盐酸达克罗宁氧氟沙星凝胶的制备与质量控制  

Preparation and quality control of ofloxacin and dydrochloride gel

作　　者：黄靖 李追懿 

机构地区：[1]浙江温州市中西医结合医院,温州325027

出　　处：《海峡药学》2008年第6期17-19,共3页Strait Pharmaceutical Journal

摘　　要：目的 选择羧甲基纤维素钠为主要基质,以聚山梨酯80为增溶剂,研制了达克罗宁氧氟沙星凝胶。方法 采用单波长分光光度法及双波长分光光度法分别测定凝胶中氧氟沙星及达克罗宁的含量。以0.1mol·L^-1HCl为溶媒分别于335nm;282nm;302.3nm处测定。结果 氧氟沙星在5-25μg.mL^-1,A=0.027841C＋0.01103其相关系数为0.9999;盐酸达克罗宁在4-20μg.mL^-1,A=0.030653C＋0.00061其相关系数为0.9999。两主药在各自浓度范围内,浓度与吸光度有良好的线性关系。氧氟沙星平均回收率为100.02%,RSD=0.6897%,（n=3）;达克罗宁平均回收率为100.08%,RSD=0.8544%,（n=3）。结论 该方法简便、快速、准确可靠。OBJECTIVE Ofloxacin and dydrochloride gel were prepared by the combination of the drug with 5 % tween-80 as the solubilizing agent and the base composed of CMC-Na. METHODS Ofloxacin and dyclonine hydrochloride in Ofloxacin and dydrochloride gel were determined by single wavelength spectrophotometry and dual wavelength spectrophotometry.The gel was dissolved in hydrochloride （0. 1mol·L^-1） and then determined at the wavelength of 335,282,302.3nm, respectively. RESULTS The absorbance difference and the concentration showed a good linear relationship in 5- 25ug· mL^- 1 for ofloxacin, A = 0. 027841C ＋ 0.01103 （r = 0. 9999）, 4 -20ug· mL^- 1 for dyclonine hydrochloride, A = 0.030653C ＋ 0.00061 （r = 0. 9999） .The mean recoveries of ofloxacin and dyclonine hydrochloride were 100.02 % （RSD = 0. 6897 %, n = 3） and 100.08 % （RSD = 0. 8544 %, n = 3）, respectively. CONCLUSIONS This method is simple, quick and accurate.

关 键 词：氧氟沙星达克罗宁凝胶 氧氟沙星 达克罗宁 单波长分光光度法 双波长分光光度法 

分 类 号：R927.11[医药卫生—药学]