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.
出处
《牙体牙髓牙周病学杂志》
CAS
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)
关键词
奥硝唑
培氟沙星
栓剂
稳定性
ornidazole
pefloxacin
suppository
stability
作者简介
张国栋（1978-）男，汉族，江西新干人，硕士生（导师：刘鲁川），主治医师
通讯作者：刘鲁川，Tel：023-68757738
