Quality Analysis of Flumazenil Injection in National Evaluation Inspection
Objective To analyze the quality of Flumazenil Injection in national evaluation inspection in 2021.Methods Based on the current standards,173 batches of Flumazenil Injection from 11 manufacturing enterprises in 31 provinces(autonomous regions,municipalities)in China were selected for 10 statutory inspections such as pH,impurity and content determination.Exploratory studies were conducted on the impurity A,osmotic pressure,edetate,trace element,accelerated test,long-term test and drug quality control based on multi-index mathematical model,and the problems found in the exploratory studies were analyzed.Results The results of statutory inspections of 173 batches of samples were all qualified(100.00%).The content of impurity A was not over 0.3%.Only one manufacturing enterprise had a low osmotic pressure(38 mOsmol/kg)for all batches of samples.Thirty batches of samples were all added in edetate,but there was a significant difference in content.The contents of arsenic,antimony,lead and cadmium in 86 batches of samples was all below 0.1 mg/L,the contents of chromium and copper in samples from different manufacturing enterprises were all below 0.02 mg/L,and there were significant differences in the contents of magnesium(0.002-0.067 mg/L),zinc(0.000 1-0.177 mg/L)and lead(0.000 2-0.044 mg/L)in samples from different manufacturing enterprises.After being placed at a temperature of 40℃and a relative humidity of 100%for one,three and five months,the impurity A and total impurities contents in 30 batches of samples showed a steady increase,while the content of flumazenil decreased to varying degrees.The main impurity in 24 batches of samples near to expiration date from six manufacturing enterprises was impurity A,the content of other biggest single impurity was below 0.2%,and the contents of impurity A and total impurities were not over 1.0%.The comprehensive inspection of the key items(pH,impurity content and flumazenil content)of samples from three manufacturing enterprises showed obvious relative aggregation,while that of samples from other three manufacturing enterprises were relatively dispersed.Impurity A,osmotic pressure and amount of edetate added in the drug were not controlled in most current standards,the packaging material was mostly low-borosilicate glass,and the labeling of drug instructions in some manufacturing enterprises were imperfect.Conclusion The overall quality of commercial Flumazenil Injection is good,but it still need to be improved,the current standards are basically feasible,but they still need to be perfected.
national evaluation inspectionFlumazenil Injectiondrug regulationquality analysis
万方数据
维普
