A study on the preparation and quality standard of Saifula granules

Abstract

Objective: To establish the decocting and formulation technology of Saifula granules, and establish a reliable TLC identification quality control standard. Methods: Orthogonal test was used to optimize the water extraction process and TLC was used for qualitative identification. Results: To optimize the process parameters of SFL granules, first, the content of total flavonoids and the total extraction rate were taken as the indexes. Through single factor and orthogonal test, the optimal extraction process was determined as follows: extraction time 1 h, solvent multiple 1:10, extract three times. After the process parameters were determined, in order to further explain the chemical composition of SFL extract, 15 compounds in SFL extract were identified by UHPLC-Q-Orbitrap-MS, 13 batches of SFL extracts were prepared, and their fingerprints were analyzed. The results showed that there were 28 common characteristic peaks in the 13 batches of SFL extracts. The similarity evaluation results of fingerprints showed that the similarities of 13 batches of SFL extracts were greater than 0.9. An HPLC-DAD method for the simultaneous determination of gallic acid, corilagin, and ellagic acid was established. The method has good repeatability, stability, and accurate results. Conclusion: The standard can comprehensively reflect the material basis of SFL granules, and the above methods are accurate, easy to operate, stable and feasible, and provide scientific basis and basis for the development, promotion, and clinical application of SFL granules.