莫西沙星玻璃酸钠滴鼻液的研制.doc

复方莫西沙星滴耳液的制备及质量控制* Preparation and Quality Control of Compound Moxifloxacin Ear Drops. 黄道秋1 祁俊生2 张斌1 汪华蓉1 丁伶1 李柏群1 HUANG Daoqiu DENG Junsheng ZHANG Bin WANG Huarong DING Ling LI Boqun 1重庆三峡中心医院, （中国 404000） Chongqing Three Gorges Central Hospital（China 404000） Junsheng QI Department of Chemistry and Environment Project， Chongqing Three Gorges College（China 404000） Abstract Objective To prepare the compound moxifloxacin ear drops for treating acute otitis media and chronic otitis media and myringitis et al. Methods The compound moxifloxacin ear drops was prepared with mixed solvent of glycerin, alcohol and distilled water; HPLC method was established to determine moxifloxacin hydrochloride and dexamethasone acetate in compound moxifloxacin ear drops simultaneously and the stability of which was investigated. Results The calibration curve for moxifloxacin hydrochloride was linear when the sample size was between 0.3~2.4μg (r=0.9999, n=5) and the average recovery rate was 99.39% (RSD=0.99%). The calibration curve for dexamethasone acetate was linear when the sample size was between 0.03~0.24μg (r=0.9999, n=5) and the average recovery rate was 98.46% (RSD=0.54%). Conclusion The new preparation is rational in formula，simple in quality control and good in stability and has good prospects in development. Key words: moxifloxacin hydrochloride; dexamethasone acetate; ear drops; HPLC 复方莫西沙星滴耳液为我院最近研制的新制剂, 由盐酸莫西沙星、醋酸地塞米松等组成.莫西沙星是第四代新型8-甲氧基喹诺酮类抗菌药, 对G+菌、G-菌、衣原体、支原体及厌氧菌均有良好的抗菌活性，不易产生耐药且毒性较低，是此类药物的必威体育精装版换代产品，目前在我国上市的有莫西沙星片、胶囊及其注射液；地塞米松具有很好的抗炎、抗过敏作用，可减轻炎性渗出，组织水肿和纤维增生，笔者将二者配伍制成复方制剂，临床上可用于治疗急慢性中耳炎、外耳道炎、鼓膜炎等耳道感染性疾病。查新显示，该配方目前国内尚无文献报道。 1材 料 LC-20A高效液相色谱仪（日本岛津），超声波清洗机（宁波新芝生物科技股份有限公司），pHs-3C数字式酸度计（上海理达仪器厂），PYX-DHS隔水式电热恒温培养箱（上海市跃进医疗器械一厂），TG328B电光分析天平（上海精密科学仪器有限公司）。盐酸莫西沙星原料（印度 Hritik Chemical Corporation，批号：MF0341006，含量为98.3%）；醋酸地塞米松（浙江仙琚制药股份有限公司，批号：060701, 含量为99.5%）；盐酸莫西沙星对照品（由含量为99.5%盐酸莫西沙星原料替代，江苏中邦制药有限公司试制，批号：060201）；醋酸地塞米松对照品（中国药品生物制品检定所，批号：100122-200304），其余辅料均为药