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Establishment of recombinant major allergens Bet v 1 and Phl p 5a as Ph. Eur. reference standards and validation of ELISA methods for their measurement. Results from feasibility studies. 重组主要过敏原betv1和php5a作为Ph. Eur。参考标准和ELISA方法的验证。可行性研究结果。
Q4 Medicine Pub Date : 2012-04-01
S Vieths, D Barber, M Chapman, A Costanzo, A Daas, H Fiebig, K M Hanschmann, M Hrabina, S Kaul, A Ledesma, P Moingeon, G Reese, C Schörner, R van Ree, B Weber, K H Buchheit

The potency of allergen extracts is determined as total allergenic activity without consideration of their composition and the units differ from one manufacturer to another, making it very difficult to compare the different products. Recently, purified major allergens have been obtained by recombinant DNA technology and produced under Good Manufacturing Practice (GMP) conditions. In principle, such recombinant allergens could be established as reference standards and could help for the standardisation of the major allergen content of allergen extracts. Two recombinant major allergens, one from birch pollen, rBet v 1, and one from Timothy grass pollen, Phl p 5a, have been selected at the end of the CREATE programme as a potential starting point for the establishment as European Pharmacopoeia (Ph. Eur.) Reference Standards through a project run by the Biological Standardisation Programme (BSP) of the European Directorate for the Quality of Medicines & HealthCare (EDQM). To this end, bulk candidate recombinant materials, produced under GMP conditions, were procured from two European manufacturers and subsequently formulated and lyophilised. Four ELISA systems from three different manufacturers were included in the project, two for Bet v 1 and two for Phl p 5a with the aim of establishing reference methods for determination of the respective major antigens both in natural allergen extracts as well as in recombinant allergen products. The project was run in 3 phases: a preparatory and preliminary testing phase (feasibility phase or Phase 1), an extended feasibility phase carried out in 3 laboratories (Phase 2) to confirm the transferability of the methods and an international collaborative study with a large number of participating laboratories (Phase 3). This article describes the work done in Phase 1 and Phase 2, i.e. the physico-chemical and biological characterisation of the recombinant candidate reference standards, the assessment of their suitability for the intended purpose as well as the evaluation of the candidate ELISA systems. The results show that both candidate reference standards are suitable for the intended purpose. In addition, three out of the four ELISA systems that were included in the preliminary phase were found to be appropriate for further evaluation in the collaborative study which was organised in 2011. The results of the collaborative study will be published separately.

过敏原提取物的效力是以总致敏活性来确定的,而不考虑其成分,并且单位因制造商而异,因此很难比较不同的产品。近年来,利用重组DNA技术获得了纯化的主要过敏原,并在良好生产规范(GMP)条件下生产。原则上,这些重组过敏原可以作为参考标准,并有助于过敏原提取物中主要过敏原含量的标准化。两个重组主要过敏原,一个来自桦树花粉,rBet v 1,一个来自Timothy草花粉,Phl p 5a,已在CREATE项目结束时被选中,作为建立欧洲药典(Ph. Eur.)的潜在起点。参考标准通过欧洲药品和保健质量理事会(EDQM)生物标准化方案(BSP)管理的一个项目。为此,在GMP条件下生产的散装候选重组材料从两家欧洲制造商处采购,随后配制并冻干。该项目包括来自三家不同制造商的四套ELISA系统,其中两套用于betv1,两套用于php5a,目的是建立测定天然过敏原提取物和重组过敏原产品中各自主要抗原的参考方法。该项目分三个阶段进行:预备和初步测试阶段(可行性阶段或第一阶段),在3个实验室进行扩展的可行性阶段(第二阶段),以确认方法的可转移性,并与大量参与的实验室进行国际合作研究(第三阶段)。本文描述了在第一阶段和第二阶段所做的工作,即重组候选参考标准的物理化学和生物学特性,评估其对预期目的的适用性以及对候选ELISA系统的评估。结果表明,两种候选参考标准均符合预期目的。此外,在2011年组织的合作研究中发现,初步阶段包含的四个ELISA系统中有三个适合进一步评估。合作研究的结果将单独发表。
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引用次数: 0
On the formation of bromhexine impurity E and its chromatographic behaviour. 溴甲辛杂质E的形成及其色谱行为。
Q4 Medicine Pub Date : 2012-04-01
B J Venhuis, M Weda, D de Kaste, E K Lamme

