十味木香散质量标准研究

Study on the Quality Standard of Shiwei Muxiang Powder

目的建立藏药十味木香散的质量标准。方法采用薄层色谱(TLC)法鉴别制剂中的木香、马尿泡、人工牛黄;采用高效液相色谱(HPLC)法测定样品含量,色谱柱为Inertsil C_(18)柱(150 mm×4.6 mm,5μm),流动相为甲醇-水(58∶42,V/V),柱温为30℃,流速为1.0 m L/min,检测波长为225 nm。结果 TLC图中各药材斑点清晰,且阴性对照无干扰;木香烃内酯、去氢木香内酯进样量分别在0.065 1～1.0302μg和0.0870～1.7400μg范围内与峰面积线性关系良好,平均加样回收率分别为98.29%和97.76%,RSD分别为0.71%和0.58%(n=6); 5批样品中木香烃内酯及去氢木香内酯含量之和均不低于3.59 mg/g。结论该方法专属性强、灵敏度高、重复性好,可用于十味木香散的质量控制。

Objective To establish the quality standard of Tibetan medicine Shiwei Muxiang Powder.Methods TLC method was used for the qualitative identification of Aucklandiae Radix,Przewalslia tangtuica Maxim and artificial Calculus bovis in the preparation.HPLC method was used for the content determination of samples.Inertsil C18 column(150 mm×4.6 mm,5μm)was adopted,the mobile phase was methanol-water(58∶42,V/V),the column temperature was 30℃,the flow rate was 1.0 mL/min,and the detection wavelength was 225 nm.Results The TLC spots of the medicinal materials were clear without interference from negative control.Costunolide and dehydrocostus lactone showed good liner relationships in the ranges of 0.065 1-1.030 2μg and 0.087 0-1.740 0μg,the average recovery rates were 98.29%and 97.76%,the RSDs were 0.71%and 0.58%(n=6).The total contents of costunolide and dehydrocostus lactone in 5 batches of samples were not less than 3.59 mg/g.Conclusion The method has high specificity,sensitivity and good reproducibility,which can be used for the quality control of Shiwei Muxiang Powder.