盐酸雷尼替丁胶囊的质量分析

目的: 评价国内盐酸雷尼替丁胶囊的质量状况。 方法: 通过对盐酸雷尼替丁胶囊的标准化检验和探索性研究考察其质量状况。 结果: 依据现行标准检验, 该产品不合格率很低, 通过有关物质的探索性研究发现虽然USP规定的标准较ChP2005严格, 但国内企业的产品参照USP检验的有关物质均能符合规定。由于USP方法更加严谨科学, 受到干扰的可能性更小, 建议新版药典中有关物质项目参照USP方法修订。 结论: 该品种质量状况总体评价良好, 现行检验标准可行, 但尚有亟待修订之处。

Objective: Evaluate the quality of the Ranitidine Hydrochloride Capsules. Methods: Through the test and the exploratory research to evaluate its quality. Results: Through the test with the original standard ,we found its passing rate is very high. Through the exploratory study for the related substances,we found the standard of USP is more strict, but the products of the domestic enterprise are all complying with USP standard certainly.The USP method is more strict and scientific.We suggest the related substances of ChP2005 to reference USP . Conclusion: The original standards is feasible and the quality is good.