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Approach to lattice-related/content-specific spectral ranges of near-infrared diffuse reflectance spectroscopy of cefazolin sodium and the construction of a quantitative model for the determination of cefazolin sodium content in different crystal forms

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Science China Chemistry 2013年第6期56卷 789-798页

作者： LIU YanYun FENG YanChun JIA Yanhua hu changqin National Institutes for Food and Drug Control hubei Institute for Food and Drug Control Institute of Medicinal Biotechnology Chinese Academy of Medical Science and Peking Union Medical College

Cefazolin sodium can form both α- and β-form crystals. It also can form dehydrated crystalline and amorphous products through different production processes. Because different polymorphic medicines usually have different physical and chemical properties, it is critical to emphasize the crystallization control of polymorphic medicines. Near-infrared （NIR） analysis, which incorporates a combination of NIR spectroscopic techniques and multivariate chemometric methods, is considered a powerful tool for the determination of the crystallinity of polymorphic drugs. The selection of optimal spectral ranges that correlate with the lattice specificity and content specificity is crucial to obtaining a specific NIR model. In the present work, near-infrared （NIR） spectra of cefazolin sodium with different crystal forms created through different processes were studied. The results suggest that wavelengths within the range of 9102.7-8597.5 cm-1 is related to the specificity of the cefazolin sodium crystal lattice and that the range of 6001.6-5496.4 cm i is associated with the quantitative content of cefazolin sodium. The two ab- sorptions are caused by the second overtone of the C-H stretching band （3nC-H） and the first overtone of C-H stretching band （2uC-H）, respectively. Using these results, we established a suitable method of constructing a universal quantitative model by using mixed samples in different crystal forms as a calibration set, selecting a content-specific range （6001.6-5496.4 cm-l）, and adding lattice-related spectral ranges where appropriate. This may provide a framework for the construction of prediction models for polymorphic medicines.

关键词： cefazolin sodium crystal form near-infrared spectroscopy crystal-specific model universal model

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Discussion on the dimerization reaction of penicillin antibiotics

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Journal of Pharmaceutical Analysis 2022年第3期12卷 481-488页

作者： Qizhang Wu Xia Zhang Jiaxin Du changqin hu National Institutes for Food and Drug Control Beijing102629China

Penicillins are one type of the most important antibiotics used in the *** of drug impurity profiles is an important part of ensuring drug *** is particularly important in penicillins where polymerization can lead to polymers as elicitors of passive cutaneous *** current understanding of penicillin polymerization is based on reactions with amino groups,but no comprehensive mechanistic understanding has been ***,we used theoretical calculations and column switching-LC/MS techniques to study penicillin *** and benzylpenicillin were selected as representative penicillins with or without amino groups in the side chain,*** identified four pathways by which this may occur and the energy barrier graphs of each reaction process were *** benzylpenicillin without an amino group in the 6-side chain,dimerization mode A is the dominant mode,where the 2-carboxyl group of one molecule reacts with the b-lactam of another ***,ampicillin with an amino group in the 6-side chain favors dimerization mode C,where the amino group of one molecule attacks the b-lactam of another *** findings can lead to a polymer control approach to maintaining penicillin antibiotics in an active formulation.

关键词： Penicillins Dimerization reaction Theoretical calculations LC/MS

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A strategy for population pharmaceutical quality assessment based on quality by design

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Journal of Pharmaceutical Analysis 2021年第5期11卷 588-595页

作者： Yu Zhao changqin hu Shangchen Yao Lihui Yin Xiaomei Ling NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs National Institutes for Food and Drug ControlBeijing102629China Acedemy for Advanced Interdisciplinary Studies Peking UniversityBeijing100088China Peking University Health Science Center Peking UniversityBeijing100191China

From a regulatory perspective,drug quality consistency evaluation must concern different processes used for the same *** this study,an assessment strategy based on quality by design(QbD)was developed for population pharmaceutical quality evaluation.A descriptive analysis method based on QbD concept was first established to characterize the process by critical evaluation attributes(CEAs).Then quantitative analysis method based on an improved statistical process control(SPC)method was established to investigate the process indicators(PIs)in the process population,such as mean distribution,batch-to-batch difference and abnormal quality *** that rules for risk assessment were established based on the SPC limitations and *** the SPC parameters of the CEAs and the risk of PIs were visualized according to the interaction test results to obtain a better understanding of the population pharmaceutical ***,an assessment strategy was built and applied to generic drug consistency assessment,process risk assessment and quality trend *** strategy demonstrated in this study could help reveal quality consistency from the perspective of process control and process risk,and further show the recent development status of domestic pharmaceutical production *** addition,a process risk assessment and population quality trend tracking provide databased information for *** only can this information serve as a further basis for decisionmaking by the regulatory authority regarding early warnings,but it can also reduce some avoidable adverse *** continuous addition of data,dynamic population pharmaceutical quality is meaningful for emergencies and decision-making regarding drug regulation.

