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微粒系指在输液的生产或临床应用过程中所污染的50μm以下的微小颗粒物质,它对人体的危害已越来越受到人们的重视。因此,各国药典相继对输液中的微粒的检测方法和限度标准作了规定。中国药典1985年版采用微孔滤膜—显微镜法(以下称显微镜法)检测注射液中的不溶性微粒,此法是直视方法,滤膜的质量、操作者的技术水平对结果均有影响,且检测时间长。英国药典采用库尔特法检测输液中的微粒,但该法所用仪器价格昂贵,且抗干扰性能及
Particulate refers to tiny particles of less than 50μm which are contaminated during the production or clinical application of infusion, and its harm to the human body has drawn more and more attention. Therefore, the pharmacopoeias of different countries successively set the test methods and the limit standards for the particles in the transfusion. Chinese Pharmacopoeia 1985 edition of microporous membrane - microscopy (hereinafter referred to as microscopy) for the determination of insoluble particles in the injection, this method is the direct method, the quality of the filter, the operator’s technical level have an impact on the results, and Detection time is long. British Pharmacopoeia Coulter method to detect particles in the infusion, but the instrument used in the method is expensive, and anti-jamming performance and