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214.718 μg·g-1,最低值18.452 μg·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 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-1 sodium dihydrogen phosphate （adjusted pH to 6.5 with triethylamine） （47∶ 53）,detection wavelength was set at 235 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-1 with 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.
出处
《中国实验方剂学杂志》
CAS
北大核心
2014年第21期123-126,共4页
Chinese Journal of Experimental Traditional Medical Formulae
基金
国家自然科学基金面上项目(81274098)
作者简介
[第一作者]任桂林，硕士，从事中药新技术、新工艺研究，Tel：18010618161，E-mail：1007866178@qq．com
[通讯作者]韩丽，教授，硕士生导师，从事中药新制剂、新技术、新剂型研究，Tel：028-61800127，E-mail：hanliyx@163．com
