透析纸阻菌性及孔隙结构影响因素的研究
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摘要
随着人民生活水平的不断提高，对医疗服务需求日益升级，医疗器械灭菌包装也越来越受到人们的重视，透析纸作为医疗器械灭菌包装的重要材料，因其阻菌性能好，使用方便，储存时间长等优点，受到行业及生产厂家的广泛关注。而医疗器械灭菌包装的检测及其材料的相关研究，尚未有统一标准与研究性资料可查，透析纸的相关影响因素研究更是一片空白。
本文初步探讨了不同工艺条件下透析纸阻菌性与孔隙结构的差异，采用正交实验设计与单因素实验方法，通过琼脂接触攻击试验及泡点法分别对试样进行阻菌性及孔隙结构检测，探究了浆料配比、打浆度、施胶量及油压压力对阻菌性及孔隙结构的影响，并总结出在实际生产中对改善透析纸阻菌性与透气性的可控因素及操作顺序优劣的建议。研究结果如下：
（1）在所研究的四个影响因素中，浆内施胶的施胶量对透析纸阻菌性影响最大，且趋势十分明显：随着施胶量的增加，透过纸样的枯草杆菌数呈直线下降，而其对孔隙结构和透气性的影响甚小；打浆度对透析纸阻菌性影响程度次于施胶量，但对孔隙结构和透气性影响最大：随着打浆度的提高，最大孔径、平均孔径及透气量均呈现出持续下降的趋势；浆料配比及油压压力对阻菌性、孔隙结构及透气性未有定向影响。
（2）实际生产及试验研究中，施胶量应控制在3%以下；综合考虑透析纸阻菌性、孔隙结构与透气性，宜采用针叶木浆与阔叶木浆混合配抄工艺，针叶木含量与阔叶木含量比为75%︰25%，打浆度以21°SR为宜，油压压力以0.32MP为宜。
（3）阻菌性与孔隙结构及透气性之间彼此关联并相互影响，但没有明确的相互制约或共同促进关系；实际生产过程中，若仅需改善透析纸阻菌性，可考虑从施胶量着手调节，效果最明显，但稳定性较差，可控性不佳，此外，还可从打浆度考虑，与改变施胶量相比，尽管效果不够明显，但稳定性和可控性方面有较好表现；若阻菌性与透气性均需改善，在实际生产中，建议从调节打浆度着手。
总体而言，施胶量、打浆度、浆料配比及油压压力的改变，均会导致透析纸阻菌性、孔隙结构以及透气性发生变化，且此三个指标之间具有相关性，彼此紧密联系相互影响。实际生产过程中，应根据实际条件与具体生产状况，结合本文对透析纸影响因素的初步探索研究所得结论而制定可行、有效的改善方案。
With the continuous improvement of people's living quality, the demand formedical services upgrades stage by stage. People pay more and more attention tomedical instrument sterilization packaging. Dialysis paper as a sterilizationpackaging material for medical equipment welcomed by industry andmanufacturers, because its good bacteria blockage performance, easy to use, longtime to be stored and other advantages. However, as to the sterilizationpackaging testing and materials research for medical devices, unified standardand comprehensive researches were unavailable, research on related factors ofdialysis paper is also blank.
This paper discussed the differences of dialysis paper’s bacteria blockageand pore structure under different conditions. Orthogonal experimental designand the single factor experiment were used in the study. The agar exposure attacktest and the bubble point method were used to detect the sample bacteriablockage property and the pore structure. Various factors on the bacteriablockage and pore structure were researched. In the actual production, thecontrollable factors and the sequence of operations on improving dialysis paperblockage bacteria property and permeability was summed up. The results are asfollows:
Four influencing factors in this study, sizing degree in internal sizingprocess plays the most important role in bacteria blockage performance ofdialysis paper; and the trend is very clear, with the sizing degree increasing, thebacillus subtilis number through the pattern shows a linear downward trend, thatis the dialysis paper bacteria blockage performance enhanced linearly with sizingdegree increasing, while the impact on pore structure and permeability is limited. Beating degree on dialysis paper blockage bacteria performance is the secondaryinfluencing factor compared to sizing, but on the pore structure and permeabilityit becomes the greatest. As the beating degree increasing, maximum aperture,average pore diameter and permeability are showing a declining trend; whilepulp ratio and hydraulic pressure on bacteria blockage performance, porestructure and permeability have no orientation influence.
