摘要
目的:探讨纸片法在厄多司坦胶囊菌落计数实验中替代药典方法的可行性。方法:采用替代方法验证指导原则的有关规定,对定量检验的各项验证参数进行实验研究,并与药典方法进行统计比较。结果:经统计纸片法的各项验证参数均与药典方法相当,结果无显著性差异(P>0.05)。结论:纸片法具有结果准确、操作简便的特点,可作为厄多司坦胶囊菌落计数检查的替代方法。
Objective： Explore the feasibility of the paper method to replace the pharmacopoeia method in bacterial count of Erdosteine Capsules. Methods： According to the alternative method validation guiding principle, the validation of quantitative test parameters are experimental researched and statistical compared with the pharmacopoeia method. Results：No statistically substantial difference in test result is found between using the paper method and the pharmacopoeia method. （ P 〉 0.05 ） Conclusion： Results prove that the paper method is accurate and easy - to - use to the alternative method of Erdosteine Capsules bacterial count.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2011年第11期2146-2149,共4页
Chinese Journal of Pharmaceutical Analysis
关键词
微生物检验
快速分析
厄多司坦胶囊
菌落计数
纸片法
替代方法
方法学评价
microbioassy
rapid detection
Erdosteine Capsules
bacterial count
paper disk method
alternative method
methodology evaluation
