Validation of Microbial Limit Test Methods of Tongmai Tangyanming Capsule

摘要

[Objectives] This study was conducted to establish a method for microbial limit test of Tongmai Tangyanming Capsule. [Methods] According to the Chinese Pharmacopoei 2015 edition of the four general rules,the microbiological limits of non-sterile products were verified. [Results]Tongmai Tangyanming Capsule has a strong inhibitory effect on Bacillus subtilis and Candida albicans. The antimicrobial activity was significantly eliminated after increasing the diluent( 1∶20); and the recoveries were in the range of 0. 5-2 when the total quantities of aerobic microbes were determined by dilution method( 1 ∶ 20). When the total quantities of mould and yeast were determined by dilution method( 1∶ 20),the recoveries were from 0. 5 to 2,and Escherichia coli,cholate-tolerant Gram-negative bacteria and Salmonella can be detected by the test solution dilution method. [Conclusions]With the plate method,the total quantities of aerobic bacteria and the quantities of mould and yeast were examined by increasing diluent,and conventional method was used for examination of control bacteria including E. coli,cholatetolerant Gram-negative bacteria and Salmonella. This method has been proved effective for microbial limit test of Tongmai Tangyanming Capsule,and can effectively control the quality of the preparation. The method is accurate and reliable.