CN108949327A - 一种医用器械润滑油及其制备方法 - Google Patents
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Abstract
本发明公开了一种医用器械润滑油,所述医用器械润滑油按重量份计算由如下组分组成:小麦胚芽油10‑15%、羟甲基纤维素1‑5%、聚乙烯吡咯烷酮2‑6%、丁卡因0.1‑2%、对羟基苯甲酸甲酯1‑5%、吐温‑80 0.5‑3%,余量为去离子水。本发明还公开了上述医用器械润滑油的制备方法。本发明采用植物油、表面活性剂、麻醉药物制备了植物油基医用器械润滑油,可在器械表面形成保护膜,且低泡、绿色、环保,抗菌效果好,并具有一定的麻醉止痛效果,能够减轻医疗器械的使用过程中对患者造成的不良影响。
Description
技术领域
本发明涉及一种医用配制品,尤其涉及一种医用器械润滑有及其制备方法。
背景技术
很多医疗器械在深入人体内时都会不同程度地对人体造成机械性损伤,使用医用器械润滑油可能最大程度减少对身体组织、黏膜的损伤。
目前,市场上的医用润滑剂主要有水溶性润滑剂、硅树脂润滑剂、润滑油三类,其中,润滑油是较为理想的医用润滑剂,其来源广泛、成本低廉、安全无刺激。因此,在医疗临床治疗过程中,润滑油是最理想、最安全的医用润滑剂。使用润滑油能够有效防治医用器械生锈、延长医用器械的使用寿命。
但目前常用的医用器械润滑油大多为矿物油基润滑油,但矿物油存在使皮肤、黏膜不透气以及不够环保的缺点,因此,开发一种水溶性的植物油基医用器械润滑油是亟待解决的一个问题。
发明内容
为了解决上述问题,本发明提供一种低泡、环保、具有抗菌效果和止痛麻醉效果的水溶性植物油基医用器械润滑油。
本发明采用的技术方案是:一种医用器械润滑油,按重量份计算由如下组分组成:小麦胚芽油10-15%、羟甲基纤维素1-5%、聚乙烯吡咯烷酮2-6%、丁卡因0.1-2%、对羟基苯甲酸甲酯1-5%、吐温-80 0.5-3%,余量为去离子水。
进一步地,所述聚乙烯吡咯烷酮为聚乙烯吡咯烷酮-K30。
进一步地,按重量份计算由如下组分组成:小麦胚芽油11.5%、羟甲基纤维素2.4%、聚乙烯吡咯烷酮-K30 3.6%、丁卡因0.5%、对羟基苯甲酸甲酯4.5%、吐温-801.2%,余量为去离子水。
或,按重量份计算由如下组分组成:小麦胚芽油14.2%、羟甲基纤维素4.2%、聚乙烯吡咯烷酮-K30 4.2%、丁卡因1.3%、对羟基苯甲酸甲酯3.2%、吐温-80 2.2%,余量为去离子水。
本发明还提供了上述医用器械润滑油的制备方法,其具体步骤如下:(1)将按配方的重量份数计算得到的所述羟甲基纤维素、聚乙烯吡咯烷酮、丁卡因、对羟基苯甲酸甲酯、吐温-80、余量的水加入混合器中在25-35℃下振荡分散,转速为800-1200rpm,分散时间为0.5-1h(2)将按配方的重量份数计算得到的小麦胚芽油缓慢加入到混合器中的上述混合物中,在40-50℃下振荡分散,转速为1500-1800rmp,分散时间为20-40min,即得到医用器械润滑油。
本发明的有益效果:
本发明采用植物油、表面活性剂、麻醉药物制备了植物油基医用器械润滑油,可在器械表面形成保护膜,且低泡、绿色、环保,抗菌效果好,并具有一定的麻醉止痛效果,能够减轻医疗器械的使用过程中对患者造成的不良影响。
具体实施方式
实施例1:
按重量份计算由如下组分组成:小麦胚芽油10%、羟甲基纤维素1%、聚乙烯吡咯烷酮-K30 2%、丁卡因0.1%、对羟基苯甲酸甲酯1%、吐温-80 0.5%,余量为去离子水。
其制备过程步骤:(1)将按配方的重量份数计算得到的所述羟甲基纤维素、聚乙烯吡咯烷酮-K30、丁卡因、对羟基苯甲酸甲酯、吐温-80、余量的水加入混合器中在25-35℃下振荡分散,转速为800rpm,分散时间为0.5h(2)将按配方的重量份数计算得到的小麦胚芽油缓慢加入到混合器中的上述混合物中,在40℃下振荡分散,转速为1500rmp,分散时间为20min,即得到医用器械润滑油。
实施例2:
按重量份计算由如下组分组成:小麦胚芽油15%、羟甲基纤维素5%、聚乙烯吡咯烷酮-K30 6%、丁卡因2%、对羟基苯甲酸甲酯5%、吐温-80 3%,余量为去离子水。
其制备过程步骤:(1)将按配方的重量份数计算得到的所述羟甲基纤维素、聚乙烯吡咯烷酮-K30、丁卡因、对羟基苯甲酸甲酯、吐温-80、余量的水加入混合器中在35℃下振荡分散,转速为1200rpm,分散时间为1h(2)将按配方的重量份数计算得到的小麦胚芽油缓慢加入到混合器中的上述混合物中,在50℃下振荡分散,转速为1800rmp,分散时间为40min,即得到医用器械润滑油。
