关键词:  , 小红参安寐合剂；制备工艺；质量标准

Abstract:    Objective： Select the optimal water extraction process for Xiaohongshen Aiding Sleep Mixture and establish its quality standards. Methods： This study employed L9(32) orthogonal experimental design and single-factor investigation methods to optimize the water extraction process of Xiaohongshen Aiding Sleep Mixture. Solvent volume and extraction duration were selected as key parameters for investigation， and their effects on the extraction rate were systematically evaluated. In terms of quality control， thin-layer chromatography technology is first used to qualitatively identify the three medicinal herbs of Gardenia jasminoides， Paeonia lactiflora， and Polygala tenuifolia in the mixture. Further quantitative analysis of geniposide， paeoniflorin， and Polygala tenuifolia glycoside A in the mixture was carried out using high-performance liquid chromatography technology. The chromatographic conditions are： Silgreen C18 (4.6 mm×250 mm， 5 μm) column； Column temperature 35 ℃； Perform gradient elution using acetonitrile-water as the mobile phase； Flow rate： 1.0 mL·min-1； Detection wavelengths： 238， 230， 320 nm； the injection volume is 10 μL. Results： The optimal extraction process for Xiaohongshen Aiding Sleep Mixture was determined as follows： initial extraction with 10 times the amount of water， heated for 1 hour， followed by a second extraction with 4 times the amount of water， also heated for 1 hour. The thin-layer chromatography results are good， and the negative sample has no significant interference. The stability of the three components in the sample is good， the repeatability test results meet the standards， and the average recovery rate meets the quality control regulations. The comprehensive score of the pilot sample is 25.30 points. Conclusion： The established qualitative and quantitative quality control methods meet the quality control requirements， are easy to operate， and can be used for quality control of Xiaohongshen Aiding Sleep Mixture.

Key words: Xiaohongshen Aiding Sleep Mixture, Preparation process, Quality standard