动态浊度法测定吡拉西坦氯化钠注射液中细菌内 - 中国药品标准杂志.docVIP

动态浊度法测定吡拉西坦氯化钠注射液中细菌内毒素含量 申应德，张新，李杰，姜庆 （临沂市食品药品检验检测中心，临沂 276000） 摘要 目的： 用动态比浊法测定吡拉西坦氯化钠注射液中细菌内毒素含量，与药典标准相比较，且以此评价不同厂家的内毒素控制水平。方法： 参考凝胶法的干扰试验结果，采用动态浊度法对4个厂家、8批样品进行细菌内毒素含量测定。结果： 当样品稀释16倍时，干扰消除，细菌内毒素回收率在80%～130%之间，所测样品的细菌内毒素含量均小于0.0314EU·ml-1。结论： 样品的细菌内毒素含量均远低于《中国药典》0.5EU·ml-1标准，提示现有标准有待提高，各厂家目前细菌内毒素的控制工艺较好，无明显差异。 关键词：细菌内毒素；动态浊度法；干扰试验；吡拉西坦氯化钠注射液 中图分类号：R921.2 文献标识码： A 文章编码： Determination of Bacterial Endotoxin in Piracetam and Sodium Chloride Injection by Kinetic Turbidimetric Assay Shen Yingde,Zhang Xin,Li Jie，Jiang Qing (Linyi Institute for Food and Drug Control, Linyi 276000)Abstract Objective: To determine the content of bacterial endotoxin in Piracetam and Sodium Chloride Injection by Kinetic Turbidimetric Assay (KTA) and compare it with the standard of Chinese Pharmacopoeia, the result was also used to evaluate the difference of endotoxin control in different manufacturers. Methods： Referencing the interference test results of Gel-Clot , KTA was adopted to determine the content of bacterial endotoxin in 8 batches of samples from 4 manufactures. Results: The interference was eliminated when the sample was diluted 16 times. The content of bacterial endotoxin in 8 batches of samples was less than 0.0314EU·ml-1 ,the recovery rate was 80%–130%. Conclusion: The content of endotoxin is far less than the standard of Chinese Pharmacopoeia 0.5EU·ml-1, which suggest that the current standard to be improved. Each manufacturer is generally good in the control process of bacterial endotoxin , no significant difference. Key words: bacterial endotoxin ; kinetic turbidimetric assay; interference test； Piracetam and Sodium Chloride Injection 吡拉西坦氯化钠注射液作为临床常用的脑代谢药物，适用于急、慢性脑血管病、脑外伤、各种中毒性脑病等多种原因所致的记忆减退及轻、中度脑功能障碍，也可用于儿童智能发育迟缓。临床上静脉滴注大量输液时，若药液中含有热原物质，易导致热原反应[1]。内毒素是目前医药工业中最普遍和最主要的外源性热原，在GMP条件下控制内毒素污染就等于控制热原污染[2]。《中国药典》2010年版二部规定，吡拉西坦氯化钠注射液的细菌内毒素限值为小于0.50EU·ml-1[3]。 细菌内毒素是评价药品安全性的一个重要参数。目前各地药检机构普遍采用凝胶法进行内毒素检查，但难以准确定量。本文采用动态浊度法检测了4个生产厂家的8批吡拉西坦氯化钠注射液的细菌内毒素含量，以期通过测定各