紫杉醇液体软胶囊制剂质量控制研究

目的：对紫杉醇液体软胶囊进行质量控制考察。方法：系统考察不同条件下本品的稳定性,条件分别为高温（40℃）、4500lx强光试验考察10d,室温（25℃）试验考察3m。建立一个HPLC法用于稳定性试验中紫杉醇和降解产物的含量测定。色谱条件为：色谱柱Symmetry-C18（3.9mm×250mm,5μm）,以乙腈-水（15∶85）为流动相,流速为1.0ml/min,测定波长227nm。结果：除室温避光条件外,紫杉醇液体软胶囊中紫杉醇含量均有明显下降。建立的HPLC法在0.12～0.6μg时线性方程为Y=（2.83e＋005）X-（3.21e＋004）,r=0.999898,RSD为0.3%。结论：紫杉醇液体软胶囊制剂贮放条件应为室温避光、质量可控。

Study on quality control of docetaxel solution softgel

Objective：To investigate the quality control of docetaxel solution softgel.Methods：Samples of docetaxel were put under different conditions（25℃,40℃and strong light of 4500 lx） to determine the content of docetaxel and its degradation products by HPLC method.HPLC analyses were performed by using symmetry-C18（250 mm×3.9 mm,5μm） and mobile phase composed of water-acetonitrile（85∶15） .The detection wavelength was 227 nm and the flow rate was 1.0 ml/min. Results：The content of docetaxel decreased remarkably under all the experimental conditions,except for 25℃without light. The calibration curve was linear within the range of 0.12～0.6μg with the calibration equation Y=2.83e＋005X-3.21e＋004,r=0.999898,and RSD was 0.3%.Conclusion：After thorough investigation of the storage conditions affecting the stability of solution softgel,it is suggested that docetaxel should be stored at 25℃without light and its quality could be controlled.