CN110506138B - 多孔纤维和吸附柱 - Google Patents
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Abstract
本发明的目的在于,提供兼顾抑制粉粒体的露出、剥离、以及提高吸附性能的多孔纤维;填充有该多孔纤维的吸附柱;将吸附柱和除水柱连结而得到的血液净化***。为了实现上述目的,本发明的多孔纤维具有下述构成。即,多孔纤维,其具有通过实心形状的纤维形成的三维微孔结构,且满足下述全部要件:(1)具有直径200μm以下的粉粒体、且所述直径200μm以下的粉粒体在所述三维微孔结构的横截面中的面积占有率为3.0%以上;(2)从最表面起在深度方向上1.0μm以内的区域中不含所述直径200μm以下的粉粒体。
Description
技术领域
本发明涉及多孔纤维。此外,涉及填充有多孔纤维的吸附柱。进一步,涉及将吸附柱和除水柱连结而得到的血液净化***。
背景技术
一直以来,为了吸附去除被处理液中的去除对象物质,作为吸附剂而使用粉粒体。粉粒体本身单独的情况下缺乏处理性,因此负载在纤维等上使用。在该情况下,为了提高粉粒体对去除对象物质的吸附性能,需要尽可能使被处理液与粉粒体的距离缩短。然而,如果被处理液与粉粒体直接接触,则产生因流通被处理液时所产生的流动应力而导致粉粒体损伤、粉粒体从负载有粉粒体的纤维等流出等的可能。进一步,使用血液作为被处理液的情况下,如果粉粒体与血细胞成分直接接触,则存在导致血液的不期望的活化的可能。因此,重要的是纤维内的粉粒体的位置,以及用于将被处理液中的去除对象物质以良好的效率引导至纤维内的粉粒体的流路设计。
例如,专利文献1中,公开了涉及在芯部和鞘部中包含粉粒体的衣料用纤维的发明。
同样地,专利文献2中规定了在鞘部中也包含粉粒体。此外,有芯部仅由粉粒体构成等记载。
另一方面,还公开了被处理液与粉粒体不直接接触的发明。专利文献3中,公开了关于水处理用途中含有粉粒体的分离膜的发明。
现有技术文献
专利文献
专利文献1:日本特开2014-189937号公报
专利文献2:日本特表2008-510083号公报
专利文献3:日本特开2010-227757号公报。
发明内容
发明所要解决的课题
然而,如专利文献1中记载的在芯部和鞘部包含粉粒体的衣料用纤维中,在应当抑制粉粒体在纤维表面上露出的方面,针对其方法没有公开。
如专利文献2中记载的在鞘部也包含粉粒体、芯部仅由粉粒体构成等结构中,纤维因外部压力而破损时,粉粒体有可能从丝截面剥离。此外,同样地,对关于抑制粉粒体在纤维表面上露出方面没有公开。
此外,如专利文献3中记载的含有吸附体的层为球状结构的情况下,存在的可能是难以控制被处理液的流路、流路直径的偏差变大。此外,特别是在球状结构与球状结构之间,还存在粉粒体的负载性也变低的可能。
如上所述,以往提出的含有粉粒体的纤维为了提高性能而着眼于提高粉粒体的添加率、和赋予纤维机械强度,关于抑制粉粒体在纤维表面上露出、从截面剥离的手段,没有发现记载。
因此,本发明提供兼顾抑制粉粒体的露出、剥离、以及提高吸附性能的多孔纤维。此外,提供填充有该多孔纤维的吸附柱。进一步,提供将吸附柱和除水柱连结而得到的血液净化***。
解决课题的手段
本发明人等为了解决上述课题而反复深入研究,结果发现,得到了抑制粉粒体的露出且吸附性能优异、安全性高的多孔纤维。
进一步本发明的多孔纤维能够吸附、去除与内包的粉粒体所具有的吸附性能不同的高分子化合物。
即,本发明的多孔纤维具有以下的构成。
多孔纤维,其具有通过实心形状的纤维形成的三维微孔结构,且满足下述全部要件:
(1)具有直径200μm以下的粉粒体、且前述直径200μm以下的粉粒体在前述三维微孔结构的横截面中的面积占有率为3.0%以上;
(2)从最表面起在深度方向上1.0μm以内的区域中不含前述直径200μm以下的粉粒体。
发明的效果
通过本发明,能够得到兼顾抑制粉粒体的露出、剥离、以及提高吸附性能的多孔纤维。此外,能够得到填充有该多孔纤维的吸附柱。进一步,能够得到将吸附柱和除水柱连结而得到的血液净化***。
具体实施方式
针对本发明的多孔纤维、吸附柱和血液净化***,以下具体说明。
本发明的多孔纤维具有通过实心形状的纤维形成的三维微孔结构,且满足下述全部要件:
(1)具有直径200μm以下的粉粒体、且前述直径200μm以下的粉粒体在前述三维微孔结构的横截面中的面积占有率为3.0%以上;
(2)从最表面起在深度方向上1.0μm以内的区域中不含前述直径200μm以下的粉粒体。
本发明中所称的实心形状的纤维是指采用不具有中空部的纤维形状、形态的实心丝。
此外,本发明中,多孔纤维具有三维微孔结构。三维微孔结构是指具有三维扩展、且被区隔的微孔的结构。
本发明中,多孔纤维在其外部和内部连续具有无数的微细的空孔。这样的微孔结构形成用于将被处理液中的去除对象物质以良好的效率引导至纤维内的粉粒体的流路。进一步,这样的微孔结构在去除对象物质为高分子化合物的情况下,可将高分子化合物留在微孔内,通过吸附而去除。
因此,本发明中,三维微孔结构的平均微孔半径优选处于特定的范围。即,本发明的多孔纤维中,前述三维微孔结构的平均微孔半径优选为0.5nm以上且100nm以下的范围。作为前述三维微孔结构的平均微孔半径的下限,优选为0.5nm、更优选为1.5nm、特别优选为2.0nm,另一方面,作为上限,优选为100nm、更优选为40nm、特别优选为25nm。如果平均微孔半径小,则去除对象物质无法进入孔中,因此吸附效率有时降低。另一方面,即使微孔半径过大,去除对象物质未在空隙部分中固定而可能脱落,因此相反吸附效率有时降低。上述的孔径范围内,根据去除对象物质的大小而存在最佳孔径。如果平均微孔半径为上述范围内,则低分子化合物容易以良好的效率被引导至纤维内的粉粒体并被吸附去除,同时高分子化合物容易留在多孔纤维的微孔内而被吸附去除。