An unknown bromhexine hydrochloride (BRH) degradation product in BRH oral solutions (finished products) was potentially related to the purity of this API. Several degradation experiments were conducted and its identity and formation were investigated using LC-DAD and LC-DAD-MS/MS. Using the LC method described in the Ph.Eur monograph BRH the degradation product was observed at RRTBRH 0.1 and the specified impurities A-D were ruled out as candidates. Impurity E was initially not considered as a candidate as EDQM reported an expected RRTBRH of 1.8. Still, the LC-DAD-MS/MS results were consistent with the M+ ion for impurity E and its expected fragment ions. Therefore, standard addition was carried out using the Ph. Eur. method which confirmed that the degradation product at RRT 0.1 was impurity E. Upon changing the column type to a column described in the knowledge database, impurity E eluted at an RRT of 1.5. Nevertheless, both columns met all of the criteria in the monograph. The formation of impurity E was even observed in BRH solutions without added reagents. As the conversion from BRH to impurity E requires a source of carbon, we suggest that one BRH molecule degrades through a radical mechanism to a reactive species which subsequently is quenched by another BRH molecule producing impurity E. We suggest the transparency list for BRH to be more explicit on the formation of impurity E, its RRT and the permissible LC columns.

BRH口服液(成品)中未知的盐酸溴甲辛(BRH)降解产物可能与该原料药的纯度有关。利用LC-DAD和LC-DAD-MS/MS对其进行了降解实验,并对其特性和形成进行了研究。使用Ph.Eur专著BRH中描述的LC方法在RRTBRH 0.1下观察降解产物,并排除指定杂质A-D作为候选。杂质E最初不被视为候选,因为EDQM报告的预期rrthbrh为1.8。尽管如此,LC-DAD-MS/MS结果与杂质E的M+离子及其预期片段离子一致。因此,使用Ph. Eur进行标准添加。将色谱柱类型改为知识库中描述的色谱柱后,杂质E以1.5的RRT洗脱。然而,这两个专栏都符合专著中的所有标准。在不添加试剂的BRH溶液中也观察到杂质E的形成。由于从BRH到杂质E的转化需要碳源,我们建议一个BRH分子通过自由基机制降解为反应物质,随后被另一个产生杂质E的BRH分子淬灭。我们建议BRH的透明度列表更明确地说明杂质E的形成、RRT和允许的LC柱。
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引用次数: 0
Collaborative study for the establishment of the 3rd international standard for dihydrostreptomycin. 二氢链霉素第三项国际标准的制定合作研究。
Q4 Medicine Pub Date : 2012-04-01
G Rautmann, A Daas, K-H Buchheit

An international collaborative study was organised to establish the World Health Organization (WHO) 3rd International Standard (IS) for dihydrostreptomycin. Eleven laboratories from different countries participated in the collaborative study. The potency of the candidate batch, a freeze-dried preparation, was estimated by microbiological assays with sensitive microorganisms. To ensure continuity between consecutive batches of the WHO IS, the 2nd IS for dihydrostreptomycin was used as standard. Based on the results of the study, the 3rd IS for dihydrostreptomycin was adopted at the meeting of the WHO Expert Committee on Biological Standardisation (ECBS) in 2011 with an assigned anti-microbiological activity of 19425 International Units (IU) per vial. The 3rd IS for dihydrostreptomycin is available from the EDQM.

