State Key Laboratory on Technologies for Chinese Medicine Pharmaceutical Process Control and Intelligent Manufacture, Jiangsu Kanion Pharmaceutical Co.,Ltd., Nanjing 211100, China.
State Key Laboratory on Technologies for Chinese Medicine Pharmaceutical Process Control and Intelligent Manufacture, Jiangsu Kanion Pharmaceutical Co.,Ltd., Nanjing 211100, China; Nanjing University of Chinese Medicine, China.
J Pharm Biomed Anal. 2024 Nov 15;250:116407. doi: 10.1016/j.jpba.2024.116407. Epub 2024 Aug 8.
Reduning injection (RDN) is a traditional chinese medicine injection widely used in clinical practice. In this study, qualitative and quantitative analysis of RDN were conducted by UPLC-Orbitrap MS/MS simultaneously. Totally 118 compounds were identified and 34 compounds were quantified in RDN. The method with completed method validation proved the high sensitivity and efficiency of the method and it was applied to quantify compounds in RDN. Multivariate statistical analysis method selected 11 key variables that affect the content consistency of RDN. 20 batches with high biological potency were screened by cox-2 enzyme activity assay. Spectrum-effect relationship analysis and multivariate statistical analysis showed that 7 batches were high-quality selected after comprehensive quality evaluation and 9 compounds were key indicators for screening it. This strategy including fingerprint, qualitative analysis and multiple-component quantification could be well applied to modern quality evaluation of RDN, which could be valuable for the further quality control of more other traditional Chinese medicines.
热毒宁注射液（RDN）是一种广泛应用于临床实践的中药注射液。在本研究中，我们采用 UPLC-Orbitrap MS/MS 同时对 RDN 进行了定性和定量分析。共鉴定出 118 种化合物，定量分析了 34 种化合物。经过方法验证的方法证明了该方法的高灵敏度和高效率，并将其应用于 RDN 中化合物的定量分析。多变量统计分析方法选择了 11 个关键变量，这些变量影响 RDN 含量的一致性。通过 cox-2 酶活性测定筛选出 20 批具有高生物活性的批次。谱效关系分析和多变量统计分析表明，经过综合质量评价后，有 7 批被选为高质量批次，其中 9 种化合物是筛选的关键指标。这种包括指纹图谱、定性分析和多组分定量的策略可以很好地应用于 RDN 的现代质量评价，这对于进一步控制更多其他中药的质量具有重要意义。
