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目的:建立一种同时测定含有乌头属药材的成药中乌头类生物碱宋果灵、新乌头碱、乌头碱、次乌头碱含量的HPLC方法。方法:采用Kromasil C18色谱柱(4.6mm×250mm,5μm),以甲醇-水-氯仿-三乙胺(70:30:1:0.15)为流动相,流速1.0mL.min-1,柱温为室温(25℃),检测波长234nm。结果:宋果灵、新乌头碱、乌头碱和次乌头碱的线性范围分别为0.1～1.5μg(r=0.9996),0.1～2.0μg(r=0.9995),0.1～3.0μg(r=0.9996),0.1～2.5μg(r=0.9997)。本法应用于中成药万通筋骨片、附子理中丸,藏药安神丸和蒙药嘎日迪五味丸中4种乌头类生物碱的同时测定,宋果灵、新乌头碱、乌头碱和次乌头碱的平均回收率分别为95.7%～105.2%,96.0%～102.1%,93.7%～99.2%,96.8%～99.2%;RSD分别为1.4%～2.3%,1.0%～1.8%,0.85%～2.2%,0.82%～1.4%。结论:本法简便、快速、准确,灵敏度高,可为含有乌头属药材的成药药品质量控制提供参考标准。
Objective: To establish a HPLC method for the simultaneous determination of aconitine alkaloids Song Guoling, mesaconitine, aconitine and hypaconitine in Chinese patent medicines containing Aconitum officinalis. METHODS: Kromasil C18 column (4.6 mm × 250 mm, 5 μm) was used with mobile phase of methanol-water-chloroform-triethylamine (70:30:1:15) as mobile phase at a flow rate of 1.0 mL · min- Room temperature (25 ℃), detection wavelength 234nm. RESULTS: The linear ranges of Song Guoling, mesaconitine, aconitine and hypaconitine were 0.1 ~ 1.5μg (r = 0.9996), 0.1 ~ 2.0μg (r = 0.9995), 0.1 ~ 3.0μg ), 0.1 ~ 2.5μg (r = 0.9997). This method is applied to the simultaneous determination of four kinds of aconite alkaloids in Chinese traditional medicine Wantong bones tablet, aconite Lizhong pills, Tibetan medicine Anshen pill and Mongolian medicine Gardi wuweiwei pill, and the combination of Sulfasone, mesaconitine, aconitine and sophora The average recoveries of caustic soda were 95.7% -102.2%, 96.0% -102.1%, 93.7% -99.2% and 96.8% -99.2%, respectively. The RSDs were 1.4% -2.3%, 1.0% -1.8%, 0.85% 2.2%, 0.82% ~ 1.4%. Conclusion: The method is simple, rapid, accurate and sensitive. It can provide a reference standard for quality control of medicines containing aconite.