Evaluation and analysis of antimicrobial effectiveness in ribavirin eye drops
Objective To evaluate the antimicrobial effectiveness of ribavirin eye drops for matching the general requirements of the 2020 edition of Chinese Pharmacopoeia(ChP)＜1121＞,and analyze the effectiveness of different kinds of antimicrobials with different concentrations for optimizing the prescription.Methods Three sample groups were investigated according to the antimicrobial effectiveness testing method in ChP,including 11 ribavirin eye drops,ribavirin solution without antimicrobials and antimicrobial solutions(benzalammonium bromide,hydroxyphenylate and thiomersal sodium).Results The antimicrobial effectiveness of ribavirin solution was fair on bacteria;however,it was not good enough on fungi.Apparently,it was necessary to add appropriate antimicrobial preservatives.The antimicrobial effectiveness of benzalkonium bromide solution(0.1 mg/mL)could meet the grade A standard;thiomersal sodium solution(0.006 mg/mL)could meet the grade B standard;but hydroxyphenylate solution(0.25 mg/mL)could not meet the grade B standard.Among the 11 samples of ribavirin eye drops,5 samples containing benzalammonium bromide could reach grade A,1 sample containing thiomersal sodium could reach grade B,and 5 samples containing hydroxyphenylate could not meet the requirements.Conclusion Based on our experimental data and information regarding the toxicity,commonly used concentrations,and limit values of the three antimicrobial preservatives,the concentration of benzalkonium bromide in ribavirin eye drops should be optimized and decreased.Hydroxyphenylate and thiomersal sodium were not suitable as antimicrobials in ribavirin eye drops,for they did not meet the requirements or had high toxicity.It was suggested to optimize the prescription by investigating the effectiveness and safety of antimicrobial preservatives.
万方数据
维普
