Preparation and Primary Quality Evaluation of Celastrol Oral Ulcer Film / 中国药房

ABSTRACT

OBJECTIVE：To prepar e Celastrol oral u lcer film ，and to evalute its quality primarily. METHODS ：The comprehensive scores of the appearance ，film formation and toughness of the drug film were used as indicators ，and the amount of celastrol was controlled to 0.05％. Orthogonal test was used to optimize the amount of excipients as starch ，sodium carboxymethyl cellulose，glycerol and condensed honey ，so as to optimize the formulation ；the validation test was performed. The adhesion force of the film prepared by the optimal formulation were determined. UV spectrophotometer was used to detect the content of celastrol in the film. RESULTS ：The optimal dosage of each excipient in Celastrol oral ulcer film was starch 1.0 g，sodium carboxymethyl cellulose 0.2 g，glycerin 0.4 g，condensed honey 1.5 g. In 3 times of validation tests ，the appearance of the prepared film was good. The average adhesion of the film prepared by the optimal formulation was 4.2 g，and the average content of celastrol was 0.135 3 mg/cm2（RSD＝1.90％，n＝3）. CONCLUSIONS ：In this study ，the best formulation of Celastrol oral ulcer film was optimized，and the film forming ability of the prepared film is good and the quality is stable and uniform.