激光散射法在铁皮洋参颗粒一步制粒工艺优化中的应用

Application of Laser Scattering Method in One-step Granulation Process Optimization of Tiepi Yangsheng Granules

目的 建立激光散射法测定铁皮洋参颗粒粒度,并优化其一步制粒工艺。方法 采用激光粒度分布仪,干法模式测定铁皮洋参颗粒粒度分布,参数设置:Mie光学模式,物质折射率1.52,吸收率0.01,遮光率5%~10%,气源压力0.20 MPa,斗料高度0.9 mm,进料速度7档。以成型率与粒度均匀性为关键质量属性,运用风险评估和正交设计优化铁皮洋参颗粒一步制粒关键工艺参数。结果 所建立的激光散射法能够快速测定铁皮洋参颗粒粒度分布情况。所得较佳一步制粒工艺以0.2 mL·g^(-1)铁皮石斛浸膏为黏合剂,西洋参浸膏粉和木糖醇粉为底料,物料温度50℃,雾化压力1.0 MPa,供液速度14 r·min^(-1),风机频率由10 Hz增至35 Hz。该工艺所得颗粒成型率为94.4%;D10值、D50值、D90值、峰值粒径依次为152.8,443.4,852.5,532.0μm;粒度均匀性为1.38;水分为1.91%;休止角为36.4°。结论 激光散射法可快速、准确测定铁皮洋参颗粒粒度,直观反映整体粒度分布。优化所得铁皮洋参颗粒一步制粒工艺可行性强,可为中药颗粒剂质量评价与工艺开发提供新思路。

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 152.8,443.4,852.5,532.0μm 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.