新复方珍珠散及其膏剂的质量控制研究

Quality control study of borneol and artificial musk in Xinfufang-Zhenzhusan and Xinfufang-Zhenzhugao Du

目的 研究新复方珍珠散和膏中冰片、人工麝香的质量控制方法。方法 采用薄层色谱法，以石油醚-甲苯-乙酸乙酯（9∶3∶2）为展开剂，鉴别异龙脑和龙脑；以石油醚-二氯甲烷（2∶3）为展开剂，鉴别麝香酮。采用Agilent 7890 B气相色谱仪，FDI检测器，色谱柱为Thermo-TG-WaxMS GC（0.25 mm×30 m，0.25 mm）；载气为高纯氮气，流速1 mg/ml；进样口温度200 ℃；检测器温度250 ℃；分流比为10∶1；进样量1 μl；程序升温。结果 异龙脑、龙脑、麝香酮在0.001～10 mg/ml范围内线性关系良好，方法的回收率在95%～105%范围内。薄层中异龙脑、龙脑、麝香酮得以较好鉴别。结论 该方法简便合理，可用于新复方珍珠散和膏中冰片、人工麝香的质量控制。

Objective To establish a quality control method for borneol and artificial musk in Xinfufang-Zhenzhusan and Xinfufang-Zhenzhugao. Methods We used petroleum ether - toluene - ethyl acetate （9：3：2）as developer for TLC to identify isoborneol and borneol and petroleum ether-dichloromethane （2：3） as developer for TLC to identificate musk ketone. Agilent 7890 B gas chromatograph, FDI detector; Column： Thermo-TG-WaxMS GC （0.25 mm × 30 m, 0.25 mm） was employed; the carrier gas was high purity nitrogen and flow rate for 1 mg/ml, the injection port temperature is 200 ℃ and detector temperature is 250 ℃; the split ratio is 10：1 and injection volume was 1 μl, using temperature programmed. Results The isoborneol, borneol and musk ketone in the range of 0.001-10 mg/ml showed good linearity. The recovery of the method is in the range of 95 % to 105 %. The TLC for isoborneol, borneol, musk ketone can be identified easily. Conclusions The method was simple and reasonable, which can be used for the quality control of borneol and artificial musk in the Xinfufang-Zhenzhusan and Xinfufang-Zhenzhugao.