时珍国医国药2025，Vol.36Issue(13)：2481-2487,7.DOI:10.70976/j.1008-0805.SZGYGY-2025-1312
红参配方颗粒质量控制方法研究
Study on the quality control method of Hongshen Formula Granal(红参配方颗粒)
摘要
Abstract
Objective To construct a quality control method for Hongshen Formula Granal(红参配方颗粒,HSFG)and provide a refer-ence for quality standard development.Methods Fifteen batches of RG standard decoction were prepared using the traditional decoction method.A quality evaluation system was constructed based on ginsenoside Rb1 content,total ginsenoside Re and ginsenoside Rg1 con-tent,transfer rate,extract yield,and UPLC characteristic fingerprint analysis.Cluster analysis and principal component analysis(PCA)were performed to analyze the fingerprint profiles.Results The average yield of the standard decoction was 34.46％.The yields of three batches of formula granules were 34.12％,36.71％,and 27.69％,respectively.The average ginsenoside Rb1 content in the standard decoction was 4.22 mg/g,with an average transfer rate of 35.48％.The total ginsenoside Rg1 and ginsenoside Re content in the stand-ard decoction averaged 5.91 mg/g,with an average transfer rate of 42.62％.In three batches of formula granules,ginsenoside Rb1 con-tents were 2.7,2.9,and 2.4 mg/g,with transfer rates of 28.6％,34.5％,and 30.6％,respectively;total ginsenoside Rg1 and gin-senoside Re contents were 4.0,4.3,and3.5 mg/g,with transfer rates of 37.9％,41.6％,and41.2％,respectively.Fingerprint a-nalysis identified nine common peaks in both the standard decoction and formula granules,among which five characteristic peaks were confirmed by comparison with control products:ginsenoside Rg1,ginsenoside Re,ginsenoside Rf,ginsenoside Rb1,and ginsenoside Ro.Cluster analysis and PCA yielded consistent results.The fingerprint similarity between the formula granules and the standard decoc-tion was 0.998,0.997,and 0.998,respectively.Conclusion The quality indexes of the three batches of HSFG were consistent with those of the standard decoction.The established method can be applied for the quality control of HSFG.关键词
红参/配方颗粒/质量控制Key words
Red ginseng/Formula granules/Quality control分类
医药卫生引用本文复制引用
杨朝帆,王艳慧,陈祥祥,郭水柱,高松..红参配方颗粒质量控制方法研究[J].时珍国医国药,2025,36(13):2481-2487,7.基金项目
河南省重大科技专项(221100310400) （221100310400）
