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[中药乙醇沉淀前浓缩液关键质量控制指标的判别方法]

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

作者信息

Yan Anyi, Gong Xingchu, Qu Haibin

机构信息

College of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2012 Jun;37(11):1558-63.

Abstract

OBJECTIVE

To suggest a method for discriminating quality control indicators of concentrated solution before traditional Chinese medicine ethanol precipitation.

METHOD

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.

RESULT

Phenolic compounds contents in SEP supernatant were mainly affected 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.

摘要

目的

提出一种鉴别中药乙醇沉淀前浓缩液质量控制指标的方法。

方法

以冠心宁二次乙醇沉淀为例,以干物质含量相同、乙醇量相同的一次乙醇沉淀浓缩上清液(CSFEP)为原料,在相同条件下进行乙醇沉淀试验。采用逐步回归和偏最小二乘回归对实验数据进行分析。二者均选取影响二次乙醇沉淀上清液中酚类化合物保留率的参数作为关键指标。

结果

二次乙醇沉淀上清液中酚类化合物含量主要受一次乙醇沉淀浓缩上清液中丹酚酸、咖啡酸和丹酚酸B含量的影响。

结论

该鉴别方法可用于发现乙醇沉淀前浓缩液的关键质量控制指标。

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