国产四环素片质量分析

目的综合评价不同企业生产的四环素片的质量。方法采用现行法定标准检验结合探索性研究结果,对市场上24家企业生产的200批四环素片的质量进行系统比较,通过对原料药和制剂含量测定、有关物质及水分等项目的考察,结合稳定性试验,分析不同企业产品的质量差异。结果法定标准检验200批四环素片,合格率为100%;探索性研究显示,法定标准中有关物质及水分检查项的缺失,导致质量控制不到位。结论国内四环素片整体质量一般,现行质量标准有待提高。

Quality analysis of domestic tetracycline tables

Objective Objective To evaluate the quality status of tetracycline tables. Methods Using statutory testing methods and combining with the exploratory research to systematically compare the quality of 200 batches of tetracycline tables of 24 production enterprises, based on the components of raw materials and preparation, related substances and water determination, the stability test, and the analysis of different enterprise product quality differences. Results Statutory tests showed the pass rate was 100% for the 200 batches tetracycline tables. Exploratory research showed that the lack of the related substances and water method leaded to poor quality control. Conclusion The overall quality of domestic tetracycline tables is normal, and quality standard needs to be