浅谈溶出度检查方法的研究

目的:建立一个有效的溶出度检查方法,并对检查方法进行验证。方法:参考相关文献和技术指导原则,结合国内药品研发生产的实际状况和笔者的工作体会,重点对溶出度检查方法的建立和相关验证工作进行介绍。结果:溶出度检查方法研究不但需关注方法的建立,更需重视对方法的合理性和方法对制剂质量变化的分辨效力等进行验证。结论:建立一个有效和适合的溶出度检查方法,不但是对药品生产和质量控制的需要,也对药品上市后产品质量的一致性的评估起着重要作用。

Studies on dissolution test methods

Objective:This article is intended to address on developing and validating an meaningful and effective dissolution methods.Method:Developing and validating methods are summarized on the basis of some articles and technical guidelines.Result:Studies on dissolution methodology,apparatus and mediums for dissolution testing is introduced.Also robustness and the discriminatory power of dissolution method should be designed to study and demonstrate the suitability of the method.Conclusion:An effective dissolution method is important to help ensure continuous drug product quality and performance after certain post approval manufacturing changes.