基于近红外光谱一致性检验模型鉴别银杏叶提取物片  

Identification of Ginkgo Biloba Leaf Extract Tablets Based on Near-infrared Spectroscopy Consistency Test Model

作　　者：李刘炜 曾文珊[1] 韩莹[1] LI Liuwei;ZENG Wenshan;HAN Ying(Guangzhou Institute for Drug Control,Guangzhou Guangdong 510160,China)

机构地区：[1]广州市药品检验所,广东广州510160

出　　处：《药品评价》2024年第6期670-673,共4页Drug Evaluation

基　　金：广州市市场监督管理局科技项目(2023KJ31)。

摘　　要：目的 利用近红外光谱(NIR)法建立进口药品银杏叶提取物片的一致性检验模型。方法 通过对国外A企业生产的46批银杏叶提取物片进行光谱采集,运用OPUS7.8光谱分析软件对建模光谱图进行二阶导数和矢量归一化预处理,并采用国产不同企业同规格银杏叶片验证模型,建立银杏叶提取物片的近红外一致性检验模型。结果 建立的国外A企业样品近红外一致性模型能鉴别该厂家生产的银杏叶提取物片。结论 利用一致性检验方法,成功建立了国外A企业生产的银杏叶提取物片一致性检验模型,适用于该品牌银杏叶提取物片快速筛查。Objective To establish a consistency testing model for imported ginkgo biloba leaf extract tablets using near-infrared spectroscopy(NIR)method.Methods Spectral data were collected from 46 batches of ginkgo biloba leaf extract tablets produced by Company A abroad.The OPUS7.8 spectral analysis software was used to preprocess the modeled spectra with second-order derivative and vector normalization.Ginkgo biloba leaf tablets of the same specification from different domestic enterprises were used to verify the model,and the near infrared consistency test model of ginkgo biloba leaf extract tablets was established.Results The established near-infrared consistency model for samples from Company A abroad can identify the ginkgo biloba leaf extract tablets produced by the manufacturer.Conclusion By using consistency testing methods,a consistency testing model for ginkgo biloba leaf extract tablets produced by Company A abroad has been successfully established,which is suitable for rapid screening of this brand of ginkgo biloba leaf extract tablets.

关 键 词：近红外 一致性检验模型 银杏叶提取物片 筛查 

分 类 号：R283.6[医药卫生—中药学]