CN111172502A - 局部镀膜制备精密药液滤膜的方法及精密药液滤膜 - Google Patents
局部镀膜制备精密药液滤膜的方法及精密药液滤膜 Download PDFInfo
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Abstract
本发明公开了一种局部镀膜制备精密药液滤膜的方法及精密药液滤膜,方法的步骤中包括:提供带有滤孔的药液过滤滤膜;其中,相邻滤孔之间形成间隔壁;在药液过滤滤膜的至少一侧上采用非保形沉积镀膜方法局部镀膜以使间隔壁的相应侧沉积出镀膜体,以得到经过缩孔的精密药液滤膜;其中,所述镀膜体在沉积过程中至少横向生成使靠近的滤孔的相应侧孔径缩小。通过局部镀膜对滤孔相应侧孔径进行调控,工艺简单,缩孔后的孔径可以达到20纳米,可以满足病毒等过滤要求,由于仅对滤孔的部分孔径进行缩小,有利于减小滤孔的流动阻力。
Description
技术领域
本发明涉及一种局部镀膜制备精密药液滤膜的方法及精密药液滤膜,属于医疗器械和医药生产中的颗粒、细菌和病毒过滤领域。
背景技术
药液的生产、运输和使用过程中,需要严格控制药液的安全性。在使用环节,通过输液器进入静脉的药液,需要严格控制药液中的颗粒污染、以及可能的细菌等污染。例如,对于婴幼儿群体,由于血管发育尚未成熟,血管的直径较小,因此输液治疗过程中,一旦发生颗粒污染堵塞的现象,极有可能严重危及生命安全。国家标准GB8368(2005)中对重力式一次性使用输液器明确规定了过滤颗粒直径要求,现有医疗行业中的一次性输液过滤器均配了可以过滤直径25微米以上颗粒的过滤器。因此在一次性输液器中,需要配置过滤膜,对颗粒污染和可能的细菌污染进行过滤。
目前越来越多的临床研究表明,有部分药物在输液中要求提高过滤器的精度,国际上已经有一些药物明确规定了微细颗粒的过滤要求,例如糖蛋白IIb/IIIa抑制剂药物阿昔单抗ReoPro、抗心律失常药物胺碘酮(可龙达)、抗肿瘤药物氯苯吩嗪(Clolar)、抗肿瘤药物紫杉醇(Taxol、Onxol)等要求过滤颗粒直径为0.2微米。
目前随着滤膜技术和医药技术的发展,过滤颗粒的直径逐渐朝着更小的方向发展。例如,对于单克隆抗体药物而言,需要进行过滤病毒。大部分的病毒直径在20纳米至数百纳米。药物生产中,有相应的法规要求必须进行对药物中的病毒数量进行严格管控。因此20纳米过滤的要求将会越来越广。
滤膜是过滤器的核心部分。滤膜从材质上,可以分为两大类,分别是有机材料,如纤维等;另外是无机材料,如氧化硅、氧化铝等。有机材料量产性能好,但是也面临着材料溶胀、过滤路径长,药物有效成分容易被吸附,以及材料强度偏低等。相比较而言,无机材料可以克服上述的缺点。因此无机材料是药物过滤纳米滤膜的发展趋势。
例如公开号为CN102527255A的中国专利公开了一种无机材料药液过滤膜及制备方法和该药液过滤膜的应用,通过氧化硅乳液的旋涂和烧结,得到纯的氧化硅陶瓷薄膜。该方法采用了无机材料,可以实现1.8微米至2.8微米直径范围及以上的微颗粒过滤。
再例如公开号为CN109092076A的中国专利公开了一种单晶硅材质精密输液滤膜及其制备方法,在单晶硅滤膜上制备有多个贯通的滤孔,滤孔的孔径为0.2微米~5微米,所述滤孔的深度为2微米~50微米。
与有机滤膜相比,无机材料滤膜的制备纳米孔径的难点在于如何图形化。无机材料上的图形化包括用掩膜版图形传递,或者材料自身的物理化学过程。前者可以采用光刻等技术,后者可以采用阳极氧化等技术。以上常见的滤孔加工技术对于大孔径而言相对容易,但对于小孔径而言,则有很大的挑战性。
发明内容
本发明所要解决的技术问题是克服现有技术的缺陷,提供一种局部镀膜制备精密药液滤膜的方法,通过局部镀膜对滤孔相应侧孔径进行调控,工艺简单,缩孔后的孔径可以达到20纳米,可以满足病毒等过滤要求,由于仅对滤孔的部分孔径进行缩小,有利于减小滤孔的流动阻力。
为了解决上述技术问题,本发明的技术方案是:一种局部镀膜制备精密药液滤膜的方法,方法的步骤中包括:
提供带有滤孔的药液过滤滤膜;其中,相邻滤孔之间形成间隔壁;
