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本文从试验设计、试验操作、试验报告三个方面,对近年来进行保健食品毒理学试验和功能验证动物学试验研究中出现的一些问题进行总结,希望从事保健食品研究与试验的实验室能够互相借鉴,避免工作中的一些失误。经总结发现:试验设计中主要存在剂量设计不合理、测定指标不合理、对照品选择不合理、受试物的处理不合理等问题;试验操作过程中主要为试验结果的处理不合理、未注意试验数据与背景数据比较、试验中记录不详细、试验中使用材料不符合规范要求等问题;试验报告中主要存在未注意全文的前后一致性、报告结果不规范、报告结果的不完整、报告失真等问题。其次提醒保健食品的检测和研究机构,在目前巨大市场需求的前提下,应该努力提高本单位的试验水平,认真解读所使用的检测标准,本着严谨、科学的态度完成受试样品的检测试验,出具检测报告。
In this paper, we summarize some of the problems in the study of zoology of health food and functional zoology in the aspects of experimental design, experimental operation and test report. It is hoped that the laboratories engaged in the research and experiment of health food will interact with each other Learn from and avoid some mistakes at work. It is concluded that there are some problems in trial design, such as unreasonable dose design, unreasonable measurement index, unreasonable selection of reference substance and unreasonable treatment of test substance. In the process of test operation, the treatment of test result is unreasonable and unnoticed Test data and background data comparison, the test is not detailed records, the use of materials in the test does not meet regulatory requirements and other issues; the main test report did not pay attention to the consistency of the full text, the report results are not standardized, the report results are not complete, the report is distorted And other issues. Second, to remind the health food testing and research institutions, under the premise of the huge market demand, we should strive to improve the level of testing units, carefully interpret the testing standards used, in a rigorous and scientific attitude to complete the test sample test Test, issued a test report.