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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: To evaluate the quality of ranitidine hydrochloride capsules in China. Methods: The quality status of Ranitidine Hydrochloride capsules was investigated by standard test and exploratory study. Results: According to the current standard test, the product failure rate is very low. According to the exploratory research of related substances, although the standards prescribed by USP are more stringent than those of ChP2005, the products of domestic enterprises can meet the requirements of the relevant substances examined by USP. Because the USP method is more rigorous and scientific, it is less likely to be disturbed. It is suggested that the related substances in the new Pharmacopoeia should be revised according to the USP method. Conclusion: The overall quality evaluation of this variety is good, and the current testing standards are feasible. However, there are still some problems needing urgent revision.