Preparation and Quality Evaluation of Bifonazole Suppositories / 中国药师

ABSTRACT

Objective: To optimize the preparation technique for bifonazole suppositories and evaluate the quality.Methods: The appearance, hardness and melting time of suppositories were used as the evaluation indices to optimize the process conditions, such as suppository matrix, drug particle size, injection molding temperature and stirring conditions, etc.The content of bifonazole was determined by HPLC.Results: The best formula was as follows the matrix was multiplicated monofatty glyceride-36, bifonazole was sieved by 100 mesh sieve and the best molding temperature was 45 ℃.The quality of the prepared suppositories with the above conditions was controllable in the appearance, melting time limit, hardness and content determination, etc.Conclusion: The formula of bifonazole suppositories is reasonable, the preparation process is feasible, and the quality control methods are reliable.