论文部分内容阅读
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 an uncertainty analysis method for the determination of insoluble particles of ceftizoxime for injection by photoplethysmography, and find out the factors affecting the uncertainty. Methods According to the relevant provisions in “Evaluation and Expression of Uncertainty in Measurement” (JJF1059-1999), various influencing factors during the examination of insoluble particles were analyzed and evaluated. Results The extended uncertainty of the insoluble particle examination was 194.72 tablets / bottle (≥10μm) and 19.90 tablets / bottle (≥25μm). Conclusions Choosing the appropriate method design and strictly regulating the operation can make the determination result more reliable.