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目的:对地塞米松尿素霜研究。方法:运用乳膏剂的常规制备方法,制备了地塞米松尿素霜,建立了酸碱度、卫生学、含量测定等质控方法,进行了刺激性试验,耐热耐寒试验和自然室温留样考察。结果:pH值7.2～7.4,卫生学检查符合规定,尿素含量测定平均回收率100,50%,RSD=0.62%(n=9),且乳膏稳定无变化,无刺激性。结论:制备地塞米松尿素霜工艺简单,所得制剂质量可控,性质稳定,可满足临床用药需求。
Objective: To study dexamethasone urea cream. Methods: The dexamethasone urea cream was prepared by the conventional preparation method of cream. Quality and control methods such as pH, hygiene and content determination were established. The irritation test, heat-resistant and cold-tolerant test and natural room temperature test were conducted. Results: The pH values ranged from 7.2 to 7.4. The hygiene tests were in compliance with the regulations. The average recovery of urea was 100,50% with a RSD of 0.62% (n = 9). The cream had no change and no irritation. Conclusion: The preparation of dexamethasone urea cream has a simple process, the quality of the obtained preparation is controlled and its properties are stable, which can meet the demand of clinical medication.