Chinese Expert Consensus on Clinical Application of Oral Ginkgo biloba Preparations (2020)
Chinese Expert Consensus on Clinical Application of Oral Ginkgo biloba Preparations (2020)
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DOI：
10.1007/s11655-021-3289-6
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发表时间：
2021-01-09
影响因子：
2.9
通讯作者：
Chen, Ke-ji
中科院分区：
文献类型：
--
作者：
Chen, Ke-ji
质量标准 目前国际银杏叶制剂质量标准基本遵循“24+6”原则，即总黄酮醇苷含量不少于24%，萜内酯含量不少于6%。该标准仍然有效，并被认为是植物药质量控制的典范。中国药典（ChP）、（9）美国药典（USP）、（10）和欧洲药典（EP）已规定了银杏叶提取物（GBE）的标准；（11）制剂标准已纳入中国药典（9）和美国药典（10）（表1）。总黄酮苷主要通过水解黄酮苷元（槲皮素、山奈酚和异鼠李素）的含量间接计算；然而，近年来又增加了更多标准，即黄酮醇苷的高效液相色谱指纹图谱。萜内酯有助于测定银杏内酯 A、B、C 和白果内酯的总量。 GBE中银杏酸总量被规定为限量成分，不得高于5 ppm。 GBE50要求总黄酮含量不低于44%。(12)
Quality Standards The current international quality standards for G. biloba preparations essentially follow the" 24+ 6" principle, ie, no less than 24% of total flavonol glycosides and 6% terpene lactones. This standard is still in place and has been considered as a model for the quality control of phytomedicines. The standards for the extract of G. biloba leaves (GBE) have been specified in the Chinese Pharmacopoeia (ChP),(9) United States Pharmacopoeia (USP),(10) and European Pharmacopoeia (EP);(11) the standards for preparations are included in the ChP (9) and USP (10)(Table 1). Total flavonol glycosides are primarily calculated indirectly from the content of hydrolyzed flavonol aglycones (quercetin, kaempferol, and isorhamnetin); however, further standards have been added in recent years, ie., the high performance liquid chromatography fingerprint of flavonol glycosides. Terpene lactones help in determining the total amounts of ginkgolide A, B, C and bilobalide. The total ginkgolic acid is stipulated as a limited ingredient and should be no higher than 5 ppm in GBE. GBE50 is required to have a total flavonoid content of no less than 44%.(12)