Abstract
Stability of traditional Chinese medicine injection (TCMI) is an important issue related with its clinical application. TCMI is composed of multi-components, therefore, when evaluating TCMI stability, several marker compounds cannot represent global components or biological activities of TCMI. Till now, when evaluating TCMI stability, method involving the global components or biological activities has not been reported. In this paper, we established a comprehensive strategy composed of three different methods to evaluate the chemical and biological stability of a typical TCMI, Danhong injection (DHI). UHPLC-TQ/MS was used to analyze the stability of marker compounds (SaA, SaB, RA, DSS, PA, CA, and SG) in DHI, UHPLC-QTOF/MS was used to analyze the stability of global components (MW 80–1000 Da) in DHI, and cell based antioxidant capability assay was used to evaluate the bioactivity of DHI. We applied this strategy to assess the compatible stability of DHI and six infusion solutions (GS, NS, GNS, FI, XI, and DGI), which were commonly used in combination with DHI in clinic. GS was the best infusion solution for DHI, and DGI was the worst one based on marker compounds analysis. Based on global components analysis, XI and DGI were the worst infusion solutions for DHI. And based on bioactivity assay, GS was the best infusion solution for DHI, and XI was the worst one. In conclusion, as evaluated by the established comprehensive strategy, GS was the best infusion solution, however, XI and DGI were the worst infusion solutions for DHI. In the compatibility of DHI and XI or DGI, salvianolic acids in DHI would be degraded, resulting in the reduction of original composition and generation of new components, and leading to the changes of biological activities. This is the essence of instability compatibility of DHI and some infusion solutions. Our study provided references for choosing the reasonable infusion solutions for DHI, which could contribute the improvement of safety and efficacy of DHI. Moreover, the established strategy may be applied for the compatible stability evaluation of other TCMIs.
Highlights
The importance of compatible stability of chemical medicine injections and infusion solutions have been reported in many studies (Binnor et al, 2013; Chen et al, 2015a,b; Myers et al, 2016)
The results showed that the content change of marker compounds was limited in the range of 0.954–1.046 (Figure 3A), and the deviation distance of response of global components was limited in the range of 0.27–0.50 (Figure 3B), which indicated the chemical stability of Danhong injection (DHI) when DHI was exposed at room temperature (25◦C) for 6 h
When DHI was mixed with infusion solutions, if the contents of marker compounds, the responses of global components or antioxidant capability showed significant changes, which must be induced by the compatibility with infusion solutions
Summary
The importance of compatible stability of chemical medicine injections and infusion solutions have been reported in many studies (Binnor et al, 2013; Chen et al, 2015a,b; Myers et al, 2016). As chemical medicine injections generally contain only single active component, the change of single active component can represent the change of injection stability. Using single active component as marker to evaluate compatible stability is suitable for chemical medicine injections. While for TCMI, the chemical components in TCMI are quite complicated, which make it much more difficult to choose appropriate markers to evaluate the stability of TCMI. Evaluation of compatible stability of TCMI and infusion solutions are still based on single or several marker compounds, while the changes of global components, or biological activity are rarely evaluated (Li J. et al, 2014)
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
