食品动物兽药残留试验注册资料评审主要内容及常见问题

食品动物使用兽药后,肉蛋奶等动物性食品中兽药残留对消费者可能产生毒害作用,影响人类健康和消费安全,因此,控制动物性食品中兽药残留问题已成为兽药研发和保障食品安全的重要内容。食品动物兽药残留试验资料主要包括兽药最大残留限量标准、兽药残留检测方法标准和休药期确定三个方面内容。本文结合近年来食品动物兽药残留试验注册资料的评审主要内容及常见问题进行综述,旨在为食品动物用兽药的研发与注册提供参考。     

兽用化学药物质量控制分析方法验证的几项内容

保证兽药安全、有效、质量可控是兽药研发和评价应遵循的基本原则,其中对兽药进行质量控制是保证兽药安全有效的基础和前提。为达到控制质量的目的,需要多角度、多层面来控制产品质量,也就是说要对药物进行多个项目测试,来全面考察产品质量。一般地,每个测试项目可选用不同分析方法,为使测试结果准确、可靠,     

动物源性食品中多兽药残留前处理方法研究进展

近年来,随着人们对食品安全问题的重视,对动物食品兽药残留检测工作提出了更高的要求,要保障动物源性食品质量安全,必须做好兽药残留检测工作.该项工作不仅影响着药物残留的准确性,同时也是保障动物源性食品质量安全的重要举措.为了更好的掌握应用多兽药残留前处理技术,做好对相关技术的分析成为一项重要工作.     

畜禽用化学药物研发动向

改革开放以来，我国畜禽用化学药物从无到有、从小到大得到了前所未有的发展，为保障我国畜牧和水产养殖业二十多年来的持续增长做出了重大的贡献。近年来，对国内外畜禽用化学药物研发的进展、我国的兽药业应如何发展等问题，已有多篇文章进行阐述。本文拟就目前兽药的研发趋势和今后我国兽药发展的思路谈点个人的认识，供动物保健品业界的同道们参考。     

在食品生产用动物中谨愤使用人医上重要的抗生素(续完)

4 当前管理体系 FDA认为,作为人食品安全评审一部分的抗生素耐药性问题与用于食品生产用动物中的新型兽药有关.FDA认为,如果按照兽用抗生素类新型药物在食品生产用动物中的推荐方法使用时的确不会对人健康构成危害;那么此新型兽药才能被认为是安全的.这一标准适用于新兽药批准前进行的安全性评估,以及兽药批准后进行的安全性评估.假如这一安全性标准在批准前不能得到满足,该药物就不会被批准.     

浅谈兽用化学药物质量标准建立的一般过程

兽药的质量研究与质量标准的制订是兽药研发的主要内容之一。在兽药的研发过程中需对兽药质量进行系统、深入地研究,制订出科学、合理、可行的质量标准,并不断修订和完善,以控制兽药质量,保证其在有效期内安全有效。为此,参考《兽用化学药物质量标准建立的规范化过程技术指导原则》,就兽用化学药物质量标准建立的一般过程进行了探讨,以供参考。     

兽用化学药物杂质的分类及其分析方法的选择与验证

杂质的研究是兽用化学药物研发的重要内容。包括选择合适的分析方法，准确地分辨与测定杂质的含量并综合药学、毒理及临床研究的结果确定杂质的合理限度，杂质研究贯穿于兽药研发的整个过程。由于兽药在临床使用中产生的不良反应除与兽药本身的药理作用有关外，还与兽药中的杂质有关。所以规范地进行杂质的研究，把杂质控制在安全、合理的范围之内，将直接关系到上市兽药的质量及安全性。     

如何科学合理使用兽药

兽药是一类特殊商品,既要保证疗效,又要保障安全。现代兽药安全的概念,包括兽药对靶动物,对生产、使用兽药的人,对动物性食品的消费者,以及对环境的安全。对动物性食品消费者的安全,属于兽药残留控制问题。为了系统的宣传安全用药的常识、普及科学用药、合理用药的理念,本刊编辑部将采编一系列抗生素药物、消毒防腐药、抗寄生虫药物、解热镇痛药物、水产用药、蜂药的文章,以飨读者。     

