溶出度系指药物从片剂或胶囊剂等固体制剂在规定介质中的溶出速度和程度,是在体外对体内生物利用度进行研究与评价的有效的替代方法,也是保证和衡量固体口服制剂生产工艺和质量是否合理和稳定的一项重要手段。据国内外研究结果表明,有的固体制剂崩解虽然很快,但主药并不一定溶出并被人体吸收,其生物利用度必然不好,因此,检查溶出度对固体口服制剂保障其质量与疗效是十分关键的环节。1970年《美国药典》首先将溶出度列入检查项,此项目一经推出便迅速得到广泛应用,先后被英国、日本及我国药典收载。十多年来,经各国药学工作者广泛实验,溶出度实验越来越接近人 Dissolution is defined as the rate and extent of drug dissolution from a solid formulation, such as a tablet or capsule, in a defined medium and is an effective alternative to in vivo bioavailability studies and evaluations as well as to assure and measure the production of solid oral preparations Technology and quality is reasonable and stable an important means. According to the domestic and foreign research results show that although some solid preparation disintegration is fast, but the main drug is not necessarily dissolved and absorbed by the body, its inevitability of bioavailability is not good, therefore, check the dissolution of solid oral preparation to ensure its quality and Efficacy is a crucial link. In 1970, “the United States Pharmacopoeia” first included in the examination of dissolution, this project has been widely used immediately after it was introduced, has been the United Kingdom, Japan and China Pharmacopoeia. For more than a decade, extensive experiments by pharmaceutical workers in various countries have led to more and more dissolution experiments