消旋卡多曲胶囊溶出度方法的研究

Investigation on Dissolution Method of Racecadotril Capsules

目的:建立国内研制的消旋卡多曲胶囊的溶出度测定方法。方法:通过筛选不同溶出介质、转速、溶出时间等确定溶出度方法;采用高效液相色谱法检测含量并计算累积溶出量,同时与国外同类样品进行溶出行为的比较。结果:确定的溶出度方法是以异丙醇-水(55∶45)为溶出介质,转速为75r·min-1,取样时间为45min,选用桨法进行考察;消旋卡多曲检测浓度线性范围为5.5～176μg·mL-1(r=0.99998),平均回收率99.7%(RSD=0.46%,n=9);与国外样品比较,3批国内样品在前20min时释药较慢,在30min后的溶出二者基本一致。结论:所建立的溶出度测定方法可作为该制剂体外释药的一种检测手段。

OBJECTIVE： To establish the method for dissolution test of Racecadotril capsules. METHODS： Dissolution method was confirmed by screening dissolution medium, rotation speed, dissolution time, etc. The content of racecadotril was determined by HPLC and accumulative dissolution amount was calculated. The dissolution of nationally developed Racecadotril capsules was compared with foreign one. RESULTS： Isopropanol-water （55 ∶ 45） was used as medium at rotation speed of 75 r·min^-1. Sampling time was 45 min and paddle method was adopted. The linear range of racecadotril was 5.5～176 μg·mL-1 （r=0.999 98） with an average recovery of 99.7% （RSD=0.46%, n=9）. The dissolution of 3 batches of nationally developed Racecadotril capsules samples was slower than foreign one at the first 20 min. After 30 min the dissolution of nationally developed samples was basically consistent with foreign one. CONCLUSION： Established method for dissolution test can be used as a quality control method for in vitro drug delivery of Racecadotril capsules.