定量用银杏叶总内酯对照提取物的量值溯源

Valuation Traceability of Reference Extract of Total Lactones from Ginkgo Leaf for Quantitative Analysis

目的制备定量用银杏叶总内酯对照提取物药品标准物质。方法建立高效液相色谱(HPLC)法,以白果内酯、银杏内酯A、银杏内酯B、银杏内酯C为指标,考察银杏叶总内酯对照提取物的均匀性和稳定性,并组织3家实验室进行协作定值。结果银杏叶总内酯对照提取物中白果内酯、银杏内酯A、银杏内酯B、银杏内酯C均匀性和稳定性的RSD均≤2.0%;对外标法量值溯源的结果进行统计分析,确定了4种成分的标示含量:白果内酯为39.54%,银杏内酯A为29.03%,银杏内酯B为15.96%,银杏内酯C为11.69%。结论制备的定量用银杏叶总内酯对照提取物可作为药品标准物质。

Objective To prepare the phmaceutical reference materials of total lactones extract from ginkgo leaf for quantitative analysis.Methods A HPLC determination method was developed to investigate the uniformity and stability of the reference extract of ginkgo leaf total lactones using with bilobalide, ginkgolide A, ginkgolide B and ginkgolide C as the indexes.Three laboratories participated in the collaborative calibration test.Results The four components in reference extract had good uniformity and stability with RSD less than 2.0%;the marked values of the four components had been determined through statistical data analysis which provided by assigned traceability values.The values of bilobalide, ginkgolide A, ginkgolide B, and ginkgolide C were 39.54%, 29.03%, 15.96% and 11.69%, respectively.Conclusion The reference extract of ginkgo leaf total lactones can be prepared for quality control in future quantitative analysis.