运动体去除Ganoderma lucidum子的发育和生殖毒性评估
Junxiu Liu1, Yisheng Song1,2, Chuanhuai Chen1
1Zhejiang Provincial Key Laboratory of Drug Discovery and Safety Evaluation for Inflammatory Chronic Diseases, Center of Safety Evaluation and Research, Hangzhou Medical College, Hangzhou, China.
Frontiers in cell and developmental biology
|January 26, 2026
概括
子皮去除的Ganoderma lucidum子 (RGLS) 对孕妇和哺乳妇女是安全的,在动物研究中没有显示出发育或生殖毒性. 这一发现支持RGLS作为对孕产妇和产周健康的安全饮食补充剂.
科学领域:
- 药理学 药理学是指药理学的学科.
- 毒理学 毒理学 毒理学
- 传统中国医药 传统中国医药
背景情况:
- 光子 (Ganoderma lucidum) 子具有药用价值,但由于其厚厚的壁,其生物利用性有限.
- 子皮去除的Ganoderma lucidum子 (RGLS) 增强了生物可用性.
- 在孕妇和哺乳期人群中,RGLS的安全性数据有限.
研究的目的:
- 评估RGLS.的发育和生殖毒性 (DART).
- 支持RGLS在孕产妇和产周人群的临床应用.
主要方法:
- 进行了符合ICH S5 (R3) 的DART研究:大鼠的胚胎胎发育 (EFD) 毒性,子的体外全胚胎培养 (WEC),大鼠的产前和产后毒性 (PPND).
- 在孕期和哺乳期给雌性大鼠服用RGLS (0.4,1.2,4.0g/kg/天).
- 暴露于RGLS提取物的子胚胎在体外.
主要成果:
- 在老鼠中没有观察到对母体的毒性,胚胎毒性或产性.
- 后代对生长,神经发育或生育能力没有任何不良影响.
- 子胚胎表现出正常的形态和器官发育;没有观察到不良影响的水平 (NOAEL) 为4.0g/kg/天.
结论:
- 在RGLS的研究中,RGLS显示出高的安全差距 (大约1. 20倍的临床剂量).
- 这项研究支持RGLS在孕妇和哺乳期妇女的安全使用.
- RGLS可以被认为是对孕产妇和产周健康的饮食的安全补充.
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