Methodological investigations and quality evaluations on the method of interference test of the bacterial endotoxin test in Chinese Pharmacopoeia

Abstract

 Objective: By comparing the Chinese Pharmacopoeia and the United States, Europe, Japan Pharmacopoeia bacterial endotoxin gel interference test whether there are differences in test methods for the Chinese Pharmacopoeia revised to provide a scientific basis. Methods: 1748 times interfere with assay data respectively Chinese Pharmacopoeia 2010 edition methods and the United States, Europe, Japan and the existing experimental results to determine the methods, summarize all the experimental data using SAS software in accordance with the "two detection methods rank ordered symmetry test data "for statistical analysis. Results: The Chinese Pharmacopoeia methods and the United States, Europe, Japan and the symmetry test methods test coefficient P = 0.0001, the difference was not statistically significant. Two experimental methods weighted kappa value was 0.9530, the results have a good consistency. Conclusions: The gel test methods amendments disturbance tests for the United States, Europe, Japan model, coming bacterial endotoxin test "in Table 1 gel interference test solution preparation" in the C series "LAL marked sensitivity control series" parallel parallel 4 revised 2, does not affect the results, experimental operation can be simplified to avoid waste of resources limulus reagent. I can also make domestic endotoxin test further with international standards.