遗传毒性评价Ames试验方法的比较分析

Ames试验是一项体外致突变性试验,被广泛用于药物、食品、化学品和农药的遗传毒性检测,以评价受试物致突变的可能性。药物、食品、化学品和农药的指导原则和国家标准中Ames试验方法不尽相同,就这几者Ames试验方法的主要异同点进行比较分析,以期能熟练掌握Ames试验实施要点,更加规范实施检测工作,不断提高试验质量。     

人参与林蛙油配伍的保健食品体外致突变试验研究

目的体外观察人参与林蛙油配伍的保健食品能否诱发鼠伤寒沙门氏菌组氨酸营养缺陷型突变株的回复突变。方法 Ames试验用TA97、TA98、TA100、TA102菌株并分加与不加肝微粒体酶活化系统（＋/-S9）试验。结果人参与林蛙油配伍的保健食品对4个菌株各剂量组的回复菌落数都未超过自然回复菌落数,Ames试验结果为阴性。结论在5000-8μg/皿剂量下未见人参与林蛙油配伍的保健食品致突变性。     

一种灵敏的细菌正向突变试验方法

目前已建立的遗传毒性检测技术有 2 0 0多种 ,其中 ,Ames试验最为常用。Ames试验 ,也就是鼠伤寒沙门菌组氨酸营养缺陷型的回复突变试验 ,是Ames等在70年代建立起来的。 1983年 ,Maron和Ames把该方法规范化 ,选用鼠伤寒沙门菌的 4种品系 (TA97,TA98,T10 0 ,TA10 2 )为标准菌株来检测外源化学物的致突变能力[1 ] 。这种方法被许多实验室采纳 ,广泛用于检测食品、化妆品、药品和饮用水等测试样中的致变物。但是 ,有 2个客观事实限制了它的应用 :(1)某些DNA分子诱变物不能使所用的细菌品系发生回变 ,因此 ,回复突变试验就不能用于这类物质…     

查处添加违禁药物成分产品

为保障保健食品、化妆品消费安全,上海市食品药品监管部门按计划开展了市售保健食品、化妆品专项监督抽检。抽检结果显示,8种保健食品被检出含西布曲明、酚酞、西地那非、他达拉非、伐地那非等违禁成分,5种祛痘类化妆品被检出含有甲硝唑、氧氟沙星等抗茵药物成分。查获的违法保健食品、化妆品已被没收,经营违禁产品的单位已受到查处。     

国家药品抽验信息系统用于保健食品、化妆品风险监测工作探讨

目的在保健食品、化妆品风险监测工作中应用国家药品抽验信息系统,提升保健食品、化妆品风险监测工作质量和效率。方法分析保健食品、化妆品风险监测工作存在的问题,探讨解决问题的方法。结果与结论通过在保健食品、化妆品风险监测工作中应用国家药品抽验信息系统,不仅可以提高工作质量和效率,也可以节约人力、物力和财力。国家药品抽验信息系统可以运用在保健食品、化妆品风险监测工作中。     

国家药品抽验信息系统在食品、保健食品、化妆品监管中的应用简

目的 应用国家药品抽验信息系统提升餐饮食品、保健食品、化妆品监管工作的质量和效率.方法 分析我国药品抽验信息系统应用现状及建立餐饮食品、保健食品、化妆品信息管理系统的必要性和必要途径.结果与结论 通过在餐饮食品、保健食品、化妆品监管工作中应用国家药品抽验信息系统,不仅可以解决人力资源匮乏,实现工作的程序化、规范化,也可以完善管理机制,提高工作效能.     

《保健食品样品试制和试验现场核查规定》之详解——专访北京市药品监督管理局保健品化妆品监管处处长邢泉

为确保保健食品质量,保证人民食用安全,2005年至2006年,国家食品药品监督管理局相继发布了<保健食品样品试制和试验现场核查规定>及<关于进一步加强保健食品注册现场核查及试验检验工作有关问题的通知>.近日本刊记者就此内容采访了北京市药品监督管理局保健品化妆品技术审评中心主任邢泉.     

