Résumé
Objective:To establish the uncertainty evaluation method for total aerobic microbial count of Jingfang granule. Meth-ods:According 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.
Résumé
Objective:To compare the microbial count method described in Chinese Pharmacopoeia ( ChP) 2010 edition and 2015 edition. Methods:The bacterial count and total aerobic microbial count for 15 samples of Jingfang granule with the same batch were tested respectively by the method described in ChP 2010 edition and 2015 edition, the average number, uncertainty, colony distribu-tion range of samples and qualified rate from the two testing items were analyzed and compared. Results:The average number of colo-nies for the bacterial count and total aerobic microbial count was 720 and 830 cfu·g-1 , the expand uncertainty of 95％ confidence in-tervals was 0. 067 and 0. 061, the colony distribution range of samples was 620-840 cfu·g-1 and 720-960 cfu·g-1 , and the qualified rate was 90％ and 100％, respectively. Conclusion:The microbial count method described in Chp 2015 edition is more sensitive with more reasonable result evaluation, which can guarantee the stability of inspection reports.