质量源于设计(QbD)在布洛芬软胶囊干燥工艺研究中的应用精要.docVIP

摘 要QbD建立在对产品及工艺的充分理解之上，通过风险评估与控制，将质量赋予设计之中。本文采用QbD理念研究布洛芬软胶囊的干燥工艺，得到了科学、可行、可控的控制策略，保证了产品质量。 关键词：Application of Quality by Design Principles for the Study of Drying Process in Ibuprofen Soft Capsules Abstract Ibuprofen as an antipyretic- analgesic and anti-inflammatory drugs is widely used in clinic. A variety of dosage forms have come into the market, where soft capsule receive a warm welcome for high bioavailability, attractive appearance, portability and other advantages. But in the drying process of soft capsules, the existence of deformation, gravure pill, adhesion, rupture, crystalliz