复方氯霉素滴鼻液的研制及质量控制

Study on Compound Chloramphenicol Nasal Drops

目的制备复方氯霉素滴鼻液并建立其质量控制方法。方法以溶剂为指标筛选处方;分别用紫外分光光度法、双波长分光光度法、薄层色谱加重量法测定氯霉素、地塞米松磷酸钠和冰片的含量。结果氯霉素质量浓度在5～30mg/L范围内与吸收度线性关系良好,平均回收率为100.4%,RSD=0.10%(n=5);地塞米松磷酸钠在2.06～12.36mg/L范围内与△A线性关系良好,平均回收率为100.2%,RSD=0.08%(n=5);冰片薄层斑点清晰,重现性好,平均回收率为98.77%,RSD=0.48%(n=5)。结论制剂处方合理,质量稳定,质量控制方法可行。

Objective To prepare Compound Chloramphenicol Nasal Drops and to establish the quality control methods. Methods The solution was adopted as the index to screen the prescription. Ultraviolet spectrophotometry, dualwavelength spectrophotometry, thin layer chromatography and gravimetric method were used to determine the content of chloramphenicol, dexamethasone sodium phosphate and borneolum syntheticum. Results Chloramphenicol had a good linear relationship with its concentration in the range of 5- 30 mg/L（ r =0. 999 9） and the average recovery rate was 100.4% （RSD=0. 10% ）; dexamethasone sodium phosphate had a good linear relationship with its concentration in the range of 2.06-12.36 mg/L （r=0.9997） and the average recovery rate was 100.2% （RSD=0.08%）;the spots of TLC were fairly clear, the repeatability was good and the average recovery rate of borneolum syntheticum was 98.77% （RSD =0. 48% ）. Conclusion The prescription of this preparation is reasonable. The quality is stable and its control method is feasible.