中山大学学报（自然科学版）Issue(3)：115-118,4.DOI:10.13471/j.cnki.acta.snus.2015.03.020
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
摘要
Abstract
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 e-luting in gradient.Dissolution was conducted by stirring paddle method with w =0.4% SDS as dissolu-tion 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 dis-persible 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Key words
clindamycin palmitate hydrochloride/related substances/dissolution分类
医药卫生引用本文复制引用
黄昕,张超,林锋,周翠兰,苏薇薇,彭维..盐酸克林霉素棕榈酸酯制剂的一致性评价研究[J].中山大学学报（自然科学版）,2015,(3):115-118,4.基金项目
广东省科技计划资助项目 （）
