不同剂型克拉霉素口服固体制剂质量比较

摘要：目的 比较不同剂型克拉霉素口服固体制剂的质量，并完善质量标准。方法 采用法定检验方法结合探索性研究 对不同剂型249批次克拉霉素口服固体制剂进行检验。结果 按法定标准检验，249批次样品的合格率为99.6%，不合格项目为 干燥失重。采用新建立的杂质谱分析方法，确证了各杂质的结构；不同生产企业溶出曲线存在较大差异；高温会加速主成分降 解，高湿条件下样品中水分增大。结论 克拉霉素胶囊平均溶出量略低于片和分散片，克拉霉素颗粒的总杂质高于其他剂型。 克拉霉素口服固体制剂总体质量较好；现行质量标准有待提高，建议增/修订有关物质检查方法；统一克拉霉素片、分散片、胶 囊溶出方法；严格控制药品生产、流通、贮藏过程中的温湿度。

Quality comparison of clarithromycin oral solid preparations in different dosage forms

Abstract Objective To compare the quality of clarithromycin oral solid preparations in different dosage forms, and improve the quality standards. Methods 249 batches of samples were tested by the statutory standard methods and the exploratory research methods. Results According to the statutory standards, the qualification rate of 249 batches was 99.6%. The unqualified item was loss on drying. Exploratory research established an impurity spectrum analysis method and confirmed the structures. The dissolution curves of samples from different enterprises were quite different. It was proved that high temperature accelerated the degradation of principal component and the water content in the sample increased under high humidity. Conclusions The average dissolution of clarithromycin capsules was slightly lower than that of tablets and dispersed tablets. The total amount of the related substancesof clarithromycin granules were higher than those of other dosage forms. The quality of clarithromycin oral solid preparations was generally under good control. However, the quality control specification needs to be improved. It was recommended to add or revise the method of the related substances and uniform the dissolution methods of clarithromycin tablets, dispersible tablets and capsules. It was suggested the temperature and humidity in the process of the production, circulation and storage of drugs should be strictly