甘油止痒乳剂的制备和质量控制研究

Preparation and Quality Control of the Glycerol Itching-relieving Emulsion

目的探讨甘油止痒乳剂的制备及其质量控制方法。方法将水相和油相分别加热至75℃,在搅拌下将水相缓缓加入到油相中,待乳剂温度降至40℃以下时,加入苯酚和薄荷脑,搅拌至凝。采用紫外分光光度法测定其苯酚含量。结果苯酚最大吸收波长为270 nm,基质对其无干扰,苯酚含量在5.6～44.8μg/ml范围内与吸收度呈线性关系,吸光系数E11%cm为160.2(r=0.9999),平均回收率为98.99%。结论甘油止痒乳剂性质稳定,制备简便,质量控制方法准确、可靠。

Objective To explore the preparation and quality control of glycerol itching-relieving emulsion. Methods The aqueous phase and oil phase were heated to 75℃ respectively. Oil phase was added slowly into aqueous phase with stirring the mixture. The eutectic of phenol and menthol was added into when the emulsion temperature decreased below 40, and stirred the emulsion into coagulation. Phenol content was measured by ultraviolet spectrophotometry. Results The maximum phenol absorptive wavelength was 270 nm without the interference of groundplasm. Linear relationship was got between phenol content and absorbance when the range of phenol content was within 5.6-44.8 μg/ml. Absorption coefficient E1cm^1% was 160.2 （r = 0. 9999）, and average recovery rate was 98.99%. Conclusion The glycerol itching-relieving emulsion is stable and it is easy to be preparated, so the quality control method is an accurate and reliable method.