摘要
目的 研究γ-氨基丁酸、姜黄素复方片剂安全性和改善睡眠的功能。方法 采用急性经口试验、3项致突变试验、30 d喂养试验进行安全性评价;采用直接睡眠实验、延长戊巴比妥钠睡眠时间实验、戊巴比妥钠阈下剂量催眠实验、巴比妥钠睡眠潜伏期实验进行改善睡眠功能评价。结果 复方片剂单次经口染毒最大耐受剂量>15 g/kg·BW,3项致突变试验均为阴性,30 d喂养试验表明各剂量组未对大鼠各项指标产生明显有害作用,雌雄大鼠未观察到有害作用的水平(NOAEL)值分别为1 879、1 773 mg/kg·BW,分别达推荐量的112、106倍;延长戊巴比妥钠睡眠时间和巴比妥钠睡眠潜伏期实验结果为阳性,且无直接睡眠作用。结论 按照《保健食品检验与评价技术规范(2003版)》,该γ-氨基丁酸、姜黄素复方片剂在推荐剂量下使用安全且具有改善睡眠的功能。
Objective To study the safety and sleep improvement function of γ-aminobutyric acid and curcumincompound tablets. Methods Acute oral test, 3 mutagenic tests and 30 d feeding test were used to evaluate the safety of compound tablets.The improvement of sleep function was evaluated by direct sleep experiment, extended pentobarbital sodium sleep time experiment, pentobarbital sodium subthreshold dose hypnosis experiment and barbital sodium sleep latency experiment. Results The maximum tolerated dose of single oral exposure of compound tablets was greater than 15 g/kg·BW.All 3 mutagenicity tests showed negative results.The feeding test showed that the compound tablets in each dose group did not had obvious harmful effects on various indexes of rats, and the NOAEL values were 1 879 and 1 773 mg/kg·BW,respectively.The prolonging pentobarbital sodium sleep time and barbital sodium sleep latency tests showed positive results.The compound tablets did not show direct sleep effect. Conclusion According to the Technical Specification for Inspection and Evaluation of Health Food(2003 ed),the compound tablets of γ-aminobutyric acid and curcumin are safe to be used at the recommended dose and have improving sleep function.
作者
陈东亚
吴俊
鹿奎奎
张颖
奚清丽
CHEN Dong-ya;WU Jun;LU Kui-kui;ZHANG Ying;XI Qing-li(Jiangsu Provincial Center for Disease Control and Prevention,Jiangsu Nanjing 210009,China)
出处
《江苏预防医学》
CAS
2022年第5期529-533,共5页
Jiangsu Journal of Preventive Medicine
基金
江苏省卫生计生委科研课题(H201634)。
