目的:考察保肾片的最佳包衣材料、薄膜包衣工艺及其稳定性。方法:选用不同包衣材料,在相同条件下包衣,常温放置3个月后,观察其外观和崩解时限,选择外观无变化,崩解时限相对较短的包衣剂作为本品的衣材;采用正交试验探寻适合薄膜包衣的最佳工艺;并对样品进行稳定性考察。结果:欧巴代是保肾片薄膜包衣的最佳包衣材料;适合保肾片薄膜包衣的工艺条件是包衣至片芯增重约4%,片床温度50℃,包衣材料浓度8%;稳定性考察结果表明保肾片经过包衣后防潮性能有较大提高。结论:该包衣工艺简便高效,科学合理,适合保肾片的薄膜包衣。

The study is aimed to optimize the film-coating material and the process technology for the film-coating of Baoshen tablets.And the stability was also observed.Different film-coating materials were used.The film-coating material was optimized by selecting tablets with better appearance and shorter disintegration time in a 3-month stability test under the same condition.The film-coating process technology was studied by the orthogonal test and the stability was observed.The result showed that optimized film-coating material for Baoshen tablets was Opadry.The optimal process technology was as follows.The coating weight was increased about 4%,the temperature was 50℃,and the concentration of the coating material was 8%.The stability test showed the coated tablets have good resistance to moisture.It is concluded that the optimized film-coating technology was reasonable and easy to operate,and can be used for Baoshen tablets.

科学技术部国家“973”计划(2010CB735604):新药研制过程化学机理,负责人:萧伟