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目的:建立洛芬葡锌那敏片的质量标准。方法:采用HPLC法测定洛芬葡锌那敏片中布洛芬和马来酸氯苯那敏的含量及含量均匀度。结果:马来酸氯苯那敏、布洛芬分别在0.42～8.32μg·ml~(-1)(r=0.999 9),30.16～603.20μg·ml~(-1)(r=0.999 9)范围内有良好的线性关系,平均回收率分别为101.8%(RSD=1.0%,n=9),101.6%(RSD=1.1%,n=9)。结论:该方法简便、快速、准确,可以有效地控制药品质量。
OBJECTIVE: To establish the quality standard of Lupofen-zinc Zinan tablets. Methods: HPLC method was used to determine the content and content uniformity of ibuprofen and chlorpheniramine maleate. Results: Chlorphenamine maleate and ibuprofen were significantly higher than those in the control group (P <0.05) The average recoveries were 101.8% (RSD = 1.0%, n = 9) and 101.6% (RSD = 1.1%, n = 9), respectively. Conclusion: The method is simple, rapid and accurate and can effectively control the quality of medicines.