[1]邱晶波,谢梦雨,沈晓敏,等.基于PXRD、DSC和NIR技术的那格列奈多晶型的定量分析方法研究（英文）[J].南京师范大学学报(自然科学版),2016,39(04):0.[doi:10.3969/j.issn.1001-4616.2016.04.013]
　Qiu Jingbo,Xie Mengyu,Shen Xiaomin,et al.A Comparative Study on Quantification of BinaryPolymorphic Mixtures of Nateglinide by Using PowderX-Ray Diffraction,Differential Scanning Calorimetryand Near Infrared Spectroscopy[J].Journal of Nanjing Normal University(Natural Science Edition),2016,39(04):0.[doi:10.3969/j.issn.1001-4616.2016.04.013]
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基于PXRD、DSC和NIR技术的那格列奈多晶型的定量分析方法研究（英文）()
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《南京师范大学学报》（自然科学版）[ISSN:1001-4616/CN:32-1239/N]

卷:
第39卷
期数:
2016年04期
页码:
0
栏目:
·生命科学·
出版日期:
2016-12-30

文章信息/Info

Title:
A Comparative Study on Quantification of BinaryPolymorphic Mixtures of Nateglinide by Using PowderX-Ray Diffraction,Differential Scanning Calorimetryand Near Infrared Spectroscopy
文章编号:
1001-4616(2016)04-0071-11
作者:
邱晶波; 谢梦雨; 沈晓敏; 周 丹; 朱慕荣; 李 钢
南京师范大学生命科学学院,分析测试中心,江苏 南京 210023
Author(s):
Qiu Jingbo; Xie Mengyu; Shen Xiaomin; Zhou Dan; Zhu Murong; Li Gang
School of Life Sciences,Testing & Analysis Center,Nanjing Normal University,Nanjing 210023,China
关键词:
那格列奈多晶型; 定量分析; X-射线粉末衍射法; 差示扫描量热法; 近红外光谱法
Keywords:
nateglinide polymorphs; quantification; powder X-ray diffraction; differential scanning calorimetry; near infrared spectroscopy
分类号:
R917
DOI:
10.3969/j.issn.1001-4616.2016.04.013
文献标志码:
A
摘要:
从晶体学、热力学和光谱学三个角度展开对那格列奈多晶型的定量分析研究,通过 X-射线粉末衍射法、差示扫描量热法及近红外光谱分析技术,并结合化学计量学的方法,建立了那格列奈 B 晶型和 H 晶型二元混合体系的定量分析模型. 结果表明,近红外光谱法虽然操作简单快速,但模型的预测准确率和方法的灵敏度较低; 差示扫描量热法虽然准确度较高,但实用性较差; 利用 PXRD 结合 PLS 法得到的结果最好,模型比较稳定,不易受样品的影响,可用于实际工作中. 为那格列奈制剂产品及其他多晶型药物的定量分析奠定了理论基础.
Abstract:
The aim of this study is to evaluate the ability of powder X-ray diffraction(PXRD),differential scanning calorimetry(DSC)and near infrared(NIR)spectroscopy to quantify two polymorphic forms(B,H)of nateglinide in binary powder mixtures. For this purpose,univariate and multivariate method are developed. The results show that PXRD(with PLS regression)provides a reliable determination of nateglinide samples(predicted accuracy of 89.1%),which is the best choice for quantification of nateglinide polymorphic mixtures in practice,while NIR spectroscopy is the least accurate(predicted accuracy of 79.6%)mainly due to the effect of sample inhomogeneity. Though a good linear relation and a high predicted accuracy(93.4%)for DSC are successfully obtained,it could not be a practical way for low-content quantification in nateglinide polymorphic mixtures.

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备注/Memo

备注/Memo:
Received data:2016-07-24.Foundation item:Supported by Jiangsu Large Scientific Instruments Shared Services Platform Foundation(BZ201403). Corresponding author:Li Gang,professor,majored in XRD analysis. E-mail:ligang1@njnu.edu.cn
更新日期/Last Update: 2016-12-31