摘要
目的制备氯雷他定口崩片并评价其稳定性.方法采用粉末直接压片法制备氯雷他定口崩片.以崩解时限和口感为评价指标,在预试验基础上,采用正交试验优化处方组成和制备工艺.按2005年版药典的规定评价其质量,通过影响因素试验,初步稳定性考察试验评价其稳定性.结果采用优化处方和工艺制备的氯雷他定口崩片口感良好,崩解时限为30s,10min溶出达95%,各项指标符合药典规定要求,稳定性良好.结论氯雷他定口崩片处方合理,制备工艺简单,适合工业生产.
OBJECTIVE To prepare Loratadine Orally Disintegrating Tablets, and evaluate its stability. METHODS Loratadine by direct compression powder made from orally disintegrating tablets. The best formulation and preparation technology were optimized by orthogonal experiment design using the disintegration time and taste as the evaluation as indexes on the basis of the pre-trial. Its quality was evaluated in accordance with the provisions of Chp 2005. The stability of Loratadine Orally Disintegrating Tablets was evaluation through the study of factors affecting test and study the preliminary stability test. RESULTS Loratadinc Orally Disintegrating Tablets prepared by the optimized prescription taste was good,the disintegration time was 30s and the dissolution was 95% in 10min, others tests comply with Chp 2005, the stability was good. CONCLUSION The flomlulation technology of Loratadine Orally Disintegrating Tablets was simple,reasonable,and was suitable for industrialization production.
出处
《齐鲁药事》
2010年第2期108-110,共3页
qilu pharmaceutical affairs
关键词
氯雷他定
口崩片
正交试验设计
崩解时间
Loratadine
orally disintegrating tablets
orthogonal experiment design
disintegration time
