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| 1 | Impurity analysis of gentamicin bulk samples by improved liquid chromatography-ion trap mass spectrometry显示文摘Several gentamicin bulk samples from different origins were investigated using an LC/MS method.LC equipped with ion trap MS with positive ionization was performed on a Capcell Pak C18(AQ) column with the mobile phase containing 50 mM trifluoroacetic(TFA) and methanol.Impurities present in batches of gentamicin bulk samples were elucidated and compared according to their fragmentation behavior.In total seventeen impurities present in samples,five impurities were not elucidated and two compounds were identified preliminarily.It was observed that the impurity profiles were different in samples from different origins which indicate necessity in the quality control of gentamicin. | ZHENG Chao WANG BoChu WANG MingJuan HOOGMARTENS Jos SCHEPDAEL Ann Van ADAMS Erwin | 2011 | Science China Chemistry2011，54，9： | 4 |
| 2 | Older age, longer procedures and tandem endoscopic-ultrasound as risk factors for post-endoscopic retrograde cholangiopancreatography bacteremia显示文摘BACKGROUND Clinically significant post-endoscopic retrograde cholangiopancreatography(ERCP) bacteremia(PEB) occurs in up to 5% of cases, while antibiotic prophylaxis is recommended only when an ERCP is unlikely to achieve complete biliary drainage. However, the current recommendations may not cover all potential risk factors for PEB.AIM To identify novel risk factors for PEB and evaluate appropriateness of antibiotic prophylaxis.METHODS A retrospective study of 1082 ERCP procedures performed between January 2012-December 2013 in a single tertiary medical center. Data collection included: Demographic and clinical characteristics such as pre and post procedure antibiotic treatment and bacterial blood cultures. Exclusion criteria were:(1) Age < 18 years;(2) Positive bacterial blood culture before ERCP;(3) Scheduled antibiotic treatment prior to ERCP;(4) Hospitalization longer than 14 d before ERCP;and(5) missing critical data. Stepwise Logistic Regression analysis and Decision Tree algorithms were used for prediction modeling of PEB.RESULTS A total of 626 ERCPs performed in 434 patients were included. Mean age 66.49 ± 15.4 years and 46.5% were males. PEB prevalence was 3.7%. Antibiotic prophylaxis was administrated in 139/626(22.2%) cases but was indicated according to the guidelines only in 44/626(7%) cases. In all the PEB cases, prophylaxis was deemed not indicated. A stepwise logistic regression [receiver operating characteristic(ROC), 0.766], identified 3 variables as independent risk factors for PEB: Age at ERCP ≥ 75 years(OR, 3.780, 95%CI: 1.519-9.408, P = 0.004);Tandem EUS/ERCP with fine needle aspiration(FNA)(OR, 14.528, 95%CI: 3.571-59.095, P < 0.001);ERCP duration longer than 60 min(OR, 5.396, 95%CI: 1.86-15.656, P = 0.002). In a decision tree model(ROC, 0.778) the probability for PEB without any risk factors was 1% regardless of prophylaxis administration.CONCLUSION The prevalence of PEB in our study is similar to previous reports, despite the fact that antibiotic prophylaxis was administrated more readily than recommended. ERCP duration longer than 60 min, tandem EUS-ERCP with FNA and age above 75 years are significant risk factors for PEB. These factors should be further evaluated as indications for prophylactic antibiotic treatment before ERCP. | Liat Deutsch Shay Matalon Adam Phillips Moshe Leshno Oren Shibolet Erwin Santo | 2020 | World Journal of Gastroenterology2020，26，41： | 3 |
| 3 | 色谱柱分类数据库用于指导天然药物化学对照品色谱纯度测定时色谱柱理性选择(英文)显示文摘由于中药化学对照品多数来源于动植物药材,很容易混有结构类似物,故有机杂质测定是可能影响其化学对照品赋值准确性的关键风险因素。中药化学对照品的有机杂质测定通常采用药典收载或文献报道的高效液相色谱法,这些方法通常仅规定'以十八烷基硅烷键合硅胶为填充剂',无适宜色谱柱的品牌信息,或者实验室无文献所用的色谱柱品牌,而目前市场上已有800多种品牌的C18柱,生产工艺的不同导致不同品牌C18柱的选择性有差异,甚至差异显著。这很容易出现由于色谱柱选择不适宜而导致测定结果不准确的风险。该文采用国外色谱柱分类数据库指导对照品纯度考察时色谱柱的理性选择,尽可能减少色谱柱盲选可能导致的纯度结果不准确的风险。首先,用数据库挑选2根选择性差异显著的色谱柱(选择性因子F≥6)进行平行实验,以尽可能反映采用不同品牌色谱柱可能出现的分离效果差异。如果这2根色谱柱的分离效果及纯度测定结果无显著性差异,则可以交叉验证该对照品纯度测定的准确性。否则需要从数据库中选择另外1根与之前试验中分离效果更好、选择性相似的色谱柱进行纯度结果验证。在N-反式-p-对香豆酰基酪胺和表儿茶素没食子酸酯首批对照品的纯度考察中,使用了上述策略并验证了其有效性和科学性,计划推广应用至更多的中药化学对照品,特别当其可能含碱性或弱酸性化合物时,更应该尝试采用本文推荐的色谱柱选择策略交叉验证其纯度测定结果的准确性。 | 王明娟 戴忠 马双成 金红宇 HOOGMARTENS Jos ADAMS Erwin | 2017 | 色谱2017，35，2： | 2 |
| 4 | Public health works: blood donationin urban China显示文摘 | Adams V Erwin K Le PV | 2009 | Soc Sci Med2009，68，3： | 1 |
| 5 | Improved reversed phase liquid chromatographic method with pulsed electrochemical detection for tobramycin in bulk and pharmaceutical formulation显示文摘Tobramycin is one of the aminoglycoside antibiotics that lack a UV absorbing chromophore. However, the application of pulsed electrochemical detection (PED) has been used successfully for the analysis of this and similar antibiotics. This work describes an improved liquid chromatographic (LC) method combined with PED, which is able to separate much more impurities than before. Using a Discovery C-18 RP column (250 mm 4.6 mm i.d., 5 mm), isocratic elution was carried out with a mobile phase, containing sodium sulfate (35 g/L), sodium octanesulphonic acid (1 