重大新药研制和药物审评审批均要求大力加强药物性能的监督和研究，而药物粒度决定其吸收性、有效性、稳定性及安全性等关键性能，因此纳米粒度测量技术必然在其中发挥无可替代的作用。为进一步简化粒度测量仪器结构，提高测量精度和效率，本项目以光的后向散射为依据，基于激光自混合干涉探索一种通用、精确、高效的纳米粒度检测技术。尝试设计Yb: YAG固体激光器作为系统光源，采用正交偏振双频激光扩展测量通道，以激光回馈下光频变化信号为直接分析对象，通过现代谱估计方法分析自混合信号功率谱，利用遗传算法求解粒度分布，以期对多种药剂粒子实现优于3%的粒径相对测量精度，为高精度、高效率的药物纳米粒度检测提供全新的理论基础和技术途径。

Development and approval of new medicine require great efforts to strengthen the supervision and research of medicine properties, and medicine’s particle size has crucial influence on its absorptivity, effectiveness, stability and safety, so nano-particle sizing technologies must play an irreplaceable and important role in this field. In order to further simplify the structure of particle sizing instruments, and improve the measurement precision and efficiency, this project explores a universal, fast and precise nano-particle size analysis technique based on optical back scatter and laser self-mixing interferometry (SMI). Taking the fluctuated laser frequency under feedback as the subject investigated, the project attempts to design a Yb: YAG solid state laser as the optical source, use orthogonally polarized dual frequency laser to expand measurement channels, use the modern spectrum analysis method to estimate the SMI signal’s power spectra, and use the genetic algorithm to obtain the concentration distribution in each particle size range, in order to achieve the relative particle size precision better than 3%. This will provide new theoretical foundation and technical approach for high-precision, high-efficiency nano-particle sizing.