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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: To investigate the feasibility of replacing the pharmacopoeia by disk-paper method in Erdosteine colony counting experiments. Methods: The relevant provisions of the Guiding Principles for the Verification of Alternative Methods were used to carry out experimental studies on the validation parameters of the quantitative test and statistical comparison with the pharmacopoeial methods. Results: The validation parameters of the statistical disk method were comparable with those of the pharmacopoeia method, with no significant difference (P> 0.05). Conclusion: The paper method is accurate and easy to operate, which can be used as an alternative method for the colony counting of erdosteine capsules.