缓释制剂的体内外相关性试验及检验  

Examination of relationship between in vivo and in vitro test for sustained-relaease formulations

作　　者：储成顶[1] 王世亮[1] 周浩炳[1] 王彭三[1] 叶红杨[1] 

机构地区：[1]合肥工业大学控释药物研究室

出　　处：《中国新药杂志》2003年第7期540-543,共4页Chinese Journal of New Drugs

基　　金：中华人民共和国科学技术部基础研究快速反应支持项目 (国科基字 [2 0 0 1] 5 1#)

摘　　要：目的 :探讨缓释制剂体内外相关试验方法。方法 :以植入用缓释依托泊苷为例 ,根据体内及体外预试验数据 ,求算对应时间点关联系数K ,按中华人民共和国药典要求作对应时间点的点对点相关试验及检验。结果 :成功进行植入用缓释依托泊苷的体内外相关试验并实现相关。结论 :此法为长效缓释制剂提供了一种体内外相关试验的参考方法。Objective:To investigate the relationship between in vivo and in vitro test for sustained-release formulations.Methods:According to the data of the preliminary experiment,the associated coefficient K of the corresponding time-points were figured out,and then the experiment and test of point-to-point correlation was conducted in the light of the regulation from China pharmacopoeia.Results:The examination of relationship between in vivo and in vitro test for etoposide(VP-16) implants (sustained-relaease VP-16)was carried out and the correlation was obtained successfully.Conclusion:The method may be a reference to sustained-release formulations to do the related experiment in vivo and in vitro.

关 键 词：缓释制剂 依托泊苷 体内外相关性试验 

分 类 号：R944.9[医药卫生—药剂学]