银杏叶提取物的制备工艺优化及质量控制

Preparation Technology Optimization and Quality Control of Ginkgo Leaves Extract

目的:优化中药银杏叶提取物的制备工艺及质量控制方法。方法:采用HPLC技术建立银杏叶提取物中总黄酮醇苷和总银杏酸的含量测定方法,以总黄酮醇苷转移率为指标,采用正交试验优化银杏叶提取物的乙醇回流提取工艺,并以总黄酮醇苷的含量和总银杏酸限量为指标成分,建立该银杏叶提取物的质量控制方法。结果:银杏叶提取物的最佳提取工艺为称取银杏叶药材细粉,采用药材质量8倍量的70%乙醇回流提取3次,每次2 h,合并提取液,过滤,回收乙醇,真空干燥,即得银杏叶提取物。制备的3批银杏叶提取物中总黄酮醇苷含量不低于100 mg·g^(-1),总银杏酸不高于10μg·g^(-1)。结论:本文所建立中药银杏叶提取物的制备工艺简单而稳定,所建立的质量控制方法可有效用于银杏叶提取物的制备过程中的质量控制,保障所制备的银杏叶提取物质量稳定一致。

Objective: To optimize the preparation process and quality control method for Ginkgo leaves extract. Methods: The determination method of total flavonol glycosides and total ginkgolic acids for Ginkgo leaves extract was established by using HPLC. And the ethanol reflux extraction process of Ginkgo leaves extract was optimized by orthogonal test with the total flavonol glycoside transfer rate as an indicator. Moreover,the quality control method for Ginkgo leaves extract was established by using total flavonol glycosides and total ginkgolic acids as the indices. Results: The optimum preparation process of Ginkgo leaves extract was as follows: the fine powder of Ginkgo leaves was extracted with 70% ethanol for 3 times with 2 h for each time,and the amount of 70% ethanol was about8 times of Ginkgo leaves powder;the extracting solution was combined and filtered,and after ethanol was recovered,the precipitant was dried in vacuum to obtain Ginkgo leaves extract. The content of total flavonol glycosides in three batches of Ginkgo leaves extract was over 100 mg·g^(-1),while the content of total ginkgolic acids was lower than 10 μg·g^(-1). Conclusion: The optimized preparation process of Ginkgo leaves extract is simple and stable,and the established quality control method can be used effectively to ensure the quality stability and consistency of Ginkgo leaves extract.