瓜蒌当归降脂颗粒质量标准研究

Quality Standard of Gualou Danggui Jiangzhi Granules

目的建立瓜蒌当归降脂颗粒的质量标准。方法采用薄层色谱(TLC)法对制剂中的当归、决明子、山楂进行定性鉴别;采用高效液相色谱(HPLC)法测定阿魏酸、橙黄决明素的含量,色谱柱为Agligent C18柱(250 mm×4.6 mm,5μm),流动相为0.1%磷酸溶液-甲醇(梯度洗脱),流速为1.0 m L/min,检测波长为284 nm,柱温为25℃,进样量为10μL。结果当归、决明子、山楂的TLC图斑点清晰,分离度好,阴性对照无干扰。精密度、重复性、稳定性试验结果的RSD均小于2.0%;阿魏酸、橙黄决明素进样量分别在0.01~0.20μg,0.02~0.40μg范围内与峰面积线性关系良好;平均加样回收率分别为101.83%和105.19%,RSD分别为3.47%和4.90%(n=6)。结论所建立的质量标准可用于瓜蒌当归降脂颗粒的质量控制。

Objective To establish the quality control standard of Gualou Danggui Jiangzhi Granules.Methods Thin-layer chromatography(TLC)method was adopted for the qualitative identification of Radix Angelicae sinensis,Semen Cassiae obtusifolia and Fructus Crataegus pinnatifidia in this preparation.High-performance liquid chromatography(HPLC)method was adopted for the content determination of ferulic acid and aurantio-obtusin,the chromatographic column was Agligent C18 column(250 mm×4.6 mm,5μm),the mobile phase was 0.1%phosphoric acid-methanol(gradient elution),the flow rate was 1.0 m L/min,the detection wavelength was 284 nm,the injection volume was 10μL,and the column temperature was 25℃.Results The TLC spots of Radix Angelicae sinensis,Semen Cassiae obtusifolia and Fructus Crataegus pinnatifidia were clear and well separated without negative interference.The RSDs of precision,repeatability and stability tests were less than 2.0%,the linear ranges of ferulic acid and aurantio-obtusin were 0.01-0.20μg and0.02-0.40μg,respectively.The average recoveries of ferulic acid and aurantio-obtusin were 101.83%and 105.19%with RSDs of3.47%and 4.90%(n=6),respectively.Conclusion The established standard can be used for the quality control of Gualou Danggui Jiangzhi Granules.