星点设计-效应面法优化硼酸乳膏基质配方及质量控制

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

目的：优化硼酸乳膏基质配方,考察制剂成品质量。方法：采用星点设计效应面法,以乳膏黏度为评价指标,优化脂肪醇醚-6（和）硬脂醇、鲸蜡硬脂醇聚醚-25、十六醇、十八醇、异硬脂醇异硬脂酸酯、霍霍巴油、轻质液状石蜡的用量;考察优化后制剂的外观性状、粒度、黏度、稳定性及硼酸的含量。结果：配方中含脂肪醇醚-6-鲸蜡硬脂醇聚醚-25（3∶2）50 g、十六醇-十八醇（3∶7）65 g、异硬脂醇异硬脂酸酯-霍霍巴油-轻质液状石蜡（5∶3∶2）125 g时,制得的成品为白色半流体乳膏,硼酸含量为标示量的98.50%,粘度为1.64×10~4m Pa·s,预测值与实测值相当,制剂稳定性较好。结论：星点设计-效应面法优化硼酸乳膏基质配方方法简单、精密度高、预测性好,制剂成品稳定、质量可控。

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 follows：50 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 about1.64 × 10^4 m Pa·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.