复方樟脑乳膏相关物质测定方法研究  

Study on Determination of Related Substances in Compound Camphor Cream

作　　者：陈亚伟[1] 聂红梅 武惠斌 陈娜[1] 

机构地区：[1]河南中医学院,河南郑州450046 [2]河南羚锐制药股份有限公司北京药物研究院,北京100070

出　　处：《中医学报》2013年第6期868-871,共4页Acta Chinese Medicine

基　　金：国家科技支撑计划项目(编号:2008DAI-5313076)

摘　　要：目的:建立复方樟脑乳膏中相关物质测定的色谱方法。方法:挥发性杂质采用气相色谱法测定,PEG-20M毛细管柱(30m×0.25mm,0.25μm),柱温:120℃,进样口温度:250℃,检测器温度:250℃;非挥发性杂质采用高效液相色谱法测定,Kro-masil氰基柱(25cm×4.6mm,5μm),流动相A为乙腈,流动相B为0.02mol.L-1醋酸铵溶液(pH值为6.50±0.05),流速为1.0mL.min-1,线性梯度洗脱;检测波长为250nm。结果:各有效成分与杂质之间分离良好,非挥发性成分盐酸苯海拉明、甘草次酸、葡萄糖氯己定的分离度分别为7.1、10.2、22.1,挥发性成分樟脑、薄荷脑、水杨酸甲酯的分离度分别为7.9、10.1、5.7。结论:所建立的测定方法简便,快速,可作为复方樟脑乳膏中相关物质检测的有效手段。Objective：To establish an chromatographic determination for related substances in compound camphor cream.Methods：Volatile impurities was detected by gas chromatography with PEG-20M capillary column（30.00 m×0.25mm,0.25μm）,column temperature：120 ℃,inlet temperature：250 ℃,detector temperature：250 ℃.Non-volatile was detected by high performance liquid chromatography with Kromasil cyano column（25.0 cm×4.6 mm,5 μm）,acetonitrile mobile phase B 0.02 mol ·L-1 as mobile phase A,ammonium acetate solution（pH=6.5±0.05） as mobile phase B,and a flow rate of 1.0 mL·min-1,linear gradient elution;detection wavelength of 250 nm.Results：Better effect was shown between the respective active ingredients and impurities good separation.The separation of the non-volatile components of diphenhydramine hydrochloride,glycyrrhetinic acid,glucose chlorhexidine was 7.1,10.2,22.1,and the volatile components camphor,menthol,methyl salicylate was 7.9,10.1,5.7.Conclusion：The established method is simple,fast,and can be used as an effective means of the related substances test compound camphor cream.

关 键 词：复方樟脑乳膏 气相色谱法 高效液相色谱法 

分 类 号：R284.1[医药卫生—中药学]