复方曲安奈德乳膏的处方筛选及稳定性考察

目的筛选复方醋酸曲安奈德乳膏处方,建立质量控制标准,并对其稳定性进行初步考察。方法以醋酸曲安奈德和樟脑为主药制备复方醋酸曲安奈德乳膏,用高效液相色谱法测定醋酸曲安奈德含量;利用单因素试验初步考察醋酸曲安奈德溶液及乳膏的稳定性,进行处方筛选。结果醋酸曲安奈德质量浓度在0.01～0.16 g/L范围内与峰面积线性关系良好,r=0.999 9（n=5）,高、中、低质量浓度的平均回收率分别为101.75%,99.10%,98.83%,RSD分别为1.52%,0.96%,1.61%（n=3）。pH≥7时,醋酸曲安奈德溶液随pH升高、温度升高而降解加速;醋酸曲安奈德乳膏的稳定性可能还受基质稠度、离子强度的影响。结论筛选所得复方曲安奈德乳膏处方合理稳定,生产工艺简便;含量测定方法准确,适用于质量控制。

Study on Stability and Prescription Screening of Compound Triamcinolone Acetonide Acetate Cream

Objective To screen the formulation of Compound Triamcinolone Acetonide Acetate Cream,to establish its quality control method and to study its stability for making preparation.Methods The cream was prepared with triamcinolone acetonide acetate and camphor as principle agents.The content of triamcinolone acetonide acetate was determined by HPLC.Single factor experiment was made to investigate the stability of triamcinolone acetonide acetate solution and cream.Results The calibration curve was linear within the range of 0.01-0.16 g/L for triamcinolone acetonide acetate（r = 0.999 9）.The high,middle and low average recovery rate was 101.75%,99.10%,98.83% with RSD of 1.52%,0.96% and 1.61% respectively（n = 3）.The degradation speed of triamcinolone acetonide acetate solution increased with the raise of pH value（pH≥7） and temperature.Apart from this,the stability of Compound Triamcinolone Acetonide Acetate Cream was also affected by thickness of the cream base and ionic strength.Conclusion The screened formulation of Compound Triam-cinolone Acetonide Acetate Cream is reasonable and stable,while its preparation process is simple.The assay method is accurate and reli-able for the quality control of this compound preparation.