摘要
目的研究复方氟尿嘧啶凝胶的制备及质量控制方法,并对其临床疗效进行观察。方法以卡波姆-940为基质,加入氟尿嘧啶、氢化可的松制成水溶性凝胶。对其外观、含量、稳定性和刺激性等质量进行考察,并对其临床治疗效果进行观察。结果本品外观均匀细腻,采用高效液相色谱法测定两种主药含量而互不干扰,临床疗效优于对照组。结论制备工艺可行,质量可控制,疗效理想。
OBJECTIVE To study the prepartion process, quality control and clinical effect of the compound fluorouracil gel. METHODS The compound fluorouracil gel was prepared by mixing the fluorouracil and hydrocortisone into carbomer 940 basis. Its quality indices, such as appearance, concentration, stability,irritation to skin etc were also detected. The clinical effect of the gel was observed,too. RESULTS The quality of the gel was promising and easy to be controlled by HPLC, and its clinical effect was better than the control group. CONCLUSION The preparation process of the compound fluorouracil gel is practicable,the method of quality control by RP-HPLC is reliable and its clinical effect is good.
出处
《中国现代应用药学》
CAS
CSCD
北大核心
2008年第5期460-462,共3页
Chinese Journal of Modern Applied Pharmacy
