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目的制备硫酸庆大霉素凝胶剂并建立其质量控制方法。方法以硫酸庆大霉素为主药,卡波姆为基质制备凝胶剂,采用紫外分光光度法测定硫酸庆大霉素含量并进行稳定性试验。结果制得的凝胶均匀细腻,含量测定方法重复性良好,线性范围为0.02～0.12mg/mL(r=0.9993),回收率为100.23%(RSD=0.52%,n=5)。结论硫酸庆大霉素凝胶剂制备工艺简便可行,制得凝胶符合要求,质量控制方法可靠。
Objective To prepare gentamicin sulfate gel and establish its quality control method. Methods gentamicin sulfate as the main drug, carbopol as matrix gel preparation, the determination of gentamicin sulfate content by UV spectrophotometry and stability test. The results showed that the gel was uniform and fine, and the method of content determination was reproducible. The linear range was 0.02-0.12 mg / mL (r = 0.9993). The recovery was 100.23% (RSD = 0.52%, n = 5). Conclusion The preparation process of gentamicin sulfate gel is simple and feasible. The prepared gels meet the requirements and the quality control method is reliable.