组织了一项国际合作研究,以制定世界卫生组织(世卫组织)关于双氢链霉素的第三个国际标准。来自不同国家的11个实验室参与了这项合作研究。冻干制剂候选批的效力是通过敏感微生物的微生物测定来估计的。为保证连续批次WHO IS的连续性,以第二批WHO IS为标准。根据研究结果,2011年世卫组织生物标准化专家委员会会议通过了双氢链霉素的第三个标准,规定每瓶抗微生物活性为19425国际单位(IU)。二氢链霉素的第三个IS可从EDQM获得。
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引用次数: 0
Feasibility studies. The use of NMR spectrometry as a possible substitute of or complement to several analytical tests in pharmacopoeia monographs. 可行性研究。使用核磁共振光谱法作为药典各论中几种分析试验的可能替代或补充。
Q4 Medicine Pub Date : 2012-04-01
I McEwen, T Arvidsson

NMR spectrometry has many analytical applications; for instance, the identification of known substances; the structure elucidation of unknown ones; the quantification of APIs, impurities, solvent and water; kinetic studies, stereochemistry determinations, and the analyses of complex mixtures as in metabonomics. NMR spectrometry has the potential to substitute or complement existing analyses that are performed on APIs. In this work, 4 different NMR analyses were done on 2 APIs: fluvastatin sodium and benzalkonium chloride with good results.

核磁共振光谱法有许多分析应用;例如,已知物质的鉴定;未知分子的结构解析;原料药、杂质、溶剂和水的定量;动力学研究,立体化学测定,以及代谢组学中复杂混合物的分析。核磁共振光谱法具有替代或补充现有的原料药分析的潜力。本文对氟伐他汀钠和苯扎氯铵这两种原料药进行了4种不同的核磁共振分析,结果良好。
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引用次数: 0
A multifunctional test mixture for chiral cyclodextrin GC columns. 手性环糊精气相色谱柱的多功能检测混合物。
Q4 Medicine Pub Date : 2012-04-01
S Wyss, I A Werner

Gas chromatography (GC) is a powerful tool in the separation science of chiral analytes. The development of a new chiral test mixture for cyclodextrin (CD) coated GC columns allows comparing, choosing and identifying most suitable columns for a given separation challenge. This test mixture contains 12 enantiomer pairs of a broad range of functional groups and it is the first mixture suitable for all types of modified cyclodextrin capillary columns. Column changes can be observed and system performance can be monitored by means of this test mixture, which is therefore a base for reliable results. Furthermore, this publication is thought to be a start-up aid for chiral GC.

气相色谱法(GC)是手性分析物分离科学的有力工具。一种新的手性测试混合物环糊精(CD)涂层气相色谱柱的开发允许比较,选择和确定最合适的柱为给定的分离挑战。该测试混合物包含12对对映体对广泛的官能团,它是第一个混合物适用于所有类型的改性环糊精毛细管柱。通过这种测试混合物,可以观察到柱的变化,并可以监控系统性能,因此这是可靠结果的基础。此外,该出版物被认为是手性气相色谱的启动援助。
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引用次数: 0
New BRP for human plasma calibrated for coagulation factors V, VIII, XI and XIII - collaborative study for establishment of batches 1 and 2.
Q4 Medicine Pub Date : 2011-11-01
P Bayer, A Daas, C Milne

A human plasma reference preparation in International Units (IU) must be used in each potency assay of the human coagulation factors V, VIII and XI in human plasma pooled and treated for virus inactivation, according to the European Pharmacopoeia (Ph. Eur.) monograph 1646 and general chapters 2.7.4 and 2.7.22 respectively, and in the potency assay of human coagulation factor XIII in fibrin sealant kits, according to Ph. Eur. monograph 0903. International reference standards for all of these factors are now established, however, regional reference standards were not available for the required routine use. It was therefore proposed by European OMCLs and manufacturers to establish a European reference preparation, and it was the goal of this study to accomplish that. Two candidate biological reference preparations (BRPs), separate lyophilisation lots of the same normal human plasma bulk material, were calibrated against the International Standards (ISs) for human coagulation factors V, VIII, XI and XIII. Twelve European laboratories including OMCLs and manufacturers participated. The candidate material was tested against the ISs in 4 separate assays for each factor using the methods described in the relevant Ph. Eur. monographs and general chapters. No discernable difference was noted between the activities of the 2 candidates. They were shown to be suitable for their intended use and it was recommended to assign to both batches a potency of 0.73 IU/mL for factor V, 0.74 IU/mL for factor VIII, 0.59 IU/mL for factor XI and 0.79 IU/mL for factor XIII. Candidate batch B is proposed to be used first as lot 1, followed upon its depletion by candidate batch A (lot 2). The BRP batches will be monitored regularly for potency throughout their lifetime. EDQM BRP batches 1 and 2 of coagulation factors V, VIII, XI and XIII plasma were formally adopted by the Ph. Eur. Commission at their session in June 2011.

