Preparation and Quality Control of Compound Fluorouracil Gel / 中国药房

ABSTRACT

OBJECTIVE:To prepare compound fluorouracil gel and to establish a method for its quality control.METHODS:Carbomer-940 was used as base material to prepare the compound fluorouracil gel.The content determination of fluorouracil and hydrocortisone was performed by RP-HPLC,and the stability and irritability of this preparation were investigated as well.RESULTS:The gel prepared was well-distributed,with property,identification and tests all in conformity with the description of China Pharmacopeia(2005 edition).The good linear ranges of fluorouracil and hydrocortisone were 0.06～ 0.14mg? mL-1(r=0.999 8)and 0.006～ 0.014mg? mL-1(r=0.999 9),respectively,and the average recovery rates of whi-ch were 100.70%(RSD=0.51%)and 99.88%(RSD=0.83%),respectively.The gel remained stable after storing for 6mo at room temperature away from light,and there was no significant difference in irritability as compared with blank base material.CONCLUSION:The preparation technique of compound fluorouracil gel is simple and practicable,and its quality is reliable.