摘要
目的：制备新型酮康唑缓释喷膜，观察其对湿疹和体癣豚鼠模型的疗效。方法：以壳聚糖盐酸盐为成膜辅料，研制新型酮康唑喷膜，采用HPLC法测定其含量。色谱条件：Waters Symttry C18色谱柱（250mm×4．6mm，5μm）；流动相为甲醇-磷酸二氢钾缓冲液（4：1）；流速为0．6ml／min；检测波长为239nm；柱温为（22±2）℃。建立新型酮康唑喷膜的质量控制标准。观察新型酮康唑喷膜对豚鼠湿疹和体癣模型的疗效，以喷膜基质作对照，并分别与地塞米松止痒霜和复方酮康唑霜的疗效相比较。结呆：酮康唑和醋酸地塞米松的线性范围分别为0．2～2．0mg／ml和0．02～0．20mg／ml；回收率分别为98．41％和97．84％；两者日内RSD和日间RSD分别为1．17％和1．26％、1．57％和1．40％。皮肤刺激性实验表明其对豚鼠皮肤无刺激。新型酮康唑喷膜对湿疹和体癣模型疗效分别与地塞米松止痒霜和复方酮康唑霜相当。结论：新型酮康唑喷膜制备工艺简单，对湿疹和体癣模型疗效确切，具备复方制剂的优势。
Objective：To prepare a novel slow-releasing ketoconazole spraying membrane and to observe its effect on eczema and tinea corporis in guinea pigs. Methods： A novel ketoconazole spraying membrane was prepared with chitosan chlorhydrate as the membrane material. The contents of ketoconazole and desamethasone in the spraying membrane were assayed by HPLC. The separation was performed on Waters Symttry C18 column（250 mm×4. 6 mm, 5μm）, with the mobile phase consisting methanol-potassium dihydrogen phosphate buffer （4 ： 1）, at a flow rate of 0.6 ml/min. The dectection was carried out with a UV detector at 239 nm, at （22~2）oC. The quality criteria for the novel ketoconazole spraying membrane was established. The curative effect of the ketoconazole spraying membrane on eczema and tinea corporis was observed in guinea pigs and was compared with those of spraying membrane matrix, desamethasone antipruritics cream and compound ketoconazole cream. Results： The calibration curves of ketoconazole and desamethasone were linear between 0.2-2.0 mg·ml^-1 and 0.02-0.20 mg·ml^-1 , respectively; the recoveries for ketoconazole and desamethasone were 98.41% and 97.84%, respectively. The intra-day and extra-day RSDs for ketoconazole were 1.17 % and 1.26 %, respectively, and for desamethasone were 1.57 % and 1.40 %, respectively. Stimulation test showed that the spraying membrane had no irritative effect on the skin of guinea pig. The novel ketoconazole spraying membrane had similar effect on eczema and tinea corporis as those of desamethasone antipruritics cream and compound ketoconazole cream. Conclusion： This novel ketoconazole spraying membrane is easy to prepare and has obvious therapeutic effects on eczema and tinea corporis in guinea pigs, making it favourable for containing combined agents.
出处
《第二军医大学学报》
CAS
CSCD
北大核心
2006年第2期146-149,共4页
Academic Journal of Second Military Medical University
基金
全军医药科研"十五"规划课题(01MA151)~~
关键词
酮康唑
地塞米松
喷膜
湿疹
体癣
豚鼠
ketoconazole
desamethasone
spraying membrane
eczema
tinea corporis
作者简介
易雪梅，硕士．
Corresponding author. E-mail：wenhai98@sohu.com.
