复方氟尿嘧啶凝胶的制备及质量控制

Preparation and Quality Control of Compound Fluorouracil Gel

目的:制备复方氟尿嘧啶凝胶并建立其质量控制方法。方法:以卡波姆-940为基质制备凝胶;采用反相高效液相色谱法测定其中主药含量,同时考察制剂稳定性及刺激性。结果:所制备凝胶涂展性好,性状、鉴别、检查等均符合2005年版《中国药典》相关规定;氟尿嘧啶、氢化可的松检测浓度的线性范围分别为0.06～0.14(r=0.9998)、0.006～0.014mg.mL-1(r=0.9999),平均回收率分别为100.70%(RSD=0.51%)、99.88%(RSD=0.83%);室温避光条件下放置6mo各项指标未见明显变化,刺激性与空白基质比较未见明显差异。结论:本制剂制备工艺简便可行,质量稳定可控。

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 RPHPLC, 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 which 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.