目的 建立曲安奈德注射液的溶出度测定方法。方法 采用SHIMSEN Superb Ⅱ C₁₈色谱柱（250 mm×4.6 mm，5 μm），以甲醇–水（21∶19）为流动相，检测波长240 nm，体积流量1.5 mL/min，柱温30 ℃，进样体积20 μL。考察溶出介质、表面活性剂浓度、转速、介质体积对曲安奈德注射液中曲安奈德溶出度的影响。结果 曲安奈德在2.22～88.80 μg/mL线性良好，平均回收率为99.88%，RSD值为0.26%。采用桨法（75 r/min）进行溶出试验，以900 mL含0.05%十二烷基硫酸钠和0.5%羟丙甲纤维素的pH 7.4磷酸盐缓冲液为介质时，可获得理想的曲安奈德注射液溶出曲线。结论 方法操作简便、结果准确，能够有效评价曲安奈德注射液的体外释放行为。

Objective To establish a dissolution method for Triamcinolone Acetonide Injection. Methods A SHIMSEN Superb Ⅱ C₁₈ column (250 mm × 4.6 mm, 5 μ m) was used, with a mobile phase of methanol-water (21∶19), detection wavelength of 240 nm, flow rate of 1.5 mL/min, column temperature of 30 ℃, and injection volume of 20 μL. The effects of dissolution medium, surfactant concentration, rotational speed, and medium volume on the dissolution rate of triamcinolone acetonide in Triamcinolone Acetonide Injection were studied. Results Triamcinolone acetonide showed good linearity within the concentration range of 2.22 — 88.80 μg/mL, with an average recovery rate of 99.88% and an RSD value of 0.26%. The dissolution test was performed using the paddle method (75 r/min), and the ideal dissolution curve of Triamcinolone Acetonide Injection was obtained with 900 mL of pH 7.4 phosphate buffer containing 0.05% SLS and 0.5% HPMC as the medium. Conclusion The method is easy to operate and the results are accurate, which can effectively evaluate the in vitro release behavior of Triamcinolone Acetonide Injection.

R927.2