目的:基于“质量源于设计”(quality by design,QbD)理念,采用设计空间法优化蒙药地格达-4味汤喷雾干燥工艺。方法:以得粉率、水分含量及4个指标成分(秦皮乙素、栀子苷、胡黄连苷I、胡黄连苷II)转移率总评“归一值”(OD)作为关键质量属...目的:基于“质量源于设计”(quality by design,QbD)理念,采用设计空间法优化蒙药地格达-4味汤喷雾干燥工艺。方法:以得粉率、水分含量及4个指标成分(秦皮乙素、栀子苷、胡黄连苷I、胡黄连苷II)转移率总评“归一值”(OD)作为关键质量属性(critical quality attribute,CQAs),采用Plackett-Burman实验设计,筛选出喷雾干燥工艺的关键工艺参数(critical process parameter,CPPs);采用中心点复合设计实验,通过逐步回归法建立CQAs和CPPs间的数学模型,根据模型建立设计空间并对其预测结果进行验证。结果:通过Plackett-Burman实验设计确定了进风温度和进料速度为喷雾干燥工艺的CPPs;中心点复合设计实验方差分析结果表明回归模型的P值小于0.05,表明所建模型具有较好的预测性,并通过设计空间确定关键工艺参数进风温度和进料速度的最佳范围分别为135~140℃和15%~20%,该范围内的工艺参数均可以满足目标要求,且经验证后与预测结果一致。结论:基于QbD理念建立蒙药地格达-4味汤喷雾干燥工艺的设计空间,可以提高喷雾干燥过程的灵活性和稳定性,有利于促进保障产品质量的一致性。展开更多
Hydrogen desorption kinetics and characteristics,residual hydrogen content and activation energy of TC21 alloy were investigated by the constant volume method.Results show that hydrogen desorption temperature and init...Hydrogen desorption kinetics and characteristics,residual hydrogen content and activation energy of TC21 alloy were investigated by the constant volume method.Results show that hydrogen desorption temperature and initial hydrogen pressure affect hydrogen desorption characteristics of TC21 alloy.The hydrogen desorption process is mainly dominated by nucleation and growth process(kt=[-ln(1-α)]^(2/3)),chemical reaction process(kt=(1-α)^(-1/2))and three-dimensional diffusion process(kt=[1-(1-α)^(1/3)]^(1/2))when the hydrogenated TC21 alloy is dehydrogenated at temperatures of 700-940°C.When the hydrogenated TC21 alloy releases hydrogen,the following relationship exists among the rate constants of each process:k(chemical reaction process)>k(nucleation and growth process)>k(three-dimensional diffusion process).The residual hydrogen content of the hydrogenated TC21 alloy after hydrogen desorption decreases gradually with the increase in hydrogen desorption temperature,and increases gradually with the increase in the initial hydrogen pressure.The activation energy of TC21 alloy in the process of hydrogen desorption is about 26.663 kJ/mol.展开更多
文摘目的:基于“质量源于设计”(quality by design,QbD)理念,采用设计空间法优化蒙药地格达-4味汤喷雾干燥工艺。方法:以得粉率、水分含量及4个指标成分(秦皮乙素、栀子苷、胡黄连苷I、胡黄连苷II)转移率总评“归一值”(OD)作为关键质量属性(critical quality attribute,CQAs),采用Plackett-Burman实验设计,筛选出喷雾干燥工艺的关键工艺参数(critical process parameter,CPPs);采用中心点复合设计实验,通过逐步回归法建立CQAs和CPPs间的数学模型,根据模型建立设计空间并对其预测结果进行验证。结果:通过Plackett-Burman实验设计确定了进风温度和进料速度为喷雾干燥工艺的CPPs;中心点复合设计实验方差分析结果表明回归模型的P值小于0.05,表明所建模型具有较好的预测性,并通过设计空间确定关键工艺参数进风温度和进料速度的最佳范围分别为135~140℃和15%~20%,该范围内的工艺参数均可以满足目标要求,且经验证后与预测结果一致。结论:基于QbD理念建立蒙药地格达-4味汤喷雾干燥工艺的设计空间,可以提高喷雾干燥过程的灵活性和稳定性,有利于促进保障产品质量的一致性。
基金National Natural Science Foundation of China(52275328,51875157)。
文摘Hydrogen desorption kinetics and characteristics,residual hydrogen content and activation energy of TC21 alloy were investigated by the constant volume method.Results show that hydrogen desorption temperature and initial hydrogen pressure affect hydrogen desorption characteristics of TC21 alloy.The hydrogen desorption process is mainly dominated by nucleation and growth process(kt=[-ln(1-α)]^(2/3)),chemical reaction process(kt=(1-α)^(-1/2))and three-dimensional diffusion process(kt=[1-(1-α)^(1/3)]^(1/2))when the hydrogenated TC21 alloy is dehydrogenated at temperatures of 700-940°C.When the hydrogenated TC21 alloy releases hydrogen,the following relationship exists among the rate constants of each process:k(chemical reaction process)>k(nucleation and growth process)>k(three-dimensional diffusion process).The residual hydrogen content of the hydrogenated TC21 alloy after hydrogen desorption decreases gradually with the increase in hydrogen desorption temperature,and increases gradually with the increase in the initial hydrogen pressure.The activation energy of TC21 alloy in the process of hydrogen desorption is about 26.663 kJ/mol.
