【摘要】 目的制备水包油型非离子复方羊毛脂尿素乳膏,考察其稳定性,并验证其治疗皮肤皲裂的临床效果。方法以羊毛脂和尿素为主药,以非离子型乳化剂司盘-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;通过离心试验、耐寒耐热试验、留样观察、p H值、乳滴粒径等考察其稳定性;并以尿素乳膏作对照,观察临床疗效。结果制备的乳膏细腻、均匀、稳定,易于涂布及洗除;稳定性试验均符合规定;临床疗效优于尿素乳膏。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,临床疗效好。更多还原

【Abstract】 Objective To prepare a nonionic compound lanolin urea cream of the oil in water type and investigate its stability, and to verify its clinical efficacy for the treatment of chapped skin. Methods The O/W compound lanolin urea cream was prepared by fast-adding reversed phase preparation method with urea and lanolin as principal components, non-ionic emulsifier span-60 and tween-60 as paired emulsifier, and glycerol monostearate as stabilizer.The stability of cream was evaluated by centrifugation test, cold and heat resistant test, sample observation test under room temperature, p H, droplet size. The clinical efficacy of cream was verified with urea cream as a reference preparation. Results The prepared cream was stable, uniform in color, homogeneous, exquisite and easy to spread and wash out. The results of stability test were in accordance with the regulations of SFDA. The clinical efficacy of the prepared cream was better than that of urea cream. Conclusion The formulation and preparation technology of compound lanolin urea cream is optimal and feasible. The prepared cream has a good stability and controllable quality. The cream has excellent clinical efficacy and is worthy of wide use in clinical practice.更多还原