正交试验优选氯化血红素缓释固体分散体处方

Orthogonal experiment optimizing the formulation of the sustained release solid dispersion of hemin

目的:探讨氯化血红素缓释固体分散体处方组成。方法:以乙基纤维素为载体,聚乙二醇为致孔剂,采用溶剂法制备氯化血红素缓释固体分散体,用体外释放度为考察指标,运用正交试验对氯化血红素缓释固体分散体最佳处方组成优选。结果:按优选出的最佳处方组成,制备氯化血红素缓释固体分散体,2h的累积体外释放度为30.3%,符合药典规定,6h的累积体外释放度为62.5%,12h的累积体外释放度大于90%,优化后处方药物释药过程符合Higuchi方程。结论:本处方组成制成固体分散体后,氯化血红素的缓释效果显著,提示本处方可行。

OBJECTIVE To study the optimal formulation of the sustained release solid dispersion of hemin. METHODS The sustained release solid dispersion of hemin was prepared by the method of solvent, with ethylcellulose（EC） as carrier and polyethylene glycol（PEG） as porosity-making agent. The best formulation of the solid dispersion of hemin was optimized with orthogonal experiments, using the in vitro dissolution as an index. RESULTS The in vitro drug release of the solid dispersion of hemin was 30.3% for 2 h in accordance with the Chinese Pharmacopoeia standent,62.5% for 6 h and 900% for 12 h, the re lease percentage of optimal formulation complied with Higuchi equation. CONCLUSION The solid dispersion of hemin was prepared,with sustained release property. The formulation is feasible.