关键词： Population pharmaceutical quality Quality by design(QbD) Crucial evaluation attributes(CEAs) Process indicators(PIs) Improved statistical process control(SPC) Risk assessment

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Characterization of impurities in cefpodoxime proxetil using LC–MS^(n)

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Acta Pharmaceutica Sinica B 2014年第4期4卷 322-332页

作者： Jin Li Dousheng Zhang changqin hu National Institutes for Food and Drug Control Beijing 100050China

Reversed-phase liquid chromatography coupled with electrospray ionization tandem mass spectrometry(ESI-MS/MS)was used to characterize impurities in cefpodoxime proxetil,an ester-modified *** on the mechanisms by which cephalosporins are degraded,stress tests were designed and *** bulk material and capsule were eluted through a C18 column with formic acid–methanol–water as the mobile *** total,15 impurities were characterized in commercial samples,including 7 known impurities and 8 new *** structures of these unknown compounds were deduced via comparison with the fragmentation patterns of cefpodoxime *** from this systematic study will help improve the safety and quality of cefpodoxime proxetil.

关键词： Cefpodoxime proxetil Cephalosporins Impurities LC–MS Structure identification

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A new strategy to iteratively update scalable universal quantitative models for the testing of azithromycin by near infrared spectroscopy

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Science China Chemistry 2013年第4期56卷 533-540页

作者： ZOU WenBo FENG YanChun DONG JiXiong SONG DanQing hu changqin National Institutes for Food and Drug Control Institute of Medicinal Biotechnology Academy of Medical Science and Peking Union Medical College

The training set of a universal near infrared (NIR) model for quantitative analysis of a drug should cover as many samples of this drug in the market as possible. Inevitably the model may fail for new products that have different excipients and production processes. In such circumstances the model should be updated. We here propose a new strategy to iteratively update a universal NIR quantitative model for azithromycin. We prove that universal quantitative models generated from this new strategy are comparably effective for azithromycin injection powders and azithromycin tablets, compared to the strategy using hierarchical clustering method which we reported previously. Furthermore, we establish the correlation coefficient r between a new sample and the training set samples can be used to decide whether or not the model should be updated.

关键词： near infrared spectroscopy universal quantitative model model updating azithromycin

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Deep belief network-based drug identification using near infrared spectroscopy

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Journal of Innovative Optical Health Sciences 2017年第2期10卷 1-10页

作者： huihua Yang Baichao hu Xipeng Pan Shengke Yan Yanchun Feng Xuebo Zhang Lihui Yin changqin hu College of Electronic Engineering and Automation Guilin University of Electronic Technology 1 Jinji Road Guilin 541004P.R.China A utomation School Beijing University of Posts 8 Telecommunications 10 Xitucheng Road Beijing 100876P.R.China National Institutes for Food and Drug Control 10 Tiantanxili Road Beijing 100050P.R.China

Near infrared spectroscopy(NIRS)analysis technology,combined with chemometrics,can be effectively used in quick and nondestructive analysis of quality and *** this paper,an effective drug identification method by using deep belief network(DBN)with dropout mecha-nism(dropout-DBN)to model NIRS is introduced,in which dropout is employed to overcome the overfitting problem coming from the small *** paper tests proposed method under datasets of different sizes with the example of near infrared diffuse refectance spectroscopy of erythromycin ethylsuccinate drugs and other drugs,aluminum and nonaluminum ***,it gives experiments to compare the proposed method's performance with back propagation(BP)neural network,support vector machines(SVMs)and sparse denoising auto-encoder(SDAE).The results show that for both binary classification and multi-classification,dropout mechanism can improve the classification accuracy,and dropout-DBN can achieve best classification accuracy in almost all *** is similar to dropout-DBN in the aspects of classification accuracy and algorithm stability,which are higher than that of BP neural network and SVM *** terms of training time,dropout-DBN model is superior to SDAE model,but inferior to BP neural network and SVM ***,dropout-DBN can be used as a modeling tool with effective binary and multi-class classification performance on a spectrum sample set of small size.

关键词： Deep belief networks near infrared spectroscopy drug classification dropout

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Multi-manufacturer drug identification based on near infrared spectroscopy and deep transfer learning

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Journal of Innovative Optical Health Sciences 2020年第4期3卷 39-50页

作者： Lingqiao Li Xipeng Pan Wenli Chen Manman Wei Yanchun Feng Lihui Yin changqin hu huihua Yang School of Automation Beijing University of Posts and Telecommunications 10 Xitucheng Road Beijing 100876P.R.China School of Computer Science and Information Security Guilin University of Electronic Technology 1 Jinji Road Guilin 541004P.R.China National Institutes for Food and Drug Control 10 Tiantanxili Road Beijing 100050 P.R.China

