1′-乙酰氧基胡椒酚乙酸酯注射液的稳定性研究及有效期预测  

Stability Study and Shelf Life Prediction of 1′ -Acetoxychavicol Acetate Injection

作　　者：边琳晶[1] 李小芳[1] 高永良[2] 

机构地区：[1]成都中医药大学,成都市610075 [2]军事医学科学院毒物药物研究所,北京市100850

出　　处：《中国药房》2011年第13期1208-1210,共3页China Pharmacy

摘　　要：目的:考察1′-乙酰氧基胡椒酚乙酸酯(ACA)注射液的稳定性,预测其有效期。方法:采用高效液相色谱法测定注射液中ACA含量,考察ACA注射液在高温40℃、光照(4500±500)lx条件下的稳定性,并以经典恒温法得到其分解速率常数K,预测有效期。结果:ACA检测浓度线性范围为5～100μg·mL-(1(r=0.9999,n=5),平均回收率为99.76%,RSD=0.43%。在高温和光照条件下,ACA注射液含量下降,有关物质有所增加。25℃药物分解速率常数K及有效期分别为1.0156×10-5h-1、1.2年。结论:本品对光、热较敏感,高温不利于ACA注射液的稳定,需置于避光阴凉处保存。OBJECTIVE： To study the stability of 1＇-acetuxychavicol acetate （ACA） injection and predict its shelf life. METHODS： The content of ACA injection was determined by HPLC. The stability of ACA injection was investigated under the condition of high temperature of 40℃ and light of （4 500 ± 500） lx. The discomposing velocity constant K was calculated by constant-temperature experiment to predict its shelf life. RESULTS： The linear range of ACA was 5-100μg.mL^-1（r=0.999 9,n=5） with an average recovery of 99.76% （RSD=0.43%）. The content of ACA injection decreased under the condition of high temperature and highlight, while the content of related substance increased. The discomposing velocity constant K and shelf life of ACA injection at 25℃ were 1.015 6×10^-5 h^-1 and 1.2 years, respectively. CONCLUSIONS： ACA injection is susceptible to light and heat. High temperature is disadvantage for the stability of ACA injection. It should be protected from light and stored in cool place.

关 键 词：1’-乙酰氧基胡椒酚乙酸酯注射液 高效液相色谱法 稳定性 经典恒温法 

分 类 号：R927.11[医药卫生—药学] R913