摘要
目的 对氨糖软骨素维生素D钙进行急性经口毒性和遗传毒性检测。方法 对一种以盐酸氨基葡萄糖、硫酸软骨素钠、碳酸钙和维生素D_(3)为主要原料的有助于改善骨密度的保健食品,依据食品安全国家标准,通过急性经口毒性试验评价其食用毒性,通过细菌回复突变试验、哺乳动物红细胞微核试验和小鼠精母细胞染色体畸变试验评价其遗传毒性。结果 在本研究条件下,急性经口半数致死量(acute oral half lethal dose,LD_(50))大于20.0 g/(kg·BW),该产品属实际无毒级。哺乳动物红细胞微核试验中,受试物在10.0、5.0、2.5 g/(kg·BW)剂量下未诱发小鼠骨髓嗜多染红细胞微核率的明显增高;细菌回复突变试验中,无论是否加肝微粒体酶(S9),受试物经两次独立试验检测,其回复突变菌落数均未超过背景自发突变数的2倍,且未呈剂量依赖性效应,试验判定为阴性;小鼠精母细胞染色体畸变试验中,阳性对照组的染色体畸变率及畸变细胞率极显著高于阴性对照组(P<0.01);受试物在10.0、5.0、2.5 g/(kg·BW) 3个剂量水平下,染色体畸变率及畸变细胞率与阴性对照组比较,未显示显著性差异(P>0.05),为阴性结果。结论 在本研究的剂量和条件下,该产品既无食用毒性也无遗传毒性。
Objective To evaluate the acute toxicity and genetic toxicity of glucosamine chondroitin vitamin D calcium.Methods A health food product with glucosamine hydrochloride,sodium chondroitin sulfate,calcium carbonate and vitamin D3 as primary ingredients,which could help improve bone mineral density,according to the national food safety standards,the edible toxicity was evaluated through acute oral toxicity test,and the genotoxicity was evaluated by bacterial reverse mutation test,mammalian erythrocyte micronucleus test and mouse spermatocyte chromosomal aberration test.Results Under the conditions of this experiment,the acute oral half lethal dose(LD50)was greater than 20.0 g/(kg·BW),and the product was practically non-toxic.In the mammalian erythrocyte micronucleus test,the test substance administered at doses of 10.0,5.0,2.5 g/(kg·BW)did not induce a significant increase in the micronucleus rate of polychromic erythrocytes in mouse bone marrow.In the bacterial reverse mutation test,regardless of whether liver microsomal enzymes(S9)were added or not,the number of revertant colonies of the test substance detected in two independent tests did not exceed twice the background spontaneous mutation number,and no dose-dependent effect was observed.The test was determined to be negative.In the mouse spermatocyte chromosomal aberration test,the incidence of chromosomal structural abnormalities and the proportion of aberrant cells in the positive control group were significantly higher than those in the negative control group(P<0.01).At 3 dose levels of 10.0,5.0 and 2.5 g/(kg·BW),the chromosome aberration rate and the rate of aberrant cells of the test substance showed no significant difference compared with the negative control group(P>0.05),which indicated a negative result.Conclusion At the doses and conditions of the tests,the product has neither edible toxicity nor genetic toxicity.
作者
单纯
李岩
贾悦
王晶
崔璐炀
李雨龙
曹春然
SHAN Chun;LI Yan;JIA Yue;WANG Jing;CUI Lu-Yang;LI Yu-Long;CAO Chun-Ran(Beijing Institute for Drug Control,Beijing 102206,China)
出处
《食品安全质量检测学报》
2025年第17期306-312,共7页
Journal of Food Safety and Quality
关键词
氨糖软骨素
急性毒性
遗传毒性
安全性评价
动物试验
glucosamine chondroitin
acute toxicity
genetic toxicity
safety evaluation
animal experiment
