银杏叶片剂的稳定性检测  

A Study on the Stability of Ginkgo biloba Leaf Tablet

作　　者：李莉[1] 周欣[2] 蒋学华[3] 袁牧[2] 

机构地区：[1]贵阳医学院药学院,贵州贵阳550004 [2]贵州省中国科学院天然产物化学重点实验室,贵州贵阳550002 [3]四川大学华西药学院,四川成都610041

出　　处：《贵阳医学院学报》2006年第2期151-153,155,共4页Journal of Guiyang Medical College

基　　金：贵阳市科技基金资助项目[筑科农字2003(04)号]

摘　　要：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 RP-HPLC （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-treatcd 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：植物制剂 二裂银杏 色谱法 高压液相 黄酮类 银杏叶片剂 

分 类 号：R284[医药卫生—中药学]