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 domestic clarithromycin sustained-release tablets,and analyze the factors affecting the product quality.Methods According to the general requirements of national assessment programs,the statutory standard methods and the exploratory research methods were used to analyze 54 batches of drugs from four enterprises.Results The statutory tests showed that the 54 batches of drugs were all qualified.Exploratory researches showed that all impurities were mainly from impurities in raw materials.The degradation of impurity I was affected by the prescription and process.Acidic materials increased the degradation of impurity I.There was a certain correlation between the uniformity of matrix materials and the drug release of clarithromycin sustained-release tablets.The HPLC-RID method was established to detect the content of hydroxypropyl methyl cellulose in the drug and we found that there was a certain coorelation between the content of hydroxypropyl methyl cellulose and the release rate.Conclusion The quality of the drug can meet the requirements of the existing quality standards,but the current drug standards still need revision.Enterprises should improve the prescription and process control.