丹参注射液与输液配伍的稳定性研究  

Study of Compatible Stability on Salvia Injection and Transfusion

作　　者：林小明[1] 黄敏[2] 朱坚[3] 

机构地区：[1]广西贵港市人民医院,广西贵港537100 [2]广西中医药大学第一附属医院,广西南宁530023 [3]广西民族医院,广西南宁530001

出　　处：《中国药物警戒》2013年第9期567-570,共4页Chinese Journal of Pharmacovigilance

摘　　要：目的考察多因素对丹参注射液与输液配伍后稳定性的影响,优选出最佳配伍方案。方法采用正交试验,以溶液中微粒、原儿茶醛含量为观察指标,用GWF-5J型微粒分析仪测定溶液中不溶性微粒数,用HPLC法测定溶液中原儿茶醛含量。结果配伍温度、放置时间对溶液中原儿茶醛的含量有显著性影响;剂量对溶液中微粒的含量有显著性影响。结论丹参注射液最佳配伍条件为25℃、剂量20mL、放置2h、与100 mL氯化钠注射配伍。Objective To investigate the effect of multiple factors on compatible stability in salvia injection and transfusion so as to achieve the optimal program. Methods The particle content was measured by GWF-5J particle analyzer with orthogonal test, and the particles in solution and protocatechuic aldehyde content were used as indicators. The pro- tocatechuic aldehyde content in solution was determined by HPLC. Results Effect of compatible temperature and stored time on protocatechuic aldehyde content was statistically significant. In addition, effect of dose on particle content in solution was statistically significant. Conclusion The optimal compatible match of salvia injection was to combine with 100 mL sodium chloride injection at 25℃ for 2 hours.

关 键 词：丹参注射液 不溶性微粒 原儿茶醛 正交实验 

分 类 号：R917[医药卫生—药物分析学]