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安梦(褪黑素)胶囊安全毒理学评价

The Toxicological Evaluation on the Substance of the Good-sleep (MLT) Capsules in Rat

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【作者】 张晖; 张婉文; 陆琮明; 孙桂兰; 张小强;

【Author】 Zhang Hui, Zhang Wanwen, Lu Zongming, Sun Guilan, Zhang Xiaoqiang (Pharmaceutical Factory of Nanjing University Nanjing 210093)

【机构】 南京大学制药厂!210093; 南京铁道医学院预防医学系;

【摘要】 对安梦(褪黑素)胶囊进行安全性毒理学评价。方法:用每克饲料中含8.33、16.67、33.33mg安梦(褪黑素)胶囊内容物的低、中、高剂量组 30 d喂养大鼠。结果:当剂量小于或等于每克饲料含 16. 67 mg安梦(褪黑素)胶囊内容物时,试验组的各项指标未发现异常,当剂量为33.33 mg时所有动物活动明显减少,常处于睡眠状态,摄食明显少于其它各组;体重和血红蛋白、红细胞压积均低于正常对照组。无作用剂量组为中剂量组。最大无作用剂量为 2. 76 g/(mm· d)。结论:一定剂量的安梦(褪黑素)胶囊安全可靠,对人体无副作用。

【Abstract】 Purpose: The safety and toxicology of the Good-sleep (MLT) capsules were evaluated through 30 day feed test with the substance of Good-sleep (MLT) capsules. Methods: By using 8. 33 mg, 16. 67 mg and 33. 33 mg of substance of Good-sleep capsules/g forage, as a low, medium and high dose respectively, to feed the rats during 30 day. Results: When the dose was at or below 16. 67 mg of substance of the Good-sleep capsules/g forage, each examining quota was found to be in the normal range among the testing groups. In the group the rats were fed with the dose of 33. 33 mg substance of Good-sleep capsules per gram of forage, the animal’s activity was notably decreased, the ingest was significantly less than that in other lower dose groups, and the growth became considerably worse. The weight, HB and HCT were found to be lower than those in the check group. Therefore, the non-effective dose group was the one with the feed of 16. 67 mg of substance of the Good-sleep capsules/g forage. The maximum non-effective dose was found to be 2. 796 g substance of capsules/kg/d. Conclusion: The results obtained imply that the given dose of the Good-sleep (MLT) capsules is safe and reliable, and is free of toxicity and side effects for human body.

【关键词】 褪黑素; 大鼠; 毒理学; 评价;
【Key words】 Melatonin(MLT); Rat; Toxicology; Evaluation;
  • 【文献出处】 中国生化药物杂志 ,CHINESE JOURNAL OF BIOCHEMICAL PHARMACEUTICS , 编辑部邮箱 ,1999年04期
  • 【分类号】R99
  • 【被引频次】8
  • 【下载频次】204
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