热熔压敏型壮骨麝香止痛膏质量标准研究  

Study on Quality Standard for Hot Melt Pressure Sensitive Type Zhuanggushexiangzhitong Plaster

作　　者：余新梅[1] 熊维政 聂红梅 

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》2015年第4期574-577,共4页Acta Chinese Medicine

摘　　要：目的:建立测定热熔压敏型壮骨麝香止痛膏中樟脑、薄荷脑、冰片、水杨酸甲酯含量的气相色谱方法及硫酸阿托品、马钱子碱、士的宁的薄层色谱鉴别方法,为其质量标准的制定提供依据。方法:采用薄层色谱法对硫酸阿托品、马钱子碱、士的宁进行定性鉴别。采用毛细管气相色谱法,色谱柱为PEG-20M(30 m×0.25 mm×0.25μm);柱温:120℃;进样口温度:230℃;检测器温度:250℃,萘为内标物。结果:在该气相色谱条件下,樟脑、薄荷脑、冰片、水杨酸甲酯的分离度和线性关系良好,回收率分别为99.56%、99.39%、99.68%、99.55%。硫酸阿托品、马钱子碱、士的宁的薄层图谱斑点清晰可见,分离度好,阴性对照无干扰。结论:本法方便、快捷、准确,可用于控制热熔压敏型壮骨麝香止痛膏的质量。Objective ： To establish a method for the determination of camphor, menthol, borneol and methylsalicylate in hot melt pressure sensitive type Zhuanggushexiangzhitong piaster by gas chromatography（GC） and to establish thin-layer ehromatography（TLC） identifi- cation method of atropine sulfate, brucine and strychnine to provide the basis for the formulation of quality standards. Methods ： Capillary GC was adopted. The chromatographic column was PEG-20M （30 m × 0.25 mm × 0, 25 μm） , column emperature ： 120 ℃ , inlet tempera- ture ：230 ℃, detector temperature ：250℃, with naphthalene as internal standard. Results：The resolution and linearity of camphor, men- thol, borneol and methylsalieylate were good under the chromatographic conditions. The average recoveries of camphor, menthol, borneol and methylsalicylate were 99.56% ,99.39% ,99.68% and 99.55%. There proves visible atlas spot, good separating degree, no inter- ference for negative control of atropine sulfate, brucine and strychnine. Conclusion ： This method is simple, rapid, accurate and with good reproducibility.

关 键 词：热溶压敏型 壮骨麝香止痛膏 气相色谱法 樟脑 薄荷脑 冰片 水杨酸甲酯 硫酸阿托品 士的宁 马钱子碱 薄层色谱法 

分 类 号：R284.2[医药卫生—中药学]