【摘要】 目的:通过比较不同厂家及批号小金丸中单酯型生物碱类成分的含量,为该制剂的临床用药安全提供参考。方法:建立小金丸中制草乌单酯型生物碱类成分(苯甲酰新乌头原碱、苯甲酰乌头原碱和苯甲酰次乌头原碱)的HPLC含量测定方法,流动相乙腈-20 mmol·L-1磷酸二氢钠(用三乙胺调节pH 6.5)(47∶53),检测波长235 nm。比较4个厂家生产的8批样品中3种生物碱类成分含量。结果:3种生物碱类成分线性范围均为4~60 mg·L-1,加样回收率分别为98.42%,101.79%,102.13%。3种单酯型生物碱总质量分数最高达214.718μg·g-1,最低值18.452μg·g-1。结论:不同厂家和同一厂家不同批次样品中3种生物碱的含量存在较大差异,可能与原材料质量、制剂工艺及生产设备等因素有关。更多还原

【Abstract】 Objective: To compare monoester-alkaloids content of different batches of Xiaojin Wan from different manufacturers and provide a reference for clinical drug safety of this preparation. Method: Determination of monoester-alkaloids from Aconiti Kusnezoffii Radix Cocta in Xiaojin Wan was established, including benzoylmesaconine,benzoylaconine and benzoylhypacoitine; mobile phase was consisted of acetonitrile-20 mmol·L- 1sodium dihydrogen phosphate( adjusted pH to 6. 5 with triethylamine)( 47∶ 53),detection wavelength was set at235 nm. The content of these three components in 8 batches of Xiaojin Wan from four manufacturers was compared. Result: Linear ranges of these three components were 4-60 mg ·L- 1,recoveries were 98.42%,101. 79% and 102. 13%,respectively. Total content of these three components was up to 214. 718 μg·g- 1with the lowest value of 18. 452 μg·g- 1. Conclusion: There is a big difference among 3 kinds of monoester-alkaloids from different manufacturers and different batches of the same manufacturer,which may be related to quality of raw materials,preparation process,production equipment and other factors.更多还原