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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 boric acid cream matrix formula and study the quality of finished products. Methods: The star point design effect surface method was used to evaluate the viscosity of cream, and the optimal parameters of the fatty alcohol ether-6 (stearyl alcohol), ceteareth-25, cetyl alcohol, Stearyl alcohol isostearate, jojoba oil and light liquid paraffin. The appearance, particle size, viscosity, stability and boric acid content of the optimized formulations were investigated. Results: The formulation contained 50 g of fatty alcohol ether-6 ceteareth-25 (3: 2), 65 g of cetyl alcohol-octadecanol (3: 7), isostearyl isostearate Acid ester - jojoba oil - light liquid paraffin (5: 3: 2) 125 g, the resulting product is a white semi-fluid cream, boric acid content of 98.50% of the nominal amount, a viscosity of 1.64 × 10 ~ 4mPa · S, the predicted value and the measured value is equivalent, the preparation stability is better. Conclusion: The method of star point design-response surface optimization boric acid cream matrix is simple, high precision, good predictability, the finished product is stable, the quality controllable.