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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。
Objective To adjust the formulation of urea ointment and investigate its stability. Methods According to the original prescription, preparation of four urea ointment. Using two different manufacturers of yellow Vaseline formulated urea ointment A and B; using the same source of raw materials, formulated in summer and winter, urea ointment C and D, observed four groups of urea ointment viscosity and sensory differences. Using single-factor experiment to adjust the prescription of urea ointment, three batches of finished product were obtained and its stability was investigated. The results were formulated according to the prescription. The viscosity of Urea Ointment prepared by Factory 1 was greater than that of Factory 2, and the formability was better. The urea ointment formulated in summer had lower viscosity and poor moldability than that of winter ointment. The amount of beeswax in the adjusted prescription increased. Three batches of adjusted urea ointment in the 11 months did not change the appearance, content and microbial limits are within the eligible range. Conclusion Different sources of raw materials manufacturers, the preparation of the external environment changes can affect the properties of urea ointment, the adjusted prescription is stable.