Effects of different light sources on the stability of cinepazide maleate in sodium chloride solution
10.3760/cma.j.cn341190-20220511-00386
- VernacularTitle:不同光源对氯化钠注射液中马来酸桂哌齐特稳定性的影响
- Author:
Fengwen LYU
1
;
Liuli REN
;
Xi CAO
;
Bo LI
;
Peng GONG
Author Information
1. 安徽医科大学第一附属医院药剂科 国家中医药管理局中药化学三级实验室，合肥 230022
- Keywords:
Cinepazide maleate;
Sodium chloride;
Drug stability;
Spectrophotometry,ultraviolet;
Light source;
Pharmacology,clinical
- From:
Chinese Journal of Primary Medicine and Pharmacy
2023;30(4):518-522
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To investigate the effects of different light sources on the stability of cinepazide maleate in sodium chloride solution, providing a theoretical basis for standardizing operation for avoiding light in clinical medication.Methods:First, a standard curve was created and methodological studies were conducted. Then, intravenous drip solutions were prepared using clinically prescribed methods. Then, the absorbance of the solution of cinepazide maleate injection under outdoor light, light emitting diode (LED) light, indoor light, artificial sunlight with a color temperature of 6 500 K (D65), and under a shading condition for 1, 2, 3, and 7 hours were brought into the standard curve to obtain the concentrations, and the change of the concentrations was studied.Results:There was no light decomposition phenomenon of cinepazide maleate injection in the shading group (control group) within 7 hours. In the other four experimental groups, there was no obvious light decomposition phenomenon of cinepazide maleate injection in the LED light group. Compared with the shading group, cinepazide maleate injection in the indoor, outdoor, and D65 groups began to exhibit a light decomposition phenomenon at 1 hour ( F = 44 840.44, P < 0.001). At 2 hours, cinepazide maleate content in the outdoor and D65 groups began to decrease significantly compared with the shading group ( F = 15 459.12, P < 0.001). At 7 hours, cinepazide maleate exhibited significantly greater light decomposition in the outdoor group [(29.84 ± 0.43) L·mol -1·cm -1] and D65 group [(21.01 ± 0.51) L·mol -1·cm -1] than the shading group [(101.65 ± 1.5) L·mol -1·cm -1] ( F = 63 106.32, P < 0.001). There was no significant difference in cinepazide maleate content between LED and shading groups ( P > 0.05). Conclusion:Cinepazide maleate injection is stable under the common LED light source and therefore it is not necessary to take lightproof operation. Cinepazide maleate injection is unstable under indoor, outdoor, and D65 light sources, and it is necessary to take lightproof operation.
