桂皮醛亚微乳注射剂中桂皮醛的含量测定研究  

Study on the Determination of Cinnamaldehyde in the Cinnamaldehyde Microemulsion Injection

作　　者：毕琳琳[1] 杨倩[1] 周暄宣[1] 李骅[1] 赵航 袁佳妮[1] 王四旺[1] BI Lin-lin, YANG Qian, ZHOU Xuan-xuan, LI Hua, ZHAO Hang, YUAN Jia-ni, WANG Si-wanga(Department of Natural Medicine, School of Pharmacy, the Fourth Military Medical University, Xi＇an, Shaanxi, 710032, Chin)

机构地区：[1]第四军医大学药学系天然药物学教研室,陕西西安710032

出　　处：《现代生物医学进展》2018年第5期972-975,910,共5页Progress in Modern Biomedicine

基　　金：陕西省科技攻关基金项目(2016SF-067)

摘　　要：目的:建立桂皮醛亚微乳注射剂中桂皮醛含量的测定方法。方法:采用高效液相色谱法,按照固定相为色谱柱Diamonsil C18柱(250 mm×4.6 mm,5μm);流动相为乙腈:0.5%冰乙酸水溶液(60:40),检测波长为288 nm,流速为1.0 m L·min^(-1),柱温为25℃,进样量为10μL的进样条件,测定桂皮醛亚微乳注射剂中桂皮醛的含量。结果:桂皮醛在5~100μg·mL^(-1)浓度范围内呈良好的线性关系,标准曲线方程为Y=1703 X-1996(r^2=0.999,n=6)。在低、中、高三个浓度下,一天内连续3次和连续3天测定样品,测定的RSD值均小于2.0%,精密度良好。加速试验中,在温度30℃,相对湿度60%的条件下放置6个月,样品测定结果与0天相比无变化。本实验中3批桂皮醛亚微乳注射剂中桂皮醛含量的均值为19.89μg·mL^(-1),平均回收率为100.98%,RSD为1.45%。结论:本方法操作简便、快速准确,稳定性高,系统重现性良好可有效控制桂皮醛亚微乳注射剂中有效成分含量。Objective： To establish the method for determining the content of cinnamaldehyde in the cinnamaldehyde microemulsion injection. Methods： Use HPLC method, with stationary phase of Diamonsil C18 column （250 mm× 4.6 mm, 5 μm）, mobile phase of acetonitrile-0.5% aqueous solution of glacial acetic acid （60：40）, detection wavelength of 288 nm, flow rate of 1.0 mL· min^-1, column temperature of 25 ℃, sample quantity of 10 μL, to determine the content of cinnamaldehyde in the cinnamaldehyde microemulsion injection. Results： The linear range of cinnamaldehyde is 5 -100 μg ·mL^-1. The standard curve equation is Y=1703 X -1996 （r^2=- 0.999, n= 6）. Precision is assess by analyzing quality-control samples at low medium and high concentrations in three duplicates a day and in three consecutive days, respectively. The precision （as relative standard deviation, RSD） was less than 2.0%. It shows that the precision is good. The determination results are unchanged to 0 days at a temperature of 30 ℃ and relative humidity of 60% after 6 month. In this experiment, the average contents of cinnamaldehyde are 19.89 μg· mL^-1, the average recovery rate is 100.98 %, and RSD is 1.45 %. Conclusion： The method is simple, accurate, reliable and reproducible, which can control the quality of cinnamaldehyde microemulsion injection effectively.

关 键 词：桂皮醛亚微乳 桂皮醛 HPLC法 含量测定 

分 类 号：R927[医药卫生—药学] R284