新一代氯霉素类动物专用广谱抗生素

近年来是我国兽用化学药物正处于比较迅猛的发展时期,其间国内相继有一些大型医药企业介入兽药研发,基于比较雄厚的资金支持和基础条件,以及国外一些原料药专利保护期限的结束,兽药药物的开发非常活跃,相继有一些产品完成开发或上报及批准。我们说随着兽药研发技术的进步,未来兽药开发应考虑到市场细分和动物种群细分,针对特定市场和动物种群开发的有效药物。专家都认为,保障肉类安全的最根本方法是依靠科技,研制"新型兽药"。本刊选取了几种新型兽药的介绍,以飨读者。     

最新第四代动物专用头孢菌素类抗生素

近年来是我国兽用化学药物正处于比较迅猛的发展时期,其间国内相继有一些大型医药企业介入兽药研发,基于比较雄厚的资金支持和基础条件,以及国外一些原料药专利保护期限的结束,兽药药物的开发非常活跃,相继有一些产品完成开发或上报及批准。我们说随着兽药研发技术的进步,未来兽药开发应考虑到市场细分和动物种群细分,针对特定市场和动物种群开发的有效药物。专家都认为,保障肉类安全的最根本方法是依靠科技,研制"新型兽药"。本刊选取了几种新型兽药的介绍,以飨读者。     

浅议兽用中药新资源的开发

近年来,在市场和政策的双重促进下,中兽药行业发展突飞猛进,但作为一个资源依赖型的产业,兽用中药资源的利用与开发对行业的健康可持续发展至关重要。本文首先就兽用中药资源的历史发展及开发现状展开了论述,然后针对如何开发兽用中药新资源进行了重点探讨。指出新资源的开发,有助于扩充中兽药行业的药物来源,减少与人药的资源争夺,降本增效,促进中兽药行业高质量健康发展;同时提出新资源的开发应坚持中兽医药理论为指导,并以临床疗效为最终导向,走中兽药特色的道路。     

Teaching of veterinary parasitology: the Italian perspective

The curriculum in veterinary medicine in Italy is undergoing important changes, as in the rest of Europe. The 2001 fall semester will mark the beginning of a new format for the degree in veterinary medicine and these changes will obviously affect the teaching of veterinary parasitology. In Italy, veterinary parasitology is usually taught in the third year with a disciplinary approach, similar to that described by Euzéby [Vet. Parasitol. 64 (1996) 21] and Eckert [Vet. Parasitol. 88 (2000) 117]. Approximately 90 h of lectures and 40 h of laboratory are offered and are usually divided into parasitology, followed by parasitic diseases. A more problem-oriented approach to parasitology is offered to fifth-year students within several professional routes (large animal medicine, small animal medicine, hygiene and food safety, etc.), amounting to approximately 15-60 h per student. Indeed, in the last year of study, there are less students and it is possible to present clinical cases and orient the students towards team work and critical discussion. This new curriculum guarantees a reduction in the number of lecture hours and an increase in both laboratory work and personal study, as suggested by the guidelines of the European association of establishment for veterinary education (EAEVE).     

Two differentiated programs of veterinary medical education at the university of veterinary and pharmaceutical sciences in the Czech Republic

This article describes the two separate programs of veterinary education offered at the University of Veterinary and Pharmaceutical Sciences in Brno, Czech Republic, which are directed to clinical veterinary medicine and to veterinary food safety, hygiene, and ecology, respectively. Both programs provide a level of training such that all graduates are competent for veterinary practice in any area of veterinary medicine; however, each offers an extended and deepened emphasis of training in clinical medicine, on the one hand, and food safety, on the other. A key feature is that the cohort of students for each program enters having pre-selected a career in one of these two areas. One of the important end results of this structure is that it fulfills the growing and important mission of providing a critical number of veterinarians in food safety and all of its allied fields.     

The consequences of generic marketing on antibiotic consumption and the spread of microbial resistance: the need for new antibiotics

In both human and veterinary medicine, it has been shown that flooding the market with different generics and/or ‘me‐too’ branded drugs has increased overall antibiotic consumption correlating with the emergence and spread of bacterial resistance to antibiotics. Another possible undesirable consequence of the promotion of generics is the promotion of an economic incentive that encourages the use of old drug products with very poor oral bioavailability, marketed with historical dosage regimens and extensively excreted in the environment. What veterinary medicine rather needs is new innovative and ‘ecofriendly’ antibiotics to actually enforce a more prudent use of antibiotics. For a pharmaceutical company, generics are inexpensive to manufacture and on a short‐term basis, the generic market is very appealing. However, on a long‐term basis, this marketing orientation provides a disincentive to the development of new and innovative products that will be required to meet the therapeutic needs of the veterinary community while being consistent with public health concerns. Indeed, for veterinary medicine, the key issue surrounding antibiotics is public health. It is the opinion of the authors that veterinary antibiotics and/or veterinary drug formulations should be innovative in terms of selectivity (no or minimal impact on the commensal gut flora), biodegradable (with minimal environmental disruption), and more expensive, with a strictly regulated market rather than unselective, cheap, and freely available drugs.     

