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目的:制备氢化可的松洗剂并建立其质量控制方法。方法:以氢化可的松为主药制备洗剂;采用紫外分光光度法测定其中主药的含量,同时考察制剂稳定性及皮肤刺激性。结果:所制制剂为无色澄明液体,检查符合2005年版《中国药典》中相关规定;氢化可的松检测浓度在5～30μg.mL-1范围内呈良好的线性关系(r=0.9990),平均回收率为100.09%(RSD=0.17%);制剂放置3、6个月各项指标均无明显变化,刺激性实验结果皮肤无红斑、水肿等不良反应。结论:本制剂制备工艺简便可行,质量稳定可控。
Objective: To prepare hydrocortisone lotion and establish its quality control method. Methods: Hydrocortisone was used as the main drug to prepare the lotion. The content of the main drug was determined by ultraviolet spectrophotometry. The stability and skin irritation of the preparation were also examined. Results: The preparation was colorless and clear liquid and the test was in accordance with the relevant regulations of the 2005 edition of Chinese Pharmacopoeia. The calibration curve of hydrocortisone showed a good linearity (r = 0.9990) in the range of 5 ~ 30μg.mL-1, The average recovery rate was 100.09% (RSD = 0.17%). No significant changes were observed in the indicators for 3 and 6 months after the preparation was placed. Irritation test results showed no skin reactions such as erythema and edema. Conclusion: The preparation process is simple and feasible, the quality is stable and controllable.