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目的:建立护骨胶囊多成分定性、定量的分析方法,为护骨胶囊质量控制、药理药效研究提供依据。方法:采用采用高效液相色谱法,Kromasil C18色谱柱,流动相为甲醇-乙腈-1%冰醋酸,梯度洗脱,检测波长270、283、320和325 nm,流速:0.8 mL/min,柱温:30℃,对护骨胶囊中的主要成分绿原酸、2,3,5,4’-四羟基二苯乙烯-2-O-β-D-葡萄糖苷、阿魏酸、柚皮苷、淫羊藿苷进行定性、定量测定。结果:所建方法可用于对绿原酸等5种成分同时进行定性分析、定量测定。5种成分在线性范围内线性均良好(r>0.9992);精密度、稳定性、重复性(以相对标准偏差表示)均小于5%,加样回收率的范围为97.4%～99.4%,RSD值均小于1.72%。结论:首次建立了HPLC同时检测护骨胶囊多成分定性、定量的新方法。该方法简单、可行,可提高护骨胶囊的质量控制水平。
OBJECTIVE: To establish a multi-component qualitative and quantitative analysis method of HuGu Capsule to provide the basis for the study on the quality control and pharmacological efficacy of HuGu Capsule. Methods: Kromasil C18 column was used. The mobile phase consisted of methanol - acetonitrile - 1% glacial acetic acid with gradient elution at detection wavelength of 270, 283, 320 and 325 nm, flow rate of 0.8 mL / Temperature: 30 ℃, the main component of the capsule in the capsule chlorogenic acid, 2,3,5,4’-tetrahydroxystilbene-2-O-β-D-glucoside, ferulic acid, naringin , Icariin qualitative and quantitative determination. Results: The proposed method can be used for qualitative analysis and quantitative determination of 5 components such as chlorogenic acid simultaneously. The linearity of the five components was linear (r> 0.9992). The precision, stability and reproducibility (relative standard deviation) were all less than 5%, and the recoveries ranged from 97.4% to 99.4%. The RSD Values are less than 1.72%. CONCLUSION: A new method for simultaneous determination of multi-component, qualitative and quantitative multi-component components of Hugu capsule by HPLC was established for the first time. The method is simple and feasible, which can improve the quality control level of the capsule for protecting the bone.