本发明的多孔纤维中,优选前述三维微孔结构中的微孔选择性吸附分子量1000以上的高分子化合物。作为被选择性吸附的高分子化合物的分子量,更优选为分子量2000以上、进一步优选为分子量3000以上、进一步更优选为分子量5000以上。另一方面,通过增大微孔而能够选择性吸附分子量高的化合物,但如果微孔过大,则多孔纤维的强度不足,因此作为上限,优选为100万、更优选为80万、进一步优选为50万、进一步更优选为20万。在此,选择性吸附分子量1000以上的高分子化合物是指在透析患者的血中浓度范围内,与分子量低于1000的低分子化合物相比更多地吸附分子量1000以上的高分子化合物。作为判定是否选择性吸附分子量1000以上的高分子化合物的方法,用超薄切片机将多孔纤维在纤维长度方向制作1μm厚度的切片,制作不含粉粒体的样品和包含粉粒体的样品。将不含粉粒体的样品50mg和包含粉粒体的样品50mg浸渍在牛血浆50mL中,在37℃下浸透4小时后,根据浸渍前后的浓度差,求出平均1g的吸附性能(平均1g的吸附质量)。不含粉粒体的样品与包含粉粒体的样品相比,更多地吸附分子量1000以上的高分子化合物的情况下,作为选择性吸附分子量1000以上的高分子化合物。求出平均1g的吸附质量的方法根据吸附对象物而不同,例如分子量1000以下的低分子化合物为尿素、尿酸、肌酸酐的情况下,可以通过酶法求出平均1g的吸附质量。此外,无机磷的情况下,可以通过钼酸直接法求出平均1g的吸附质量。另一方面,分子量1kDa以上的化合物为β2-MG的情况下,可以通过胶乳免疫凝集方法求出吸附量。应予说明,本说明书中,有时将分子量1000简称为1kD。为了选择性吸附分子量1kDa以上的高分子化合物,优选具有上述的范围的平均微孔半径。
在此,作为去除对象物质的高分子化合物没有特别限定。
本发明的多孔纤维优选用于医疗用途。本发明的多孔纤维用于医疗用途是指例如在下述所示的医疗设备中使用。即,没有特别限定,可以举出例如人工透析中使用的透析膜、或者直接与血液接触且吸附血液中的有害物质的用途中使用的吸附柱等。在用于医疗用途的情况下,可以举出在血液内存在且物质的性质本身有害的物质、和因过量存在而表现有害作用的物质。作为有害或表现有害作用的高分子化合物,可以举出例如细胞因子、HMGB1、肿瘤生成蛋白质、β2微球蛋白(β2MG)、α1微球蛋白(α1MG)、抗A抗体、抗B抗体、抗乙酰胆碱受体抗体、抗心磷脂抗体、抗DNA抗体、免疫复合体、胆汁酸、安眠物质、药物和风湿因子等。另一方面,优选尽可能不吸附作为营养蛋白质的白蛋白(分子量66kDa)。即,作为去除对象物质,可以举出细胞因子(分子量8~30kDa)、β2MG(分子量12kDa)、HMGB1(分子量30kDa)、α1MG(分子量33kDa)。特别地,可以举出被指出在体外循环中去除不充分的β2MG。
本发明中,细胞因子是指作用于细胞的增殖、分化、功能表达的蛋白质。例如,可以举出白细胞介素-1β、白细胞介素-2、白细胞介素-3、白细胞介素-4、白细胞介素-6、白细胞介素-8、TNFα、M-CSF、G-CSF、GM-CSF、干扰素α、干扰素β、干扰素γ、TGF-β、SCF、BMP、EGF、KGF、FGF、IGF、PDGF、HGF、VEGF等。本发明中的细胞因子是指炎症性细胞因子,特别地,可以举出白细胞介素-1β、白细胞介素-6、白细胞介素-8、TNFα。
针对这些去除对象物质,只要三维微孔结构的平均微孔半径为上述范围,则能够以良好的效率吸附在本发明的多孔纤维上。
本发明的多孔纤维的平均微孔半径通过使用差示扫描量热计(DSC)的差示扫描量热(DSC)测定而求出。具体而言,通过利用微孔内的水的毛细管凝集测量冰点降低度,作为1次平均微孔半径而求出。将吸附材料骤冷至-55℃,以0.3℃/min升温至5℃而测定,将所得曲线的峰位温度记作熔点,根据下式1算出微孔的1次平均微孔半径。针对测定和算出方法,参照文献(Kazuhiko Ishikiriyama et al.; JOURNAL OF COLLOID AND INTERFACESCIENCE,VOL.171,103-111(1995))的p104的记载。
式1
1次平均微孔半径[nm]=(33.30-0.3181×熔点降低量[℃])/熔点降低量[℃]
本发明的多孔纤维为了吸附去除对象物质,通过增大微孔的比表面积,能够进一步提高吸附性能。因此,本发明的多孔纤维中,前述三维微孔结构中的微孔的比表面积优选为10m2/g以上。作为前述微孔的比表面积的下限,优选为10m2/g、更优选为20m2/g、进一步优选为30m2/g、进一步更优选为40m2/g、特别优选为50m2/g。另一方面,如果微孔比表面积过大,则多孔纤维的机械强度不足,因此作为微孔的比表面积的上限,优选为1000m2/g、更优选为800m2/g、进一步优选为650m2/g、进一步更优选为500m2/g。
微孔的比表面积的测定与平均微孔半径的测定方法同样地使用DSC进行。微孔的比表面积的算出方法如上述文献的p104中记载所述。
此外,本发明的多孔纤维具有直径200μm以下的粉粒体。前述直径由于优选尽可能小的粉粒体,因此为200μm以下、更优选为100μm以下、特别优选为50μm以下。如果前述直径为200μm以下,则例如将粉粒体负载在多孔纤维的内部而使用的情况下,在纺丝时喷丝头难以堵塞,纺丝性能难以降低,故而优选。此外,前述直径越小,则比表面积越大,越容易提高吸附效率。然而,在前述直径小于多孔纤维的微孔的情况下,存在粉粒体通过微孔而在血液等被处理液中溶出的可能性,因此优选大于微孔直径,具体而言,前述直径大于100nm则可以称为优选。然而,粉粒体为一次颗粒的凝集体的情况下,作为一次颗粒的凝集体而为上述直径的范围即可,一次粒径不需要处于上述直径的范围。
在多孔纤维上负载的粉粒体的直径通过扫描型电子显微镜(例如株式会社日立ハイテクノロジーズ公司制、S-5500)观察。首先,使多孔纤维充分润湿后浸渍在液氮中,用液氮瞬间冻结微孔内的水分。其后,迅速弯折多孔纤维,在露出多孔纤维截面的状态下,在0.1torr以下的真空干燥机内去除冻结的水分而得到干燥试样。其后,通过溅射而在多孔纤维表面上形成铂(Pt)、铂-钯(Pt-Pd)等薄膜,制成观察试样。将该试样的截面用扫描型电子显微镜观察。用扫描型电子显微镜(1000倍)拍摄包含粉粒体的视野的纤维截面的电子显微镜像,测定任意的30个粉粒体的直径,进行数量平均而求出。形状为圆以外的形状的情况下,如果将内切于其形状的圆的直径记作a、外接于其的圆的直径记作b,则将(a×b)0.5作为等价圆直径而求出。此外,粉粒体凝集的情况下,将内切于凝集体的圆的直径记作a、外接于凝集体的圆的直径记作b,与上述同样地求出等价圆直径。
在此内切圆是指与形成纤维横截面的轮廓的曲线在至少2处内切,仅存在于纤维的内部,具有在内切圆的圆周与形成纤维的轮廓的曲线不交叉的范围中能够取得的最大直径的圆。此外,外接圆是指在纤维横截面轮廓中,通过任意的2点的圆之中具有最大直径的圆。
此外,多孔纤维因施加来自外部的物理力而破损的情况下,重要的是降低粉粒体从破损的纤维截面剥离并流出至外部的风险。因此,本发明中使用的粉粒体优选负载于多孔纤维的内部而使用。粉粒体负载于内部的状态主要是指将粉粒体以不损害其功能的方式与多孔纤维物理地混合,附着在多孔纤维内部而保持的状态。但是,不必限于与多孔纤维物理混合的状态,只要不损害粉粒体的功能,化学地与多孔纤维内部的构成分子键合的情况也可以称为粉粒体负载于内部的状态。
