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目的对《食品安全性毒理学评价程序》和《保健食品检验与评价技术规范(2003年版)》中的小鼠精子畸形试验进行方法学探讨。方法 30只雄性昆明小鼠完全随机分为3组,空白对照组以蒸馏水灌胃,环磷酰胺组(Cyclophosphamide,CP)分别用国产环磷酰胺和进口环磷酰胺灌胃(40mg/kg.BW),灌胃体积为20ml/kg.BW,每日1次,连续5d,于试验第5天和第35天称重,观察环磷酰胺对小鼠体重的影响。第35天麻醉并处死动物,取双侧睾丸和附睾称重,计算睾丸指数和附睾指数,以附睾研磨涂片,观察精子数量及畸形率情况。结果试验第5天和第35天,CP组小鼠体重均显著轻于空白对照组,差异有统计学意义。但国产CP和进口CP组小鼠体重差异无统计学意义。环磷酰胺组小鼠睾丸重量和附睾重量均显著低于空白对照组,但睾丸指数和附睾指数差异无统计学意义。环磷酰胺显著增加小鼠精子畸形率,精子畸形类型以不定型和无钩为主。结论经口途径给予环磷酰胺使昆明小鼠精子畸形率显著升高,但抑制小鼠体重增长。在进行小鼠精子畸形试验时,应根据体重调整每日灌胃量。阳性药品的选用应综合考虑诱变效果、可获得性和经济性。
Objective To investigate the method of mouse sperm deformity test in “Food Safety Toxicology Evaluation Program” and “Technical Specification of Health Food Inspection and Evaluation (2003 Edition)”. Methods Thirty male Kunming mice were randomly divided into three groups randomly. The blank control group was given gavage with distilled water. Cyclophosphamide (CP) was intragastrically administered with domestic cyclophosphamide and imported cyclophosphamide (40mg / kg.BW ), Gavage volume of 20ml / kg.BW, once a day for 5 days, on the 5th and 35th day of the experiment weighed to observe the impact of cyclophosphamide on body weight in mice. On the 35th day, the animals were anesthetized and sacrificed. The testis and epididymis were weighed, testis index and epididymis index were calculated, and the epididymis was used to test the number of sperm and the rate of deformity. Results On day 5 and day 35, the body weight of CP mice was significantly lower than that of the blank control group, the difference was statistically significant. However, there was no significant difference in weight between domestic CP and imported CP mice. The weight of testis and the weight of epididymis of mice in cyclophosphamide group were significantly lower than that of the blank control group, but there was no significant difference between testis index and epididymis index. Cyclophosphamide significantly increased the rate of sperm deformity in mice, sperm deformity type to non-stereotypes and no hook based. Conclusion Cyclophosphamide was administered orally to Kunming mice, which significantly increased the rate of sperm deformity but inhibited the weight gain of mice. In the mouse sperm abnormality test, should be adjusted according to body weight daily gavage. Positive drug selection should take into account the mutagenic effect, availability and economy.