UPLC-UV法应用于丹红注射液多个活性成分的稳定性研究

Study on the stability of multiple bioactive compounds in Danhong injection by UPLC-UV method

关键词:  丹红注射液  超高效液相色谱-紫外法  影响因素  配伍稳定性

Key words:  Danhong injection  UPLC-UV  influencing factors  compatible stability

摘要:

[目的] 考察丹红注射液多个活性成分在高温、强光照射、与不同注射液配伍后的稳定性。[方法] 采用已建立的超高效液相色谱-紫外法(UPLC-UV)检测丹红注射液中16个主要活性成分在60 ℃高温、(4 500±500)lx强光照射,与0.9%氯化钠注射液和5%葡萄糖注射液配伍混合后的含量变化情况。[结果] 丹红注射液5-羟甲基糠醛、酚酸类成分(咖啡酸、原儿茶醛、迷迭香酸、丹酚酸B、A、C等)在高温和强光照射下含量降低;紫草酸在高温下含量增加。丹红注射液与两种不同注射液配伍后,丹酚酸B、A、C迅速下降;在4 h内丹酚酸A随着时间延长不断降低,丹酚酸C随着时间延长不断升高;其他成分基本稳定。[结论] 阐明了影响丹红注射液中多个活性成分稳定性的影响因素,为丹红注射液的储存和临床用药提供了科学依据。

Abstract:

[Objective] To investigate the stability of major constituents in Danhong injection, subjected to different influencing factors or combined with different injections. [Methods] The variation of the content of sixteen compounds were simultaneously determined by ultra-performance liquid chromatography with ultraviolet (UPLC-UV), when Danhong injection was exposed to high temperature (60 ℃) or strong light [(4 500±500) lx], or mixed with 5% glucose injection/0.9% sodium chloride injection at different temperatures in the presence or absence of light. [Results] The contents of 5-hydroxymethylfurfural and phenolic acids (caffeic acid, protocatechuic aldehyde, rosmarinic acid, salvianolic acid B, salvianolic acid A and salvianolic acid C) in Danhong injection had a significant decrease under high temperature or strong light, but the lithospermic acid had an increase of content at 60 ℃。Once combined with 5% glucose injection or 0.9% sodium chloride injection, the content of salvianolic acid B, salvianolic acid A and salvianolic acid C in Danhong injection decreased. Salvianolic acid A and C had significant variation in 4 h. The content of salvianolic acid B was consistent in 4 h. [Conclusion] The manufacturers, distributors and end users should attach great importance to impact of high temperature and strong light on stability of multiple bioactive compounds in Danhong injection during the processing and storage of it.