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