本发明中,负载于多孔纤维内部的粉粒体在三维微孔结构的横截面中的面积占有率为3.0%以上。前述面积占有率的下限优选为5.0%、更优选为10%、进一步优选为20%。此外,作为前述面积占有率的上限,优选为80%、更优选为70%以下、进一步优选为60%以下。如果粉粒体的面积占有率为3.0%以上,则制成柱时,容易减少为了发挥充分的吸附性能而需要的多孔纤维的量,容易减少柱体积。另一方面,粉粒体在多孔纤维横截面中的面积占有率为了容易得到充分的多孔纤维的纤维强度、纺丝性容易变得良好,优选为80%以下。此外,粉粒体负载于纤维原材料,因此在纤维因外部压力而破损时,容易抑制粉粒体从丝截面剥离。
粉粒体在多孔纤维横截面中的面积占有率可以通过以下的方法测定。
首先,使多孔纤维充分润湿后浸渍在液氮中,用液氮瞬间冻结微孔内的水分。其后,迅速弯折多孔纤维,在露出多孔纤维截面的状态下,在0.1torr以下的真空干燥机内去除冻结的水分而得到干燥试样。其后,通过溅射而在多孔纤维表面上形成铂(Pt)、铂-钯(Pt-Pd)等薄膜,制成观察试样。将该试样的截面通过扫描型电子显微镜(例如株式会社日立ハイテクノロジーズ公司制、S-5500)观察。在用扫描型电子显微镜(400倍)印刷的任意纤维截面的电子显微镜像之上重叠透明片材,使用黑笔等将粉粒体涂黑。此外,还使用直尺和黑笔,正确地描绘比例尺。其后,将透明片材复制在白纸上,由此粉粒体为黑、非粉粒体部分为白,能够明确地区分。其后,使用图像分析软件,可以求出粉粒体的面积占有率(%)。作为图像分析软件,例如可以使用“Image J”(开放商WayneRasband(NIH))的“AnalyzeParticles”测量并求出粉粒体的总面积。粉粒体所占的面积比例、即面积占有率(%)通过下式2求出。应予说明,多孔纤维截面的电子显微镜像拍摄30个任意的多孔纤维截面,以平均值算出。
式2 粉粒体的面积占有率(%)=粉粒体总面积/纤维截面积×100%
此外,重要的是,本发明的多孔纤维从最表面起在深度方向上1.0μm以内的区域中不含前述直径200μm以下的粉粒体。
在此“从最表面起在深度方向上”是指具有从多孔纤维的表面以垂直的角度朝向深度方向、即多孔纤维的中心的含义。此外,“1.0μm以内的区域”是指深度1.0μm和与其相比更靠近外表面侧的整体的含义。因此,是指前述一定的外表面侧“不含粉粒体”。
通过减少在多孔纤维的最表面上露出的粉粒体,容易抑制粉粒体在被处理液中露出,容易防止因流动的应力而导致粉粒体损伤。这样的结构在将血液用作被处理液的情况下,通过抑制粉粒体与血细胞成分的直接接触,容易减少血液的活化,故而是特别优选的。
本发明中的“不含粉粒体”如下所述地定义。即,多孔纤维横截面中,从最表面起在深度方向上1.0μm以内的区域中包含的粉粒体为多孔纤维横截面中包含的粉粒体总量的3%以下。更优选为2%以下、进一步优选为1%以下、进一步更优选为0.5%以下。
在此,纤维截面为圆形以外的形状的情况下,以30度间隔选择12个通过纤维截面外接圆的中心点的半径,连接在各半径下的从外表面起1μm的点,作为从外表面起1μm以内的区域。应予说明,粉粒体在多孔纤维横截面中,从最表面起在深度方向上1.0μm以内的区域中包含的比例可以通过以下的方法测定。
首先,与面积占有率测定时同样地制作观察试样,将该试样的截面通过扫描型电子显微镜(例如株式会社日立ハイテクノロジーズ公司制、S-5500)观察。在用扫描型电子显微镜(400倍)印刷的任意纤维截面的电子显微镜像之上重叠透明片材,使用黑笔等将粉粒体涂黑。其后,将透明片材复制在白纸上,由此,粉粒体为黑、非粉粒体部分为白,进行明确地区分,通过图像分析软件求出纤维截面整体中包含的粉粒体面积(A1)和1μm以内包含的粉粒体所占的面积(A2),通过A2/A1×100%而求出。应予说明,多孔纤维截面的电子显微镜像拍摄30个任意的多孔纤维截面,以平均值算出。
作为使多孔纤维从最表面起在深度方向上1.0μm以内的区域中不含前述直径200μm以下的粉粒体的方法,可以举出例如在对后述的芯鞘型结构的多孔纤维进行纺丝时,使用包含粉粒体的芯液和不含粉粒体的鞘液的方法。
本发明中,作为能够负载于纤维内部的粉粒体,可以举出例如木炭、竹炭、活性炭、碳纤维、分子筛碳、碳纳米管、石墨烯、石墨、氧化石墨烯、介孔碳等碳系粉粒体、二氧化硅凝胶、大孔二氧化硅、活性氧化铝、沸石、蒙皂石、羟基磷灰石、金属氢氧化物、含金属的氢氧化物、金属碳酸盐等无机颗粒、离子交换树脂、螯合树脂、有机金属络合物、壳聚糖、纤维素等有机颗粒、无机介孔体、有机无机杂化介孔物质、碳黑凝胶等,可以使用它们中的1种或其以上。
本发明中,粉粒体优选选择性吸附分子量低于1000的低分子化合物。在此,选择性吸附分子量低于1000的低分子化合物是指在透析患者的血中浓度范围内,与分子量1000以上的高分子化合物相比更多地吸附分子量低于1000的低分子化合物。判定是否选择性吸附分子量低于1000的低分子化合物的方法与上述的判定是否选择性吸附分子量1000以上的高分子化合物的方法相同地制备样品,在牛血浆中浸渍的情况下,包含粉粒体的样品与不含粉粒体的样品相比,如果对低分子化合物的平均1g的吸附性能高,则作为选择性吸附分子量低于1kDa的低分子化合物。求出平均1g的吸附性能的方法也与上述的判定是否选择性吸附分子量1000以上的高分子化合物的方法相同。
作为分子量低于1kDa的低分子化合物,没有特别限定,可以举出例如磷酸、尿素、尿酸、肌酸酐、硫酸吲哚酚、高半胱氨酸等。这样的低分子化合物是沉积在透析患者体内的废弃物,因此是体外循环的去除对象物质。
作为一例,在以磷酸等离子性的低分子化合物作为去除对象物质的情况下,本发明的多孔纤维中,前述粉粒体优选为无机颗粒。此外,本发明的多孔纤维中,前述粉粒体优选为无机颗粒,且具有磷吸附性能。作为所述无机颗粒,优选的是氧化钛复合体、稀土元素氢氧化物、含稀土元素的氢氧化物、稀土元素碳酸盐。在此,稀土元素是指在周期表的位置中原子序数第21号的钪(Sc)、原子序数39的钇(Y)这2种元素、以及原子序数第57的镧(La)至第71号的镥(Lu)的La、Ce、Pr、Nd、Pm、Sm、Eu、Gd、Tb、Dy、Ho、Er、Tm、Yb、Lu这15种元素的总计17种元素。其中,稀土元素的碳酸盐在水中的溶解性低,进一步在生理食盐水中的pH变化小,因此能够特别优选地用于医疗用途。
