中国药物警戒 ›› 2016, Vol. 13 ›› Issue (3): 180-182.

• 安全性评价与合理用药 • 上一篇    下一篇

血必净注射液与多种溶媒配伍的稳定性研究

高声传,王童超   

  1. 沈阳军区总医院药剂科,辽宁 沈阳110016
  • 收稿日期:2015-09-24 修回日期:2016-04-12 出版日期:2016-03-20 发布日期:2016-04-12
  • 作者简介:高声传,男,硕士,主任医师,临床药学。

Research on Stability of Xuebijing Injection Combined with Different Transfusions

GAO Sheng-chuan, WANG Tong-chao   

  1. Department of Pharmacy, General Hospital of Shenyang Military Area Command, Liaoning Shenyang 110016, China
  • Received:2015-09-24 Revised:2016-04-12 Online:2016-03-20 Published:2016-04-12

PDF (PC)

970

摘要： 目的 探讨血必净注射液与5%葡萄糖注射液、10%葡萄糖注射液、葡萄糖氯化钠注射液和0.9%氯化钠注射液配伍时溶液中pH值、澄明度和不溶性微粒的变化,为临床应用提供依据。方法 参照2010版《中国药典》附录IVC,分别将血必净注射液用5%葡萄糖注射液、10%葡萄糖注射液、葡萄糖氯化钠注射液和0.9%氯化钠注射液配制成临 床常用浓度,放置在室温,并于0、0.5、2、4、8 h和24 h取样,测定其pH值和10 μm、25 μm的不溶性微粒数量,观察溶液澄明度的变化。结果 血必净注射液在葡萄糖注射液中的不溶性微粒较氯化钠注射液中少; 10%葡萄糖注射液中的不溶性微粒较5%葡萄糖注射液中少。因而血必净注射液在10%葡萄糖注射液中稳定性更好。室温条件下放置不同时间,溶液的澄明度和 pH值变化不大, RSD<2%,符合要求。0.9%氯化钠注射液中的不溶性微粒显著增加,超过2010版 《中国药典》 规定的微粒数量。 结论 血必净注射液宜选用10%葡萄糖注射液作为溶媒,其次为5%葡萄糖注射液,并且配置后4小时内应用。

关键词: 血必净注射液, 输液, 配伍, 稳定性

Abstract: Objective To explore the changes of insoluble particle numbers, pH value and clarity of Xuebijing injection in 5% glucose injection, 10% glucose injection, sodium chloride glucose injection and 0.9% sodium chloride injection respectively and to provide evidence for clinical application. Methods According to Chinese Pharmacopoeia (2010) appendix IVC, the changes of Xuebijing mixed solutions were observed in particle numbers, pH value and clarity in clinically used concentrations on 0, 0.5 , 2 , 4 , 8 h and 24 h at room temperature. Results The number of insoluble particles in glucose injection was less than that in 0.9% sodium chloride injection. The number of insoluble particles in 10% glucose injection was less than that in 5% glucose injection. The Xuebijing injection was more stable when blended with 10% glucose injection. At room temperature, there were no significant changes in clarity and pH value, RSD<2%. The result was up to the requirement of Chinese Pharmacopoeia (2010) appendix IVC. The number of insoluble particles in Xuebijing injection exceeded the standard of Chinese Pharmacopoeia (2010) appendix IVC after being blended with 0.9% sodium chloride injection. Conclusion The suitable solvent for Xuebijing injection is 10% glucose injection,secondly 5% glucose injection. The Xuebijing solution should be used in 4 h after being mixed with solvents.

Key words: Xuebijing injection, transfusion, compatibility, stability

中图分类号: