复方氟替阴道泡腾栓的制备及其质量控制  

Preparation and Quality Control of Compound Fleroxacin-tinidazole Vaginal Effervescent Suppository

作　　者：陈梅[1] 

机构地区：[1]连云港市第一人民医院药学部,江苏连云港222001

出　　处：《中国药房》2014年第25期2343-2345,共3页China Pharmacy

摘　　要：目的：制备复方氟替阴道泡腾栓，并进行质量控制。方法：以盐酸氟罗沙星、替硝唑为主药制成复方氟替阴道泡腾栓，采用高效液相色谱法同时测定两种主药含量，并初步考察其稳定性和家兔阴道刺激性。结果：所制栓剂为淡黄色圆锥形，鉴别、检查项均符合2010年版《中国药典》相关要求，每粒泡腾栓含氟罗沙星200mg、替硝唑500mg；氟罗沙星和替硝唑的检测质量浓度线性范围分别为10．0～80．0μg／ml（r=0．9986）和20．0～160．0μg／ml（r=0．9994），平均回收率分别为99．90％（RSD=0．57％，n=3）、99．94％（RSD=0．23％，n=3）：该制剂于5、25、35℃下放置3个月稳定性指标未见明显变化；局部用药对家兔阴道无明显刺激性。结论：该制刑制备工艺可行，质量稳定可控。OBJECTIVE： To prepare the Compound fleroxacin-tinidazole vaginal effervescent suppository and establish a method for its quality control. METHODS： Fleroxacin hydrochloride was compatible with tinidazole to form the vaginal effervescent suppository. The contents of 2 main components were determined by HPLC, and quality control method was initially used to investigate its stability and irritation. RESULTS： The preparation was faint yellow conical in shape. The identification and examination items were in line with the requirements of Chinese Pharmacopeia （2010 edition）, and each suppository contained fleroxacin 200 mg and tinidazole 500 rag. The linear ranges of fleroxacin and tinidazole were 10.0-80.0 μg/ml （r=0.998 6） and 20.0-160.0 μg/ml （r=0.999 4）, respectively; average recoveries were 99.90%（RSD=0.57%, n=3）and 99.94%（RSD=0.23%, n=3）respectively. The indicator of preparation was stable at 5℃, 25 ℃and 35 ℃ for 3 months, and local use of the preparation had no significant irritation to vagina of rabbits. CONCLUSIONS： The preparation is feasible in technology and controllable in quality.

关 键 词：氟罗沙星 替硝唑 阴道泡腾栓 制备 质量控制 高效液相色谱法 

分 类 号：R943[医药卫生—药剂学] R944.23[医药卫生—药学]