
角膜接触镜护理溶液的应用
将表1各个实施例制备的护理溶液以10mL的容量分别倒入装有角膜接触镜的容器内，随后分别加入约5g的固体颗粒，护理溶液和固体颗粒反应完成消毒程序。消毒效果如下表3所示：
表3
按照国家标准GB19192-2003《隐形眼镜护理液卫生要求》附录A消毒效果实验方法进行细菌消除率测试。选取大肠杆菌(ATCC8739)(图1)、白色念珠菌(ATCC10231)(图2)为代表菌种，步骤按照附录A进行，从细菌消除率(图1、图2)可以看出：
图1：(a)阳性对照、(b)PBS的阴性对照、(c)中和剂的阴性对照、(d)消毒时间2.5min的杀菌效果、(e)消毒时间5min的杀菌效果、(f)消毒时间7.5min的杀菌效果、(g)消毒时间10min的杀菌效果；
图2：(a)阳性对照、(b)PBS的阴性对照、(c)中和剂的阴性对照、(d)消毒时间2.5min的杀菌效果、(e)消毒时间5min的杀菌效果、(f)消毒时间7.5min的杀菌效果、(g)消毒时间10min的杀菌效果。
根据上述消毒效果的对比得出，本发明角膜接触镜护理溶液符合国家标准，且具有较优的消毒效果。
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 (10)
1.一种角膜接触镜护理溶液，其特征在于：所述护理溶液包括：
液体组分：以质量分数计的2.0-5.0wt％消毒剂、0.01wt％-1.0wt％非离子表面活性剂或阴离子表面活性剂、甜菜碱类表面活性剂、0.01wt％-2.0wt％渗透压调节剂和97.98％-92.0wt％H2O；
固体组分：以质量分数计的20.0wt％-60.0wt％过氧化氢还原剂、10.0wt％-75.0wt％赋形剂和5.0wt％-30.0wt％延迟释放包衣；
所述液体组分的pH为3.0-7.0。
2.根据权利要求1所述的一种角膜接触镜护理溶液，其特征在于：所述非离子表面活性剂为聚氧乙烯/聚氧丙烯缩聚物，
和
系列、Poloxamer、Poloxamine、高分子山梨酸醋80、硬脂酸聚氧醋40和聚氧乙烯硬化蓖麻油60等中的一种或两种；
所述阴离子表面活性剂为低聚-羧甲基-D-吡喃葡萄糖-C10-16-烷基苷钠盐、ProteolTMAPL。
3.根据权利要求2所述的一种角膜接触镜护理溶液，其特征在于：所述渗透压调节剂为磷酸盐、硼酸盐、柠檬酸盐、碳酸盐、酒石酸盐、氨肌醇、氯化钠中的一种或两种。
4.根据权利要求3所述的一种角膜接触镜护理溶液，其特征在于：所述过氧化氢还原剂为硫代硫酸钠、亚硫酸钠、抗坏血酸、L-半胱氨酸、亚硫酸钙和谷胱甘肽中的一种。
5.根据权利要求4所述的一种角膜接触镜护理溶液，其特征在于：所述赋形剂为聚乙烯吡咯烷酮、淀粉、阿拉伯胶、聚乙烯醇、环糊精、聚乙二醇、改性纤维素、硬脂酸镁、微晶纤维素、羟丙基纤维素、低取代羟丙纤维素、羟丙基甲基纤维素、羧甲淀粉钠、羧甲纤维素钠中的一种或两种。
6.根据权利要求5所述的一种角膜接触镜护理溶液，其特征在于：所述延迟释放包衣由从羟乙基纤维素、羟丙基纤维素、羟丙基甲基纤维素、聚乙二醇和明胶中的一种或两种。
7.根据权利要求6所述的一种角膜接触镜护理溶液的制备方法，其特征在于，包括所述液体组分的制备和固体组分的制备：
所述液体组分制备过程包括以下步骤：
步骤1.1、在无菌容器中加入H2O、消毒剂，搅拌直至完全溶解；
步骤1.2、在上述溶液中加入渗透压调节剂，搅拌至完全溶解；
步骤1.3、加入非离子表面活性剂，搅拌溶解后，静止至气泡消失，得到护理溶液；
所述固体组分制备过程包括以下步骤：
步骤2.1、将过氧化氢还原剂和赋形剂混合研磨至细粉末状；
步骤2.2、将研磨样品通过压片机压制成合适大小的颗粒；
步骤2.3、将颗粒用延迟释放包衣进行包裹，得到固体颗粒。
8.根据权利要求7制备的一种角膜接触镜护理溶液的应用，其特征在于：在装有角膜接触镜的容器内倒入所述护理溶液，随后加入所述固体颗粒，待所述固体颗粒完全溶解反应后完成消毒。
9.根据权利要求8所述的一种角膜接触镜护理溶液的应用，其特征在于，所述护理溶液与固体颗粒的配比为：每10mL液体组分添加固体组分范围为1.4-10.8g。
10.根据权利要求1所述的一种角膜接触镜护理溶液在义齿清洁中的应用。
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| CN113615708A (zh) * | 2021-07-19 | 2021-11-09 | 西安交通大学 | 一种角膜接触镜护理组合物及制备方法和应用 |
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| CN1225021A (zh) * | 1997-04-03 | 1999-08-04 | 奥福泰克斯株式会社 | 隐形眼镜消毒、中和、洗涤用的一液型制剂和消毒、中和、洗涤的方法 |
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| CN115595214A (zh) * | 2022-10-10 | 2023-01-13 | 陕西尼得克医疗科技股份有限公司（Cn） | 一种角膜接触镜护理组合物、制备方法及其应用 |
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