麝香化瘀醒脑颗粒质量标准研究

Study on Quality Standard of Shexiang Huayu Xingnao Granules

目的建立麝香化瘀醒脑颗粒的质量标准。方法采用薄层色谱(TLC)法定性鉴别制剂中的麝香、黄芪、大黄;采用高效液相色谱(HPLC)法测定制剂中人参皂苷Rb1的含量,色谱柱为Ultimate^(TM)C_(18)柱(250 mm×4.6 mm,5μm),流动相为乙腈-水(梯度洗脱),流速为1.0 mL/min,检测波长为203 nm,柱温为40℃,进样量为10μL。结果麝香、黄芪、大黄的TLC图斑点清晰,分离度好,且阴性对照无干扰;人参皂苷Rb1质量浓度在78.04~780.40μg/mL范围内与峰面积线性关系良好(R^(2)=0.9991,n=6);精密度、稳定性、重复性试验结果的RSD均小于3.0%;平均加样回收率为96.84%,RSD为3.16%(n=9)。结论该方法操作简便,重复性好,结果准确可靠,可用于麝香化瘀醒脑颗粒的质量控制。

Objective To establish a quality standard for Shexiang Huayu Xingnao Granules.Methods The Moschus,Astragali Radix and Rhei Radix et Rhizoma in the preparation were identified qualitatively by the thin-layer chromatography(TLC)method.The content of ginsenoside Rb1 in the preparation was determined by high-performance liquid chromatography(HPLC)method;the chromatographic column was the Ultimate^(TM)C_(18)column(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-water(gradient elution),the flow rate was 1.0 mL/min,the detection wavelength was 203 nm,the column temperature was 40℃,and the injection volume was 10μL.Results The TLC chromatograms of Moschus,Astragali Radix and Rhei Radix et Rhizoma had clear spots and good resolution,and there was no interference from the negative reference.The linear range of ginsenoside Rb1 was 78.04-780.40μg/mL(R^(2)=0.9991,n=6).The RSDs of precision,stability and repeatability tests were all lower than 3.0%.The average recovery rate of ginsenoside Rb1 was 96.84%with an RSD of 3.16%(n=9).Conclusion This method is simple,repeatable,accurate and reliable,which can be used for quality control of Shexiang Huayu Xingnao Granules.