舒血宁注射液溶媒配伍研究

Study on Solvent Compatibility of Shuxuening Injection

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。

Objective To study the safety of Shuxuening injection using different solvent. Methods 5% 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. Results The 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. Conclusion Although 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.