健脾和胃颗粒质量标准的研究

Study on the quality standard 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 C_（18）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 m L/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/m L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。

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＆#215;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.