醋氯芬酸栓的制备及质量控制

Preparation and Quality Control of Aceclofenac Suppository

目的:制备醋氯芬酸栓并建立其质量控制方法。方法:以醋氯芬酸为主药,半合成脂肪酸甘油酯为基质制备栓剂;采用高效液相色谱法测定其中主药的含量,同时经强光、加速、长期试验考察制剂稳定性。结果:所制制剂为类白色至淡黄色栓,鉴别、检查项均符合相关规定。醋氯芬酸检测浓度的线性范围为5.08～30.48μg·mL-1(r=0.9998),平均回收率为99.3%,日内平均RSD=1.23%,日间平均RSD=1.88%。稳定性试验考察显示各项指标无变化。结论:该制剂制备工艺简单可行,质量稳定可控。

OBJECTIVE： To prepare Aceclofenac suppository and to establish a method for its quality control. METHODS： The suppository was prepared using aceclofenac as main component and semi-synthetic glyceride as matrix. The content of aceclofenac was determined by HPLC and the stability of suppository was investigated by high-light test, accelerated test and long-term test. RESULTS： The preparation was white-like to faint-yellow suppository. The identification of suppository was in line with the standard. The linear range of aceclofenac was 5.08--30.48 μg·mL^-1（r=0.999 8） with an average recovery of 99.3%. The RSD of intra-day and inter-day was 1.23% and 1.88%. The stability test of preparation showed indices of it had no change. CONCLUSION： The preparation technology of suppository is simple and feasible, and its quality is stable and controllable.