[关键词]
[摘要]
目的 结合质量源于设计(quality by design,QbD)理念,对仙曲片的薄膜包衣工艺进行考察,以提高包衣效率和稳定性。方法 以"质量源于设计"理念为指导和Design-Expert软件为工具,确定影响仙曲片薄膜包衣目标的关键质量属性为响应值,影响关键质量属性的工艺参数为因素,运用Box-Behnken响应面法优化工艺参数,建立控制空间,通过测定仙曲片的吸湿性,对设计空间进行验证。结果 通过95%置信区间对空间进行优化,减小实际误差,得到最佳工艺参数范围:片床温度37~43℃,包衣液浓度9%~11%,包衣增重4%~5%,在既定条件下对仙曲片薄膜包衣后,片剂色泽均匀,片面光滑细腻,吸湿性显著降低。结论 以QbD为根本,采用合理的实验设计理念,通过建立合理的设计空间为仙曲片薄膜包衣过程提供预测模型,提高了包衣过程的可控性和可适用性,保证了稳定的产品质量。
[Key word]
[Abstract]
Objective To investigate the film coating process of Xianqu Tablets based on the concept of quality by design (QbD), and improve the coating efficiency and stability.Methods Using the QbD as an experimental guidance and the Design-Expert software as a tool, the critical quality attributes affecting Xianqu film coating targets were first determined as the response values, and the process parameters of influencing critical quality attributes were selected as the key factors. Then the Box-Behnken design was used to optimize the process parameters and establish a control space. Finally, the design space were verified by measuring the hygroscopicity of Xianqu Tablets.Results The results showed that the design space was optimized to reduce the actual error by 95% confidence interval, the best range of process parameters were obtained as follow:bed temperature 37-43℃, coating solution concentration 9%-11%, coating weight gain 4%-5%. After the Xianqu Tablets were coated under the given conditions, the hygroscopicity of Xianqu Tablets, which had a smooth surface and uniform color, was significantly reduced.Conclusion The desired effects by using a reasonable experimental design concept of QbD were efficiently achieved, it provides a predictive model for the film coating process of Xianqu Tablets through constructing reasonable design space, which not only enhances the flexibility and applicability of the coating process, but also ensures the stable product quality.
[中图分类号]
[基金项目]
自治区科技惠民项目"仙人掌健康产业关键技术集成示范"(2014KJHM16)