【摘要】 目的:改进复方林可霉素乳膏的质量标准。方法:对盐酸林可霉素和醋酸曲安奈德分别进行定性鉴别;建立HPLC法对盐酸林可霉素和醋酸曲安奈德同时定量检测的方法。结果:定性鉴别方法准确可行;盐酸林可霉素和醋酸曲安奈德的浓度分别在2.036~4.072μg/ml和0.052 7~0.105 4μg/ml范围内有良好的线性关系(r=0.999 5和r=0.999 0),平均回收率为99.27%(RSD为1.01%,n=9)和99.35%(RSD为0.91%,n=9)。结论:完善后的质量标准具有专属性强、准确度高、重复性好的特点,可用于该制剂的质量控制。更多还原

【Abstract】 Objective: To improve the quality standards of Compound Lincomycin Cream. Methods: Lincomycin hydrochloride and triamcinolone acetonide acetate were qualitatively identified simultaneously. A method for simultaneous determination of lincomycin hydrochloride and triamcinolone acetonide acetate was established. Results: The linear ranges were 2. 036 ~ 4. 072 μg/ml for lincomycin hydrochloride,and 0. 052 7 ~ 0. 105 4 μg/ml for triamcinolone acetonide acetate(r = 0. 999 5 and r = 0. 999 0); their average recoveries were 99. 27%(RSD was 1. 01%,n = 9),and 99. 35%(RSD was 0. 91%,n = 9). Conclusions: The improved quality standards are specific,accurate and reproducible. They can be used for quality control of Compound Lincomycin Cream.更多还原