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小容量注射液中微粒的存在一直是医院药师长期未得到解决的问题。对注射液中微粒有关问题的关心要追溯到30年代,事实是除了要求调配前肉眼检查外,对大容量注射液并无适当分析方法,直到1975年才制订标准。按美国药典规定,适用作注射液的大容量静脉溶液就是包装多于100毫升供静脉使用的大容量注射液;1975年采用的显微镜检查仍是药典的法定标准。从那时起,有关大容量注射液中微粒问题的数量向美国药典的
The presence of small particles in small volume injection has long been a problem that hospital pharmacists have not solved. The concern with particles-related issues in injections dates back to the 1930s, the fact that there was no appropriate analytical method for large volume injections in addition to the pre-deployment visual inspection and no standard was established until 1975. According to the United States Pharmacopoeia, suitable for injection of large-volume intravenous solution is packed more than 100 ml for intravenous use of large volume injection; microscopy used in 1975 is still the legal standard Pharmacopoeia. Since then, the number of particle problems associated with large volume injections has been reported to the United States Pharmacopeia