ABSTRACT
OBJECTIVE： To provide reference for the establishment of quality standard of Tussilago farfara formula granules. METHODS： TLC method was used for qualitative identification of tussilagone in T. farfara formula granules. The content of tussilagone in T. farfara formula granule was determined by HPLC. The determination was performed on a Thermo ODS Hypersil C18 column with the mobile phase consisted of methanol-water （85 ∶ 15， V/V） at the flow rate of 1.0 mL/min. The detection wavelength was set at 220 nm， the column temperature was 25 ℃. Sample size was 20 μL. RESULTS： TLC spots of tussilagone were clear and well-separated， without interference from negative control. The linear range of tussilagone was 1.39-27.75 μg/mL （r＝0.999 9）. The limits of quantification and detection were 0.153 87 and 0.051 42 μg/mL， respectively. RSDs of precision， stability and reproducibility tests were lower than 2％. The recoveries were 97.12％-103.96％ （RSD＝2.60％， n＝6）. CONCLUSIONS： The method is simple， accurate and reproducible， and suitable for quality control of T. farfara formula granules.
ABSTRACT
Objective@#Rebiqing granules were prepared and the rolling drying granulation process parameters were optimized.@*Methods@#According to the previous knowledge and experience, the feed rate, pressure and speed of rolling were used as the factors for investigation, and the primary forming rate and the solubility of the Rebiqing granule were taken as the evaluation indexes, and the Box-Behnken response surface method was used to optimize the rolling drying granulation parameters.@*Results@#The optimum rolling drying granulation parameters were as follows: feed rate was 8.5 Hz, rolling pressure was 6.0 Mpa and rolling speed was 8.5 Hz. After continuous production of 3 batches of validation, the Rebiqing granules had high molding rate and good solubility.@*Conclusions@#The rolling drying granulation processes were optimized by the experimental design, which could improve the robustness of the processes and control the stability of the product quality.