摘要
目的建立芪英颗粒的质量标准。方法参照《中国药典》2020年版,采用薄层色谱法(TLC)定性鉴别芪英颗粒中大黄、肉桂、炙甘草和白及4味药材;同时,应用高效液相色谱法测定方剂中黄芪甲苷的含量;并检测方剂的粒度、溶化性、水分、装量差异等指标。结果TLC鉴别专属性强,图谱斑点清晰,分离度良好;黄芪甲苷在质量浓度0.1028~0.5140 mg/ml范围内,线性关系良好(r=0.9997),精密度(n=6)、重复性(n=6)、稳定性(24 h)RSD均小于2%,平均加样回收率为98.08%(RSD=0.60%,n=6);样品的水分、粒度、溶化性和装量差异均符合要求。结论本研究建立的质量标准,方法专属性高,重复性好,可用于芪英颗粒的质量评价,为芪英颗粒的质量控制提供可靠方法。
Objective To establish the quality standard of Qiying Granules.Methods Referring to Chinese Pharmacopoeia(2020 edition),thin-layer chromatography(TLC)was used to qualitatively identify Cinnamomi Cortex,Glycyrrhizae Radix et Rhizome Praeparata Cum Melle,Rhei Radix et Rhizome,Bletillae Rhizoma in Qiying Granules.High performance liquid chromatography(HPLC)was used to determine the content of astragaloside IV.In addition,the indicators such as particle size,solubility,moisture and loading difference of the formula were detected.Results TLC identification was specific,with clear spots and good resolution.With the concentration range of 0.1028-0.5140mg/ml,the linear relationship of astragaloside IV was good(r=0.9997).RSDs of precision(n=6),repeatability(n=6)and stability(24 h)tests were all less than 2%.The average recovery was 98.08%with RSD of 0.60%(n=6).The moisture,particle size,solubility and loading difference of the three batches of samples were all in line with the requirements.Conclusion With high specificity and good repeatability,the quality standards established in this study can be used for the quality evaluation of Qiying Granules,and can provide a reliable method for the quality control of Qiying Granules.
作者
陈明
王芳
袁振海
王栋
贾婵媛
陈彬合
宋莉
CHEN Ming;WANG Fang;YUAN Zhen-hai;WANG Dong;JIA Chan-yuan;CHEN Bin-he;SONG Li(Shandong Key Laboratory of Biopharmaceuticals,Shandong Academy of Pharmaceutical Sciences,Jinan 250101,China)
出处
《食品与药品》
CAS
2023年第1期30-35,共6页
Food and Drug
基金
山东省重点研发计划(重大科技创新工程)项目(编号:2021CXGC010508)。
作者简介
陈明,硕士,从事中药新药研发、药物分析工作,E-mail:chenmingklts@163.com;通讯作者:王芳,博士,主管中药师,从事中药新药、天然活性产物的分离鉴定与结构修饰研究,E-mail:wangfang_84@163.com;通讯作者:宋莉,硕士,药师,E-mail:jnsl@163.com。
