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目的考察用乌头碱水解物、新乌头碱水解物、次乌头碱水解物的含量作为附片水煎剂及附片质量控制指标的可行性。方法采用高效液相色谱分析法,色谱柱为Shimpack CLC-ODS,以甲醇-乙酸铵溶液(0.2 mol/L)(200?210)为流动相,流速1.0 mL/min,检测波长为241 nm,对乌头碱新,乌头碱、次乌头碱水解物的含量测定进行研究。结果 3种水解物检测方法测得水解物在进样范围有良好线性关系,重现性好,稳定性好,生药提取时间宜选定为40 min,不同批号的附片中3种水解物含量差别较大。结论此方法简便,使用新乌头碱、乌头碱、次乌头碱的水解物作为含附片制剂的质量控制指标是可行的。
Objective To investigate the feasibility of using aconitine hydrolysates, mesaconitine hydrolysates and hypaconitine hydrolysates as indicators of the quality control of epicatechin decoction and epidural. Methods High performance liquid chromatography (HPLC) was used. The chromatographic column was Shimpack CLC-ODS with a flow rate of 1.0 mL / min with methanol-ammonium acetate solution (0.2 mol / L) The contents of aconitine, aconitine and hypaconitine hydrolyzate were studied. Results The results showed that the hydrolyzate had a good linearity in the injection range with good reproducibility and good stability. The extraction time of crude drug should be chosen as 40 min. The content of three hydrolyzate in different batches The difference is bigger. Conclusion This method is simple and convenient. It is feasible to use the mesaconitine, aconitine and hypaconitine hydrolysates as the quality control indexes of the preparation containing the appendices.