【摘要】 目的:制备盐酸莫西沙星即型凝胶滴眼剂并建立其质量控制方法。方法:以盐酸莫西沙星为主药制备滴眼剂;采用高效液相色谱法测定其中主药含量,并进行家兔刺激性实验。结果:所制制剂为无色或淡黄色澄明液体,检查符合2005年版《中国药典》中的相关规定;盐酸莫西沙星检测浓度的线性范围为0.4~3.2μg.mL-1(r=0.999 4),平均回收率为99.99%(RSD=0.343%);该制剂对家兔眼未见刺激性发生。结论:本制剂制备工艺简便可行,质量稳定可控。更多还原

【Abstract】 OBJECTIVE: To prepare moxifloxacin hydrochloride in-situ gel of eye drops and establish a method for its quality control.METHODS: The eye drops was prepared with moxifloxacin hydrochloride as chief agent,and the content of which was determined by HPLC.The irritation test on rabbit eye was conducted. RESULTS: The prepared eye drops was colorless or yellowish limpid liquid,and the results of its tests were in conformity with the standards of Chinese Pharmacopoeia(2005 Edition).There was a good linear relationship within the concentration range of 0.4～3.2 μg·mL-1(r=0.999 4),and the average recovery rate was 99.99%(RSD=0.343%).The result of irritation test showed that the eye drops had no irritation.CONCLUSION: The preparation technology for the eye drops is simple and feasible and the quality of the preparation is stable and controllable.更多还原