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目的:对中国药典2010年版和2015年版微生物计数法进行比较分析。方法:采用两个版本药典微生物计数法测试15份同批次荆防颗粒剂中的细菌数及需氧菌总数,计算两个检验项目的平均数、不确定度、样本菌落分布范围及合格率。结果:按中国药典2010年版和2015年版微生物计数检查法测试的细菌数和需氧菌总数的平均菌落数分别为720、830 cfu·g~(-1),95%置信区间下的扩展不确定度分别为0.067,0.061,样本菌落分布范围分别为620~840 cfu·g~(-1),720~960 cfu·g~(-1),合格率分别为90%,100%。结论:中国药典2015版微生物计数法检测灵敏度高,结果判定原则合理,更能保证检验报告的稳定性。
Objective: To compare and analyze the microbial count method of Chinese Pharmacopoeia 2010 edition and 2015 edition. Methods: The number of bacteria and aerobic bacteria in 15 batches of Jing Jing Granules were tested by two versions of Pharmacopoeia counting method. The average of two test items, the uncertainty, the distribution range of samples and the pass rate . Results: The average number of bacteria and aerobic bacteria tested according to the Chinese Pharmacopoeia 2010 edition and the 2015 edition of the microbial count test were 720 and 830 cfu · g -1, respectively, and the expansion under the 95% confidence interval was indefinite Degrees were 0.067, 0.061 respectively. The distribution range of the samples was 620 ~ 840 cfu · g -1, 720 ~ 960 cfu · g -1, the pass rates were 90% and 100% respectively. Conclusion: The Chinese Pharmacopoeia 2015 microbiological counting method has the advantages of high detection sensitivity, reasonable result determination principle and more assurance of the stability of the test report.