熔融法制备非诺贝特固体分散体及体外溶出研究

Preparation of Solid Dispersion of Fenofibrate by Melting Method and Its Dissolution Rate

目的:制备非诺贝特固体分散体。方法:采用熔融法制备,考察药物和载体的比例、混合温度、冷却温度对溶出率的影响,比较固体分散体和物理混合物的溶出率的区别。结果:药物和载体比例达到1∶2时,载体的量足够使药物分散均匀;混合温度对溶出率影响较大;冷却温度对溶出率影响不大。与物理混合物相比,固体分散体将非诺贝特的溶出率显著提高。结论:非诺贝特固体分散体提高了非诺贝特的体外溶出率。

Objective：To prepare solid dispersion of fenofibrate.Methods：Melting method was adopted to prepare solid dispersion.The influences of the ratio of the drug to carrier,mixing temperature and cooling temperature on the dissolution of drug were investigated.The differences among the dissolutions of fenofibrate,physical mixture and solid dispersion were explored.Results：When the ratio of the drug to carrier rose to 1∶2,the amount of the carrier was enough to distribute the drug evenly.Cooling temperature had little influence on the dissolution of drugs while mixing temperature had strong influence on the dissolution of drugs.The in vitro test showed that dissolution rate of the prepared solid dispersion was faster than that of fenofibrate and physical mixture.As compared with physical mixture,the dissolution rate of fenofibrate was significantly improved by solid dispersion.Conclusion：Solid dispersion with melting improves the in vitro dissolution rate of fenofibrate.