0903年专著。所有这些因素的国际参考标准现已确立,但是,没有区域参考标准供必要的日常使用。因此,欧洲omcl和制造商建议建立欧洲参考制剂,本研究的目标是实现这一目标。包括omcl和制造商在内的12个欧洲实验室参与了研究。使用相关博士论文中描述的方法,对候选材料进行4次单独的ISs检测。专著和总章。两位候选人的活动没有明显差异。候选批B建议首先作为批号使用,然后由候选批A(批号2)耗尽。BRP批次将在其整个生命周期内定期监测其效力。委员会2011年6月届会。
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引用次数: 0
Biological indicators, tools to verify the effect of sterilisation processes - position paper prepared on behalf of group 1 (biological methods and statistical analysis). 生物指标,验证灭菌过程效果的工具-代表第1组(生物方法和统计分析)准备的意见书。
Q4 Medicine Pub Date : 2011-11-01
K Haberer, H van Doorne

Biological indicators (BIs) are test systems containing viable microorganisms (usually spores of bacteria) providing a defined challenge to a specified sterilisation process. General chapter 5.1.2 of the European Pharmacopoeia [1] (Ph. Eur.) sets specifications for BIs and gives some guidance for their use. As shown in this text, the approach followed by Ph. Eur. as well as by ISO standards is outdated and could create nowadays some confusion among the users of the pharmacopoeia. It is the objective of this paper to provide the theoretical background of BIs as tools for the design and qualification of reliable moist heat sterilisation processes. The principles laid down in this article will form the basis of a future draft on a revised chapter on BIs in Pharmeuropa.

生物指示剂(BIs)是含有活菌(通常是细菌孢子)的测试系统,对特定的灭菌过程提供确定的挑战。欧洲药典通论5.1.2章[1](Ph. Eur.)规定了BIs的规格并给出了一些使用指南。如本文所示,Eur博士所采用的方法。以及ISO标准已经过时,并且可能在药典用户中造成一些混乱。本文的目的是提供BIs作为设计和确定可靠的湿热灭菌工艺的工具的理论背景。本条规定的原则将构成今后关于《Pharmeuropa》中关于BIs的修订章节草案的基础。
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引用次数: 0
Collaborative study for the establishment of the second international standard for vancomycin. 万古霉素第二部国际标准制定的合作研究。
Q4 Medicine Pub Date : 2011-11-01
G Rautmann, A Daas, K-H Buchheit

An international collaborative study has been organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM) to establish the World Health Organization (WHO) 2nd International Standard (IS) for Vancomycin. Twelve laboratories from 10 different countries participated. The potency of the candidate material, a freeze-dried preparation, was estimated by microbiological assays with sensitive micro-organisms. As the stocks of the 1st IS for Vancomycin had been completely depleted, in order to ensure continuity between consecutive batches of the WHO IS, the European Pharmacopoeia Chemical Reference Standard (CRS) for Vancomycin batch 2 was used as a standard. It had been calibrated in a large international collaborative study against the WHO 1st IS for Vancomycin. Based on the results of the study, the 2nd IS for Vancomycin was adopted at the meeting of the WHO Expert Committee on Biological Standardisation (ECBS) in 2010 with an assigned antimicrobiological activity of 109,700 IU per vial. The 2nd IS for Vancomycin is available from the EDQM.

