尿素软膏处方优化及其稳定性考察

发布时间：2018-12-11 01:34

【摘要】：目的对尿素软膏处方进行调整,并对其稳定性进行考察。方法按照原规定处方,配制4组尿素软膏。采用两个不同厂家的黄凡士林配制成尿素软膏A和B;采用同样来源的原料,在夏季和冬季配制成尿素软膏C和D,观察4组尿素软膏黏度及感官成型性差异。采用单因素影响实验调整尿素软膏处方,制得3批成品,考察其稳定性。结果按照原规定处方配制,使用厂家1配制的尿素软膏黏度大于厂家2,成型性较好;夏季配制的尿素软膏相对于冬季配制的软膏黏度较小,成型性较差。调整后的处方中蜂蜡的量有所增加。3批调整后的尿素软膏在11个月内外观未发生变化,含量及微生物限度均在合格范围内。结论原料厂家来源不同、配制的外部环境改变可影响尿素软膏的性状,调整后的处方是稳定的。
[Abstract]:Objective to adjust the prescription of urea ointment and investigate its stability. Methods four groups of urea ointment were prepared according to the original prescriptions. Urea ointment A and B were prepared from two different factories of Huangvaseline, and urea ointment C and D were prepared in summer and winter with the same raw materials. The viscosity and sensory formability of urea ointment were observed in four groups. Three batches of finished products were prepared by adjusting the prescription of urea ointment by single factor experiment, and its stability was investigated. Results according to the original prescription, the viscosity of urea ointment prepared by manufacturer 1 was higher than that of manufacturer 2, and the formability of urea ointment prepared in summer was lower than that in winter. Three batches of adjusted urea ointment had no change in appearance within 11 months, and the content and microbial limit were within the range of eligibility. Conclusion the change of external environment can affect the properties of urea ointment, and the adjusted prescription is stable.
【作者单位】：解放军总医院制剂中心;
【分类号】：R943

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