g/L), tetrahydrofuran (14 mL/L) and 0.2 M phosphate buffer pH 3.0 (50 mL/L). Using these experimental conditions, the limit of quantification (LOQ, S/N 10) was 5 ng. The linearity was examined in the range LOQ-60 mg/mL and the coefficient of determination was 0.998. The method also proved to be repeatable and the recovery was close to 100%. The influence of the different chromatographic parameters on the separation was investigated by means of an experimental design. The proposed method is useful in quality control of tobramycin drug substances and drug products. | Vicky Manyanga Ehab Elkady Jos Hoogmartens Erwin Adams | 2013 | Journal of Pharmaceutical Analysis2013，3，3： | 1 |
| 6 | 甲硝唑光降解杂质的研究及对药典有关物质方法的优化建议显示文摘目的:对采用现有各国药典中甲硝唑有关物质方法考察甲硝唑强光照射影响因素试验出现的物料不平衡(甲硝唑降解程度明显高于有关物质增长幅度)的原因进行调查。方法:用液相色谱-二极管阵列检测-串联质谱法(LC PDA-MS)对强光破坏的甲硝唑水溶液及其复方阴道洗剂的光降解产物进行定性鉴别和紫外光谱研究;用推导结构(N-(2-羟乙基)-5-甲基-l, 2,4-(口恶)二唑-3-甲酰胺)的杂质对照品,通过与甲硝唑光降解杂质保留时间和提取PDA光谱的一致性对比,及与甲硝唑氢谱的平行比较,对推导的甲硝唑光降解杂质结构进行确证;根据定性和光谱研究结果,依据现有药典方法优化了能同时检测该光降解杂质的方法并进行全面方法学验证。结果:甲硝唑在溶液、紫外光照条件下容易发生光降解,该杂质最大吸收约在230 nm,而在各论项下有关物质方法中设置的315/319 nm处吸收强度很弱。已上市甲硝唑注射液(需要缓慢输液)在室温光照条件下放置48 h或在5 000 lx条件下处理2 d和5 d后,光降解产物的量从“未检出”快速增加至0.15%、0.36%和0.88%,均超过本品的鉴定限(0.10%)和界定限(0.15%)。用230 nm检测并引入梯度洗脱、在各论项方法基础上优化建立的方法,能同时检测该光降解杂质和甲硝唑特定杂质2-甲基-5-硝基咪唑,方法的专属性、灵敏度、精密度、溶液的稳定性等指标均满足要求。结论:通过对甲硝唑光降解杂质的结构鉴定和光谱特征研究,揭示了采用现有药典检查方法考察甲硝唑光破坏样品出现的物料不平衡原因;建立了能同时控制该光降解杂质和甲硝唑现有特定杂质的优化方法;甲硝唑注射液慢速输液过程存在较大的光降解风险,需引起关注。 | 陈美玲 许红霞 袁伟峰 赵隋红 李雪 朱兰新 谌宗永 刘宇晶 马昂 王明娟 HOOGMARTENS Jos ADAMS Erwin | 2022 | 药物分析杂志2022，42，9： | 1 |
| 7 | Identification and characterization of a novel family of pneumococcal proteins that are protective against sepsis 显示文摘 | Adamou J E Heinrichs J H Erwin A L | 2001 | Infect Immunol2001，69，2： | 1 |
| 8 | 乙酰螺旋霉素组分分析中色谱柱的理性选择方法探讨(英文)显示文摘乙酰螺旋霉素为碱性的多组分抗生素,是以螺旋霉素为起始原料的半合成抗生素。乙酰螺旋霉素原料药中除了单-乙酰螺旋霉素Ⅱ和Ⅲ、双-乙酰螺旋霉素Ⅱ和Ⅲ四种主成分外,还能检出70多种小组分,这些小组分的结构与主成分相似或为主成分的同分异构体,故将乙酰螺旋霉素的各组分基线分离很具挑战性;在实际工作中还发现,采用不同品牌的C_(18)柱所得的乙酰螺旋霉素组分测定结果有时差异较大,有必要采用科学的方式理性挑选适宜的色谱柱进行其组分测定。本文利用国际上较有影响力的鲁汶大学所建的色谱柱分类系统数据库,以文献报道的CAPCELL PAK MG C_(18)柱(250 mm×4.6 mm,5μm)作为参比柱,选择了3组选择性不同的色谱柱,并按照中国药典2010版乙酰螺旋霉素各论项下的方法考察了这3组色谱柱的实际分离情况。与参比柱的结果相比,F<2组的分离效果最好,F>6组的分离效果最差,而26组色谱柱(F≥9.9)的绝对差异则超过2.5%,甚至高达8.2%,进一步验证了该色谱柱分类系统在适宜色谱柱选择方面的作用。 | 王明娟 郑超 胡昌勤 金少鸿 Hoogmartens Jos VanSchepdael Ann Adams Erwin | 2011 | Journal of Chinese Pharmaceutical Sciences2011，20，6： | 1 |
| 9 | Comparison of liquid chromatographic methods with direct detection for the analysis of gentamicin显示文摘 | Vicky Manyanga Olga Grishina Erwin Adams | 2007 | Journal of Pharmaceutical and Biomedical Analysis2007，45，： | 1 |