进一步,前述无机颗粒中,最优选前述稀土元素选自镧、铈、镨、钐和钕。在该情况下,稀土元素的碳酸盐为碳酸镧、碳酸铈、碳酸镨、碳酸钐和碳酸钕。这些稀土元素的碳酸盐在水中的溶解性低,pH变化小,而且离子性的低分子化合物的吸附性能高,因此特别适合于体外循环。
在此,本发明中的体外循环是指将生物体内的血液诱导至体外,进行规定的物质的去除等后,再次返回至体内。
此外,作为另一例,以作为低分子化合物的尿毒素作为去除对象物质的情况下,本发明的多孔纤维中,前述粉粒体优选包含选自活性炭、碳纳米管、石墨烯、石墨和氧化石墨烯中的1种以上。该粉粒体的比表面积优选为100~2500m2/g、更优选为200~2000m2/g、最优选为300~1500m2/g。如果比表面积为上述范围,则良好地发挥出这些碳系粉粒体所具有的吸附去除性能。此外,尿毒素是指尿素、尿酸、肌酸酐、硫酸吲哚酚、高半胱氨酸等。
本发明所涉及的粉粒体优选水难溶性高。即,优选在水中的溶解性低。在此,水难溶性是指在100g水中的溶解度为1mg以下,更优选上述溶解度为0.1mg以下,最优选上述溶解度为0.01mg以下。
上述溶解度的测定中,将在恒温槽中设为20℃的水100g和转子加入烧瓶中,投入所测定的粉粒体1mg,搅拌12小时以上。其后,使用No.5A的滤纸过滤,连同滤纸在60度下干燥直至达到衡量,称量不溶成分的重量。投入量1mg与不溶成分重量之差记作在100g水中的溶解度。无法滤出不溶成分的情况下,记作溶解度大于1mg。
本发明的多孔纤维优选pH变化为-1以上且+1以下。
此外,本发明的多孔纤维更优选pH变化为-1.0以上且+1.0以下。进一步优选为-0.8以上且+0.8以下(±0.8以内),进一步更优选为±0.6以内,特别优选pH几乎不变、即±0.1以内。
一般而言,环境和生物体内的pH平衡是非常重要的,特别是如果生物体内的平衡紊乱,则导致各种各样的疾病。本发明的多孔纤维在与血液接触时,生理学上血液的pH变化小,因此对血液等体液的pH影响少。在此,本发明中,以生理食盐水中的pH变化作为生物体内pH平衡是否优异的指标。具体而言,测定将多孔纤维投入生理食盐水中并在200rpm下搅拌4小时前后的pH变化。
作为pH测定方法,使用一般最常用的测定法、即玻璃电极法。其是下述方法:使用玻璃电极和参比电极这2根电极,通过知晓该2个电极之间产生的电压(电位差),从而测定对象溶液的pH。具体而言,可以使用堀场制作所制的紧凑pH计LAQUAtwin(コンパクトpHメータLAQUAtwin)等。该仪器中,首先,使用已知的标准缓冲液(pH4.01和6.86),进行pH刻度的校正。测定生理食盐水的pH,记作pH(开始)。其后,称量测定用纤维0.1g,添加与上述同样的生理食盐水10mL,在室温下搅拌4小时。取样1mL,在9000rpm下离心分离5分钟,将上清液500μL添加至测定室,测定pH,记作pH(4H)。pH变化可以通过式3求出。
式3 pH变化=pH(4H)-pH(开始)
本发明的多孔纤维优选表面开孔率为0.5%以上且30.0%以下的范围。多孔纤维的表面开孔率优选为0.5%以上、更优选为1.5%以上、特别优选为2.0%以上。如果开孔率变高,则处理液中的去除对象物质容易扩散至纤维内部的吸附位点,故而优选。另一方面,作为上限,优选为30%、更优选为16%、进一步优选为12%。如果开孔率为30%以下,则能够提高纤维强度,此外能够抑制表面粗糙度的增大,故而优选。此外,容易抑制在微孔内部产生的微粒向纤维外部流出。
作为表面开孔率测定方法,将通过与上述测定粉粒体的面积占有率时制作的观察试样相同的方法所得的纤维截面用扫描型电子显微镜观察,用(株式会社日立ハイテクノロジーズ公司制、S-5500)以50000倍观察,在计算机中读取图像。读取的图像的尺寸可以为640像素×480像素。将SEM像在任意的位置切取6μm×6μm的范围,通过图像处理软件进行图像分析。通过二值化处理,以结构体部分形成明亮度、除此之外的部分形成暗亮度的方式确定阈值,得到将明亮度部分设为白、暗亮度部分设为黑的图像。在图像内的对比度之差小,因此无法区分结构体部分与除此之外的部分的情况下,在对比度的范围为相同程度的部分中,切分图像而分别进行二值化处理后,按原样接合而恢复为一张图像。或者,也可以将结构体部分以外的部分涂黑,进行图像分析。针对图像中包含噪音,连续的像素数为5个以下的暗亮度部分,由于无法区分噪音和孔,因此作为结构体,当作明亮度部分处理。作为消除噪音的方法,在像素数的计测时排除连续的像素数为5以下的暗亮度部分。或者,也可以将噪音部分涂白。计测暗亮度部分的像素数,算出相对于分析图像的总像素数的百分数,记作开孔率。在30张图像中进行相同测定,算出平均值。
作为本发明中的多孔纤维的形态,为实心丝。实心丝的情况下,丝截面的形状未必限定于真圆,也可以为异形截面。作为异形截面形状,可以举出椭圆形、三角形、多叶系等。通过设为异形截面,能够提高单位实心丝体积的表面积,预期吸附性能提高。
此外,本发明的多孔纤维优选纤维的机械安全性、纺丝性和粉粒体的剥离的风险少。因此,本发明的多孔纤维优选为芯鞘型结构或海岛型结构。此外,只要内包的粉粒体不剥离,能够控制多孔化和微孔,则也可以通过将粉粒体内包聚合物的外表面进一步用相同或不同的聚合物涂布的方法而实现。
芯鞘型结构的多孔纤维的情况下,同芯型、偏芯型中任一者均可,从多孔纤维的稳定性、防止粉粒体的露出的观点出发,适合使用同芯型。
芯鞘型结构的多孔纤维中,优选鞘部的厚度为0.1μm以上且50μm以下。如果鞘的厚度过薄,则纺丝性差,存在粉粒体的溶出风险。另一方面,如果过厚,则被处理液中包含的去除对象物质无法扩散至纤维的内部,存在无法充分发挥出粉粒体的吸附性能的可能性。
此外,芯鞘型结构的多孔纤维中,芯部和鞘部的原材料可以为相同组成也可以为不同组成,优选粘度接近。粘度差接近的情况下,在芯鞘界面难以发生剥离,故而优选。
本发明中,海岛型结构是指具有多个岛成分的多芯海岛型结构,从减少粉粒体的露出的观点出发,粉粒体优选包含在岛成分中。此外,通过增大岛数,能够提高在岛成分中内包的粉粒体的吸附效率。作为所述海岛型结构的岛的数量,优选为2个以上且300个以下。特别地,考虑到纺丝喷丝头设计、纺丝作业性、纤维物性、吸附材料的加工性和性能,更优选为5~50个。
本发明的多孔纤维不仅限于芯鞘型结构的多孔纤维、海岛型结构的多孔纤维,也能够使用通常的单纤维、双金属型纤维、多层结构型纤维等多孔纤维。
