2007年安徽省药品监管系统查处医疗器械重大案件

2007年，安徽省食品药品监督管理局依法行政，严厉打击制售假劣药品、医疗器械违法犯罪行为，全系统共出动执法人员51005人次、车辆15784台次，检查药品、医疗器械生产经营企业14348家次、医疗机构16551家次，捣毁制假售假窝点16个，没收制假工具18台（套），销毁假劣药械标值731万元，立案查处4864起，移送司法机关案件19起，有效打击了制售假劣药械违法犯罪行为。     

2007年安徽省药品监管系统查处医疗器械重大案件

2007年，安徽省食品药品监督管理局依法行政，严厉打击制售假劣药品、医疗器械违法犯罪行为，全系统共出动执法人员51005人次、车辆15784台次，检查药品、医疗器械生产经营企业14348家次、医疗机构16551家次，捣毁制假售假窝点16个，没收制假工具18台（套），销毁假劣药械标值731万元，立案查处4864起，移送司法机关案件19起，有效打击了制售假劣药械违法犯罪行为。     

行政处罚对象确定之我见

打击制售假劣药品违法犯罪行为,是药品监督管理部门主要职责之一,是践行"三个代表"重要思想的具体体现.在查处制售假劣药品违法案件过程中,经常遇到行政处罚对象的确定问题.本人根据工作实践和体会,提出自己的意见与各位同仁探讨.     

上海市食药监局销毁假劣、过期药品超2吨

日前。上海市长宁区食药监部门将辖区内药房上交的过期回收、清理家庭小药箱活动中回收、医疗机构委托销毁以及2009年行政处罚案件涉案罚没的280余箱总计2.25吨假劣、过期药品予以了销毁。与去年同期销毁1．11吨药品相比,此次销毁药品数量增长达100％以上。     

假劣药品案件案由的确定

假劣药品案件案由的确定张树森吴慈俊（江西省赣州地区卫生局３４１０００）自《药品管理法》实施以来，我国各级卫生行政部门依法查处了大量制售假劣药品违法案件。但在填写执法文书过程中，限于药品监督员素质而不够规范。笔者仅对假劣药品案件案由存在的问题及确定方式...     

陕西省定边县2007～2009年药品行政处罚案件分析

目的提高监督效能,最大限度的消除监管盲区、盲点。方法通过对3年来行政处罚案件的收集、整理,按年度、办案总数、案件来源、违法主体、性质、监督类别、假药定性依据、处罚程序等进行分类统计。结果 3年来行政处罚案件数量呈逐年上升趋势。结论增加稽查人力和执法装备,建立目标责任制,完善内部协作机制,健全激励机制和多渠道举报投诉制度,是提高基层一线执法监督效能的有效手段。     

偏远地区药品举报途径待拓宽

北京市发布的质量案件通报显示,从2008～2012年,药品共计立案2021起。案件来源涉及有投诉举报、监督抽验（抽查检验）、专项检查、部门移送和其他等五大类。前不久,笔者对北京市密云县2008～2012年药品立案案件及来源进行梳理汇总,分析该区县药品立案案件原因、案件来源的特点,以找出稽查执法日常监管工作与药品立案案件数量之间的关系,提出可行的监管措施,在日常工作中有目的地采取措施,及时发现药品违法情况,提高案件查办效率,有效打击辖区生产、销售、使用假劣药品的违法行为,保障人民用药安全。     

浅谈药品快检在基层药品监督管理中的作用、现状和建议

我国是发展中国家,农村人口占全国总人口的70%。由于基层群众医药基础知识欠缺,医疗和用药水平偏低,使得假劣药品在基层出现的频率较高。特别是近几年,随着制假水平的不断提高,假劣药品在基层呈现出范围广、流通快、制售手段和形式多变的现象,给基层稽查工作带来了新的问题。例如某省在2001年公布的统计数字显示该省查处制售假冒伪劣药品案件80%以上发生在基层,县以下医疗单位、个体诊所和药品经营网点是假劣药品的重灾区。我局在2002~2005年查处的案件中,基层假劣药品案件占68%。提高基层药品监督人员对假劣药品的识别能力已刻不容缓。为此…     

加强药品监督,注意制售假药的新动向

<正> 《药品管理法》实施五年来,我市加强药品监督管理,查处了336起假劣药品案件,销毁金额达32万多元假劣药品,保证了临床用药安全。但是,一些不法分子,无视党纪国法,变换着手法,无空不入,到处兜售假劣药品,欺骗群众,危害人民健康。根据我市医药市场管理情况证明,目前制售假劣药品又出现了     

