摘要
目的:为确保制剂的质量、疗效和使用的安全性,在确定了槐定碱微球的最佳处方和工艺后,对微球的形态、粒径、红外以及体外释药等方面的制剂学性质进行考察和评价。方法:用乳化交联法制备槐定碱微球,用光学显微镜、扫描电镜、高效液相色谱仪、红外光谱法、差示扫描量热测定法等检测手段对槐定碱微球的理化性质进行考察。结果:槐定碱微球外观圆整,分散性良好,平均粒径为8.95μm。利用红外光谱扫描法和差示扫描量热测定验证了槐定碱与微球之间没有发生化学反应,两者之间只发生了物理包埋。体外释放时,利用动态透析法考察微球的体外释药特性,结果表明,原料药在4h内基本释放完全,而槐定碱微球在24h内累计释放量近75%,说明槐定碱微球具有缓释作用。结论:乳化交联法制备得到的槐定碱微球制剂的质量良好。
Objective:In order to ensure the quality,efficacy and safety of sophoridine microspheres,the morphology,particle size,infrared spectrum and in vitro drug release of sophoridine microspheres were investigated and evaluated after determining the optimal formulation and technology.Methods:Sophoridine microspheres were prepared by emulsion crosslinking method.The physicochemical properties of sophoridine microspheres were investigated by optical microscope,scanning electron microscope,high performance liquid chromatography,infrared spectroscopy and differential scanning calorimetry.Results:Sophoridine microspheres were round in appearance and well dispersed with an average particle size of 8.95μm.Infrared spectroscopy and differential scanning calorimetry were used to verify that there was no chemical reaction between sophoridine and microspheres,but only physical embedding between them.The results showed that the drug substance was basically released within 4 hours,while the cumulative release of sophoridine microspheres was nearly 75% within 24 hours,indicating that sophoridine microspheres had sustained-release effect.Conclusion:The quality of sophoridine microspheres prepared by emulsion crosslinking method is good.
作者
王瑞琳
樊彦会
侯伟娜
董雪婷
Wang Ruilin(School of Pharmacy,Harbin University of Commerce,Harbin 150076)
出处
《黑龙江医药》
CAS
2022年第2期257-260,共4页
Heilongjiang Medicine journal
基金
国家级大学生创新创业训练计划项目(编号:202010240011)。
关键词
槐定碱
微球
乳化交联法
制备工艺
质量评价
Sophoridine
microspheres
emulsion crosslinking method
preparation technology
quality evaluation
