一种中药醇沉前浓缩液关键质量控制指标的辨析方法

Method for discriminating key quality control indicators of concentrated solution before traditional Chinese medicine ethanol precipitation

目的:提出一种辨析中药醇沉前浓缩液关键质量控制指标的方法。方法:以冠心宁注射液二次醇沉为例,以固含量相同但固形物化学组成不同的一回液为原料,在相同条件下进行醇沉试验;分别采用逐步回归法和偏最小二乘回归法分析实验数据,选择2种方法均认为重要的指标作为一回液中影响醇沉上清液酚酸类成分保留率的关键指标。结果:冠心宁注射液二次醇沉上清液酚酸类成分的保留率主要受一回液中丹参素、咖啡酸、丹酚酸B含量的影响。结论:采用该辨析方法可以发现醇沉前浓缩液的关键质量控制指标。

Objective： To suggest a method for discriminating quality control indicators of concentrated solution before tradi- tional Chinese medicine ethanol precipitation. Method： The second ethanol precipitation （SEP） of Guanxinning was taken as an exam- ple, 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 ana- lyzed 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. Result： Phenolic compounds contents in SEP supernatant were mainly affect- ed by the contents of danshensu, caffeic acid and salvianolic acid B in CSFEP. Conclusion ： The discrimination method can be used to discover key quality control indicators of concentrated solution before ethanol precipitation.