Study on preparation technology and physical fingerprint of Carthami Flos Granules based on quality by design / 中草药

ABSTRACT

Objective: To study the prescription and preparation technology of Carthami Flos Granules and evaluate its physical quality based on quality by design. Methods: Carthami Flos was used as a model drug. The evaluation indicators were retention rate of hydroxysafflor yellow A (HSYA) and total flavonoid, primary formation rate, bulk density, tap density, relative homogeneity index, Hausner ratio, angle of repose, loss on drying, and hygroscopicity. The single factor experiments and the Box-Behnken design response surface method were used to investigate the particle forming process parameters. The physical fingerprint of granules was constructed by seven indexes including bulk density, tap density, relative homogeneity index, Hausner ratio, angle of repose, loss on drying, and hygroscopicity. Results: The optimum conditions were as follows the dosage ratio of drug to adjuvant was 10.8, the amount of wetting agent (95% ethanol) was 32%, and dried at 70 ℃ for 120 min. The similarity of the physical fingerprint of 10 batches of Carthami Flos Granules was higher than 0.99. Conclusion: The prescription and preparation technology of Carthami Flos Granules and the physical quality were scientific and reasonable, which can provide ideas and methods for the research and development of Chinese materia medica.