Optimization of the Base Formula of Boric Acid Cream by Central Composite Design-response Surface Methodology and Its Quality Control / 中国药师

ABSTRACT

Objective:To optimize the base formula of boric acid cream,and investigate its quality. Methods:Using central composite design-response surface methodology,with the viscosity of cream as the index,the amounts of Cremophor A6,Cremophor A25,cetyl alcohol,stearyl alcohol,isooctadecyl isooctadecanoate,jojoba oil and light liquid paraffin were optimized. The appearance characteristics,particle size,viscosity and stability of the preparation and the content of boric acid were studied. Results:The optimal conditions were as follows50 g Cremophor A6-Cremophor A25(3 ∶2),65 g cetyl alcohol-stearyl alcohol(3∶7),and 125 g isooctadecyl isooctadecanoate-jojoba oil- light liquid paraffin(5 ∶3 ∶2). According to the optimal formula,the cream showed the property of semi-fluid cream,the content of boric acid was 98. 5% of the labeling amount,and the viscosity was about 1. 64 × 104 mPa·s. The predicted value was equivalent to the measured one,and the stability of the preparation was promising. Conclusion:The central composite design-response surface methodology used in the base optimization of boric acid cream is simple with high precision and good predictability,and the quality of the preparation is stable and controllable.