In experimental study and practical production, sizing degree should keepbelow3%. Considering dialysis paper bacteria blockage performance, porestructure and permeability, the optimal ratio of bleached softwood pulp andhardwood pulp for papermaking is75%:25%, beating degree of21oSR is thebest and oil pressure in the0.32MP is the best.
Bacteria blockage performance, pore structure and permeability are relatedand influenced mutually with each other, but there is no clear mutual restrict orpromote relations. In the production process, if only improve dialysis paperblockage bacteria performance, sizing regulation is the first choice with the mostobvious effect, but its stability and controllability are poor. In addition, beatingdegree can also be considered as its better stability and controllability, althoughthe effect is not obvious compared to sizing regulation; Lastly if the blockagebacteria performance and permeability are both required to improve, beatingdegree regulation is recommended.
Overall, sizing, beating degree, pulp ratio and hydraulic pressureregulations, all lead to changes for the dialysis paper blockage bacteriaperformance, pore structure and permeability which these three indexes areclosely related and mutually influenced with each other. In the productionprocess, feasible and effective improvement scheme can be made according tothe actual conditions, as long as combined with the primary research conclusionsto the influencing factors of dialysis paper in this study.
本文初步探讨了不同工艺条件下透析纸阻菌性与孔隙结构的差异，采用正交实验设计与单因素实验方法，通过琼脂接触攻击试验及泡点法分别对试样进行阻菌性及孔隙结构检测，探究了浆料配比、打浆度、施胶量及油压压力对阻菌性及孔隙结构的影响，并总结出在实际生产中对改善透析纸阻菌性与透气性的可控因素及操作顺序优劣的建议。研究结果如下：
（1）在所研究的四个影响因素中，浆内施胶的施胶量对透析纸阻菌性影响最大，且趋势十分明显：随着施胶量的增加，透过纸样的枯草杆菌数呈直线下降，而其对孔隙结构和透气性的影响甚小；打浆度对透析纸阻菌性影响程度次于施胶量，但对孔隙结构和透气性影响最大：随着打浆度的提高，最大孔径、平均孔径及透气量均呈现出持续下降的趋势；浆料配比及油压压力对阻菌性、孔隙结构及透气性未有定向影响。
（2）实际生产及试验研究中，施胶量应控制在3%以下；综合考虑透析纸阻菌性、孔隙结构与透气性，宜采用针叶木浆与阔叶木浆混合配抄工艺，针叶木含量与阔叶木含量比为75%︰25%，打浆度以21°SR为宜，油压压力以0.32MP为宜。
（3）阻菌性与孔隙结构及透气性之间彼此关联并相互影响，但没有明确的相互制约或共同促进关系；实际生产过程中，若仅需改善透析纸阻菌性，可考虑从施胶量着手调节，效果最明显，但稳定性较差，可控性不佳，此外，还可从打浆度考虑，与改变施胶量相比，尽管效果不够明显，但稳定性和可控性方面有较好表现；若阻菌性与透气性均需改善，在实际生产中，建议从调节打浆度着手。
总体而言，施胶量、打浆度、浆料配比及油压压力的改变，均会导致透析纸阻菌性、孔隙结构以及透气性发生变化，且此三个指标之间具有相关性，彼此紧密联系相互影响。实际生产过程中，应根据实际条件与具体生产状况，结合本文对透析纸影响因素的初步探索研究所得结论而制定可行、有效的改善方案。
With the continuous improvement of people's living quality, the demand formedical services upgrades stage by stage. People pay more and more attention tomedical instrument sterilization packaging. Dialysis paper as a sterilizationpackaging material for medical equipment welcomed by industry andmanufacturers, because its good bacteria blockage performance, easy to use, longtime to be stored and other advantages. However, as to the sterilizationpackaging testing and materials research for medical devices, unified standardand comprehensive researches were unavailable, research on related factors ofdialysis paper is also blank.
