中国药业2025，Vol.34Issue(9)：70-74,5.DOI:10.3969/j.issn.1006-4931.2025.09.015
舒肝颗粒质量标准提升研究
Improvement of Quality Standard of Shugan Qranules
摘要
Abstract
Objective To improve the quality standard of Shugan Granules.Methods Thin-layer chromatography(TLC)method was used for the qualitative identification of Moutan Cortex,Gardeniae Fructus,Paeoniae Radix Alba,Glycyrrhizae Radix and Rhizoma,Bupleuri Radix,and Atractylodis Macrocephalae Rhizoma.High-performance liquid chromatography(HPLC)method was used for the simultaneously determination of geniposide and paeoniflorin in the preparation,the chromatographic column was Agilent Zorbax SB-C18 column(250 mm×4.6 mm,5 µm),the mobile phase was acetonitrile-0.1%phosphoric acid solution(86∶14,V/V),the flow rate was 1.0 mL/min,the detection wavelength was 242 nm,the column temperature was 35℃,and the injection volume was 10 µL.Results The TLC spots of Moutan Cortex,Gardeniae Fructus,Paeoniae Radix Alba,Glycyrrhizae Radix and Rhizoma,Bupleuri Radix,and Atractylodis Macrocephalae Rhizoma were clear,and the negative control had no interference.The linear ranges of geniposide and paeoniflorin were 23.09-369.51 µg/mL and 13.82-221.16 µg/mL,(r=1.000 0,n=5)respectively.The RSDs of precision,stability,and repeatability test results were all lower than 1.5%(n=6).The average recoveries of geniposide and paeoniflorin were 97.90%and 97.39%,with RSDs of 0.61%and 0.66%(n=6),respectively.The average contents of geniposide and paeoniflorin in 10 batches of samples were 1.08 mg/g and 1.52 mg/g(n=2),respectively.Conclusion The established method is simple,accurate,and has good specificity,which can be used for the quality control of Shugan Granules.关键词
舒肝颗粒/薄层色谱法/高效液相色谱法/质量标准Key words
Shugan Granules/TLC/HPLC/quality standard分类
药学引用本文复制引用
殷世宁,杨晓云,傅超,单秀明,祝波..舒肝颗粒质量标准提升研究[J].中国药业,2025,34(9):70-74,5.基金项目
《中国药典》药品标准提高项目[508]. （）
