Objective To study the preparation and quality standard of Compound Shenqu Granules (SG).Methods With the content, fluidity and hygroscopicity of salvianolic acid B as evaluation indexes, the extraction,purification , concentration, drying and forming process of SG was studied. According to Chinese Pharmacopoeia,half medicinal materials of SG were identified by thin-layer chromatography (TLC). With salvianolic acid B content as observation index, the optimal extraction process of SG was screened through investigating extraction methods,extraction time and solvent amount for SG. The methodological evaluation included linearity, precision, specificity,stability and accuracy of the test. HPLC method was used to determine the content of salvianolic acid B. The chromatographic analysis was carried out on Phenomenex Luna C 18 column with octadecylsilane chemically bonded silica as loading agent. The mobile phase consisted of methanol-acetonitrile-2％ water solution of formic acid (28∶ 10∶62 ), detection wavelength was 286 nm, and external standard was applied. Results The quality of pilotplant products was good when the products were produced with the optimal forming process which was stable in laboratory. The content of salvianolic acid B of pilotplant products was the highest by the method of refluxing with 50 mL 75％ hot ethanol for 30 minutes. The relevant parameters were qualified, and the accuracy and recovery rate of sample content determination met the requirement issued by Chinese Pharmacopoeia (2005). Conclusion The optimal forming process of Compound Shenqu Granules has been established successfully. TLC analysis is set up with ginsenoside Rgl, hesperidin and harpagoside as control, which will provide a basis for the qualitative study of Compound Shenqu Granules. HPLC analysis is also established with salvianolic acid B as content determination index. The content of total saponins in the granules is determined.
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维普
万方数据
