摘要
目的探讨一种用于小体积注射液制剂装量的检测方法。方法用移液器移液,计算每1 mL供试品[人白介素-12(human interleukin-12,hIL-12)]的重量(即供试品的相对密度),分析不同条件(实验员、温度、供试品批次、强制条件)对相对密度测定的影响,再通过供试品重量/相对密度计算装量。结果hIL-12相对密度平均值为1.004 g/mL,不同条件下供试品相对密度测定结果的变异系数(CV)均小于2%,差异均无统计学意义(P>0.05)。重量/相对密度计算装量的方法适用于hIL-12装量的测定,CV小于2%,且不同人员操作差异无统计学意义(P>0.05)。结论采用重量/相对密度的方法,无需量筒和比重瓶,能够更快速、准确、真实地测定hIL-12等小体积注射液的装量,确保临床用药安全。
Objective To investigate a method for examination of filling quantity of injectionin a small volume.Methods The weight of 1 mL of test sample of human interleukin-12(hIL-12),i.e.the relative density of test sample,was calculated by pipetting,on which the influence of different conditions such as operator,temperature,batch of test sample and mandatory conditions were analyzed,and the filling quantity was calculated with the weight/relative density.Results The mean relative density of hIL-12 was 1.004 g/mL,of which all the coefficients of variation(CVs)under various conditions were less than 2%without significant differences(P>0.05).The calculation method with weight/relative density was suitable for examination of filling quantity of hIL-12,of which the CV was less than 2%without significant differences between different operators(P>0.05).Conclusion The calculation method with weight/relative density needs no measuring cylinder or pycnometer,by which the filliing quantity of injection in a small volume,such as hIL-12,may be examined more quickly,accurately and truthfully,ensuring the safety of clinical medication.
作者
魏文
王彦娜
吴明远
王建刚
WEI Wen;WANG Yan-na;WU Ming-yuan;WANG Jian-gang(Kanglitai Pharmaceutical Co.Ltd,Qingdao 266000,Shandong Province,China)
出处
《中国生物制品学杂志》
CAS
CSCD
北大核心
2022年第8期997-1001,共5页
Chinese Journal of Biologicals
基金
山东省重大科技创新工程项目(2018CXGC1404).
关键词
装量
相对密度
注射液
Filling quantity
Relative density
Injection
