Study on Optimization of spray Drying Process of Banlangen Formula Granules
- VernacularTitle:板蓝根配方颗粒喷雾干燥工艺优化研究
- Author:
Lanlan ZHANG
1
;
Wenting SHI
;
Weimei CHEN
;
Zan YANG
;
Xingpeng HUANG
;
Qingqing TIAN
;
Zheng ZHANG
Author Information
- Keywords: Quality by design; Banlangen(Isatidis Radix)formula granules; Spray drying; Plackett-Burman experimental design; Central-composite design
- From: World Science and Technology-Modernization of Traditional Chinese Medicine 2024;26(1):202-210
- CountryChina
- Language:Chinese
- Abstract: Objective To optimize the spray drying process of Banlangen(Isatidis Radix)formula granules based on quality by design(QbD)concept.Methods Using powder yield and the contents of uridine,adenosine,guanosine,and(R,S)-goitron as the critical quality attributes(CQAs),Plackett-Burman design was used to screen out critical process parameters(CPPs)for inlet temperature,spray pressure,liquid temperature,pump speed,and liquid relative density.The central-composite design(CCD)test was used to optimize the CPPs,which were screened.Based on the quadratic polynomial regression model,the design space of spray drying process of Banlangen(Isatidis Radix)formula granules was established,and further validated by experiments.Results Plackett-burman test results show that liquid relative density and inlet velocity are the key parameters for the study.The variance analysis results of CCD test showed that the constructed model in a good prediction ability,since the P-values of model was less than 0.01 and P-values of items lack of fit was more than 0.05.The optimized design space of CPPs was the liquid relative density 1.05-1.08,and pump speed 30%-40%.Conclusion Based on the QbD concept,the design space for the spray drying process of Banlangen(Isatidis Radix)formula granules can improve the stability of its process and help ensure the consistency of product quality.