| 10 | Identificationand characterization of a novel family of pneumococcalproteins that are protective against sepsis显示文摘 | Adamou JE Heinrichs JH Erwin AL | 2001 | Infect Immun2001，69，2： | 1 |
| 11 | Identification and characterization of a novel family of pneumococcal proteins that are protective against sepsis显示文摘 | Adamou JE Heindchs JH Erwin AL | 2001 | Infect Immun2001，69，： | 1 |
| 12 | 高效液相色谱-质谱联用技术对缬草三酯稳定性的研究(英文)显示文摘缬草三酯属于多酰基类环烯醚萜化合物。中国药典2010年版一部蜘蛛香项下收载缬草三酯作为质量控制对照品使用。然而,结构不稳定是该类对照品发放中亟待解决的问题。本文通过高效液相色谱-质谱联用的方法对缬草三酯的稳定性进行了研究。根据ICH导则要求,使用加速稳定性实验对缬草三酯适宜贮存条件、运输和实验条件进行研究。结果表明,缬草三酯在碱性和加热条件下不稳定,而在酸性、氧化和强光照射条件下保持相对稳定。实验中有九个缬草三酯降解产物被检出,其中N1–N4为碱性水解时产生,B1–B5为热降解中产生。研究结果为本对照品的稳定性分析提供了依据。本文还对缬草三酯的制备、贮藏和使用等条件进行研究,该对照品在避光低温(–20 oC)条件下贮藏。通过长期稳定性研究,在拟定的贮藏条件下,缬草三酯在3年内可以保持稳定。 | 王菲菲 王明娟 张聿梅 王琰 于健东 王瑞忠 程显龙 汪祺 郑笑为 刘燕 戴忠 马双成 Erwin Adam | 2014 | Journal of Chinese Pharmaceutical Sciences2014，23，12： | 1 |
| 13 | Identification and characterization of anovel family of pneumococcal proteins that are proteins that are protective against sepsis显示文摘 | Adamou J E Heinrichs J H Erwin A L | | 0，，02： | 1 |
| 14 | 短期摄入硝酸盐膳食补充剂对健康人血液中基质金属蛋白酶9的影响(英文)显示文摘目的:研究硝酸盐膳食补充剂对血液中基质金属蛋白酶9的作用。方法:受试者血液中亚硝酸盐和硝酸盐的含量采用毛细管电泳紫外法检测。相应血液中基质金属蛋白酶9的含量采用酶联免疫荧光法和毛细管电泳质谱法检测。结果:研究表明,相比服用安慰剂,受试者在服用甜菜饮料后血液中的硝酸盐和亚硝酸盐分别显示3.5倍和40%增长。酶联免疫荧光法和毛细管电泳质谱法均线性良好,血液中基质金属蛋白酶9的定量限为0.25 ng·m L^(-1)。其中在8个受试者中,有4个受试者显示增长的硝酸盐/亚硝酸盐对血液中基质金属蛋白酶9有抑制作用。结论:结果显示短期服用硝酸盐膳食补充剂和血液中基质金属蛋白酶9降低有关。 | 王旭 陈慧 李克峰 曹小红 范艳红 章启鹏 罗之纲 Louise DELDICQUE Erwin ADAMS Ann Van SCHEPDAEL | 2016 | 药物分析杂志2016，36，3： | 0 |
| 15 | 高效液相色谱法测定生物样品中3PO的方法建立与验证(英文)显示文摘目的:建立并验证用于大鼠血清、脑脊液、大脑和脊髓中3-(3-吡啶)-1-(4-吡啶)-2-丙烯-1-酮(3PO)含量测定的HPLC-UV法。方法:样品处理使用蛋白沉淀的方法;色谱条件:色谱柱为Chromolith RP-18e(100 mm×4.6 mm),流动相A为乙腈-水(2.5∶97.5,v/v)添加0.1%TFA,流动相B为乙腈添加0.1%TFA,梯度洗脱[0~2.3 min,0%B→100%B(线性梯度);2.3~2.6 min,100%B(等度);2.6~2.7 min,100%B→0%B(线性梯度);2.7~5 min,0%B(等度)],流速2 mL·min-1,检测波长304 nm,进样量10μL。结果:大鼠的血清、脑脊液、大脑和脊髓中内源性物质不干扰3PO的测定,在上述4种基质中,该方法的检测限分别为0.2、0.1、0.1、0.1μg·mL-1;定量限分别为0.8、0.2、0.5、0.5μg·mL-1;线性范围分别为3~150、0.3~150、0.9~150、0.6~150μg·mL-1,相关系数均大于0.999;高、低浓度的回收率均在79.9%~100.3%的范围内;方法重复性(n=5)的RSD均大于0.9%。结论:建立的方法简单,线性范围宽,且选择性、耐用性均佳。 | Yemarshet K.Gebreyohannes 王旭 Getu Kahsay Weldu Erwin Adams Ann Van Schepdael | 2013 | 药物分析杂志2013，33，11： | 0 |
| 16 | 高效的MIMO OTA双通道测试方法显示文摘现代的无线通信技术如LTE,HSPA+和WiMAX,都采用MIMO(多输入/多输出)技术实现了数据传输速度的提高。相应地,天线测试系统(OTA)也同样需要升级到支持MIMO的测试模式。本文介绍了用一种简单而且经济的测试方法来验证MIMO设备的OTA性能,包括各向同性灵敏度(EIS)和吞吐率。 | Erwin Bohler Adam Tankielun | 2011 | 电信网技术2011，，7： | 0 |
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