Quality evaluation of doxycycline hyclate for injection
Objective The quality of domestic doxycycline hydrochloride for injection was evaluated.Methods A total of 86 batches of samples underwent testing in accordance with the prescribed regulatory criteria.According to the requirements of consistency evaluation of injections,the quality difference of preparations from different enterprises and the rationality of current standards were analyzed by comparing the refining process of apis,quality control of vitamin C,formulation process,packaging materials,related substances,vascular irritation test and hemolysis test with reference preparations.Results The qualified rate of 86 batches of samples was 100％.The method of determination of related substances was optimized and the source of impurities was attributed.The method of impurity and content determination of vitamin C was established.It was found that the impurity content of the enterprises using unrefined raw materials was obviously higher than that of the enterprises using refined raw materials.There were differences in properties,filling amount,packing materials,related substances and stability between the domestic generic preparation and the reference preparation.Associations were found between clinical use and adverse reactions.Conclusion The quality status of the three domestic production enterprises was"good,average and poor"respectively,and there were differences in some quality attributes with the reference preparations.It was recommended that domestic enterprises optimize the production process,especially the freeze-drying process and the use of better quality packaging materials toimprove product quality.Current standards could be further improved.
Doxycycline hydrochloride for injectionEvaluative testingQuality evaluationConsistency evaluationImpurityVitamin C
NETL
NSTL
万方数据
