复方龙胶囊对大鼠长期毒性的实验研究月利
|
摘要
目的:观察复方龙月利胶囊对大鼠的长期毒性反应。方法:将SPF级SD大鼠80只随机分为4组,每组20只。复方龙脷胶囊高、中、低(19.6、9.8、4.9 g/kg)3个剂量组相当于人用临床剂量(0.14 g/kg)的140、70、35倍,空白对照组给予同体积蒸馏水,连续灌胃30天,停药后观察14天。每日观察大鼠的一般状况,检测给药后及停药观察期大鼠的血液学指标、血液生化学指标、脏器系数,并做组织病理学检查。结果:给药30天及停药观察14天未见药物引起的毒性反应及延迟性毒性反应。结论:复方龙月利胶囊长期用药对大鼠无明显毒性,按临床拟用剂量服用应是安全的。
Objective: To observe long-term toxicity of compound LongLi capsules in rats. Methods: Eighty rats were randomized into four groups, 20 rats each group. High, moderate and low dose groups(19.6, 9.8 and4.9 g/kg) of compound LongLi capsules equal to 140, 70 and 35 times of clinical dose(0.14 g/kg), blank control group were given distilled water of the same volume. The rats were drenched for 30 consecutive days and observed for 14 days after drug withdrawal. To observe general conditions of the rats each day, to detect hematological indexes, blood chemical indexes and organ coefficient of the rats after medicating and during the observation period after drug withdrawal, and perform histopathological examination. Results: No drug-induced toxic reaction or delayed toxic reaction has been found after medicating for 30 days and within 14 days after drug withdrawal.Conclusion: Long-term application of compound LongLi capsules shows no obvious toxicity in rats, it should be safe to administer in clinical dose.
Objective: To observe long-term toxicity of compound LongLi capsules in rats. Methods: Eighty rats were randomized into four groups, 20 rats each group. High, moderate and low dose groups(19.6, 9.8 and4.9 g/kg) of compound LongLi capsules equal to 140, 70 and 35 times of clinical dose(0.14 g/kg), blank control group were given distilled water of the same volume. The rats were drenched for 30 consecutive days and observed for 14 days after drug withdrawal. To observe general conditions of the rats each day, to detect hematological indexes, blood chemical indexes and organ coefficient of the rats after medicating and during the observation period after drug withdrawal, and perform histopathological examination. Results: No drug-induced toxic reaction or delayed toxic reaction has been found after medicating for 30 days and within 14 days after drug withdrawal.Conclusion: Long-term application of compound LongLi capsules shows no obvious toxicity in rats, it should be safe to administer in clinical dose.
引文
[1]国家食品药品监督管理局.药物研究技术指导原则[M].北京:中国医药科技出版社,2006:217-226.
[2]陈奇.中药药理研究方法学[M].3版.北京:人民卫生出版社,2011:121-132.
[3]袁伯俊.新药非临床安全性研究的实验设计和实施[J].中国新药杂志,2004,13(9):772-775.
[4]钟鸣,周智,余胜民,等.壮药复方铁草胶囊毒理学研究[J].中国实验方剂学杂志,2011,17(1):173-177.
[5]史传道,刘海英,张荣强,等.抗疏健骨颗粒的长期毒性实验研究[J].西部中医药,2015,28(3):14-19.
[6]国家药典委员会.中国药典:一部[M].北京:中国医药科技出版社,2015:97.
[7]全国中草药汇编编写组.全国中草药汇编:下册[M].北京:人民卫生出版社,1978:174-175.
[8]广西壮族自治区食品药品监督管理局.广西壮族自治区壮药质量标准:第一卷[M].南宁:广西科技出版社,2008:77.
[9]陈晓军,李燕婧,谭建宁,等.复方龙脷胶囊通便作用的实验研究[J].中国中医药科技,2015,22(6):631-632.
[2]陈奇.中药药理研究方法学[M].3版.北京:人民卫生出版社,2011:121-132.
[3]袁伯俊.新药非临床安全性研究的实验设计和实施[J].中国新药杂志,2004,13(9):772-775.
[4]钟鸣,周智,余胜民,等.壮药复方铁草胶囊毒理学研究[J].中国实验方剂学杂志,2011,17(1):173-177.
[5]史传道,刘海英,张荣强,等.抗疏健骨颗粒的长期毒性实验研究[J].西部中医药,2015,28(3):14-19.
[6]国家药典委员会.中国药典:一部[M].北京:中国医药科技出版社,2015:97.
[7]全国中草药汇编编写组.全国中草药汇编:下册[M].北京:人民卫生出版社,1978:174-175.
[8]广西壮族自治区食品药品监督管理局.广西壮族自治区壮药质量标准:第一卷[M].南宁:广西科技出版社,2008:77.
[9]陈晓军,李燕婧,谭建宁,等.复方龙脷胶囊通便作用的实验研究[J].中国中医药科技,2015,22(6):631-632.