新型药物递送系统在兽药制剂领域的研究进展

新型药物递送系统在新药研发中的应用近年来在国内外受到了广泛的重视。兽用新型载药系统的研究,解决了兽用药物在动物体内半衰期短、靶向性差、药物利用率低以及药物溶解性特定要求等问题,可开发出新型、高效、安全的生物药物剂型。兽药新型递药系统已在兽药领域展现出广阔的前景,并成为兽药研发的新方向之一。本文就目前主要递药系统(如缓控释递药系统、纳米递药系统、靶向给药系统、透皮给药系统、生物粘附给药系统、植入控释给药系统以及自乳化给药系统等)在兽药制剂领域的研究进展进行综述,并分析和探讨了新型递药系统在兽医领域应用瓶颈、现有研究面临的挑战及未来的发展趋势,以期为新型递药系统在兽药领域的应用提供参考。     

兽用化学药物研发动向

分析了国外兽用化学药物的研发趋势和特点,主要是食品动物用药减少,宠物用药明显增加,重点研发抗寄生虫药;认为应重视开发复方制剂和系列制剂,大力开发非甾体抗炎药.介绍了我国兽药的研发趋势和特点:食品动物用药、抗微生物药占主导地位,兽药剂型和制剂种类单一,中兽药品种繁多,认为我国兽药研发应当以仿制为主、创新为辅,积极研发新剂型和新制剂,加强水产养殖动物用药及宠物用药的开发,加强复方药物、饲料药物添加剂、中兽药和生物工程药物的研发.     

纳米混悬制剂在兽药中的研究进展

部分兽药原料药由于水溶性较差或渗透性较低，导致生物利用度低，不能发挥良好的疗效。将药物制成纳米混悬制剂，能够减小药物粒度，改善药物溶解度，增加药物溶出度，并改变药物在生物体内的药代动力学特征，有效提高生物利用度。另外，纳米混悬制剂具备制造方法简单、条件温和等优势，满足理想的兽药开发条件。本文就纳米混悬制剂的制备方法，及其在兽药应用领域给药途径进行了综述，为纳米混悬制剂在兽药领域的研制提供参考及借鉴。     

脂质体递药系统设计思路及其兽药应用研究进展

脂质体作为一种优良的药物载体,具有载药范围广、高效、低毒等特点,能增加包载药物的稳定性和溶解度,赋予药物靶向和缓释的递药特性,并能有效提高药物的生物利用度,是近年来多领域研究和应用的热点。作者从脂质体的结构、粒径设计及制备方法筛选层面总结脂质体的构建思路,结合兽药应用特点和用药需求归纳脂质体递药系统在兽药领域的研究进展,以期为新型递药系统在兽药领域的研发应用提供参考。     

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。     

水产药特性及发展

凡是用于增加水产养殖生物产量和改善其品质所应用的一切药物，均可称为水产药。在我国水产药属兽药管理范围，实行兽药生产许可证制，执行国家或地方兽药管理质量标准。1．我国水产药发展的现状：我国水产药研究始于1953年，经过四十余年的发展，广大科技工作者从化学药品、农药、医药、中草药和其它材料中进行了广泛的研究，已形成了化学治疗药、消毒药、营养剂和饲料添加剂、生物制品、麻醉剂、环境改良剂等七大系列几十个品种的水产药物系统。在药物的使用和功能上从单一型向多品种复合型用药发展，在药物的使用功能上从单一治疗型向多…     

我国新兽药开发现状及存在问题

兽药是一种特殊的产品，它既与人用药物类似就是能够预防疾病，又与人用药物不同，就是使用时避免给人的食物带来不良影响——兽药残留。我国兽药行业经过二十年的发展，虽然生产总量在提高，研究开发能力在增强，但是和国外的同行相比，我们的研究开发能力还很弱，完全能够自己创新开发新兽药的企业还不多，得到国际认可的属于自己知识产权和产品还很少，新兽药的开发仍然处于仿制为主的阶段。     

