• 中国核心期刊(遴选)数据库收录期刊
  • 中文科技期刊数据库收录期刊
  • 中国期刊全文数据库收录期刊
  • 中国学术期刊综合评价数据库统计源期刊等
评价技术与方法

肉苁蓉配方茶的一般毒性和遗传毒性评价

展开
  • 新疆华春生物药业股份有限公司, 新疆 乌鲁木齐 830000
董惠娟,女,硕士,中级实验师,研究方向:毒理学

收稿日期: 2025-08-07

  修回日期: 2025-08-29

  录用日期: 2025-11-27

  网络出版日期: 2025-12-15

General Toxicity and Genotoxicity Evaluation of Cistanche Deserticola Formula Tea

Expand
  • Xinjiang Huachun Biopharmaceutical Co., Ltd., Xinjiang Urumqi 830000, China

Received date: 2025-08-07

  Revised date: 2025-08-29

  Accepted date: 2025-11-27

  Online published: 2025-12-15

摘要

目的:系统评价肉苁蓉配方茶的一般毒性和遗传毒性,提供肉苁蓉配方茶的安全性资料,为深化肉苁蓉配方茶的功能学研究提供依据。方法:采用ICR小鼠急性毒性试验和SD大鼠30 d喂养试验来评价肉苁蓉配方茶的一般毒性,采用细菌Ames试验、昆明小鼠骨髓嗜多染红细胞微核试验和精子畸形试验对肉苁蓉配方茶的遗传毒性进行评价。结果:肉苁蓉配方茶浓缩液对ICR小鼠的最大耐受剂量(MTD)大于20.00 g·kg-1,属无毒级;肉苁蓉配方茶浓缩液的遗传毒性试验结果均为阴性;为期30 d的SD大鼠灌胃实验中,分别灌服3.75、7.50、15.00 g·kg-1剂量的肉苁蓉配方茶浓缩液,实验期间,大鼠生长发育状况良好,肉苁蓉配方茶浓缩液组大鼠体重、食物利用率、血液生化指标、血常规参数、主要脏器重量及脏体比值均未观察到异常改变(P>0.05),经大体解剖学观察和组织病理学检查,亦未发现可明确归因于肉苁蓉配方茶浓缩液处理的异常病变,综合上述结果,表明该提取液在30 d喂养周期内对大鼠未产生明显的毒性效应。结论:基于本实验条件,肉苁蓉配方茶浓缩液的一般毒理学评价及遗传毒理学检测结果均为阴性,其安全性可为后续开展功能学研究提供支持依据。

本文引用格式

董惠娟, 杨朝竣, 蒲长兵, 郝娟 . 肉苁蓉配方茶的一般毒性和遗传毒性评价[J]. 中国药物评价, 2025 , 42(5) : 366 -366-372 . DOI: magtech-2025-08-07-00002

Abstract

Objective: Systematically evaluate the general toxicity and genetic toxicity of Cistanche formula tea, provide safety data for Cistanche formula tea, and offer a basis for further advancing the functional research of Cistanche formula tea. Methods: The general toxicity of Cistanche formula tea was evaluated using acute toxicity test in ICR mice and 30-day feeding test in SD rats. The genetic toxicity was assessed by bacterial Ames test, micronucleus test in polychromatic erythrocytes of bone marrow in Kunming mice, and sperm deformity test. Results: The maximum tolerated dose (MTD) of Cistanche formula tea concentrate in ICR mice was greater than 20.00 g·kg-1, classifying it as non-toxic. All genetic toxicity test results of Cistanche formula tea concentrate were negative. In the 30-day gavage experiment in SD rats with doses of 3.75, 7.50, and 15.00 g·kg-1of Cistanche formula tea concentrate, the rats showed good growth and development during the experiment. No statistically significant differences (P>0.05) were observed in body weight, food utilization rate, blood biochemical indicators, blood routine parameters, main organ weights, and organ/body weight ratios between the Cistanche formula tea concentrate groups and the control group. No abnormal lesions clearly attributable to the treatment with Cistanche formula tea concentrate were found through gross anatomical observation and histopathological examination. These results indicated that the concentrate did not produce obvious toxic effects on rats within the 30 d feeding period. Conclusion: Under the experimental conditions, both the general toxicological evaluation and genetic toxicological test results of Cistanche formula tea concentrate were negative, and its safety can provide a supporting basis for subsequent functional studies.

