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目的建立秋水仙碱片的溶出度测定方法,并考察不同厂家产品的体外溶出情况。方法采用小杯法测定溶出度,溶出介质为200mL水,转速为50r·min-1,色谱柱为Luna C8柱(250mm×4.6mm,5μm),流动相为甲醇-水(40:60),流速为1.0mL·min-1,检测波长为254nm;比较不同厂家秋水仙碱片的体外溶出行为。结果秋水仙碱的进样量40～400ng与峰面积呈良好的线性关系(r=0.9999),平均回收率为100.2%(n=9),4个厂家秋水仙碱片的体外溶出行为有较大差异。结论文中方法简便、准确,能区别不同工艺所制秋水仙碱片的体外溶出行为,可用于秋水仙碱片的溶出度测定。
OBJECTIVE To establish a method for the determination of the dissolution of colchicine tablets and investigate the in vitro dissolution of the products from different manufacturers. Methods The dissolution rate was determined by the cuvette method. The dissolution medium was 200 mL water and the rotation speed was 50 r · min-1. The column was Luna C8 column (250 mm × 4.6 mm, 5 μm) with methanol-water (40:60) The flow rate was 1.0 mL · min-1, the detection wavelength was 254 nm. The in vitro dissolution behavior of colchicine tablets from different manufacturers was compared. Results Colchicine had a good linearity (r = 0.9999) between the injection volume of 40 ~ 400 ng and the peak area, with an average recovery of 100.2% (n = 9). The in vitro dissolution behavior of colchicine tablets Big difference. Conclusion The method in this paper is simple and accurate, and can distinguish the dissolution behavior of colchicine tablets from different processes in vitro. It can be used to determine the dissolution of colchicine tablets.