The quality standards for Fructus Comi have been established based on the effects of the manufacturing processes.Three critical process parameters(CPPs)of extraction,filtration,and concentration to prepare Fructus Com...The quality standards for Fructus Comi have been established based on the effects of the manufacturing processes.Three critical process parameters(CPPs)of extraction,filtration,and concentration to prepare Fructus Comi concentrate were identified by Plackett-Burman design with a single batch of Fructus Corni,which were heating medium temperature,extraction time,and water addition.Morroniside yield,loganin yield,and dry matter yield were process critical quality attributes(CQAs).CPPs arranged with a Box-Behnken design were applied to treat different batches of Fructus Comi After constructing a model that included CPPs,material propertie s,and process CQAs,loganin content was found to be the critical material attribute(CMA).The design space was calculated with a probability method.According to the limits of process CQAs,the minimum content of loganin in Fructus Corni was calculated with an error propagation method,which was 6.92 mg·g^(-1).When the content of loganin in Fructus Corni reaches up to 6.92 mg·g^(-1),the material is considered high-quality and is most suitable for the process.High-quality material can be used for production of Fructus Comi concentrate.This method can also be used to set material quality standards for other Chinese medicines.展开更多
Phar.Eur.Herbal Drug(HD)monographs state which aspects have to be considered for quality assurance through the relevant chapters'Definition'.'Characters','Identification','Tests',and...Phar.Eur.Herbal Drug(HD)monographs state which aspects have to be considered for quality assurance through the relevant chapters'Definition'.'Characters','Identification','Tests',and'Assay'.Identification of botanical material is achieved by macroscopic and microscopic morphology,generally examined by a trained expert.Content or assay is the most difficult area of展开更多
Industrial mixers for powders and granular materials operate with no effective control of mixture quality and lack scientific design. The last twenty years have seen growth in understanding of mixing and mixers. Howev...Industrial mixers for powders and granular materials operate with no effective control of mixture quality and lack scientific design. The last twenty years have seen growth in understanding of mixing and mixers. However, research falls far short of what is needed for on-line characterisation of mixture quality. Secondly, although theoretical descriptions of a few mixer types have been reported, these fall far short of what is needed for equipment design. Two thrusts could revolutionise this situation. One is a scientific characterisation of mixer structure applicable to industrial scale as well as laboratory scale equipment; this is now within our grasp using digital imaging. The other is the development of ideas to overcome the restricted number of particles that can be used in the Distinct Element Method （DEM） for mixers. The goal should be to take the designer through a sequence of steps to the most appropriate mixer size, configuration and operating conditions for a given process duty.展开更多
基金Supported by the Open Fund of Key Laboratory of Modern Chinese Medicine Preparations,Ministry of Education,Jiangxi University of Traditional Chinese Medicine and First-class Discipline Construction Project of Jiangxi Province(JXSYLXK-ZHYAO009,JXSYLXK-ZHYAO010)。
文摘The quality standards for Fructus Comi have been established based on the effects of the manufacturing processes.Three critical process parameters(CPPs)of extraction,filtration,and concentration to prepare Fructus Comi concentrate were identified by Plackett-Burman design with a single batch of Fructus Corni,which were heating medium temperature,extraction time,and water addition.Morroniside yield,loganin yield,and dry matter yield were process critical quality attributes(CQAs).CPPs arranged with a Box-Behnken design were applied to treat different batches of Fructus Comi After constructing a model that included CPPs,material propertie s,and process CQAs,loganin content was found to be the critical material attribute(CMA).The design space was calculated with a probability method.According to the limits of process CQAs,the minimum content of loganin in Fructus Corni was calculated with an error propagation method,which was 6.92 mg·g^(-1).When the content of loganin in Fructus Corni reaches up to 6.92 mg·g^(-1),the material is considered high-quality and is most suitable for the process.High-quality material can be used for production of Fructus Comi concentrate.This method can also be used to set material quality standards for other Chinese medicines.
文摘Phar.Eur.Herbal Drug(HD)monographs state which aspects have to be considered for quality assurance through the relevant chapters'Definition'.'Characters','Identification','Tests',and'Assay'.Identification of botanical material is achieved by macroscopic and microscopic morphology,generally examined by a trained expert.Content or assay is the most difficult area of
文摘Industrial mixers for powders and granular materials operate with no effective control of mixture quality and lack scientific design. The last twenty years have seen growth in understanding of mixing and mixers. However, research falls far short of what is needed for on-line characterisation of mixture quality. Secondly, although theoretical descriptions of a few mixer types have been reported, these fall far short of what is needed for equipment design. Two thrusts could revolutionise this situation. One is a scientific characterisation of mixer structure applicable to industrial scale as well as laboratory scale equipment; this is now within our grasp using digital imaging. The other is the development of ideas to overcome the restricted number of particles that can be used in the Distinct Element Method （DEM） for mixers. The goal should be to take the designer through a sequence of steps to the most appropriate mixer size, configuration and operating conditions for a given process duty.