本发明的多孔纤维优选前述实心形状的纤维的丝直径为20μm以上且1000μm以下的范围。前述实心形状的纤维的丝直径的下限优选为20μm、更优选为50μm、进一步优选为100μm。此外,作为上限,优选为1000μm、更优选为800μm、进一步优选为500μm。前述实心形状的纤维的丝直径为20μm以上的情况下,即使提高颗粒添加率,纤维强度也难以降低,生产率容易提高。另一方面,前述纤维的丝直径为1000μm以下的情况下,在吸附柱内填充的多孔纤维的填充率容易变大,吸附性能容易提高。
作为纤维的丝直径的测定方法,在吸附柱内填充的丝(纤维)之中,任意抽取50根。将所抽取的丝(纤维)洗涤后,用纯水完全替代洗涤液,夹持在载玻片与盖玻片之间。使用投影机(例如Nikon公司制V-10A)针对同一丝在任意各2个部位测定丝的外径(最外周的直径),取其平均值,将小数点以后第1位四舍五入。应予说明,所填充的丝根数低于50根的情况下,测定其全部的丝,同样取平均值。
作为本发明中的多孔纤维的原材料,没有特别限定,从成型加工的容易性、成本等观点出发,适合使用有机物,可以使用聚甲基丙烯酸甲酯(以下称为PMMA)、聚丙烯腈(以下称为PAN)、聚砜、聚醚砜、聚芳基醚砜、聚丙烯、聚苯乙烯、聚碳酸酯、纤维素、三乙酸纤维素、乙烯-乙烯醇共聚物等。其中,优选包含作为非晶性的高分子且具有能够吸附蛋白质的特性的原材料,可以举出例如PMMA、PAN等。PMMA、PAN容易得到孔径分布尖锐的结构,故而优选。本发明的多孔纤维特别优选由聚甲基丙烯酸甲酯(PMMA)构成。PMMA的成型加工性、成本优异,此外透明性也高,因此多孔纤维的内部状态也比较容易观察,容易评价污染状态。但是,不排除包含微量的其他成分。
此外,多孔纤维可以带负电荷。通过在原材料的至少一部分中包含带负电荷的官能团,亲水性增加,存在微分散(即形成大量细微的孔)的倾向。
可以举出作为带负电荷的官能团具有磺基、羧基、酯基、亚硫酸基、连二亚硫酸基、硫醚基、酚基、羟基甲硅烷基等取代基的原材料。其中,优选为选自磺基、羧基、酯基中的至少1种。
作为具有磺基的物质,可以举出乙烯基磺酸、丙烯酰基磺酸(アクリルスルホン酸、)、甲基丙烯酰基磺酸(メタクリルスルホン酸)对苯乙烯磺酸、3-甲基丙烯酰氧基丙磺酸、3-丙烯酰氧基丙磺酸、2-丙烯酰胺基-2-甲基丙磺酸和它们的钠盐、钾盐、铵盐、吡啶盐、喹啉盐、四甲基铵盐等。
作为负电荷量,干燥的纤维平均1g优选为5μeq以上且30μeq以下。
负电荷量例如可以使用滴定法测定。
以下,针对本发明所涉及的吸附柱的制作例,示出作为丝形状使用芯鞘型结构的多孔纤维的一例,但本发明不限于此。
尤其作为其一例,在医疗用途的血液净化领域中,已知产生因无机磷的去除不充分而导致的高磷血症、因β2MG的去除不充分而导致的透析淀粉样症等各种各样的透析并发症。现在,高磷血症的治疗使用口服磷吸附药,透析淀粉样症使用内藏有多孔性的纤维素珠的β2MG去除柱。然而,如果能够同时吸附并去除无机磷和β2MG,则改善患者的QOL。
因此,在评价本发明中的多孔纤维的吸附性能中,作为低于1kDa的低分子化合物,以无机磷作为去除对象物质,作为1kDa以上的高分子化合物,以β2MG作为去除对象物质,进行评价。
吸附纤维的单位表面积的吸附性能低的情况下,作为吸附材料是不优选的,即使填充在吸附柱等中,也不表现良好的吸附性能。为了确保吸附性能而不得不增多填充的纤维数,由此导致柱体积的增大,发生成本上升、处理性的降低。特别是在以血液作为被处理液的情况下,向体外的血液携带量增大,因此存在引起血压降低等危重副作用的可能性。因此,作为纤维吸附性能,在去除对象物质为无机磷的情况下,优选为1.0mg/cm3以上、更优选为2.0mg/cm3以上、进一步优选为3.0mg/cm3以上、特别优选为4.0mg/cm3以上。本发明中,粉粒体具有磷吸附性能是指无机磷的纤维吸附性能为1.0mg/cm3以上。
另一方面,去除对象物为β2MG的情况下,优选为0.010mg/cm2以上、更优选为0.015mg/cm2以上、进一步优选为0.020mg/cm2以上、特别优选为0.030mg/cm2以上。
[多孔纤维的制作]
将成为芯部的原料的聚合物溶解在适当的溶剂中后,添加规定量的选定的粉粒体,制备芯液。溶剂根据聚合物种类而不同,一般而言使用二甲基甲酰胺、二甲基亚砜、己酮、二甲苯、四氢化萘、环己酮、四氯化碳等。例如,作为聚合物使用PMMA的情况下,优选采用二甲基亚砜(DMSO)。
纺丝原液的粘度为了制造多孔纤维而言是重要的。即,如果粘度过低,则原液的流动性高,难以维持目标的形状。因此,作为原液粘度的下限,为10poise、更优选为90poise、进一步优选为400poise、特别优选为600poise。另一方面,粘度过高的情况下,因原液喷出时的压力损失的增大,有时喷出的稳定性降低,原液的混合有时变得困难。因此,作为纺丝喷丝头部的温度下的原液粘度的上限,为100000poise、更优选为50000poise。
成为鞘液的原料的聚合物优选与芯液的原液粘度接近,更优选为相同的原液组成。
作为用于得到本发明中的纤维的纺丝方法,熔融纺丝、溶液纺丝中任一者均可,溶液纺丝中,从使支撑成分在溶剂中均匀溶解的状态迅速仅去除溶剂,由此容易得到具有较为均匀的结构的多孔纤维,故而优选。因此,作为纺丝原液,优选包含聚合物等基质成分和能够溶解其的溶剂。
以下,以利用溶液纺丝的芯鞘型结构的多孔纤维为例,说明纺丝方法。纺丝原液从喷丝头喷出,通过凝固浴而凝固为实心丝形状。作为喷丝头,在得到芯鞘型结构的多孔纤维的情况下,可以举出具有环状狭缝的双重管形状、三重管形状等,特别地,双重管形状优选从内侧喷出芯液、从外侧喷出鞘液。芯液和鞘液的喷出量可以用一个齿轮泵控制,更优选各自连接齿轮泵而进行控制。通过用2台齿轮泵进行控制,容易变更芯与鞘的喷出量比率。例如,通过使芯的喷出量恒定、并降低鞘的喷出量,能够得到鞘薄的纤维。
应予说明,在海岛型结构的多孔纤维的情况下,能够使用常规的海岛型纤维纺丝喷丝头,作为喷丝头形状,优选为将岛部分均等配置的设计。凝固浴通常包含水、醇等凝固剂、或构成纺丝原液的溶剂和凝固剂的混合物。此外,通过控制凝固浴的温度,能够改变纤维的空隙率。空隙率会根据纺丝原液的种类等而受到影响,因此,还适当选择凝固浴的温度,一般而言,通过提高凝固浴温度,能够提高空隙率。其机理尚未正确阐明,但可以认为,通过由原液的脱溶剂和凝固收缩的竞争反应,在高温浴中脱溶剂快,在收缩前被凝固固定。然而,如果凝固浴温度过高,则微孔直径变得过大,因此例如在作为基材包含PMMA的实心丝、且在内管中通入气体的情况下的凝固浴温度优选为20℃以上。
