微滤无菌过滤膜处理生物药品性能研究
关键词： 起泡点；扩散流；溶出物；无菌过滤
Study of the performance of Microporous sterile filtration membrane disposing Biotechnology drugs
Abstract: At present, sterilized by filtration technology has been widely used in the pharma- cyeutical field, especially for some thermo sensitive drugs. High temperature sterilization is no longer applicable. the sterilized filter material mainly includes polyether sulfone (PES), polyvi- nylidene fluoride (PVDF), polytetrafluoroethylene (PTFE), polypropylene (PP) etc.. Selecting the appropriate sterilizing filter according to the characteristics of drugs, and combining with t- he specific process conditions sufficiently validates the sterilization efficiency is critical and n- ecessary conditions to ensure drugs achieving the appropriate sterile level. Departure from the efficacy and safety of the filter sterilization process, the four aspects that affect the efficiency of the sterilization filter sterilization included bubble point, diffusion flow, leachable, specific ads- orption was studied. The bubble point and the microbial challenge test has a direct relationship, while the diffusion flow and the microbial challenge test with indirect correlation. The leachab- les and the precipitation reflects the security of the filter sterilization process.
Key words: Bubble point；Diffusion flow；Leachables；Sterile filtration
目录
1 绪论 1
1.1 微孔滤膜发展概述 1
1.1.1 微孔滤膜定义与分类 1
1.1.2 微孔滤膜的主要特征 1
1.1.3 微孔滤膜过滤技术运用 2
1.2 微孔滤膜过滤器的验证方案 3
1.2.1兼容性验证 3
1.2.2溶出物/析出物验证 6
1.3 微孔滤膜的研究现状及前景 9
1.4 本文研究方向，重点与意义 11
2 实验部分 12
2.1 仪器与试剂 12
2.1.1 实验试剂 12
2.1.2 实验仪器 12
2.2 起泡点扩散流测定 13
2.2.1 泡点测试方法 13
2.2.2 产品扩散流测试方法 13
2.3 吸附含量测定 14
2.4 溶出物测定 14
3 结果与讨论 15
3.1起泡点测试结果及分析 15
3.2 扩散流测试结果及分析 16
3.3 吸附含量测试结果及分析 17
3.3.1 硫酸依替米星注射液吸附含量测试 17
3.3.2 复方骨肽注射液吸附含量测试 18
3.4 溶出物测试结果及分析 19
4 结论 22
致谢 23
参考文献 24
1 绪论
1.1 微孔滤膜发展概述
1.1.1 微孔滤膜定义与分类
微孔滤膜是功能分离膜大家族中的一个主要成员，可分为有机微孔滤膜和无机微孔滤膜。通常认为微孔滤膜的主要功能是用于分离液相或气相中大于0.05µm的微粒或物质。以孔径大小来说，这并没有一个严格的限定，因为在上、下界限中它与超滤膜和粗过滤有一部分重叠区，通常认为微孔滤膜的孔径定在0.05µm到8µm之间的较多。