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左氧氟沙星(levofloxacin)是消旋体氧氟沙星的光学活性S-(-)体,其体外抗菌活性为氧氟沙星的两倍。由于左氧氟沙星具有抗菌谱广,抗菌作用强,毒副作用小等优点,目前临床应用有注射剂,片剂,胶囊剂,滴眼剂等。国外有左氧氟沙星凝胶剂的报道,其疗效优于氧氟沙星、环丙沙星凝胶剂。国内尚未见有关报道,本文介绍左氧氟沙星凝胶剂的处方、制备、质量控制及临床应用等。1 处方及工艺1.1 处方 左氧氟沙星5g,乳酸2.5g,羟苯乙酯0.5g,羧甲基纤维素纳25g,甘油200g,丙二醇50ml,氢氧化钠适量,蒸馏水加至1000g。
Levofloxacin is an optically active S - (-) of ofloxacin in racemic mixture with twice the antibacterial activity of ofloxacin in vitro. As levofloxacin has broad antibacterial spectrum, strong antibacterial activity, toxicity and other advantages, the current clinical application of injections, tablets, capsules, eye drops and so on. Foreign reports of levofloxacin gel, the effect is superior to ofloxacin, ciprofloxacin gel. The domestic has not seen the report, this article describes the formulation, preparation, quality control and clinical application of levofloxacin gel. 1 Prescription and Process 1.1 Prescription Levofloxacin 5g, lactic acid 2.5g, hydroxyethyl ethyl ester 0.5g, carboxymethyl cellulose Na 25g, glycerol 200g, propylene glycol 50ml, sodium hydroxide amount, distilled water added to 1000g.