欧洲药品和保健质量理事会(EDQM)组织了一项国际合作研究,以建立世界卫生组织(世卫组织)万古霉素第二项国际标准。来自10个不同国家的12个实验室参与了研究。候选材料的效力,冻干制剂,估计与敏感微生物微生物测定。由于万古霉素第1批IS库存已完全耗尽,为保证WHO IS连续批次之间的连续性,采用欧洲药典万古霉素第2批化学参考标准(CRS)作为标准。它已在一项大型国际合作研究中与世卫组织万古霉素第一IS进行了校准。根据研究结果,2010年世卫组织生物标准化专家委员会(ECBS)会议通过了万古霉素的第二份标准,指定的抗微生物活性为每瓶109,700 IU。万古霉素的第二个IS可从EDQM获得。
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引用次数: 0
Determination of water content by capillary gas chromatography coupled with thermal conductivity detection. 毛细管气相色谱-热导检测法测定水的含量。
Q4 Medicine Pub Date : 2011-11-01
A Lodi, M S Bellini, A Clavel, N Pijnenburg

This article presents some experience obtained by applying capillary gas chromatography coupled with thermal conductivity detection (GC/TCD) to the determination of water in substances for pharmaceutical use. This technique represents a useful, orthogonal tool complementary to water determination methods based on volumetric or coulometric titration. It can also represent an alternative technique when such titrations are not applicable. This article presents the preliminary results obtained in a number of case studies where a GC/TCD procedure was applied in comparison with pharmacopoeial methods to substances with different water contents.

本文介绍了用毛细管气相色谱-热导检测(GC/TCD)法测定药用物质中水分的一些经验。这项技术代表了一种有用的正交工具,补充了基于体积或库仑滴定的水测定方法。当这种滴定法不适用时,它也可以作为一种替代技术。本文介绍了在一些案例研究中获得的初步结果,其中GC/TCD程序与药典方法对不同含水量的物质进行了比较。
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引用次数: 0
An alternative to animal testing in the quality control of erythropoietin. 红细胞生成素质量控制的一种替代动物试验方法。
Q4 Medicine Pub Date : 2011-06-01
H Zimmermann, D Gerhard, L A Hothorn, T Dingermann

A physico-chemical method has been developed as an alternative to the current bioassay in normocythaemic mice for estimating the biological activity of erythropoietin batches. Capillary zone electrophoresis was used for quantification of the isoforms and their substructures were further elucidated by N-glycan mapping techniques. The analytical study was carried out on a total of 40 batches of epoetin beta which were selected to cover an adequate range of precisely established potency values. The relationship between the biological and chemical parameters was evaluated statistically in order to identify suitable covariates for the prediction of the biological activity. Out of several alternatives, a prediction model which is based on the percentages of isoforms per batch and the degree of sialidation was selected and tested. This model is comparable in terms of accuracy to the established in vivo bioassay, but is far superior in terms of precision. Further advantages of the method are improved animal welfare and savings in time and effort. The question whether the prediction model already meets the requirements for replacing the bioassay according to the ICH guideline Q6B is discussed.

一种物理化学方法已被开发,作为替代目前的生物测定,在正常红细胞血症小鼠中估计促红细胞生成素批次的生物活性。采用毛细管区带电泳技术对其进行定量分析,并利用n -聚糖定位技术对其亚结构进行进一步分析。分析研究共对40批epoetin β进行了选择,以覆盖精确建立的效价值的足够范围。对生物参数和化学参数之间的关系进行了统计评估,以确定预测生物活性的合适协变量。在几种替代方案中,选择并测试了基于每批同种异构体百分比和鉴定程度的预测模型。该模型在准确性方面与已建立的体内生物测定法相当,但在精度方面要优越得多。该方法的进一步优点是改善动物福利和节省时间和精力。讨论了预测模型是否已经满足ICH指南Q6B替代生物测定法的要求。
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引用次数: 0
期刊
Pharmeuropa bio & scientific notes
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