头孢克肟肠溶滴丸的制备及其质量评价

Preparation and Quality Evaluation of Cefixime Enteric Coated Drop Pills

目的:制备头孢克肟肠溶滴丸并评价其质量。方法:采用滴制法制备头孢克肟滴丸,并包肠溶衣,以圆整度、重量差异及溶散时限作为评定指标,设计正交试验对包衣材料、包衣液浓度、包衣层数进行考察,优选出肠溶滴丸的最佳包衣工艺并进行验证试验,同时考察制剂的体外累积释放度。结果:最佳包衣工艺为包衣材料聚丙烯酸树脂Ⅱ号,包衣液浓度10%,包衣层数3层。验证试验表明制剂的各项指标均符合《中国药典》2010年版相关要求;45min时在碱性释放介质(pH=6.8)中体外累积释放度为(93.4±1.67)%。结论:头孢克肟肠溶滴丸的制备工艺合理,在碱性介质中释放完全,质量合格。

OBJECTIVE：To prepare Cefixime enteric coated drop pills and to evaluate their qualities. METHODS：The drop pills were prepared by dropping method and coated with enteric materials. Enteric coated materials,concentration and the number of layers were checked by orthogonal test using spherical degree,dissolution time and weight difference as evaluation index. And optimal coating conditions were selected. The in vitro accumulative release rate of drop pills was investigated. RESULTS：Optimal coating conditions were as follows：polyacrylic resin Ⅱ,10% concentration of enteric coated materials,3 coating layers. Results of validation test indicated that the quality of drop pills was up to the requirements stated in Chinese Pharmacopeia（2010 edition） . The in vitro accumulative release rate was（93.4±1.67） % at 45 min in the alkalescent medium（pH=6.8） . CONCLUSION：Cefixime enteric coated drop pills are reasonable in preparation technology and have high release rate in the alkalescent medium.