RESUMEN
OBJECTIVE: To prepare double-layer sustained release ornidazole films and investigate its release rate in vitro.METHODS: The double-layer sustained release ornidazole films film were prepared by the method of homogenate.The formula of the films were optimized by orthogonal experiment with the mass ratio of polyviol to CMC-Na(factor A),the total amount of polyviol and CMC-Na(B) and the amount of glycerol(C) as factors.The concentration of ornidazole was determined by ultraviolet spectrophotometry and its release rate was also computed.RESULTS: The double-layer sustained release film was well-shaped.The optimized formula of the film was as follows: factor A=1∶1,B=4.5 g,C=4.0 g.The standard curve of ornidazole was linear within a range of 1～20 ?g?mL-1(r=0.999 5,n=6),with an average recovery of 100.3%(RSD=1.3%,n=5).A continuous releasing of 11.0 hours was achieved for the prepared films and its cumulative release amount in vitro within 8 hours reached 81.50%.CONCLUSIONS: The preparative method of the films was simple,and the film had a slow-release property.