癌变·畸变·突变 ›› 2017, Vol. 29 ›› Issue (1): 70-73,77.doi: 10.3969/j.issn.1004-616x.2017.01.014

• 检测研究 • 上一篇    下一篇

小球藻片对大鼠的致畸试验

蔡铁全1, 吕晶2, 高晓新2, 曹春然2, 胡宇驰2, 吴虓飞2   

  1. 1. 国家食品药品监督管理总局保健食品审评中心, 北京 100070;
    2. 北京市药品检验所中药成分分析与生物评价北京市重点实验室, 北京 100035
  • 收稿日期:2016-07-17 修回日期:2016-11-03 出版日期:2017-01-31 发布日期:2017-01-31
  • 通讯作者: 吴虓飞,E-mail:wuxiaofei@bidc.org.cn E-mail:wuxiaofei@bidc.org.cn
  • 作者简介:蔡铁全,E-mail:ctq@zybh.gov.cn

Teratogenic investigation of chlorella vulgaris tablet on Sprague Dawley rats

CAI Tiequan1, LÜ Jing2, GAO Xiaoxin2, CAO Chunran2, HU Yuchi2, WU Xiaofei2   

  1. 1. Center for Health Food Evaluation, CFDA, Beijing 100070;
    2. Analysis of Chinese Medicines and Biological Evaluation of Beijing Municipal Key Laboratory, Beijing Institute for Drug Control, Beijing 100035, China
  • Received:2016-07-17 Revised:2016-11-03 Online:2017-01-31 Published:2017-01-31

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摘要：

目的：评价小球藻片是否对SD大鼠具有致畸毒性，对其安全性进行毒理学评价。方法：孕鼠按体质量随机分为小球藻片低、中、高剂量组（分别为1 875、3 750、7 500 mg/kg，相当于人服用量的12.5、25、50倍），阳性对照组（300 mg/kg阿司匹林）和阴性对照组（等体积纯净水）。于孕期7~16 d灌胃给予受试物，试验期间称量孕鼠体质量，第20天处死。剖腹检查子宫连胚胎质量、着床数、活胎数、死胎数、吸收胎数、胎质量和体长、胎仔雌雄比例、胎仔外观、骨骼和内脏发育情况。结果：阳性对照组大鼠具有明显的母体毒性、胚胎毒性和致畸毒性。低、中、高剂量组小球藻片无母体毒性、胚胎毒性和致畸毒性。高剂量组出现少数胎仔外观畸形和骨骼畸形，畸形率与阴性对照组比较差异无统计学意义（P > 0.05）。结论：在本实验条件下，小球藻片对SD大鼠无母体毒性、胚胎毒性和致畸毒性。

关键词: 小球藻片, 胚胎, 致畸作用, 畸形

Abstract:

OBJECTIVE: The teratgenic and toxic effects of chlorella vulgaris tablets were evaluated in SD rats for health food safety concerns. METHODS: Pregnant rats were randomly assigned to chlorella vulgaris tablet groups (1 875,3 750,7 500 mg/kg),positive control group (300 mg/kg aspirin) and negative control group. Rats were treated on the 7th to the 16th day during the gestation period and were killed on the 20th day. Indicators for teratogenicity were examined:weight of uterus with embryo,fetal weight and body length,proportion of male and female fetuses,number of implantation,live fetuses,dead fetuses and reabsorbed fetuses,the morphology of fetuses,and abnormalities in the fetal skeletons and internal organs. RESULTS: Aspirin dose of 300 mg/kg produced maternal toxicity,embryonic toxicity and substantial teratogenic effects. The groups treated with doses of 1 875,3 750 and 7 500 mg/kg of the tablets did not produce maternal toxicity,embryonic toxicity nor teratogenicity. None of the observed effects was significantly different from the negative control group (P > 0.05). CONCLUSION: Chlorella vulgaris tablet did not cause maternal toxicity,embryonic toxicity,or teratogenicity in pregnant rats.

Key words: chlorella vulgaris tablet, embryo toxicity, teratogenicity, malformation

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