贵州医科大学学报

2006, (02) 151-153+155

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银杏叶片剂的稳定性检测
A Study on the Stability of Ginkgo biloba Leaf Tablet

李莉;周欣;蒋学华;袁牧;
LI Li~(1,2),ZHOU Xin~2,JIANG Xue-hua~3,YUAN Mu~2(1.Department of Pharmocology,Guiyang Medical College,Guiyang 550004,China;2.The Key Lab.of Chemistry for Natural Products of Guizhou Province and Chinese Academy of Sciences,Guiyang 550002,China; 3.West China School of Pharmacy,Sichuan University,Chengdu 610041,China)

摘要(Abstract):

目的:检测银杏叶片剂(银杏天宝)的稳定性。方法:用反相高效液相色谱法(RP-HPLC)测定,ShimPACK CLC-ODS柱(150 mm×6.0 mm,5μm),流动相为0.4%磷酸溶液-甲醇(1∶1),检测样品经不同条件存放后总黄酮的含量,同时检测性状、崩解时限。结果:经强光照射(4 000 lx)10 d,高温存放(40℃,60℃)10 d,高湿存放[25℃RH(75±5)%、(90±5)%]10 d,加速试验[(40±2)℃,RH(75±5)%]6个月,长期实验[(25±2)℃,RH(60±10)%]12个月,样品除易吸潮软化外,其它观测指标均符合质量标准要求。结论:本品对强光、高温较稳定但易潮解。
Objective: To investigate the stability of Ginkgo biloba leaf tablet(Yinxingtianbao).Methods: The total flavonol in samples were determinated by RPHPLC(Shim-Pack CLC-ODS column,5 μm,150 mm×6.0 mm) the mobile phase was 0.4% phosphoric acid :methanol(1∶1),after the samples were pre-treated by stress testing,acceleration testing and long-term room temperature testing.In the same time,description and identification of them were done and the disintegrating time was observed.Results: Items of the sample were stable after ten days of strong light test(4 000 lx),ten days of high temperature test(40 ℃,60 ℃),ten days of high wet test[25 ℃ RH(75±5)%,RH(90±5)%],six months of accelerated test[(40±2)℃,RH(75±5)%],and one year of long-term room temperature test.Conclusions: The samples are stable against strong light and high temperature,and meet the requirement of the quality standard.Since it is easily to get moisture,it is important to keep it dry.

关键词(KeyWords): 植物制剂;二裂银杏;色谱法,高压液相;黄酮类;银杏叶片剂
plant preparation;Ginkgo biloba;chromatography,high pressure liquid;flavones;Ginkgo biloba leaf tablet

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基金项目(Foundation): 贵阳市科技基金资助项目[筑科农字2003(04)号]

作者(Author): 李莉;周欣;蒋学华;袁牧;
LI Li~(1,2),ZHOU Xin~2,JIANG Xue-hua~3,YUAN Mu~2(1.Department of Pharmocology,Guiyang Medical College,Guiyang 550004,China;2.The Key Lab.of Chemistry for Natural Products of Guizhou Province and Chinese Academy of Sciences,Guiyang 550002,China; 3.West China School of Pharmacy,Sichuan University,Chengdu 610041,China)

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