温度对注射用红花黄色素与6种溶剂配伍稳定性的影响  

Effect of Temperature on the Compatible Stability of Safflower Yellow for Injection Combined with Six Kinds of Solvents

作　　者：陈虹 杨礼聪 赖芸 刘兴欣 唐燕 韩惟芳 李德勋 CHEN Hong;YANG Licong;LAI Yun;LIU Xingxin;TANG Yan;HAN Weifang;LI Dexun(Zhaotong Hospital of Traditional Chinese Medicine,Zhaotong,Yunnan,China 657000;Zhaotong Institute for Food and Drug Control,Zhaotong,Yunnan,China 657000)

机构地区：[1]云南省昭通市中医医院,云南昭通657000 [2]云南省昭通市食品药品检验所,云南昭通657000

出　　处：《中国药业》2022年第8期61-64,共4页China Pharmaceuticals

基　　金：云南省科技厅计划项目[2017FF116(-050)]。

摘　　要：目的探讨不同温度下注射用红花黄色素分别与6种溶剂配伍后的稳定性。方法采用高效液相色谱法测定样品中羟基红花黄色素A的含量。模拟临床用药浓度,分别将注射用红花黄色素与氯化钠注射液(NS)、5%葡萄糖注射液(GS)、10%GS、葡萄糖氯化钠注射液(GNS)、转化糖注射液及果糖注射液配伍后,分别置常温(10~30℃)、高温(35~37℃)、低温(4~8℃)下,考察8 h内成品输液的外观、pH、不溶性微粒数量。结果羟基红花黄色素A质量浓度在42.825~428.250μg/mL范围内与峰面积线性关系良好(n=6),精密度、重复性试验的RSD均小于2.0%,平均加样回收率为99.64%,RSD为0.79%(n=6)。8 h内,6种成品输液均澄清,呈亮黄色,无肉眼可见异物,不溶性微粒数量均在药典规定范围内(少数特殊情况除外),pH无明显变化(除5%GS为溶剂的成品输液外,其pH在常温、高温、低温条件下的RSD分别为2.25%,3.86%,4.10%);不同温度下,羟基红花黄色素A含量无明显变化(RSD<1%),最低为98.31%。结论3种温度环境下注射用红花黄色素与6种溶剂配伍后8 h内稳定性较好。Objective To investigate the effect of different temperatures on compatible stability of Safflower Yellow for Injection combined with six kinds of solvents respectively.Methods The content of hydroxysafflor yellow A was determined by high-performance liquid chromatography(HPLC).After combining Safflower Yellow for Injection with Sodium Chloride Injection(normal saline,NS),5%Glucose Injection(GS),10%GS,Glucose Sodium Chloride Injection(GNS)and Invert Sugar Injection,Fructose Injection respectively,then they were placed under the normal temperature(10-30℃),the high temperature(35-37℃)and the low temperature(4-8℃).The appearance,pH and the number of insoluble particles of finished infusion within 8 h were investigated.Results The mass concentration of hydroxysafflor yellow A showed a good relationship with the peak area in the range of 42.825-428.250μg/mL(n=6).The RSDs of precision and repeatability tests were less than 2.0%.The average recovery was 99.64% with the RSD of 0.79%(n=6).Six kinds of finished infusion were transparent with bright yellow color and no visible foreign matter,the insoluble particles number of them were in the range of the defined limits of the Chinese Pharmacopoeia(except for a few special cases).The pH of them had no significant change(except for finished infusion with 5% GS as solvent,which the RSDs of pH under the normal temperature,high temperature and low temperature were 2.25%,3.86%,4.10% respectively).The content of hydroxysafflor yellow A had no significant change under different temperatures,while the lowest content was 98.31%.Conclusion The compatibility of Safflower Yellow for Injection combined with six kinds of solvents within 8 h can be stable under three kinds of temperatures.

关 键 词：注射用红花黄色素 温度 高效液相色谱法 配伍稳定性 

分 类 号：R942[医药卫生—药剂学]