接着,通过洗涤在凝固的实心丝上附着的溶剂的步骤。洗涤实心丝的手段没有特别限定,优选使用在多段的设有水的浴(水洗浴)中通过实心丝的方法。水洗浴中的水的温度根据构成丝的聚合物的性质决定即可。例如,在包含PMMA的丝的情况下,使用30~50℃。
此外,为了保持通过水洗浴后的实心丝中的微孔直径,可以加入赋予保湿成分的步骤。在此所称的保湿成分是指能够保持实心丝的湿度的成分,或能够防止在空气中实心丝的湿度降低的成分。作为保湿成分的代表例,有甘油、其水溶液等。
结束水洗、赋予保湿成分后,为了提高收缩性高的实心丝的尺寸稳定性,还可以通过充满经加热的保湿成分的水溶液的浴(热处理浴)的步骤。在热处理浴中充满经加热的保湿成分的水溶液,实心丝通过该热处理浴,由此受到热作用而收缩,在以后的步骤中难以收缩,能够使丝结构稳定。此时的热处理温度根据丝原材料而不同,在包含PMMA的丝的情况下,优选为75℃以上、更优选为82℃以上。此外,设定为:优选为90℃以下、更优选为86℃以下的温度。像这样纺丝的纤维通过卷取在线轴上而集束。
[吸附柱的制作]
本发明的吸附柱是填充有本发明的多孔纤维的吸附柱。
如果示出使用以上述方式制造的芯鞘型结构的多孔纤维而制成本发明的吸附柱的方法的一例,则如下所述。
作为吸附柱的外壳形状,可以举出两端为开放端、例如四棱筒体、六棱筒体等棱筒体、圆筒体,其中,优选为圆筒体、特别是截面为真圆状的筒体。其理由在于,外壳不具有角,由此能够抑制被处理液的血液在角部滞留。此外,通过使两侧为开放端,被处理液的流动难以变为湍流,能够容易地将压力损失抑制为最小限度。
此外,外壳优选为由塑料、金属等构成的器具。前者的情况下,可以通过利用模具的注射成型、将原材料进行切削加工而制作。此外,后者的情况下,可以通过将原材料进行切削加工而制作器具。其中,从成本、成型性、重量、血液适应性的观点出发,适合使用塑料。
塑料的情况下,可以使用例如机械强度、热稳定性优异的热塑性树脂。作为这样的热塑性树脂的具体例,可以举出聚碳酸酯系树脂、聚乙烯醇系树脂、纤维素系树脂、聚酯系树脂、聚芳酯系树脂、聚酰亚胺系树脂、环状聚烯烃系树脂、聚砜系树脂、聚醚砜系树脂、聚烯烃系树脂、聚苯乙烯树脂、聚乙烯醇系树脂和它们的混合物。这些之中,在外壳所要求的成型性、透明性、放射线耐性的方面,优选为聚苯乙烯、聚碳酸酯和它们的衍生物。其理由在于,透明性优异的树脂由于能够在血液灌流时确认内部的情况,因此在确保安全性方面是有利的,放射线耐性优异的树脂在灭菌时照射放射性的情况下是优选。
本发明的吸附柱的外壳长度优选为1cm以上且500cm以下、更优选为3cm以上且50cm以下。在此,外壳长度是指设置隔离壁、安装盖之前的筒状外壳的轴向的长度。如果吸附柱的外壳长度为500cm以下、更优选为50cm以下,则多孔纤维在吸附柱内的***性容易变得良好,可以认为作为吸附柱而实际使用时的处理性容易变得容易。此外,如果为1cm以上、更优选为3cm以上,则在例如形成隔离壁部的情况等中容易变得有利,制成吸附柱时的处理性容易变得良好。
作为内藏于吸附柱中时的多孔纤维的形状,优选为直线形状,优选将直线形状的纤维相对于吸附柱外壳的长度方向平行***。直线形状的多孔纤维由于容易确保被处理液的流路,因此容易在吸附柱内均等地分配被处理液,此外,容易抑制流路阻抗,对因被处理液中的溶质的附着等而导致的压力损失的增大也是有利的。因此,在以粘性高的血液作为被处理液的情况中,容易将外壳内的凝固等风险抑制为小。还可以将多孔纤维加工为针织物、机织物、无纺布等。但是,加工时对丝施加大的张力,因此产生无法提高多孔纤维的空孔率等制约。进一步,通过加工多孔纤维,有时导致步骤数的增加、成本的增大。
本发明的吸附柱中内藏的多孔纤维的丝根数优选为1000根~500000根左右。
作为吸附柱的外壳内的多孔纤维的填充率的上限,优选为70%、进一步优选为63%。作为多孔纤维的填充率的下限,优选为13%、进一步优选为30%、特别优选为45%。通过使多孔纤维的填充率为13%以上,血液净化所需要的血液量减少,因此容易减轻患者的负担。此外,如果使多孔纤维的填充率为70%以下,则排气性容易变得良好。进一步,多孔纤维填充容易,因此作业效率容易提高。应予说明,在此所称的填充率是指多孔纤维体积在设有净化前的血流流入的入口部与净化后的血流排出的出口部的外壳体积中所占的比例,不包括头部等。
填充率是由根据外壳的截面积和长度而计算的外壳体积(Vc)、纤维截面积和外壳长度、纤维根数所计算的纤维体积(Vf)的比率,如下所述地求出。
Vc(cm3)=外壳主体的截面积(cm2)×有效长度(cm)
Vf(cm3)=纤维截面积(cm2)×纤维根数×有效长度(cm)
填充率=Vf(cm3)/Vc(cm3)×100(%)
应予说明,针对外壳主体的截面积,外壳具有锥度时,取外壳中央处的截面积。
在此所称的Vc中,不包括不含多孔纤维的构件、例如被称为头部、头部盖那样的成为被处理液的出入口端口的构件的体积。此外,针对Vf,在使用用于防止在外壳内多孔纤维彼此的密合的间隔物纤维等的情况下,也包括其体积。多孔纤维的有效长度是指外壳长度减去隔离壁的长度而得到的长度,作为多孔纤维的有效长度的上限,从纤维难以弯曲、制成柱时容易减少压力损失等观点出发,优选为5000mm、更优选为500mm、特别优选为210mm。此外,作为多孔纤维的有效长度的下限,从能够减少为了使丝的长度一致而裁切从吸附柱突出的多余丝时等废弃的丝的量、容易提高生产率、此外,纤维束的处理变得容易等观点出发,优选为5mm、更优选为20mm、特别优选为30mm。作为纤维的有效长度的测定方法,在施加卷曲等蜷缩的丝的情况下,在将丝两端拉伸得到的直线形状的状态下测定丝长度。具体而言,将从吸附柱中取出的纤维的一边用胶带等固定,垂直垂下,将另一边赋予单位丝截面积(mm2)为8g左右的砝码,快速测定纤维达到直线状时的总长度。该测定针对在吸附柱等内任意选择的30根纤维进行,以mm单位算出30根的平均值,将小数点以后第1位进行四舍五入。
此外,用于医疗用具等时,优选杀菌或灭菌使用。作为杀菌、灭菌方法,可以例示出各种各样的杀菌·灭菌方法、例如、高压蒸气灭菌、伽马射线灭菌、环氧乙烷气体灭菌、药剂杀菌、紫外线杀菌等。这些方法之中,伽马射线灭菌、高压蒸气灭菌、环氧乙烷气体灭菌对灭菌效率和材料造成的影响少,故而优选。
本发明中的吸附柱的使用用途也是多种多样的,可以用作水处理、纯化、血液净化等用途。血液净化用途的情况下,处理方法中有将全血进行直接灌流的方法、和从血液中分离血浆后使血浆在吸附柱中通过的方法,本发明的吸附柱可以用于任一方法。
