论文部分内容阅读
绪言注射剂特别是输液中异物的存在大有发生致命事故的危险。微生物污染的危险性是不言而喻的。现在日本及其各国药典都对注射剂的异物的限度与规格作了规定。实验方法: 1·试验用10ml及20ml的聚乙烯安瓿。 2·安瓿的开启方法:用剪刀剪断或用带有18号注射针的注射器直接抽取。 3·混入异物的搜集及测定:剪断安瓿后的注射液用薄膜过滤器过滤(孔径为0.45μ,直径为13mm的白色微细薄膜),在过滤器上搜集到的混入异物,用光学显微镜直接观察,同时将试料真空镀金、钯后再用扫描型电子显微镜观察。用荧光X线衍射仪分析混
Introduction Injectable agents, especially the presence of foreign objects in infusion, are at great risk of fatal accidents. The danger of microbial contamination is self-evident. Now Japan and its national pharmacopoeia on the injection of foreign body limits and specifications for the provisions. Experimental Methods: 1. The test used 10ml and 20ml polyethylene ampoules. 2. Ampoule opening method: cut with a scissors or directly with a syringe with a syringe needle 18 extraction. 3. Collection and measurement of mixed foreign matter: After the ampoules were ampouled, the injection liquid was filtered through a membrane filter (0.45 μ pore size, white fine film with a diameter of 13 mm), and the collected foreign material collected on the filter was observed directly under an optical microscope , While the sample gold-plated vacuum, palladium and then observed with a scanning electron microscope. Analysis by fluorescence X-ray diffractometer