Quality analysis and evaluation of lomefloxacin hydrochloride ear drops
Objective This study evaluated the quality status of lomefloxacin hydrochloride ear drops produced by different domestic manufacturers.Methods A comprehensive evaluation of 111 batches of samples was carried out using legal specifications combined with exploratory research,including impurity analysis,bacteriostatic agents,excipient compatibility,packaging materials,bacteriostatic efficacy and formulation compliance.The quality of domestic products and the controllability of current specifications were comprehensively evaluated.Results The statutory determination results showed that the qualification rate of 111 batches of lomefloxacin hydrochloride ear drops was 100％.However,the reproducibility,impurity separation,and detection ability of the related substance methods in the current specifications were poor,and the bacteriostatic agent determination method did not cover the types used in the products.The exploratory research results showed that the impurity level of the products was mainly related to the formulation process,and the impurity detection situations varied significantly among different manufacturers.There were significant differences between the formulation and excipients of domestic manufacturers and the original drugs,and there was a significant negative correlation between the content of photodegradation impurities and the organic content in their formulation.There were significant differences in the shading effect of packaging materials from different manufacturers.The results of the bacteriostatic efficacy determination of one manufacturer reached the B standard for the judgment in the 2020 edition of the Chinese Pharmacopoeia but did not meet the A standard.The levels of bacteriostatic agents,EDTA and ethanol in 111 batches were consistent with the prescribed amount.Conclusion The overall quality of domestically produced lomefloxacin hydrochloride ear drops was good at present.The current specification should be further improved.The difference in formulation process of the products had a significant impact on their quality,and they differed greatly from the original drugs,so it was recommended to conduct quality and efficacy consistency evaluations as soon as possible.
NETL
NSTL
万方数据