This paper discussed the differences of dialysis paper’s bacteria blockageand pore structure under different conditions. Orthogonal experimental designand the single factor experiment were used in the study. The agar exposure attacktest and the bubble point method were used to detect the sample bacteriablockage property and the pore structure. Various factors on the bacteriablockage and pore structure were researched. In the actual production, thecontrollable factors and the sequence of operations on improving dialysis paperblockage bacteria property and permeability was summed up. The results are asfollows:
Four influencing factors in this study, sizing degree in internal sizingprocess plays the most important role in bacteria blockage performance ofdialysis paper; and the trend is very clear, with the sizing degree increasing, thebacillus subtilis number through the pattern shows a linear downward trend, thatis the dialysis paper bacteria blockage performance enhanced linearly with sizingdegree increasing, while the impact on pore structure and permeability is limited. Beating degree on dialysis paper blockage bacteria performance is the secondaryinfluencing factor compared to sizing, but on the pore structure and permeabilityit becomes the greatest. As the beating degree increasing, maximum aperture,average pore diameter and permeability are showing a declining trend; whilepulp ratio and hydraulic pressure on bacteria blockage performance, porestructure and permeability have no orientation influence.
In experimental study and practical production, sizing degree should keepbelow3%. Considering dialysis paper bacteria blockage performance, porestructure and permeability, the optimal ratio of bleached softwood pulp andhardwood pulp for papermaking is75%:25%, beating degree of21oSR is thebest and oil pressure in the0.32MP is the best.
Bacteria blockage performance, pore structure and permeability are relatedand influenced mutually with each other, but there is no clear mutual restrict orpromote relations. In the production process, if only improve dialysis paperblockage bacteria performance, sizing regulation is the first choice with the mostobvious effect, but its stability and controllability are poor. In addition, beatingdegree can also be considered as its better stability and controllability, althoughthe effect is not obvious compared to sizing regulation; Lastly if the blockagebacteria performance and permeability are both required to improve, beatingdegree regulation is recommended.
Overall, sizing, beating degree, pulp ratio and hydraulic pressureregulations, all lead to changes for the dialysis paper blockage bacteriaperformance, pore structure and permeability which these three indexes areclosely related and mutually influenced with each other. In the productionprocess, feasible and effective improvement scheme can be made according tothe actual conditions, as long as combined with the primary research conclusionsto the influencing factors of dialysis paper in this study.
引文
[1]陈忠伟．中国特种纸工业现状背景下的浙江发展策略[J].纸和造纸,2011,30(10)
[2]刘仁庆．特种纸的概念[J].湖北造纸,2002(2):23-24
[3]2007年全球纸浆、纸和纸板的产量及消费量[J]．纸和造纸,2009(1)：63-64.
[4]唐树田,马宁,齐晶,刘国传,叶光．EN868最终医疗器械灭菌包装材料系列标准要点解读[J].包装工程,2010,31(19)
[5]裴晓辉．最终灭菌医疗器械包装材料的选择[J]．中国医疗器械信息,2011,1（78）：14-15.
[6]吴春明．中国医疗器械包装现状[J]．中国医疗器械信息,2007(5)：6-8.
[7]吴春明．中国医疗器械灭菌包装现状及其相关思考之MDSP国内现状[J].中国医疗器械信息,2007,13(3):39-40.
[8]董翠芳,邓开发.浅析医药包装[J].包装工程,2003,24(4):133-134.
