注射液中不溶性微粒的统计学分析  

Statistical Analysis of Insoluble Particulates in Injection

作　　者：魏静 秦天琦 吴愫青 Wei Jing;Qin Tianqi;Wu Suqing(Zhuhai Institute for Food and Drug Control,Guangdong,519090)

机构地区：[1]珠海市食品药品检验所,广东519090

出　　处：《当代化工研究》2022年第19期63-65,共3页Modern Chemical Research

摘　　要：目的:考察不同容量和剂型的注射剂不溶性微粒的统计学特征。方法:测定静脉用注射液,注射用无菌粉末共计172个批次,获取它们≥2μm、≥10μm、≥25μm三种粒径的不溶性微粒数据,并对数据进行统计学分析。结果:≥2μm、≥10μm、≥25μm三种粒径的微粒数据按每瓶的微粒总数计,样本数量与微粒数量呈负指数相关;不同批次注射剂微粒数量差别较大;注射用无菌粉末的微粒数量介于大容量与小容量注射液之间。结论:采用统计学手段对不同容量和剂型的注射剂不溶性微粒测定结果进行分析,可获得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注射剂不溶性微粒污染的现状。Objective:The statistical characteristics of insoluble particles in different volumes and dosage forms were investigated.Methods:A total of 172 batches of intravenous injection and sterile powder for injection were determined.Insoluble particle data of≥2μm,≥10μm and≥25μm were obtained,and the data were statistically analyzed.Results:≥2μm,≥10μm,≥25μm,according to the total number of particles per bottle,the num-ber of samples was negatively correlated with the number of particles.The number of particles in different batches of injection varies greatly.The num-ber of particles of sterile powder for injection is between high volume and low volume injection.Conclusion:By analyzing the results of injection in-soluble particles of different volumes and dosage forms,the statistical characteristics of insoluble particle pollution can be obtained,which is helpful to understand the status of injection insoluble particle pollution.

关 键 词：静脉用注射液 注射用无菌粉末 不溶性微粒 微粒数量 统计学分析 

分 类 号：TQ[化学工程]