盐酸替罗非班氯化钠注射剂与不锈钢管道的相容性

Study on compatibility of tirofiban hydrochloride sodium chloride injection with stainless steel pipe

将盐酸替罗非班氯化钠注射液用不锈钢管道置于盐酸替罗非班氯化钠注射液和pH 2.5缓冲液两种不同介质中,在70℃烘箱中孵育0 h、6 h、12 h条件下进行提取试验,试验检测方法的线性、回收率良好,提取样品试验结果良好。检测结果显示,不锈钢管道中的铬、锰、铁、锌、铝元素溶出量均远小于PDE值,未溶出有毒有害物质。盐酸替罗非班氯化钠注射液与不锈钢管道相容性良好,为医药企业不锈钢管道安全性研究提供技术支持。

In this paper,the stainless steel pipeline for tirofiban hydrochloride sodium chloride injection was used for extraction test in two different media of tirofiban hydrochloride sodium chloride injection and pH 2.5 buffer solution in an oven at 70℃under the conditions of 0 h,6 h and 12 h.The linearity and recovery of the test method were good,and the test results of extraction samples were good.The test results showed that the dissolution of chromium,manganese,iron,zinc and aluminum in the stainless steel pipeline was far less than the PDE value,No toxic and harmful substances are dissolved.Tirofiban hydrochloride sodium chloride injection has good compatibility with stainless steel pipes.This study provides technical support for the safety research of stainless steel pipes in pharmaceutical enterprises.