典型文献
Development and validation of global prediction models for monitoring the manufacturing process of herbal medicine by ultraviolet spectroscopy
文献摘要：
Objective:Process monitoring for traditional Chinese medicine (TCM) preparations is necessary to ensure the quality of the product. A typical pharmaceutical process of TCM preparations consists of multiple manufacturing units, such as ethanol precipitation, concentration, and water precipitation, among others. Compared with the traditional practice of one prediction model for one unit, the global model covers the variation from samples with different backgrounds or processes and can be used to monitor intermediates from substeps. Methods:We used ultraviolet (UV) spectroscopy to establish global models for a typical TCM preparation—Danhong injection. The concentrations of danshensu, protocatechualdehyde, rosmarinic acid, salvianolic acid A, salvianolic acid B, and hydroxyl saffior yellow A and the total phenolic and total sugar contents were quantified for every intermediate from operation units of Danhong injection. New samples prepared by mixing different intermediates were introduced for the calibration set to cover more variations. An accuracy profile was employed to validate the developed method from the aspects of specificity, trueness, precision, accuracy, linearity, and robustness. Results:The developed models showed a high determination coefficient (R2) value up to 0.97 and a low root-mean-square error of the prediction set. Five components of the models passed all validation tests, whereas the total sugar was not suitable for modeling with UV and did not apply to the whole process. Conclusions:This study indicates that the global models of UV spectroscopy for the quantitative determination of phenolic acids are feasible and reliable with a simple, rapid, and non-destructive method.
文献关键词：
中图分类号：
作者姓名：
Jie Zhao;Zimei Zhou;Fang Zhao;Xu Yan;Jianyang Pan;Haibin Qu
作者机构：
Pharmaceutical Informatics Institute,College of Pharmaceutical Sciences,Zhejiang University,Hangzhou,China;Innovation Center in Zhejiang University,State Key Laboratory of Component-Based Chinese Medicine,Hangzhou,China
文献出处：
引用格式：
[1]Jie Zhao;Zimei Zhou;Fang Zhao;Xu Yan;Jianyang Pan;Haibin Qu-.Development and validation of global prediction models for monitoring the manufacturing process of herbal medicine by ultraviolet spectroscopy)[J].针灸和草药（英文）,2022(02):118-129
A类：
substeps,danshensu,saffior,trueness
B类：
Development,validation,global,prediction,models,monitoring,manufacturing,herbal,medicine,by,ultraviolet,spectroscopy,Objective,Process,traditional,Chinese,TCM,preparations,necessary,ensure,quality,product,typical,pharmaceutical,consists,multiple,units,such,ethanol,precipitation,water,among,others,Compared,practice,covers,from,samples,different,backgrounds,processes,can,be,used,intermediates,Methods,We,UV,establish,Danhong,injection,concentrations,protocatechualdehyde,rosmarinic,salvianolic,hydroxyl,yellow,total,phenolic,sugar,contents,were,quantified,every,operation,New,prepared,mixing,introduced,calibration,set,more,variations,An,accuracy,profile,was,employed,validate,developed,method,aspects,specificity,precision,linearity,robustness,Results,showed,high,determination,coefficient,value,up,root,mean,square,error,Five,components,passed,all,tests,whereas,not,suitable,modeling,did,apply,whole,Conclusions,This,study,indicates,that,quantitative,acids,feasible,reliable,simple,rapid,destructive
AB值：
0.548649
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