摘要：制药工业中常用的灭菌或除菌方法有热力灭菌,如湿热灭菌和干热灭菌,气体灭菌、γ射线辐射灭菌和除菌过滤。其中前三种方法的灭菌机理是使细菌蛋白质变性或者碳化细菌而将其杀灭,而除菌过滤器是通过截留药液中的细菌而达到除菌的目的,其本身并不破坏细菌。微孔滤膜过滤法作为一种重要的除菌方法 ,已在制药工业中广泛应用。对于关键的除菌级过滤工艺而言，完整性测试是一种必要的手段，以确保过滤工艺的安全性。溶出物是指在合适溶剂中, 于超过最差工艺条件的夸大的时间和温度条件下, 从任一产品接触材料包括弹性体、塑料、玻璃、不锈钢或涂层组分中迁移的化合物, 溶出物代表了迁移至产品中物质。科学的做法是获得最差条件下的溶出物数据, 将其用于药品的风险评估。由于溶出物在超过最差工艺条件的夸大的时间和温度条件下, 使用模拟药物性质的合适溶剂获得, 它反应了析出物的最大可能。同时，滤芯材质是否与药品相互作用或溶入药中也是一个重要的问题。关键词：滤芯，完整性，起泡点，扩散流，溶出物8180
Microporous membrane in the use of medicines filter
Abstract: The commonly methods of sterilization or sterilization used in the pharmaceutical industry have heat sterilization, such as moist heat and dry heat sterilization, gas sterilization, gamma-ray radiation sterilization and sterilization filter. The first three methods of sterilization mechanism is the bacterial protein denaturing or carbonation and kill bacteria, but sterilization filter through the retention of bacteria in the liquid to achieve the purpose of sterilization, it alone does not destroy bacteria.
The filter membrane method as a sterilization method has been widely used in the pharmaceutical industry. For key sterilizing grade filtration process, the integrity test is a necessary means to ensure the security of the filtration process. Leachables refers in a suitable solvent, and in the worst conditions exaggerated over time and temperature conditions, including elastic, plastic, glass, stainless steel or transfer coating component compounds from the contact material for any product, leachables represents the material migration to products. Science is the practice of data release for worst conditions, be used for risk assessment of drugs. Because the dissolved substances in exaggerated over the worst conditions of time and temperature conditions, a suitable solvent using simulated drug properties is obtained, which reflects the maximum possible precipitation.Meanwhile, the filter material interaction with drugs or dissolved drug is also an important problem.
Key words: Filter, completeness, bubble point, diffusion flow, leachables
目录
1. 绪论    1
1.1 微孔滤膜的发展背景、种类及应用    1
1.1.1 我国微孔滤膜的发展历程    1
1.1.2 微滤技术的分离特点    1
1.1.3 滤膜材料的研究进展及种类    1
1.1.4  微滤技术的分离机制    2
1.1.5 微孔滤膜的应用    2
1.1.6 微孔滤膜的应用领域    3
1.1.7 微滤技术的应用现状    3
1.2 完整性    3
1.2.1 完整性检测方案    3
1.2.2 完整性检测方法    4
1.2.3完整性测试目的    4
1.2.4完整性测试失败的可能原因    4
1.3 起泡点    4
1.3.1 起泡点的定义    4
1.3.2 起泡点与膜直径计算公式    5
1.4 扩散流    5
1.4.1 扩散流定义    5
1.4.2扩散流计算公式    5
1.5 溶出物    5 微孔滤膜在药品处理中的应用:http://www.751com.cn/huaxue/lunwen_6416.html