Study on the trial and pilot process optimization of insomnia granules

Abstract

Objective To optimize a method for extracting traditional Chinese medicine composition with insomnia, and to prepare the insomnia granules for quality control. Methods The optimal extraction process was screened by orthogonal test using high-performance liquid chromatography with geniposide as the evaluation index. The particle size, bulk density, angle of repose, moisture, solubility, hygroscopicity and loading difference of the insomnia granule were evaluated, and the difference between the trial test and the pilot test were analyzed to comprehensively monitor the quality of the insomnia granule. Results The best extraction process was to add 10 times of water and cooked it three times for 1.5 hours each time. The average yield rate of dry extract of the pilot test and trial test was 22.10%, 15.52%, and the average yield of powder was 84.96% and 93.12%, respectively. The conversion rate from the pilot test to the trial test is 76.97%. Both the trial test and the pilot test particles met the quality requirements of the 2015 edition of the pharmacopoeia. Conclusions The preparation method of the insomnia granules is simple and the quality is uniform. The results of the pilot scale showed that the conversion rate is high, the quality is controllable, and the technical feasibility of industrial production is obtained. Key words: Orthogonal test; Extraction; Jasminoidin; Pilot test; Assay (TCD); Quality control; Technology improving (TCD)