中国药物经济学2024，Vol.19Issue(11)：97-101,5.DOI:10.12010/j.issn.1673-5846.2024.11.020
正交试验法优选"支炎一号"合剂的制备工艺及质量标准研究
Optimization of the Preparation Process Using Orthogonal Experimental Design and Quality Standard Study of"Zhiyan No.1"Mixture
摘要
Abstract
Objective To optimize the preparation process of"Zhiyan No.1"mixture,conduct thin layer chromatography(TLC)identification research on the traditional Chinese medicinal materials in the mixture,establish a content determination method for hesperidin,and accordingly determine the quality control standards for the preparation.Methods The L9(34)orthogonal test method was used to optimize the water extraction process of"Zhiyan No.1"mixture.Three factors were considered:water addition,soaking time,and decoction time.The transfer rate of hesperidin and the dry extract rate were used as comprehensive evaluation indicators.TLC identification was performed on the traditional Chinese medicinal materials of tangerine peel,Belamcanda chinensis,and Uncaria rhynchophylla in the mixture.The high performance liquid chromatography(HPLC)method was employed,utilizing an Agilent ZORBAX SB C18 column.The mobile phase consisted of acetonitrile-water(21:79),with a flow rate of 1 ml/min,the column temperature was set at 40℃,and the detection wavelength was 283 nm,for the quantitation of hesperidin.Results The optimal extraction process was to add water and decoct twice,add 10 parts water and 8 parts water respectively,and cook for 1 hour each time.The TLC identification of tangerine peel,Belamcanda chinensis,and Uncaria rhynchophylla had good resolution,reproducibility,and strong specificity.Hesperidin has a good linear relationship within the sample injection range of 0.050 41～0.756 21 µg grams,and the regression equation was Y=2 145 448.558 6 X-621.500 0,r2=0.999 8(n=6).The stability and precision were good,and the average sample recovery rate of this product was 98.86％,with an RSD of 1.2％(n=6).Conclusion The optimized preparation process in this study is scientific and reasonable,and the thin layer chromatography identification has good resolution and strong specificity,quantitative determination method for hesperidin is accurate and reliable,which is suitable for the preparation and quality control of"Zhiyan NO.1"mixture and provides a reliable basis for the next step of production and rational drug use.关键词
"支炎一号"/正交试验/制备工艺/薄层色谱/橙皮苷Key words
Zhiyan NO.1/Orthogonal test/Preparation technology/TLC/Hesperidin分类
医药卫生引用本文复制引用
汤韦奇,叶琛琛,李文撼,万国强,裴昶..正交试验法优选"支炎一号"合剂的制备工艺及质量标准研究[J].中国药物经济学,2024,19(11):97-101,5.基金项目
华通国康医学科研专项(2023HT038) （2023HT038）