尤溪县2016～2020年药品医疗器械案件查处情况分析

目的 通过分析尤溪县2016～2020年药械监管案件办理情况,探讨机构改革以来全县药械监管存在的问题,为今后加强药械监管提供参考。方法 调取案管系统、翻阅卷宗资料、查找有关文献,对数据进行分析和研究。结果 药械监管存在不同程度弱化,城区案件查处情况不如乡镇、农村,案件来源不平衡,违法主体主要是医疗机构,执法人员专业能力不足,案件货值和罚没款波动较大。结论 在增加基层监管人员数量,加强城区药械监管,强化业务培训并丰富监管手段,充分行使自由裁量权,建立激励担当机制等方面提出建议。     

Quantitative in vivo and in vitro sex differences in artemisinin metabolism in rat

1. The pharmacokinetics of the antimalarial compound artemisinin were compared in the male and female Sprague-Dawley rat after single dose i.v. (20 mg.kg) or i.p. (50 mg.kg) administration of an emulsion formulation. 2. Plasma clearance of artemisinin was 12.0 (95% confidence interval: 10.4, 13.0) l.h. kg in the male rat and 10.6 (95% CI: 7.5, 15.0) l.h. kg in the female rat suggesting high hepatic extraction in combination with erythrocyte uptake or clearance. Artemisinin half-life was 0.5 h after both routes of administration in both sexes. Values for plasma clearance and half-lives did not statistically differ between the sexes. 3. After i.p. administration artemisinin AUCs were 2-fold higher in the female compared with male rat (p 0.001). Artemisinin disappearance was 3.9-fold greater in microsomes from male compared with female livers and it was inhibited in male microsomes by goat or rabbit serum containing antibodies against CYP2C11 and CYP3A2 but not CYP2B1 or CYP2E1. 4. The unbound fraction of artemisinin in plasma was lower (p 0.001) in plasma obtained from the male (8.8 2.0%) compared with the female rat (11.7 2.2%). 5. The possibility of a marked sex difference, dependent on the route of administration, has to be taken into account in the design and interpretation of toxicological studies of artemisinin in this species.     

Quantitative in vivo and in vitro sex differences in artemisinin metabolism in rat

1. The pharmacokinetics of the antimalarial compound artemisinin were compared in the male and female Sprague-Dawley rat after single dose i.v. (20 mg x kg(-1)) or i.p. (50 mg x kg(-1)) administration of an emulsion formulation. 2. Plasma clearance of artemisinin was 12.0 (95% confidence interval: 10.4, 13.0) 1 x h(-1) x kg(-1) in the male rat and 10.6 (95% CI: 7.5, 15.0) 1 x h(-1) x kg(-1) in the female rat suggesting high hepatic extraction in combination with erythrocyte uptake or clearance. Artemisinin half-life was approximately 0.5 h after both routes of administration in both sexes. Values for plasma clearance and half-lives did not statistically differ between the sexes. 3. After i.p. administration artemisinin AUCs were 2-fold higher in the female compared with male rat (p < 0.001). Artemisinin disappearance was 3.9-fold greater in microsomes from male compared with female livers and it was inhibited in male microsomes by goat or rabbit serum containing antibodies against CYP2C11 and CYP3A2 but not CYP2B1 or CYP2E1. 4. The unbound fraction of artemisinin in plasma was lower (p < 0.001) in plasma obtained from the male (8.8 +/- 2.0%) compared with the female rat (11.7 +/- 2.2%). 5. The possibility of a marked sex difference, dependent on the route of administration, has to be taken into account in the design and interpretation of toxicological studies of artemisinin in this species.     

Interindividual variability in metabolic activation in humans in vivo

In assessing interindividual variability in metabolic activation, the toxic metabolite is often too unstable for conventional analysis. Possible alternatives include a stable product of the reactive metabolite e.g. cysteinyl derivatives of N-acetyl-4-benzoquinoneimine, the toxic metabolite of paracetamol, adducts with DNA or protein, and indirect measurement of the activity of the enzyme(s) producing the active metabolite. An example of the last approach is the use of furafylline, a highly specific inhibitor of human CYP1A2, to determine the extent of the metabolic activation of the cooked food mutagens PhIP and MeIQx. The extent of inhibition, determined from levels of unchanged amine in urine, is an indirect measure of the activity of the activation pathway. Further refinement of this approach, allied to improved measures of the biological process of interest should prove of value in evaluating interindividual variability and its role in the risk assessment process.     

