Abstract:
OBJECTIVE To establish a laser scattering method for determination of the Tiepi Yangsheng granules, and to optimize the one-step granulation process.
METHODS The particle size distribution of Tiepi Yangsheng granules was measured by laser particle size distribution instrument in dry mode. The parameter settings were Mie optical mode with sample refractive index of 1.52, sample absorbency of 0.01, shading degree of 5%-10%, air press of 0.20 MPa, slit width of 0.9 mm, feeding speed of 7. Taking the molding rate and particle size uniformity as the critical quality attributes, the critical process parameters of one-step granulation of Tiepi Yangsheng granules were optimized by risk assessment and orthogonal design.
RESULTS Particle size distribution of Tiepi Yangsheng granules could be determined quickly through established laser scattering method. The better one-step granulation process was as follows:the 0.2 mL·g
-1 extract of
Dendrobium officinale was took as the adhesive, the
Panax quinquefolium L. extract powder and xylitol powder were as base material, the material temperature was 50℃, the atomization pressure was 1.0 MPa, the liquid supply speed was 14 r·min
-1, and the fan frequency was increased from 10 Hz to 35 Hz. The molding rate of particles obtained by this process was 94.4%, with the results of D10, D50, D90 values, peak particle size were 152.8, 443.4, 852.5, 532.0 μm and the particle size uniformity was 1.38. The moisture content of granules was 1.91% and the angle of repose was 36.4°.
CONCLUSION The laser scattering method can rapidly and accurately determine the particle size of Tiepi Yangsheng granules, and directly reflect the overall particle size distribution. The one-step granulation process of Tiepi Yangsheng granules optimized is feasible, which can provide a new idea for the quality evaluation and process development of traditional Chinese medicine granules.