个月长期啮齿类致癌性试验的饲料选择与管理-中国比较医学杂志.DOC

中美日三国啮齿类饲料样品比较分析 ——24个月长期啮齿类致癌性实验的饲料选择 梁春南1，王三龙1，张海峰2，韩春兰3，沈连忠4，李保文1，汪巨峰1 （1 中国食品药品检定研究院 国家药物安全评价监测中心，北京 100176；2 北京科澳协力饲料有限公司(上海）商贸有限公司 上海 200050；4 山东欣博药物研究有限公司 山东 251500) 摘要：[目的]评估饲料品质、供应风险及价格，为一个24个月长期致癌性试验寻找最佳的饲料及饲料供应商。[方法] 将日本进口MF18饲料，美国进口LabDiet?饲料以及北京科澳生产的啮齿类饲料样品分别包装，委托专业检测实验室对常规营养成分、毒理及微生物指标进行检测，评估饲料品质；对各来源饲料的运输风险、非可控因素等可能影响饲料品质及稳定供应的方面进行评估；兼顾饲料价格作为参考评估因素。[结果] 经评估,三种饲料品质均符合饲料国标GB14924-2001*的要求；以毒性研究关注的毒理指标作为评价标准，则三种饲料品质排序为：MF18饲料（最佳）— LabDiet?饲料（较佳）—科澳国产饲料（佳）；进口饲料的运输及供应稳定性相比存在较大风险；国产饲料价格相对便宜但未成为关键评估因素。[结论] 经过综合评估,特殊定制的本地国产饲料被认定为是国家药物安全评价监测中心24个月致癌性试验用的最佳饲料。 关键词：致癌性试验；饲料；分析 Comparison of Three Rodents Diet Samples from Japan, USA and China: Evaluation and Selection of Diet Used in 24-Month Rodent Carcinogenicity Study Liang Chunnan1，Wang Sanlong1，Zhang Haifeng2，Han Chunlan3，Shen Lianzhong4，Li Baowen1，Wang Jufeng1 （1 National Centre for Safety Evaluation of Drugs, National Institutes Food and Drug Control, Beijing 100176；2 Beijing Keao Xieli Feed Co.LTD., Beijing 100107; 3 Nisshin Seifun OYC (Shanghai)Co.LTD., Shanghai 2000504 Shandong Xinbo Pharmaceutical RD, Ltd., Shandong 251500) Abstract: [Objective] To find the best feed and feed supplier for 24-months rodent carcinogenicity study by assessing the quality, supply risks and price of three rodent diets. [Methods] The MF18 diet, LabDiet? diet, and SPF Local rodent diet were sent to a professional laboratory for conventional nutrients, metals and pesticides, and microbiological indicators testing to evaluate the quality of feeds. Risks on feed transport, and non-controllable factors which might affect feed quality and supply were evaluated. The price of each feed as a reference factor was also considered. [Results] The quality of the three feeds met the standard GB14924-2001. According to the evaluation criteria for general toxicological indicators concerned in toxicity studies, the quality sort of the three feed was ranked as: MF18 feed (the best) - LabDiet? feed (better) - Local feed produced in beijing (g