气相色谱法测定消栓通络片中龙脑和异龙脑的含量及质量评价  

Determination and Quality Evaluation of Borneol and Isoborneol in Xiaoshuan Tongluo Tablets by GC

作　　者：刘艳梅 许妍 张静 洪挺 LIU Yanmei;XU Yan;ZHANG Jing;HONG Ting(Jiangxi Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Nanchang Jiangxi 330029,China)

机构地区：[1]江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,江西南昌330029

出　　处：《药品评价》2022年第21期1298-1301,共4页Drug Evaluation

摘　　要：目的:建立消栓通络片中龙脑和异龙脑的含量测定方法,并对11家企业26批次消栓通络片的质量进行评价。方法:样品经乙酸乙酯超声提取后,采用气相色谱法(GC)进行测定,通过DB-WAX色谱柱进行分离。结果:龙脑在7.5816~377.0776μg/mL范围内呈良好的线性关系,平均回收率为98.33%,异龙脑在8.2499~412.4928μg/mL范围内呈良好的线性关系,平均回收率为98.73%。不同批次的消栓通络片中龙脑、异龙脑含量差异较大,26批次样品中龙脑和异龙脑总量在0.42~4.49 mg/片之间。低于拟定限度(2.41 mg/片)的有10批次,合格率为61.5%。结论:该方法准确、可靠,能够有效评价消栓通络片中合成冰片的质量。Objective:To establish the content determination method of borneol and isoborneol in xiaoshuan tongluo tablets,and to evaluate the quality of 26 batches of xiaoshuan tongluo tablets from 11 manufacturers.Methods:The samples were determined by gas chromatography(GC)and separated by DB-WAX column after ultrasonic extraction with ethyl acetate.Results:The linear range of borneol was 7.5816~377.0776μg/mL and the average recovery was 98.33%.The linear range of isoborneol was 8.2499~412.4928μg/mL and the average recovery was 98.73%.Different batches of xiaoshuan tongluo tablets had great differences in the content of borneol and isoborneol,and the total amount of borneol and isoborneol in 26 batches of samples was between 0.42 and 4.49 mg per tablet.And 10 batches was lower than the proposed limit(2.41 mg per tablet),the qualified rate was 61.5%.Conclusion:This method is accurate and reliable,and can effectively evaluate the quality of synthetic borneol in xiaoshuan tongluo tablets.

关 键 词：消栓通络片 气相色谱法 龙脑 异龙脑 含量测定 质量评价 

分 类 号：R286.0[医药卫生—中药学] O657.71[医药卫生—中医学]