银杏叶提取物中总银杏酸HPLC法限量检测  

Limit determination of total ginkgolic acid in Ginkgo biloba extract by HPLC

作　　者：姚建标 金辉辉 王如伟 何厚洪 郑成 

机构地区：[1]浙江康恩贝制药股份有限公司,杭州310052 [2]浙江省中药制药技术重点实验室,杭州310052 [3]浙江省食品药品检验研究院,杭州310052

出　　处：《药物分析杂志》2015年第11期2041-2044,共4页Chinese Journal of Pharmaceutical Analysis

基　　金：国家药品标准提高暨2015年版药典科研任务

摘　　要：目的：建立银杏叶提取物中总银杏酸HPLC限量检测方法。方法：银杏叶提取物以甲醇直接溶解,制备供试品溶液;HPLC条件：以十八烷基硅烷键合硅胶为填充剂,0.1%三氟乙酸乙腈为流动相A,0.1%三氟乙酸水为流动相B,梯度洗脱（0~30 min,75%A→90%A;30~35 min,90%A）,流速1 m L·min-1,检测波长310 nm。结果：白果新酸的线性关系良好,平均回收率（n=9）为93.8%。6个厂家10批银杏叶提取物依法进行测定,结果显示：不同厂家提取物总银杏酸含量存在较大差异。结论：该法经方法学验证,可用于银杏叶提取物中总银杏酸的限量检测。Objective： To establish a method for the limit determination of total ginkgolic acid in Ginkgo biloba ex- tract by HPLC. Methods： Ginkgo biloba extract C18 column with 0. 1% trifluoroacetic acid in ac was dissolved with methanol. The determination was performed on etonitrile as the mobile phase A and 0. 1% trifluoroacetic acid in water as the mobile phase B with gradient elution mode （0-30 min, 75% A→90% A; 30-35 min, 90% A）, at a flow rate of 1 mL · min-1. The detection wavelength was 310 nm. Results： There was a good linear relationship with ginkgoneolic acid ,and the average recovery（ n = 9 ）was 93.8%. Ten batches of Ginkgo biloba extract from six manu- facturers were determined. Extracts from different manufacturers showed significant differenes of content of total ginkgo acid. Conclusion： Through the validation of mothodology, this method can be used as the limit determination of ginkgolic acid.

关 键 词：银杏酸 酚酸类化合物 银杏叶提取物 毒性成分 高效液相色谱 

分 类 号：R917[医药卫生—药物分析学]