胶塞可挥发性物质的迁移及其对头孢曲松钠的可能影响
The migration and possible influences of the volatile substances from rubber stoppers on ceftriaxone sodium
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摘要: 目的: 研究来源于胶塞的可挥发性物质向头孢曲松钠的迁移,并对这些可挥发性物质与头孢曲松钠的可能影响进行分析。 方法: 应用气相色谱方法对澄清度不合格注射用头孢曲松钠及所用胶塞的可挥发性物质进行测定。 结果: 在头孢曲松钠样品中可测得来源于胶塞的较高沸点可挥发性物质,而较低沸点可挥发性物质及C13H23Br未在头孢曲松钠样品中测得。 结论: 来源于胶塞的高沸点可挥发性物质能够迁移进入头孢曲松钠,并被头孢曲松钠吸附,部分物质能与头孢曲松钠发生进一步的作用。Abstract: Objective To study on the migration and possible influences of the volatile substances from rubber stoppers on ceftriaxone sodium. Methods GC method was used to detect the volatile substances from rubber stoppers and powders of ceftriaxone sodium for injection with clarity problems. Results The volatile substances from rubber stoppers with higher boiling point could be detected in the contacted ceftriaxone sodium samples while the volatile substances with lower boiling point and C13H23Br could not be detected in the samples. Conclusion The volatile substances with high boiling point originated from the rubber stoppers could migrate to ceftriaxone sodium powders and could be absorbed by the powders,and some transferred substances could even further react with ceftriaxone sodium.
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Key words:
- stopper /
- volatile substance /
- ceftriaxone sodium /
- Gas chromatography
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