国家食品药品监督管理局要求加强保健食品、化妆品生产经营日常监管

为加强保健食品、化妆品生产经营日常监督检查,规范保健食品、化妆品生产经营秩序,保障保健食品质量安全和化妆品卫生质量安全,日前,国家食品药品监督管理局印发通知,对保健食品、化妆品生产经营企业日常监督的检查内容和检查重点提出了明确要求。     

国家食品药品监督管理局要求：加强保健食品、化妆品生产经营日常监管

据国家食品药品监督管理局网站信息．为加强保健食品、化妆品生产经营日常监督检查,规范保健食品、化妆品生产经营秩序,保障保健食品质量安全和化妆品卫生质量安全,国家食品药品监督管理局日前印发通知,对保健食品、化妆品生产经营企业日常监督的检查内容和检查重点提出了明确要求。     

北京市药品监督管理局关于发布2012年北京市保健食品化妆品监督抽检中发现的假冒产品的通知

在2012年北京市保健食品化妆品监督抽检中,以下产品经生产企业确认,为假冒产品。详情见附表一和附表二。所在地分局应依法对这些假冒产品进行查处。各保健食品、化妆品经营单位如果有此通知中涉及批号的假冒产品,应及时封存,并报告当地药品监督管理部门。附件:1.假冒保健食品明细表2.假冒化妆品明细表     

Effect of food azo dyes tartrazine and carmoisine on biochemical parameters related to renal,hepatic function and oxidative stress biomarkers in young male rats

Tartrazine and carmoisine are an organic azo dyes widely used in food products, drugs and cosmetics. The present study conducted to evaluate the toxic effect of these coloring food additives; on renal, hepatic function, lipid profile, blood glucose, body-weight gain and biomarkers of oxidative stress in tissue.     

Mutagenicity studies on two triphenylmethane dyes, bromophenol blue and tetrabromophenol blue.

Bromophenol blue and tetrabromophenol blue are two triphenylmethane dyes. Triphenylmethane derivatives and their structurally related compounds, such as fluoresceins and xathenes, are widely used as industrial dyes for foods, drugs, cosmetics, textiles, printing inks or laboratory indicators. Since a number of these types of dyes have been reported to be genotoxic, safety concerns on these two dyes of interest have been raised. Consequently, a battery of genetic toxicology assays, including the Ames Salmonella/microsome assay, L5178Y TK+/- mouse lymphoma assay, mouse micronucleus test and mitotic recombination assay with yeast Saccharomyces cerevisiae strain D5, has been performed on each of the two dyes. The results of the evaluations indicate that both bromophenol blue and tetrabromophenol blue were not active and can be considered non-genotoxic for the three genetic endpoints assessed (gene mutation, chromosome aberrations and primary DNA damage). Genetic activities in some structurally related compounds of these dyes have been reported but may be attributed to the presence of mutagenic impurities rather than the compound itself.     

Evaluation of the genotoxicity of (-)-hydroxycitric acid (HCA-SX) isolated from Garcinia cambogia

(-)-Hydroxycitric acid (HCA) is widely used as an ingredient for nutritional supplements aimed at reducing food intake, appetite, and body weight. In this study, the genotoxicity of HCA was evaluated using three tests: a bacterial reverse mutation assay (Ames test), an in vitro chromosomal aberration (CA) test, and an in vivo micronucleus (MN) test. HCA was negative by the Ames test in the presence or absence of a microsomal metabolizing system. HCA did not induce mutagenic activity in the Ames test, and no significant mutagenic potency was indicated by CA tests. However, HCA significantly and dose-dependently increased the number of MNPCEs (micronucleated polychromatic erythrocytes/1000 polychromatic erythrocytes) and PCE/(PCE + NCE) ratios according to the MN test. These results suggest that HCA preferentially induce micronuclei.     

鞣花鞣质类成分研究进展

摘 要鞣花鞣质（ellagitannin）是一类复杂的植物多酚类化合物,是许多常用天然药物的药效物质,被广泛应用于医药、化妆品、食品、保健品等多个领域。本文就鞣花鞣质的结构来源、生物活性和代谢转归进行综述,为富含鞣花鞣质类有效成分的天然药物的深入研究和资源开发提供依据。     

