Method for determining release degree of aripiprazole microspheres by using flow cell method

The invention provides a method for determining the release degree of aripiprazole microspheres by using a flow cell method, which comprises the following steps: respectively taking PBS buffer solutions containing monopotassium phosphate, sodium hydroxide and a surfactant with different pH values as a first release medium and a second release medium to sequentially release aripiprazole microspheres, wherein the pH value of the first release medium is 1.4 to 3.4 higher than the pH value of the second release medium. Compared with a traditional release method, the method can better simulate the in-vivo process of the drug, has good in-vivo and in-vitro correlation, is more suitable for determination of insoluble preparations, and does not cause sample loss during liquid change. 本发明提供了一种使用流通池法测定阿立哌唑微球的释放度的方法，其以pH值不同的包含磷酸二氢钾、氢氧化钠和表面活性剂的PBS缓冲液分别作为第一释放介质和第二释放介质依次使阿立哌唑微球进行释放，其中所述第一释放介质的pH值比所述第二释放介质的pH值高出1.4-3.4。所述方法相对于传统的释放方法更能模拟药物在体内的过程，具有良好的体内外相关性，也更适合难溶性制剂的测定，且换液时不会导致样品损失。