Establish an uncertainty assessment method for drug microbiological testing using artificial addition of bacteria.Ac-cording to the microbial count method in the microbial limit test of non-sterile products in the general rule 1105 of Chi-nese Pharmacopoeia 2020,after the drug adjuvant corn starch was artificially added with bacteria,analyze the uncertainty in-troduced during the inspection process,and establish a mathematical model to evaluate the uncertainty.The combined uncer-tainty of sample was 0.046(calculated as a logarithmic result,confidence interval P=95％,k=2).The evaluation method and conclusion of uncertainty established by the method of artificially contaminating samples with known strains can provide ba-sis and reference for the internal quality control of microbiology laboratory drug testing.
Drug microorganismsTotal number of coloniesUncertainty
维普
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