复方雪莲胶囊的质量标准研究  

Quality standard for Compound Xuelian Capsule

作　　者：黎玉红[1] 朱国强[1] 吴育新 李革 

机构地区：[1]新疆维吾尔自治区人民医院,新疆乌鲁木齐830001 [2]新疆维吾尔自治区药品检验所,新疆乌鲁木齐830001

出　　处：《中成药》2005年第5期526-529,共4页Chinese Traditional Patent Medicine

摘　　要：目的:建立复方雪莲胶囊(雪莲,延胡索,制川乌等)的质量标准,以便更有效地控制产品质量。方法:鉴别项、检查项采用薄层色谱法(TLC)。含量项采用高效液相色谱法(HPLC)测定制剂中的延胡索乙素。高效液相色谱条件:Kroma silODS 1C18柱,流动相:甲醇磷酸盐缓冲液( 65∶35 )。结果:TLC具有专属性。HPLC准确可靠,回收率为100. 7 ,RSD为1. 6 。结论:该标准可用于复方雪莲胶囊的质量控制。AIM: To establish the quality standard for Compound Xuelian Capsule (Saussurea sacra, Rhizoma Corydalis, Radix Aconiti Preparata, etc.) METHODS: The identification and inspect were carried out by TLC. D1 tetrahydropalmatine in preparation was determined by HPLC. The HPLC conditions: Kromasil ODS 1 C 18 column, mobile phase of MeoH phosphate buffer solution (65∶35). RESULTS: TLC method was specific, HPLC method was accurate and reliable, the recovery was 100.7%, RSD was 1.6%. CONCLUSION: This standard can be used for the quality control of Compound Xuelian Capsules.

关 键 词：复方雪莲胶囊 雪莲 延胡索 乌头碱 延胡索乙素 薄层色谱 高效液相色谱 

分 类 号：R927.2[医药卫生—药学]