RESUMO
<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>
Assuntos
Precipitação Química , Etanol , Química , Medicina Tradicional Chinesa , Padrões de Referência , Controle de Qualidade , SoluçõesRESUMO
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.