在药液过滤滤膜的至少一侧上采用非保形沉积镀膜方法局部镀膜以使间隔壁的相应侧沉积出镀膜体,以得到经过缩孔的精密药液滤膜;其中,所述镀膜体在沉积过程中至少横向生成使靠近的滤孔的相应侧孔径缩小。
进一步,所述非保形沉积镀膜方法为真空镀膜方式。
进一步,所述非保形沉积镀膜方法为热蒸发镀膜或电子束蒸发镀膜或溅射镀膜或等离子体化学气相沉积镀膜。
进一步,所述药液过滤滤膜的滤孔的孔径为深亚微米级或纳米级。
进一步,所述药液过滤滤膜由无机材料制成;和/或所述镀膜体由无机材料或金属制成。
进一步,所述无机材料为氧化硅或氧化铝或氧化钛或氧化铪。
进一步,当所述镀膜体由金属制成时,方法步骤中含有:
将经过缩孔的精密药液滤膜进行氧化处理,使镀膜体氧化成金属氧化物。
进一步,所述精密药液滤膜的滤孔的相应侧孔径缩小至2纳米~240纳米。
进一步,在局部镀膜前,将所述药液过滤滤膜清洗干净,并进行干燥。
进一步,在局部镀膜中,当滤孔的相应侧孔径缩小到所需尺寸时,停止局部镀膜。
本发明还提供了一种精密药液滤膜,它包括:
膜本体,所述膜本体具有滤孔,相邻滤孔之间形成有间隔壁,间隔壁在滤孔轴向上的至少一侧设有至少横向生成使靠近的滤孔的相应侧孔径缩小的镀膜体。
进一步,精密药液滤膜由以上方法制备得到。
采用了上述技术方案后,本发明方法通过局部镀膜对滤孔顶部孔径进行调控,工艺简单,缩孔后的孔径可以达到20纳米,可以满足病毒等过滤要求。由于仅对滤孔的顶部孔径进行缩小,有利于减小滤孔的流动阻力,此外,对于无机直孔滤膜而言,还具有过滤路径短,结构强度高,密封性能好,过滤压差小,滤膜溶胀小,药物吸附少等特点,可以更好的满足不同类型药物输液的超滤过滤要求。
附图说明
图1为本发明的精密药液滤膜的结构示意图。
具体实施方式
本发明提供了一种局部镀膜制备精密药液滤膜的方法及精密药液滤膜,本领域技术人员可以借鉴本文内容,适当改进工艺参数实现。特别需要指出的是,所有类似的替换和改动对本领域技术人员来说是显而易见的,它们都属于本发明保护的范围。本发明的方法及应用已经通过较佳实施例进行了描述,相关人员明显能在不脱离本发明内容、精神和范围内对本文的方法和应用进行改动或适当变更与组合,来实现和应用本发明技术。
一种局部镀膜制备精密药液滤膜的方法,方法的步骤中包括:
提供带有滤孔1的药液过滤滤膜;其中,相邻滤孔1之间形成间隔壁2;
在药液过滤滤膜的至少一侧上采用非保形沉积镀膜方法局部镀膜以使间隔壁2的相应侧沉积出镀膜体3,以得到经过缩孔的精密药液滤膜;其中,所述镀膜体3在沉积过程中至少横向生成使靠近的滤孔1的相应侧孔径缩小。
具体地,所述非保形沉积镀膜方法可以为真空镀膜方式。
具体地,所述非保形沉积镀膜方法包括但不限于热蒸发镀膜或电子束蒸发镀膜或溅射镀膜或等离子体化学气相沉积镀膜。
具体地,所述药液过滤滤膜的滤孔的孔径为深亚微米级(250纳米至50纳米)或纳米级(50纳米以下)。
具体地,所述药液过滤滤膜由无机材料制成;所述镀膜体3由无机材料或金属制成。
具体地,所述药液过滤滤膜包括但不限于成由氧化硅或氧化铝制成,所述镀膜体3包括但不限于由氧化硅或氧化铝或氧化钛或氧化铪制成。
具体地,当所述镀膜体3由金属制成时,方法步骤中含有:
将经过缩孔的精密药液滤膜进行氧化处理,使镀膜体氧化成金属氧化物。
具体地,所述精密药液滤膜的滤孔1的相应侧孔径缩小至2纳米~240纳米。
具体地,在局部镀膜前,将所述药液过滤滤膜清洗干净,并进行干燥。
具体地,在局部镀膜中,当滤孔的相应侧孔径缩小到所需尺寸时,停止局部镀膜。
如图1所示,制备得到的精密药液滤膜的具体结构如下:它包括:
膜本体4,所述膜本体4具有滤孔1,相邻滤孔1之间形成有间隔壁2,间隔壁2在滤孔轴向上的至少一侧设有至少横向生成使靠近的滤孔1的相应侧孔径缩小的镀膜体3。
在本发明中,镀膜体4不仅横向生长,还纵向生长(滤孔1的轴向)。
本发明在用其他方法制备大孔径滤膜的基础上,在滤孔1顶部或底部表面进行薄膜沉积,在镀膜过程中,沉积材料沿着间隔壁2顶部或底部的横向和纵向两个方向过程生长,横向生长过程中,原有的孔径会逐步缩小从而减小了孔径。由于滤孔1内部表面沉积速度不均匀,沉积主要发生在滤孔1的表面区域,因此这种局域镀膜方法可以很好的调控滤孔顶部直径。
