| 摘要: |
| 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。 |
| 关键词: 大肠杆菌测试片 吡拉西坦片 大肠埃希菌检查 |
| DOI： |
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| Application of E.Coil Count Plate in E.Coil Test of Piracetam Tablets |
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WANG Zhijian, LI Jue
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Zhejiang Institute for Drug Control, Hangzhou 310004, China
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| Abstract: |
| OBJECTIVE To explore the feasibility of the E.coil count plate to replace the pharmacopoeia method in E.coil test of Piracetam tablets. METHODS According to the alternative method validation guiding principle, the validation of qualitative test parameters were tested and compared with the pharmacopoeia method. RESULTS No statistically substantial difference in test result was found between E.coil count plate and the pharmacopoeia method (P>0.05). CONCLUSION Results prove that the E.coil count plate is accurate and easy-to-use to the alternative method of piracetam tablets E.coil test. |
| Key words: E.coil count plate piracetam tablets E.coil test |
