基于QbD理念优化抗骨增生片喷雾干燥工艺及其物理指纹图谱研究  

Optimization of spray drying process and physical fingerprint of Kanggu Zengsheng tablets based on quality by design

作　　者：蒋鑫铖 吴样明 刘紫璇 况弯弯 季巧遇 JIANG Xin-cheng;WU Yang-ming;LIU Zi-xuan;KUANG Wan-wan;JI Qiao-yu(School of Pharmacy,Jiangxi University of Traditional Chinese Medicine,Nanchang 330004;Jiangzhong Pharmaceutical Co.,Ltd.,Nanchang 330004)

机构地区：[1]江西中医药大学药学院,南昌330004 [2]江中药业股份有限公司,南昌330004

出　　处：《中南药学》2021年第6期1062-1066,共5页Central South Pharmacy

摘　　要：目的基于质量源于设计(QbD)理念优化抗骨增生片喷雾干燥工艺并建立浸膏粉物理指纹图谱对其进行质量控制。方法采用响应曲面法以得粉率为关键质量属性对关键工艺参数构建数学模型,从而确定设计空间。采用物理指纹图谱对抗骨增生片浸膏粉进行综合表征,建立由11个二级物理质量指标构成的指纹图谱用于批次间物理性质评价。结果关键工艺参数进风温度和料液密度最佳范围分别为124~127℃、1.089~1.097 g·mL^(-1);在设计空间内制得的6批浸膏粉物理指纹图谱相似度均在99.6%以上,表明工艺产出质量稳定。结论基于QbD理念优化的抗骨增生片喷雾干燥工艺稳定可行,浸膏粉物理性质质量评价科学合理,可为后期研究及放大生产提供参考。Objective To optimize the spray drying process of Kanggu Zengsheng tablets based on quality by design(QbD)concept and establish the physical fingerprint of the extract powder for quality control.Methods The response surface method was used to establish a mathematical model for the critical parameters based on the powder yield rate and the critical quality attributes to determine the design space.The physical fingerprints were used to comprehensively characterize Kanggu Zengsheng tablet extract powder,and a fingerprint with 11 secondary physical quality indicators was established to evaluate the physical properties among batches.Results The optimal ranges of the inlet air temperature and material liquid density were 124~127℃and 1.089~1.097 g·mL^(-1).The similarity of the physical fingerprints of 6 batches extract powder was above 99.6%,indicating stable quality of the process output.Conclusion The spray drying process of Kanggu Zengsheng tablets based on QbD is stable and feasible.The physical properties of the extract powder are evaluated scientifically,which can provide a reference for future research and mass production.

关 键 词：抗骨增生片 质量源于设计 喷雾干燥 物理指纹图谱 

分 类 号：TS225.24[轻工技术与工程—粮食、油脂及植物蛋白工程]