【摘要】：目的對尿素軟膏處方進行調整,并對其穩(wěn)定性進行考察。方法按照原規(guī)定處方,配制4組尿素軟膏。采用兩個不同廠家的黃凡士林配制成尿素軟膏A和B;采用同樣來源的原料,在夏季和冬季配制成尿素軟膏C和D,觀察4組尿素軟膏黏度及感官成型性差異。采用單因素影響實驗調整尿素軟膏處方,制得3批成品,考察其穩(wěn)定性。結果按照原規(guī)定處方配制,使用廠家1配制的尿素軟膏黏度大于廠家2,成型性較好;夏季配制的尿素軟膏相對于冬季配制的軟膏黏度較小,成型性較差。調整后的處方中蜂蠟的量有所增加。3批調整后的尿素軟膏在11個月內外觀未發(fā)生變化,含量及微生物限度均在合格范圍內。結論原料廠家來源不同、配制的外部環(huán)境改變可影響尿素軟膏的性狀,調整后的處方是穩(wěn)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.
【作者單位】： 解放軍總醫(yī)院制劑中心;
【分類號】：R943

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