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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。
OBJECTIVE: To provide references for the clinical drug safety of this preparation by comparing the content of monoester alkaloids in different manufacturers and batch number Xiaojin pills. Methods: The HPLC method was established for the determination of the content of the monklodipine alkaloids in Radix Aconiti Kusnezoffii (benzoyl mesaconitine, benzoyl aconitine and benzoyl aconitine). The mobile phase Acetonitrile -20 mmol·L-1 monobasic sodium phosphate (adjusted to pH 6.5 with triethylamine) (47:53) at a detection wavelength of 235 nm. The contents of three alkaloids in eight batches of samples from four factories were compared. Results: The linear range of the three alkaloids was 4 ~ 60 mg · L-1, and the recoveries were 98.42%, 101.79% and 102.13% respectively. The total content of three monoester alkaloids was up to 214.718μg · g-1, the lowest value was 18.452μg · g-1. Conclusion: The contents of three alkaloids in different batches of samples from different manufacturers and same manufacturers are quite different, which may be related to the quality of raw materials, preparation technology and production equipment.