实施例3:
按重量份计算由如下组分组成:小麦胚芽油11.5%、羟甲基纤维素2.4%、聚乙烯吡咯烷酮-K30 3.6%、丁卡因0.5%、对羟基苯甲酸甲酯4.5%、吐温-80 1.2%,余量为去离子水。
其制备过程步骤:(1)将按配方的重量份数计算得到的所述羟甲基纤维素、聚乙烯吡咯烷酮-K30、丁卡因、对羟基苯甲酸甲酯、吐温-80、余量的水加入混合器中在25℃下振荡分散,转速为1000rpm,分散时间为0.5h(2)将按配方的重量份数计算得到的小麦胚芽油缓慢加入到混合器中的上述混合物中,在40℃下振荡分散,转速为1500rmp,分散时间为20min,即得到医用器械润滑油。
实施例4:
按重量份计算由如下组分组成:小麦胚芽油14.2%、羟甲基纤维素4.2%、聚乙烯吡咯烷酮-K30 4.2%、丁卡因1.3%、对羟基苯甲酸甲酯3.2%、吐温-80 2.2%,余量为去离子水。
其制备过程步骤:(1)将按配方的重量份数计算得到的所述羟甲基纤维素、聚乙烯吡咯烷酮-K30、丁卡因、对羟基苯甲酸甲酯、吐温-80、余量的水加入混合器中在25℃下振荡分散,转速为1000rpm,分散时间为0.5h(2)将按配方的重量份数计算得到的小麦胚芽油缓慢加入到混合器中的上述混合物中,在40℃下振荡分散,转速为1500rmp,分散时间为20min,即得到医用器械润滑油。
实施例5:
实施例1-4配方得到的医用器械润滑油浸泡后得到的医用手术剪与未进行涂覆处理的医用手术剪相比较其各方面性能见下表:
表1 试验结果
实施例6:
取重0.5-5g的蚯蚓,平均分成5组,分别为实施例1-4组及对照组,每组20条,保存于含水量为25-30%的含腐殖质土壤内,实验前将之移入通气的Ringer液内2h,实验时5组蚯蚓分别进入各组的药液中。每组于1、3、5、8、12和16min各取3条浸入300mL 0.0125mol/LHCl溶液中1min,观察急剧退缩反应,计算其副反应数,按下式计算麻醉指数:
麻醉指数=负反应数/实验蚯蚓数×100%
各组蚯蚓的麻醉指数如下表所示:
表2 麻醉指数测定结果
麻醉指数/% | |
实施例1 | 86 |
实施例2 | 87 |
实施例3 | 92 |
实施例4 | 94 |
对照组 | 0 |
由上表可知,本发明的医用器械润滑油配方中的乳化剂、油基、麻醉剂选择恰当,提高了麻醉剂的溶解效果,因此得到了较好的麻醉效果。
上述实施例只是为了说明本发明的技术构思及特点,其目的是在于让本领域内的普通技术人员能够了解本发明的内容并据以实施,并不能以此限制本发明的保护范围。凡是根据本发明内容的实质所作出的等效的变化或修饰,都应涵盖在本发明的保护范围。
Claims (5)
1.一种医用器械润滑油,其特征在于,按重量份计算由如下组分组成:小麦胚芽油10-15%、羟甲基纤维素1-5%、聚乙烯吡咯烷酮2-6%、丁卡因0.1-2%、对羟基苯甲酸甲酯1-5%、吐温-80 0.5-3%,余量为去离子水。。
2.如权利要求1所述的一种医用器械润滑油,其特征在于,所述聚乙烯吡咯烷酮为聚乙烯吡咯烷酮-K30。
3.如权利要求1或2任一项所述的一种医用器械润滑油,其特征在于,按重量份计算由如下组分组成:小麦胚芽油11.5%、羟甲基纤维素2.4%、聚乙烯吡咯烷酮-K30 3.6%、丁卡因0.5%、对羟基苯甲酸甲酯4.5%、吐温-80 1.2%,余量为去离子水。
4.如权利要求1或2任一项所述的一种医用器械润滑油,其特征在于,按重量份计算由如下组分组成:小麦胚芽油14.2%、羟甲基纤维素4.2%、聚乙烯吡咯烷酮-K30 4.2%、丁卡因1.3%、对羟基苯甲酸甲酯3.2%、吐温-80 2.2%,余量为去离子水。
5.如权利要求1-4任一项所述的一种医用器械润滑油,其特征在于:(1)将按配方的重量份数计算得到的所述羟甲基纤维素、聚乙烯吡咯烷酮、丁卡因、对羟基苯甲酸甲酯、吐温-80、余量的水加入混合器中在25-35℃下振荡分散,转速为800-1200rpm,分散时间为0.5-1h(2)将按配方的重量份数计算得到的小麦胚芽油缓慢加入到混合器中的上述混合物中,在40-50℃下振荡分散,转速为1500-1800rmp,分散时间为20-40min,即得到医用器械润滑油。
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