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目的:建立巴洛沙星眼用原位凝胶剂的制备及质量控制方法。方法:以泊洛沙姆407为基质,卡波姆940为增稠剂,尼泊金乙酯为抑菌剂,氯化钠为渗透压调节剂,制备巴洛沙星眼用原住凝胶剂;采用HPLC法测定含量。结果:巴洛沙星浓度在5.0～50.0μg·ml~(-1)范围内线性关系良好(r=0.999 6),平均回收率为100.6%(RSD=1.41%);家兔眼刺激性实验表明本制剂无刺激性,符合《中国药典》对眼用制剂的质量要求。结论:该制剂处方设计合理,制备方法简便,含量测定方法适用于本品质量控制。
Objective: To establish the method of preparation and quality control of balofloxacin in situ gels. Methods: Poloxamer 407 was used as matrix, Carbomer 940 as thickener and nipagin as bacteriostat, and sodium chloride as osmotic regulator to prepare Balofloxacin ocular native gel Agent; using HPLC method to determine the content. Results: The linearity of balofloxacin was in the range of 5.0-50.0 μg · ml -1 (r = 0.999 6), with an average recovery of 100.6% (RSD = 1.41%); eye irritation in rabbits Show that this preparation is non-irritating, in line with “Chinese Pharmacopoeia” on the quality requirements of ophthalmic preparations. Conclusion: The formulation prescription is reasonable, the preparation method is simple, and the content determination method is suitable for quality control of the product.