Gallic acid and gallic acid derivatives: effects on drug metabolizing enzymes

Gallic acid and its structurally related compounds are found widely distributed in fruits and plants. Gallic acid, and its catechin derivatives are also present as one of the main phenolic components of both black and green tea. Esters of gallic acid have a diverse range of industrial uses, as antioxidants in food, in cosmetics and in the pharmaceutical industry. In addition, gallic acid is employed as a source material for inks, paints and colour developers. Studies utilising these compounds have found them to possess many potential therapeutic properties including anti-cancer and antimicrobial properties. In this review, studies of the effects of gallic acid, its esters, and gallic acid catechin derivatives on Phase I and Phase II enzymes are examined. Many published reports of the effects of the in vitro effects of gallic acid and its derivatives on drug metabolising enzymes concern effects directly on substrate (generally drug or mutagen) metabolism or indirectly through observed effects in Ames tests. In the case of the Ames test an antimutagenic effect may be observed through inhibition of CYP activation of indirectly acting mutagens and/or by scavenging of metabolically generated mutagenic electrophiles. There has been considerable interest in the in vivo effects of the gallate esters because of their incorporation into foodstuffs as antioxidants and in the catechin gallates with their potential role as chemoprotective agents. Principally an induction of Phase II enzymes has been observed however more recent studies using HepG2 cells and primary cultures of human hepatocytes provide evidence for the overall complexity of actions of individual components versus complex mixtures, such as those in food. Further systematic studies of mechanisms of induction and inhibition of drug metabolising enzymes by this group of compounds are warranted in the light of their distribution and consequent ingestion, current uses and suggested therapeutic potential. However, it must be noted that numerous constituents of foodstuffs have been found to be potent modulators of xenobiotic metabolism and the net human health effects may depend on concentrations of individual components and individual genetic makeup.     

Comparison of the relative mutagenic activity for eight antineoplastic drugs in the Ames Salmonella/microsome and TK+/- mouse lymphoma assays.

Eight antineoplastic drugs were evaluated for their ability to induce mutation in the Ames Salmonella/microsome and the TK+/- mouse lymphoma assay. Dose response data were utilized to determine the relative potency of each of these drugs. They were then ranked based on this information. Vincristine, the most potent compound tested in the mouse lymphoma assay, was not active in the Salmonella assay, nor were DTIC and Methotrexate. Excluding these compounds from the comparison ranking, we found that the only difference in the order between the Ames and lymphoma assays was between Daunomycin and Adriamycin. Daunomycin was most potent in the Ames assay, compounds was reversed in the mouse lymphoma assay. This observation of relative activity is of interest because it underscores the ability to extrapolate between microbial and mammalian test systems, provided one keeps in mind the differences associated with chromosome structure and modes of segregation in these two cell types. Furthermore, it is suggested that relative potency ranking may provide prospective insight into expectations of risk for human populations exposed to these drugs.     

微核试验方法的研究进展

微核试验作为遗传毒性的检测方法,广泛应用于药品、化妆品、保健食品等领域的毒性评价,能够灵敏地反映出遗传毒性物质对染色体的损伤.随着检测技术的进步和新方法的应用,对于微核的检测手段也越来越多样.本文着重阐述了目前微核检测的技术方法,以期对现有的微核检测技术的应用提供参考依据.     

Primary mutagenicity screening of food additives currently used in Japan

Salmonella/microsome tests (Ames tests) and chromosomal aberration tests in vitro using a Chinese hamster fibroblast cell line were carried out on 190 synthetic food additives and 52 food additives derived from natural sources, all of which are currently used in Japan. Fourteen out of 200 tested in the Ames assay showed positive effects and 54 out of 242 were positive in the chromosome test. Three additives (erythorbic acid, chlorine dioxide and beet red) were positive only in the Ames test, although their mutagenic potentials were relatively weak, while 43 additives were positive only in the chromosome test. Eleven additives (calcium hypochlorite, cinnamic aldehyde, L-cysteine monohydrochloride, Food Green No. 3 (Fast Green FCF), hydrogen peroxide, potassium bromate, sodium chlorite, sodium hypochlorite, sodium nitrite, cacao pigment and caramel) were positive in both the Ames test and the chromosome test. The usefulness of such primary screening tests combining two different genetic end-points, gene mutation and chromosomal aberration, and some correlation between mutagenicity and carcinogenicity of food additives are discussed.     

补肾调冲方含药血清对大鼠卵巢颗粒细胞增殖、激素分泌和mRNA表达的影响

目的 运用血清药理学方法观察补肾调冲方对大鼠卵巢颗粒细胞增殖、激素分泌功能以及抑制素B (INHB)、胰岛素样生长因子-1 (1GF-1) mRNA表达的影响.方法向培养的SD大鼠卵巢颗粒细胞中分别加入10％空白血清(对照组)、人转基因重组促卵泡激素(hFSH)含药血清(阳性对照组)、补肾调冲方含药血清(补肾调冲方组...