水凝胶型与橡胶型伤湿止痛膏中挥发性成分的含量测定  

Determination of Volatile Components in Hydrogel-type and Rubber-type Shangshi Zhitong Plasters

作　　者：尚庆霞 李磊 郭立 Shang Qingxia;Li Lei;Guo Li(Food and Drug Inspection Office of Xinyang City,Henan Xinyang 464000,China;Henan Lingrui Pharmaceutical Company Limited)

机构地区：[1]信阳市食品药品检验所,河南信阳464000 [2]河南羚锐制药股份有限公司

出　　处：《中国药师》2020年第2期352-354,共3页China Pharmacist

摘　　要：目的:分析不同类型伤湿止痛膏中挥发性成分的含量,为产品质量评价提供参考依据。方法:色谱柱:聚乙二醇20000(PEG-20M)毛细管柱(30 m×0.32 mm,0.25μm);载气:氮气,流量:2 ml·min^-1;燃气:氢气,流量:35 ml·min^-1;助燃气:空气,流量:400 ml·min^-1;检测器FID,温度:230℃;柱温:140℃;进样口温度:180℃;分流比20∶1;进样量1μl。在上述色谱条件下测定不同类型伤湿止痛膏中樟脑、薄荷脑、冰片、水杨酸甲酯的含量,并比较橡胶型和水凝胶型伤湿止痛膏中挥发性成分的保留率。结果:樟脑、薄荷脑、冰片、水杨酸甲酯分别在0.4002~2.4014 mg·ml^-1(r=0.9999)、0.2407~1.4440mg·ml^-1(r=0.9999)、0.2400~1.4420 mg·ml^-1(r=0.9999)、0.2400~1.4420 mg·ml^-1(r=0.9999)范围内与其内标物质的峰面积比值呈良好的线性关系,平均加样回收率分别为99.74%,99.23%,100.23%,100.17%,RSD分别为1.19%,0.32%,0.27%,0.24%(n=6)。两种类型伤湿止痛膏中樟脑、薄荷脑、冰片、水杨酸甲酯含量差异较大,水凝胶型样品中挥发性成分保留率高于橡胶型(P<0.05)。结论:本方法灵敏、准确,重现性好,可用于不同类型伤湿止痛膏中樟脑、薄荷脑、冰片、水杨酸甲酯含量的测定。结果显示水凝胶型的制备工艺能保留更多的挥发性药物,优于橡胶型。Objective:To analyze the content of volatile components in different types of Shangshi Zhitong plasters to provide reference for the quality evaluation.Methods:A PEG-20 M capillary column(30 m×0.32 mm,0.25μm)was used.The carrier gas was nitrogen with the flow rate of 2 ml·min^-1;the gas was hydrogen with the flow rate of 35 ml·min^-1 and the oxidant gas was air with the flow rate of 400 ml·min^-1.The detector was FID and the inlet temperature was 230℃;the column temperature was 140℃;the inlet temperature was 180℃;the split ratio was 20∶1.The injection volume was 1μl.Results:The linear range of camphor,menthol,borneol and methyl salicylate was 0.4002-2.4014 mg·ml^-1(r=0.9999),0.2407-1.4440 mg·ml^-1(r=0.9999),0.2400-1.4420 mg·ml^-1(r=0.9999)and 0.2400-1.4420 mg·ml^-1(r=0.9999),respectively.The average recovery was 99.74%,99.23%,100.23%and 100.17%with the RSD of 1.19%,0.32%,0.27%and 0.24%,respectively(n=6).The contents of camphor,menthol,borneol and methyl salicylate in the two types of Shangshi Zhitong plasters were significantly different.In the hydrogel-type sample,the contents of the above components were higher with statistical significance(P<0.05).Conclusion:The method is sensitive and accurate with good stability,which can be used to determine the contents of camphor,menthol,borneol and methyl salicylate in hydrogel-type and rubber-type Shangshi Zhitong plasters.Through the test comparison,there are significant differences in the contents of volatile components between the above two types of Shangshi Zhitong plasters.

关 键 词：伤湿止痛膏 水凝胶 气相色谱法 挥发性成分 

分 类 号：R927.2[医药卫生—药学]