[9]周亮.抗菌纸的研究进展[J].包装工程,2005,26(5):103-104.
[10]马爽,钱省三.医疗器械包装透视[J].包装工程,2007,28(6):198-200.
[11]沈伟．灭菌医疗用品包装的应用与评价[J].中国消毒学杂志,2006,26(3):305-307.
[12]张曙云,叶丽蝉,张如莲,等．潮湿季节无菌物品保存期限的探讨[J].南方护理学报,2005,12(10):13-14.
[13]李洁,于志军,王淑霞,等．医用邹纹纸与全棉布包装物品性能比较分析[J].中国护理管理,2009,9(2):62-63.
[14]洪花,陈碧群,林惠兰．不同灭菌包装材料阻菌效果和成本比较分析[J].中国中医药现代远程教育,2009,7(12):160-161.
[15]钟文泉．无菌器械透气包装材料阻菌性测试仪[P]．中国专利：102174385A，1983-08-12．
[16]白新桂．数据分析与试验优化设计[M].北京：清华大学出版社,1989
[17]朱燕堂，杨敬娟，赵选民．应用概率统计理论[M].北京：清华大学出版社,1986
[18]蓝燧灯．两种不同浆料分别打浆与混合打浆制拷贝纸浅析[J].广东造纸,1993（2）：19-21.
[19]邹文中，曾广植．简论分别打浆与混合打浆[J].江苏造纸，1989（2）：63-65.
[20]轻工业标准编辑出版委员会．造纸工业测试方法标准汇编[S]．北京：中国轻工业出版社，1999．
[21]王向钦，张鹏，靳向煜．湿润剂对泡点法测定纤维过滤材料孔径特性的影响［J］．产业用纺织品，2011(5):40-43.
[22]殷保璞，吴海波．非织造过滤材料的孔隙结构与透气性能研究［J］．产业用纺织品，2007,25(5):20-23.
[23]卢谦和．造纸原理和工程[M].北京：中国轻工业出版社,2004.
[24]黄友发.打浆对卷烟纸透气度的影响[J/OL].中国学术期刊电子出版社,1994-2012.
[25]王文庆侯丽吴平黄经春.接触性创面敷料阻菌性试验方法标准介绍及改进构想[J].中国医疗器械信息,2010,16(7):40-44
[26]梁云，胡健．纤维过滤材料孔径及孔径分布测试方法的研究［J］．纺织科学研究，2004(4):23-27.
[27]周小凡杜炜.纸张的孔隙结构与特种纸[J].中国造纸,2010,29(z1):41-45
[28]冯长龄.装饰原纸的透气度和吸水性[J].上海造纸2004,35(04):36-39
[29]殷保璞，吴海波．CFP-1100-AI多功能孔径仪在纺材性能测试中的应用［J］．纺织标准与质量,2002(4):33-35.
[30] YY/T047.5~2004接触性创面敷料试验方法第5部分:阻菌性
[31]浙江华邦特种纸有限公司[J],福建纸业信息.2011,11:14
[32]宋婉丽张红鹰王华生.医用包装纸阻菌效果研究.中华医院感染杂志.2003,2(13)
[33] prEN13726-5:2000Test method for primary wound dressing Part5:Bacterial BarrierProperti.
[34]魏静蓉邹英向国春.国产医用纸/塑包装材料阻菌效果试验分析[J].第三军医大学学报.2004,24(26)：2275-2276
[35]赵博. Amicor抗菌纤维的性能特点及产品开发.针织工业,2006.12:19-20
[36]李焰.麻织物的舒适性和抗菌性研究.苏州大学硕士学位论文(2004届)
[2]刘仁庆．特种纸的概念[J].湖北造纸,2002(2):23-24
[3]2007年全球纸浆、纸和纸板的产量及消费量[J]．纸和造纸,2009(1)：63-64.
