Study On The Quality Of Clotrimazole Vaginal Tables

Objective: The quality standard of clotrimazole vaginal tablets is various.And the testing standards are not uniform,which differs in the experimental settings and the prescribed limits,etc.To evaluate their qualities from the aspects of safety and effectiveness collected the clotrimazole vaginal tablets circulating in different provinces.Through quality research,we can improve and unify the quality standard by studying its quality,to ensure the quality is controllable and the clinical medication is safe,to provide a reference for relevant regulatory departments to evaluate their safety level in the pharmaceutical market.Methods: First,we collected the clotrimazole vaginal tablets from various domestic manufacturers,then tested the collected samples according to the drug standard of "Chinese Pharmacopoeia"(The version of 2015),including traits,identification,inspection,content determination and other items were tested,and analyzed the results.Second,we highlighted further exploration and research on the preparation from the aspects of safety and effectiveness.According to the "Chinese Pharmacopoeia"(The version of 2015),the packaging material of clotrimazole vaginal tablets and the analysis of stability were researched,and conducted correlation analysis.Analysis of related substances in clotrimazole vaginal tablets by high performance liquid chromatography(HPLC).Determination of residual solvents in clotrimazole vaginal tablets by gas chromatography(GC).According to the fourth edition of "Chinese Pharmacopoeia"(The version of 2015)and the "United States Pharmacopoeia"(The version of 39),some excipients and drug dissolution was determined and analyzed,using the flow-through cell method to determine the drug dissolution.The acid-base titration method was used to determine the maintenance and buffering capacity of the local low pH environment in different companies’ samples,and microbiological testing was performed according to the fourth edition of Chinese Pharmacopoeia(The version of 2015)on the auxiliary drug delivery tools in clotrimazole vaginal tablets.Results: Through the relevant experiments,we obtained the following results:(i)According to the current quality standards test,clotrimazole vaginal tablets are in compliance.(ii)we identified the packaging materials used by various manufacturers,and analyzed their effects on the water content of preparation,the result showed that both the double aluminum packaging and double aluminum composite film packaging could actively barrier the moisture,but the effect of aluminum-plastic packaging was poorer.In the accelerated test,the characters of some samples were changed obviously,showing that acidity value and content of impurity I increased in different degree,and there was a significant correlation between the content of impurity I and acceleration time(P<0.01).(iii)Combined the destruction test of raw material medicines and preparations,to study the impurities,analyze the source of major impurities and its degradation pathways,establish to determine the imidazole content from clotrimazole vaginal tablets by HPLC methods.(iv)Acetone was detected in samples collected from the manufacturer.The highest residue was 0.3mg in each tablet,and the lowest was0.1mg in each tablet.(v)Inspected some of the pharmaceutical excipients provided by some companies and discovered that there was not a high correlation between the disintegration and melting time of the preparations.Dissolution studies were conducted on samples from various production companies.The results showed that some of the production companies compared with the original samples had large differences in the dissolution curves.(vi)The maintenance and the buffering ability of different enterprise samples to local low pH environment’s capabilities are different in these companies’ samples.There were significant differences in the maintenance and buffering capabilities of samples from different production companies for the local low pH environment.Aspirating aids were sampled from each manufacturer’s sample for sterility inspection.Performed sterility inspection of the auxiliary drug delivery equipment in the samples from various production enterprises.The results showed that aseptic packaging for vaginal applicators can achieve sterility requirements,while there is a degree of pollution which by some disposable finger tips are packaged in non-sterile ziplock bags and here is a certain degree of safety risk in the process of use.Conclusion: In accordance with the current quality standards,the basic tests of clotrimazole vaginal tablets were carried out and the exploratory development of the relevant substances in the preparations,solvent residues,dissolution,maintenance and buffering capacity of local low pH environment,and microbiological investigation of auxiliary drug delivery tools were carried out.And analyzing the impact of packaging materials and accessories on the quality of clotrimazole vaginal tablets,to provide experimental basis for further improving the quality standard of clotrimazole vaginal tablets,so as to provide the most basic safety guarantee for the use of clinical medication.