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目的制备硫磺乳膏,建立其质量控制方法并考察其稳定。方法以升华硫为主药,以司盘-60和吐温-60为配对乳化剂,以单硬脂酸甘油酯为稳定剂,采用反相快速加入法制备O/W型乳剂基质;通过回流,以碘量法测定硫含量;通过离心试验、耐寒热试验、留样观察等考察其稳定性。结果制备的乳膏细腻、均匀、美观,易于涂布及洗除;平均回收率为99.5%(RSD=0.61%);稳定性试验均符合规定。结论按本处方及制备工艺所得乳膏质量合格、性质稳定,所建立的质控方法可靠。
Objective To prepare sulfur cream, establish its quality control method and investigate its stability. Methods The sublimation sulfur was used as the main drug, Span-60 and Tween-60 as emulsifier, and glycerol monostearate as stabilizing agent. O / W emulsion matrix was prepared by reverse phase fast addition method. , And the content of sulfur was determined by iodometric method. The stability was investigated by centrifugation test, cold and heat resistance test and sample retention observation. Results The prepared cream was delicate, uniform, beautiful and easy to apply and wash. The average recovery was 99.5% (RSD = 0.61%). The stability test was in accordance with the regulations. Conclusion According to the prescription and preparation process obtained cream quality qualified, stable quality, established quality control methods and reliable.