Comparison of Microbial Count Test Method Described in Chinese Pharmacopoeia 2010 Edition and 2015 Edition / 中国药师

ABSTRACT

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.