溶出度试验在药品质量控制中的应用

论述溶出度试验在药品质量控制中的发展概况、试验方法、溶出介质的选择、溶出量的测定及溶出度试验在片剂、胶囊剂、栓剂、微丸等固体制剂中的应用。溶出度试验是在体外对体内生物利用度进行研究与评价的有效替代方法,是衡量制剂工艺是否合理的一项重要手段,它的研究和应用不断促进了药物研制水平,强化了药品质量控制手段,在药物的研制、生产和指导临床用药方面具有重要意义。

The research and application of dissolution test in drug quality control

This paper reports the development survey in test method and the selectivity of dissolution medium as well as the determination of elution amount during drug quality control by means of dissolution test(DT).It elucidates the research and application of DT in various solid preparations such as tablets,capsules,suppository,micro-pills indicating the DT is an effective substitution methods for the research and evaluation of the biology efficacy from vitro to vivo of body and also an important method to evaluate whether medicine procession is reasonable.The research and application of DT will promote the level of drug preparations and enforce the drug quality control process.It shows it has significance in the research,production and utilization of clinical drugs.