一、概述溶出度测定是近几年中迅速发展起来的一种控制固体药物制剂质量的体外检测方法,是研究固体制剂及半固体制剂所含主药的晶型,粒度,处方组成,辅料品种和性质,生产工艺等对制剂质量的影响的方法。由于溶出试验方法的发展和应用,证实了它在控制制剂质量方面所占的重要地位,所以各国药典都相当重视,美国药典从第20版收载58个品种到21版时已收载有370个品种,美国认为对所有口服固体制剂都需要做溶出度测定。我国药典1985年版收载有7个品种,而1990年版准备收载几十个品种。而且对溶出度测定的原则也有新的概念: First, an overview Dissolution is the rapid development in recent years, a control solid pharmaceutical preparations in vitro detection method is to study solid formulations and semi-solid formulations containing the main drug crystal form, particle size, prescription composition, accessories varieties And the nature of the production process, such as the impact of the quality of the preparation method. Due to the development and application of dissolution test methods, it confirms its importance in controlling the quality of preparations, so the pharmacopoeia of all countries attach great importance to the United States Pharmacopeia from the 20th edition contains 58 varieties to version 21 has been loaded with 370 A variety of the United States that all oral solid preparations need to do dissolution testing. China Pharmacopoeia 1985 edition contains seven varieties, while the 1990 edition ready to contain dozens of varieties. But also the dissolution of the principle of determination of a new concept: