目的 以清润丸为模型药，制备混合均匀的清润丸原料粉体，并采用快速分析方法评价清润丸原料粉体的混合均匀性。方法 基于粒子设计技术制备清润丸的原料粉体，以粒径为指标建立核壳粒子，再通过近红外光谱技术，以移动块标准偏差为指标分析清润丸原料粉体的混合均匀性。最后用高效液相色谱法进行验证。结果 按照粒子设计技术设计清润丸原料粉体。包括壳粒子（大黄等药材）和核粒子（黄芩等药材）；壳粒子在超微粉碎12 min粒径d_0.9（代表90%的粒子的粒径）约为5 μm，核粒子在超微粉碎6 min粒径d_0.9约为130 μm，核粒子与壳粒子之比大于10：1，符合粒子设计要求。近红外光谱技术显示壳粒子超微粉碎12 min，再将核粒子复合超微粉碎6 min时混合均匀。结论 基于粒子设计技术制备清润丸原料粉末，并采用近红外光谱技术对粉末混合均匀性进行评价。该方法具有简便可行、实时快速、不破坏样品等优点。

Objective Using Qingrun Pill as model drug, the raw material powder of Qingrun Pill with uniform mixture was prepared. The rapid analysis method was used to evaluate the mixing uniformity of Qingrun Pill raw materials. Methods Based on the particle design technology, the raw material powder of Qingrun Pill was prepared, the core-shell particles were established with the particle size as the index, and the mixing uniformity of the raw material powder of Qingrun Pill was analyzed with the standard deviation of moving block as the index by near infrared spectroscopy. Finally, it was verified by HPLC. Results According to the particle design technology, the raw material powder of Qingrun Pill was designed. Shell particles:Rheum officinale and other materials; Nuclear particles:Scutellaria baicalensis and other materials; The particle size (d_0.9) of shell particles at ultrafine grinding for 12 min was about 5 μm, and that of nuclear particles at ultrafine grinding for 6 min was about 130 μm. The ratio of nuclear particles to shell particles was more than 10:1, which met the requirements of particle design. Near-infrared spectroscopy showed that shell particles were ultrafine comminuted for 12 min, and then the nuclear particles were mixed evenly for 6 min. Conclusion In this study, Qingrun Pill powder was prepared based on particle design technology, and the mixing uniformity of powder was evaluated by near infrared spectroscopy. This method is simple and feasible, real-time, and without destroying the sample.

R283.6

国家自然科学基金项目（81760716）；江西省"双一流"学科建设项目（JXSYLXK-ZHYAO009）；江西省"双一流"学科建设项目（JXSYLXK-ZHYAO010）