CHINESE JOURNAL OF DRUG EVALUATION >

2025 , Vol. 42 >Issue 5: 366 - 366-372

DOI: https://doi.org/magtech-2025-08-07-00002

General Toxicity and Genotoxicity Evaluation of Cistanche Deserticola Formula Tea

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  • 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

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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.

Key words： ; font-size:medium; ">Cistanche； Safety evaluation； Toxicology； General toxicity； Genetic toxicity

Cite this article

123 . General Toxicity and Genotoxicity Evaluation of Cistanche Deserticola Formula Tea[J]. CHINESE JOURNAL OF DRUG EVALUATION, 2025 , 42(5) : 366 -366-372 . DOI: magtech-2025-08-07-00002

References

[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.
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