此外,用作血液净化器的情况下,从1次处理量、操作的简便性等观点出发,优选组装在体外循环回路中而在线进行吸附去除的方法。在该情况下,可以单独使用本发明的吸附柱,也可以在透析时等与人工肾脏串联连接使用。通过使用这样的方法,能够去除在透析的同时仅通过人工肾脏去除不充分的物质。特别地,通过使用本发明所涉及的吸附柱而吸附去除通过人工肾脏去除不充分的无机磷、β2MG,能够补充人工肾脏的功能。
此外,与人工肾脏同时使用的情况下,在回路内,可以连接在人工肾脏之前,也可以连接在人工肾脏之后。作为连接在人工肾脏之前的优点,由于难以受到利用人工肾脏的透析的影响,因此有时容易发挥出吸附柱本身的性能。另一方面,作为连接于人工肾脏之后的优点,由于对通过人工肾脏进行了除水后的血液等进行处理,因此溶质浓度高,能够期待无机磷的吸附去除效率的增加。
纺丝性如下所述地评价。
1:进行5hr的连续纺丝,没有发生任何纺丝时的断丝,纺丝性极好
2:进行5hr的连续纺丝,纺丝时的断丝发生多于3次、或者喷嘴压力达到20kPa以上等纺丝性极不好。
[血液净化***]
本发明的血液净化***是将本发明的吸附柱和除水柱连结而得到的血液净化***。
作为本发明的血液净化***,例如可以将本发明的吸附柱和除水柱串联连结而进行体外循环。除水柱是指去除血液中的水分的柱,可以使用人工肾脏。此时,作为中空丝的内侧的B侧与透析同样地流通血液,但作为中空丝的外侧的D侧不流通透析液,通过过滤而去除水分。通过使用这样的方法,不使用透析液,能够与人工透析同样地去除水分和除了水分之外的废弃物。人工透析通过扩散原理而去除废弃物,但在本发明中,水分通过过滤而去除,除了水分之外的废弃物通过吸附而去除。
当前的人工透析需要一次使用100L以上的透析液,但本方法不使用透析液,也能够期待与人工透析相同的效果。
作为用于除水的人工肾脏的血液容量,作为上限,优选为60mL、更优选为50mL、特别优选为40mL,另一方面,作为下限,优选为10mL、更优选为20mL、特别优选为30mL。如果血液容量多,则一次从体内携带的血液量多,因此有时引起血压降低。另一方面,如果血液容量少,则存在无法充分实现除水效果的可能性。
此外,中空丝内藏在除水柱内,但中空丝材料没有特别限定,可以使用已经临床使用的聚甲基丙烯酸甲酯、聚丙烯腈、聚砜、聚醚砜、聚芳基醚砜、聚丙烯、聚苯乙烯、聚碳酸酯、纤维素、三乙酸纤维素、乙烯-乙烯醇共聚物等。
实施例
以下,举出实施例来说明本发明。
实施例中,作为粉粒体,使用了各种颗粒。此外,关于去除对象物质,作为低分子化合物的模型物质,选择无机磷,作为高分子化合物的模型物质,选择β2MG。但是,本发明不因这些例子而受到限定。
[实施例1~2]
<芯液纺丝原液制备>
首先,进行21质量%PMMA原液的制备。将31.7质量份的质均分子量为40万的间同立构-PMMA(syn-PMMA、三菱レイヨン株式会社制、“ダイヤナール”BR-85)、31.7质量份的质均分子量为140万的syn-PMMA(住友化学株式会社制、“スミペックス”AK-150)、16.7质量份的质均分子量为50万的全同立构-PMMA(iso-PMMA、东レ株式会社制)、20质量份的包含1.5mol%的对苯乙烯磺酸钠的分子量30万的PMMA共聚物(东レ株式会社制)与二甲基亚砜(DMSO)376质量份混合,在110℃搅拌8小时,制备纺丝原液。
在此,实施例1中,在上述中得到的纺丝原液476g中,添加二甲基亚砜190g、作为粉粒体的成为磷吸附剂的氧化钛颗粒100g,制备包含50质量%的该粉粒体的氧化钛/PMMA原液,在110℃搅拌5小时,制成芯液。所得原液的粘度为750poise。
另一方面,实施例2中,在上述中得到的纺丝原液476g中,添加作为粉粒体的成为磷吸附剂的碳酸钕50g,制备包含50质量%的该粉流体的碳酸钕/PMMA原液,在110℃搅拌5小时,制成芯液。所得原液的粘度为1200poise。
<鞘液纺丝原液制备>
将32.4质量份的质均分子量为40万的syn-PMMA、32.4质量份的质均分子量为140万的syn-PMMA、16.7质量份的质均分子量为50万的iso-PMMA与二甲基亚砜355质量份混合,在110℃搅拌8小时,制备纺丝原液。所得原液的粘度为2650poise。
<纺丝>
使用外径/内径=2.1/1.95mmφ的环状狭缝型喷丝头。喷丝头升温至100℃,从狭缝部以0.673g/min的比例喷出鞘液,从中心部以0.735g/min的比例喷出芯液。使喷出的原液在空中部分行进500mm后,导入凝固浴中。凝固浴中使用水,水温(凝固浴温度)为42℃。丝在水洗浴中洗涤,导入包含作为保湿剂的含有70质量%甘油的水溶液的浴槽中后,通过温度设为84℃的热处理浴内,以16m/min卷取在线轴上。
洗涤所得芯鞘型结构的多孔纤维后,将洗涤液用纯水完全置换,夹持在载玻片与盖玻片之间,使用投影机(例如Nikon公司制V-10A)针对同一丝在任意各2个部位测定丝的外径(最外周的直径),取其平均值,将小数点以后第1位四舍五入,记作丝直径。
[比较例1]
用与实施例1相同的原液组成和喷丝头进行纺丝。此时,从喷丝头狭缝部喷出的鞘的喷出量设为0g/min。
[比较例2]
用与实施例2相同的原液组成和喷丝头进行纺丝。此时,从喷丝头狭缝部喷出的鞘的喷出量设为0g/min。
[比较例3]
使用作为非多孔纤维的尼龙替代多孔纤维。
实施例1~2、比较例1~3的多孔纤维和非多孔纤维的无机磷和β2MG吸附性能的评价结果示于表1、2。
<测定方法>
(1)被处理液制备方法
关于被处理液,如下所述地处理牛血液而使用。
首先,将柠檬酸(テルモ株式会社ACD-A液)相对于牛血100mL添加15mL,将采血得到的牛血液在3000rpm下离心分离30分钟,由此得到牛血浆。针对该牛血浆,调整以使得总蛋白量(TP)达到6.5±0.5g/dL。应予说明,牛血浆使用采血后5日以内的血浆。
接着,以相对于上述牛血浆100mL无机磷浓度达到6mg/dL的方式添加7.85mg的磷酸氢二钠(Na2HPO4)和3.45mg的磷酸二氢钾(KH2PO4)。
进一步,以相对于上述牛血浆100mLβ2MG浓度达到1mg/L的方式,添加β2MG,制成被处理液。
被处理液的无机磷浓度测定通过以下的方法进行。即,将被处理液200μL在-20℃以下的冰柜中保存后,发送给オリエンタル酵母工业株式会社的长浜life sciencelaboratory(长浜ライフサイエンスラボラトリー),通过使用Determiner L IPII的酶法来测定无机磷浓度,记作C1(mg/dL)。
另一方面,被处理液中的β2MG浓度测定通过以下的方法进行。即,将被处理液1mL在-20℃以下的冰柜中保存后,发送给株式会社エスアールエル,用胶乳凝集法测定β2MG浓度,记作C2(mg/mL)。
