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目的:建立复方妥布霉素滴眼液的质量控制方法并对其进行刺激性研究。方法:采用高效液相色谱法测定复方妥布霉素滴眼液中主药的含量。给家兔右眼滴用复方妥布霉素滴眼液,每天5次,连续21 d后观察兔眼结膜、角膜、虹膜的刺激反应并评分。结果:妥布霉素和地塞米松分别在10.00～100.00 mg·L~(-1)(r=0.999 7)和6.25～200.00 mg·L~(-1)(r=0.999 8)范围内呈良好的线性关系,家兔眼刺激的综合平均分值在0～2范围内。结论:该方法简便快速,结果准确可靠,可用于复方妥布霉素滴眼液的定量分析。该滴眼液对家兔眼无明显刺激。
Objective: To establish a quality control method for compound tobramycin eye drops and conduct irritation research. Methods: The content of main drug in compound tobramycin eye drops was determined by high performance liquid chromatography. To the right eye drop rabbit compound tobramycin eye drops, 5 times a day for 21 days after the observation rabbit conjunctiva, cornea, iris stimulation reaction and score. Results: Tobramycin and dexamethasone were in the range of 10.00-100.00 mg · L -1 (r = 0.999 7) and 6.25-200.00 mg · L -1 (r = 0.999 8) respectively Good linear relationship, rabbit eye irritation comprehensive average score in the 0 ~ 2 range. Conclusion: The method is simple and rapid, the results are accurate and reliable, which can be used for the quantitative analysis of compound tobramycin eye drops. The eye drops on the rabbit eye no significant stimulation.