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目的:观察水溶性珍珠粉的安全性。方法与结果:急性毒性试验采用最大耐受剂量法,雌雄小鼠经口MTD>10.0g/kgBw,属实际无毒级。在遗传毒性试验中的Am es试验中的各浓度下,无论是否加入S9混合液,回变菌落数均未大于自发回变数的2倍,并且未见剂量-反应关系。而各阳性对照组均显示强烈的诱变作用。在骨髓细胞微核试验中,试验组动物在各试验剂量下,嗜多染红细胞(PCE)微核出现率、PCE/成熟红细胞(RBC)与阴性对照组相比,差异均无显著性(P>0.05),而阳性对照组与阴性对照组相比,差异有显著性(P<0.05),显示强烈的致突变作用;在小鼠精子畸形试验中,阴性对照组的精子畸形率为1.86%,阳性对照组(环磷酰胺组)的精子畸形率为5.32%,与阴性对照组相比差异有显著性(P<0.05),而试验3个剂量组的精子畸形率分别为1.92%、2.02%、2.06%,与阴性对照组相比差异无显著性(P>0.05);大鼠30天喂养试验结果表明,与对照组比较,水溶性珍珠粉3个剂量组大鼠的一般情况、体重、食物利用率、血液学、血液生化学、脏体比及病理组织学检查均未见异常。结论:水溶性珍珠粉属实际无毒级,未见遗传毒性,长期服用是安全的。
Objective: To observe the safety of water-soluble pearl powder. Methods and Results: Acute toxicity test using maximum tolerated dose, male and female mice oral MTD> 10.0g / kgBw, is an actual non-toxic grade. At each concentration in the Am es test in the genotoxicity test, no change in the number of colonies returned more than twice the spontaneous regression regardless of the addition of the S9 cocktail, and no dose-response relationship was observed. The positive control group showed a strong mutagenic effect. In the micronucleus test of bone marrow cells, there was no significant difference in micronucleus rate of PCE between experimental group and PCE / mature erythrocytes (RBC) at each test dose (P > 0.05), while the positive control group compared with the negative control group, the difference was significant (P <0.05), showing a strong mutagenic effect; sperm deformity test in mice, the negative control group sperm deformity was 1.86% , The positive control group (cyclophosphamide group) sperm deformity rate was 5.32%, compared with the negative control group, the difference was significant (P <0.05), while the test 3 dose group sperm deformity rates were 1.92%, 2.02 %, 2.06% respectively. There was no significant difference between the control group and the negative control group (P> 0.05). The results of 30-day feeding experiment showed that compared with the control group, the water- , Food utilization, hematology, blood biochemistry, body mass ratio and histopathological examination were normal. Conclusion: Water-soluble pearl powder is actually non-toxic grade, no genetic toxicity, long-term use is safe.