摘要
目的在模拟流通和使用条件下研究鲑鱼降钙素鼻喷剂的稳定性。方法采用高效液相色谱法,测定分别在25,40,60℃,相对湿度60%的条件下储存3 d,在5℃冰箱中放置2周,再于25℃放置2周和4周后,国产和进口鲑鱼降钙素喷鼻剂含量、pH、有关物质(降钙素C以及其他杂质)的含量变化。结果国产和进口两种鼻喷剂在模拟运输使用条件下pH、有关物质(降钙素C以及其他杂质)均没有发生显著变化。鲑鱼降钙素含量显著下降,但是仍在质量标准规定的范围内。结论国产鲑鱼降钙素喷鼻剂与进口药品具有相似的稳定性。
OBJECTIVE To investigate the stability of salmon ealeitonin nasal spray under stimulated transportation and usage condition. METHODS The domestic and imported salmon calcitonin nasal sprays were under 25,40,60 ℃, RH 60% for 3 d, then at 5 ℃ for 2 weeks, at last under 25 ℃ for 2 weeks （imported） and 4 weeks （domestic）. Samples were collected at designed time intervals. The pH, contents of salmon calcitonin, calcitonin C and related peptides were determined by HPLC method. RESULTS There are no significant difference in pH, calcitonin C and related peptides between domestic and imported nasal sparys. The contents of salmon calcitonin were decreased during the storage period, CONCLUSION Domestic and imported drugs show similar stability under the storage conditions.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2007年第4期298-300,共3页
Chinese Pharmaceutical Journal
关键词
鲑鱼降钙素喷鼻荆
流通
使用
稳定性
salmon calcitonin nasal spray
transportation
usage
stability
