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  

Effects of different light sources on the stability of cinepazide maleate in sodium chloride solution

作　　者：吕凤文 任刘丽 曹曦 李波[1] 宫鹏[1] Lyu Fengwen;Ren Liuli;Cao Xi;Li Bo;Gong Peng(Department of Pharmacy,The First Affiliated Hospital of Anhui Medical University,Third-Level Laboratory of Chinese Medicine and Chemistry,National Administration of Traditional Chinese Medicine,Hefei 230022,Anhui Province,China)

机构地区：[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

出　　处：《中国基层医药》2023年第4期518-522,共5页Chinese Journal of Primary Medicine and Pharmacy

基　　金：安徽省卫生健康委科研项目(AHWJ2021a018)。

摘　　要：目的研究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,从而为规范临床用药避光操作提供理论依据。方法先制定标准曲线并进行方法学考察,再采用临床规定方法配制静脉滴注液,然后使用紫外分光光度仪测定马来酸桂哌齐特注射液在室外光、发光二极管(LED)光、室内光、色温为6500 K(D65)的模拟人工日光和遮光条件下1、2、3、7 h的溶液吸光度,带入已经制得的标准曲线中求出浓度,然后研究其浓度变化情况。结果遮光组作为对照组在7 h内并无分解,而在其余4个实验组中,LED光源组并无明显分解现象,室内组、室外组和D65组在1 h的桂哌齐特的含量与遮光组相比已经开始出现分解(F=44840.44,P<0.001)。在2 h时间点,室外组、D65组与遮光组相比,桂哌齐特含量出现了显著的降低(F=15459.12,P<0.001)。在7 h时间点,室外组[(29.84±0.43)L·mol^(-1)·cm^(-1)]、D65组[(21.01±0.51)L·mol^(-1)·cm^(-1)]与遮光组[(101.65±1.5)L·mol^(-1)·cm^(-1)]相比几乎降解了大部分(F=63106.32,P<0.001)。实验中LED组与遮光组之间,桂哌齐特的含量差异无统计学意义(P>0.05)。结论马来酸桂哌齐特注射液在常用LED光源下稳定,可以不采取避光操作,在室内、室外及D65光源下不稳定,需要采取适宜避光措施。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 6500 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=44840.44,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=15459.12,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=63106.32,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.

关 键 词：马来酸桂哌齐特 氯化钠注射液 药物稳定性 分光光度法 紫外线 光源 药理学 临床 

分 类 号：R942[医药卫生—药剂学]