1％盐酸林可霉素乳膏的制备及质量控制  

Preparation and Quality Control of 1% Lincomycin Hydrochloride Cream

作　　者：舒冰[1] 方焱[1] 肖明[1] 张善堂[1] 

机构地区：[1]安徽医科大学附属省立医院药剂科,合肥230001

出　　处：《中国药师》2008年第9期1047-1049,共3页China Pharmacist

摘　　要：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 to establish a method for its quality control. Method： The cream was prepared with O/W as base. The content of the cream was determined by HPLC. Chromatographic determination was performed on Hypersil Cls column（250 mm× 4.6,m,5 μm） with phosphoric acid buffer（ adjusted to pH 6.8）-methanol（40： 60） as the mobile phase and flow rate was 0.8 ml.min-1. Detection wavelength was at 214 nm ,and the column temperature was 30 ℃. Result： The prepared cream was up to the standard stated in China Pharmacopeia. The linear range of lincomycin hydrochloride was 0. 240 2 - 0. 560 6 mg· ml-1 （ r = 0.999 8 ）, and the average recovery was 99.7 %. Conclusion： The preparation process of lincomycin hydrochloride cream was simple. The method of quality control was rapid and accurate.

关 键 词：盐酸林可霉素 乳膏 质量控制 

分 类 号：R944.21[医药卫生—药剂学]