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目的:对部分厂家的银杏叶制剂进行游离槲皮素、山奈素、异鼠李素的限量检查,为严格质量控制以及临床选择品种提供科学依据。方法:按国家银杏叶药品补充检验方法的标准采用HPLC法对8个厂家不同剂型银杏叶制剂的游离槲皮素、山奈素、异鼠李素进行限量检查。结果:8个厂家不同剂型银杏叶制剂游离槲皮素、山奈素、异鼠李素的限量检查结果表明,按国家银杏叶药品补充标准评价,C、D两厂的产品不合格;其余厂家限量检查虽然合格,但含量差异较大,且主峰之间的比例差异也较大。结论:不同厂家银杏叶中有效物质含量差异较大,这也是临床反映的不同厂家不同剂型的银杏叶制剂疗效不稳定的因素之一。
OBJECTIVE: To limit the quantity of free quercetin, kaempferol and isorhamnetin in some manufacturers of Ginkgo biloba preparations to provide a scientific basis for strict quality control and clinical selection of varieties. Methods: According to the standard of national Ginkgo biloba drug supplement test method, the free quercetin, kaempferol and isorhamnetin of 8 different manufacturers of Ginkgo biloba preparations were tested by HPLC. Results: The limited test results of free quercetin, kaempferol and isorhamnetin of 8 different manufacturers of Ginkgo biloba preparations showed that the products of C and D plants failed according to the national supplement standard of Ginkgo biloba. The rest manufacturers’ Check though qualified, but the content of large differences, and the ratio between the main peak is also greater. Conclusion: The content of effective substances in Ginkgo biloba leaves from different manufacturers is quite different, which is also one of the factors of unstable efficacy of Ginkgo biloba preparations of different dosage forms from different manufacturers.