Objective: Based on a sequential analysis method of “physicochemical properties-main component content-fingerprint similarity-anaphylactoid reaction”, the stability and safety of Danhong injection with commonly used clinical solvents 0.9% sodium chloride and 5% glucose injections were evaluated. Methods: According to the clinical application, Danhong injection was mixed with 0.9% sodium chloride injection or 5% glucose injection in the ratios of 20 mL: 100 mL, 30 mL: 100 mL, 40 mL: 100 mL and 30 mL: 250 mL, 40 mL: 250 mL, respectively. Then, they were placed at room temperature within 10 h. The properties, osmotic pressure, insoluble particles and pH value in the solutions were observed or measured at different time points. The contents of the main components at different time points were determined. The HPLC and 1H NMR fingerprints at different time points were analyzed by similarity evaluation. The in vitro anaphylactoid reaction assay of RBL-2H3 cell degranulation was used to evaluate the safety of the mixture solutions. Results: The properties, osmotic pressure, insoluble particles and pH value of solutions were stable within 10 h after mixing, and there was no significant difference in the contents of the main components. The HPLC and 1H NMR fingerprints showed good similarity, and the mixture solutions didn't induce obvious degranulation in RBL-2H3 cells. Conclusion: In this study, the comprehensive evaluation from the physical, chemical and biological perspectives showed that in the concentration range of 30 mL: 250-40 mL: 100 mL, Danhong injection combined with 0.9% sodium chloride injection or 5% glucose injection had good stability and safety within 10 h, which provides evidences for the clinical practice.
WANG An-jing, ZHU Yue, HAN Shi-qing, HAN Zhu, ZHUGE Hui, JIA Xiao-zhuan, WANG Ying-chao, YANG Zhen-zhong
. Stability and safety evaluation of Danhong injection with different clinical solvents based on sequential analysis*[J]. Chinese Journal of Pharmaceutical Analysis, 2024
, 44(3)
: 493
-500
.
DOI: 10.16155/j.0254-1793.2024.03.15
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