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目的:建立测定安立生坦片体外溶出度的方法,并将安立生坦片仿制与原研药的溶出曲线进行比较。方法:采用高效液相色谱法。色谱柱为Phenomenex Gemini C18,流动相为乙腈-0.02%三氟乙酸水溶液(60∶40,V/V),流速为1.2 ml/min,检测波长为220 nm,柱温为40℃,进样量为100μl。溶出度测定以水、0.1 mol/L盐酸溶液(p H=1.0)、醋酸盐缓冲液(p H=5.0)、磷酸盐缓冲液(p H=6.8)为溶出介质,转速为50 r/min,5~120 min分别取样。结果:安立生坦质量浓度在1.14~6.83μg/ml范围内与峰面积呈良好线性关系(r=0.999 9);精密度、稳定性、重复性试验的RSD均<0.3%;平均回收率为99.38%,RSD为0.50%(n=9);在4种溶出介质中,仿制与原研安立生坦片的溶出曲线相似因子(f2)均>50,酸值(AV)均<15。结论:仿制与原研安立生坦片的体外溶出行为一致。该方法可用于安立生坦片仿制药的一致性评价。
OBJECTIVE: To establish a method for the determination of in vitro dissolution of Andrographolide tablets, and to compare the dissolution profile of Andrographis tablet with that of the original drug. Methods: Using high performance liquid chromatography. The chromatographic column was Phenomenex Gemini C18 with a mobile phase of acetonitrile-0.02% trifluoroacetic acid (60:40, V / V) at a flow rate of 1.2 ml / min and a detection wavelength of 220 nm at a column temperature of 40 ° C. 100 μl. Dissolution was measured with water, 0.1 mol / L hydrochloric acid solution (p H = 1.0), acetate buffer solution (p H = 5.0) and phosphate buffer solution min, 5 ~ 120 min were sampled. Results: The calibration curve was linear in the range of 1.14-6.83μg / ml (r = 0.999 9). The RSDs of precision, stability and repeatability were all less than 0.3%. The average recoveries were 99.38% and RSD of 0.50% (n = 9). The similar dissolution factors (f2) and the acid value (AV) were all found in all four dissolution media. Conclusion: In vitro dissolution behavior of imitation is consistent with that of original Anritsu Tablets. This method can be used to evaluate the consistency of anlisamycin generic drugs.