激光粒度分析技术在药物研究和质量控制中的应用进展
Advances of Application of Laser Diffraction Technique of Particle Size Analysis in Pharmaceutical Quality Analysis
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摘要: 近年来,激光粒度分析技术广泛应用于药物的质量研究和质量控制领域.从激光散射测定粒度的原理、仪器的一般要求和影响测试结果的因素、方法验证的要求以及该技术在药物领域中最新应用等方面进行综述,为激光粒度分析技术在药物中的应用开发提供有益的参考.Abstract: Laser diffraction technique of particle size analysis was widely used in pharmaceutical quality control recently. In this review, the principle of the laser diffraction technique, normal test requirements for the instruments, influence factor for the determination, method validation and current application in pharmaceutical science fields were discussed. It provides references for the further study of pharmaceutical particle size analysis.