目的 對75批次鹽酸艾司洛爾注射液的質(zhì)量及質(zhì)量標(biāo)準(zhǔn)進(jìn)行評價和分析，為該品種的安全監(jiān)管和質(zhì)量標(biāo)準(zhǔn)完善提供參考。方法 采用法定標(biāo)準(zhǔn)檢驗方法對75批次樣品進(jìn)行檢驗，將檢驗結(jié)果進(jìn)行統(tǒng)計分析，并采用探索性研究方法對有關(guān)物質(zhì)、甲醇量、含量測定、細(xì)菌內(nèi)毒素以及穩(wěn)定性等進(jìn)行考察，建立了該品種的拉曼光譜模型。結(jié)果 法定檢驗結(jié)果顯示，75批鹽酸艾司洛爾注射液中4批不合格，合格率94.7%；探索性研究結(jié)果表明，現(xiàn)行標(biāo)準(zhǔn)在檢驗方法的專屬性和檢驗項目設(shè)置方面尚存在不足，有關(guān)物質(zhì)檢出含量較高的單個雜質(zhì)（雜質(zhì)Ⅰ），部分樣品的甲醇量超出限度。結(jié)論 該品種雖然法定檢驗合格率高，但探索性研究發(fā)現(xiàn)現(xiàn)行標(biāo)準(zhǔn)和產(chǎn)品質(zhì)量均有待于進(jìn)一步提高，同時需加大該品種的監(jiān)管，以減少臨床用藥的風(fēng)險。

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(ImpurityⅠ) 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.