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EGb 761:银杏叶提取物,金纳多。

EGb 761: ginkgo biloba extract, Ginkor.

出版信息

Drugs R D. 2003;4(3):188-93. doi: 10.2165/00126839-200304030-00009.

DOI:10.2165/00126839-200304030-00009
PMID:12757407
Abstract

EGb 761 [Ginkgo biloba extract EGb 761, Rökan, Tanakan, Tebonin] is a standardised extract of Ginkgo biloba leaves and has antioxidant properties as a free radical scavenger. A standardised extract of Ginkgo biloba leaves is a well defined product and contains approximately 24% flavone glycosides (primarily quercetin, kaempferol and isorhamnetin) and 6% terpene lactones (2.8-3.4% ginkgolides A, B and C, and 2.6-3.2% bilobalide). Ginkgolide B and bilobalide account for about 0.8% and 3% of the total extract, respectively. Other constituents include proanthocyanadins, glucose, rhamnose, organic acids, D-glucaric and ginkgolic acids. EGb 761 promotes vasodilation and improves blood flow through arteries, veins and capillaries. It inhibits platelet aggregation and prolongs bleeding time. EGb 761, which was originated by Dr Willmar Schwabe Pharmaceuticals (Dr Willmar Schwabe Group), has been available in Europe as a herbal extract since the early 1990s. However, products containing EGb 761 are not approved for use by the US FDA. As a dietary supplement, Nature's Way in the US distributes and markets a standardised extract of Ginkgo biloba leaves (the EGb 761 Formula) under the name Gingold Nature's Way. The French company Beaufour-Ipsen and its German subsidiary Ipsen Pharma are co-developing EGb 761 with Dr Willmar Schwabe Group. Beaufour-Ipsen (France) is developing EGb 761 as Tanakan, Dr Willmar Schwabe Pharmaceuticals (Germany) as Tebonin and Ipsen Pharma (Germany) as Rökan. Intersan was formerly developing EGb 761 in Germany, but Intersan appears to have been merged into Ipsen Pharma. However, there has been no recent development for these indications. In the UK and other European countries, the cardioprotective effects of EGb 761 in myocardial ischaemia and reperfusion are being investigated in preclinical studies. The psychological and physiological benefits of ginkgo are said to be based on its primary action of regulating neurotransmitters and exerting neuroprotective effects in the brain, protecting against or retarding nerve cell degeneration. Ginkgo also benefits vascular microcirculation by improving blood flow in small vessels and has antioxidant activity. There has been conflicting evidence about the benefits of ginkgo, e.g. the ginkgo clinical trial published in August 2002 in JAMA concluded that a leading ginkgo supplement did not produce measurable benefits for memory in healthy adults over 60, although a month earlier, another study concluded that the same ginkgo extract is effective in helping normal healthy older adults in memory and concentration. However, in December 2002, the Cochrane Collaboration, the world's most respected scientific reviewer of clinical trials in medicine, concluded that the published literature strongly supports the safety and potential benefits of ginkgo in treating memory loss and cognitive disorders associated with age- related dementia. A phase II study of EGb 761 in combination with fluorouracil is in progress in Germany in patients with pancreatic cancer. German researchers are investigating the potential of EGb 761 for the treatment of sudden deafness and tinnitus in clinical studies. EGb 761 was undergoing preclinical development for the potential treatment of diabetes in France, diabetic neuropathies in Russia, and cancer in Brazil. However, there has been no recent development for these indications. Beaufour-Ipsen has expressed the intention to license out its diabetes projects that may include EGb 761.

摘要

EGb 761(银杏叶提取物EGb 761、Rökan、Tanakan、Tebonin)是一种标准化的银杏叶提取物,具有作为自由基清除剂的抗氧化特性。标准化的银杏叶提取物是一种明确界定的产品,含有约24%的黄酮苷(主要是槲皮素、山奈酚和异鼠李素)和6%的萜类内酯(2.8 - 3.4%的银杏内酯A、B和C,以及2.6 - 3.2%的白果内酯)。银杏内酯B和白果内酯分别约占总提取物的0.8%和3%。其他成分包括原花青素、葡萄糖、鼠李糖、有机酸、D - 葡糖二酸和银杏酸。EGb 761可促进血管舒张并改善动脉、静脉和毛细血管中的血流。它抑制血小板聚集并延长出血时间。EGb 761由威尔玛·施瓦贝制药公司(威尔玛·施瓦贝集团)研发,自20世纪90年代初以来在欧洲作为草药提取物上市。然而,含有EGb 761的产品未获美国食品药品监督管理局批准使用。作为一种膳食补充剂,美国的自然之路公司以Gingold Nature's Way的名称分销和销售标准化的银杏叶提取物(EGb 761配方)。法国公司博福 - 益普生及其德国子公司益普生制药与威尔玛·施瓦贝集团共同开发EGb 761。博福 - 益普生(法国)将EGb 761开发为Tanakan,威尔玛·施瓦贝制药公司(德国)开发为Tebonin,益普生制药(德国)开发为Rökan。Intersan曾在德国开发EGb 761,但Intersan似乎已并入益普生制药。然而,这些适应症最近没有新的进展。在英国和其他欧洲国家,正在进行临床前研究以调查EGb 761在心肌缺血和再灌注中的心脏保护作用。据说银杏的心理和生理益处基于其调节神经递质的主要作用以及在大脑中发挥神经保护作用,预防或延缓神经细胞退化。银杏还通过改善小血管中的血流使血管微循环受益并具有抗氧化活性。关于银杏益处的证据存在矛盾,例如2002年8月发表在《美国医学会杂志》上的银杏临床试验得出结论,一种领先的银杏补充剂对60岁以上健康成年人的记忆力没有产生可测量的益处,尽管一个月前另一项研究得出结论,相同的银杏提取物对正常健康的老年人在记忆力和注意力方面有效。然而,2002年12月,世界上最受尊敬的医学临床试验科学评审机构考科蓝协作组织得出结论,已发表的文献有力地支持了银杏在治疗与年龄相关痴呆相关的记忆力丧失和认知障碍方面的安全性和潜在益处。德国正在对胰腺癌患者进行EGb 761与氟尿嘧啶联合使用的II期研究。德国研究人员正在临床研究中调查EGb 761治疗突发性耳聋和耳鸣的潜力。EGb 761在法国曾进行治疗糖尿病的临床前开发,在俄罗斯进行糖尿病神经病变的临床前开发,在巴西进行癌症的临床前开发。然而,这些适应症最近没有新的进展。博福 - 益普生已表示有意授权其可能包括EGb 761的糖尿病项目。

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