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药物释放度是指药物从制剂中释放出来的速度和程度。片剂释放度则专指药片在适当的介质中,主药释放出来的速度和程度。用片剂释放度的测试方法,可测定片剂在体外溶出的速率,以预测它的生物利用度。片剂释放度的测试方法有多种,标准(包括释放浓度、释放时限、每分钟转速等)也各不同。目前常用的测试方法有:旋转吊篮法、烧杯法、崩解仪法、转瓶法等。下面仅介绍收载在美国药典第19版中的旋转吊篮法。
Drug release refers to the rate and extent of drug release from the formulation. Tablet release refers specifically to the tablet in the appropriate medium, the release rate of the main drug and extent. Using the test for the release of tablets, the rate of dissolution of the tablets in vitro can be determined to predict their bioavailability. There are many ways to test the release of tablets. Standards (including release concentration, release time, RPM, etc.) are also different. At present, the commonly used test methods are: rotating basket method, beaker method, disintegration method, bottle method and so on. The following is a description of the spinning basket method that is included in the 19th edition of the U.S. Pharmacopeia.