复方异烟肼凝胶剂制备及质量控制

目的：制备复方异烟肼凝胶剂并建立质量控制的方法。方法：以异烟肼和盐酸左氧氟沙星为主药，卡泊姆为基质制备凝胶剂。采用高效液相色谱法同时测定异烟肼和盐酸左氧氟沙星的含量并进行稳定性试验。结果：异烟肼和盐酸左氧氟沙星均在2～20μg·ml-1的范围内线性良好（r=0．9998），平均回收率分别为99．51％和99．70％。结论：该制剂制备工艺可行，凝胶性质稳定，质控方法准确、可靠。

Preparation of Compound Isoniazid Gel and Its Quality Control

Objective： To prepare compound isoniazid gel and establish the method of quality control. Method： The gel was prepared by taking isoniazid and levofloxacin as main components and carbopol as material. The contents of the two components in the gel were determined by HPLC. Result： A good linearity were obtained over the range of 2-20/μg.m1-1 （r =0. 999 8） for isoniazid and levo- floxacin. Conclusion： The gel can be prepared feasibly. The property of the gel is stable. The quality of the gel can be controlled easily.