中国保健食品标准体系概述

目的：分析我国保健食品质量标准体系存在的问题,就加强我国保健食品质量标准化建设提出相应建议。方法：运用文献调查方式及比较分析的方法,系统梳理目前保健食品的标准体系,比较保健食品和药品标准体系的不同之处,以及存在的问题和解决的对策。结果：我国已经形成了国家食品安全标准、部门规章及规范性文件、产品技术要求和备案企业标准等4个层级的保健食品标准体系。结论：我国保健食品标准体系尚不完善,需要进一步明确部分标准执行或理解中存在的问题和产品技术要求与备案企业标准的关系,建立保健食品原料标准体系,以及提高标准的专属性、可行性和统一性等,为保健食品上市后监管提供依据和保障。     

保健食品市场存在的问题以及监管对策

目的：探讨保健食品市场存在的问题并提出建议。方法：通过检索文献和从网上获取相关讯息，分析保健食品市场中存在的问题。结果：市场上夸大宣传、销售劣质保健食品的现象尚存在，监管存在不足，令消费者对保健食品心存疑虑，不利于该行业的可持续发展。结论：针对上述问题从法规、标准、监测技术以及宣传教育方面进行了讨论，并提出相应的对策，为保健食品监管提供参考。     

从药品质量标准的视角探讨药品的监督与管理

目的：从药品质量标准的视角探讨如何进一步加强药品的监督与管理,促进医药产业发展、保障公众用药安全。方法：通过对监督抽检发现的药品质量标准存在的问题进行分析研究,提出相应的解决措施和意见建议。结果与结论：部分药品质量标准在标准制定、审批发布、标准管理、标准执行以及质量标准的可及性等方面存在不足,影响了质量标准的执行和药品生产及安全监管,应从建立药品审评审批与药品质量标准管理的联动机制、完善监督抽检机制、加强对药品质量标准执行的监管等方面加以解决。     

基于网络搜索快速鉴定抗风湿类中成药和保健食品中非法添加的非那西丁及小檗碱

目的 鉴定抗风湿类中成药和保健食品中非法添加的2个未知成分。方法 采用高效液相色谱-二极管阵列检测器联用（HPLC-DAD）技术进行抗风湿类中成药和保健食品非法添加筛查时发现2个可疑色谱峰,采用UPLC-MS/MS技术获得其准分子离子和二级质谱图,然后通过网络搜索分析初步确定可疑成分,最后与对照品比较检测,最终确定2个非法添加化合物的结构。结果 在抗风湿类保健食品中检出盐酸小檗碱,中成药中检出非那西丁。结论 这2个化合物不在现有抗风湿类中成药和保健食品检验标准13种目标化合物范围内,容易逃脱标准监管范围。     

新疆民族药质量标准研究现状及展望

目的：综述新疆民族药质量标准的研究现状及发展前景，为民族医药市场的发展壮大及监管提供参考。方法：通过专项检查、市场调研、文献查询以及民族药质量标准提升工作，分析当前民族药质量标准的现状、问题及发展契机。结果：民族药药材，尤其是进口药材中基原混乱现象普遍，民族药制剂质量标准难以准确评价产品质量。结论：澄清民族药材的基原、调研药材资源情况并加强民族药的对照品/对照药材研究，是为民族药质量评价与监管提供更有效的技术支撑的必由之路。     

食品理化检验原始记录控制要求

目的：为保证食品理化检验原始记录的完整性、准确性、及时性和溯源性,制订了食品理化检验原始记录控制要求。方法：按照CNAS-CL10《检测和校准实验室能力认可准则在化学检测领域的应用说明》要求,从11个方面对食品理化检验原始记录的内容进行了探讨。结果与结论：通过建立食品理化检验原始记录控制要求,保证了食品理化检验原始记录内容的真实性和完整性、原始记录书写和更改的规范性、检验数据的准确性和溯源性。     

拉祜族常用药山菅兰的生药学及初步理化鉴别研究

目的：对拉祜族常用药山菅兰[Dianella ensifolia（L.）DC.]进行初步的生药学研究。方法：采用来源鉴别、性状鉴别、显微鉴别、理化鉴别的方法进行分析。结果：详细描述了山菅的生药学特征,进行了初步理化研究。结论：该植物含有糖类、酚类、香豆素类、黄酮、挥发油、三萜及甾萜类等化学成分。本研究为山菅的鉴别、质量标准的制定以及进一步开发利用提供了依据。     

