联苯苄唑中空泡腾栓的制备及质量标准研究

目的:制备联苯苄唑中空泡腾栓并建立其质量标准。方法:用半合成脂肪酸甘油酯作为栓剂基质,碳酸氢钠、柠檬酸为发泡剂,联苯苄唑为主药,热熔法制备中空泡腾栓,用紫外分光光度法对主药进行含量测定。结果:所制中空泡腾栓栓重约为2.3g,最大发泡量体积平均值大于8mL;联苯苄唑检测浓度线性范围为1.015～10.15μg·mL-(1r=0.9999),平均回收率99.74%(RSD=1.28%)。结论:联苯苄唑中空泡腾栓制备方法简便可行,达到了设计要求;含量测定方法精密度高,结果准确。

Preparation and Quality Standard of Bifonazole Hollow Effervescent Suppository

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 μg·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.