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.
出处
《中国药物警戒》
2013年第9期567-570,共4页
Chinese Journal of Pharmacovigilance
关键词
丹参注射液
不溶性微粒
原儿茶醛
正交实验
salvia injection
insoluble particle
protocatechuic aldehyde
orthogonal test
