盐酸普鲁卡因注射液稳定性考察  

Investigation on stability of procaine hydrochloride injection

作　　者：尤本明[1] 宋洪杰[1] 

机构地区：[1]第二军医大学长海医院药学部,上海200433

出　　处：《药学实践杂志》2011年第2期125-127,共3页Journal of Pharmaceutical Practice

摘　　要：目的考察温度和湿度对普鲁卡因注射液的稳定性影响。方法取3批供试品,在温度(40±2)℃、相对湿度(75±5)%的条件下,分别取放置0、2、4、6个月的样品。用高效液相色谱法测定盐酸普鲁卡因注射液中盐酸普鲁卡因和其降解产物对氨基苯甲酸的含量。结果普鲁卡因注射液中盐酸普鲁卡因的含量随时间延长逐渐下降,6个月下降了10.42%,降解产物对氨基苯甲酸随时间延长逐渐增加,6个月增加了412.89%。结论普鲁卡因注射液在温度(40±2)℃和相对湿度(75±5)%条件下不稳定。Objective To investigate the effect of temperature and humidity on the stability of procaine hvdrochloride injection. Methods Three batches of the test samples were stored in condition of 40±2 centigrade,relative humidity 75%±5%for 0 month,2 months.4 months and 6 months respectively.Contents of procaine hydrochloride and its degradation product p-amino benzoic acid were determined in procaine hydrochloride injection by RP-HPLC.Results The content of procaine hydrochloride injection gradually decreased by 10%in 6 months,degradation products p-amino benzoic acid gradually increased by 412.89%in 6 months.Conclusion Procaine hydrochloride injection was instability in 40±2 centigrade and 75%±5%relative humidity condition

关 键 词：盐酸普鲁卡因注射液 稳定性 对氨基苯甲酸 高效液相色谱法 

分 类 号：R971.2[医药卫生—药品] R94[医药卫生—药学]