Preparation and Quality Standard of Bifonazole Hollow Effervescent Suppository / 中国药房

ABSTRACT

OBJECTIVE: To prepare bifonazole hollow effervescent suppository and establish its quality standard. METHODS: Bifonazole hollow effervescent suppository was prepared by hot-melting method, 38-type semisynthetic glyceride as the base material, NaHCO3 and citric acid as the effervescent agent, bifonazole as main ingredient. UV spectrophotometry was used for the content determination of bifonazole. RESULTS: The weight of prepared suppository was about 2.3 g and mean size of maximal foaming capacity were all above 8 mL. The linear range of bifonazole were 1.015～10.15 ?g?mL-1(r=0.999 9) with an average recovery of 99.74% (RSD=1.28%). CONCLUSION: The established preparation is simple, practical and up to the standard. The content determination method is precise and accurate.