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机构地区:[1]天津市第一中心医院药剂科,天津300192 [2]天津医科大学药学院,天津300070
出 处:《药品评价》2010年第24期11-16,共6页Drug Evaluation
摘 要:目的:研究银杏叶提取物注射液含量测定的方法,评价市售银杏叶提取物注射液的质量。方法:采用高效液相色谱法测定银杏叶提取物注射液中总黄酮苷成分,使用外标法,色谱柱为HiQ sil C18(250mm×4.6mmID,5μm);流动相为甲醇-0.4%磷酸(55:45);检测器波长为360nm;流速为1.0ml·min^(-1);柱温40℃。结果:建立了高效液相色谱测定银杏叶提取物注射液总黄酮苷含量的方法,线性与范围、回收率、精密度和稳定性等方法学实验均可控制在合格范围内。并利用此方法对市售四个厂家的银杏叶提取物注射液进行了质量评价。结论:建立的银杏叶提取物注射液总黄酮苷含量测定方法简便、快速、准确,稳定。Objective: The determination method of ginkgo biloba extract injection was researched, which was used to evaluate the quality of commercially available ginkgo biloba injections. Methods: HPLC method was used to determine flavonoids glycoside components in ginkgo biloba extract injections. External standard method was used, column used was HiQ sil C18 (250mm × 4.6mm ID, 5μm), mobile phase was methanol -0.4% phosphoric acid (55:45), detector wavelength was set at 360 nm, flow rate was 1.0 ml.min^-1, and column temperature was 40℃. Results: Determination method of flavonoid glycosides in ginkgo biloba extract injection by HPLC was established, the linearity, the recovery, precision and stability are all in controlled scope. This method was used on quality evaluation of ginkgo biloba extract injection provided by the four manufacturers. Conclusions: The established method was simple, rapid, accurate and stable.
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