ABSTRACT
OBJECTIVE:To optimize the preparation technology of Compound bovis calculus sativus gel. METHODS:The ul-trasonic emulsifying technology was optimized by orthogonal test using ultrasonic power,ratio of ultrasonic time to interval time, total ultrasonic time as factors,using centrifugal stability constant(KE)as index.Ultrasonic emulsifying method was applied to pre-pare O/W emulsions using paeonol,berberine hydrochloride and eucalyptus oil;then calculus bovis sativus powder was added into O/W emulsions,and then mixed with carbomer(940)gel matrix to prepare gel. The formulation of gel was optimized by orthogo-nal test with the amount of carbomer (940),glycerool and triethanolamine as factors,using compactibility score,comprehensive score of release rate in vitro as index. Validation test,stability test and content determination of bilirubin were conducted for gel pre-pared by optimized technology. RESULTS:The optimal ultrasonic emulsifying technology was as follows as ultrasonic power 450 W,ratio of ultrasonic time to interval time 2:1,and total ultrasonic time 5 min. The optimal formulation of gel was as follows as carbomer(940)0.5%,glycerool 15%,triethanolamine 0.20%(g/100 g). The average of KE of validation test and average compre-hensive score were 0.175 and 98.67(RSD<2%,n=3);the appearance of the preparation had no obvious change in stability test, and average percentage of bilirubin in labeled content was 100.8%. CONCLUSIONS:The optimal formulation and preparation tech-nology of gel is feasible,and the prepared gel is stable and controllable in quality.