[4]唐树田,马宁,齐晶,刘国传,叶光．EN868最终医疗器械灭菌包装材料系列标准要点解读[J].包装工程,2010,31(19)
[5]裴晓辉．最终灭菌医疗器械包装材料的选择[J]．中国医疗器械信息,2011,1（78）：14-15.
[6]吴春明．中国医疗器械包装现状[J]．中国医疗器械信息,2007(5)：6-8.
[7]吴春明．中国医疗器械灭菌包装现状及其相关思考之MDSP国内现状[J].中国医疗器械信息,2007,13(3):39-40.
[8]董翠芳,邓开发.浅析医药包装[J].包装工程,2003,24(4):133-134.
[9]周亮.抗菌纸的研究进展[J].包装工程,2005,26(5):103-104.
[10]马爽,钱省三.医疗器械包装透视[J].包装工程,2007,28(6):198-200.
[11]沈伟．灭菌医疗用品包装的应用与评价[J].中国消毒学杂志,2006,26(3):305-307.
[12]张曙云,叶丽蝉,张如莲,等．潮湿季节无菌物品保存期限的探讨[J].南方护理学报,2005,12(10):13-14.
[13]李洁,于志军,王淑霞,等．医用邹纹纸与全棉布包装物品性能比较分析[J].中国护理管理,2009,9(2):62-63.
[14]洪花,陈碧群,林惠兰．不同灭菌包装材料阻菌效果和成本比较分析[J].中国中医药现代远程教育,2009,7(12):160-161.
[15]钟文泉．无菌器械透气包装材料阻菌性测试仪[P]．中国专利：102174385A，1983-08-12．
[16]白新桂．数据分析与试验优化设计[M].北京：清华大学出版社,1989
[17]朱燕堂，杨敬娟，赵选民．应用概率统计理论[M].北京：清华大学出版社,1986
[18]蓝燧灯．两种不同浆料分别打浆与混合打浆制拷贝纸浅析[J].广东造纸,1993（2）：19-21.
[19]邹文中，曾广植．简论分别打浆与混合打浆[J].江苏造纸，1989（2）：63-65.
[20]轻工业标准编辑出版委员会．造纸工业测试方法标准汇编[S]．北京：中国轻工业出版社，1999．
[21]王向钦，张鹏，靳向煜．湿润剂对泡点法测定纤维过滤材料孔径特性的影响［J］．产业用纺织品，2011(5):40-43.
[22]殷保璞，吴海波．非织造过滤材料的孔隙结构与透气性能研究［J］．产业用纺织品，2007,25(5):20-23.
[23]卢谦和．造纸原理和工程[M].北京：中国轻工业出版社,2004.
[24]黄友发.打浆对卷烟纸透气度的影响[J/OL].中国学术期刊电子出版社,1994-2012.
[25]王文庆侯丽吴平黄经春.接触性创面敷料阻菌性试验方法标准介绍及改进构想[J].中国医疗器械信息,2010,16(7):40-44
[26]梁云，胡健．纤维过滤材料孔径及孔径分布测试方法的研究［J］．纺织科学研究，2004(4):23-27.
[27]周小凡杜炜.纸张的孔隙结构与特种纸[J].中国造纸,2010,29(z1):41-45
[28]冯长龄.装饰原纸的透气度和吸水性[J].上海造纸2004,35(04):36-39
[29]殷保璞，吴海波．CFP-1100-AI多功能孔径仪在纺材性能测试中的应用［J］．纺织标准与质量,2002(4):33-35.
[30] YY/T047.5~2004接触性创面敷料试验方法第5部分:阻菌性
[31]浙江华邦特种纸有限公司[J],福建纸业信息.2011,11:14
[32]宋婉丽张红鹰王华生.医用包装纸阻菌效果研究.中华医院感染杂志.2003,2(13)
[33] prEN13726-5:2000Test method for primary wound dressing Part5:Bacterial BarrierProperti.
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