酮康唑滴眼剂的研制

The preparation of ketoconazole eye drops

目的：扩大酮康唑的临床应用，满足眼科抗霉菌治疗的需要。方法：采用聚山梨酯８０作增溶剂，酸水溶解酮康唑，碱水调高ｐＨ值；无水亚硫酸氢钠作抗氧剂，羟苯乙酯作防腐剂，按照制备滴眼剂的一般方法制备酮康唑滴眼剂。结果：所得制剂很稳定，无刺激性，质量可控，疗效确切（另文报道）。结果：酮康唑可以制成滴眼剂，应用于临床。

OBJECTIVE: To extend clinical application scope of ketoconazole, and satisfy the needs of ophthalmologists with mycotic infection. METHODS: Polysorbate 80 was used as solubilization, acidic water dissolent, basic water pH regulator, anhydrous sodium bisufite stabilizer, and ethylparaben preservative. The eye drops were prepared according to the ordinary method of manufacturing. RESULTS: The eye drops have good stability without stimulation to eye. Its quality can by controlled for good curative effect. CONCLUSION: Ketoconazole could be prepared eye drops for clinical application.