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作 者:鲁艺 闫研 闫凯 刘凯双 殷果 王珏 王铁杰 LU Yi;YAN Yan;YAN Kai;LIU Kaishuang;YIN Guo;WANG Jue;WANG Tiejie(Shenzhen Institute for Drug Control,Shenzhen Key Laboratory of Drug Quality Standard Research,Guangdong 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:《中国药房》2016年第24期3420-3422,共3页China Pharmacy
摘 要:目的:建立快速鉴别复方鱼腥草片(A公司)的方法。方法:利用近红外漫反射光谱(NIRDRS)技术,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。选择谱段为9 002~7 497.8 cm^(-1)、6 903.8~5 596.4cm^(-1)和5 002.4~4 246.4 cm^(-1),预处理方法为一阶导数+矢量归一化,平滑点数为17,CI值为7.0;通过相关系数(r)法建立特征谱段r模型,选择谱段为6 200~5 500 cm^(-1)、5 000~4 700 cm^(-1),预处理方法为一阶导数,平滑点数为17;r阈值为97%。结果:两个模型均可快速鉴别并准确区分复方鱼腥草片(A公司)与其他生产厂家的同类产品,验证样品的CI值均>7.0,r均<97%。结论:该方法简便、快速,可用于复方鱼腥草片的现场快速筛查。OBJECTIVE:To establish a method of quick identification of Fufang yuxingcao tablel(manufactured by A). METHODS:NIRDRS was adopted,the near-infrared diffuse reflectance spectrum were recorded by a fiber optic probe,and the conformitytest model was established through the consistency index(CI)value and the CI limit comparison method. The spectral range of9 002 -7 497.8 cm- 1 ,6 903.8-5 596.4 cm- 1 and 5 002.4-4 246.4 cm-1 was selected as the characteristic spectral band ,the spectrawere preprocessed by first derivation and vector normalization with 17 smoothing points ,and 7.0 was set as the CI value ;thecharacteristic spectrum correlation coefficient model was established through the correlation coefficient method ,the spectral rangeof 6 200 -5 500 cm-1,5 000-4 700 cm-1 was selected as the characteristic spectral band,the spectra were preprocessed by first derivationwith 17 smoothing points,and 97% was set as the threshold. RESULTS:The above established models can rapidly identifyand accurately distinguish Fufang yuxingcao tablet(manufactured by A)from similar products of other manufacturers,the CI valueof the validation samples was beyond 7.0,the correlation coefficient(r)were less than 97% compared with the reference sample.CONCLUSIONS:The method is simple and rapid,and can be used for fast screening of Fufang yuxingcao tablet.
关 键 词:近红外光谱 一致性检验 相关系数 复方鱼腥草片 快速鉴别
分 类 号:R917[医药卫生—药物分析学]
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