摘要
目的优化碘化钾蜡质骨架缓释片的包衣工艺并考察其稳定性。方法采用正交设计优化包衣工艺,以片剂外观性状、释放度、吸湿增重和含量为评价指标,采用多指标正交试验综合评分法评价正交试验结果,并用加速试验考察包衣后片剂的稳定性。结果正交试验优化的最佳包衣工艺条件为:遮光剂加入量为4%、包衣增重比例6%。通过优化包衣工艺包衣的碘化钾缓释片对光、湿和热稳定。结论包薄膜遮光衣能有效的解决碘化钾蜡质骨架型缓释片光、湿、热不稳定性问题。
Objective To optimize the coating process for potassium iodine wax matrix sustained-release tablets and its stability. Methods The optimization of coating was performed by orthogonal design and multi index compositive score method. The appearance, release, moisture absorption rate and content of tablets were the index of evaluation. Acceleration test was used to study the stability of the film coated tablets. Results The optimized coating conditions were 4% of opaquer content, and 6% of coating weight ratio. The potassium iodine wax matrix sustained-release tablets by coating film were stable under light, heat and wet condition. Conclusion Coating film with opaquer can effectively improve the instability of potassium iodine wax matrix sustained-release tablets under light, wet and heat condition.
出处
《中南药学》
CAS
2010年第1期24-27,共4页
Central South Pharmacy
关键词
碘化钾
缓释片
稳定性
薄膜衣
potassium iodine
sustained release tablet
stability
film coated
