Since 2016,a number of studies have been published on standard decoctions used in Chinese medicine.However,there is little research on statistical issues related to establishing the quality standards for standard deco...Since 2016,a number of studies have been published on standard decoctions used in Chinese medicine.However,there is little research on statistical issues related to establishing the quality standards for standard decoctions.In view of the currently established quality standard methods for standard decoctions,an improvement scheme is proposed from a statistical perspective.This review explores the requirements for dry matter yield rate data and index component transfer data for the application of two methods specified in‘‘Technical Requirements for Quality Control and Standard Establishment of Chinese Medicine Formula Granules,"which include the average value plus or minus three times the standard deviation (■±3SD) or 70%to 130%of the average value (■±30%■).The square-root arcsine transformation method is used as an approach to solve the problem of unreasonable standard ranges of standard decoctions.This review also proposes the use of merged data to establish a standard.A method to judge whether multiple sets of standard decoction data can be merged is also provided.When multiple sets of data have a similar central tendency and a similar discrete tendency,they can be merged to establish a more reliable quality standard.Assuming that the dry matter yield rate and transfer rate conform to a binomial distribution,the number of batches of prepared slices that are needed to establish the standard decoction quality standard is estimated.It is recommended that no less than 30 batches of prepared slices should be used for the establishment of standard decoction quality standards.展开更多
基金supported by National S&T Major Project of China (2018ZX09201011-002)the Student Research Training Program of the College of Pharmaceutical Sciences of Zhejiang University (Y201936333)the National Project for Standardization of Chinese Materia Medica (ZYBZH-C-GD-04)
文摘Since 2016,a number of studies have been published on standard decoctions used in Chinese medicine.However,there is little research on statistical issues related to establishing the quality standards for standard decoctions.In view of the currently established quality standard methods for standard decoctions,an improvement scheme is proposed from a statistical perspective.This review explores the requirements for dry matter yield rate data and index component transfer data for the application of two methods specified in‘‘Technical Requirements for Quality Control and Standard Establishment of Chinese Medicine Formula Granules,"which include the average value plus or minus three times the standard deviation (■±3SD) or 70%to 130%of the average value (■±30%■).The square-root arcsine transformation method is used as an approach to solve the problem of unreasonable standard ranges of standard decoctions.This review also proposes the use of merged data to establish a standard.A method to judge whether multiple sets of standard decoction data can be merged is also provided.When multiple sets of data have a similar central tendency and a similar discrete tendency,they can be merged to establish a more reliable quality standard.Assuming that the dry matter yield rate and transfer rate conform to a binomial distribution,the number of batches of prepared slices that are needed to establish the standard decoction quality standard is estimated.It is recommended that no less than 30 batches of prepared slices should be used for the establishment of standard decoction quality standards.
