Uncertainty Evaluation for Total Aerobic Microbial Count of Jingfang Granule / 中国药师

ABSTRACT

Objective:To establish the uncertainty evaluation method for total aerobic microbial count of Jingfang granule. Meth-odsAccording to Chinese Pharmacopoeia (2015 edition, volume IV), the total aerobic microbial count of 20 samples of the same batch of Jingfang granule was detected. National specification of measuring instruments JJF1059.1-2012 was used to perform the uncer-tainty evaluation on the total count of aerobic microbial type A and type B,and the combined uncertainty and the extended uncertainty were calculated. SPSS statistics 19.0 software was used to analyze the normal distribution of data. Results:The combined standard was 0.043 9, the expanded measurement uncertainty was 0.088(k=2),the colony distribution range of the samples was 690-1 000 cfu· g-1,and the data was normal distribution. Conclusion:The established method for uncertainty assessment is simple and convenient, and the results of new test samples can be added. New range of uncertainty can be obtained by recalculating the standard deviation of the combined samples.