Study On Process Control Of Quality Of Triamcinolone Acetonide And Econazole Nitrate Cream

Objective:The new preparation standard of the triamcinolone cetonide and econazole nitrate cream was established by testing the reference preparation in this thesis. The generic drug quality and reference substances were evaluated in the raw materials, the laboratory scale test, the pilot scale production and the industrialized production. The quality consistency evaluation of the drugs was showed. Methods:1. To determine the new preparation formulation goals according to the reference preparation standards and the standard of the domestic and foreign pharmacopoeia and literature.2. For ensuring the raw and auxiliary materials met the standard, the raw material drug, auxiliary, and process control standard were established. For identifing two unknown impurity of econazole. For screeing control of process, the quality of the semi-finished and finished products was detected. Finally, the drug quality of the laboratory, pilot and industrialized product were compared.3. To establish and validate the quality detection HPLC method.4. To test and determine the effective period by investigating the influencing factors of stability test, i.e. 6 months’ acceleration, quality changes of the 12 months’ long trial.5. To summary and establish the quality process control SOP of the triamcinolone acetonide and econazole nitrate cream according to the above study results. Results:1. The raw and auxiliary materials are fully qualified, and their quality meets the implementating standards.2. The two unknown impurity of econazole are identified.3. The quality of the finished and semi-finished products meets the process contro L standard and the technology is feasible.4. There was not any new impurity in the quality detection of the laboratory, pilot scale and industrialized product, and the various technical indices meet the standard.5. The quality of the preparation was qualified and there was no significant change of the impurity and content in the stability test. Conclusion:The results indicated that the preparation and reference preparation achieved consistency, and the reasonable, effective, quality control of the preparation were evaluated.