低密度聚乙烯药用滴眼剂瓶质量状况分析

目的：分析我国低密度聚乙烯药用滴眼剂瓶的质量状况,为其生产和检验提出建议与对策。方法：在法定检验项目基础上,通过对国内外检验标准现状的比较分析及探索性研究,探讨低密度聚乙烯药用滴眼剂瓶工艺的可控性、产品的安全性、阻隔性和与药物的相容性。结果：我国法定标准与国外药典相比,鉴别性状项目尚未采用专属性极强的DSC方法,红外光谱法可操作性欠缺但密度指标范围相对合理,安全性方面的收载项目各异且部分项目指标相对宽松;而阻隔性和相容性研究表明低密度聚乙烯滴眼剂瓶不适合作为含冰片等挥发性成分以及用三氯叔丁醇和硫柳汞钠作为防腐剂的滴眼剂药物的包装。结论：质量标准方面应规范样品名称,增加修订试验方法,提高限度要求,建立统一的红外对照图谱;企业监管方面应规范生产,严格控制配方与工艺的一致性,加强相容性研究。     

液质联用法检查中成药及保健食品非法添加的17种辅助改善记忆类药物

摘 要 目的：建立准确、灵敏的LC MS/MS方法甄别中药制剂及保健食品中可能非法添加的17种辅助改善记忆类药物。方法: 采用液相色谱-串联质谱法（LC-MS/MS）,以Eclipse XDBC₁₈（100 mm×3.0 mm,1.8 μm）为分析柱,以电喷雾电离（ESI）、多反应监测（MRM）扫描方式,对中药制剂及保健食品中非法添加的17种化学成分进行快速定性定量分析。结果: 建立了快速分离检测17种非法添加成分的测定方法,检测限低于10 ng·mL^-1。结论:该方法专属性强、灵敏度高,可用于辅助改善记忆类中药制剂及保健食品中非法添加化学成分的定性和定量分析。     

关注眼用注射剂质量标准及临床应用安全性

目的：对眼用注射剂的相关质量标准进行分析汇总,为临床安全使用眼用注射剂提供建议。方法：全面检索国内外药典及近10年相关文献,比较眼用注射剂相关质量标准的变迁和异同。结果：各国药典对眼用制剂和注射剂的限定越来越严格,但仍未对眼用注射剂单独提出质量标准,且部分指标仍与国际标准存在差距。结论：建议对特定部位使用的特殊制剂（如眼用注射剂）加强管理,提高相关质量标准,以确保临床用药的安全性。     

Efficacy of gut lavage,hemodialysis, and hemoperfusion in the therapy of paraquat or diquat intoxication

Clinical and in vitro investigations were carried out to test the efficacy of gut lavage, hemodialysis, and hemoperfusion in the treatment of poisoning with paraquat or diquat. In a patient suffering from diquat intoxication 130 times more diquat was removed by gut lavage 30 h after ingestion than was removed by complete aspiration of the gastric contents.Determination of in vitro clearances for paraquat and diquat by hemodialysis showed that, at serum concentrations of 1–2 ppm, such as are frequently encountered in poisoning in man, toxicologically relevant quantities of herbicide cannot be removed from the body. At a concentration of 20 ppm, on the other hand, hemodialysis proved to be effective, the clearance being 70 ml/min at a blood flow rate of 100 ml/min. The efficacy of hemoperfusion with coated activated charcoal was on the whole better. Especially at concentrations around 1–2 ppm, the clearance values for hemoperfusion were some 5–7 times higher than those for hemodialysis.In a patient suffering from paraquat poisoning, both hemodialysis as well as hemoperfusion were carried out. The in vitro results could be confirmed: At serum concentrations of paraquat less than 1 ppm no clearance could be obtained by hemodialysis while by hemoperfusion with activated charcoal quite high clearance values were measured and the serum level dropped down to zero.

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Zusammenfassung Klinische Untersuchungen und Laboratoriumsversuche wurden durchgeführt, um die Wirksamkeit von Darmspülung, Hämodialyse und Hämoperfusion bei Paraquat- und Deiquat-Vergiftungen zu prüfen.Bei einem Patienten wurde 30 Std nach Deiquat-Aufnahme durch Darmspülung 130mal mehr Deiquat entfernt als durch vollständige Aspiration des Mageninhaltes. In vitro-Versuche ergaben, daß bei Blutserumkonzentrationen von 1–2 ppm, die bei Vergiftungen oft gemessen werden, durch Hämodialyse keine toxikologisch relevanten Paraquat- oder Deiquat-Mengen entfernt werden können. Dagegen erwies sich die Hämodialyse bei 20 ppm und einer Blutumlaufgeschwindigkeit von 100 ml/min mit einer Clearance von 70 ml/min als wirksam. Die Hämoperfusion mit beschicheter Aktivkohle war in diesen Versuchen aber eindeutig überlegen, denn insbesondere bei Konzentrationen um 1–2 ppm waren die Clearance-Werte 5–7mal höher als bei der Hämodialyse.Die in vitro-Ergebnisse wurden bei einem Patienten mit einer Paraquat-Vergiftung bestätigt: Bei Konzentrationen unter 1 ppm war die Hämodialyse wirkungslos, während durch Hämoperfusion relativ hohe Clearance-Werte erreicht wurden, so daß der Serumspiegel rasch unter die Nachweisgrenze abfiel.

