盐酸艾司洛尔注射液质量评价

Quality evaluation of Esmolol Hydrochloride Injection

目的对75批次盐酸艾司洛尔注射液的质量及质量标准进行评价和分析,为该品种的安全监管和质量标准完善提供参考。方法采用法定标准检验方法对75批次样品进行检验,将检验结果进行统计分析,并采用探索性研究方法对有关物质、甲醇量、含量测定、细菌内毒素以及稳定性等进行考察,建立了该品种的拉曼光谱模型。结果法定检验结果显示,75批盐酸艾司洛尔注射液中4批不合格,合格率94.7%;探索性研究结果表明,现行标准在检验方法的专属性和检验项目设置方面尚存在不足,有关物质检出含量较高的单个杂质(杂质Ⅰ),部分样品的甲醇量超出限度。结论该品种虽然法定检验合格率高,但探索性研究发现现行标准和产品质量均有待于进一步提高,同时需加大该品种的监管,以减少临床用药的风险。

Objective To evaluate the quality status and analyze the existing problems of 75 batches of Esmolol Hydrochloride injection, so as to provide references for safety supervision and standard improvement of the preparations.Methods Statutory testing methods were used to examine 75 batches of samples, and the results were assessed by statistical analysis, the related substances,determination of methanol, assay, bacterial endotoxin and stability were all investigated in exploratory study, the Raman spectrum model of this preparation was also established.Results The statutory test showed four out of the 75 batches of esmolol hydrochloride injection were unqualified and the pass rate was 94.7%. The exploratory study showed the existing standards were inadequate in the specificity of analytical methods and project settings, and there was a single impurity(Impurity Ⅰ) which had a high content in the related substances of certain products, determination of methanol in some samples exceeded the limit.Conclusion Although the pass rate of the statutory inspection was high, the exploratory study indicated that the qualities of products and the levels of standards still needed to be improved. At the same time, we need to strengthen the supervision to reduce the risk of clinical medication.