乙肝清缓释片质量标准  

Quality Standard of Yiganqing Sustained-released Tablet

作　　者：王兴[1] 张卫国[1] 李莹[1] 李晓倩[1] 王萍[1] 雷磊[1] 

机构地区：[1]西南交通大学生命科学与工程学院,成都610031

出　　处：《中国实验方剂学杂志》2011年第15期105-107,共3页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：中央高校基本科研业务会专项资金(SWJTU09ZT29)

摘　　要：目的:建立乙肝清缓释片的质量标准。方法:采用薄层色谱法(TLC)对制剂中的贯叶连翘进行鉴别;采用高效液相色谱法(HPLC)测定制剂中的金丝桃素含量,Phenomenence Luna C18色谱柱(4.6 mm×250 mm,5μm),流动相乙腈-0.025mol.L-1 KH2 PO4水溶液(85∶15),检测波长588 nm。并对制剂进行释放度考察。结果:TLC图谱分离度好,检出斑点清晰;金丝桃素在0.076～0.76μg呈良好的线性关系,r=0.999 9,平均回收率98.66%,RSD 2.51%。结论:该法操作简便、可行,重复性好,可作为乙肝清缓释片的质量控制标准。Objective：To establish the quality standard of Yiganqing Sustained-released-tablet.Method：Hypericum perfortum L,the main ingredient in Yiganqing Sustained-released-tablet was identified by TLC.The content of hypericin in the tablet was determined by using HPLC.The column was Phenomenex Luna C18 column（4.6 mm×250 mm,5 μm）.The mobile phase was acetonitrile-0.025 mol·L-1 KH2PO4 solution（85：15）,and the detection wavelength was at 588 nm.Result：The TLC spots were clear and the separation degree was good.Hypericin was linear in the range of 0.076～0.76（r=0.999 9）.The average recovery was 98.66% and RSD was 2.51%.Conclusion：The results indicate that the method is simple,feasible and repeatable and can be used for quality control of Yiganqing Sustained-released-tablet.

关 键 词：乙肝清缓释片 质量标准 薄层色谱法 金丝桃素 高效液相色谱法 

分 类 号：R284.1[医药卫生—中药学]