羟基喜树碱缓释片的制备工艺及处方优化研究

目的:制备可脑内植入的羟基喜树碱(HCPT)缓释片,并对其制备工艺及处方进行优化。方法:以辅料聚乳酸(PLA)类型(A)、压片压力(B)、HCPT与PLA的比例(C)3个因素作为考察因素,体外累积释放百分率的偏离度为评价指标,采用正交试验进行工艺及处方的筛选,并进行验证。结果:筛选得到最佳工艺及处方:A为PLA(20000),B为250N,C为1:5。验证处方的偏离度为2.963。结论:采用最优工艺及处方制备的HCPT缓释片符合制剂要求。

Preparation Technology and Optimization of Formulation of Hydroxycamptothecin Sustained - released Tablets

OBJECTIVE： To prepare hydroxycamptothecin sustained - release tablets and to optimize its preparation technology and formulation. METHODS： The preparation technology and formulation were optimized by orthogonal experiment taking the type of excipient polylactic acid （A）, tabletting pressure （B）, ratio of HCPT to PLA （C） as factors with the deviation degree of the accumulative release percentage as evaluation index. Then the optimized results were verified. RESULTS： The optimal technology and formulation were as follows： A was PLA （20 000）, B was 250 N, C was 1 ： 5. The deviation degree of the formulation was verified to be 2.963. CONCLUSION： The hydroxycamptothecin sustained release tablets prepared in optimized preparation technology and formulation are up to the standard on preparation.