摘要
目的:对按《中国药典》2010年版抗生素微生物检定法测定注射用乳糖酸阿奇霉素含量进行不确定度评价。方法:建立数学模型,对含量测定过程中各种影响因素进行分析评估。结果:通过计算各变量的不确定度分量,计算出合成不确定度。代入包含因子(k),得到本次含量测定的扩展不确定度。结论:建立了测定注射用乳糖酸阿奇霉素含量的不确定度评定方法。
Objective： To evaluate the uncertainty of determination of azithromycin lactobionate for injection by the microbiological method in Chinese Pharmacopoeia（edition 2010）.Methods： A mathematied model was established to evaluate the factors affecting sample determination.Results： Each components of uncertainty was calculated by analyzing the various variable parameters among the procedures.The combined uncertainty was finally obtained by synthesizing the uncertainties of various component variables.Conclusion： The method of uncertainty evaluation is reasonable and reliable for the determination of antibiotic drug by the microbiological method.
出处
《药学与临床研究》
2011年第6期573-576,共4页
Pharmaceutical and Clinical Research
关键词
微生物检定法
注射用乳糖酸阿奇霉素
不确定度评价
Microbiological method
Azithromycin lactobionate for injection
Uncertainty evaluation
