复方樟脑薄荷醑的质量控制研究

目的建立薄层色谱法定性鉴别复方樟脑薄荷醑中薄荷脑，并建立高效液相色谱法测定复方樟脑薄荷醑中樟脑的方法。方法Diamonsil C18色谱柱（250mm×4．6mm，5μm）；流动相为甲醇-0．2％磷酸水溶液（60：40）；体积流量为1．0mL／min；进样量为20此；检测波长为289nm：柱温为30℃。结果薄层色谱法鉴别出薄荷脑，樟脑在0．2-1．6mg／mL与峰面积呈良好线性关系（r=0．9993），平均回收率为99．6％，RSD值为0．96％。结论薄荷脑的薄层色谱定性鉴别，操作简便，且阴性无干扰；樟脑的测定方法准确、简便、重现性好，可用于复方樟脑薄荷醑的质量控制。

Quality control of Compound Camphor and Menthol Spirit

Objective To establish a TLC method for the qualitative identification of the menthol in Compound Camphor and Menthol Spirit, and an HPLC method for the determination of the camphor in Compound Camphor and Menthol Spirit. Methods Diamonsil C18 column （250mm×4.6mm,5μm） was used. The mobile phase consisted of methanol-0.2% phosphoric acid water （60 ： 40）, the flow rate was 1.0 mL/min with the injection volume of 20 μL. The detection wavelength was set at 289 nm. The temperature of column was set at 30 ℃. Results Menthol was identified by TLC. The linear ranges of camphor was 0.2 - 1.6 mg/mL （r=0.999 3）. The average recoveries were 99.6% with RSD 0.96%. Conclusion The method for the identification of menthol in Compound Camphor and Menthol Spirit by TLC is simple, and the negative sample has no interference. The method for the determination of camphor is accurate, simple, and reproducible, and could be used as the quality control for the drug.