金脂泰胶囊质量标准研究  

Study on quality standard for Jinzhitai Capsule

作　　者：叶小强 

机构地区：[1]贺州地区药品检验所,广西梧州543001

出　　处：《中成药》2003年第4期284-288,共5页Chinese Traditional Patent Medicine

摘　　要：目的 :建立金脂泰胶囊 (黄精、制何首乌、泽泻、绞股蓝醇提物、山楂、决明子等 )的质量标准。方法 :采用薄层色谱法对方中的制何首乌、泽泻、决明子进行鉴别。用高效液相色谱法对方中所含的大黄素、大黄酚、大黄素甲醚进行含量测定。采用ODS C18柱 ,流动相为甲醇 0 .1%磷酸溶液 (94∶6 ) ,检测波长为 4 4 0nm。结果 :薄层鉴别色谱特征斑点明显。大黄素、大黄酚、大黄素甲醚分别在 0 .0 39～ 0 .35 μg ,0 .0 39～ 0 .35 μg ,0 .0 37～ 0 .33μg范围内呈良好的线性关系。平均加样回收率大黄素为 97.4 % (RSD =1.70 % ) ,大黄酚为 98.0 % (RSD =1.5 6 % ) ,大黄甲醚为 97.1% (RSD =1.83% )。结论Objective: To establish a quality standard for Jinzhitai Capsule(Rhizoma Polygonati, Radix Polygoni Multiflori Preparata, Rhizoma Alismatis, alcohol extract of Gynostemma Pentaphyllun, Fructus Crataegi, Semen Cassiae, etc.). Methods: Radix Polygoni Multiflori Preparata, Rhizoma Alismatis, Semen Cassiae were identified by TLC. The content of emodin and chrysophand and physcion in Jinzhitai Capsule were determined by HPLC, using a Kroma. sil C 18 column, methanol 0.1% phoaphoeic acid(94∶6) as the mobile phase. The detection wavelength was 440nm. Results: The TLC spots developed were quite clear. The linear ranges of emodin and chrysophanol and physcion were 0.039～0.35μg and 0.039～0.35μg and 0.037～0.33μg, respectively. The average recovery of emodin and chrysophanol and physcion was 97.4% and 98.0% and 97.1%, with RSD of 1.70% and 1.56% and 1.83%, respectively. Conclusion: The method can be used to the quality control of Jinzhitai Capsule.

关 键 词：金脂泰胶囊 TLC 大黄素 大黄酚 大黄素甲醚 HPLC 

分 类 号：R927.2[医药卫生—药学]