兽药生产经营企业如何面对WTO和最新的市场需求

改革开放２０多年来，我国兽药产业从无到有，从小到大，得到了一个长足的发展，经过了一个从原始资本积累到仿制国外产品的发展过程。从基本仿制国外的化学合成药到少量地自主创新生产个别兽药，２０年的发展是一个依靠独立自主的发展历程，使得资本经营，新兽药开发都迈上了新的台阶。为保障我国畜牧业，水产养殖业的可持续发展作出了重大贡献。但是，我们不得不承认，虽然我们的生产总量在提高，研究开发能力不断地增强，但和国外同行相比，我国兽药行业的实力还很簿弱，兽药的开发仍然处于仿制为主的阶段。加入WTO之后，这种竞争劣势…     

美国兽药产品不良反应事件管理

兽药(注:本文兽药如非特别指明均指化学药品)不良反应事件管理是兽药风险管理的重要组成内容,对兽药不良反应事件的分析、汇总和评价有利于指导和规范兽药产品临床合理用药、有利于鼓励创新兽药的研究与发展,并且为兽药再评价和兽药使用说明书修订等提供科学依据,也对兽用药物流行学研究具有重要的价值和意义.     

药动/药效同步模型在兽用抗菌药物研究的应用概况

药动/药效同步模型是将药动学和药效学结合,用于研究药理效应随时间变化规律的一种模型。药动/药效同步模型在药理学和毒理学研究、临床应用及新药评价等领域得到越来越广泛的应用。随着抗菌药物的发展,耐药性问题日益成为全球关注的焦点。将药动/药效同步模型引入兽药研究中,不仅能够优化给药方案,避免细菌耐药性的产生,也能够为新药的开发提供研究基础。论文对兽用抗菌药物的分类、药动/药效同步模型的研究方法及其在国内外兽药研究中的应用现状进行综述,以期为药动/药效同步模型的兽医临床应用提供参考。     

Considerations for application of biopharmaceutics classification system in chicken: Exemplified by seven drugs classification

Biopharmaceutics Classification System (BCS) has gained broad acceptance in promoting the development of human drugs. To date, the applicability of existing human BCS criteria has not been evaluated in chickens. The objective of this study was to discuss the feasibility of BCS extrapolation between species and establish a preliminary chicken BCS by classifying seven veterinary commonly used drugs including metronidazole, amoxicillin, sulfamethoxazole, sulfadiazine, ciprofloxacin hydrochloride, doxycycline hydrochloride, and trimethoprim. Firstly, we finished the determination of physiological parameters affecting solubility in chickens, including body temperature, gastrointestinal pH, and the fluid volume in the gastrointestinal tract (GI), and the drug is considered highly soluble in chicken BCS when the highest dose strength is soluble in 20.40 ml (fed) or 6.73 ml (fasted) over the pH range of 1–8 at 41°C. Drug solubility classification was based on dose number calculation. Metronidazol and amoxicillin were classed differently under fed and fasted conditions. Secondly, we discussed the effect of ABC transporters (MDCK vs. MDCK-chAbcb1/Abcg2) and pH (5.5 vs. 7.4) on drug permeability and classification. The drug is classified as highly permeable when its permeability is equal to or greater than metoprolol tartrate. Though ABC transporters and pH significantly affected the permeability values of drugs (p < .05), the permeability classification of the drugs has not been changed except for sulfamethoxazole. This work highlights some of the significant challenges that would be encountered in order to develop a chicken BCS, this valuable information could serve as a helpful tool during chicken drugs development and to minimize the potential risks when developing formulations.     

