复方奥硝唑甲磺酸培氟沙星缓释牙栓的稳定性试验  

Stability test of sustained-release periodontal suppository of ornidazole and pefloxacin

作　　者：张国栋[1] 刘鲁川[1] 傅若秋[1] 徐靖[1] 苏军[1] 刘娜[1] 

机构地区：[1]第三军医大学大坪医院野战外科研究所,重庆400042

出　　处：《牙体牙髓牙周病学杂志》2008年第4期216-219,共4页Chinese Journal of Conservative Dentistry

基　　金：重庆市科委基金资助项目(CSTC;2004BB5065)

摘　　要：目的:考察复方奥硝唑甲磺酸培氟沙星缓释牙栓的稳定性。方法:按中国药典的规定进行影响因素试验和加速试验,考察其性状、外观、含量、释放度以及有关物质的变化。结果:本品在高湿(25℃、RH92.5%、75%)、高温(40、60℃)条件下,其性状、外观、含量、溶出率以及有关物质均符合规定;在光照(4500±500)Lx条件下,其含量、释放度和有关物质符合规定,但其颜色由浅黄色变为棕褐色。进行6个月的加速试验后,其上述各项指标均符合规定。结论:缓释牙栓稳定性良好,本品应在凉暗处保存。AIM： To study the stability of the sustained - release periodontal suppository of ornidazole and pefloxacin. METHODS： According to the relevant guidelines of the Chinese Pharmacopoeia, the stress condition testing and accelerated test were conducted to investigate the changes of ornidagole and perfloxaein in appearence, content, dissolution rate and related substances. RESULTS： Under conditions of high humidity（25℃ , RH 92.5% ,75% ） and hight temperature（40,60℃ ） ,its appearance,content, dissolution rate and related substances were eligible, After irradiation of strong light（4500 ± 500）Lx,its content,dissolution rate and related substances were eligible, but it g colour was changed from light yellow to brown. After six monthg accelerated test, its index of above mentioned were eligible too. CONCLUSION： The sustained-release periodontal suppository have good stability. The preparation should be stored in cool place and protected from strong light.

关 键 词：奥硝唑 培氟沙星 栓剂 稳定性 

分 类 号：R781.4[医药卫生—口腔医学]