国产乳酸左氧氟沙星片质量评价

Quality Assessment of Domestic Levofloxacin Lactate Tablets

目的:对浙江省市场上乳酸左氧氟沙星片的质量现状进行评价,初步分析影响产品质量的原因。方法:按省级药品质量风险考核抽验总体要求,采用现行质量标准检验结合探索性研究,对5家企业的49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,49批样品全部符合规定;探索性研究发现制剂中的杂质主要来源于原料药的工艺杂质,其降解产物为杂质E和杂质F;溶出度与制剂的处方有关。结论:乳酸左氧氟沙星片产品质量总体较好,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 levofloxacin lactate tablets,and analyze the factors affecting the product quality. Methods: According to the provincial drug quality risk assessment results,the statutory standard methods and the exploratory research methods were used to analyze 49 batches of samples from five enterprises.Results: The statutory tests showed that the49 batches were all qualified. The exploratory researches showed that all the impurities were mainly from the impurities in the raw materials.The degradation products were impurity E and impurity F. The formula of the tablets had a certain correlation with the dissolution of the preparation. Conclusion: The quality of the tablets can meet the requirements of the existing quality standard,while the current standard still needs to be revised,and enterprises should further improve the formula and preparation technology control.