黄芪健骨胶囊质量标准研究

Study on Quality Standard of Huangqi Jiangu Capsules

目的建立黄芪健骨胶囊的质量标准。方法采用薄层色谱(TLC)法对制剂中黄芪、山茱萸药材进行定性鉴别;采用高效液相色谱(HPLC)法测定制剂中马钱苷、毛蕊异黄酮苷、柚皮苷的含量,色谱柱为XSelect HSS T_(3)柱(250 mm×4.6 mm,3.5μm),流动相为甲醇-0.3%磷酸水溶液(梯度洗脱),流速为0.8 mL/min,检测波长为240 nm,柱温为25℃,进样量为10μL。结果黄芪、山茱萸的TLC图特征斑点清晰,分离度好,且阴性对照无干扰。马钱苷、毛蕊异黄酮苷、柚皮苷质量浓度分别在21.54~430.80μg/mL(R^(2)=0.9993)、5.02~100.40μg/mL(R^(2)=0.9999)、20.28~405.60μg/mL(R^(2)=0.9997)范围内与峰面积线性关系良好;精密度、稳定性、重复性试验结果的RSD均小于3.0%;平均加样回收率分别为100.66%,98.58%,100.17%,RSD分别为1.70%,2.36%,1.98%(n=6)。结论该方法操作简便,结果准确,重复性好,可用于黄芪健骨胶囊的质量控制。

Objective To establish the quality standard of Huangqi Jiangu Capsules.Methods Astragali Radix and Corni Fructus in the preparation were identified qualitatively by the thin-layer chromatography(TLC)method.The contents of loganin,calycosin-7-O-β-D-glucoside and naringin in the preparation were determined by the high-performance liquid chromatography(HPLC)method;the chromatographic column was the XSelect HSS T_(3) column(250 mm×4.6 mm,3.5μm),the mobile phase was methanol-0.3%phosphoric acid aqueous solution(gradient elution),the flow rate was 0.8 mL/min,the detection wavelength was 240 nm,the column temperature was 25℃,and the injection volume was 10μL.Results The TLC chromatograms of Astragali Radix and Corni Fructus had clear characteristic spots,good resolution,and there was no interference from the negative reference.The linear ranges of loganin,calycosin-7-O-β-D-glucoside and naringin were in the range of 21.54-430.80μg/mL(R^(2)=0.9993),5.02-100.40μg/mL(R^(2)=0.9999),20.28-405.60μg/mL(R^(2)=0.9997)respectively.The RSDs of precision,stability and repeatability tests were all lower than 3.0%.The average recovery rates of the above three components were 100.66%,98.58%,100.17%,with RSDs of 1.70%,2.36%,1.98%(n=6)respectively.Conclusion This method is simple,accurate and repeatable,which can be used for the quality control of Huangqi Jiangu Capsules.