中国药业2025，Vol.34Issue(8)：82-86,5.DOI:10.3969/j.issn.1006-4931.2025.08.019
黄云通便胶囊质量标准提升研究
Improvement of Quality Standard of Huangyun Tongbian Capsules
摘要
Abstract
Objective Improve the quality standards of Huangyun Tongbian Capsules.Methods Perform microscopic identification of Rhei Radix Et Rhizoma and Citri Reticulatae Pericarpium in the preparation.Thin-layer chromatography(TLC)method was used to qualitatively identify Rhubarb,Tangerine peel,and Cistanche deserticola.The high-performance liquid chromatography(HPLC)method was used to simultaneously determine the contents of aloe-emodin,rhein,emodin,chrysophanol,physcion in the preparation.the chromatography column was the Hypersil ODS2 C18 column(250 mm×4.6 mm,5 μm),the mobile phase was methanol-0.1%phosphoric acid solution(80∶15,V/V),the flow rate was 0.9 mL/min,the detection wavelength was 254 nm,the column temperature was 40℃,and the injection volume was 10 μL.Results The medicinal materials of Rhei Radix et Rhizoma and Citri Reticulatae Pericarpium exhibited distinct microscopic characteristics.The TLC chromatograms of Rhubarb,Tangerine peel,and Cistanche deserticola showed clear spots,good separation,with no interference from the negative reference.The linear ranges of aloe-emodin,rhein,modin,chrysophanol,physcion were in the range of 0.039 0-0.195 0 μg/mL,0.092 8-0.464 4 μg/mL,0.032 5-0.162 8 μg/mL,0.093 4-0.467 0 μg/mL,0.102 4-0.512 4 μg/mL,respectively(r≥0.999 9).The RSDs of precision,stability and repeatability tests were all lower than 2.0%.The average recovery rates of the above four components were 99.38%,99.69%,100.75%,100.86%,101.04%,with RSDs of 0.39%,0.38%,0.85%,0.24%,0.60%(n=6),respectively.Conclusion The established method is easy,accurate and reliable,which can be used to control the quality of Huangyun Tongbian Capsules.关键词
黄云通便胶囊/薄层色谱法/高效液相色谱法/质量标准Key words
Huangyun Tongbian Capsules/thin layer chromatography/high-performance liquid chromatography/quality standard分类
医药卫生引用本文复制引用
方剑儒,赵翠琴,陈晓青,黄保停..黄云通便胶囊质量标准提升研究[J].中国药业,2025,34(8):82-86,5.基金项目
甘肃省药品科研项目[2022GSMPA0040]. （）
