摘要
目的 针对醋酸曲安奈德(TAA)在复方酊剂(曲安奈德苯海拉明水杨酸酊)中溶解度低导致的制剂均一性差、生物利用度不足等问题,本研究采用Box-Behnken响应面法系统优化溶解工艺,为提高曲安奈德苯海拉明水杨酸酊的制剂质量提供参考。方法 通过预实验筛选液料比(A)、超声时间(B)、超声功率(C)3个关键参数,结合高效液相色谱法(HPLC)定量分析,建立二次多项式回归模型。结果 模型显示A与B、C存在显著协同效应(P<0.01)。最优工艺参数:A为8∶1(ml/g)、B为20min、C为200W;模型预测平衡溶解度为99.01 mg/ml。验证实验实测值为98.51 mg/ml,与预测值偏差<2%,重现性良好,较传统工艺提升49.2%。结论 响应面法显著改善了药物溶出特性,为皮肤科复方制剂的工业化生产提供标准化解决方案。
Objective In response to the problems of poor homogeneity and insufficient bioavailability caused by the low solubility of triamcinolone acetonide acetate(TAA)in compound tinctures(triamcinolone-diphenhydramine-salicylic acid tincture),this study used the Box-Behnken response surface methodology system to optimize the dissolution process,and provide a reference for enhancing the formulation quality of triamcinolone-diphenhydramine-salicylic acid tincture.Methods Through pre-experiment screening of three key parameters,namely liquid to material ratio(A),ultrasound time(B),and ultrasound power(C),combined with quantitative analysis by high performance liquid chromatography(HPLC),a quadratic polynomial regression model was established.Results The model showed a significant synergistic effect between A and B/C(P<0.01).The optimal process parameters were A of 8∶1(ml/g),b of 20 min,and C of 200 W.The model predicted an equilibrium solubility of 99.04 mg/ml.The measured value of the verification experiment was 98.51mg/ml,with a deviation of<2%from the predicted value,and good reproducibility,which was 49.2%higher than the traditional process.Conclusion Response surface methodology significantly improves the drug dissolution characteristics and provides a standardized solution for the industrial production of dermatological compound preparations.
作者
陈雅慧
CHEN Ya-hui(Huizhou Institute of Dermatology Prevention and Control,Huizhou 516001,China)
出处
《中国实用医药》
2025年第24期176-180,共5页
China Practical Medicine
关键词
醋酸曲安奈德
曲安奈德苯海拉明水杨酸酊
溶解度
响应面法
工艺优化
Triamcinolone acetonide acetate
Triamcinolone-diphenhydramine-salicylic acid tincture
Solubility
Response surface methodology
Process optimization
