Study on the optimization of the ethanol precipitation process of Penyanling Granules by using Box-Behnken response surface methodology
CAI Pei1,2 ZHENG Yi1 WANG Zheming2 WEN Xiaoke1,2
1.Department of Pharmaceutical Research, Hu′nan Provincial Maternal and Child Health Care Hospital, Hu′nan Province, Changsha 410008, China;
2.Hu′nan Engineering Research Center for Optimization of Drug Formulation and Early Clinical Evaluation, Hu′nan Province, Changsha 410008, China
Abstract：Objective To optimize the ethanol precipitation process for Penyanling Granules. Methods Based on the single factor test, the relative density of the liquid before ethanol precipitation, the final ethanol concentration and the ethanol precipitation time were used as factors. The transfer rates of chlorogenic acid, paeoniflorin, ferulic acid, salvianolic acid B, norisoboldine, liquiritin, tetrahydropalmatine, astilbin and the composite score of solid removal rate were selected as evaluation indexes. The ethanol precipitation process of Penyanling Granules was optimized by Box-Behnken response surface method. Chromatographic conditions: the column was Agilent TC-C18 (250 mm×4.6 mm, 5 μm), the flow rate was 1.0 mL/min. The mobile phase A was acetonitrile and the mobile phase B was 0.2% phosphoric acid solution with gradient elution (0-10 min, 2% A; 10-40 min, 2%-12% A; 40-80 min, 12%-18% A; 80-110 min, 18%-25% A; 110-120 min, 25%-50% A). The column temperature was 30℃ and the detection wavelength was 200-400 nm. Results The optimal ethanol precipitation process was as followed: the relative density of the extract was 1.13, and ethanol was added to allow the content of ethanol to reach 60%, and then been placed for 21 h. The test results indicated that the relative difference of comprehensive scoring value between predicated value and measured value was 0.7%. Conclusion The optimal ethanol precipitation process is simple, easy to operate and the results are accurate and stable, which can provide a reliable theoretical basis for the preparation production of Penyanling Granules.
蔡霈1,2 郑艺1 王哲明2 文晓柯1,2. Box-Behnken响应面法优化盆炎灵颗粒的醇沉工艺研究[J]. 中国医药导报, 2020, 17(22): 32-37.
CAI Pei1,2 ZHENG Yi1 WANG Zheming2 WEN Xiaoke1,2. Study on the optimization of the ethanol precipitation process of Penyanling Granules by using Box-Behnken response surface methodology. 中国医药导报, 2020, 17(22): 32-37.
2020, Vol. 17 
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