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中国药物评价 ›› 2023, Vol. 40 ›› Issue (5): 396-401.

• 评价技术与方法 • 上一篇    下一篇

几种药物配伍对常见塑料包装输液产品中不溶性微粒的影响研究

田洁, 郝爱鱼, 鹿麟, 邹翩, 董斌*   

  1. 大连市药品检验检测院, 辽宁 大连 116021
  • 收稿日期:2023-04-21 修回日期:2023-08-14 出版日期:2023-10-28 发布日期:2023-10-28

Effect of Several Drug Compatibility on Sub-visible Particles in Infusions with Common Plastic Packagings

  1. Dalian Institute for Drug Control, Liaoning Dalian,China 116021
  • Received:2023-04-21 Revised:2023-08-14 Online:2023-10-28 Published:2023-10-28

摘要: 目的:比较配伍环境、药物、输液包装、注射器、加药次数5个因素对配伍后输液中不溶性微粒的影响。方法:检测内封式聚丙烯输液袋、直立式聚丙烯输液袋、多层共挤输液用袋3种常见塑料包装的氯化钠注射液与2种常用药物经不同方式配伍后所得溶液中的不溶性微粒,并使用方差分析(ANOVA)工具比较5个因素对不溶性微粒的影响。结果:注射器和药物类型是影响最终用于注射的溶液中不溶性微粒数量的主要因素,其次是配伍环境和加药次数,输液包装对最终溶液中不溶性微粒的影响较小。结论:临床上对输液进行配伍时,相比输液包装,更要考虑医疗器械、药物对不溶性微粒的影响。
 

关键词: font-size:medium, ">不溶性微粒;输液;可立袋;吹灌封(BFS)工艺;软袋;药物配伍

Abstract: Objective:To compare effects of five factors,namely,compatible environment, drugs, infusion packagings, syringe and dosage times, on the sub-visible particles in compatible infusions. Methods: Measured the sub-visible particles in sodium chloride infusions with three common plastic packagings (including inner sealed polypropylene bag, collapsible PP bottle and multi-layer co-extrusion bag) and two commonly used drugs after the compatibility through different compatibility modes, analysis of variance (ANOVA) was used to compare the effect of five factors on the sub-visible particles. Results: The results showed that syringe and drugs were the main factors affecting the number of sub-visible particles in the infusions after drug compatibility, followed by the compatible environment and dosage times. Type of infusion packagings had little effect on the number of sub-visible particles in the infusions after drug compatibility. Conclusion: When dispensing infusion solutions in clinic, it is more important to consider the influence of medical instruments and drugs on sub-visible particles than infusion packaging.
 

Key words: font-size:medium, ">Sub-visible particles; Infusion; Collapsible PP bottle; Blow-fill-seal(BFS); Soft bag; Drug compatibility

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