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目的制备洛索洛芬钠涂膜剂,建立其质量控制方法。方法采用壳聚糖为成膜材料,按药剂学原理制备洛索洛芬钠涂膜剂;采用高效液相色谱法测定洛索洛芬钠含量。结果洛索洛芬钠质量浓度与峰面积的线性范围为10～90μg.mL-1,平均回收率为100.22%,RSD为0.44%。结论洛索洛芬钠涂膜剂制备工艺合理,质量控制方法可行,各项指标均符合《中华人民共和国药典》2005年版涂膜剂项下相关要求。
Objective To prepare loxoprofen sodium coating agent and establish its quality control method. Methods Chitosan was used as film-forming material, and loxoprofen sodium coating agent was prepared according to the principle of pharmacy. The content of loxoprofen sodium was determined by HPLC. Results The linear range of the concentration and peak area of loxoprofen sodium was 10-90 μg.mL-1 with the average recovery of 100.22% and RSD 0.44%. Conclusion Loxoprofen sodium coating agent preparation process is reasonable, quality control methods are feasible, the indicators are in line with the “People’s Republic of China Pharmacopoeia” 2005 version of the coating agent under the relevant requirements.