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目的对国内市场上克拉霉素缓释片的质量现状进行评价,并初步分析影响产品质量的原因。方法按照国家评价性抽验计划总体要求,采用现行质量标准检验结合探索性研究,对4家企业的54批次样品进行分析,综合评价产品质量及现行质量标准对产品质量的可控性。结果按现行标准检验,54批样品全部符合规定;探索性研究发现制剂中杂质的基本来源于原料药中的工艺杂质,其降解杂质I的含量受制剂处方工艺的影响;克拉霉素缓释片的释放度与制剂的处方及骨架材料的均匀性有关。结论该药品的产品质量总体较好,但现行药品标准仍需修订;而企业在处方及工艺控制方面仍有改进空间。
Objective To evaluate the quality status of clarithromycin sustained-release tablets in the domestic market and to analyze the reasons that affect product quality. Methods According to the general requirements of the national appraisal sampling plan, the current quality standard test combined with exploratory research was used to analyze 54 batches of samples of 4 enterprises to evaluate the product quality and the controllability of the current quality standards on product quality. The results were tested according to the current standards and all 54 batches of samples were in compliance with the regulations. The exploratory study found that the impurities in the preparation originated from the process impurities in the drug substance. The content of degraded impurity I was affected by the formulation process. The clarithromycin sustained- The degree of release is related to the formulation of the formulation and the uniformity of the matrix material. Conclusion The product quality of the drug is generally good, but the current drug standards still need to be revised; and the company still has room for improvement in prescription and process control.