正交试验优选洛伐他汀胶囊处方工艺

Optimization of the Formulation and Technology of Lovastatin Capsule by Orthogonal Test

目的:优选洛伐他汀胶囊处方工艺。方法:设计正交试验优选最佳制备条件并进行体外溶出度试验。结果:根据单因素分析及正交试验结果,得最佳处方:以10%聚乙烯吡咯烷酮为黏合剂、羧甲基淀粉钠内外加法(2∶1)为崩解剂,并以颗粒装囊,二次制粒时以75%乙醇为润湿剂。优选工艺所制胶囊30min体外溶出度在92%以上。结论:该制剂工艺稳定,重现性好,体外溶出速率高。

OBJECTIVE： To optimize the preparation technology for the lovastatin capsules. METHODS： Orthogonal test was used to optimize the conditions for the technology of preparation meanwhile a dissolution test was conducted. RESULTS： According to the results of the single factor analysis and orthogonal test, the optimal condition for the lovastatin capsules were as follows： agglomerant： 10%PVP; disintegrator： CMS-Na was used by combining exterior and interior addition （2 ： 1）; stuffing capsule by granules; wetting agent of twice granulating： 75% alcohol. The 30 min dissolution rate of the capsules prepared in the optimized technology reached above 92%. CONCLUSION： This preparation is stable in technology, reproducible and with high dissolution rate.