小容量注射剂不溶性微粒污染特征的统计学分析___

摘要 目的： 考察小容量注射剂不溶性微粒污染的统计学特征。方法：测定化学药注射液、中药注射液及注射用无菌粉末共计327个批次，获取它们≥2 μm，≥5 μm，≥10 μm，≥25 μm 等4种直径的微粒数据，并采用SPSS统计学软件对数据进行分析。结果：小容量注射剂的≥2 μm，≥5 μm，≥10 μm等3种直径的微粒数据均呈指数分布，且化学药注射液及中药注射液这3种直径的微粒浓度与注射液的标示体积呈极显著的负相关性（P<0.01） 注射用无菌粉末的微粒含量比化学药注射液及中药注射液高且其微粒污染模式与后两者有明显不同。结论：采用统计学手段对小容量注射剂不溶性微粒测定结果进行分析可获知其不溶性微粒污染的统计学特征，从而有助于在整体上了解小容量注射剂不溶性微粒污染的现状。

Abstract Objective:To investigate the statistical characteristics of particulate matter contamination of small-volume injections.Methods:Determine 327 batches of chemical drug injections,Chinese medical injections and sterile powders obtain the particulate matter data of different particle sizes (≥2 μm,≥5 μm,≥10 μm,≥25 μm) and analyze the data with SPSS software.Results:The particulate matter data at three particle sizes (≥2 μm,≥5 μm,≥10 μm) accord with exponential distribution,and there is highly significant negative correlation between particle concentration and labeled volume of injections (P<0.01) the particle content of sterile powders is higher than that of chemical drug injections and Chinese medical injections,and the particulate matter contamination pattern of sterile powder is obviously different from that of chemical drug injections and Chinese medical injections.Conclusions:The statistical characteristics of particulate matter contamination can be obtained by the means of statistical analysis,which can help us to find out the current state of the particulate matter contamination of small-volume injections.

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