注射用黄金菊冻干粉针质量标准研究  

The Quality Standard for Huangjinju Injections

作　　者：韩茹[1] 张贵君[1] 张春晖[1] 崔萌萌[1] 

机构地区：[1]北京中医药大学中药学院,北京100102

出　　处：《世界科学技术-中医药现代化》2010年第2期237-240,共4页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：广东省教育部产学研项目(03032):注射用黄金菊的研发;负责人:张贵君

摘　　要：目的:建立注射用黄金菊(冻干)的质量标准。方法:采用薄层色谱法鉴别处方中4种药效组分;并用RP-HPLC法对制剂中的4种药效组分进行定量分析。色谱柱:Agela Venusil HPLCClumns(4.6mm×250mm,5μm);流动相:乙腈-0.6%磷酸水(12∶88～30∶70);检测波长:340nm。结果:薄层色谱斑点清晰,阴性无干扰。黄芩苷在1.652～9.912μg范围内线性关系良好,平均回收率为99.59%;绿原酸在0.1096～0.6576μg范围内线性关系良好,平均回收率99.39%;荭草苷在0.1944～1.164μg范围内线性关系良好,平均回收率为99.13%;牡荆苷在0.0472～0.2832μg范围内线性关系良好,平均回收率为99.19%。结论:本方法简便易行,可有效地控制黄金菊粉针质量。This study aimed to establish the quality standard of Huangjinju Injection. An RP-HPLC method was developed for the quantitative determination of four components baicalin,chlorogenic acid ,orientin and vitexin in Huangjinju Injection. The analysis was performed on an Agela Venusil HPLC Column （4.6 mm×250 mm, 5 μm） using isocratic elution with the mobile phase consisting of acetonitrile, water and 0.6%phosphoric acid （12：88-30：70） at 340 nm. The TLC sports developed were clear, and the blank test showed no interference. A good linear relationship was obtained with a correlation coefficient〉0.999, ranging from 1.652 to 9.912 pug for baicalin, from 0.1096 to 0.6576μg for chlorogenic acid, from 0.1944 to 1.164 lug for orientin, and from 0.0472 to 0.2832 μg for vitexin. The recoveries were respectively 99.59%, 99.39%, 99.13% and 99.19%, with RSD below 0.6%. This method is simple, reliable and accurate, and may be usable for the quality evaluation of Huangjinju Injection.

关 键 词：注射用黄金菊 质量标准 药效组分 TLC RP—HPLC 

分 类 号：R927.11[医药卫生—药学]