毒理性
◉ 母乳喂养期间使用的总结:美国人参(Panax quinquefolius)、亚洲人参(Panax ginseng)以及其他几种植物的根部含有被称为人参皂苷的类固醇皂苷,据称具有适应原作用(即增加耐力和改善记忆力)。人参在母乳喂养期间没有特定用途。人参在成人中通常耐受性良好,并被美国食品药品监督管理局(FDA)认定为“一般认为安全”(GRAS)。最常见的副作用包括头痛、高血压、腹泻、失眠、皮疹和阴道出血。人参降低某些药物的血药水平,如华法林,并增强镇静药物的效果。长期使用可能导致神经紧张、腹泻、混乱、抑郁或人格解体。已经报告了男性乳房发育和乳房疼痛的情况。目前没有关于人参在哺乳母亲或婴儿中的安全性和有效性的数据。由于可能的雌激素活性和哺乳期间信息不足,许多来源建议在哺乳期间不要使用人参。
膳食补充剂不需要美国食品药品监督管理局的广泛市场前批准。制造商负责确保安全,但在市场销售前不需要证明膳食补充剂的安全性和有效性。膳食补充剂可能含有多种成分,标签和实际成分或其含量之间经常存在差异。制造商可以与独立组织签订合同,以验证产品的质量或其成分,但这并不证明产品的安全或有效性。由于上述问题,一个产品的临床测试结果可能不适用于其他产品。关于膳食补充剂的更详细信息可以在LactMed网站的其它地方找到。
◉ 对哺乳婴儿的影响:截至修订日期,没有找到相关的已发布信息。
◉ 对泌乳和母乳的影响:截至修订日期,没有找到相关的已发布信息。
◉ Summary of Use during Lactation:The roots of American ginseng (Panax quinquefolius), Asian ginseng (Panax ginseng), and several other species contain steroidal saponins called ginsenosides that are purported to be adaptogens (i.e., to increase endurance and improve memory). Ginseng has no specific uses during breastfeeding. Ginseng is generally well tolerated in adults and is "generally recognized as safe" (GRAS) by the U.S. Food and Drug Administration. The most common side effects include headache, hypertension, diarrhea, sleeplessness, skin rash, and vaginal bleeding. Ginseng decreases the blood levels of some drugs, such as warfarin, and enhances the effect of sedating drugs. With long-term use, nervousness, diarrhea, confusion, depression or depersonalization may occur. Gynecomastia and breast pain have been reported. No data exist on the safety and efficacy of ginseng in nursing mothers or infants. Because of its possible estrogenic activity and lack of information during breastfeeding, many sources recommend that ginseng not be used during lactation.
Dietary supplements do not require extensive pre-marketing approval from the U.S. Food and Drug Administration. Manufacturers are responsible to ensure the safety, but do not need to prove the safety and effectiveness of dietary supplements before they are marketed. Dietary supplements may contain multiple ingredients, and differences are often found between labeled and actual ingredients or their amounts. A manufacturer may contract with an independent organization to verify the quality of a product or its ingredients, but that does not certify the safety or effectiveness of a product. Because of the above issues, clinical testing results on one product may not be applicable to other products. More detailed information about dietary supplements is available elsewhere on the LactMed Web site.
◉ Effects in Breastfed Infants:Relevant published information was not found as of the revision date.
◉ Effects on Lactation and Breastmilk:Relevant published information was not found as of the revision date.
来源:Drugs and Lactation Database (LactMed)