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Stability and safety evaluation of Danhong injection with different clinical solvents based on sequential analysis*
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An-jing WANG1, 2, Yue ZHU1, 2, Shi-qing HAN1, Zhu HAN1, Hui ZHUGE1, 2, Xiao-zhuan JIA1, 2, Ying-chao WANG1, 2, Zhen-zhong YANG1, 2, **
Chinese Journal of Pharmaceutical Analysis | 2024, 44(3) : 493 - 500
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Chinese Journal of Pharmaceutical Analysis | 2024, 44(3): 493-500
Safety Monitoring
Stability and safety evaluation of Danhong injection with different clinical solvents based on sequential analysis*
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An-jing WANG1, 2, Yue ZHU1, 2, Shi-qing HAN1, Zhu HAN1, Hui ZHUGE1, 2, Xiao-zhuan JIA1, 2, Ying-chao WANG1, 2, Zhen-zhong YANG1, 2, **
Affiliations
  • 1.College of pharmaceutical sciences,Zhejiang University,Hangzhou 310058,China
  • 2.Innovation Institute for Artificial Intelligence in Medicine of Zhejiang University,Hangzhou 310018,China
Published: 2024-03-31 doi: 10.16155/j.0254-1793.2024.03.15
Outline
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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.

Danhong injection  /  solvent compatibility  /  content determination  /  fingerprint  /  anaphylactoid reaction  /  sequential analysis  /  stability research  /  safety evaluation
An-jing WANG, Yue ZHU, Shi-qing HAN, Zhu HAN, Hui ZHUGE, Xiao-zhuan JIA, Ying-chao WANG, Zhen-zhong YANG. 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
Year 2024 volume 44 Issue 3
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Article Info
doi: 10.16155/j.0254-1793.2024.03.15
  • Receive Date:2023-07-11
  • Online Date:2026-03-13
  • Published:2024-03-31
Article Data
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History
  • Received:2023-07-11
Funding
Affiliations
    1.College of pharmaceutical sciences,Zhejiang University,Hangzhou 310058,China
    2.Innovation Institute for Artificial Intelligence in Medicine of Zhejiang University,Hangzhou 310018,China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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