N-亚硝胺类基因毒性杂质的研究进展

自“缬沙坦事件”之后，N-亚硝胺类基因毒性杂质引起了业界的广泛关注。本文概述了药物中N-亚硝胺类基因毒性杂质和相关检测方法的研究进展，以及近20年来国内外有关药物中基因毒性杂质监管指南的完善历程。N-亚硝胺类基因毒性杂质作为一类高反应活性的基因毒性杂质，主要来源于药物合成过程中发生的副反应，以及药物在储存或者运输过程中发生的氧化或还原等反应。所有的动物实验表明，N-亚硝胺类具有很强的致癌性。在理论上，所有药物都存在N-亚硝胺类杂质或被N-亚硝胺类杂质污染的风险，由于该类化合物在药物中常以痕量形式存在，在分析检测过程中药物基质干扰大，因此建立便捷、高效的分析方法是非常有必要的。     

Multivariate comparison of elemental concentrations in human teeth

R-mode factor analysis was applied to characterize the chemical composition of human teeth investigated by particle induced X-ray emission (PIXE), Rutherford backscattering spectrometry (RBS) and X-ray fluorescence (XRF) techniques. The approach developed in this study enabled the separation between essential mineral teeth components and the pollutants deposited in teeth tissues during the human life. The three independent sources of metals incorporated in human teeth were found. The first source, representing about 43% of the variance of the concentration data, was characterized by pollutant elements of power industry emissions. The second factor was loaded with toxic elements of general urban pollution. The third factor represented the tooth source as it contained mainly large fractions of the mineral components of the tooth tissue as Ca and K.     

Setting out the frame conditions for feasible use of FFPE derived RNA

Introduction

The usage of formalin-fixed paraffin embedded (FFPE) tissue is characterized by its long shelf-life and simple handling. Therefore it is the most commonly available tissue specimen in routine diagnostics and histological studies. Formaldehyde fixation may result in RNA degradation and cross linking with proteins, while storage conditions also affect RNA integrity. The present study was designed to investigate the influence of these factors on RNA analysis.

用层析法研究X—CT的论证问题

为改善技术论证的定量程度，作者用层析法对Ｘ－ＣＴ的选型操作进行了研究，并提出此方法可推广应用于一般医院的大型装备。     

高等医学院校分析化学类课程教学改革探讨

分析化学类课程是高等医学院校卫生、检验、药学及法医等专业的主干课程． 作者根据长期教学经验, 分析了我国高等医学院校分析化学类课程的教学现状, 提出必须改变现有的教学体制, 克服片面追求小而全、相互封闭的思想; 将分散在各系（ 部） 的分析化学类课程教学人员集中起来成立统一的分析化学教研室, 并与实验中心的分析测试室合并, 将分散的分析仪器集中起来建立统一的实验室, 这样可对全院各系（ 专业） 开分析化学类课程, 并承担校内外各种测试分析任务, 以提高办学效益．     

Proficiency testing for psychoactive substances in Italy

This paper describes the general design and main results of the Italian proficiency testing program for the analysis of psychoactive substances in urine, a long-term initiative created in 1995 on an educational basis and characterized by an innovative internet-based service for data exchange between laboratories and the organizing body. Batches of six urine samples, validated by reference laboratories, are sent every 3 months to participating laboratories, which may choose which classes of substances to test from those planned by the program panel and, within those classes, which type of analytical commitment to work on: identification of just one class (Option 1), identification of single substances (Option 2), or identification and quantification of single substances (Option 3). Comprehensive periodical reports and annual reports are provided to participants with evaluation of their performance and an annual workshop is organized to discuss technical-scientific topics related to clinical, forensic and analytical toxicology. About 200 laboratories currently participate in the program and a total of 67,059 analyses have been carried out since 1995. The mean percentage of correct results was 96.8%, with a yearly improvement of about 0.4%. The best average false positive and false negative rates were obtained for methadone (0.2% and 2.1% respectively) and cocaine (0.3% and 2.2%). The worst average false positive rates were obtained for amphetamines and opiates (3.2% and 5.0%) and worst average false negative rates for amphetamines, barbiturates and cannabinoids (17.4%, 30.7% and 19.9%). Received: 29 June 1998 / Received in revised form: 23 February 1999     

蛋白质不稳定性及其分析技术

蛋白质不稳定性包括两种形式：化学不稳定性和物理不稳定性，这两种不稳定性可采取不同的分析技术。了解蛋白质不稳定性及其分析技术在生物工程药物的质量控制中有十分重要的作用。     

丹皮酚的分析方法

目的：概述丹皮酚的定量分析方法，为丹皮酚及其复方制剂的质量控制提供参考，同时便于药学工作者根据各种实际情况加以选择应用。方法：对近年来的相关文献进行追踪、整理分类。结果：归纳出丹皮酚的9种定量分析方法。结论：对丹皮酚的定量分析方法的研究已相当深入和广泛，为丹皮酚制剂的质量控制打下良好的基础。     

Performance evaluation of serum IgG subclass quantification using a SPAPLUS turbidimetric analyzer and comparison with the BNII nephelometer

Abstract

IgG consists of four subclasses: IgG1, IgG2, IgG3, and IgG4. Changes in the serum concentration of each subclass reflect different clinical situations, and quantification of each subclass is important to assess patients’ clinical states. Herein, we evaluated the analytical performance of the SPAPLUS turbidimetric analyzer (The Binding Site, Birmingham, UK) for IgG subclass. Precision, linearity, comparison with the BNII system (Siemens Healthineers, Erlangen, Germany), and reference interval were assessed according to the Clinical and Laboratory Standards Institute (CLSI) guidelines. The repeatability and within-laboratory precision were within 5% for all IgG subclasses. The coefficient of determination (R²) was higher than 0.99 for the analytical measurement range in all IgG subclasses. Comparison between SPAPLUS and BNII revealed significant differences in IgG1, IgG3, and IgG4 (p?相似文献   

Analytical Quality by Design Approach in RP-HPLC Method Development for the Assay of Etofenamate in Dosage Forms

By considering the current regulatory requirement for an analytical method development, a reversed phase high performance liquid chromatographic method for routine analysis of etofenamate in dosage form has been optimized using analytical quality by design approach. Unlike routine approach, the present study was initiated with understanding of quality target product profile, analytical target profile and risk assessment for method variables that affect the method response. A liquid chromatography system equipped with a C₁₈ column (250×4.6 mm, 5 μ), a binary pump and photodiode array detector were used in this work. The experiments were conducted based on plan by central composite design, which could save time, reagents and other resources. Sigma Tech software was used to plan and analyses the experimental observations and obtain quadratic process model. The process model was used for predictive solution for retention time. The predicted data from contour diagram for retention time were verified actually and it satisfied with actual experimental data. The optimized method was achieved at 1.2 ml/min flow rate of using mobile phase composition of methanol and 0.2% triethylamine in water at 85:15, % v/v, pH adjusted to 6.5. The method was validated and verified for targeted method performances, robustness and system suitability during method transfer.