Discussion on several statistical problems in establishing quality standards of standard decoctions / 中草药·英文版

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 (X-±3SD) or 70% to 130% of the average value (X-±30%X-). 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.

Method for discriminating key quality control indicators of concentrated solution before traditional Chinese medicine ethanol precipitation / 中国中药杂志

<p><b>OBJECTIVE</b>To suggest a method for discriminating quality control indicators of concentrated solution before traditional Chinese medicine ethanol precipitation.</p><p><b>METHOD</b>The second ethanol precipitation (SEP) of Guanxinning was taken as an example, with the concentrated supernatant of first ethanol precipitation (CSFEP) prepared with same dry matter content and the same amount of ethanol as raw materials, to conduct the ethanol precipitation test under the same conditions. The experimental data was analyzed by stepwise regression and partial least squares regression. Both of them selected the parameters which affect phenolic compounds retention ratios in SEP supernatant as the key indicators.</p><p><b>RESULT</b>Phenolic compounds contents in SEP supernatant were mainly affected by the contents of danshensu, caffeic acid and salvianolic acid B in CSFEP.</p><p><b>CONCLUSION</b>The discrimination method can be used to discover key quality control indicators of concentrated solution before ethanol precipitation.</p>

Study on quality indicators for concentration process of supernatant obtained in first ethanol precipitation in production of Danshen injection / 中国中药杂志

According to the effect of second ethanol precipitation (SEP) in the production of Danshen injection, the indicators for controlling the quality of a concentration process of the supernatant obtained in the first ethanol precipitation (FEP) were investigated. The concentrated supernatants of FEP with different constituents were prepared and treated with the same amount of ethanol. The parameters which affect phenolic compound retention ratios in SEP supernatant were found using a stepwise regression method. Phenolic compound contents in SEP supernatant were mainly affected by pH and caffeic acid content of the concentrated supernatant of FEP. Caffeic acid content and pH should be set as quality indicators and strictly controlled in concentrating the supernatant of FEP.

Correlations of three important technological parameters in first ethanol precipitation of Danshen / 中国中药杂志

<p><b>OBJECTIVE</b>Water content in concentrated extract (WCCE), the concentration of ethanol used in precipitation (CEA) and the quantity of ethanol added( QEA) are three important variables in the first ethanol precipitation of Danshen injection. In this work, the relationships between the three variables and total solid removal, Danshensu (DSS)retention and DSS purity were investigated.</p><p><b>METHOD</b>Experiments according to central composite design were carried out and mathematical models were developed.</p><p><b>RESULT</b>The models were accurate and predictive. The relative deviations between prediction results and experimental results were less than 3%. The influences of the three variables were discussed with a response surface method. The decrease of WCCE and the increase of CEA both caused more precipitation and increase the purity of DSS. However, more loss of DSS was observed. The increase of QEA increased total solid removal. DSS retention and DSS purity increased first and then decreased when QEA increased.</p><p><b>CONCLUSION</b>This result suggests the addition of ethanol should be optimized according to WCCE and CEA to obtain better supernatant</p>