不同制备方法对盐酸普鲁卡因注射液稳定性的影响  

Effects of the Preparative Method on the Stability of Procaine Hydrochloride Injection

作　　者：冯锁民[1] 鲁会侠[2] 罗宇[2] 赵宁[1] 

机构地区：[1]西安医学院,陕西西安710021 [2]西安交通大学医学院第一附属医院,陕西西安710061

出　　处：《儿科药学杂志》2010年第3期44-46,共3页Journal of Pediatric Pharmacy

摘　　要：目的:研究不同制备方法对盐酸普鲁卡因注射液稳定性的影响。方法:在盐酸普鲁卡因注射液制备过程中加入氯化钠、活性炭及依地酸钠等附加剂,用正交函数分光光度法测定灭菌前后注射液中盐酸普鲁卡因的含量,同时用初均速法预测制剂室温的有效期。结果:配制2.0%盐酸普鲁卡因注射液,加入0.9%氯化钠既可调整渗透压,又可抑制盐酸普鲁卡因的水解;加入0.1%活性炭既能除色又能吸附杂质;0.005%依地酸钠既阻止盐酸普鲁卡因水解又抑制其氧化变色。结论:盐酸普鲁卡因注射液处方中加入附加剂氯化钠、依地酸钠,制备过程中加入活性炭制备的制剂稳定性最好,室温保存的有效期最长。Objective：To study the effect of different preparative methods on the stability of procaine hydrochloride injection.Methods：The additional agents of NaCl,activated carbon and EDTA-2Na were added in the preparation process of procaine hydrochloride injection.Orthogonal function Spectrophotometric was used to determination the content of procaine hydrochloride before and after sterilization.Meanwhile the validity duration under room temperature was predicted.Results：NaCl（0.9%）adjusted the osmotic pressure and inhibited the hydrolysis of procaine hydrochloride;0.1%activated carbon adsorpted impurities;0.005%EDTA-2Na not only prevented hydrolysis of procaine hydrochloride,but also inhibited oxidation discoloration.Conclusions：The procaine hydrochloride injection that added the additional agents mentioned above has the longest validation.

关 键 词：盐酸普鲁卡因注射液 稳定性 附加剂 正交函数分光光度法 

分 类 号：R927.2[医药卫生—药学]