健脾和胃颗粒质量标准的研究

摘要

Objective To study and establish the quality standard for Jianpihewei Granules. Methods TLC was used to i⁃dentify salvia miltiorrhizae, crataegus pinnatifida and codonopsis pilosula in Jianpihewei Granules. The content of salvianolic acid B in salvia miltiorrhizae was determined by HPLC. Methanol⁃acetonitrile⁃1.67% formic acid solution (27∶9∶64) was used for mobil phase of Agilent Eclipse Plus C18(4.6×250 mm,5μm). The detection wavelength was 286 nm, flow rate was 1.0 mL/min and the temperature of column was 25 ℃. The injection volume was 10μL. Results The spots on TLC are clear without negative sample interfrence. The concentration of salvianolic acid B in salvia miltiorrhizae determined by HPLC showed a good linear relationship withpeak area in the range of 12.1856-389.94μg/mL of salvianolic acid B. The linear regression equation was Y=6.5459X-3.7811( r=0.9999,n=6) . The recovery was 99.97% and RSD was 1.07%. Conclusion The method is simple, sensibility and accuracy, which can be used in quality control of Jianpihewei Granules.%目的：研究并建立健脾和胃颗粒的质量标准。方法采用TLC法对健脾和胃颗粒中的丹参、山楂和党参三味药进行定性鉴别；采用HPLC法测定健脾和胃颗粒丹参中的丹酚酸B含量，Agilent Eclipse Plus C18柱（4�6×250 mm，5μm），以甲醇⁃乙腈⁃1�67％甲酸水溶液（27∶9∶64）为流动相；检测波长为286 nm，柱温25℃，流速1�0 mL／min，进样量10μL。结果试验采用TLC定性鉴别的三味药色谱斑点清晰，阴性对照无干扰；以HPLC法测定健脾和胃颗粒丹参中的丹酚酸B，丹酚酸B浓度在12�1856～389�94μg／mL范围内与峰面积呈良好的线性关系，线性回归方程为Y＝6�5459X－3�7811（ r＝0�9999，n＝6），回收率为99�97％，RSD为1�07％。结论本试验确定的方法操作简单、灵敏、准确，可用于健脾和胃颗粒的质量控制。