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目的:制备盐酸林可霉素乳膏并建立其质量控制方法。方法:以水包油基质制备乳膏;采用高效液相色谱法测定盐酸林可霉素的含量;色谱柱:Hypersil C_(18)柱(250 mm×4.6 mm,5μm);流动相:磷酸缓冲液(pH=6.8)-甲醇(40∶60);流速0.8 ml·min~(-1);检测波长:214 nm;柱温:30℃。结果:制剂各项检查均符合《中国药典》2005年版相关规定;盐酸林可霉素的线性范围为0.240 2～0.560 6 mg·ml~(-1)(r=0.999 8),平均回收率为99.7%。结论:本制剂制备工艺简便,控制方法快速、准确。
Objective: To prepare lincomycin hydrochloride cream and establish its quality control method. Methods: The cream was prepared with oil-in-water matrix. The content of lincomycin hydrochloride was determined by high performance liquid chromatography. The column was Hypersil C 18 column (250 mm × 4.6 mm, 5 μm) Liquid (pH = 6.8) -methanol (40:60); flow rate 0.8 ml · min -1; detection wavelength: 214 nm; Results: All the preparations were in accordance with the relevant provisions of the 2005 edition of Chinese Pharmacopoeia. The linear range of lincomycin hydrochloride was 0.240 2-0.560 6 mg · ml -1 (r = 0.999 8). The average recovery was 99.7%. Conclusion: The preparation process of the preparation is simple and the control method is fast and accurate.