Clinical Trials in Veterinary Medicine: A New Era Brings New Challenges

Randomized clinical trials (RCTs) are among the most rigorous ways to determine the causal relationship between an intervention and important clinical outcome. Their use in veterinary medicine has become increasingly common, and as is often the case, with progress comes new challenges. Randomized clinical trials yield important answers, but results from these studies can be unhelpful or even misleading unless the study design and reporting are carried out with care. Herein, we offer some perspective on several emerging challenges associated with RCTs, including use of composite endpoints, the reporting of different forms of risk, analysis in the presence of missing data, and issues of reporting and safety assessment. These topics are explored in the context of previously reported veterinary internal medicine studies as well as through illustrative examples with hypothetical data sets. Moreover, many insights germane to RCTs in veterinary internal medicine can be drawn from the wealth of experience with RCTs in the human medical field. A better understanding of the issues presented here can help improve the design, interpretation, and reporting of veterinary RCTs.     

Recombinant vaccine technology in veterinary medicine.

Recombinant technology is relatively new to veterinary medicine. It combines safety, purity, potency, and efficacy in the vaccine. Its positive features include not exposing the vaccinate to the pathogen, the lack of need for adjuvants, and stability that allows some vaccine to remain viable at ambient temperatures. These recombinants can receive multiple genetic inserts and present an opportunity to have multiple combination vaccines for use in animals. Licensed recombinant vaccines in veterinary medicine include those protecting against Lyme disease, pseudorabies, rabies, canine distemper, Newcastle disease, and a strain of avian influenza.     

The problem of oral administration of antimicrobially effective substances. Experiences from Switzerland

The oral medication of sick animals is very common and a very preserve therapy. This method of therapy demands a high level of know-how for the veterinarians and also for meet-producers relating to food safety and bacterial resistance. In the new ordinance on veterinary medicine in 2004 many aspects of production and application of medicated feed are regulated in the legislation. This ordinance pretends to control all technical equipments used for production, transport and application of medicated feed by a qualified person (QP) on farms. Important criteria are defined in the ordinance on veterinary medicines.     

甘肃省兽药行业发展现状评价与对策

动物药品作为动物疫病防控的有力武器和养殖业增产的重要手段,是养殖业、快速健康、持续发展的不可或缺的重要保障。我国动物药品业现已基本实现了产品从单一化向多元化的转化,并出现了从生产型、数量型向效率型、质量型的变化。随着企业规模不断扩大、效率不断提高,产品结构不断升级,动物药品已经由需求、质量层面向强调安全和科学发展过渡。针对当前我国兽药行业的现状以及甘肃省兽药行业发展中存在的问题,报道了目前甘肃省兽药生产企业的发展状况,并对存在的主要问题进行了探讨和分析,结合甘肃省实际情况和兽药行业的发展趋势,进一步对甘肃省今后兽药研制发展的目标和重点进行了探讨。     

The use of IV lipid emulsion for lipophilic drug toxicities

IV lipid emulsion (ILE) therapy is emerging as a potential antidote for lipophilic drug toxicities in both human and veterinary medicine. ILE has already gained acceptance in human medicine as a treatment of local anesthetic systemic toxicity, but its mechanism of action, safety margins, and standardized dosing information remains undetermined at this time. Experimental and anecdotal use of ILE in the human and veterinary literature, theorized mechanisms of action, current dosing recommendations, potential adverse effects, and indications for use in human and veterinary emergency medicine are reviewed herein.     

2010年版《中华人民共和国兽药典》二部编制特色

与历版兽药典相比,2010年版《中华人民共和国兽药典》二部更加体现出了中兽药的特色,通过专属性鉴别、检测和新技术的应用,使中兽药在安全性、有效性和可控性等方面得到了极大的提高;并对中兽药鉴别、含量测定、性味与归经、用法与用量、注意事项和中药材拉丁名、拉丁学名等进行了大幅度的修订和规范。