亚太传统医药2026，Vol.22Issue(2)：16-22,7.DOI:10.11954/ytctyy.202602004
五味子破壁饮片单次和重复给药毒性实验研究
Toxicity Test Study on Single and Repeated Administration of Schisandra Chinensis Wall-Broken Tablets
顾蕾蕾 1邓雯 2张前亮 2陈炜璇 2刘莎1
作者信息
- 1. 江苏省药物研究所有限公司,江苏 南京 211800
- 2. 中山市中智药业集团有限公司,广东 中山 528437||国家企业技术中心,广东 中山 528437||中药破壁饮片国家地方联合工程研究中心,广东 中山 528437
- 折叠
摘要
Abstract
Objective:To evaluate the non-clinical safety of Schisandra chinensis wall-broken tablets in SD rats and compare them with Schisandra chinensis to provide reference information for clinical research and application.Meth-ods:Schisandra chinensis wall-broken tablets and Schisandra chinensis were given to SD rats by single gavage at a dose of 8 g/(kg·d)for 2 weeks of continuous observation;Schisandra chinensis wall-broken tablets were given to SD rats by gavage at doses of 1.5 g/(kg·d),3.0 g/(kg·d),6.0 g/(kg·d),and Schisandra chinensis were given to SD rats by gavage at doses of 1.5 g/(kg·d),6.0 g/(kg·d)for 13 weeks and recovery was achieved in 4 weeks.Observe the appearance and signs of the animals and perform various examinations such as body weight,food intake,haematolo-gy,serum biochemistry and pathology.Results:No significant toxic effects were observed in SD rats given Schisandra chinensis wall-broken tablets and Schisandra chinensis(8 g/(kg·d))by single gavage.In the repeated dosing toxicity test,at the middle and end of dosing,the liver of the animals of Schisandra chinensis wall-broken tablets 6.0 g/(kg·d)group showed hepatocellular hypertrophy of the lobule-central type,which was of a slight to mild degree,with a higher prevalence in females,and in the reference preparation.No such pathological changes were seen in the livers of animals in the Schisandra chinensis group.After 4 weeks of drug withdrawal and recovery,the liver lesions in all dose groups of Schisandra chinensis wall-broken tablets had completely recovered,and no other delayed pathological changes were seen.Conclusion:The no-adverse-effect dose level(NOAEL)of Schisandra chinensis wall-broken tablets was 3 g/(kg·d)in the group;the NOAEL of Schisandra chinensis was 6 g/(kg·d)in the group.关键词
五味子破壁饮片/五味子饮片/单次给药毒性实验/重复给药毒性实验Key words
Schisandra Chinensis Wall-Broken Tablets/Schisandra Chinensis Tablets/Single Dose Toxicity Study/Re-peated Dose Toxicity Study分类
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顾蕾蕾,邓雯,张前亮,陈炜璇,刘莎..五味子破壁饮片单次和重复给药毒性实验研究[J].亚太传统医药,2026,22(2):16-22,7.
