盐酸克林霉素棕榈酸酯制剂的一致性评价研究  

Consistency Evaluation of Two Clindamycin Palmitate Hydrochloride Preparations

作　　者：黄昕[1] 张超 林锋[1] 周翠兰 苏薇薇[1] 彭维[1] 

机构地区：[1]中山大学生命科学大学院,广东广州510275 [2]广州一品红制药有限公司,广东广州510760

出　　处：《中山大学学报（自然科学版）》2015年第3期115-118,共4页Acta Scientiarum Naturalium Universitatis Sunyatseni

基　　金：广东省科技计划资助项目(2012B090600020)

摘　　要：对国产盐酸克林霉素棕榈酸酯分散片及国外原研产品盐酸克林霉素棕榈酸酯干混悬剂进行一致性评价研究。采用高效液相色谱法,流动相A为乙腈,流动相B为5 mmol·L-1醋酸铵溶液-乙腈(50∶50),进行梯度洗脱,检测其有关物质;采用桨法,以w=0.4%十二烷基硫酸钠为溶出介质,转速为75 r/min测定其溶出度。研究发现:国产盐酸克林霉素棕榈酸酯分散片有关物质种类及总量均低于国外原研产品干混悬剂;在20min时,溶出度均达标示量的94%以上。Consistency evaluation was processed between domestic clindamycin palmitate hydrochloride dispersible tables and the original oral solution. HPLC method was applied to detect related substances with acetate（ A） and 5 mmol / L ammonium acetatesolution-acetonitrile（ 50∶ 50）（ B） as mobile phase eluting in gradient. Dissolution was conducted by stirring paddle method with w = 0. 4% SDS as dissolution medium,at the rotate speed of 75 r / min for quality comparison between two products. The results showed that the kinds and total contents of related substances in clindamycin palmitate hydrochloride dispersible tablets were lower than that of the original oral solution products and the dissolution rates of both products reached more than 94% in 20 minutes.

关 键 词：盐酸克林霉素棕榈酸酯 有关物质 溶出度 

分 类 号：R94[医药卫生—药剂学]