[关键词]
[摘要]
目的 对不同批次的热毒宁注射液进行质量分析,为其他中药注射剂的品质评价提供参考。方法 收集不同批次的热毒宁注射液,按照国家药品标准YBZ08202005-2009-Z对药品的质量进行分析和统计。结果 根据目前实施的热毒宁注射液质量标准,对不同批次的药品进行分析,结果显示,45批次的热毒宁注射液均符合规定,且质量均一性良好。结论 中药注射剂尤其是复方中药注射剂,应该通过开展严格的品质评价研究,确保质量稳定、均一后方能运用于临床,避免在治疗过程中因质量不达标而影响药效或产生不良反应。
[Key word]
[Abstract]
Objective To analyze the quality of different batches of Reduning Injection which could provide references for the quality of other Chinese materia medica injections. Methods In accordance with the national drug standards YBZ08202005-2009-Z, we analyzed and added up the quality of Reduning Injection by collecting different batches. Results Different batches of Reduning Injection was analyzed according to the current implementation of quality standards. The results showed that 45 batches of Reduning Injection all conform to the provisions. Their quality was relatively uniform. Conclusions Chinese materia medica injections, especially compound Chinese medicine injections, should be strictly quality-monitored before being used in clinic to make sure their quality is stable and uniform, so as to avoid the below-standard quality in the process of treatment, and adverse reactions of patients.
[中图分类号]
[基金项目]