冠脉宁片中樟脑的限量检查及冰片的含量测定研究  

Limit Test of Camphor and Content Determination of Borneol in Guanmaining Tablets

作　　者：丁宁 王栋 何轶[2] 张玉荣[3] 王瑞忠[2] 张聿梅[2] 鲁静[2] 戴忠[2] 

机构地区：[1]内蒙古自治区食品药品检验所,呼和浩特010070 [2]中国食品药品检定研究院,北京100050 [3]西安交通大学医学院药理学系,西安710061

出　　处：《中国药学杂志》2015年第4期310-313,共4页Chinese Pharmaceutical Journal

基　　金：国家十二五"重大新药创制"专项(2014ZX09304307-002)

摘　　要：目的建立冠脉宁片中冰片的质量控制方法。方法采用气相色谱法分别对龙脑、异龙脑进行含量测定,并对樟脑进行检查。FID检测器;色谱柱为HP-INNOWAX聚乙二醇毛细管柱（30 m×0.25 mm,0.25μm）;初始温度120℃,以每分钟20℃升至180℃,保持7 min。结果龙脑、异龙脑和樟脑分别在3.980μg·m L^-1-1.990 mg·m L^-1,4.012μg·m L^-1-2.051mg·m L^-1,4.170μg·m L^-1-0.208 5 mg·m L^-1内呈良好的线性关系。平均回收率分别为100.10%（n=6,RSD=1.6%）;98.21%（n=6,RSD=1.8%）;101.00%（n=6,RSD=1.2%）。结论所建立的方法简便,准确,快速,可用于冠脉宁片中冰片的质量控制。OBJECTIVE To establish a method for the quality control of borneol in Guanmaining tablets.METHODS Gas chromatography was used for the quantitative determination of borneol and isoborneol and the test of camphor.FID was used as detector and HP-INNOWAX column（ 30 m × 0.25 mm,0.25 μm） was used as the stationary phase.Column temperature was increased by programming from the original temperature of 120 ℃ to 180 ℃ at the rate of 20 ℃ ·min^-1and kept for 7 min.RESULTS Borneol,isoborneol and camphor showed good linear relationships in the ranges of 3.980 μg·m L^-1-1.990 mg·m L^-1,4.012 μg·m L^-1-2.051 mg·m L^-1,4.170 μg·m L^-1-0.208 5 mg · m L^-1,respectively.The average recoveries were 100.10%（ n = 6,RSD =1.6%） for borneol,98.21%（ n = 6,RSD = 1.8%） for isoborneol,and 101.00%（ n = 6,RSD = 1.3%） for camphor,respectively.CONCLUSION The method is simple,accurate,and rapid,and can be used for the quality control of borneol in Guanmaining tablets.

关 键 词：气相色谱法 冠脉宁片 龙脑 异龙脑 樟脑 

分 类 号：R917[医药卫生—药物分析学]