盐酸左旋多巴甲酯眼膏的制备及质量控制

Preparation and Quality Control of L-dopa Methyl Ester Hydrochloride Eye Ointment

目的：制备盐酸左旋多巴甲酯眼膏并建立其质量控制方法。方法：以盐酸左旋多巴甲酯为主药制备眼膏；采用高效液相色谱法测定其中主药的含量。结果：所制制剂为浅黄色软膏，鉴别、检查均符合2005年版《中国药典》中的相关规定；盐酸左旋多巴甲酯进样量的线性范围为1．016-8．128μg（r=0．9999，n=5），平均回收率为100．89%（RSD=1．60％，n=6）。结论：本制剂制备工艺简便可行，质量稳定可控。

OBJECTIVE： To prepare L-dopa methyl ester hydrochloride（LDME） eye ointment and establish a method for its quality control. METHODS： The eye ointment was prepared with LDME as the principal agent, and the content of LDME was determined by HPLC. RESULTS： The preparation was yellowish ointment with its indexes （in test and identification） all in conformity with the related standards stated in China Pharmacopeia （2005 edition）. There was good linearity of LDME over the range of 1.016-8.128μg （r=0.9999, n=5）, and its average recovery was 100.89% （RSD=1.60%, n=6） . CONCLUSION： The method is simple and feasible, and the oualitv of the ointment is,stable and controllable.