不同厂家细辛脑注射液的质量分析

Quality analysis of asarone injection from different manufacturers

目的为加强对细辛脑注射液的监管,保障人民的临床用药安全,故对市场现行流通使用的细辛脑注射液进行抽样检测。方法本文依照国家食品药品监督管理总局批准的国家药品标准,考察了本机构抽样的26批次细辛脑注射液的质量状况,完成了该品种性状、鉴别、pH值、颜色、有关物质、装量、可见异物及含量测定的项目评价。结果抽检的26批次细辛脑注射液依标准检测,各项目均符合规定。结论评价该品种整体质量较好,但考察到该品种有见光降解的性质,建议进一步优化生产、使用条件,减少曝光时长,避免杂质生成。

Objective In order to increase the supervision of asarone injection and ensure the safety of clinical use,the samples of asarone injection in circulation in the market were tested.Methods In this paper,according to the national drug standards approved by the State Food and Drug Administration,the quality of 26 batches of asarone injection sampled by the institute was investigated,and the project evaluation of the variety traits,identification,pH value,color,related substances,loading,visible foreign bodies and content determination was completed.Results 26 batches of asarone injection were tested according to the standard,and all items were in conformity with the regulations.Conclusion The overall quality of this variety is good,but the properties of light degradation are observed.It is suggested to further optimize the production and use conditions,reduce the exposure time and avoid the formation of impurities.