国家食品药品监督管理局发布2003年第三季度国家药品质量公告

根据 2 0 0 3年国家药品抽验计划 ,中国药品生物制品检定所组织各省级药品检验所在全国范围内对药品生产企业、经营企业、医疗机构进行了抽查检验。现将抽验结果予以公告。(1)本季度完成国家计划抽验概况 :中国药品生物制品检定所组织省级药品检验所完成了对消炎利胆片等 2 0种中成药在经营企业、医疗机构的统一抽验工作。共抽验了 2 4 2 9个批次 ,合格批次为 2 36 6批 ,合格率 (批次 ) 7 4 %。中国药品生物制品检定所为考评我国药品生产质量状况 ,派员去部分药品生产企业监督抽样 1731个批次 ,合格批次为 1714个批次 ,合格率为 99 0 %。(2 …     

山东省药品质量公告

根据2004年山东省药品抽验计划，山东省药品检验所和各市药品检验所在全省范围内对药品生产、经营企业和医疗机构进行了抽查检验(结果详见附件)，现将抽验结果予以公告并将有关事宜通知如下：一、2004年第二季度完成计划抽验情况山东省药品检验所和17个市药品检验所二季度共完成计划抽验5120批，其中不合格药品218批，不合格率为4．26％。计划抽验药品批次中从生产企业抽验548批，不合格药品2批，不合格率为0．36％；从经营企业抽验1608批，不合格药品38批，不合格率为2．36％；     

山东省药品质量公告(总第15期)

根据 2 0 0 4年山东省药品抽验计划 ,山东省药品检验所和各市药品检验所在全省范围内对药品生产、经营企业和医疗机构进行了抽查检验 (结果详见附件 ) ,现将抽验结果予以公告并将有关事宜通知如下 :一、2 0 0 4年第二季度完成计划抽验情况　山东省药品检验所和 17个市药品检验所二季度共完成计划抽验 5 12 0批 ,其中不合格药品 2 18批 ,不合格率为4 2 6 %。计划抽验药品批次中从生产企业抽验 5 48批 ,不合格药品 2批 ,不合格率为 0 36 % ;从经营企业抽验 16 0 8批 ,不合格药品 38批 ,不合格率为 2 36 % ;从医疗机构抽验 2 96 4批 ,不合格…     

山东省药品质量公告

根据2006年省药品抽验计划,省局组织省药品检验所和各市药品检验所在全省范围内对药品生产、经营企业和医疗机构的药品质量进行了抽查检验,现将抽验结果予以公告:一、2006年第四季度完成计划抽验情况省药品检验所和17个市药品检验所第四季度共完成计划抽验2117批,不合格药品111     

山东省药品质量公告(总第37期)

根据2009年全省药品抽验计划,省食品药品监督管理局组织省药品检验所和各市药品检验所对全省范围内药品生产、经营企业和医疗机构的药品质量进行了抽查检验,现将抽验结果予以公告: 一、2009年第四季度完成计划抽验情况 省药品检验所和17个市药品检验所第四季度共完成计划抽验1418批,不合格药品56批,不合格率为3.95%.     

山东省药品质量公告(第26期)

根据2007年全省药品抽验计划,省局组织省药品检验所和各市药品检验所对全省范围内药品生产、经营企业和医疗机构的药品质量进行了抽查检验,现将抽验结果予以公告:一、2007年第一季度完成计划抽验情况省药品检验所和17个市药品检验所第一季度共完成计划抽验508批,不合格药品22批     

山东省药品质量公告

(总第21期)为认真贯彻《药品管理法》等法律法规,严厉打击制售假劣药品的违法行为,保障人体用药安全有效。根据2005年山东省药品抽验计划,组织山东省药品检验所及各市药品检验所在全省范围内对药品生产、经营企业和医疗机构的药品质量进行了抽样检验,现将2005年第四季度抽验结果予以公告。本期公告分为三个部分:第一部分为省药品检验所从药品生产、经营企业、医疗机构抽验的药品;第二部分为省、市药品检验所从药品生产、经营企业和医疗机构中抽验的不合格药品(见附表2-1、2-2、2-3、2-4);第三部分为假冒标示生产单位生产的假药。对公告附表2…     

山东省药品质量公告(总第24期)

根据2006年省药品抽验计划,省局组织省药品检验所和各市药品检验所在全省范围内对药品生产、经营企业和医疗机构的药品质量进行了抽查检验,现将抽验结果予以公告:一、2006年第三季度完成计划抽验情况省药品检验所和17个市药品检验所第三季度共完成计划抽验3551批,不合格药品97批,不合格率为2.73%.其中从生产企业抽验479批,不合格药品6批,不合格率为1.25%;从经营企业抽验1387批,不合格药品21批,不合格率为1.51%;从使用单位抽验1685批(包括医院自制制剂),不合格药品70批(5批为医院自制制剂),不合格率为4.15%.从药品使用单位抽验的药品不合格率…     

山东省药品质量公告

根据2007年全省药品抽验计划,省局组织省药品检验所和各市药品检验所对全省范围内药品生产、经营企业和医疗机构的药品质量进行了抽查检验,现将抽验结果予以公告:一、2007年第三季度完成计划抽验情况省药品检验所和17个市药品检验所第三季度共完成计划抽验2182批,不合格药品112批,不合格率为5·13%。其中从生产企业抽验365批,不合格药品6批,不合格率为1·64%;从经营企业抽验828批,不合格药品29批,不合格率为3·50%;从使用单位抽验989批(包括医院自制制剂),不合格药品77批(6批为医院自制制剂),不合格率为7·79%。从药品使用单位抽验的药品不…     

国家药品监督管理局发布2002年第三季度国家药品质量公告

根据 2 0 0 2年国家药品抽验计划 ,中国药品生物制品检定所组织各省级药品检验所 ,在全国范围内对药品生产企业、经营企业、医疗机构进行抽查检验。现将抽验结果予以公告如下 :1　 2 0 0 2年第三季度国家计划药品抽验概况。本季度对上年度国家药品质量公告中不合格药品实施跟踪抽验 ,共 194个批次 ,合格 189批次 ,合格率为 97 4%。按照国家抽验计划同品种质量考核抽验共 2 4个品种5 3 2 4个批次 ,合格 5 187批次 ,合格率为 97 4%。按抽验品种的种类分 :化学类药品抽验了 3 3 13个批次 ,合格 3 2 67批次 ,合格率为 98 6% ;中成药抽验 2 0 11…     

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.     

Trichinellosis in immigrants in Switzerland

We describe a case of trichinellosis diagnosed at the Division of Infectious Diseases, Hospital of Lugano, in January 2009. This case was associated with a cluster of cases and was traced to the consumption of contaminated meat after a wild boar hunt in Bosnia.