基于QbD理念和层次分析-熵权法优化小承气颗粒的喷雾干燥工艺  

Optimization of Spray Drying Process for Xiaochengqi Granules Based on QbD Concept and Analytic Hierarchy Process Combined with Entropy Method

作　　者：施文婷 杨赞 冯倩仪 陈伟媚 陈江平 SHI Wenting;YANG Zan;FENG Qianyi;CHEN Weimei;CHEN Jiangping(Guangdong Provincial Key Lab.of Traditional Chinese Medicine Formula Granule,Guangdong Yifang Pharmaceutical Co.,Ltd.,Foshan 528244)

机构地区：[1]广东一方制药有限公司,广东省中药配方颗粒企业重点实验室,广东佛山528244

出　　处：《中国医药工业杂志》2024年第9期1229-1230,1231-1235,共7页Chinese Journal of Pharmaceuticals

基　　金：佛山市核心技术攻关项目(1920001000378)。

摘　　要：该研究基于质量源于设计(QbD)理念,构建了小承气颗粒喷雾干燥工艺的设计空间。以得粉率、水分、柚皮苷含量、新橙皮苷含量、和厚朴酚含量、厚朴酚含量、大黄素含量、大黄酚含量作为关键质量属性(CQAs),通过层次分析-熵权法确定各质量指标的综合权重系数,并计算综合评分值。通过Plackett-Burman设计确定了药液相对密度和进料速度为小承气颗粒喷雾干燥工艺的关键工艺参数(CPPs);继而运用中心复合设计试验优化筛选出的CPPs。通过模型拟合获得设计空间,并在设置95%置信区间的基础上确定药液相对密度为1.03~1.06,进料速度为6~12 mL/min。并且验证结果表明,该设计空间内的工艺参数能保证小承气颗粒喷雾干燥过程和产品质量的稳定性。This study constructed and optimized the design space of the spray drying process for Xiaochengqi granules based on the concept of quality by design(QbD).The powder yield,moisture content,contents of naringin,neohesperidin,honokiol,magnolol,emodin and chrysophanol were taken as critical quality attributes(CQAs).The comprehensive weight coefficient of each CQA was determined by the analytic hierarchy process combined with entropy method,then the comprehensive scores of evaluation were calculated.According to the results of Plackett-Burman design,the relative density of the liquid medicine and the feeding speed were identified as the critical process parameters(CPPs)for the spray drying process of Xiaochengqi granules.Then,the central composite design was used to optimize the ranges of the selected CPPs.The design space was obtained through model fitting,and based on a 95%confidence interval,the relative density of the liquid medicine was determined to be 1.03-1.06,and the feeding speed was 6-12 mL/min.The verification results showed that the process parameters within the design space could ensure the stability of the spray drying process and product quality of Xiaochengqi granules.

关 键 词：质量源于设计 小承气颗粒 喷雾干燥 层次分析法 熵权法 PLACKETT-BURMAN设计 中心复合设计 设计空间 

分 类 号：R283.6[医药卫生—中药学] R944.27[医药卫生—中医学]