Near infrared(NIR)spectrum analysis technology has outstanding advantages such as rapid,nondestructive,pollution-free,and is widely used in food,pharmaceutical,petrochemical,agricultural products production and testing *** neural network(CNN)is one of the most successful methods in big data analysis because of its powerful feature ex-traction and abstraction ability,and it is especially suitable for solving multi-classification ***-based transfer learning is a machine learning technique,which migrates para-meters of trained model to the new one to improve the *** transfer learning strategy can speed up the learning efficiency of the model instead of learning from *** view of the difficulty in acquisition of drug NIR spectral data and high labeling cost,this paper proposes three simple but very effective transfer learning methods for multi-manufacturer identification of drugs based on one-dimensional *** with the original CNN,the transfer learning method can achieve better classification performance with fewer NIR spectral data,which greatly reduces the dependence on labeled NIR spectral *** the same time,this paper also compares and discusses three different transfer learning methods,and selects the most suitable transfer learning model for drug NIR spectral data *** with the current popular methods,such as SVM,BP,AE and ELM,the proposed method achieves higher classification accuracy and scalability in multi-variety and multi-manufacturer NIR spectrum classification experiments.

关键词： Near-infrared spectroscopy transfer learning drug identification multi-manufacturer

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药品微生物控制体系建设现状与展望

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中国现代应用药学 2021年第5期38卷 513-519页

作者：胡昌勤中国食品药品检定研究院北京100050

药品微生物控制是药品安全性保障的重要措施。本文通过对中国药典2020年版增修订重点工作的回顾,阐述中国药品微生物控制体系的发展过程。药品微生物污染控制体系包括药品微生物实验室建设、药品微生物控制标准体系建设和中药微生物控... 详细信息

药品微生物控制是药品安全性保障的重要措施。本文通过对中国药典2020年版增修订重点工作的回顾,阐述中国药品微生物控制体系的发展过程。药品微生物污染控制体系包括药品微生物实验室建设、药品微生物控制标准体系建设和中药微生物控制体系建设3个部分。中药微生物控制体系建设作为中药国际化的重要组成部分,目前已经取得了实质性的进展,提升业界对微生物污染风险的认识是关键;而药品微生物控制标准体系的建设围绕着推进微生物过程控制理念的实施,促使企业成为微生物污染控制的主体开展;其中,全面提升企业药品微生物实验室的能力与管理水平是关键。

关键词：中国药典2020年版药品微生物标准药品微生物控制标准修订

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β-内酰胺酶抑制剂的稳定性与降解反应特性

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中国抗生素杂志 2024年第3期49卷 241-251页

作者：胡昌勤中国食品药品检定研究院北京102629

β-内酰胺酶抑制剂与广谱β-内酰胺抗生素的联合使用是一种有效解决细菌耐药的策略之一。目前上市的β-内酰胺酶抑制剂按其化学结构主要包括氧青霉烯类(克拉维酸)、青霉烷砜类(舒巴坦和他唑巴坦)和二氮杂二环辛烷类化合物(阿维巴坦),本... 详细信息

β-内酰胺酶抑制剂与广谱β-内酰胺抗生素的联合使用是一种有效解决细菌耐药的策略之一。目前上市的β-内酰胺酶抑制剂按其化学结构主要包括氧青霉烯类(克拉维酸)、青霉烷砜类(舒巴坦和他唑巴坦)和二氮杂二环辛烷类化合物(阿维巴坦),本文对临床常见的β-内酰胺酶抑制剂的稳定性与降解反应特性进行综述,并结合当前药典标准中的有关物质检查项,探讨上述β-内酰胺酶抑制剂的杂质谱控制策略。

关键词： β-内酰胺酶抑制剂稳定性降解反应杂质谱控制

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高效液相色谱法测定吉它霉素组分含量

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分析化学 2006年第1期34卷 95-99页

作者：杨清马仕洪胡敏胡昌勤湖南省药品检验所中国药品生物制品检定所湖北省药品检验所

采用D iamonsil C18色谱柱,流动相为0.1 mol/L醋酸铵溶液(pH 5.5)-甲醇-乙腈(40∶55∶5,V/V);流速0.8 mL/m in,柱温60℃,检测波长231 nm。在该色谱条件下,吉他霉素的9个主组分及5个小组分均能被完全分离并由LC-MS在色谱图中定位;诸组分... 详细信息

采用D iamonsil C18色谱柱,流动相为0.1 mol/L醋酸铵溶液(pH 5.5)-甲醇-乙腈(40∶55∶5,V/V);流速0.8 mL/m in,柱温60℃,检测波长231 nm。在该色谱条件下,吉他霉素的9个主组分及5个小组分均能被完全分离并由LC-MS在色谱图中定位;诸组分在10100μg范围呈良好线性(r>0.999);最低定量限小于1μg;方法的重复性、粗放性均满足质控分析的需要;已被中国药典2005版收载用于吉他霉素的组分控制。

关键词：高效液相色谱液相色谱-质谱吉他霉素组分

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