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目的:考察氯氮平片在4种不同pH溶出介质中的溶出行为与参比制剂之间的差异,比较不同厂家药品的内在品质为药品质量控制提供参考。方法:通过体外溶出度试验,测定18家企业生产的46批氯氮平片在4种不同pH的溶出介质中的溶出曲线,用相似因子(f_2)法与参比制剂进行比较。结果:共绘制46条溶出曲线,与参比制剂完全相似的批次仅占4%(一个企业的2个批次),其余样品与参比制剂的溶出行为不一致。结论:目前国内该品种生产工艺差异较大,溶出行为与参比制剂存在差异。生产企业应加强处方工艺的筛选、优化提高改进生产工艺。
OBJECTIVE: To investigate the difference between the dissolution behavior of clozapine tablets in four different pH dissolution media and the reference formulation, and to compare the intrinsic quality of different drugs for the quality control of the drug. Methods: Dissolution curves of 46 batches of clozapine tablets produced by 18 enterprises in four different pH dissolution media were determined by in vitro dissolution test. The similar factors (f_2) were compared with reference preparations. RESULTS: A total of 46 dissolution curves were plotted, accounting for only 4% of batches that were exactly similar to the reference formulation (two batches for a single company), and the dissolution behavior of the remaining samples was inconsistent with that of the reference formulation. Conclusion: At present, there is a big difference in the production technology of this variety between China and other countries. There is difference between the dissolution behavior and the reference preparation. Manufacturers should strengthen the selection of prescription process, optimize and improve the production process.