Lifestyle risk factors for progesterone-related diabetes mellitus in elkhounds - a case-control study

Objectives : This study aims to investigate lifestyle risk factors for the development of progesterone‐related diabetes mellitus in female elkhounds. Methods : Owners of 48 diabetic elkhounds and 58 healthy elkhounds were interviewed by phone concerning lifetime diet and exercise routines. A logistic model was developed to assess the impact of diet and exercise on diabetes diagnosis. The agreement between lifetime owner‐perceived body condition score (BCS) and veterinary‐perceived BCS at inclusion was estimated in healthy control dogs using the Kappa statistic. Results : The model showed that diabetic dogs had increased odds for having been overweight (before diagnosis) compared with controls (OR=2·8, 95% confidence interval 1·1–7·5, P=0·034). Although feeding other food than commercial dog feed was associated with diabetes case status, the effect was not significant after BCS was entered into the model. The overall agreement between lifetime owner‐ and veterinary‐perceived BCS at inclusion in the study was 75% and had a Kappa statistic of 0·16 (P=0·12). Clinical Significance : This study indicates that a high owner‐perceived lifetime BCS is associated with progesterone‐related diabetes in elkhounds.     

基于非线性混合效应模型分析兽药药代动力学研究进展

利用数学建模分析兽药药代动力学历来已久。兽药药代动力学中应用数学建模和模拟分析可简化和加快兽药研发进程。非线性混合效应模型分析方法是兽药药代动力学建模和模拟的主要方法之一,该方法对临床合理用药、新药研发及评审更高效具有很大意义,同时阐明一些传统药动学无法回答的问题。本文综述了非线性混合效应模型在分析兽药药代动力学主要原理及应用进展,以期望非线性混合效应模型分析方法在我国新兽药研发与评审中应用提供积极有益的参考。     

山东省减抗背景下的中兽药产业调研分析

基于对山东省兽药生产企业和养殖企业中兽药生产和使用情况的调研,本文深入分析了我省中兽药发展现状和存在的问题,针对性地提出了中兽药产业发展的对策建议。需着力构建全产业链发展格局;不断释放市场创新创业活力;快速实现我省中兽药产业现代化;充分发挥好政策对产业引领作用;着力打造专业化人才队伍。并不断推进兽用抗菌药减量化示范行动等综合措施,从根本上遏制兽用抗菌药滥用,提倡使用中兽药等绿色高效产品的减抗行动,以期降低细菌耐药性的发生和发展,保障畜禽产品质量安全。     

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。     

Body condition scoring (BCS) in corn snakes (Pantherophis guttatus) and comparison to pre-existing body condition index (BCI) for snakes

In the veterinary profession, the body condition score (BCS) plays an important role in the assessment of patients. It is a subjective, tactile method of evaluating body fat and muscle mass and is used in numerous species. Recognizing obesity (or the contrary, emaciation) is important for veterinarians treating reptiles and could be facilitated by a BCS. An existing form of body condition assessment already used is the body condition index (BCI), where the residuals from a regression of body mass on body length are calculated. Therefore, the goal of this study was to provide practitioners with a BCS system for corn snakes (Pantherophis guttatus) and to test it against the BCI. A total of 22 corn snakes (Pantherophis guttatus), stationed at the “Auffangstation für Reptilien” in Munich (reptile rescue centre, RRC), were subject of this study. Each had the following measurements taken: body weight (BW), snout–tail tip length (STL), snout–vent length (SVL) and circumference in the middle (C). Manual palpation of spine, area between vertebral spinous and transverse process, ribs and neck of each snake was performed by three veterinarians and assigned to specific scores by each examiner. A BCS (mean of examiners’ scores) was given to each snake according to manual palpation. The BCS system was chosen to be out of 5 in 0.5-point steps with 2.5 considered as ideal BCS. In the studied snakes, the BCS ranged from 1.5 to 3.5, with a median of 2.5. The median BW was 309 g (75–967 g), the median STL was 123 cm (79–153 cm), the median SVL was 104 cm (73–133 cm) and the median C was 7.5 cm (4.3–11 cm). BCS and BCI were positively correlated. A BCS includes a manual palpation of the animal and thus gives the examiner additional information to the objectively measured/calculated index.     

新兽药监测期规定对我国兽药产品批准文号申报审查的新变化

本文介绍了农业部关于新兽药监测期的新规定,从新兽药监测期计算方法、监测期内生产企业数量、监测期内不良反应报告和监测期新规定的适用范围等四方面阐述了新兽药监测期规定对兽药产品批准文号申报、审查带来的新变化,希望能为兽药产品批准文号申报、审查工作提供参考。