基于AOTF-近红外光谱技术的复方丹参片快速无损质量控制研究  

Rapid nondestructive quality control of Compound Danshen Tablet by AOTFnear infrared spectroscopy

作　　者：武卫红 王宁 石俊英[2] 董海平[3] 

机构地区：[1]山东医学高等专科学校,山东济南250002 [2]山东中医药大学,山东济南250355 [3]济南金宏利实业有限公司,山东济南250100

出　　处：《中成药》2010年第7期1140-1144,共5页Chinese Traditional Patent Medicine

基　　金：山东省自然科学基金(Y2007C144)

摘　　要：目的:探索应用声光可调滤光器(AOTF)-近红外(NIR)光谱技术对复方丹参片进行快速无损质量控制研究。方法:收集56个厂家215个批号复方丹参片为样本,选用便携式AOTF-NIR光谱仪采集光谱,采用The Unscrambler分析软件,以主成分分析法(PCA)对样本进行了快速定性分析;利用偏最小二乘法(PLS)对复方丹参片中丹酚酸B、丹参酮ⅡA、水浸出物、醇浸出物4个指标进行了同时、快速定量分析。结果:所建定性分析模型能正确区别复方丹参片与其他对照品;定量分析模型对外部验证集的验证结果经显著性t检验表明,4个指标预测值与化学值之间无显著性差异,RSD值分别为3.62%,4.75%,2.22%,2.14%(n=20)和1.73%,2.08%,3.32%,1.32%(n=9)。结论:该方法实现了对复方丹参片的无损、直接快速分析,初步建立了对复方丹参片进行整体质量控制的方法。AIM：A new method to rapidly non-destructive quality control Compound Danshen Tablet was developed by portable acousto-optic tunable filter （AOTF）-near infrared （NIR） spectroscopy. METHODS：A portable AOTF-NIR spectrometer was used to test 215 different batches of Compound Danshen Tablet collected from fifty-six pharmaceutical factories. The samples were analyzed by the Unscrambler program using principal component analysis（PCA）. Quantitative analytical models invoking the partial least squares （PLS） algorithm simultaneously predicted the contents of four major constituents in Compound Danshen Tablet：salvianolic acid B,tanshinoneⅡA,water extract and alcohol extract. RESULTS：The qualitative analysis models accurately identified the differences between Compound Danshen Tablet and other reference substances. The results of external validation showed by the significant t-test that no significant difference between predictive and the chemical value,RSD was equal to 0. 990 9,0. 991 3,0. 964 0 and 1. 73% ,2. 08% ,3. 32% ,1. 32% ,respectively. CONCLUSION：The method of rapid non-destructive analyzing Compound Danshen Tablet is explored.

关 键 词：声光可调滤光器 近红外光谱技术 复方丹参片 无损 质量控制 

分 类 号：R927.2[医药卫生—药学]