实验动物,毒性研究 z-bo 2020-08-14 487

　　1. Species: Animals of different species have their own characteristics and may have different responses to the same test substance. From the perspective of fully exposing the toxicity of the test substance, using different species of animals for testing can obtain more sufficient safety information. Therefore, for chemical drugs, a single-dose toxicity test should be conducted with at least two mammals. Generally, one rodent and one non-rodent should be used. If non-rodent animals are not used for testing, the rationality should be clarified. For traditional Chinese medicines and natural medicines, rodents and/or non-rodents can be selected for testing according to specific conditions.

　　Experimental animals should meet the national quality requirements for animals of corresponding grades, and have a certificate of quality for experimental animals.

　　2. Gender: usually two sexes of animals are used for testing, with half males and half males. If single-sex animals are used for testing, its rationality should be clarified.

　　3. Age: Normally, healthy adult animals are used for testing. If the test substance is intended or may be used in children, juvenile animals should be used for testing if necessary.

　　4. Number of animals: The number of animals required should be determined according to the species of animals and the purpose of the research. The number of animals should meet the needs of test methods and result analysis and evaluation.

　　5. Body weight: The weight difference of each batch of animals in the experiment should not be too large at the time of initial administration, and the weight of rodents should not exceed or be less than 20% of the average body weight at the time of initial administration.