对照提取物在浙贝母配方颗粒质量分析中的应用研究
Applied Research of Extractive Reference Substance for the Quality Analysis of Fritillariae Thunbergii Bulbus Formula Granules
陈海燕 1吴垠 1巫少娟 1曾名德 1钟健宇 1张坚潮 1林丹丹 1张奕尧 1郭隆钢1
作者信息
- 1. 广州科曼生物科技有限公司,广东 广州 510663
- 折叠
摘要
目的 以浙贝母对照提取物(水提)和湖北贝母对照提物(水提)为参照,对 12 个不同厂家的 22 批浙贝母配方颗粒进行质量分析.方法 以乙酸乙酯-甲醇-三乙胺-水(17∶1∶1∶0.5)为展开剂进行高效薄层色谱(HPTLC)指纹图谱分析;采用Agilent Eclipse XDB-C18 色谱柱(4.6 mm×250 mm,5 μm),流动相为乙腈-0.03%二乙胺溶液,梯度洗脱,柱温 25℃,蒸发光检测器,进行高效液相色谱(HPLC)指纹图谱分析.根据浙贝母配方颗粒标准含量测定项下方法测定含量.结果 HPTLC和HPLC分析结果表明,22 批标识为浙贝母配方颗粒的样品存在明显差异,其中有 3 家生产企业的 4 批浙贝母配方颗粒检出湖北贝母指纹图谱特征,其余 18 批浙贝母配方颗粒样品贝母素甲和贝母素乙的总量为 0.291～3.179 mg·g-1,差异较大.结论 目前市售的浙贝母配方颗粒样品质量差异较大,经标准化制备的对照提取物(水提)对分析浙贝母配方颗粒的质量比对照药材具有更好的适用性.
Abstract
Objective To analyze the quality of 22 batches of Fritillariae thunbergii bulbus Formula Granules from 12 different manufacturers by using water-extraction reference substance of Fritillariae thunbergii bulbus(ZBM ERS ST)and water-extraction reference substance of Fritillariae hupehensis bulbus(HBBM ERS ST)as references.Methods Ethyl acetate-methanol-triethylamine-water(17∶1∶1∶0.5)was used as the developing solvent for high-performance thin-layer chromatography(HPTLC)fingerprint analysis.The high-performance liquid chromatography(HPLC)fingerprint analysis was performed on a Agilent Eclipse XDB-C18 column(4.6 mm×250 mm,5 μm)with the gradient mobile phase consisted of acetonitrile-0.03%diethylamine solution.The column temperature was set at 25℃and evaporative light-scattering detector was used.The determination was conducted according to standard test method for measurement of Fritillariae thunbergii bulbus Formula Granules(Guangdong PFKL00117).Results The results of HPTLC and HPLC analysis showed that there are significant differences among the 22 batches of Fritillariae thunbergii bulbus Formula Granules.There were 4 batches of Fritillariae thunbergii bulbus Formula Granules from 3 manufacturers among them showed fingerprint characteristics of Fritillariae hupehensis bulbus.The total amount of peimine and peiminine in the remaining 18 batches of Fritillariae thunbergii bulbus Formula Granules was 0.291-3.179 mg·g-1,which were quite different.Conclusion Currently,the quality of Fritillariae thunbergii bulbus Formula Granules on the market varies greatly.Standardized water-extract reference substance has better applicability for the analysis of the quality of Fritillariae thunbergii bulbus Formula Granules than the control medicinal materials.
关键词
浙贝母/湖北贝母/配方颗粒/对照提取物/高效薄层色谱/指纹图谱Key words
Fritillariae thunbergii bulbus/Fritillariae hupehensis bulbus/formula granules/extractive reference substance/HPTLC/fingerprint引用本文复制引用
出版年
2024
NETL
NSTL
万方数据