食品安全监管合规性体系信息化建设路径研究

食品安全监管合规性体系建设,是落实"加强和规范事中事后监管"和优化营商环境的要求,也是智慧监管建设的必由之路.是基于食品安全合规性的研究进展、制度安排文件,以及国外实践经验和我国食品安全示范城市创建、属地监管责任和党政同责的责任落实评估实践的阐述,本文分析了食品安全监管合规性信息化的大数据决策、"双随机、一公开"、风险...     

对中药材在直播背景下网络销售规制路径的思考

目的 从新型网络销售特点及中药材自身特性的角度，为中药材网络销售监管提供可行的规制路径。方法 通过对电商平台中药材销售形式的调研以及中药材网络纠纷案件的检索，分析中药材在新型网络销售模式下监管的难点及存在的问题，并提出相应的对策。结果与结论 厘清中药材与中药饮片、食用农产品、食品的概念边界是规范中药材网售的重要因素。以中药材是否流入药用渠道判断是否属于药品管理的监管准则，并未考虑中药材网络销售渠道的多样性、中药材自身安全性以及变相销售中药饮片的问题。应该树立中药材分级管理理念，严格限制直播中对中药材的功能主治类宣传及销售中药饮片的行为，完善中药材虚假宣传的界定路径，落实直播营销主体及平台的责任与义务，维护消费者合法权益。     

建立纵向到底横向到边的监管网络和责任体系

上虞市是国家首批药品"两网一规范"建设的示范县级市。我们在实践中深切体会到:只有把监管任务分解到乡镇(街道),把监管责任落实到村(社区)的具体责任人,药品监管责任体系才是完整的系统的体系,药品监管责任才能在基层"落地"、"扎根"。分解领导责任。明确市政府领导责任。市政府于2006年成立"两网一规范"示范市工作领导小组。市政府办公室下发了《上虞市农村医疗机构用药规     

美国药品监管人员培训模式分析及其对我国的启示

目的:为发展和完善我国药品监管人员培训制度提供建议。方法:介绍美国法规事务办公室大学的具体运作模式,分析中美两国药品监管人员培训模式的差别。结果与结论:美国药品监管人员培训现已建立了系统、连续、统一的体系,较之我国有一定的灵活性、先进性。我国可借鉴美国的相关经验,在我国药品监管人员培训统一性、预算机制以及培训方式多样化等方面作出相关改进。     

三峡中药公共服务平台建设探索与实践

目的:探索搭建三峡中药公共服务平台的建设思路,为三峡中药教学、科研、科普教育和产业发展服务。方法:在多年积淀和三峡中药材生产与流通信息发掘整理等研究基础上,开展"三峡中药科技馆"建设。结果:建成了集中药教学、科研、科普教育及服务中药产业发展等多功能体系的三峡中药科技馆。结论:以中药信息源开发与集成为基础,以中草药资源数据库平台建设和中药实物展示平台建设为支撑,以现代科技为手段,可建设区域性中药公共服务平台。     

基于溯源系统的中药质量信用行为保障机制构建研究

提出通过构建中药溯源系统为辅助手段,形成中药信息的流通和数据闭环,为中药质量信用提供辅助支撑。以计算机技术、网络通信技术、软件工程技术、数据库技术等现代技术为手段,开发中药溯源系统,实现中药种植--加工--流通--销售四环节信息的完整呈现和数据闭环,政府对药材市场的监管和用户使用该系统,则是中药溯源形成信息闭环的关键,三者相结合共同完成中药质量信用行为的监督,为中药材质量安全提供保障机制。     

中药汤剂溯源体系的构建探析

中药汤剂的质量和安全,直接影响着汤剂的临床疗效。汤剂原料药来源混杂,且从医院到患者手中经医生处方、配药、煎煮、配送等环节,均能影响其质量安全。引入中药汤剂溯源体系,对以上环节进行全过程监管,是中药质量溯源的关键环节,从而实现"放心中药"工程。借鉴中药质量追溯体系的研究、相关技术的引入和数据共享接口的结合,以及前期试点取得的成果,逐步建立和推广汤剂溯源体系,将促进整个中医药行业的发展。     

基于博弈论分析中药饮片质量监管策略

目的:探讨中药饮片质量监管存在的主要问题,并找出有效策略。方法:首先分别构建中药饮片生产经营企业与地方药监部门之间的静态与动态博弈模型,并对其进行纯策略纳什均衡分析和混合策略纳什均衡分析;然后,构建上级监管部门与基层监管部门间的博弈模型,并对此模型进行混合策略分析,以找出与饮片质量相关的监管因素。结果与结论:结合中药饮片质量监管的现状和博弈模型的分析结果,建议现阶段我国中药饮片监管部门应着力推动监管体制改革,降低监管成本(包括引导规模化、集中化的中药材生产和对中药饮片统一实施批准文号管理)、建立系统全面的奖惩体系、建设一支专业化的监管队伍(包括加强基层监管队伍建设和提高人员素质、规范监管部门的执法行为、适当放权与"硬"监督结合起来),并理顺政府监管工作与公众的关系,培养公众的责任意识。     

中药材监督管理现状及全产业链监管模式创新初探

中药材是生产中药饮片、中药制剂和中成药的原料,其质量好坏将直接影响中药饮片、中药制剂、中成药的安全性和有效性,对中医药事业的发展影响巨大。文章以现行法律法规为基础,采用文献查阅、个案分析、数据分析等方法对中药材监督管理困境和质量现状进行分析,提出全新的中药材全产业链管理规范及监管模式:一是开展中药材全产业链质量管理模式,研究制定中药材种子种苗标准到建立溯源体系,以此从源头保障中药饮片、中药制剂和中成药的质量;二是充分发挥中药材管理相关职能部门的作用,各司其职,齐抓共治,共同保障中药材质量。     

基于我国药品流通模式的供应链优化创新研究

目的:为优化药品流通供应链结构、促进医药流通领域改革等提供参考。方法:采用文献研究、企业实地调研和高校专家咨询相结合的方法,分析我国药品流通模式的缺点,并提出改革创新的对策和建议。结果与结论:当前,我国药品流通模式以业务自营/外包药品流通模式、市场集中交易模式、基本药物集中招标采购模式等为主,这些模式集中反映出药品供应链式结构中信息不对称、药品流通缺乏完整的监管体系、药品流通溯源困难等缺点。建议通过建立药品流通信息平台以增强流通信息可视化程度、转变医务人员补偿方式及正确引导处方外流以合理实现医药分开、完善药品监管体系以发挥市场中介组织服务作用、构建药品安全防火墙以实现药品可溯源性等措施,促进医药流通供应链的合理化。     

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.