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目的探讨大肠杆菌测试片在吡拉西坦片大肠埃希菌检查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,对定性检验的各项验证参数进行实验研究,并与药典方法进行比较。结果经统计,测试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)。结论大肠杆菌测试片具有结果准确、操作简便的特点,可作为吡拉西坦片大肠埃希菌检查的替代方法。
Objective To investigate the feasibility of replacing the pharmacopoeia of Escherichia coli test tablets in the investigation of Piracetam Escherichia coli. Methods The relevant provisions of the Guiding Principles were verified by alternative methods. The validation parameters of the qualitative test were experimentally studied and compared with the pharmacopoeial methods. Results According to the statistics, the validation parameters of the test strip method were comparable with those of the pharmacopoeia method, with no significant difference (P> 0.05). Conclusion The test piece of Escherichia coli has the characteristics of accurate results and easy operation, and can be used as an alternative method for detecting Escherichia coli of Piracetam tablets.