摘要
目的:制备复方加替沙星凝胶并建立其质量控制方法。方法以加替沙星为主药配伍地塞米松磷酸钠,选用卡波姆-940为基质制备复方凝胶。采用高效液相色谱法测定加替沙星、地塞米松的含量,并进行离心试验耐热耐塞等试验。结果加替沙星、地塞米松检测浓度线性范围分别为20-140μg／mL和4-28μg／mL,平均回收率分别为100．55％(RSD=0．88％)、100．38％(RSD=0．62％),其他试验均符合凝胶剂有关规定。结论本制剂制备工艺简单、性质稳定、质量可控。
OBJECTIVE： To establish the preparation and method of quality control of compound Gatifloxacin gel （CGG）. METHODS： Gatifloxacin was used as principal agent to be mixed with dexamethasone sodium phosphate. Carbomer-940 Was taken as base material for preparation CGG. The content of Gatifloxacin and Dexamethasone were determined by HPLC method. Test of centrifugation, heat-resistant and cold-resistant were prosecuted. RESULTS： The linear ranges for detection concentration of Gatifloxacin and Dexamethasone were 20~140 μg/mL and 4~28 μ g/mL, respectively. The average recovery rates of which were 100.55% （RSD=0.88%）, and 100.38% （RSD=0.62%） respectively. Other tests accord with the requirements of gel. CONCLUSION： the preparation of CGG is simple, the gel is stable and its quality can be controlled.
出处
《医药世界》
2006年第8期53-55,共3页
Medicine World
关键词
加替沙星
地塞米松
复方凝胶
制备
质量控制
Gatifloxacin
Dexamethasone
Compound Gel~ preparation
Quality control.
