2种晶型利福平制剂之间溶出曲线的差异  

Differences of dissolution profiles between two crystallines types of fixed dose combinations of rifampin

作　　者：陈华[1] 赵文[1] 毛睿[1] 南楠[1] 丁丽霞[1] 金少鸿[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《药物分析杂志》2013年第5期881-884,893,共5页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:比较不同晶型制剂之间利福平溶出度的差异。方法:采用中国药典溶出度桨法装置测定溶出曲线,3种不同pH的溶出介质体积为900 mL,溶出介质温度为37℃,桨转速为75 r.min-1;使用适当的HPLC方法对利福平的溶出度进行测定。结果:大多数Ⅰ晶型制剂比作为参比的Ⅱ晶型制剂所得到的溶出度结果相似或较高。结论:排除制剂工艺的影响后,Ⅰ晶型制剂与作为参比的Ⅱ晶型在溶出度结果上相似或更优。Objective： To compare the differences of the dissolution profiles of two crystalline types of the fixed dose combinations（FDCs） of rifampin. Methods：Three dissolution profiles in media（900 mL）with different pH were obtained using the dissolution determination apparatus of paddle method in ChP. The temperature of the media was 37 ℃ and the rotation speed was 75 r·min^-1. A proper HPLC method was selected and used to determine the dissolution. Results：Most dissolution results of the FDCs made by crystalline type Ⅰ were similar to or higher than those reference substances made by crystalline type Ⅱ. Conclusion：It indicates that Rifampin of crystalline type Ⅰ hasthe similar or better dissolubility compared with the type Ⅱ , excluding the influence of pharmaceutical technologies.

关 键 词：半合成抗结核药 利福平 多晶型制剂 相似因子 溶出度差异 崩解时限 

分 类 号：R917[医药卫生—药物分析学]