气相色谱法测定复方薄荷脑滴鼻液中薄荷脑和樟脑含量  

Determination of menthol and camphor contents in compound menthol nasal drops by gas chromatography

作　　者：邱财荣[1] 殷萌[2] 孔爱英[2] 杨翠平[3] 王晓英[3] 宣边霏 张天宏[3] 

机构地区：[1]解放军第三医院药剂科,陕西宝鸡721004 [2]总后卫生部药品仪器检验所 [3]军事医学科学院毒物药物研究所

出　　处：《西北国防医学杂志》2015年第9期582-585,共4页Medical Journal of National Defending Forces in Northwest China

基　　金：军队医疗机构制剂标准提高专项基金资助项目(13ZJZ19)

摘　　要：目的：建立毛细管气相色谱法（GC）,测定复方薄荷脑滴鼻液中薄荷脑、樟脑的含量。方法：采用色谱柱为DBWAXetr弹性石英毛细管柱（固定相：键合交联聚乙二醇,30m×0.25mm×0.25μm）,载气为N2,程序升温,检测器为氢焰离子化检测器（FID）,对6家医院6批产品进行了测定。结果：薄荷脑在18.94~132.58μg/ml,樟脑在14.60~102.20μg/ml范围内呈良好的线性关系,相关系数r〉0.999,样品的绝对回收率为97%~103%。各制剂样品的测定结果显示,薄荷脑和樟脑的含量均在标示量的90%~110%之间。结论：本方法简便、准确,重复性好,可快速测定制剂中薄荷脑和樟脑的含量,适用于提高该制剂的质控标准。Objective：To establish a gas chromatography（GC） method to determine menthol and camphor contents in the compound menthol nasal drops. Methods：The DB-WAXetr capillary column （30m×0.25mm×0.25μm） was used. The solid phase was cross-linked polyethylene glycol. The detector was flame ionization detector with nitrogen as carrier gas, and the temperature was increased by procedure. Six batches of products from six hospitals were determined by this GC method. Results： A good linear relationship was observed in the concentration range of 18.94- 132.58 μg/ml for menthol and 14.60- 102.20 μg/ml for camphor. The correlation coefficient （r） was greater than 0. 999 respectively and the absolute recovery was 97%-103%. The detection results showed that the contents of both menthol and camphor were between 90% and 110% of the labeled amount in each batch of preparations. Conclusion：The established method is simple, accurate, reproducible and can be used in the rapid determination of menthol and camphor contents, which might contribute to improve the quality control standards of this preparation.

关 键 词：气相色谱法 复方薄荷脑滴鼻液 薄荷脑 樟脑 

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