Methods for Examining Viable Bacterial Count and Contaminating Bacteria of Bacillus cereus Tablets
OBJECTIVE To discuss the rationality of the current methods for examining viable bacterial count and contaminating bacteria in the standard of Bacillus cereus tablets,and optimize the two methods.METHODS The factors that affect the method for viable bacterial count were compared and analyzed,such as medium,diluent,dilution ratio,and pre-treatment,then the optimal ex-perimental conditions were selected.The microbial limit test in the current standard was replaced with the contaminating bacteria test under the general chapter for probiotic in Chinese Pharmacopoeia part Ⅲ,and its suitability was studied.RESULTS The optimized method for determination of viable bacterial count could more effectively recover Bacillus cereus in the sample,and the results were sig-nificantly higher than the current standard method.The use of a new method for detecting non-pathogenic bacteria can discover potential risks in the sample,and its suitability investigation results basically met the requirements of the Chinese Pharmacopoeia.CONCLUSION The new methods are suitable for the determination of viable bacterial count and detection of contaminating bacteria in Bacillus cereus tablets.The current standards for the determination of viable bacterial count and microbial limit testing cannot effec-tively monitor product quality risks.It is recommended to revise the methods.This can not only more effectively regulate products,but also better assist manufacturers in improving product quality.
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