目的 混合过程是滴丸制备过程中的关键工艺，为保证药物均匀分散在熔融基质中，提出一种基于近红外光谱（near-infrared spectroscopy，NIRS）技术的混合过程监测方法。方法 以银杏叶滴丸（Ginkgo Folium Dripping Pills，GFDP）料液的混合过程为研究对象，基于近红外光谱技术并结合化学计量学手段，开发了一种适用于GFDP料液混合过程的在线监测方法。通过移动块标准偏差法来评价熔融物料的混合均匀度，并对混合终点进行判断。结果 在波长900～1650 nm，采集的光谱最大偏差值为0.013 81，最大标准偏差值为0.005 54，所建立的监测方法具有较好的重复性和稳健性，不同取样点的总黄酮苷含量RSD小于5%，验证了终点判断的可靠性。结论 为熔融物料混合过程监测及终点判断提供了思路，提高了滴丸制备过程关键环节的监控能力。

Objective The blending process is a crucial process in the preparation of dripping pills. To ensure the homogeneous dispersion of drugs in the molten matrix, a blending process monitoring method based on near-infrared spectroscopy (NIRS) technology was proposed. Methods This study focused on the blending process of Ginkgo Folium Dripping Pills (GFDP). An on-line monitoring method for this process was developed using near-infrared spectroscopy and chemometrics. The blending uniformity of molten materials was evaluated by moving block standard deviation method to determine the end-point. Results In the wavelength range of 900—1650 nm, the maximum deviation value of the acquired spectrum was 0.013 81, and the maximum standard deviation value was 0.005 54. The established monitoring method showed good repeatability and robustness. The RSD (relative standard deviation) of total flavonoid glycosides content at different sampling points were below 5%, which verified the reliability of end-point determination. Conclusion This study provides insights into monitoring and determining end-point during the blending process of molten materials, thereby improving capabilities for monitoring bottlenecks in the preparation of dripping pills.

R283.6

国家中医药管理局“组分中药与智能制药多学科交叉创新团队”项目（ZYYCXTD-D-2020002）