与以上其他无机滤膜加工方法相比,滤孔1顶部或底部表面薄膜沉积对顶部孔径或底部孔径进行调控,工艺简单,缩孔后的孔径可以达到20纳米,可以满足病毒等过滤要求。由于仅对滤孔1的局部孔径进行缩小,有利于减小滤孔的流动阻力。此外,对于无机直孔滤膜而言,还具有过滤路径短,结构强度高,密封性能好,过滤压差小,滤膜溶胀小,药物吸附少等特点,可以更好的满足不同类型药物输液的超滤过滤要求。
为了使本发明的内容更容易被清楚地理解,下面根据具体实施例并结合附图,对本发明作进一步详细的说明。
实施例一
把原滤孔直径250纳米的多孔阳极氧化铝AAO滤膜,通过本发明方法,转换为100纳米滤孔的镀膜体4为氧化铝的精密药液滤膜,具体包括以下步骤:
(1)选用孔径为250纳米的多孔阳极氧化铝AAO滤膜作为样品,对样品进行清洗并干燥处理;
(2)样品放入电子束蒸发镀膜备中。电子枪的电压5kV,靶材选用金属铝;
(3)根据滤膜缩孔的要求,滤膜表面沉积1~4微米厚的金属镀层,直至滤孔顶部的孔径减少到100纳米为止;
(4)电子束蒸发镀膜结束后,把药液过滤器无机滤膜取出,放入快速热处理中,进行快速氧化,表面Al转换为氧化铝,修饰后的精密药液滤膜的滤孔直径降至100纳米。
实施例二
把原滤孔直径90纳米的多孔阳极氧化铝AAO滤膜,通过本发明方法,转换为50纳米滤孔、镀膜体4为氧化硅的精密药液滤膜,包括以下步骤:
(1)选用孔径为50纳米的多孔阳极氧化铝AAO滤膜作为样品,对样品进行清洗并干燥处理;
(2)样品放入等离子体增强化学强沉积PECVD设备中。
(3)根据滤膜缩孔的要求,滤膜表面沉积1~4微米厚的氧化硅,直至滤孔顶部的孔径减少到50纳米为止。
以上所述的具体实施例,对本发明解决的技术问题、技术方案和有益效果进行了进一步详细说明,所应理解的是,以上所述仅为本发明的具体实施例而已,并不用于限制本发明,凡在本发明的精神和原则之内,所做的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (12)
1.一种局部镀膜制备精密药液滤膜的方法,其特征在于,方法的步骤中包括:
提供带有滤孔(1)的药液过滤滤膜;其中,相邻滤孔(1)之间形成间隔壁(2);
在药液过滤滤膜的至少一侧上采用非保形沉积镀膜方法局部镀膜以使间隔壁(2)的相应侧沉积出镀膜体(3),以得到经过缩孔的精密药液滤膜;其中,所述镀膜体(3)在沉积过程中至少横向生成使靠近的滤孔(1)的相应侧孔径缩小。
2.根据权利要求1所述的方法,其特征在于,
所述非保形沉积镀膜方法为真空镀膜方式。
3.根据权利要求2所述的方法,其特征在于,
所述非保形沉积镀膜方法为热蒸发镀膜或电子束蒸发镀膜或溅射镀膜或等离子体化学气相沉积镀膜。
4.根据权利要求1所述的方法,其特征在于,
所述药液过滤滤膜的滤孔的孔径为深亚微米级或纳米级。
5.根据权利要求1所述的方法,其特征在于,
所述药液过滤滤膜由无机材料制成;和/或所述镀膜体(3)由无机材料或金属制成。
6.根据权利要求5所述的方法,其特征在于,
所述无机材料为氧化硅或氧化铝或氧化钛或氧化铪。
7.根据权利要求1所述的方法,其特征在于,
当所述镀膜体(3)由金属制成时,方法步骤中含有:
将经过缩孔的精密药液滤膜进行氧化处理,使镀膜体氧化成金属氧化物。
8.根据权利要求1所述的方法,其特征在于,
所述精密药液滤膜的滤孔(1)的相应侧孔径缩小至2纳米~240纳米。
9.根据权利要求1所述的方法,其特征在于,
在局部镀膜前,将所述药液过滤滤膜清洗干净,并进行干燥。
10.根据权利要求1所述的方法,其特征在于,
在局部镀膜中,当滤孔的相应侧孔径缩小到所需尺寸时,停止局部镀膜。
11.一种精密药液滤膜,其特征在于,它包括:
膜本体(4),所述膜本体(4)具有滤孔(1),相邻滤孔(1)之间形成有间隔壁(2),间隔壁(2)在滤孔轴向上的至少一侧设有至少横向生成使靠近的滤孔(1)的相应侧孔径缩小的镀膜体(3)。
12.如权利要求11所述的精密药液滤膜,其特征在于,它由如权利要求1至10中任一项所述的方法制备得到。
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