贮存温度对复方薄荷脑滴鼻液中樟脑和薄荷脑含量的影响  

Effect of Storage Temperature on the Contents of Camphor and Menthol in Compound Menthol Nasal Drops

作　　者：肖宏华 胡妍文 张淑君[2] 王海洋[2] 赫军[2] 马秉智[2] Xiao Honghua;Hu Yanwen;Zhang Shujun;Wang Haiyang;He Jun;Ma Bingzhi(Beijing Chaoyang District Food and Drug Safety Monitoring Center,Beijing 100124,China;Department of Pharmacy,China-Japan Friendship Hospital)

机构地区：[1]北京市朝阳区食品药品安全监控中心,北京100124 [2]中日友好医院药学部

出　　处：《中国药师》2021年第8期582-585,共4页China Pharmacist

摘　　要：目的:考察贮存温度对复方薄荷脑滴鼻液中樟脑和薄荷脑含量的影响情况。方法:采用顶空-气相色谱(HS-GC)法,色谱条件:色谱柱:Agilent DB-WAX毛细管柱,柱温:120℃,进样口温度:200℃;检测器:氢火焰离子化检测器(FID),检测器温度:230℃;载气:氮气,流速:5.0 ml·min^(-1),分流比15∶1;顶空平衡温度:100℃,顶空进样时间:1 min。分别贮存于(25±2)℃和(6±2)℃,连续6个月测定制剂中樟脑和薄荷脑的含量变化。结果:樟脑和薄荷脑质量浓度分别在0.89168.916 mg·ml^(-1)和0.92219.221 mg·ml^(-1)范围内呈良好的线性关系,平均加样回收率分别为99.56%,97.45%,RSD分别为0.94%,0.52%(n=6)。贮存6个月间,制剂中樟脑和薄荷脑含量均呈现下降趋势,且在(25±2)℃条件下,樟脑和薄荷脑含量降低的趋势比(6±2)℃条件下更快。在相同条件下,包装瓶之间密封性存在一定差异,且对樟脑的含量影响较大。结论:建立的顶空-气相色谱(HS-GC)法操作简便、结果准确、重复性好,可用于测定复方薄荷脑滴鼻液中樟脑和薄荷脑的含量。贮存温度对该制剂中两个成分含量影响较大,贮存在(6±2)℃(即冷藏)有利于其含量的稳定。Objective:To investigate the influence of storage temperature on the contents of camphor and menthol in compound menthol nasal drops.Methods:The contents of camphor and menthol were determined by headspace-gas chromatography(HS-GC).An Agilent DB-WAX capillary column was used,the column temperature was 120℃,the inlet temperature was 200℃,an FID detector was used at the temperature of 230℃,the carrier gas was nitrogen gas,the flow rate was 5.0 ml·min^(-1),the split ratio was 15∶1,the headspace equilibrium temperature was 100℃and the injection time was 1 min.The preparations were divided into two parts.One part was stored at(25±2)℃,the other part was stored at(6±2)℃.They were determined once a month for 6 months.Results:The concentrations of camphor and menthol showed good linear relationships within the range of 0.8916-8.916 mg·ml^(-1)and 0.9221-9.221 mg·ml^(-1),respectively.The average recovery was 99.56%(RSD=0.94%)and 97.45%(RSD=0.52%)(n=6),respectively.In 6 months,the contents of camphor and menthol in the preparation decreased with the extension of storage time.At(25±2)℃,the contents of camphor and menthol decreased more rapidly than those at(6±2)℃.Under the same conditions,the sealing of packaging bottles had a great influence on the content of camphor.Conclusion:The HS-GC method is simple,accurate and reproducible,and can be used to determine the contents of camphor and menthol in compound menthol nasal drops.Storage temperature has great influence on the contents of the two components in the preparation.The temperature at(6±2)℃(refrigeration)is conducive to the stability of ingredients’contents.

关 键 词：复方薄荷脑滴鼻液 贮存温度 顶空-气相色谱法 樟脑 薄荷脑 含量 

分 类 号：R927.2[医药卫生—药学]