高原护唇膏的质量控制

Quality Control of Altiplano Lipcare Balm

目的:制定高原护唇膏的耐热、耐冻试验标准,采用HPLC法测定主要成分烟酰胺的含量。方法:将高原护唇膏分别置于45℃恒温培养箱和-10,-20,-70℃冰箱内,放置后观察。烟酰胺的含量测定采用高效液相色谱法,Shimpack ODS柱(150mm×4.6 mm,5μm),流动相为:甲醇-水(10:90);流速1.0 ml·min^(-1),检测波长为261 nm。结果:护唇膏在45,-10,-20,-70℃温度下放置24～72 h后,恢复至室温后膏体外观无明显变化,均能正常使用。烟酰胺在7.5～120.0μg·ml^(-1)范围内线性关系良好(r=0.999 9),平均回收率为100.5%,RSD为0.61%。结论:为高原护唇膏提供了一种准确可靠的质量控制方法。

Objective ： To establish a standard of heat/cold-resistant and a method for determination of the nicotinamide in ahiplano lipcare balm by HPLC. Method ： Altiplano lipeare balms were put in 45, - 10, - 20, - 70 ℃ constant temperature incubator or refrigerator. Nicotinamide were separated with a mobile phase of methanol-water solution （ 10： 90） on Shimpack ODS column （ 150 mm×4. 6 mm,5 μm） and detected at 261 nm. Result： After being placed in incubator or refrigerator for 24-72 h,there were not chang in ap pearance of the balms and the balms could be used normally. Good linearity appeared in the concentration of nicotinamide 7.5-120 μg·ml^-1 ,r =0. 999 9,the average recovery was 100. 5% ,RSD was 0. 61% （n =5）. Conclusion： The method can control the quality of altiplano lipeare balm.