     

In vitro studies on sterically stabilized liposomes (SL) as enzyme carriers in organophosphorus (OP) antagonism

This study describes a new approach for organophosphorous (OP) antidotal treatment by encapsulating an OP hydrolyzing enzyme, OPA anhydrolase (OPAA), within sterically stabilized liposomes. The recombinant OPAA enzyme was derived from Alteromonas strain JD6. It has broad substrate specificity to a wide range of OP compounds: DFP and the nerve agents, soman and sarin. Liposomes encapsulating OPAA (SL)* were made by mechanical dispersion method. Hydrolysis of DFP by (SL)* was measured by following an increase of fluoride ion concentration using a fluoride ion selective electrode. OPAA entrapped in the carrier liposomes rapidly hydrolyze DFP, with the rate of DFP hydrolysis directly proportional to the amount of (SL)* added to the solution. Liposomal carriers containing no enzyme did not hydrolyze DFP. The reaction was linear and the rate of hydrolysis was first order in the substrate. This enzyme carrier system serves as a biodegradable protective environment for the recombinant OP-metabolizing enzyme, OPAA, resulting in prolongation of enzymatic concentration in the body. These studies suggest that the protection of OP intoxication can be strikingly enhanced by adding OPAA encapsulated within (SL)* to pralidoxime and atropine.     

Aquatic Insects and Trace Metals: Bioavailability,Bioaccumulation, and Toxicity

Abstract

The uptake of metals from food and water sources by insects is thought to be additive. For a given metal, the proportions taken up from water and food will depend both on the bioavailable concentration of the metal associated with each source and the mechanism and rate by which the metal enters the insect. Attempts to correlate insect trace metal concentrations with the trophic level of insects should be made with a knowledge of the feeding relationships of the individual taxa concerned. Pathways for the uptake of essential metals, such as copper and zinc, exist at the cellular level, and other nonessential metals, such as cadmium, also appear to enter via these routes. Within cells, trace metals can be bound to proteins or stored in granules. The internal distribution of metals among body tissues is very heterogeneous, and distribution patterns tend to be both metal and taxon specific. Trace metals associated with insects can be both bound on the surface of their chitinous exoskeleton and incorporated into body tissues. The quantities of trace meals accumulated by an individual reflect the net balance between the rate of metal influx from both dissolved and particulate sources and the rate of metal efflux from the organism. The toxicity of metals has been demonstrated at all levels of biological organization: cell, tissue, individual, population, and community. Much of the literature pertaining to the toxic effects of metals on aquatic insects is based on laboratory observations and, as such, it is difficult to extrapolate the data to insects in nature. The few experimental studies in nature suggest that trace metal contaminants can affect both the distribution and the abundance of aquatic insects. Insects have a largely unexploited potential as biomonitors of metal contamination in nature. A better understanding of the physico-chemical and biological mechanisms mediating trace metal bioavailability and exchange will facilitate the development of general predictive models relating trace metal concentrations in insects to those in their environment. Such models will facilitate the use of insects as contaminant biomonitors.     

Alzheimer’s disease – current trends in basic and clinical research. Highlights from the 16th ECNP

Advances in the molecular biological knowledge of neuronal nicotinic acetylcholine receptors (nAChRs) have led to a growing interest by the pharmaceutical industry in the development of novel compounds that selectively modulate nAChR function. The ability of (-)-nicotine, an activator of nAChRs, to enhance attentional aspects of cognition in animals and humans, to exert neuroprotective and anxiolytic-like effects, and presumably to mediate the negative correlation between smoking and Alzheimer's (and Parkinson's) Disease, has focused interest on the potential therapeutic utility of modulators of nAChR function for treatment of some of the deficits associated with these progressive, neurodegenerative conditions. Numerous compounds are known which activate nAChRs and which might serve as lead compounds toward the development of such agents. The pharmacologic diversity of neuronal nAChR subtypes suggests the possibility of developing selective compounds which would have more favourable side-effect profiles than existing agents. This broader class of agents, collectively called cholinergic channel modulators (ChCMs), is anticipated to encompass compounds which would have more favourable side-effect profiles than existing agents, which generally exhibit low selectivity. This selectivity may be achieved by preferentially activating some subtypes of nAChRs (i.e., Cholinergic Channel Activators, ChCAs) or inhibiting the function of other subtypes (Cholinergic Channel Inhibitors, ChCIs). An overview of the biology of nAChRs and the rationale for the use of ChCMs for the treatment of dementia related to neurodegenerative diseases are presented, followed by a discussion of lead compounds and compounds under consideration for clinical evaluation.     

Steroidal sapogenin contents in some domestic plants

In order to find out the values of the steroid resources for the future use. the compositions and contents of steroidal sapogenins from 13 domestic plants have been investigated. As a result,Dioscorea nipponica, D. quinqueloba andSmilax china were found to have large amount of diosgenin. And pennogenin inTrillium kamtschaticum andParis verticillata, yuccagenin inAllium fistulosum, hecogenin inAgave americana and neochlorogenin inSolanum nigum were appeared to be major steroidal sapogenins.