抗乳腺小叶增生合剂的质量标准研究

Quality Standard of Anti-lobular Hypertrophy Mixture

目的:建立抗乳腺小叶增生合剂的质量标准。方法:采用薄层色谱(TLC)法对处方中的白芍、当归和丹参进行定性鉴别;采用高效液相色谱法对芍药苷、阿魏酸和甘草酸进行含量测定。结果:TLC特征斑点明显、专属性强。芍药苷、阿魏酸和甘草酸的检测浓度分别在25.96～259.65、2.15～21.55、31.63～316.30μg.mL-1范围内与各自峰面积积分值呈良好线性关系(r分别为0.9995、0.9998、0.9996);平均加样回收率分别为100.82%、98.61%和100.39%,RSD分别为2.64%、2.43%和2.98%(n均为6)。结论:所建标准可用于抗乳腺小叶增生合剂的质量控制。

OBJECTIVE： To establish a quality standard of Anti-lobular hypertrophy mixture. METHODS：Paeonia lactiflora, Angelica sinensis and Salvia miltiorrhiza in the formula were identified qualitatively by TLC. The contents of paeoniflorin, ferulic acid and glycyrrhizic acid were determined by HPLC. RESULTS： The TLC spots were clear and specific. The linear ranges for paeoniflorin, ferulic acid and glycyrrhizic acid were 25.96-259.65 μg. mL- t （r= 0.999 5）, 2.15-21.55 μg mL- 1 （r： 0.999 8） and 31.63-316.30 μg.mL-1 （r=0.999 6） respectively. The average recoveries were 100.82%, 98.61% and 100.39% ,RSD were 2.64% - 2.43 % and 2.98% （n=6）. CONCLUSION： The established standard can be used for the quality control of Anti-lobular hypertrophy mixture.