基于近红外光谱技术的当归养血丸多指标成分快速分析与质量评价  

Rapid Analysis of Multiple Index Components and Quality Evaluation of Danggui Yangxue Pills Based on Near Infrared Spectroscopy

作　　者：闫研 谢耀轩 秦斌 王铁杰 殷果 YAN Yan;XIE Yao-xuan;QIN Bin;WANG Tie-jie;YIN Guo(Shenzhen InstituteforDrug Control,Shenzhen Key Laboratory ofDrug Quality Standard Research,Shenzhen 518057,China)

机构地区：[1]深圳市药品检验研究院深圳药品质量标准研究重点实验室,广东深圳518057

出　　处：《食品与药品》2020年第6期421-426,共6页Food and Drug

基　　金：2019年国家药品评价抽验项目。

摘　　要：目的利用近红外光谱(NIR)技术对当归养血丸建立一种快速定性定量分析与质量评价的方法。方法以当归养血丸为对象,采用光纤探头测定样品近红外光谱,通过一致性指数(CI)值和CI限度比较法建立一致性检验模型;通过偏最小二乘回归方法(PLS)建立当归养血丸中水分、芍药苷、丹皮酚的定量分析模型。结果建立的一致性检验模型可快速鉴别并准确区分不同厂家的当归养血丸,有效区分当归养血丸与其成分和功能相近的其他产品;建立的水分、芍药苷和丹皮酚定量分析模型内部交叉验证相关系数(R2)分别为0.9492,0.9166,0.9260,交叉验证均方根偏差(RMSECV)分别为0.290%,0.0833 mg/g,0.0726 mg/g。结论方法快速、简便、准确,可用于当归养血丸的快速定性定量分析和质量评价。Objective To establish a method for rapid analysis of multiple index components and quality evaluation of Danggui Yangxue Pills by near-infrared spectroscopy(NIR). Methods NIR spectrum of Danggui Yangxue Pills were measured by near infrared spectrometer with fiber optic probe. Conformity test model was established by comparing consistency index(CI) values and CI limits. The quantitative analysis model of moisture, paeoniflorin and paeonol in Danggui Yangxue Pills was established using partial least squares(PLS) algorithm. Results The established conformity test model can accurately distinguish Danggui Yangxue Pills from different manufacturers. The correlation coefficients(R2) of the quantitative analysis model were 0.9492, 0.9166 and 0.9260, and the root mean square error of cross validation(RMSECV) was 0.290 %, 0.0833 mg/g and 0.0726 mg/g, respectively. Conclusion The method is rapid, simple and accurate, and can be used for rapid qualitative and quantitative analysis and quality evaluation of Danggui yangxue Pills.

关 键 词：当归养血丸 近红外光谱 快速分析 质量评价 一致性检验模型 定量分析模型 

分 类 号：R917[医药卫生—药物分析学] O657.33[医药卫生—药学]