正交试验优化氢化可的松乳膏基质工艺及含量测定

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Optimization of hydrocortisone ointment matrix preparation process and content determination by orthogonal experimentShu Wenjiang，Ma Peijie，Zhao Ting，Liu Xuan. “ ，

【Abstract】 Objective To optimize the formulation process and content determination method of hydrocortisonecream.MethodsThe emulsified matrix and process parameterswere optimizedusing orthogonal design.A high-performance liquid chromatography （HPLC）method was established with a Symmetry C18 column （ 4.6×250 （2 mm， 5μm ），using acetonitrile-water（35：65） as the mobile phase，a flow rate of 1.0ml/min ，adetection wavelength of 245nm ，acolumn temperature of ，andan injection volume of 10μl ，This method was developed to replace the ultraviolet spectrophotometryspecified inthe currentstandard，aiming toimprove the accuracy of content determination.ResultsThe optimized formulation comprises 33% oil phase， 1% emulsifier （Tween 80），and a10-minute homogenization time，whichsignificantly enhances thephysicochemical propertiesand stabilityof the hydrocortisone cream.The established HPLC method demonstrates excellent linearity（ r=1 1）across the concentration range of 8.01-200.20μg/ml ，withan averagerecoveryrate of 99.5% （RSD=O.79），effectively validating its applicabilityforprecise content determinationof hydrocortisone in cream formulations.ConclusionThe optimized formulation matrixand stable feasibleproces，combinedwith anaccurateand simplecontent-determinationmethod， provide a scientific basis for the industrial production and quality control of hydrocortisone cream.

【Key Words】Hydrocortisone ointment； Orthogonal experiment;Excipient ratio;Process optimization

氢化可的松乳膏为我院依据《中国医院制剂操作规范》研制的标准制剂，其通过抗炎、抗过敏及免疫调节等机制1，主要用于接触性皮炎、过敏性湿疹、脂溢性皮炎等2皮肤病的局部治疗，临床效果显著[3]。（剩余6816字）