摘要
目的建立光阻法检查注射用头孢唑肟钠不溶性微粒的不确定度分析方法,找出影响不确定度的因素。方法根据《测量不确定度评定与表示》(JJF1059-1999)中有关规定,对不溶性微粒检查过程中各种影响因素进行分析评估。结果本次不溶性微粒检查的扩展不确定度为194.72粒/瓶(≥10μm)、19.90粒/瓶(≥25μm)。结论选择适宜的方法设计、严格规范操作,可使测定结果更加可靠。
OBJECTIVE To establish a light obscuration for the particulate matter uncertainty of ceftizoxime sodium for injection,and to identify the factors that affected its uncertainty. METHODS The factors affect the uncertainty in the determination of the particulate matter were analyzed and evaluated based on＂Evaluation and Expression of Uncertainty in Measurement（ JJF1059-1999） ＂.RESULTS The expanded uncertainties in determination of the particulate matter were 194.72 particle/bottle（ ≥10 μm） and 19.90particle/bottle（ ≥25 μm）. CONCLUSION The more reliable result of the measurement can be obtained by suitable method design and standard operation.
作者
郭芯岐
潘建文
GUO Xinqi PAN Jianwen(Changzhou Center of Food and Drug Control, Changzhou, Jiangsu 231000, China)
出处
《今日药学》
CAS
2017年第3期168-170,共3页
Pharmacy Today
关键词
注射用头孢唑肟钠
不溶性微粒
不确定度
光阻法
ceftizoxime sodium for injection
particulate matter
uncertainty
light obscuration
