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目的探讨O/W型复方二氧化钛乳膏的制备工艺。方法采用反相高效液相色谱法(RP-HPLC)测定乳膏中水杨酸苯酯的含量为指标,采用水相充分分散二氧化钛、油相熔融水杨酸苯酯后,两相混合乳化的新工艺制备乳膏。结果采用改进工艺制备的乳膏细腻度得到改善,更易于涂布。用高效液相色谱法测定的水杨酸苯酯在0.04~0.16μg/ml范围内,线性良好(r=0.9999);平均回收率为99.3%,RSD=1.9%(n=3)。结论经过改进的制备工艺科学合理,稳定可控;采用高效液相色谱法测定的水杨酸苯酯方法简便,且快速准确,适宜作为该制剂的质控方法。
Objective To investigate the preparation of O / W compound titanium dioxide cream. Methods The content of phenyl salicylate in cream was determined by reversed-phase high-performance liquid chromatography (RP-HPLC). After the aqueous phase was used to disperse the titanium dioxide and the oil phase to melt the phenyl salicylate, New technology to prepare cream. Results The cream made with the improved process was improved in texture and easier to apply. The phenyl salicylate measured by HPLC had a good linearity (r = 0.9999) in the range of 0.04-0.16 μg / ml with an average recovery of 99.3% and RSD = 1.9% (n = 3). Conclusion The improved preparation process is scientifically reasonable, stable and controllable. The determination of phenyl salicylate by high performance liquid chromatography is simple, rapid, accurate and suitable for quality control of the preparation.