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目的:建立实时监测呋塞米片溶出过程的方法,比较11个不同仿制药厂家与原研药厂家生产的呋塞米片在4种溶出介质中溶出曲线的相似性,评价我国呋塞米片的体外溶出过程。方法:采用光纤药物溶出度实时测定仪监测11个厂家的仿制药与原研药的溶出过程;采用桨法,转速50 r·min~(-1),分别以900 ml pH 1.2盐酸溶液,pH 4.0醋酸盐缓冲液、pH 6.8磷酸盐缓冲液和水为溶出介质,在277 nm波长处测定吸光度,绘制溶出曲线,并采用溶出曲线f2相似因子法考察其相似性。结果:光纤溶出度法的辅料和溶出介质不干扰测定。呋塞米在4.44-26.66μg·ml~(-1)浓度范围内线性关系良好(r=0.9997)。呋塞米的平均回收率为101.26%,RSD%为1.84%(n=9)。11个厂家中只有1个厂家仿制药与原研药的相似度均能达到要求。结论:建立了一个简便、快捷、准确的光纤溶出度实时测定方法,该方法能够有效监测药物的体外溶出过程,为改进药物制剂工艺、监控工艺稳定性、提高药品分析能力提供参考。
OBJECTIVE: To establish a real-time monitoring method for the dissolution of furosemide tablets, and to compare the dissolution profiles of furosemide tablets produced by 11 different generic drug manufacturers with the original drug manufacturers in four dissolution media to evaluate the dissolution rate of furosemide tablets In vitro dissolution process. Methods: The elution process of generic drugs and original drugs of 11 manufacturers was monitored by real-time optical fiber drug dissolution tester. The paddle method was used at the speed of 50 r · min -1 with 900 ml pH 1.2 hydrochloric acid solution and pH 4.0 Acetate buffer, pH 6.8 phosphate buffer solution and water as dissolution medium, the absorbance was measured at 277 nm wavelength, the dissolution curve was drawn, and the similarities were examined by the f2 similar factor method of dissolution curve. Results: The optical fiber dissolution method excipients and dissolution medium do not interfere with the determination. Furosemide had good linearity (r = 0.9997) in the range of 4.44-26.66μg · ml -1. The average recovery of furosemide was 101.26% with RSD% of 1.84% (n = 9). Only one of the 11 manufacturers can meet the requirements for the similarity between the generic drug and the original drug. CONCLUSION: A simple, rapid and accurate method for real-time determination of optical fiber dissolution is established. The method can effectively monitor the in vitro dissolution process of drugs and provide reference for improving the pharmaceutical preparation process, monitoring the process stability and improving the drug analysis ability.