Theophylline kinetics in peripheral tissues in vivo in humans

Several biochemical and cellular effects have been described for methylxanthines under in vitro conditions. However, it is unknown, whether threshold concentrations required to exert these effects are attained in target tissues in vivo. We therefore employed the microdialysis technique for measuring theophylline concentrations in peripheral tissues under in vivo conditions.Following in vitro and in vivo calibration, microdialysis probes were inserted into the medial vastus muscle and into the periumbilical subcutaneous adipose layer of healthy volunteers. Following single oral dose administration of 300 mg or i.v. infusion of 240 mg theophylline, in vivo time courses of theophylline concentrations were monitored in tissues and plasma. Major pharmacokinetic parameters (c_max, t_max, AUC) were calculated for plasma and tissue time courses. The mean AUC_tissue /AUC_plasma-ratio was 0.56 (p.o.) and 0.55 (i.v.) for muscle and 0.55 (p.o.) and 0.72 (i.v.) for subcutaneous adipose tissue.We conclude that microdialysis provides important information on the distribution and the tissue pharmacokinetics of theophylline.Abbreviations FPIA Fluorescence polarisation immuno assay - AUC Area under the curve - t_max Time to peak concentration - c_max Peak concentration     

休克时血中氧自由基的变化

本实验测定10名休克患者血浆和红细胞的丙二醛(MDA)、血浆总抗的氧化活性(AOA)的含量。结果表明:休克病人红细胞膜和血浆 MDA 含量(4.298±0.722;5.348±0.834)与对照组(3.235±0.682;4.356±1.081)比较明显增高(P<0.05);血浆 AOA(39.65±7.858)与对照组(48.21±10.81)比较明显降低(P<0.01)。提示:休克时,患者机体内自由基反应增强是引起组织细胞损伤的原因之一。     

Changes in angiopoietin expression in glomeruli involved in glomerulosclerosis in rats with daunorubicin-induced nephrosis

AIM: To study the potential pathological role of endogenous angiopoietins in daunorubicin-induced progressive glomerulosclerosis in rats. METHODS: Seventy male Wistar rats were allocated randomly into a daunorubicin group (DRB; n=40) or a control group (n=30). The rats in the DRB group were injected with DRB (15 mg/kg), in their tails. Subsequently, at intervals of 1, 2, 4, 6, 8, and 12 weeks, 5 male Wistar rats in each group were chosen randomly for 24 h urinary protein quantitative measurements (24 h UPQM), and determination of plasma tumor necrosis factor alpha (TNF-alpha), angiopoietin-1 (Ang1), and angiopoietin-2 (Ang2) levels. Kidney sections were examined by electron microscopy, Periodic Acid Schiff (PAS) staining, immunohistochemical staining and in situ hybridization histochemistry. RESULTS: As glomerulosclerosis progressed in the DRB group, expression of Ang1 mRNA and protein in glomeruli decreased and expression of TNF-alpha protein, Ang2 mRNA and protein in glomeruli increased. Expression of Ang1 mRNA and protein in glomeruli were negatively correlated with 24 h UPQM, Fn protein expression, and mean area of extracellular matrix (MAECM). In comparison, expression of Ang2 mRNA and protein in glomeruli were positively correlated with 24 h UPQM, Fn protein expression and MAECM; furthermore, there was a positive correlation between plasma Ang2 and 24 h UPQM. Plasma TNF-alpha and expression of TNF-alpha in glomeruli were positively correlated with expression of Ang2 mRNA and protein in glomeruli. There was a negative correlation between Ang1 protein expression and Ang2 protein expression in glomeruli. CONCLUSION: During DRB-induced glomerulosclerosis, podocyte injury led to a shift in the balance of Ang1 and Ang2 in glomeruli. Increased TNF-alpha in plasma and glomeruli may upregulate Ang2 expression in glomeruli. Elevated Ang2 in both plasma and glomeruli may mediate protein permeability through the glomerular filtration barrier. Moreover, local expression of Ang2 may facilitate the progress of glomerulosclerosis by upregulating a component expression of extracellular matrix.     

Deoxynivalenol in cereals in Russia

A survey of the occurrence of deoxynivalenol (DON) and zearalenone (ZEN) in wheat, rye, barley and maize harvested in 1989-2001 in several regions of Russia has been conducted. A total of 5652 samples of cereals were analysed for DON and ZEN by using TLC and normal-phase HPLC with UV-detector. DON was detected in 69% of 2166 samples from Krasnodar region which is considered to be the major Fusarium endemic region of Russia. The contamination levels ranged from 0.1 till 8.6 ppm, MTEL was exceeded in 37% of these samples. The positive correlation between DON concentration and a percentage of Fusaria-damaged wheat kernels has been shown. DON occurrence and contamination levels were much lower that for wheat. Based on the results of monitoring and the data of average actual consumption of wheat products in Russia, the estimated daily intake of DON per 1 kg of body weight (EDI)was calculated. EDI varied from 0.07 ug in 1990-1991 till 1.40 ug in 1992. Although average EDI were lower than adopted tolerable daily intake (TDI, 3 ug/kg body weight) EDIs for the North-Caucasian region in some cases exceeded TDI.