Study on preparation technology and physical fingerprint of Huanghuai Tablets based on quality by design / 中草药

ABSTRACT

Objective: To study the prescription and preparation technology of Huanghuai Tablets and evaluate the physical quality of intermediate particles based on quality by design. Methods: Using Huanghuai (Scutellaria baicalensis and Sophora japonica) extract as the main component, the single factor experiments were used to screen adjuvant, and the forming rate, quality difference, hardness, friability, and disintegration time of tablets were used as indicators to optimize the optimal preparation processing of Huanghuai Tablets by wet granulation process. Physical indicators of granules were characterized by using micromeritics evaluation method. The physical fingerprint of granules were constructed by nine indexes including relative homogeneity index, interparticle porosity, Carr index, bulk density, tapped density, loss on drying, hygroscopicity, Hausner ratio, and angle of repose. The granules physical fingerprint is of great importance to evaluate the quality consistency of different batches of Huanghuai granules and analyze the compressibility of the granules. Results: The optimum formula was Huanghuai granule 0.25 g, 7% croscarmellose sodium, and 2% talc powder. The optimum conditions were as follows granulated with 16 mesh sieve, dried at 60 ℃ for 1 h, and unified with 18 mesh screen. The similarity of the physical fingerprint of five batches of Huanghuai granules was higher than 0.983, the parameters of five batches of particle parameters were all greater than 0.4, and the parameter profile index was 4.82-5.70, and the good pressure index was from 4.44 to 5.25. Conclusion: The prescription and preparation technology of Huanghuai Tablets and the physical quality of intermediate particles were scientific and reasonable, which can provide ideas and methods for the research and development of Chinese materia medica formula.