Barber T A, Lannis M D, Williams J G
J Parenter Sci Technol. 1989 Jan-Feb;43(1):27-47.
Accurate enumeration and sizing of contaminant particles in parenteral solutions are critical to the assessment of product quality and suitability for patient use. Current manual microscopic and instrumental (light obscuration) methodologies specified by the USP both result in data of high variability. The microscopic assay for large volume parenterals is time consuming and incorporates an undesirable level of subjectivity; light obscuration counters tend to undersize larger particles and fibers and have low detection efficiency for some particle types commonly present in small volume injections. Light microscopic image analysis is proposed as a method which combines the best features of the two present methods and allows an accurate, precise, and cost effective analysis of parenteral contaminant particles. This paper briefly summarizes the principles of microscopic image analysis and discusses its application in concert with optimized sampling and counting techniques as an improved compendial methodology. Instrument performance requirements are discussed with reference to a number of currently available image analysis systems.
准确计数和测定注射用溶液中的污染物颗粒大小对于评估产品质量和患者使用的适用性至关重要。美国药典规定的当前手动显微镜法和仪器法（光阻法）都会产生高变异性的数据。大容量注射剂的显微镜检测耗时且主观性较强；光阻计数器往往会使较大颗粒和纤维的尺寸测定偏小，并且对于小容量注射剂中常见的某些颗粒类型检测效率较低。提出了光学显微镜图像分析方法，该方法结合了现有两种方法的最佳特性，能够对注射用污染物颗粒进行准确、精确且经济高效的分析。本文简要总结了显微镜图像分析的原理，并讨论了其与优化的采样和计数技术协同应用，作为一种改进的药典方法。参照一些现有的图像分析系统讨论了仪器性能要求。
