摘要
目的 :制备富马酸氯马斯汀干混悬剂。方法 :考察常用的羟丙基甲基纤维素 ( HPMC)、羧甲基纤维素钠( CMC- Na)、聚维酮 ( PVP K90 )、黄原胶、甲基纤维素 ( MC)等辅料对干混悬剂的影响。通过对其沉降体积比、再分散性指标的考察 ,筛选了 2 % HPMC作为助悬剂 ,从流变学、混悬剂黏度及显微形态的观察对其稳定性进行研究。同时考察了药物在加速试验下粒子形态的稳定性。结果 :所制干混悬剂工艺简单、稳定性良好 ,形成混悬液 ,符合干混悬剂的各项质量标准。结论 :本品达到干混悬剂要求 。
Object To prepare clemastine fumarate dry suspension. Methods Effects of following hydrophilic polymer: HPMC, CMC Na, PVP K90, Xanthan gum and MC on the dry suspension were investigated. 2% of HPMC appeared to be a satisfying suspending agent by evaluating the sedimentation rate and its redispersion. Its stability was studied by observing the rheology property, the difference between suspending medium and suspension, microscopic analysis and the influence of polyelectrolyte, respectively. The stability of drug's particle form was also studied at acceleration test Results The dry suspension is stable and can be easily prepared. Conclusion The dry suspension conforms to the quality standard and can be used conveniently for clinic.
出处
《天津药学》
2004年第2期27-29,共3页
Tianjin Pharmacy
关键词
富马酸氯马斯汀
沉降体积比
助悬剂
稳定性
clemastine fumarate,sedimentation rate, suspending agent, stability