舒血宁注射剂中活性成分含量检测及其指纹图谱优化研究

发布者:孙大雨发布时间:2024-01-17浏览次数:10

doi:10.16597/j.cnki.issn.1002-154x.2023.05.006

舒血宁注射剂中活性成分含量检测及其指纹图谱优化研究

罗祥敏1 许成艳1 雷芳2 何珺2∗

(1. 贵州中医药大学时珍学院,贵州 贵阳 550025;2. 贵州大学 药学院,贵州 贵阳 550025)


Determination of Active Compound in Shuxuening Injection and Optimization of its Fingerprint

Luo Xiangmin1 Xu Chengyan1 Lei Fang2 He Jun2∗

(1. Shizhen College of Guizhou University of Traditional Chinese Medicine, Guizhou Guiyang 550025; 2. School of Pharmaceutical Science, Guizhou University, Guizhou Guiyang 550025)


摘要:

舒血宁注射剂是银杏叶提取物制成的灭菌水溶液。 采用高效液相色谱(HPLC)法对舒血宁注射剂进行定性 定量分析,同时在 2020 年版的中国药典基础上利用指纹图谱技术优化舒血宁注射剂的指纹图谱。 结果表明,舒血宁注射剂中含有黄酮、萜内酯、儿茶素、表儿茶素、葛根素、圣草酚、香叶木素、大麦芽碱、芫花素、芝麻素、β-谷甾醇、绿原酸、莽草酸、木犀草素等活性成分,结果显示:6 批次注射用银杏叶提取物中结构明确的活性成分含量之和均大于总固体量的 60%;在 2020 年版药典测定银杏叶提取物指纹图谱方法基础上,舒血宁注射剂指纹图谱中定位到了 6 个新化合物,分别是儿茶素、表儿茶素、葛根素、香叶木素、绿原酸及莽草酸。 本研究验证了舒血宁注射剂的组成成分非常复杂。

关键词:高效液相色谱 指纹图谱优化 活性成分 含量检测


Abstract

Shuxuening injection is a solution of Ginkgo biloba extract. The active substances and their contents in Shuxuening injection were determined by high performance liquid chromatography ( HPLC), and the fingerprint of Shuxuening injection was improved on the basis of the Chinese Pharmacopoeia 2020. The results showed Shuxuening injection contained total flavonoids, total terpene lactones, catechins, epicatechin, puerarin, shengcao phenol, vanillin, maltine, genkwarin, sesamin, β-glutosterol, chlorogenic acid, shikimic acid and luteolin. The results showed that the sum of active compounds with clear structure in 6 batches of ginkgo biloba extract for injection was more than 60% of the total solid content; On the basis of the fingerprint method of Ginkgo biloba extract determined in the Pharmacopoeia 2020, six new compounds were identified in the fingerprint of Shuxuening injection, namely catechin, epicatechin, puerarin, vanillin, chlorogenic acid and shikimic acid. This study verified that the components of Shuxuening injection is very complex.

Keywordshigh performance liquid chromatography; fingerprint optimization; active substances; content detection;