氟比洛芬干混悬剂的制备及其质量控制

目的:制备氟比洛芬干混悬剂并建立其质量控制方法。方法:以羟丙基甲基纤维素为助悬剂制备氟比洛芬干混悬剂,考察制剂的沉降体积比、再分散性、形态、粒径分布、黏度等,采用高效液相色谱法测定制剂中主药的含量,并考察了制剂在40℃、75%湿度的条件下放置6个月的稳定性。结果:氟比洛芬干混悬剂沉降体积比平均值不低于0.90,再分散性好;呈颗粒状,大小均匀,粒径分布主要集中在3～5μm(75%以上),黏度为59mPa·s,流动性良好;6批样品标示含量平均值为99.66%;制剂放置6个月各检测指标无明显变化。结论:所制氟比洛芬干混悬剂工艺简单、可行、重现性好,且性质稳定、质量可控。

Preparation and Quality Control of Flubiprofen Dry Suspension

OBJECTIVE：To prepare Flubiprofen dry suspension and to establish quality control method. METHODS：Flurbiprofen dry suspension was prepared using hydroxypropyl methyl cellulose as suspending agent. The sedimentation ratio,redispersibility,morphology,particle size distribution and suspension viscosity were investigated. HPLC method was used to determine the content of main components in formulations. The stability of suspension kept at 40 ℃ and 75% humidity condition for 6 months was studied. RESULTS：Average sedimentation ratio of Flurbiprofen dry suspension was no less than 0.90 with good redispersibility. Flurbiprofen dry suspension was granular and uniform. Particle size of Flubiprofen dry suspension mainly ranged 3～5 μm（more than 75%） . The viscosity of Flurbiprofen dry suspension was 59 mPa·s with good liquidity. The average labelled amount of 6 batches of samples was 99.66%. Flurbiprofen dry suspension showed no significant change in each index after 6 months. CONCLUSION：Prepared Flubiprofen dry suspension is simple and feasible in preparation technology and reproducible,stable and controllable in property.