阿奇霉素滴眼剂的制备及质量控制  

Preparation and Quality Control of Azithormycin Eye Drops

作　　者：刘洋[1,2] 李志[2] 郭新红[2] 唐星[1] 

机构地区：[1]沈阳药科大学药学院,沈阳110016 [2]郑州大学药学院,郑州450001

出　　处：《中国药房》2014年第33期3131-3133,共3页China Pharmacy

摘　　要：目的：制备阿奇霉素滴眼剂并对其质量进行控制。方法：以海藻糖为渗透压调节剂、柠檬酸为助溶剂、氢氧化钠调节pH、尼泊金乙酯为抑菌剂，制备阿奇霉素滴眼剂。采用高效液相色谱法，测定药物含量，初步考察其稳定性和家兔眼部刺激性。结果：制备的阿奇霉素滴眼剂为无色澄明液体，pH为6．7～6．9，渗透压为0．287~0．2960smol／kg，与泪液等渗，鉴别、检查项均符合《中国药典》中的相关规定；阿奇霉素检测质量浓度的线性范围为200～1200gg／ml（r=0．9998），回收率为99．15％～100．4％，RSD为1．047％～1．909％；与0时比较，高温、高湿、强光、加速、长期试验下该制剂检查指标均无明显变化；该制剂对家兔眼部刺激性评分均小于1。结论：该制剂制备工艺简单可行，质量稳定可控，有效期初步预测为2年，对眼无刺激性。OBJECTIVE： To prepare Azithormycin eye drops and control its quality. METHODS： Azithormycin eye drops were prepared using fucose as osmotic pressure regulator, citric acid as latent solvent, sodium hydroxide as pH regulator and ethylpara- ben as bacteriostat. HPLC was used to measure the content of azithormycin. We investigated the stability of the preparation and eye irritation to rabbit eyes. RESULTS： Azithromycin eye drops were colorless and transparent liquid with pH of 6.7-6.9 and osmotic pressure of 0.287-0.296 Osmol/kg; it was isotonic to tear, and the identification and examination items met the requirements of Chinese Pharmacopeia. The linear range of azithromycin were 200-1 200 μg/ml （r=0.999 8） with average recoveries of 99.15%-100.4% （RSD= 1.047%-1.909% ）. No significant changes in indexes were found in high-temperature, high-humidity, accelerated and longterm tests, compared with 0 h; the drops had no irritation to rabbit eyes. CONCLUSIONS： The preparation is simple, feasible in technology and controllable in quality without eye irritation; the period of validity forecast is 2 years preliminarily.

关 键 词：阿奇霉素 滴眼剂 制备 刺激性 稳定性 高效液相色谱法 

分 类 号：R444.1[医药卫生—诊断学] R988.1[医药卫生—临床医学]