(2)吸附性能
将实施例1~2、比较例1~2中得到的多孔纤维和比较例3的尼龙裁切为长度8cm的束,以纤维的体积达到0.0905cm3的方式,加入グライナー公司制的15mL的离心管中。向其中加入上述被处理液12mL,使用摇动振动器(seesaw shaker)等、本实施例中使用TAITEC公司制Wave-SI,设定为刻度38、角度最大(1.7秒1个往返),在室温(20~25℃)下搅拌1h。为了测定搅拌后的无机磷的浓度C3(mg/dL)、β2MG浓度C4(mg/mL),分别各取样1.5ml,在9000rpm下离心分离5分钟,回收上清液。搅拌前、搅拌后的样品在-20℃以下的冰柜中保存。无机磷浓度发送给オリエンタル酵母工业株式会社的长浜life science laboratory(长浜ライフサイエンスラボラトリー),测定上清液中的无机磷浓度。此外,β2MG浓度发送给株式会社エスアールエル,通过胶乳凝集法测定,根据式4算出单位纤维体积的无机磷的吸附量,根据式5算出单位纤维表面积的β2MG吸附量。
式4 单位纤维体积的吸附量〔mg/g〕=〔(C1-C3)×0.12(dL)〕/多孔纤维总体积(cm3)
式5 单位纤维表面积的吸附量(μg/cm2)=(C2-C4)×12/纤维的总表面积(cm2)×1000多孔纤维
(3)粉粒体溶出量测定
将实施例1~2、比较例1~2中得到的多孔纤维和比较例3的尼龙裁切为10cm长度,将250根加入グライナー公司制的50mL的离心管中,首先用大塚注射用水40mL洗涤5次,取样第5次的洗涤液,记作搅拌前(N1)。其后,进一步加入40mL的注射用水,使用摇动振动器等、例如TAITEC公司制Wave-SI,设定为刻度38、角度最大(1.7秒1个往返),在室温(20~25℃)下搅拌1h,记作搅拌后的溶出液(N2)。洗涤液和溶出液使用微粒计数器(RION公司制KL-04)测定,根据式6计算溶出的粉粒体数。
式6 溶出的微粒数=N2-N1
(4)丝直径测定
夹持在载玻片与盖玻片之间,使用Nikon公司制V-10测定。
(5)平均微孔直径
通过差示扫描量热计(DSC)来测定。
(6)粉粒体面积占有率
通过如前所述的方法,通过电子显微镜(SEM)(株式会社日立ハイテクノロジーズ公司制、S-5500)测定并计算。
[实施例3]
<吸附柱的制作>
将多根实施例1中得到的多孔纤维各自填充在内径10mm、轴向长度17.8mm的聚碳酸酯制圆筒状外壳内。
更具体而言,将实施例1中得到的丝直径290μm的丝裁切为长度17.8mm,总计填充655根,得到填充率为55.1%的柱。接着,在柱的两侧端面的被处理液的流出流入口上,安装裁切为与外壳内径为相等直径的网眼等效直径84μm、开口率36%的聚丙烯制筛网过滤器。最后,在外壳端部安装具有被处理液的流入口、流出口的被称为头部的盖,得到吸附柱。针对所得吸附柱,基于下述<吸附柱的磷吸附性能测定>,进行评价。结果示于表3。
[实施例4]
将实施例2中得到的丝直径170μm的丝裁切为长度17.8mm,在与实施例3相同的吸附柱中总计填充760根,得到填充率为22.2%的吸附柱。针对所得吸附柱,基于下述<吸附柱的磷吸附性能测定>,进行评价。结果示于表3。
<吸附柱的磷吸附性能测定>
作为吸附性能评价,测定吸附柱的磷吸附性能。以与上述实施例1~2、比较例1~3的吸附性能评价相同的方式,得到牛血浆。针对该牛血浆,调整以使得总蛋白量达到6.5±0.5g/dL。应予说明,牛血浆使用采血后5日以内的血浆。接着,在上述牛血浆平均100mL中,溶解7.85mg的磷酸氢二钠(Na2HPO4)和3.45mg的磷酸二氢钾(KH2PO4),制作模仿高磷血症的被处理液。
在吸附柱的入口、出口上安装硅酮管,将入口、出口均浸渍在被处理液中,制成循环体系。被处理液以流速2.5mL/min流动,从吸附柱入口在吸附柱中通液后,从出口将已净化的液体返回至被处理液。取样被处理液和出口的已净化的液体,测定样品中的无机磷浓度。
Claims (15)
1.多孔纤维,其具有通过实心形状的纤维形成的三维微孔结构,所述实心形状的纤维的丝直径为20μm以上且1000μm以下的范围,且满足下述全部要件:
(1)具有直径200μm以下的粉粒体、且所述直径200μm以下的粉粒体在所述三维微孔结构的横截面中的面积占有率为3.0%以上;
(2)从最表面起在深度方向上1.0μm以内的区域中不含所述直径200μm以下的粉粒体。
2.根据权利要求1所述的多孔纤维,其中,所述三维微孔结构的平均微孔半径为0.5nm以上且100nm以下的范围。
3.根据权利要求1或2所述的多孔纤维,其中,表面开孔率为0.5%以上且30.0%以下的范围。
4.根据权利要求1或2所述的多孔纤维,其中,所述三维微孔结构中的微孔的比表面积为10m2/g以上。
5.根据权利要求1或2所述的多孔纤维,其为芯鞘型结构或海岛型结构。
6.根据权利要求1或2所述的多孔纤维,其中,所述粉粒体为无机颗粒。
7.根据权利要求1或2所述的多孔纤维,其中,所述粉粒体包含选自活性炭、碳纳米管、石墨烯、石墨和氧化石墨烯中的1种以上。
8.根据权利要求1或2所述的多孔纤维,其中,所述粉粒体选择性吸附分子量低于1000的低分子化合物。
9.根据权利要求1或2所述的多孔纤维,其中,所述粉粒体为无机颗粒,且具有磷吸附性能。
10.根据权利要求1或2所述的多孔纤维,其中,所述三维微孔结构中的微孔选择性吸附分子量1000以上的高分子化合物。
11.根据权利要求1或2所述的多孔纤维,其由聚甲基丙烯酸甲酯构成。
12.根据权利要求1或2所述的多孔纤维,其中,pH变化为-1以上且+1以下,使用堀场制作所制的紧凑pH计LAQUAtwin,该仪器中,首先,使用已知的标准缓冲液,pH分别为4.01和6.86,进行pH刻度的校正,测定生理食盐水的pH,记作pH(开始),其后,称量测定用纤维0.1g,添加与上述同样的生理食盐水10mL,在室温下搅拌4小时,取样1mL,在9000rpm下离心分离5分钟,将上清液500μL添加至测定室,测定pH,记作pH(4H),pH变化通过式3求出,
式3 pH变化=pH(4H)-pH(开始)。
13.根据权利要求1或2所述的多孔纤维,其用于医疗用途。
14.吸附柱,其填充有权利要求1~13中任一项所述的多孔纤维。
15.血液净化***,其为将权利要求14所述的吸附柱和除水柱连结而得到的。
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