论文部分内容阅读
本文综述了检查注射液中污染粒子的各种方法。并报导在薄膜过滤基础上采用手工计数和电子扫描两种方法,测定了一些市售小容量注射液产品中污染的粒子。手工计数法:是将检品溶液通过薄膜过滤器,然后用显微镜检查存留在薄膜上的粒子大小及数目。此薄膜可作为永久性的记录。过滤装置按照Millipere Corp的AR-2方法。所有操作均要在非常洁净的层流柜中进行。粒子计数分5～25微米,25～50微米,50～100微米,>100微米和纤维等五
This article reviews various ways to check for contaminated particles in injection. And reported on the basis of the membrane filtration using manual counting and electronic scanning of two methods to determine the number of commercially available small volume injection of contaminated particles. Manual counting method: the test solution through the membrane filter, and then use the microscope to check the size and number of particles left in the film. This film can be used as a permanent record. The filtration device was according to Millipere Corp’s AR-2 method. All operations should be carried out in a very clean laminar flow cabinet. Particle count points 5 to 25 microns, 25 to 50 microns, 50 to 100 microns,> 100 microns and five fibers