参考文献

[1] 刘傲雪,万凤,胡江雪,等. 基于细胞实验、网络药理学和分子对接探究苯乙醇苷类成分的促神经再生作用构效关系及机制[J]. 药物评价研究,2025,48(1):136-142.
     [2] 郝梅,李红艳. 肉苁蓉苯乙醇苷抗小鼠抑郁作用及机制研究[J]. 天然产物研究与开发,2025,37(2):204-214,327.
     [3] 王力伟,曹瑞,房永雨,等. UPLC-QQQMS法测定肉苁蓉中有效成分的含量[J]. 中药材,2017,40(2):295-300.
     [4] Liu X, Yang Z, Han M, et al. Bioactive components, pharmacological properties, and applications of cistanche deserticola Y. C. Ma: a Comprehensive Review[J]. Nutrients, 2025, 17(9):1501.
     [5] 陈晓真,韦怡含,蓝平,等. 茶多酚的提取纯化技术研究进展[J]. 中国酿造,2024,43(11):20-25.
     [6] 张松江,李龙洋,周春光,等. 茶多酚干预运动疲劳模型小鼠的中枢抗炎作用与机制[J]. 中国组织工程研究,2025,29(30):6474-6481.
     [7] He F, Ye B, Chen J, et al. Effect of EGCG on inflammatory reaction in rats suffered cerebral ischemia/reperfusion injury[J]. Zhong Nan Da Xue Xue Bao Yi Xue Ban, 2021,46(12):1325-1331.
     [8] 吴苏果,彭雪,阳伟红,等. 《神农本草经》与经方应用之大枣篇[J]. 山东中医药大学学报,2025,49(2):189-195.
     [9] 赵其达拉吐,孙美艳. 富含大枣多糖食品对运动员缓解运动性疲劳的效果研究[J]. 食品研究与开发,2016,37(18):182-185.
     [10] 廖香莲,吴涛,梅菊,等. 淫羊藿苷及其代谢产物生物活性研究进展[J]. 中成药,2025,47(2):504-512.
     [11] 陈梁,梁兆昌,刘洋,等. 基于网络药理学和分子对接技术的淫羊藿和杜仲雄花药对抗疲劳作用机制研究[J]. 井冈山大学学报(自然科学版),2024,45(5):65-72.
     [12] 邹悦,萧闵,孟宇豪,等. 基于p38 MAPK/NF-κB信号通路探讨淫羊藿多糖对运动性疲劳小鼠的影响及作用机制[J]. 中国实验方剂学杂志,2024,30(10):20-28.
     [13] 吴凡,安丽凤,黄敬文,等. 刺五加的化学成分及药理作用研究进展[J]. 中医药导报,2025,31(2):107-111.
     [14] 孙婕,刘涛,杨琨,等. 刺五加注射液对顺铂诱导的HEI-OC1细胞自噬、凋亡的影响[J]. 中国老年学杂志,2025,45(6):1485-1490.
     [15] 石超. 刺五加叶提取物对运动疲劳的缓解作用及其机制研究[D]. 吉林大学,2024。
     [16] 廖萍. 白木香叶提取物毒理学安全性评价的实验研究[D]. 中南大学, 2014.
     [17] 马宏伟,马文俊,刘有菊. 越橘叶黄素片的毒理学安全性评价研究 [J]. 青海科技, 2024, 31 (3): 58-67.
     [18] 肖承鸿,周涛,江维克,等. 参力汁保健饮料安全性研究 [J]. 时珍国医国药, 2016, 27 (9): 2060-2064.
文章导航

/