摘要
目的评价地黄叶总苷胶囊在幼龄Wistar大鼠体内的安全性特征,为地黄叶总苷胶囊应用于儿童及青少年患者提供参考。方法使用27 d Wistar大鼠,分为辅料对照组和地黄叶总苷胶囊低(30 mg·kg^(-1))、中(150 mg·kg^(-1))、高(750 mg·kg^(-1))剂量组,各给药组重复灌胃给予地黄叶总苷胶囊内容物8周,停药后恢复4周,考察大鼠临床症状、体质量和摄食量变化、血液学和血清生化指标、神经系统功能及学习记忆能力、骨骼发育、生殖系统功能、脏器质量和组织病理学变化特点。结果地黄叶总苷胶囊对动物临床症状、体质量、摄食量、血液学指标、血清生化指标、主要脏器质量均未见明显影响,对动物中枢神经系统功能及学习记忆能力、骨骼发育未见明显影响,雌性动物性周期、雄性动物精子数量、活力及形态未见明显变化,未见与给予地黄叶总苷胶囊相关的组织病理学改变。结论地黄叶总苷胶囊重复给药8周对幼龄Wistar大鼠的无明显毒性作用剂量(NOAEL)为750 mg·kg^(-1)。本研究数据可为地黄叶总苷胶囊应用于儿童及青少年患者提供参考。
OBJECTIVE To evaluate the safety characteristics of Rehmannia glutinosa leaf total glycosides capsules in juvenile Wistar rats,and provide reference for the use of Rehmannia glutinosa leaf total glycosides capsules in child and adolescent patients.METHODS Twenty-seven-day-old Wistar rats were randomly divided into control and low-,medium-,and high-dosage groups.Each dosage group was given the Rehmannia glutinosa leaf total glycosides by gavage repeatedly for 8 weeks,followed by a 4 week recovery.The clinical symptoms,body weight,food consumption,hematological and serum biochemical indexes,central nervous system function,learning and memory ability,skeletal development,reproductive function,organ weight and histopathological changes of the rats was observed.RESULTS Rehmannia glutinosa leaf total glycosides capsules did not show significant effects on the clinical symptoms,body weight,food consumption,hematological and serum biochemical indexes,main organ weights,central nervous system function,bones,sexual cycle,sperm counts,vitality and form of the rats.No histopathological changes were observed associated with Rehmannia glutinosa leaf total glycosides capsules.CONCLUSION The no-observed-adverse-effect-level(NOAEL)for Rehmannia glutinosa leaf total glycosides capsules in juvenile rats is determined to be 750 mg·kg^(-1)in the 8 week feeding study.The data provides reference for the use of Rehmannia glutinosa leaf total glycosides capsules in child and adolescent patients.
作者
赵曼曼
肖华
杨莹
梁子禾
林志
周晓冰
刘艳华
ZHAO Manman;XIAO hua;YANG Ying;LIANG Zihe;LIN Zhi;ZHOU Xiaobing;LIU Yanhua(Key Laboratory of Beijing for Nonclinical Safety Evaluation Research of Drugs,Institute for Safety Evaluation,National Institutes for Food and Drug Control,Beijing 100176,China;Sichuan Medco Pharmaceutical Stock Co.,Ltd.,Shifang 618400,China;State Key Laboratory of Natural Medicines,China Pharmaceutical University,Nanjing 210009,China)
出处
《中国药学杂志》
北大核心
2025年第5期481-487,共7页
Chinese Pharmaceutical Journal
关键词
地黄叶总苷胶囊
幼龄大鼠
发育
毒性评价
Rehmannia glutinosa leaf total glycosides capsule
juvenile rat
development
toxicity evaluation
