包茎松凝胶的制备及质量控制

Preparation and Quality Control of Baojingsong Hydrogel

目的:制备包茎松凝胶并建立质量控制方法。方法:以倍他米松和红霉素为主药,卡波姆-940为主要基质制备凝胶;采用紫外可见分光光度法测定其中主药含量。结果:所得凝胶符合凝胶剂质量要求,质量控制方法准确可靠.倍他米松检测浓度在6.15～20.49μg·ml^(-1)范围内线性关系良好(r=0.999 4),平均回收率为98.34%,RSD=0.80%;红霉素检测浓度在10.09～60.55μg·ml^(-1)范围内线性关系良好(r=0.999 1),平均回收率为97.79%,RSD=1.79%。结论:本制备工艺简单可行;质控方法可控制该制剂质量。

Objective： To prepare Baojingsong hydrogel and establish its quality control method. Method： Erythomycin and betamethasone were used as principal drugs, carboner-940 was used as key base material, and the Baojingsong hydrogel was preparaed; The contents of the principal drugs were determined by vis-UV spectrophotometry. Result： The Baojingsong hydrogel was suitable with quality requirement, and the quality control method was reliable, accurate. The detection concentration of betamethasone was linear within the ranges of 6.15 - 20.49 μg·ml-1 （ r = 0. 999 4）, and the average recovery rate was 98.34% with RSD 0, 80%. The detection concentration of crythromycin was linear within the ranges of 10.09 -60.55μg·ml-1（r = O. 999 1 ）, and the average recovery rate was 97.79% with RSD 1.79%. Conclusion： The preparing procedure was convenient and feasible. The quality control method could control the quality of Baojingsong hydrogel.