摘要
目的通过不溶性微粒检查和微生物检查比较塑料安瓿注射液和玻璃安瓿注射液两种内包装材料在药品使用过程中对注射液质量的不同影响。方法按中国药典2005年版二部收载的不溶性微粒检查法和微生物限度检查法进行试验,同时无菌检查法。结果开启安瓿瓶后,易开型聚乙烯塑料安瓿和玻璃安瓿中均未检测到25μm的不溶性微粒,但3μm和5μm和10μm微粒塑料安瓿显著少于玻璃安瓿;经微生物培养后,易开型聚乙烯塑料安瓿的菌落数少于玻璃安瓿。结论使用易开型聚乙烯塑料安瓿可明显减少在开启过程中产生的不溶性微粒,且可以减少在使用过程中的微生物污染。
OBJECTIVE To investigate the difference of insoluble particles and microorganism contamination of plastic and glass ampoules produced by clinical use.METHODS To determine according the detection method of insoluble particles and microorganism investigation in Chinese pharmacopoeia of 2005 edition.RESULTS The insoluble particles with the diameter of 25 μm were not determined in plastic and glass ampoules.The microorganism amount and insoluble particles with 3 μm,5 μm and 10 μm diameter of plastic ampoule are less than glass ampoule.CONCLUSION The insoluble particles amount and microorganism contamination are reduced with using plastic ampoules in clinical therapy.
出处
《中国现代应用药学》
CAS
CSCD
北大核心
2007年第z1期652-653,共2页
Chinese Journal of Modern Applied Pharmacy
关键词
氯化钠注射液
不溶性微粒
微生物污染
塑料安瓿
玻璃安瓿
sodium chloride injection
insoluble particle
microorganism contamination
plastic ampoules
glass ampoules
