| 毕琳琳,杨 倩,周暄宣,李 骅,赵 航,袁佳妮,王四旺.桂皮醛亚微乳注射剂中桂皮醛的含量测定研究[J].,2018,(5):972-975 |
| 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 |
| 投稿时间：2017-10-10 修订日期：2017-11-17 |
| DOI：10.13241/j.cnki.pmb.2018.05.039 |
| 中文关键词: 桂皮醛亚微乳 桂皮醛 HPLC法 含量测定 |
| 英文关键词: Cinnamaldehyde microemulsion Cinnamaldehyde HPLC Content determination |
| 基金项目:陕西省科技攻关基金项目（2016SF-067） |
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| 中文摘要: |
| 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，5 μm）；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 mL?min-1，柱温为25 ℃，进样量为10 μL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5～100 μg?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（r2=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19.89 μg?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。 |
| 英文摘要: |
| ABSTRACT Objective: To establish the method for determining the content of cinnamaldehyde in the cinnamaldehyde microemul- sion 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 in- jection. Results: The linear range of cinnamaldehyde is 5～100 μg?mL-1. The standard curve equation is Y=1703 X -1996 (r2= 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 ex- periment, 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. |
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