盐酸米诺环素胶囊的质量评价

Quality evaluation of minocycline hydrochloride capsules

目的对国产盐酸米诺环素胶囊的质量现状进行评价。方法采用法定标准检验与探索性研究相结合,对国家药品计划抽验的159批次样品与调研企业收集样品进行检验与统计分析。结果法定标准检验结果显示159批次盐酸米诺环素胶囊合格率100%。探索性研究建立新的有关物质HPLC测定方法分离效果更好,对产品有关物质质量的评价更全面准确;本品以差向米诺环素为主要杂质,抽验样品中杂质的种类及个数基本相同,但不同内容物性状胶囊的杂质含量存在差异;无复合袋包装的产品更易吸潮及降解;国内外原料为同一晶型;不同内容物性状胶囊的溶出行为存在差异。结论国内盐酸米诺环素胶囊质量总体良好,现行质量标准需进一步修订完善。建议企业对制剂生产工艺进行优化,选用阻隔性能优良的包材,以保证产品质量。

Objective To evaluate the quality status of domestic minocycline hydrochloride capsules. Methods According to the combination of legal standard test and exploratory research, 159 batch samples from national drug plan and samples collected from survey enterprises were tested and analyzed. Results The legal test results showed that the pass rate of 159 batches of tablets was 100%. A new HPLC determination methodology of related substances was established in the exploratory research. The separation was better, and the evaluation of product quality in related substances was more comprehensive and accurate. Exploratory research showed that epiminocycline was the main impurity. The kinds and numbers of impurities from different batches of different manufacturers were roughly the same, but the impurity contents of capsule content which had different properties were different. Products without laminated pouches were easy to absorb moisture and degrade. The crystal types of domestic and foreign APIs were the same;the dissolution behaviors in capsule contents which had different properties were significantly different. Conclusion The quality of domestic minocycline hydrochloride capsules was generally under good control. However, the quality control specification needs to be further improved. An improvement was put forward to promote the quality by preparation optimization and good barrier property packaging materials.