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本实验对酮洛芬肠溶胶囊的溶出速率进行了方法学考察,经人工肠液为溶出介质,分别设立篮法(100和120RPM)、桨法(50和75RPM)等四种测定条件,结果显示:篮法测定离散度较小。以篮法100RPM对国内3个厂家5个批号的样品在人工肠液中的溶出速率作了考察,结果表明:尽管各批号Td间差距悬殊(6.22～87.40min),但同批号内溶出速率的离散度更大,使得各批号Td间无显著性差异(p>0.05)。
In this experiment, the dissolution rate of ketoprofen enteric-coated capsules was studied by methodology. The artificial intestinal juice was used as the dissolution medium. Four test conditions, basket method (100 and 120RPM), paddle method (50 and 75RPM) : Basket method to determine the dispersion is small. The results showed that although the dissolution rates of artificial lotion in five batches of three batches of domestic manufacturers (6.22 ~ 87.40 min) were different from each other, the dissolution rate of batches in batches was discretized Degree greater, making no significant difference between the batch number Td (p> 0.05).