尿素软膏处方优化及其稳定性考察

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.

Prescription optimization and stability investigation of urea ointment

Objective To adjust the prescription of urea ointment and investigate its stability .Methods In accordance with the original prescription , four groups of urea ointment were prepared .Group A and group B were made with yellow vaseline from different manufacturers , while groups C and D were prepared in summer and winter respectively with the same source materials.The viscosity and moldability of the four groups were evaluated through the senses .The prescription was slightly adjusted through the single-factor effect experiment .Three batches of urea ointment were prepared according to the new prescription and their stability was investigated .Results Using the original prescription , the urea ointment made with yellow vaseline provided by Manufacturer One had better viscosity and moldability than that from Manufacturer Two .The urea ointment made in summer had lower viscosity and poorer moldability than the one made in winter .The amount of beeswax increased in the adjusted prescription .Three batches of urea ointment were prepared with the new prescription and their stability was maintained .There were no changes in appearance , and the content and microbial limit remained in the standard range for 11 months.Conclusion The source of materials and change of the external environment could affect the characteristics of urea ointment .The adjusted prescription is feasible and stable .