Analysis And Study On Quality Of Erythromycin Estolate Tablets

Objective:The analysis and evaluation of drug quality is one of the main contents of drug development and is the basis for ensuring the safety and effectiveness of drug quality.In this paper,the quality of erythromycin estolate tablets was analyzed from the basic quality analysis and exploratory analysis,which provided basis for the development of quality standards of erythromycin estolate tablets.Methods: According to the "Chinese Pharmacopoeia"(2015 version)of the erythromycin estolate tablets test methods,including samples of traits,physical constants,identification,inspection,determination of the content and other items were basically tested and the basic quality of erythromycin estolate tablets were analyzed;Exploratory analysis of related substances before and after hydrolysis of erythromycin estolate tablets was performed by high performance liquid chromatography(HPLC),and the structure confirmation of a major related substance was carried out by mass spectrometry.In accordance with "Guidelines for Drug Stability Testing",stability studies were conducted on erythromycin estolate tablets;The content of free erythromycin in the sample was determined by Karl Fischer's method and the content of free erythromycin in the sample was determined by high performance liquid chromatography(HPLC).The correlation between the two was analyzed.On the basis of "Guidelines for bioequivalence test of generic drugs",the dissolution profile of the sample and the effect of different concentrations of sodium dodecyl sulfate on the dissolution of the sample were analyzed.Results: In the light of the current quality standards,erythromycin estolate tablets are in compliance;The erythromycin tablets had relatively many related substances before and after hydrolysis,and the source of some of the components was related to the bulk.The structure of the unknown related substance 19 with high content before hydrolysis waserythromycin A propionate enol ether.According to the results of the stability study,the erythromycin estolate tablets are relatively stable in high temperature and high humidity environment.There is a positive correlation between water and free erythromycin;The dissolution curves of 14 erythromycin tablets based on different dissolution media and different concentrations of sodium dodecylsulfate in 14 companies are different,suggesting that there may be differences in the release and bioavailability of each product in vivo.Conclusion: According to the current quality standards,the erythromycin estolate tablets were basically tested and the related substances before and after hydrolysis were explored,the stability of erythromycin tablets,the relationship between water and free erythromycin,the dissolution curve comparison.A comprehensive and objective evaluation of the overall quality of the erythromycin-based tablets is provided,which has a certain reference value for the clinical use of drugs and ensuring the safety of people's medications.