中国药物警戒 ›› 2015, Vol. 12 ›› Issue (6): 335-337.

• 质量与工艺研究 • 上一篇    下一篇

近红外特征谱段相关系数法测定胶囊中非法添加格列齐特和氢氯噻嗪

夏方亮   

  1. 滨州市食品药品检验检测中心,山东 滨州256618
  • 收稿日期:2015-03-16 出版日期:2015-06-08 发布日期:2015-07-27
  • 作者简介:夏方亮,男,本科,主管药师,药品质量研究。

Near Infrared Correlation Coefficient Method with Characteristic Spectral Band for Determination of Illegally Added Gliclazide and Hydrochlorothiazide in Capsule Preparations

XIA Fang-liang   

  1. Binzhou Food and Drug Inspection and Testing Center, Shandong Binzhou 256618, China
  • Received:2015-03-16 Online:2015-06-08 Published:2015-07-27

摘要: 目的 利用近红外特征谱段相关系数法检测胶囊中是否非法添加格列齐特和氢氯噻嗪。方法 以格列齐特和氢氯噻嗪化学对照品的近红外光谱为参照光谱,选择特征谱段,根据格列齐特和氢氯噻嗪被掺入胶囊中的量建立待测样品光谱和参照光谱在该谱段的相似系数阈值,定性判断胶囊中是否含有格列齐特或氢氯噻嗪。结果 选定5 850~5 700 cm-1谱段为格列齐特的特征谱段,设定阈值为60%;选定6 150~5 950 cm-1谱段为氢氯噻嗪的特征谱段,设定阈值为70%。结论 两个模型均有较高的准确性和较强的适用性,可作为检测市售中成药和保健品胶囊剂中非法添加格列齐特和氢氯噻嗪的快检方法

关键词: 近红外漫反射光谱, 相关系数法, 定性分析, 非法添加, 格列齐特, 氢氯噻嗪

Abstract: Objective To detect the illegally added gliclazide and hydrochlorothiazide in capsule preparations with the near infrared (NIR) correlation coefficient method. Methods The near infrared spectrum of the chemical reference substance of gliclazide and hydrochlorothiazide was used as reference spectrum, the specific spectrum was selected. According to the added amount of gliclazide and hydrochlorothiazide in capsule preparations, the threshold value of similarity coefficient in this spectral band of the tested sample spectrum and the reference spectrum was established. Whether the tested sample contained gliclazide or hydrochlorothiazide was qualitatively estimated. Results The spectral band 5 850~5 700 cm-1 was selected as the characteristic band for gliclazide, and the threshold value was set as 60%. The spectral band 6 150~5 950 cm-1 was selected as the characteristic band for hydrochlorothiazide, and the threshold value was set as 70%. Conclusion The two models have high accuracy and strong applicability, which may be used as a fast detection method to determine illegally added gliclazide and hydrochlorothiazide in traditional Chinese medicine and health food capsule preparations on market.

Key words: near infrared diffuse reflection spectrum, correlation coefficient method, qualitative analysis, illegal addition, gliclazide, hydrochlorothiazide

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