中国药物警戒 ›› 2014, Vol. 11 ›› Issue (5): 309-311.

• 医院药事管理与合理用药 • 上一篇    下一篇

舒血宁注射液溶媒配伍研究

王艳春1, 李旭东1, 刘莹2, 冯影1   

  1. 1抚顺市药品不良反应监测中心,辽宁 抚顺 113006;
    2大连市药品不良反应监测中心,辽宁 大连 116021
  • 收稿日期:2016-02-03 修回日期:2016-02-03 出版日期:2014-05-08 发布日期:2016-03-02
  • 作者简介:王艳春,女,本科,主管药师,药械不良反应监测与评价。

Study on Solvent Compatibility of Shuxuening Injection

WANG Yan-chun1, LI Xu-dong1, LIU Ying2, FENG Ying1   

  1. 1Fushun Center for ADR Monitoring, Liaoning Fushun 113006, China;
    2Dalian Center for ADR Monitoring, Liaoning Dalian 113006, China
  • Received:2016-02-03 Revised:2016-02-03 Online:2014-05-08 Published:2016-03-02

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摘要： 目的研究舒血宁注射液溶媒变化对用药安全性的影响。方法选取1家医疗机构,对其正在使用的舒血宁注射液分别用5%葡萄糖注射液和0.9%氯化钠注射液做溶媒进行实验室研究,并以0.9%氯化钠注射液做溶媒进行临床病例的回顾性分析。结果舒血宁注射液应用0.9%氯化钠注射液为溶媒,其稳定性、pH值、不溶性微粒均符合《中国药典》2010年版附录项下规定,且临床观察病例未发现不良反应。结论舒血宁注射液以0.9%氯化钠注射液做溶媒进行静脉滴注,虽然说明书中未载明此种用法,但根据临床情况和患者需要,通过实验室比对与临床病例观察相结合的方法进行研究,其安全性在该实验条件下是稳定可靠的,建议在研究数据完备的情况下修改药品使用说明书,为临床合理用药提供依据。

关键词: 舒血宁注射液, 溶媒, 稳定性, 不溶性微粒, pH, 临床研究

Abstract: ObjectiveTo study the safety of Shuxuening injection using different solvent. Methods5% glucose in water as solvent and 0.9% NaCl in water as solvent of Shuxuening injection were studied, and the results of 0.9% NaCl in water were analyzed retrospectively in one of our supervised hospital. ResultsThe stability, pH and insoluble substance of Shuxuening injection using 0.9% NaCl in water as solvent were in line with the Chinese Pharmacopoeia(2010 edition), and none adverse reactions were detected. ConclusionAlthough there were no instructions of Shuxuening injection concerning 0.9% NaCl in water as solvent, but our research results could certify the safety and stability of 0.9% NaCl in water as solvent of Shuxuening injection. We suggested that the instruction of Shuxuening injection could be changed for reasonable administration to patients.

Key words: Shuxuening injection, solvent, stability, insoluble particles, pH, clinical research

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