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.
出处
《中国新药杂志》
CAS
CSCD
北大核心
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#)
关键词
缓释制剂
依托泊苷
体内外相关性试验
sustained-release formulations
etoposide(VP-16)
relationship between in vivo and in vitro test
