银杏类制剂安全性研究进展  

Research Advance in the Safety of Ginkgo Biloba Preparation

作　　者：郑伟然[1,2,3] 韩兆忠 王正宽[1,2,3] 施静 马晓瑛[1,2] 孙郊 黄文哲[1,2] 屠鹏飞 于学敏 萧伟[1,2] Zheng Weiran;Han Zhaozhong;Wang Zhengkuan;Shi Jing;Ma Xiaoying;Sun Jiao;Huang Wenzhe;Tu Pengfei;Yu Xuemin;Xiao Wei(Jiangsu Kanion Pharmaceutical Co.,Ltd. Lianyungang 222001,China;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process,Lianyungang 222001,China;Enterprises Academician Workstations of Jiangsu Province,Lianyungang 222001,China;Peking University,Beijing 100871,China)

机构地区：[1]江苏康缘药业股份有限公司,连云港222001 [2]中药制药过程新技术国家重点实验室,连云港222001 [3]江苏省企业院士工作站,连云港222001 [4]北京大学,北京100871

出　　处：《世界科学技术-中医药现代化》2019年第3期437-443,共7页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：江苏省科学技术厅双创计划(苏人才办[2015]26号):创新团队,负责人:屠鹏飞

摘　　要：银杏已有600多年的药用历史。历代中医药文献大多认为银杏有毒或有小毒。大量的临床试验均表明银杏类制剂具有较好的耐受性。多数不良反应如过敏反应、自发性出血、癫痫发作等多散见于个案报道。虽然动物毒理学试验发现银杏类制剂具有致癌性,细胞毒理学试验发现某些黄酮苷类如槲皮素、山柰酚具有基因毒性,但大量的临床和流行病学研究尚未发现银杏类制剂或其中的成分与癌症具有相关性。与抗血小板、抗凝药物、精神神经类药物、钙离子拮抗剂等联用时,要注意药物之间的相互作用引发的不良反应。企业应发挥不良反应监测的主体作用,积极构建药物上市后安全性证据体。本文对银杏类制剂的安全性研究进行综述,以期为临床应用和进一步开发此类制剂提供参考。Ginkgo Biloba has a medical history of more than 600 years. Most of the Chinese medicine literatures of the past dynasties indicated that ginkgo was poisonous or slightly poisonous. A large number of clinical trials have shown that Ginkgo Biloba preparations have good tolerance. Most of adverse reactions, such as allergic reactions, spontaneous hemorrhages, seizures, etc. were sporadic in case reports. Although toxicological experiment in animals have found the carcinogenicity of Ginkgo Biloba preparations and cell toxicology tests have found the genotoxicity of some flavonoid glycosides such as quercetin and kaempferol, a large number of clinical and epidemiological studies have not found the correlation between Ginkgo Biloba preparations or their components and cancer. When combined with antiplatelet agents, anticoagulants, psychotropic drugs and calcium ion antagonist, attentions should be paid to the adverse reactions caused by the interactions between drugs. Enterprises should play a major role in adverse reaction monitoring, and actively establish the body of safety evidence of post-marketing drug. This paper reviewed the safety literatures of Ginkgo Biloba preparations to provide references for clinical application and further development of Ginkgo Biloba preparations.

关 键 词：银杏 安全性 不良反应 药物相互作用 

分 类 号：R285.1[医药卫生—中药学]