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目的:考察国内氯雷他定制剂与原研药之间溶出行为的差异。方法:通过体外溶出度试验,测定33家企业生产的氯雷他定片或胶囊在4种不同pH的溶出介质中的溶出曲线,用f2相似因子法与原研药进行比较。结果:共绘制105条溶出曲线,与原研药完全相似的企业仅4家,其余样品与原研药的溶出行为不一致。结论:目前国内该品种生产工艺差异较大,溶出行为与原研药存在差异。
Objective: To investigate the differences of dissolution behavior between domestic loratadine and the original drug. Methods: Dissolution curves of loratadine tablets or capsules produced by 33 enterprises in four different pH dissolution media were determined by in vitro dissolution test. The f2 similar factor method was used to compare with the original drug. Results: A total of 105 dissolution curves were drawn. Only 4 enterprises were completely similar to the original drug. The dissolution behavior of the remaining samples was different from that of the original drug. Conclusion: At present, the varieties of the domestic production process vary greatly, dissolution behavior and the original research medicine differences.