盐酸莫西沙星即型凝胶滴眼剂的制备及质量控制

Preparation and Quality Control of Moxifloxacin Hydrochloride In-situ Gel of Eye Drops

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=0．9994），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。

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.