Objective Based on the concept of quality by design(QbD),to establish the design space of Zhihuang detumescence gel plaster extraction process.Methods With Zhihuang detumescence gel plaster as the model drug,geniposide content and extract yield as critical quality attributes(CQA),failure mode effects analysis(FMEA)combined with fishbone diagram was used to evaluate the risk of extraction process,and single factor experiment was used to determine the critical process parameters(CPPs).The mathematical model of CPPs and CQAs was established by Box-Behnken experimental design,and the design space was obtained and verified by Monte Carlo method.Results The ethanol volume fraction,solvent multiplication and extraction times were determined as CPPs,the mathematical model established by Box-Behnken experimental design was statistically significant at P＜0.05,and combined with the production experience,the resulting operable space was:ethanol volume fraction of 67％-70％,solvent multiplication of 7.5-9 times,and the number of times of extraction was 3 times,Extraction time 1 h.Conclusion The establishment of the extraction process design space of Zhihuang detumescence gel plaster is helpful to improve the quality stability and controllability of the traditional Chinese medicine compound preparation,lay an experimental foundation for the development of subsequent preparations,and provide a reference for the application of the design space method to the compound preparation of traditional Chinese medicine.

Objective Based on the concept of quality by design(QbD),to establish the design space of Zhihuang detumescence gel plaster extraction process.Methods With Zhihuang detumescence gel plaster as the model drug,geniposide content and extract yield as critical quality attributes(CQA),failure mode effects analysis(FMEA)combined with fishbone diagram was used to evaluate the risk of extraction process,and single factor experiment was used to determine the critical process parameters(CPPs).The mathematical model of CPPs and CQAs was established by Box-Behnken experimental design,and the design space was obtained and verified by Monte Carlo method.Results The ethanol volume fraction,solvent multiplication and extraction times were determined as CPPs,the mathematical model established by Box-Behnken experimental design was statistically significant at P＜0.05,and combined with the production experience,the resulting operable space was:ethanol volume fraction of 67％-70％,solvent multiplication of 7.5-9 times,and the number of times of extraction was 3 times,Extraction time 1 h.Conclusion The establishment of the extraction process design space of Zhihuang detumescence gel plaster is helpful to improve the quality stability and controllability of the traditional Chinese medicine compound preparation,lay an experimental foundation for the development of subsequent preparations,and provide a reference for the application of the design space method to the compound preparation of traditional Chinese medicine.

Atherosclerosis is a chronic vascular inflammatory disease caused by abnormal lipid metabolism.The formation of lipid-rich foam cells acts as the initial trigger for development of atherosclerotic lesions.Recent studies have shown that lipophagy,a form of selective autophagy,can selectively degrade lipid droplets stored intracellularly and promote cholesterol efflux through the autophagic lysosomal pathway.As a result,intracellular lipid accumulation is re-duced and foaming is inhibited,making lipophagy a potential new target for current anti-atherosclerosis therapy.This arti-cle reviews the crucial role and molecular mechanism of lipophagy in the link between lipid metabolism and atherosclero-sis.Its objective is to outline the regulatory mechanism of lipophagy and present fresh insights for the treatment of athero-sclerotic diseases.