Objective To preliminarily screen the preparation process of Ji Shenqi anti-cancer granules (JSQ) and establish the quality standard.

Methods The excipient types were examined and the formulation moulding process was preferred using the soft material making situation, particle yield, angle of repose and solubility as evaluation indexes. Thin-layer chromatography (TLC) was used for the qualitative identification of Suberect Spatholobus Stem, ginseng, and astragalus; high performance liquid chromatography (HPLC) was used to determine the mass fractions of ginsenosides (Rg1, Re, and Rb1) and catechins in the preparations.

Results The excipients were soluble starch and mannitol, and the best preparation process was that the ratio of main drug to soluble starch and mannitol was 1∶1.5∶0.3. Combined with the previous research results of the extraction process by the research group, the preparation process of JSQ was as follows: The prescription amount of herbs with 9 times the amount of water was soaked for 80 min for the first time, and the remaining two times were added with 8 times the amount of water; each time was decocted for 1 h; after a total of three extractions, the filtrates were filtered and combined, and then concentrated under reduced pressure to achieve the relative density in the range of 1.20-1.30; the thick paste was then mixed with excipients (soluble starch: mannitol=1.5∶0.3) in accordance with the ratio of drugs and auxiliaries for 1∶1.8. The mixture was evenly combined to make a soft material, which was then granulated, dried, and granulated again to obtain the final product. The TLC spots were clear, well-separated, negative and non-interfering, with strong specificity; the quality check was in accordance with the provisions of the Pharmacopoeia; the results showed that the linear ranges of the mass concentrations of ginsenosides (Rg1, Re and Rb1) and catechins were 6.96-139.20 μg/mL, 7.51-150.20 μg/mL, 7.35-147.00 μg/mL and 5.86-187.52 μg/ mL, respectively (all r > 0.99), with good linear relationship with the peak area; the average recoveries were 102.72%, 103.81%, 99.66% and 106.29%, with RSDs of 1.18%, 2.33%, 1.58% and 1.64%, respectively. The average contents of ginsenosides and catechins in the three batches of samples were 446.14 μg/g, 475.91 μg/g, 559.71 μg/g and 50.40 μg/g, respectively, and the amount of catechins in this product was not less than 40.32 μg per 1 g, and the amount of ginsenosides (Rg1, Re, and Rb1) was not less than 356.91 μg, 380.73 μg and 447.77 μg.

Conclusion The process is stable and feasible, and the established TLC and HPLC methods are exclusive, sensitive and reproducible, laying a foundation for the subsequent research and development and quality control.