多因素多水平多指标考察丹参注射液与溶媒配伍的稳定性  

Study on Compatibility Stability of Salvia Injections in Solvents by Multiple Factors,Levels and Indices

作　　者：林小明[1] 黄敏[2] 朱坚[3] 

机构地区：[1]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 [3]广西民族医院

出　　处：《中国药师》2013年第10期1478-1481,共4页China Pharmacist

摘　　要：目的：考察多因素对丹参注射液与溶媒配伍后稳定性的影响,优选出最佳配伍方案.方法：选择温度、剂量、放置时间、溶媒、溶媒用量5个影响因素,采用L18（37）正交试验表,用GWF-5J 型微粒分析仪测定溶液中微粒含量,用HPLC法测定溶液中丹参素钠、原儿茶醛、丹酚酸B和迷迭酸含量.结果：配伍温度、放置时间对溶液中丹参素钠、原儿茶醛、丹酚酸B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：丹参注射液合理配伍条件为25℃、剂量20 ml、与100 ml 0.9%氯化钠注射配伍放置2h、稳定性较好.Objective： To investigate multiple factors on the compatibility stability of salvia injections mixed with different sol- vents. Method： L18 （3^7 ） of orthogonal design was used with five factors ： temperature, dose, storage time, solvent and amount of sol- vent. The insoluble particles were observed by a GWF-5J type particle analyzer. Sodium danshensu, protocatechuic ,salvianolic acid B and rosmarinci acid were determined by HPLC. Result： The temperature and time showed significant effects on the contents of sodium danshensu, salvianolic acid B and protoeatechuic aldehyde, and dosage could influence the number of insoluble particles. Conclusion ： The optimal compatibility conditions are the follows： temperature of 25℃, concentration of 20 ml, compatibility time of 2 h, and 100 ml sodium chloride injections as the solvent.

关 键 词：丹参注射液 配伍 含量 稳定性 

分 类 号：R942[医药卫生—药剂学]