盐酸氨溴索-离子交换树脂口服缓释混悬液的制备、体外释放及体内药动学评价

中国药物警戒 ›› 2017, Vol. 14 ›› Issue (1): 22-26.

盐酸氨溴索-离子交换树脂口服缓释混悬液的制备、体外释放及体内药动学评价

张永娥, 张学农^*

苏州大学医学部药学院,江苏苏州 215006

收稿日期:2016-10-27 修回日期:2017-02-16 出版日期:2017-01-20 发布日期:2017-02-16
作者简介:张永娥,女,本科,高级工程师,药物新型给药系统及缓控释新材料与新技术。

Preparation and in Vitro Release and in Vivo Pharmacokinetics Evaluation of Ambroxol Hydrochloride-resin Complex Sustained Release Suspension

ZHANG Yong-e, ZHANG Xue-nong^*

College of Pharmaceutical Science, Soochow University, Jiangsu Suzhou 215006, China

Received:2016-10-27 Revised:2017-02-16 Online:2017-01-20 Published:2017-02-16
Contact: 张学农,男,博士,教授,靶向递药系统和缓控释新材料与新技术。E-mail：zhangxuenong@163.com

摘要/Abstract

摘要： 目的制备盐酸氨溴索口服缓释混悬液,对其释放度和体内药动学行为进行初步考察。方法采用离子交换树脂为载体制备含药树脂微粒,并通过浸渍、包衣后,制备盐酸氨溴索缓释混悬液。对包衣前后的含药树脂微粒及含药树脂缓释混悬液进行释药进行释放度考察和Beagle犬体内药动学研究。结果制得的药物树脂复合物混悬液的释放度与市售缓释胶囊的释药行为一致,且两种制剂的Beagle犬体内药动学行为不存在显著性差异。结论盐酸氨溴索-离子交换树脂复合物混悬液药物传递系统具有良好的缓释效果。

关键词: 盐酸氨溴索, 离子交换树脂, 缓释混悬液, 体外释放, 药动学评价

Abstract: ObjectiveTo prepare the ambroxol hydrochloride-resin complex sustained release suspension and evaluate its in vitro release and in vivo pharmacokinetics. MethodsThe sustained release suspension was prepared by resin optimization, saturation, file coating and dispersion of the complex. Evaluation of the in vitro and in vivo performance of the suspension was carried out. ResultsThe ambroxol hydrochloride-resin complex suspension had similar release behavior and pharmacokinetic parameters with the sustained release capsule product. ConclusionThe resin complex suspension would be another sustained release drug delivery system for ambroxol hydrochloride.

Key words: ambroxol hydrochloride, ion exchange resin, sustained-release suspension, in vitro release, pharmacokinetics evaluation

中图分类号:

R945

张永娥, 张学农. 盐酸氨溴索-离子交换树脂口服缓释混悬液的制备、体外释放及体内药动学评价[J]. 中国药物警戒, 2017, 14(1): 22-26.

ZHANG Yong-e, ZHANG Xue-nong. Preparation and in Vitro Release and in Vivo Pharmacokinetics Evaluation of Ambroxol Hydrochloride-resin Complex Sustained Release Suspension[J]. Chinese Journal of Pharmacovigilance, 2017, 14(1): 22-26.

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